%0 Journal Article %J J Thorac Cardiovasc Surg %D 2022 %T Importance of high-performing teams in the cardiovascular intensive care unit %A Kennedy-Metz, Lauren R %A Barbeito, Atilio %A Dias, Roger D %A Zenati, Marco A %B J Thorac Cardiovasc Surg %V 163 %P 1096-1104 %8 2022 Mar %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/33931232?dopt=Abstract %R 10.1016/j.jtcvs.2021.02.098 %0 Journal Article %J Ann Surg %D 2022 %T Measuring and Improving Emotional Intelligence in Surgery: A Systematic Review %A Abi-Jaoudé, Joanne G %A Kennedy-Metz, Lauren R %A Dias, Roger D %A Yule, Steven J %A Zenati, Marco A %X OBJECTIVE: Evaluate how emotional intelligence (EI) has been measured among surgeons and to investigate interventions implemented for improving EI. SUMMARY BACKGROUND: EI has relevant applications in surgery given its alignment with nontechnical skills. In recent years, EI has been measured in a surgical context to evaluate its relationship with measures such as surgeon burnout and the surgeon-patient relationship. METHODS: A systematic review was conducted by searching MEDLINE, EMBASE, CINAHL, and PSYCINFO databases using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MeSH terms and keywords included "emotional intelligence," "surgery," and "surgeon." Eligible studies included an EI assessment of surgeons, surgical residents, and/or medical students within a surgical context. RESULTS: The initial search yielded 4627 articles. After duplicate removal, 4435 articles were screened by title and abstract and 49 articles proceeded to a full-text read. Three additional articles were found via hand search. A total of 37 articles were included. Studies varied in surgical specialties, settings, and outcome measurements. Most occurred in general surgery, residency programs, and utilized self-report surveys to estimate EI. Notably, EI improved in all studies utilizing an intervention. CONCLUSIONS: The literature entailing the intersection between EI and surgery is diverse but still limited. Generally, EI has been demonstrated to be beneficial in terms of overall well-being and job satisfaction while also protecting against burnout. EI skills may provide a promising modifiable target to achieve desirable outcomes for both the surgeon and the patient. Future studies may emphasize the relevance of EI in the context of surgical teamwork. %B Ann Surg %V 275 %P e353-e360 %8 2022 02 01 %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/34171871?dopt=Abstract %R 10.1097/SLA.0000000000005022 %0 Journal Article %J Hum Factors %D 2021 %T Analysis of Dynamic Changes in Cognitive Workload During Cardiac Surgery Perfusionists' Interactions With the Cardiopulmonary Bypass Pump %A Kennedy-Metz, Lauren R %A Dias, Roger D %A Srey, Rithy %A Rance, Geoffrey C %A Conboy, Heather M %A Haime, Miguel E %A Quin, Jacquelyn A %A Yule, Steven J %A Zenati, Marco A %X OBJECTIVE: This novel preliminary study sought to capture dynamic changes in heart rate variability (HRV) as a proxy for cognitive workload among perfusionists while operating the cardiopulmonary bypass (CPB) pump during real-life cardiac surgery. BACKGROUND: Estimations of operators' cognitive workload states in naturalistic settings have been derived using noninvasive psychophysiological measures. Effective CPB pump operation by perfusionists is critical in maintaining the patient's homeostasis during open-heart surgery. Investigation into dynamic cognitive workload fluctuations, and their relationship with performance, is lacking in the literature. METHOD: HRV and self-reported cognitive workload were collected from three Board-certified cardiac perfusionists (N = 23 cases). Five HRV components were analyzed in consecutive nonoverlapping 1-min windows from skin incision through sternal closure. Cases were annotated according to predetermined phases: prebypass, three phases during bypass, and postbypass. Values from all 1min time windows within each phase were averaged. RESULTS: Cognitive workload was at its highest during the time between initiating bypass and clamping the aorta (preclamp phase during bypass), and decreased over the course of the bypass period. CONCLUSION: We identified dynamic, temporal fluctuations in HRV among perfusionists during cardiac surgery corresponding to subjective reports of cognitive workload. Not only does cognitive workload differ for perfusionists during bypass compared with pre- and postbypass phases, but differences in HRV were also detected within the three bypass phases. APPLICATION: These preliminary findings suggest the preclamp phase of CPB pump interaction corresponds to higher cognitive workload, which may point to an area warranting further exploration using passive measurement. %B Hum Factors %V 63 %P 757-771 %8 2021 Aug %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/33327770?dopt=Abstract %R 10.1177/0018720820976297 %0 Journal Article %J J Surg Educ %D 2021 %T Analysis of Mirrored Psychophysiological Change of Cardiac Surgery Team Members During Open Surgery %A Kennedy-Metz, Lauren R %A Dias, Roger D %A Stevens, Ronald H %A Yule, Steven J %A Zenati, Marco A %K Cardiac Surgical Procedures %K Humans %K Operating Rooms %K Pilot Projects %K Surgeons %K Workload %X OBJECTIVE: Mirrored psychophysiological change in cognitive workload indices may reflect shared mental models and effective healthcare team dynamics. In this exploratory analysis, we investigated the frequency of mirrored changes, defined as concurrent peaks in heart rate variability (HRV) across team members, during cardiac surgery. DESIGN: Objective cognitive workload was evaluated via HRV collected from the primary surgical team during cardiac surgery cases (N = 15). Root mean square of the successive differences (RMSSD) was calculated as the primary HRV measure. Procedures were divided into consecutive nonoverlapping 5-minute segments, and RMSSD along with deviations from RMSSD were calculated for each segment. Segments with positive deflections represent above-average cognitive workload. Positive deflections and peaks across dyads within the same segment were counted. SETTING: Data collection for this study took place in the cardiovascular operating room during live surgeries. PARTICIPANTS: Physiological data were collected and analyzed from the attending surgeon, attending anesthesiologist, and primary perfusionist involved with the recorded cases. RESULTS: Of the 641 five-minute segments analyzed, 325 (50.7%) were positive deflections above average, concurrently across at least 2 team members. Within the 325 positive deflections, 26 (8%) represented concurrent peaks in HRV across at least 2 active team members. Mirrored peaks across team members were observed most commonly during the coronary anastomoses or valve replacement phase (N = 12). CONCLUSIONS: In this pilot study, mirrored physiological responses representing peaks in cognitive workload were observed uncommonly across dyads of cardiac surgery team members (1.73 peaks/case on average). Almost half of these occurred during the most technically demanding phases of cardiac surgery, which may underpin teamwork quality. Future work should investigate interactions between technical and nontechnical performance surrounding times of mirrored peaks and expand the sample size. %B J Surg Educ %V 78 %P 622-629 %8 2021 Mar-Apr %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/32863172?dopt=Abstract %R 10.1016/j.jsurg.2020.08.012 %0 Journal Article %J JAMA Netw Open %D 2021 %T Characteristics of Randomized Clinical Trials in Surgery From 2008 to 2020: A Systematic Review %A Robinson, N Bryce %A Fremes, Stephen %A Hameed, Irbaz %A Rahouma, Mohamed %A Weidenmann, Viola %A Demetres, Michelle %A Morsi, Mahmoud %A Soletti, Giovanni %A Di Franco, Antonino %A Zenati, Marco A %A Raja, Shahzad G %A Moher, David %A Bakaeen, Faisal %A Chikwe, Joanna %A Bhatt, Deepak L %A Kurlansky, Paul %A Girardi, Leonard N %A Gaudino, Mario %K General Surgery %K Humans %K Randomized Controlled Trials as Topic %K Time Factors %X Importance: Randomized clinical trials (RCTs) provide the highest level of evidence to evaluate 2 or more surgical interventions. Surgical RCTs, however, face unique challenges in design and implementation. Objective: To evaluate the design, conduct, and reporting of contemporary surgical RCTs. Evidence Review: A literature search performed in the 2 journals with the highest impact factor in general medicine as well as 6 key surgical specialties was conducted to identify RCTs published between 2008 and 2020. All RCTs describing a surgical intervention in both experimental and control arms were included. The quality of included data was assessed by establishing an a priori protocol containing all the details to extract. Trial characteristics, fragility index, risk of bias (Cochrane Risk of Bias 2 Tool), pragmatism (Pragmatic Explanatory Continuum Indicator Summary 2 [PRECIS-2]), and reporting bias were assessed. Findings: A total of 388 trials were identified. Of them, 242 (62.4%) were registered; discrepancies with the published protocol were identified in 81 (33.5%). Most trials used superiority design (329 [84.8%]), and intention-to-treat as primary analysis (221 [56.9%]) and were designed to detect a large treatment effect (50.0%; interquartile range [IQR], 24.7%-63.3%). Only 123 trials (31.7%) used major clinical events as the primary outcome. Most trials (303 [78.1%]) did not control for surgeon experience; only 17 trials (4.4%) assessed the quality of the intervention. The median sample size was 122 patients (IQR, 70-245 patients). The median follow-up was 24 months (IQR, 12.0-32.0 months). Most trials (211 [54.4%]) had some concern of bias and 91 (23.5%) had high risk of bias. The mean (SD) PRECIS-2 score was 3.52 (0.65) and increased significantly over the study period. Most trials (212 [54.6%]) reported a neutral result; reporting bias was identified in 109 of 211 (51.7%). The median fragility index was 3.0 (IQR, 1.0-6.0). Multiplicity was detected in 175 trials (45.1%), and only 35 (20.0%) adjusted for multiple comparisons. Conclusions and Relevance: In this systematic review, the size of contemporary surgical trials was small and the focus was on minor clinical events. Trial registration remained suboptimal and discrepancies with the published protocol and reporting bias were frequent. Few trials controlled for surgeon experience or assessed the quality of the intervention. %B JAMA Netw Open %V 4 %P e2114494 %8 2021 06 01 %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/34190996?dopt=Abstract %R 10.1001/jamanetworkopen.2021.14494 %0 Journal Article %J ECCE %D 2021 %T The Cognitive Relevance of a Formal Pre-incision Time-out in Surgery %A Kennedy-Metz, Lauren R %A Dias, Roger D %A Zenati, Marco A %X Surgical time-outs are designed to promote situation awareness, teamwork, and error prevention. The pre-incision time-out in particular aims to facilitate shared mental models prior to incision. Objective, unbiased measures to confirm its effectiveness are lacking. We hypothesized that providers' mental workload would reveal team psychophysiological mirroring during a formal, well-executed pre-incision time-out. Heart rate variability was collected during cardiac surgery cases from the surgeon, anesthesiologist, and perfusionist. Data were analyzed for six cases from patient arrival until sternal closure. Annotation of surgical phases was completed according to previously developed standardized process models of aortic valve replacement and coronary artery bypass graft procedures, producing thirteen total surgical phases. Statistical analysis revealed significant main effects. Tukey HSD post hoc tests revealed significant differences across provider roles within various phases, including Anesthesia Induction, Heparinization, Initiation of Bypass, Aortic Clamp and Cardioplegia, Anastomoses or Aortotomy, Separation from Bypass, and Sternal Closure. Despite these observed differences between providers over various surgical phases, the Pre-incision Time-out phase revealed almost negligible differences across roles. This preliminary work supports the utility of the pre-incision safety checklist to focus the attention of surgical team members and promote shared team mental models, measured via psychophysiological mirroring, using an objective mental workload measure. Future studies should investigate the relationship between psychophysiological mirroring among surgical team members and the effectiveness of the pre-incision time-out checklist. %B ECCE %V 2021 %8 2021 Apr %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/34676380?dopt=Abstract %R 10.1145/3452853.3452867 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2021 %T Commentary: Nontechnical skills redux %A Zenati, Marco A %A Dias, Roger D %A Kennedy-Metz, Lauren R %B J Thorac Cardiovasc Surg %8 2021 Feb 26 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/33773815?dopt=Abstract %R 10.1016/j.jtcvs.2021.02.072 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2021 %T Commentary: The conundrum of cerebral malperfusion in aortic dissection %A Zenati, Marco A %K Aneurysm, Dissecting %K Aortic Aneurysm %K Humans %K Registries %B J Thorac Cardiovasc Surg %V 161 %P 1721 %8 2021 05 %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/31926685?dopt=Abstract %R 10.1016/j.jtcvs.2019.11.103 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2021 %T Commentary: The need for emotional intelligence coaching in cardiothoracic surgery %A Zenati, Marco A %A Megighian, Chiara H %K Emotional Intelligence %K Humans %K Mentoring %B J Thorac Cardiovasc Surg %V 162 %P 1141-1142 %8 2021 10 %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/33160616?dopt=Abstract %R 10.1016/j.jtcvs.2020.06.111 %0 Journal Article %J IEEE Trans Med Robot Bionics %D 2021 %T Computer Vision in the Operating Room: Opportunities and Caveats %A Kennedy-Metz, Lauren R %A Mascagni, Pietro %A Torralba, Antonio %A Dias, Roger D %A Perona, Pietro %A Shah, Julie A %A Padoy, Nicolas %A Zenati, Marco A %X Effectiveness of computer vision techniques has been demonstrated through a number of applications, both within and outside healthcare. The operating room environment specifically is a setting with rich data sources compatible with computational approaches and high potential for direct patient benefit. The aim of this review is to summarize major topics in computer vision for surgical domains. The major capabilities of computer vision are described as an aid to surgical teams to improve performance and contribute to enhanced patient safety. Literature was identified through leading experts in the fields of surgery, computational analysis and modeling in medicine, and computer vision in healthcare. The literature supports the application of computer vision principles to surgery. Potential applications within surgery include operating room vigilance, endoscopic vigilance, and individual and team-wide behavioral analysis. To advance the field, we recommend collecting and publishing carefully annotated datasets. Doing so will enable the surgery community to collectively define well-specified common objectives for automated systems, spur academic research, mobilize industry, and provide benchmarks with which we can track progress. Leveraging computer vision approaches through interdisciplinary collaboration and advanced approaches to data acquisition, modeling, interpretation, and integration promises a powerful impact on patient safety, public health, and financial costs. %B IEEE Trans Med Robot Bionics %V 3 %P 2-10 %8 2021 Feb %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/33644703?dopt=Abstract %R 10.1109/tmrb.2020.3040002 %0 Journal Article %J Ann Surg %D 2021 %T Dissecting Cardiac Surgery: A Video-based Recall Protocol to Elucidate Team Cognitive Processes in the Operating Room %A Dias, Roger D %A Zenati, Marco A %A Conboy, Heather M %A Clarke, Lori A %A Osterweil, Leon J %A Avrunin, George S %A Yule, Steven J %K Adult %K Boston %K Cardiac Surgical Procedures %K Clinical Competence %K Female %K Humans %K Male %K Middle Aged %K Operating Rooms %K Patient Care Team %K Patient Safety %K Role %K Task Performance and Analysis %K Video Recording %X OBJECTIVE: The aim of this study was to elucidate the cognitive processes involved in surgical procedures from the perspective of different team roles (surgeon, anesthesiologist, and perfusionist) and provide a comprehensive compilation of intraoperative cognitive processes. SUMMARY BACKGROUND DATA: Nontechnical skills play a crucial role in surgical team performance and understanding the cognitive processes underlying the intraoperative phase of surgery is essential to improve patient safety in the operating room (OR). METHODS: A mixed-methods approach encompassing semistructured interviews with 9 subject-matter experts. A cognitive task analysis was built upon a hierarchical segmentation of coronary artery bypass grafting procedures and a cued-recall protocol using video vignettes was used. RESULTS: A total of 137 unique surgical cognitive processes were identified, including 33 decision points, 23 critical communications, 43 pitfalls, and 38 strategies. Self-report cognitive workload varied substantially, depending on team role and surgical step. A web-based dashboard was developed, providing an integrated visualization of team cognitive processes in the OR that allows readers to intuitively interact with the study findings. CONCLUSIONS: This study advances the current body of knowledge by making explicit relevant cognitive processes involved during the intraoperative phase of cardiac surgery from the perspective of multiple OR team members. By displaying the research findings in an interactive dashboard, we provide trainees with new knowledge in an innovative fashion that could be used to enhance learning outcomes. In addition, the approach used in the present study can be used to deeply understand the cognitive factors underlying surgical adverse events and errors in the OR. %B Ann Surg %V 274 %P e181-e186 %8 2021 08 01 %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/31348036?dopt=Abstract %R 10.1097/SLA.0000000000003489 %0 Journal Article %J Perfusion %D 2021 %T Fraction of expired oxygen: an additional safety approach to monitor oxygen delivery to the heart lung machine oxygenator %A Srey, Rithy %A Rance, Geoffrey %A Handrahan, John %A Smith, Trevor %A Leissner, Kay B %A Zenati, Marco A %X BACKGROUND: Monitoring oxygen delivery to the oxygenator of a heart lung machine (HLM) is typically accomplished with an O2 analyzer connected to the gas inflow line. It is assumed when the FiO2 is greater than 21% that oxygen is being delivered to the oxygenator. However, this assumption is imperfect because the connection of the inflow line to the oxygenator is downstream from the O2 analyzer. FiO2 monitoring will not alert the perfusionist if the inflow line is not actually connected to the oxygenator. Measuring the fraction of expired oxygen (FEO2) is a more reliable way of monitoring O2 delivery. METHODS: An O2 analyzer was placed on the scavenging line that is attached to the exhaust port of oxygenator (FEO2). RESULTS: Whenever the FiO2 is greater than 21%, and the inflow line is properly connected, the FEO2 exiting the oxygenator is greater than 21%. The FEO2 falls to 21% when the inflow line is not functioning. CONCLUSION: Monitoring the FEO2 is a more reliable way to verify O2 delivery to an oxygenator. An alarm can be set on the FEO2 monitor to alert the perfusionist if the FEO2 falls below a predetermined threshold so any issue with O2 delivery will always be recognized. %B Perfusion %P 2676591211001594 %8 2021 Mar 19 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/33739181?dopt=Abstract %R 10.1177/02676591211001594 %0 Journal Article %J JAMA Netw Open %D 2021 %T Intermediate-Term Outcomes of Endoscopic or Open Vein Harvesting for Coronary Artery Bypass Grafting: The REGROUP Randomized Clinical Trial %A Zenati, Marco A %A Bhatt, Deepak L %A Stock, Eileen M %A Hattler, Brack %A Wagner, Todd H %A Bakaeen, Faisal G %A Biswas, Kousick %K Aged %K Coronary Artery Bypass %K Coronary Artery Disease %K Endoscopy %K Female %K Follow-Up Studies %K Humans %K Male %K Prospective Studies %K Saphenous Vein %K Time Factors %K Tissue and Organ Harvesting %K Treatment Outcome %B JAMA Netw Open %V 4 %P e211439 %8 2021 03 01 %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/33720367?dopt=Abstract %R 10.1001/jamanetworkopen.2021.1439 %0 Journal Article %J Minerva Cardioangiol %D 2020 %T Artificial intelligence in cardiothoracic surgery %A Dias, Roger D %A Shah, Julie A %A Zenati, Marco A %K Artificial Intelligence %K Cardiac Surgical Procedures %K Humans %K Thoracic Surgical Procedures %X The tremendous and rapid technological advances that humans have achieved in the last decade have definitely impacted how surgical tasks are performed in the operating room (OR). As a high-tech work environment, the contemporary OR has incorporated novel computational systems into the clinical workflow, aiming to optimize processes and support the surgical team. Artificial intelligence (AI) is increasingly important for surgical decision making to help address diverse sources of information, such as patient risk factors, anatomy, disease natural history, patient values and cost, and assist surgeons and patients to make better predictions regarding the consequences of surgical decisions. In this review, we discuss the current initiatives that are using AI in cardiothoracic surgery and surgical care in general. We also address the future of AI and how high-tech ORs will leverage human-machine teaming to optimize performance and enhance patient safety. %B Minerva Cardioangiol %V 68 %P 532-538 %8 2020 Oct %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/32989966?dopt=Abstract %R 10.23736/S0026-4725.20.05235-4 %0 Journal Article %J IEEE CogSIMA (2020) %D 2020 %T Autonomic Activity and Surgical Flow Disruptions in Healthcare Providers during Cardiac Surgery %A Kennedy-Metz, Lauren R %A Bizzego, Andrea %A Esposito, Gianluca %A Dias, Roger D %A Zenati, Marco A %A Furlanello, Cesare %X Cardiac surgery represents a complex sociotechnical environment relying on a combination of technical and non-technical team-based expertise. Surgical flow disruptions (SFDs) may be influenced by a variety of sources, including social, environmental, and emotional factors affecting healthcare providers (HCPs). Many of these factors can be readily observed, except for emotional factors (i.e. distress), which represents an underappreciated yet critical source of SFDs. The aim of this study was to demonstrate the sensitivity of autonomic activity metrics to detect an SFD during cardiac surgery. We integrated heart rate variability (HRV) analysis with observation-based annotations to allow data triangulation. Following a critical medication administration error by the anesthesiologist in-training, data sources were consulted to identify events precipitating this near-miss event. Using pyphysio, an open-source physiological signal processing package, we analyzed the attending anesthesiologists' HRV, specifically the low frequency (LF) power, high frequency (HF) power, LF/HF ratio, standard deviation of normal-to-normal (SDNN), and root mean square of the successive differences (RMSSD) as indicators of ANS activity. A heightened SNS response in the attending anesthesiologists' physiological arousal was observed as elevations in LF power and LF/HF ratio, as well as depressions in HF power, SDNN, and RMSSD prior to the near-miss event. The attending anesthesiologist subjectively confirmed a state of high distress induced by task-irrelevant environmental factors during this time. Qualitative analysis of audio/video recordings objectively revealed that the autonomic nervous system (ANS) activation detected was temporally associated with an argument over operating room management. This study confirms that it is possible to recognize detrimental psychophysiological influences in cardiac surgery procedures via advanced HRV analysis. To our knowledge, ours is the first such case demonstrating ANS activity coinciding with strong self-reported emotion during live surgery using HRV. Despite extensive experience in the cardiac OR, transient but intense emotional changes may have the potential to disrupt attention processes in even the most experienced HCP. A primary implication of this work is the possibility to detect real-time ANS activity, which could enable personalized interventions to proactively mitigate downstream adverse events. Additional studies on our large database of surgical cases are underway and new studies are actively being planned to confirm this preliminary observation. %B IEEE CogSIMA (2020) %V 2020 %8 2020 Aug %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/34350424?dopt=Abstract %R 10.1109/cogsima49017.2020.9216076 %0 Journal Article %J Int J Surg Protoc %D 2020 %T Characteristics, results, and reporting of contemporary surgical trials: A systematic review and analysis %A Bryce Robinson, N %A Naik, Ajita %A Hameed, Irbaz %A Ruan, Yongle %A Rahouma, Mohamed %A Weidenmann, Viola %A Zenati, Marco A %A Bhatt, Deepak L %A Girardi, Leonard N %A Kurlansky, Paul %A Raja, Shahzad G %A Moher, David %A Fremes, Stephen %A Chikwe, Joanna %A Gaudino, Mario %X Introduction: The complexities and risks inherent to the field of surgery and surgical interventions present unique challenges to the design and analysis of surgical randomized controlled trials (RCT). Prior studies have investigated the practical and methodologic challenges posed by surgical RCTs. To date, however, a comprehensive analysis of the contemporary literature across multiple surgical subspecialties does not exist. In this descriptive analysis, we set out to characterize surgical RCTs over the past 10 years across six major surgical specialties. Methods and analysis: A literature search by a medical librarian will be performed to identify all surgical randomized clinical trials published between January 2009 and December 2019 in the two journals with the highest impact factor for six surgical specialties as well as two large general medicine journals. Two reviewers will independently screen the citations retrieved from the literature search and extract data according to a previously described protocol via a pre-defined data collection form. Categorical variables will be reported as counts and percentages. Following assessment of normality, continuous variables will be reported as mean (standard deviation) or median (inter-quartile range). Based on normality of data, independent t-test or the Mann-Whitney U test will be used to compare continuous variables and chi-square and Fisher's exact tests to compare categorical variables. Comparisons across multiple sets will be performed using ANOVA or Kruskak-Wallis tests. Two-sided significance testing will be used and a p-value <0.05 will be considered significant without adjustment for multiple testing. All analyses will be performed using SPSS version 24 and R within RStudio. PROSPERO (ID number: 162797). Ethics and dissemination: There are no ethical concerns directly pertinent to this systematic review. The retrieved data will be made available upon request. The study will be written in English and submitted for publication in a peer-reviewed journal. %B Int J Surg Protoc %V 21 %P 1-4 %8 2020 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/32258836?dopt=Abstract %R 10.1016/j.isjp.2020.03.002 %0 Journal Article %J Semin Thorac Cardiovasc Surg %D 2020 %T Cognitive Engineering to Improve Patient Safety and Outcomes in Cardiothoracic Surgery %A Zenati, Marco A %A Kennedy-Metz, Lauren %A Dias, Roger D %K Attitude of Health Personnel %K Cardiac Surgical Procedures %K Clinical Competence %K Cognition %K Cognitive Science %K Ergonomics %K Health Knowledge, Attitudes, Practice %K Humans %K Medical Errors %K Mentalization %K Patient Care Team %K Patient Safety %K Postoperative Complications %K Risk Assessment %K Risk Factors %K Surgeons %K Thoracic Surgical Procedures %K Treatment Outcome %K Workload %X Cognitive engineering is focused on how humans can cope and master the complexity of processes and technological environments. In cardiothoracic surgery, the goal is to support safe and effective human performance by preventing medical errors. Strategies derived from cognitive engineering research could be introduced in cardiothoracic surgery practice in the near future to enhance patient safety and outcomes. %B Semin Thorac Cardiovasc Surg %V 32 %P 1-7 %8 2020 Spring %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/31629782?dopt=Abstract %R 10.1053/j.semtcvs.2019.10.011 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2020 %T Commentary: Another Dutch treat %A Zenati, Marco A %A Yule, Steven J %K Cardiac Surgical Procedures %K Humans %K Postoperative Period %B J Thorac Cardiovasc Surg %V 159 %P 1893-1894 %8 2020 05 %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/31630837?dopt=Abstract %R 10.1016/j.jtcvs.2019.08.123 %0 Journal Article %J IEEE CogSIMA (2020) %D 2020 %T Digital Cognitive Aids to Support Adaptation of Surgical Processes to COVID-19 Protective Policies %A Conboy, Heather M %A Kennedy-Metz, Lauren R %A Avrunin, George S %A Clarke, Lori A %A Osterweil, Leon J %A Dias, Roger D %A Zenati, Marco A %X Surgical processes are rapidly being adapted to address the COVID-19 pandemic, with changes in procedures and responsibilities being made to protect both patients and medical teams. These process changes put new cognitive demands on the medical team and increase the likelihood of miscommunication, lapses in judgment, and medical errors. We describe two process model driven cognitive aids, referred to as the Narrative View and the Smart Checklist View, generated automatically from models of the processes. The immediate perceived utility of these cognitive aids is to support medical simulations, particularly when frequent adaptations are needed to quickly respond to changing operating room guidelines. %B IEEE CogSIMA (2020) %V 2020 %P 205-210 %8 2020 Aug %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/34723287?dopt=Abstract %R 10.1109/cogsima49017.2020.9215995 %0 Journal Article %J J Cardiothorac Vasc Anesth %D 2020 %T Epiaortic Ultrasound for Assessment of Intraluminal Atheroma; Insights from the REGROUP Trial %A Shapeton, Alexander D %A Leissner, Kay B %A Zorca, Suzana M %A Amirfarzan, Houman %A Stock, Eileen M %A Biswas, Kousick %A Haime, Miguel %A Srinivasa, Venkatesh %A Quin, Jacquelyn A %A Zenati, Marco A %K Aorta %K Aortic Diseases %K Coronary Artery Bypass %K Humans %K Plaque, Atherosclerotic %K Prospective Studies %X OBJECTIVES: To assess the use of epiaortic ultrasound in contemporary cardiac surgery, as well as its impact on surgical cannulation strategy and cerebrovascular events. DESIGN: Epiaortic ultrasound data was prospectively collected in the Randomized Endovein Graft Prospective (REGROUP) trial (VA Cooperative Studies Program #588, ClinicalTrials.gov, NCT01850082), which randomized 1,150 coronary artery bypass graft patients between 2014 and 2017 to endoscopic or open-vein graft harvest. SETTING: Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting. PARTICIPANTS: Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment. INTERVENTIONS: Epiaortic ultrasound was performed by the surgeon using a high frequency (>7 MHz) ultrasound transducer. Two-dimensional images of the ascending aorta in multiple planes were acquired before aortic cannulation and cross-clamping. MEASUREMENTS AND MAIN RESULTS: Epiaortic ultrasound was performed in 34.1% (269 of 790) of patients in REGROUP. Among these patients, simple intraluminal atheroma was observed in 21.9% (59 269), and complex intraluminal atheroma comprised 2.2% (6 of 269). The aortic cannulation or cross-clamp strategy was modified based on these findings in 7.1% of cases (19 of 269). There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523). CONCLUSIONS: Despite current guidelines recommending routine use of epiaortic ultrasound (IIa/B) to reduce the risk of stroke in cardiac surgery, in this contemporary trial, use remains infrequent, with significant site-to-site variability. %B J Cardiothorac Vasc Anesth %V 34 %P 726-732 %8 2020 Mar %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/31787434?dopt=Abstract %R 10.1053/j.jvca.2019.10.053 %0 Journal Article %J HCI Int 2020 Late Break Posters (2020) %D 2020 %T Feasibility of Healthcare Providers' Autonomic Activation Recognition in Real-Life Cardiac Surgery Using Noninvasive Sensors %A Kennedy-Metz, Lauren R %A Bizzego, Andrea %A Dias, Roger D %A Furlanello, Cesare %A Esposito, Gianluca %A Zenati, Marco A %X Cardiac surgery is one of the most complex specialties in medicine, akin to a complex sociotechnical system. Patient outcomes are vulnerable to surgical flow disruptions (SFDs), a source of preventable harm. Healthcare providers' (HCPs) sympathetic activation secondary to emotional states represent an underappreciated source of SFDs. This study's objective was to demonstrate the feasibility of detecting elevated sympathetic nervous system (SNS) activity as a proxy for emotional distress associated with a medication error using heart rate variability (HRV) analysis. After obtaining informed consent, audio/video and HRV data were captured intraoperatively during cardiac surgery from multiple HCPs. Following a critical medication administration error by the anesthesiologist in-training, the attending anesthesiologists' recorded HRV data was analyzed using pyphysio, an open-source signal analysis package, to identify events precipitating this near-miss event. We considered elevated low-frequency/high-frequency (LF/HF) HRV ratio (normal value <2) as a primary indicator of SNS activity and emotional distress. A heightened SNS response by the attending anesthesiologist, observed as an LF/HF ratio value of 3.39, was detected prior to the near-miss event. The attending anesthesiologist confirmed a state of significant SNS activity/distress induced by task-irrelevant environmental factors, which led to a temporarily ineffective mental model. Qualitative analysis of audio/video recordings revealed that SNS activation coincided with an argument over operating room management causing SFD. This preliminary study confirms the feasibility of recognizing potentially detrimental psychophysiological states during cardiac surgery in the wild using HRV analysis. To our knowledge, this is the first case demonstrating SNS activation coinciding with self-reported and observable emotional distress during live surgery using HRV. Irrespective of the HCP's expertise, transient but intense emotional changes may disrupt attention processes leading to SFDs and preventable errors. This work supports the possibility to detect real-time SNS activation, which could enable interventions to proactively mitigate errors. Additional studies on our large database of surgical cases are underway to confirm this observation. %B HCI Int 2020 Late Break Posters (2020) %V 1293 %P 402-408 %8 2020 Jul %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/33659965?dopt=Abstract %R 10.1007/978-3-030-60700-5_51 %0 Journal Article %J Circ Cardiovasc Imaging %D 2020 %T Postoperative Echocardiographic Appearance of the Mitral Valve After Nonresectional Leaflet Remodeling Repair Mimicking Thrombus %A Bloom, Jordan P %A Shapeton, Alexander D %A Rasalingam, Ravi %A Zenati, Marco A %K Aged %K Coronary Thrombosis %K Diagnosis, Differential %K Echocardiography %K Humans %K Male %K Mitral Valve Insufficiency %K Tricuspid Valve %B Circ Cardiovasc Imaging %V 13 %P e009853 %8 2020 01 %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/31906701?dopt=Abstract %R 10.1161/CIRCIMAGING.119.009853 %0 Journal Article %J J Am Coll Cardiol %D 2020 %T Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week %A Gaudino, Mario %A Kappetein, A Pieter %A Di Franco, Antonino %A Bagiella, Emilia %A Bhatt, Deepak L %A Boening, Andreas %A Charlson, Mary E %A Flather, Marcus %A Gelijns, Annetine C %A Grover, Frederick %A Head, Stuart J %A Jüni, Peter %A Lamy, Andre %A Miller, Marissa %A Moskowitz, Alan %A Reents, Wilko %A Shroyer, A Laurie %A Taggart, David P %A Tam, Derrick Y %A Zenati, Marco A %A Fremes, Stephen E %K Cardiac Surgical Procedures %K Cost-Benefit Analysis %K Data Interpretation, Statistical %K Humans %K Randomized Controlled Trials as Topic %K Research Design %X Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs. %B J Am Coll Cardiol %V 75 %P 1593-1604 %8 2020 04 07 %G eng %N 13 %1 http://www.ncbi.nlm.nih.gov/pubmed/32241376?dopt=Abstract %R 10.1016/j.jacc.2020.01.048 %0 Journal Article %J Sensors (Basel) %D 2020 %T Sensors for Continuous Monitoring of Surgeon's Cognitive Workload in the Cardiac Operating Room %A Kennedy-Metz, Lauren R %A Dias, Roger D %A Srey, Rithy %A Rance, Geoffrey C %A Furlanello, Cesare %A Zenati, Marco A %K Cognition %K Humans %K Operating Rooms %K Spectroscopy, Near-Infrared %K Surgeons %K Workload %X Monitoring healthcare providers' cognitive workload during surgical procedures can provide insight into the dynamic changes of mental states that may affect patient clinical outcomes. The role of cognitive factors influencing both technical and non-technical skill are increasingly being recognized, especially as the opportunities to unobtrusively collect accurate and sensitive data are improving. Applying sensors to capture these data in a complex real-world setting such as the cardiac surgery operating room, however, is accompanied by myriad social, physical, and procedural constraints. The goal of this study was to investigate the feasibility of overcoming logistical barriers in order to effectively collect multi-modal psychophysiological inputs via heart rate (HR) and near-infrared spectroscopy (NIRS) acquisition in the real-world setting of the operating room. The surgeon was outfitted with HR and NIRS sensors during aortic valve surgery, and validation analysis was performed to detect the influence of intra-operative events on cardiovascular and prefrontal cortex changes. Signals collected were significantly correlated and noted intra-operative events and subjective self-reports coincided with observable correlations among cardiovascular and cerebral activity across surgical phases. The primary novelty and contribution of this work is in demonstrating the feasibility of collecting continuous sensor data from a surgical team member in a real-world setting. %B Sensors (Basel) %V 20 %8 2020 Nov 19 %G eng %N 22 %1 http://www.ncbi.nlm.nih.gov/pubmed/33227967?dopt=Abstract %R 10.3390/s20226616 %0 Journal Article %J Surg Innov %D 2020 %T Surgery Task Load Index in Cardiac Surgery: Measuring Cognitive Load Among Teams %A Kennedy-Metz, Lauren R %A Wolfe, Hill L %A Dias, Roger D %A Yule, Steven J %A Zenati, Marco A %K Cardiac Surgical Procedures %K Cognition %K Humans %K Retrospective Studies %K Surgeons %K Task Performance and Analysis %K Thoracic Surgery %K Workload %X Background. The most commonly used subjective assessment of perceived cognitive load, the NASA Task Load Index (TLX), has proven valuable in measuring individual load among general populations. The surgery task load index (SURG-TLX) was developed and validated to measure cognitive load specifically among individuals within a surgical team. Notably, the TLX lacks temporal sensitivity in its typical retrospective administration. Objective. This study sought to expand the utility of SURG-TLX by investigating individual measures of cognitive load over time during cardiac surgery, and the relationship between individual and team measures of cognitive load and proxies for surgical complexity. Materials & Methods. SURG-TLX was administered retrospectively in the operating room immediately following each case to approximate cognitive load before, during, and after cardiopulmonary bypass for cardiac surgery team members (surgeon, anesthesiologist, and perfusionist). Correlations were calculated to determine the relationship of individual and team measures of cognitive load over the entire procedure with bypass length and surgery length. Results. Results suggest that perceived cognitive load varies throughout the procedure such that cognitive load during bypass significantly differs compared to before or after bypass, across all 3 roles. While on bypass, results show that anesthesiologists experience significantly lower levels of perceived cognitive load than both surgeons and perfusionists. Correlational analyses reveal that perceived cognitive load of both the surgeon and the team had significant positive associations with bypass length and surgery length. Conclusion. Our findings support the utility of SURG-TLX in real cardiac cases as a measure of cognitive load over time, and on an individual and team-wide basis. %B Surg Innov %V 27 %P 602-607 %8 2020 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/32938323?dopt=Abstract %R 10.1177/1553350620934931 %0 Journal Article %J N Engl J Med %D 2019 %T Endoscopic versus Open Vein-Graft Harvesting for CABG. Reply %A Zenati, Marco A %A Bhatt, Deepak L %A Stock, Eileen M %K Coronary Artery Bypass %K Endoscopy %K Tissue and Organ Harvesting %B N Engl J Med %V 380 %P e43 %8 2019 05 30 %G eng %N 22 %1 http://www.ncbi.nlm.nih.gov/pubmed/31141653?dopt=Abstract %R 10.1056/NEJMc1904533 %0 Journal Article %J J Extra Corpor Technol %D 2019 %T Establishing a Ventilator-Heart Lung Machine Communication Bridge to Mitigate Errors when Weaning from Bypass %A Rance, Geoffrey %A Arney, David %A Srey, Rithy %A Goldman, Julian M %A Zenati, Marco A %K Cardiopulmonary Bypass %K Humans %K Vascular Surgical Procedures %K Ventilators, Mechanical %X If a perfusionist weans a patient off the heart lung machine (HLM) and the anesthesiologist has not re-started the ventilator, the patient will become hypoxic. The objective of this project was to create a redundant safety system of verbal and electronic communication to prevent failure to ventilate errors after cardiopulmonary bypass. This objective could be realized by building an electronic communication bridge directly between the HLM and ventilator. A software application was created to retrieve and interpret data from the pump and ventilator and trigger a programmed smart alarm. The software is able to interpret data from the pump and ventilator. When both are off simultaneously (defined as a pump flow of 0 L/min with a respiratory rate of 0 breaths/min), the application will raies an alarm. Communication between a pump and ventilator is possible, enabling the deployment of a safety system that could exist in the operating room (OR) as a standalone alarm. A device dataset can be used to optimize clinical performance of the alarm. The application could also be integrated into smart checklists and computer-assisted OR process models that are currently in development. %B J Extra Corpor Technol %V 51 %P 38-40 %8 2019 Mar %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/30936587?dopt=Abstract %0 Journal Article %J Semin Thorac Cardiovasc Surg %D 2019 %T First Reported Use of Team Cognitive Workload for Root Cause Analysis in Cardiac Surgery %A Zenati, Marco A %A Leissner, Kay B %A Zorca, Suzana %A Kennedy-Metz, Lauren %A Yule, Steven J %A Dias, Roger D %K Administration, Intravenous %K Anesthetists %K Clinical Competence %K Cognition %K Coronary Artery Bypass %K Heart Rate %K Heparin Antagonists %K Humans %K Medication Errors %K Near Miss, Healthcare %K Patient Care Team %K Protamines %K Risk Assessment %K Risk Factors %K Root Cause Analysis %K Workload %X Cognitive workload data of members of the cardiac surgery team can be measured intraoperatively and stored for later analysis. We present a case of a near-miss (medication error) that underwent root cause analysis using workload data. Heart rate variability data, representing workload levels, were collected from the attending surgeon, attending anesthesiologist, and lead perfusionist using wireless heart rate monitors. An episode of cognitive overload of the anesthesiologist due to a distractor was associated with the preventable error. Additional studies are needed to better understand the role of psychophysiological data in enhancing surgical patient safety. %B Semin Thorac Cardiovasc Surg %V 31 %P 394-396 %8 2019 Autumn %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/30578828?dopt=Abstract %R 10.1053/j.semtcvs.2018.12.003 %0 Journal Article %J J Am Coll Cardiol %D 2019 %T The "Fragility" of Mortality Benefit of Coronary Artery Bypass Graft Surgery in Diabetics %A Bangalore, Sripal %A Zenati, Marco A %K Coronary Artery Bypass %K Diabetes Mellitus %K Freedom %K Humans %B J Am Coll Cardiol %V 73 %P 639-642 %8 2019 02 19 %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/30428397?dopt=Abstract %R 10.1016/j.jacc.2018.11.006 %0 Journal Article %J Int J Med Robot %D 2019 %T Organ-mounted robot localization via function approximation %A Wood, Nathan A %A Schwartzman, David %A Passineau, Michael J %A Halbreiner, M Scott %A Moraca, Robert J %A Zenati, Marco A %A Riviere, Cameron N %K Animals %K Robotic Surgical Procedures %K Swine %X BACKGROUND: Organ-mounted robots adhere to the surface of a mobile organ as a platform for minimally invasive interventions, providing passive compensation of physiological motion. This approach is beneficial during surgery on the beating heart. Accurate localization in such applications requires accounting for the heartbeat and respiratory motion. Previous work has described methods for modeling quasi-periodic motion of a point and registering to a static preoperative map. The existing techniques, while accurate, require several respiratory cycles to converge. METHODS: This paper presents a general localization technique for this application, involving function approximation using radial basis function (RBF) interpolation. RESULTS: In an experiment in the porcine model in vivo, the technique yields mean localization accuracy of 1.25 mm with a 95% confidence interval of 0.22 mm. CONCLUSIONS: The RBF approximation provides accurate estimates of robot location instantaneously. %B Int J Med Robot %V 15 %P e1971 %8 2019 Apr %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/30414248?dopt=Abstract %R 10.1002/rcs.1971 %0 Journal Article %J J Biomed Inform %D 2019 %T Physiological synchronization and entropy as measures of team cognitive load %A Dias, Roger D %A Zenati, Marco A %A Stevens, Ronald %A Gabany, Jennifer M %A Yule, Steven J %K Clinical Competence %K Cognition %K Communication %K Coronary Artery Bypass %K Entropy %K Heart Arrest %K Heart-Lung Machine %K Humans %K Ischemia %K Medical Errors %K Monitoring, Ambulatory %K Operating Rooms %K Patient Care Team %K Pilot Projects %K Surgeons %K Task Performance and Analysis %K Tertiary Care Centers %K Video Recording %X The operating room (OR) is a high-risk and complex environment, where multiple specialized professionals work as a team to effectively care for patients in need of surgical interventions. Surgical tasks impose high cognitive demands on OR staff and cognitive overload may have deleterious effects on team performance and patient safety. The aim of the present study was to investigate the feasibility and describe a novel methodological approach to characterize dynamic changes in team cognitive load by measuring synchronization and entropy of heart rate variability parameters during real-life cardiac surgery. Cognitive load was measured by capturing interbeat intervals (IBI) from three team members (surgeon, anesthesiologist and perfusionist) using an unobtrusive wearable heart rate sensor and transmitted in real-time to a smartphone application. Clinical data and operating room audio/video recordings were also collected to provide behavioral and contextual information. We developed symbolic representations of the transient cognitive state of individual team members (Individual Cognitive State - ICS), and overall team (Team Cognitive State - TCS) by comparing IBI data from each team member with themselves and with others. The distribution of TCS symbols during surgery enabled us to display and analyze temporal states and dynamic changes of team cognitive load. Shannon's entropy was calculated to estimate the changing levels of team organization and to detect fluctuations resulting from a variety of cognitive demands and/or specific situations (e.g. medical error, emergency, flow disruptions). An illustrative example from a real cardiac surgery team shows how cognitive load patterns shifted rapidly after an actual near-miss medication event, leading the team to a more organized and synchronized state. The methodological approach described in this study provides a measurement technique for the assessment of team physiological synchronization, which can be applied to many other team-based environments. Future research should gather additional validity evidence to support the proposed methods for team cognitive load measurement. %B J Biomed Inform %V 96 %P 103250 %8 2019 08 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/31295623?dopt=Abstract %R 10.1016/j.jbi.2019.103250 %0 Journal Article %J J Extra Corpor Technol %D 2019 %T A Quick Reference Tool for Goal-Directed Perfusion in Cardiac Surgery %A Srey, Rithy %A Rance, Geoffrey %A Shapeton, Alexander D %A Leissner, Kay B %A Zenati, Marco A %K Cardiac Surgical Procedures %K Cardiopulmonary Bypass %K Goals %K Humans %K Oxygen %K Oxygen Consumption %K Perfusion %X Traditionally, blood flow rates on cardiopulmonary bypass are based primarily on a formula that matches cardiac index to the patient's body surface area (BSA). However, Ranucci and associates in the Goal-Directed Perfusion Trial (GIFT) trial have shown that coupling the BSA with delivery of oxygen (DO2), known as goal-directed perfusion (GDP), may be a safer approach to determine appropriate blood flows. The objective of this study was to create a GDP reference tool that would allow perfusionists to quickly determine the lowest acceptable blood flow needed to provide a patient of any BSA with a satisfactory DO2 without the need for additional dedicated technology. We approached this problem by deriving a formula for flow (L/min), based on BSA, oxygen content of the blood, and a minimum DO2 of 280 mL·min-1m-2. A quick reference GDP chart was created based on the derived formula, requiring only the patient's BSA and hemoglobin level to determine a safe minimum flow rate. The proposed tool allows any cardiac surgery center to adopt the GDP technique, even in the absence of instantaneous DO2 monitoring equipment. %B J Extra Corpor Technol %V 51 %P 172-174 %8 2019 Sep %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/31548741?dopt=Abstract %0 Journal Article %J N Engl J Med %D 2019 %T Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass %A Zenati, Marco A %A Bhatt, Deepak L %A Bakaeen, Faisal G %A Stock, Eileen M %A Biswas, Kousick %A Gaziano, J Michael %A Kelly, Rosemary F %A Tseng, Elaine E %A Bitondo, Jerene %A Quin, Jacquelyn A %A Almassi, G Hossein %A Haime, Miguel %A Hattler, Brack %A DeMatt, Ellen %A Scrymgeour, Alexandra %A Huang, Grant D %K Aged %K Coronary Artery Bypass %K Endoscopy %K Female %K Follow-Up Studies %K Heart Diseases %K Humans %K Male %K Middle Aged %K Myocardial Infarction %K Reoperation %K Saphenous Vein %K Surgical Wound Infection %K Tissue and Organ Harvesting %K Vascular Surgical Procedures %X BACKGROUND: The saphenous-vein graft is the most common conduit for coronary-artery bypass grafting (CABG). The influence of the vein-graft harvesting technique on long-term clinical outcomes has not been well characterized. METHODS: We randomly assigned patients undergoing CABG at 16 Veterans Affairs cardiac surgery centers to either open or endoscopic vein-graft harvesting. The primary outcome was a composite of major adverse cardiac events, including death from any cause, nonfatal myocardial infarction, and repeat revascularization. Leg-wound complications were also evaluated. RESULTS: A total of 1150 patients underwent randomization. Over a median follow-up of 2.78 years, the primary outcome occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group (hazard ratio, 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). A total of 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group died (hazard ratio, 1.25; 95% CI, 0.81 to 1.92); myocardial infarctions occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group (hazard ratio, 1.27; 95% CI, 0.77 to 2.11), and revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group (hazard ratio, 1.14; 95% CI, 0.70 to 1.85). Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group (relative risk, 2.26; 95% CI, 0.99 to 5.15). CONCLUSIONS: Among patients undergoing CABG, we did not find a significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the risk of major adverse cardiac events. (Funded by the Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs; REGROUP ClinicalTrials.gov number, NCT01850082 .). %B N Engl J Med %V 380 %P 132-141 %8 2019 01 10 %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/30417737?dopt=Abstract %R 10.1056/NEJMoa1812390 %0 Journal Article %J Int J Med Robot %D 2018 %T Beating-heart registration for organ-mounted robots %A Wood, Nathan A %A Schwartzman, David %A Passineau, Michael J %A Moraca, Robert J %A Zenati, Marco A %A Riviere, Cameron N %K Algorithms %K Animals %K Cardiac Surgical Procedures %K Cardiac-Gated Imaging Techniques %K Coronary Artery Bypass, Off-Pump %K Humans %K Models, Anatomic %K Models, Animal %K Motion %K Movement %K Myocardial Contraction %K Respiration %K Robotic Surgical Procedures %K Swine %K Tomography, X-Ray Computed %X BACKGROUND: Organ-mounted robots address the problem of beating-heart surgery by adhering to the heart, passively providing a platform that approaches zero relative motion. Because of the quasi-periodic deformation of the heart due to heartbeat and respiration, registration must address not only spatial registration but also temporal registration. METHODS: Motion data were collected in the porcine model in vivo (N = 6). Fourier series models of heart motion were developed. By comparing registrations generated using an iterative closest-point approach at different phases of respiration, the phase corresponding to minimum registration distance is identified. RESULTS: The spatiotemporal registration technique presented here reduces registration error by an average of 4.2 mm over the 6 trials, in comparison with a more simplistic static registration that merely averages out the physiological motion. CONCLUSIONS: An empirical metric for spatiotemporal registration of organ-mounted robots is defined and demonstrated using data from animal models in vivo. %B Int J Med Robot %V 14 %P e1905 %8 2018 Aug %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/29508506?dopt=Abstract %R 10.1002/rcs.1905 %0 Journal Article %J 2018 IEEE Conf Cogn Comput Asp Situat Manag CogSIMA (2018) %D 2018 %T Cognitive Support to Promote Shared Mental Models during Safety-Critical Situations in Cardiac Surgery (Late Breaking Report) %A Tarola, Christopher L %A Hirji, Sameer %A Yule, Steven J %A Gabany, Jennifer M %A Zenati, Alessandro %A Dias, Roger D %A Zenati, Marco A %X To address the, currently unmet, need for intra-operative safety-critical cognitive support in cardiac surgery, we have developed, validated, and implemented a series of customized checklists to address intra-operative emergencies, using a simulated operative setting. These crisis checklists are designed to provide cognitive and communication support to the operative team to reduce the likelihood of adverse events and improve adherence to best-practice guidelines. We recruited a number of content specialists including members of the hospital safety network and intraoperative cardiac surgery team members, and utilized a Delphi consensus method to develop procedure-specific guidelines for select intraoperative crises. Cardiac surgery team members were subsequently trained on utilizing the developed checklists, performed operative simulations, and were surveyed to determine checklist facility and effectiveness. We developed and validated five checklists for the following cardiac surgery crisis scenarios: (a) Cardiopulmonary Bypass Failure; (b) Systemic Air Embolism; (c) Venous Air Lock; (d) Protamine Reaction; Heparin Resistance. Upon initiation of the crisis management, a crew resource management approach was triggered. A member of the operative team was designated as the "reader" for each scenario to guide the team through the process. After training, 89% of operative team members surveyed indicated that they would like the crisis checklist to be used if they had one of these events occurring to them. Crisis management challenges members of the cardiac surgery team in reasoning accurately and according to best practice during periods of high cognitive workload and psychological stress. These crisis checklists were developed, validated, and simulated with the goal of supporting human performance and shared mental models in the clinical setting. %B 2018 IEEE Conf Cogn Comput Asp Situat Manag CogSIMA (2018) %V 2018 %P 165-167 %8 2018 Jun %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/30740198?dopt=Abstract %R 10.1109/COGSIMA.2018.8423991 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2018 %T Cutting off the lizard's tail in surgery %A Zenati, Marco A %A Scarinci, Andrea %K Animals %K Lizards %B J Thorac Cardiovasc Surg %V 156 %P 1220-1221 %8 2018 09 %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/30119285?dopt=Abstract %R 10.1016/j.jtcvs.2018.02.047 %0 Journal Article %J IEEE Int Interdiscip Conf Cogn Methods Situat Aware Decis Support %D 2018 %T Development of an Interactive Dashboard to Analyze Cognitive Workload of Surgical Teams During Complex Procedural Care %A Dias, Roger D %A Conboy, Heather M %A Gabany, Jennifer M %A Clarke, Lori A %A Osterweil, Leon J %A Avrunin, George S %A Arney, David %A Goldman, Julian M %A Riccardi, Giuseppe %A Yule, Steven J %A Zenati, Marco A %X In the surgical setting, team members constantly deal with a high-demand operative environment that requires simultaneously processing a large amount of information. In certain situations, high demands imposed by surgical tasks and other sources may exceed team member's cognitive capacity, leading to cognitive overload which may place patient safety at risk. In the present study, we describe a novel approach to integrate an objective measure of team member's cognitive load with procedural, behavioral and contextual data from real-life cardiac surgeries. We used heart rate variability analysis, capturing data simultaneously from multiple team members (surgeon, anesthesiologist and perfusionist) in a real-time and unobtrusive manner. Using audio-video recordings, behavioral coding and a hierarchical surgical process model, we integrated multiple data sources to create an interactive surgical dashboard, enabling the analysis of the cognitive load imposed by specific steps, substeps and/or tasks. The described approach enables us to detect cognitive load fluctuations over time, under specific conditions (e.g. emergencies, teaching) and in situations that are prone to errors. This in-depth understanding of the relationship between cognitive load, task demands and error occurrence is essential for the development of cognitive support systems to recognize and mitigate errors during complex surgical care in the operating room. %B IEEE Int Interdiscip Conf Cogn Methods Situat Aware Decis Support %V 2018 %P 77-82 %8 2018 06 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/30547096?dopt=Abstract %R 10.1109/COGSIMA.2018.8423995 %0 Journal Article %J OR 2.0 Context Aware Oper Theaters Comput Assist Robot Endosc Clin Image Based Proced Skin Image Anal (2018) %D 2018 %T Intelligent Interruption Management System to Enhance Safety and Performance in Complex Surgical and Robotic Procedures %A Dias, Roger D %A Conboy, Heather M %A Gabany, Jennifer M %A Clarke, Lori A %A Osterweil, Leon J %A Arney, David %A Goldman, Julian M %A Riccardi, Giuseppe %A Avrunin, George S %A Yule, Steven J %A Zenati, Marco A %X Procedural flow disruptions secondary to interruptions play a key role in error occurrence during complex medical procedures, mainly because they increase mental workload among team members, negatively impacting team performance and patient safety. Since certain types of interruptions are unavoidable, and consequently the need for multitasking is inherent to complex procedural care, this field can benefit from an intelligent system capable of identifying in which moment flow interference is appropriate without generating disruptions. In the present study we describe a novel approach for the identification of tasks imposing low cognitive load and tasks that demand high cognitive effort during real-life cardiac surgeries. We used heart rate variability analysis as an objective measure of cognitive load, capturing data in a real-time and unobtrusive manner from multiple team members (surgeon, anesthesiologist and perfusionist) simultaneously. Using audio-video recordings, behavioral coding and a hierarchical surgical process model, we integrated multiple data sources to create an interactive surgical dashboard, enabling the identification of specific steps, substeps and tasks that impose low cognitive load. An interruption management system can use these low demand situations to guide the surgical team in terms of the appropriateness of flow interruptions. The described approach also enables us to detect cognitive load fluctuations over time, under specific conditions (e.g. emergencies) or in situations that are prone to errors. An in-depth understanding of the relationship between cognitive overload states, task demands, and error occurrence will drive the development of cognitive supporting systems that recognize and mitigate errors efficiently and proactively during high complex procedures. %B OR 2.0 Context Aware Oper Theaters Comput Assist Robot Endosc Clin Image Based Proced Skin Image Anal (2018) %V 11041 %P 62-68 %8 2018 Sep %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/30506066?dopt=Abstract %R 10.1007/978-3-030-01201-4_8 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2018 %T Mitral valve surgery in the US Veterans Administration health system: 10-year outcomes and trends %A Bakaeen, Faisal G %A Shroyer, A Laurie %A Zenati, Marco A %A Badhwar, Vinay %A Thourani, Vinod H %A Gammie, James S %A Suri, Rakesh M %A Sabik, Joseph F %A Gillinov, A Marc %A Chu, Danny %A Omer, Shuab %A Hawn, Mary T %A Almassi, G Hossein %A Cornwell, Lorraine D %A Grover, Frederick L %A Rosengart, Todd K %A Graham, Laura %K Aged %K Comorbidity %K Female %K Heart Valve Prosthesis Implantation %K Humans %K Male %K Middle Aged %K Mitral Valve %K Mitral Valve Annuloplasty %K Mitral Valve Insufficiency %K Mortality %K Outcome and Process Assessment, Health Care %K Postoperative Complications %K Quality Improvement %K Risk Factors %K United States %K United States Department of Veterans Affairs %K Veterans %K Veterans Health %X OBJECTIVE: To compare mitral valve repair (MVRepair) and mitral valve replacement (MVReplace) trends in the Veterans Affairs (VA) Surgical Quality Improvement Program. METHODS: Trends were compared by bivariate analyses, followed by backward stepwise selection and multivariable logistic modeling to determine the effect of preoperative comorbidities and facility-level factors on MVRepair (vs MVReplace) rate. A subgroup analysis focused on patients who underwent elective surgery for isolated primary degenerative mitral regurgitation. Propensity matching was done in the overall and primary degenerative cohorts. RESULTS: From October 2000 to October 2013, 4165 veterans underwent MVRepair (n = 2408) or MVReplace (n = 1757) for MV disease of any cause at 40 VA medical centers (procedural volume, 0-29/y; median 7/y). The MVRepair percentage increased from 48% in 2001 to 63% in 2013 (P < .001). MVRepair rates varied widely among centers; center volume explained only 19% of this variation after adjustment for case mix (R2 = 0.19, P = .005). Unadjusted 30-day and 1-year mortality rates were lower after MVRepair than after MVReplace (3.5% vs 4.8%, P = .04; 9.8% vs 12.1%, P = .02). Among the propensity-matched patients (n = 2520), 30-day and 1-year mortality were similar after MVRepair and MVReplace. In the propensity-matched primary degenerative subgroup (n = 664), unadjusted long-term mortality for up to 10 years postoperatively was lower after MVRepair (28% vs 37%, P = .003), as was risk-adjusted long-term mortality (hazard ratio, 0.78; 95% confidence interval, 0.61-1.01). CONCLUSIONS: In the VA Health System, mortality after MV operations is low. Despite the survival advantage associated with MV repair in primary mitral regurgitation, repair is infrequent at some centers, representing an opportunity for quality improvement. %B J Thorac Cardiovasc Surg %V 155 %P 105-117.e5 %8 2018 01 %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/29074046?dopt=Abstract %R 10.1016/j.jtcvs.2017.07.089 %0 Journal Article %J OR 2.0 Context Aware Oper Theaters Comput Assist Robot Endosc Clin Image Based Proced Skin Image Anal (2018) %D 2018 %T A Novel Interoperable Safety System for Improved Coordination and Communication in Cardiac Surgery %A Arney, David %A Rance, Geoffrey %A Rithy, Srey %A Goldman, Julian M %A Zenati, Marco A %X During cardiac surgery there is an unmet need for safe transfer of responsibility for patient oxygenation back and forth from the anesthesia to the perfusion teams. Prior to cardiopulmonary bypass (CPB), lung ventilation is performed by the anesthesia machine ventilator and is the responsibility of the anesthesia team. During CPB, lung ventilation is halted and oxygenation is performed by the CPB oxygenator and perfusion team This recurrent transfer throughout the procedure introduces the rare but serious possibility of a "never event", resulting in the patient's lungs not being ventilated upon stopping the CPB and potentially leading to catastrophic hypoxemia. Monitors and alarms on the anesthesia and bypass machines would not be useful when the other device is operating so they are routinely put into a standby mode until needed. Consequently, in the event that the handoff is missed, there are no alarms to catch the situation. To solve this unmet need, we propose a novel interoperable, context-aware system capable of detecting and acting if this rare situation occurs. Our system is built on the open-source OpenICE framework, allowing it to seamlessly work with a variety of ventilator and bypass machines. %B OR 2.0 Context Aware Oper Theaters Comput Assist Robot Endosc Clin Image Based Proced Skin Image Anal (2018) %V 11041 %P 39-45 %8 2018 Sep %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/30729236?dopt=Abstract %R 10.1007/978-3-030-01201-4_5 %0 Journal Article %J J Am Heart Assoc %D 2018 %T Off-Pump Coronary Artery Bypass Grafting: 30 Years of Debate %A Gaudino, Mario %A Angelini, Gianni D %A Antoniades, Charalambos %A Bakaeen, Faisal %A Benedetto, Umberto %A Calafiore, Antonio M %A Di Franco, Antonino %A Di Mauro, Michele %A Fremes, Stephen E %A Girardi, Leonard N %A Glineur, David %A Grau, Juan %A He, Guo-Wei %A Patrono, Carlo %A Puskas, John D %A Ruel, Marc %A Schwann, Thomas A %A Tam, Derrick Y %A Tatoulis, James %A Tranbaugh, Robert %A Vallely, Michael %A Zenati, Marco A %A Mack, Michael %A Taggart, David P %K Blood Coagulation %K Cardiopulmonary Bypass %K Coronary Artery Bypass %K Coronary Artery Bypass, Off-Pump %K Coronary Artery Disease %K Health Care Costs %K Humans %K Inflammation %K Platelet Activation %K Treatment Outcome %B J Am Heart Assoc %V 7 %P e009934 %8 2018 08 21 %G eng %N 16 %1 http://www.ncbi.nlm.nih.gov/pubmed/30369328?dopt=Abstract %R 10.1161/JAHA.118.009934 %0 Journal Article %J AMIA Annu Symp Proc %D 2018 %T Process Driven Guidance for Complex Surgical Procedures %A Avrunin, George S %A Christov, Stefan C %A Clarke, Lori A %A Conboy, Heather M %A Osterweil, Leon J %A Zenati, Marco A %K Cardiac Surgical Procedures %K checklist %K Communication %K Humans %K Medical Errors %K Medical Records Systems, Computerized %K Models, Organizational %K Operating Rooms %K Surgery, Computer-Assisted %X Surgical team processes are known to be complex and error prone. This paper describes an approach that uses a detailed, validated model of a medical process to provide the clinicians who carry out that complex process with offline and online guidance to help reduce errors. Offline guidance is in the form of a hypertext document describing all the ways the process can be carried out. Online guidance is in the form of a context-sensitive and continually updated electronic "checklist" that lists next steps and needed resources, as well as completed steps. In earlier work, we focused on providing such guidance for single-clinician or single-team processes. This paper describes guiding the collaboration of multiple teams of clinicians through complex processes with significant concurrency, complicated exception handling, and precise and timely communication. We illustrate this approach by applying it to a highly complex, high risk subprocess of cardiac surgery. %B AMIA Annu Symp Proc %V 2018 %P 175-184 %8 2018 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/30815055?dopt=Abstract %0 Journal Article %J J Thorac Cardiovasc Surg %D 2018 %T Real-world revascularization therapy in heart failure: It's a jungle out there! %A Zenati, Marco A %A Bhatt, Deepak L %K Coronary Artery Bypass %K Heart Failure %K Humans %K Percutaneous Coronary Intervention %B J Thorac Cardiovasc Surg %V 156 %P 1422-1423 %8 2018 10 %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/29778338?dopt=Abstract %R 10.1016/j.jtcvs.2018.04.070 %0 Journal Article %J Br J Surg %D 2018 %T Systematic review of measurement tools to assess surgeons' intraoperative cognitive workload %A Dias, R D %A Ngo-Howard, M C %A Boskovski, M T %A Zenati, M A %A Yule, S J %K Clinical Competence %K Cognition %K Humans %K Self Report %K Surgeons %K Workload %X BACKGROUND: Surgeons in the operating theatre deal constantly with high-demand tasks that require simultaneous processing of a large amount of information. In certain situations, high cognitive load occurs, which may impact negatively on a surgeon's performance. This systematic review aims to provide a comprehensive understanding of the different methods used to assess surgeons' cognitive load, and a critique of the reliability and validity of current assessment metrics. METHODS: A search strategy encompassing MEDLINE, Embase, Web of Science, PsycINFO, ACM Digital Library, IEEE Xplore, PROSPERO and the Cochrane database was developed to identify peer-reviewed articles published from inception to November 2016. Quality was assessed by using the Medical Education Research Study Quality Instrument (MERSQI). A summary table was created to describe study design, setting, specialty, participants, cognitive load measures and MERSQI score. RESULTS: Of 391 articles retrieved, 84 met the inclusion criteria, totalling 2053 unique participants. Most studies were carried out in a simulated setting (59 studies, 70 per cent). Sixty studies (71 per cent) used self-reporting methods, of which the NASA Task Load Index (NASA-TLX) was the most commonly applied tool (44 studies, 52 per cent). Heart rate variability analysis was the most used real-time method (11 studies, 13 per cent). CONCLUSION: Self-report instruments are valuable when the aim is to assess the overall cognitive load in different surgical procedures and assess learning curves within competence-based surgical education. When the aim is to assess cognitive load related to specific operative stages, real-time tools should be used, as they allow capture of cognitive load fluctuation. A combination of both subjective and objective methods might provide optimal measurement of surgeons' cognition. %B Br J Surg %V 105 %P 491-501 %8 2018 04 %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/29465749?dopt=Abstract %R 10.1002/bjs.10795 %0 Journal Article %J Softw Eng Healthc Syst SEHS IEEE ACM Int Workshop %D 2018 %T Toward Improving Surgical Outcomes by Incorporating Cognitive Load Measurement into Process-Driven Guidance %A Avrunin, George S %A Clarke, Lori A %A Conboy, Heather M %A Osterweil, Leon J %A Dias, Roger D %A Yule, Steven J %A Goldman, Julian M %A Zenati, Marco A %X This paper summarizes the accomplishments and recent directions of our medical safety project. Our process-based approach uses a detailed, rigorously-defined, and carefully validated process model to provide a dynamically updated, context-aware and thus, "Smart" Checklist to help process performers understand and manage their pending tasks [7]. This paper focuses on support for teams of performers, working independently as well as in close collaboration, in stressful situations that are life critical. Our recent work has three main thrusts: provide effective real-time guidance for closely collaborating teams; develop and evaluate techniques for measuring cognitive load based on biometric observations and human surveys; and, using these measurements plus analysis and discrete event process simulation, predict cognitive load throughout the process model and propose process modifications to help performers better manage high cognitive load situations. This project is a collaboration among software engineers, surgical team members, human factors researchers, and medical equipment instrumentation experts. Experimental prototype capabilities are being built and evaluated based upon process models of two cardiovascular surgery processes, Aortic Valve Replacement (AVR) and Coronary Artery Bypass Grafting (CABG). In this paper we describe our approach for each of the three research thrusts by illustrating our work for heparinization, a common subprocess of both AVR and CABG. Heparinization is a high-risk error-prone procedure that involves complex team interactions and thus highlights the importance of this work for improving patient outcomes. %B Softw Eng Healthc Syst SEHS IEEE ACM Int Workshop %V 2018 %P 2-9 %8 2018 May %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/30140792?dopt=Abstract %R 10.1145/3194696.3194705 %0 Journal Article %J IEEE Int Interdiscip Conf Cogn Methods Situat Aware Decis Support %D 2017 %T Cognitive Support During High-Consequence Episodes of Care in Cardiovascular Surgery %A Conboy, Heather M %A Avrunin, George S %A Clarke, Lori A %A Osterweil, Leon J %A Christov, Stefan C %A Goldman, Julian M %A Yule, Steven J %A Zenati, Marco A %X Despite significant efforts to reduce preventable adverse events in medical processes, such events continue to occur at unacceptable rates. This paper describes a computer science approach that uses formal process modeling to provide situationally aware monitoring and management support to medical professionals performing complex processes. These process models represent both normative and non-normative situations, and are validated by rigorous automated techniques such as model checking and fault tree analysis, in addition to careful review by experts. Context-aware Smart Checklists are then generated from the models, providing cognitive support during high-consequence surgical episodes. The approach is illustrated with a case study in cardiovascular surgery. %B IEEE Int Interdiscip Conf Cogn Methods Situat Aware Decis Support %V 2017 %8 2017 Mar %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/28752132?dopt=Abstract %R 10.1109/COGSIMA.2017.7929610 %0 Journal Article %J Int J Med Robot %D 2017 %T Physiological motion modeling for organ-mounted robots %A Wood, Nathan A %A Schwartzman, David %A Zenati, Marco A %A Riviere, Cameron N %K Algorithms %K Animals %K Equipment Design %K Fourier Analysis %K Heart %K Heart Rate %K Humans %K Imaging, Three-Dimensional %K Internet %K Models, Biological %K Movement %K Respiration %K Robotics %K Rotation %X BACKGROUND: Organ-mounted robots passively compensate heartbeat and respiratory motion. In model-guided procedures, this motion can be a significant source of information that can be used to aid in localization or to add dynamic information to static preoperative maps. METHODS: Models for estimating periodic motion are proposed for both position and orientation. These models are then tested on animal data and optimal orders are identified. Finally, methods for online identification are demonstrated. RESULTS: Models using exponential coordinates and Euler-angle parameterizations are as accurate as models using quaternion representations, yet require a quarter fewer parameters. Models which incorporate more than four cardiac or three respiration harmonics are no more accurate. Finally, online methods estimate model parameters as accurately as offline methods within three respiration cycles. CONCLUSIONS: These methods provide a complete framework for accurately modelling the periodic deformation of points anywhere on the surface of the heart in a closed chest. %B Int J Med Robot %V 13 %8 2017 Dec %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/28211607?dopt=Abstract %R 10.1002/rcs.1805 %0 Journal Article %J JAMA Surg %D 2016 %T Computer-Assisted Process Modeling to Enhance Intraoperative Safety in Cardiac Surgery %A Tarola, Christopher L %A Quin, Jacquelyn A %A Haime, Miguel E %A Gabany, Jennifer M %A Taylor, Kristin B %A Leissner, Kay B %A Zenati, Marco A %K Algorithms %K Cardiac Surgical Procedures %K Feasibility Studies %K Guideline Adherence %K Humans %K Intraoperative Period %K Medical Errors %K Patient Care Team %K Patient Safety %K Pilot Projects %K Process Assessment, Health Care %K Prospective Studies %K Speech Recognition Software %K Surgery, Computer-Assisted %K Workflow %B JAMA Surg %V 151 %P 1183-1186 %8 2016 12 01 %G eng %N 12 %1 http://www.ncbi.nlm.nih.gov/pubmed/27706489?dopt=Abstract %R 10.1001/jamasurg.2016.2839 %0 Journal Article %J Ann Thorac Surg %D 2016 %T Design of a Coupled Thermoresponsive Hydrogel and Robotic System for Postinfarct Biomaterial Injection Therapy %A Zhu, Yang %A Wood, Nathan A %A Fok, Kevin %A Yoshizumi, Tomo %A Park, Dae Woo %A Jiang, Hongbin %A Schwartzman, David S %A Zenati, Marco A %A Uchibori, Takafumi %A Wagner, William R %A Riviere, Cameron N %K Animals %K Biocompatible Materials %K Hydrogel, Polyethylene Glycol Dimethacrylate %K Injections %K Myocardial Infarction %K Pyrrolidinones %K Robotics %K Swine %K Ventricular Remodeling %X BACKGROUND: In preclinical testing, ventricular wall injection of hydrogels has been shown to be effective in modulating ventricular remodeling and preserving cardiac function. For some approaches, early-stage clinical trials are under way. The hydrogel delivery method varies, with minimally invasive approaches being preferred. Endocardial injections carry a risk of hydrogel regurgitation into the circulation, and precise injection patterning is a challenge. An epicardial approach with a thermally gelling hydrogel through the subxiphoid pathway overcomes these disadvantages. METHODS: A relatively stiff, thermally responsive, injectable hydrogel based on N-isopropylacrylamide and N-vinylpyrrolidone (VP gel) was synthesized and characterized. VP gel thermal behavior was tuned to couple with a transepicardial injection robot, incorporating a cooling feature to achieve injectability. Ventricular wall injections of the optimized VP gel have been performed ex vivo and on beating porcine hearts. RESULTS: Thermal transition temperature, viscosity, and gelling time for the VP gel were manipulated by altering N-vinylpyrrolidone content. The target parameters for cooling in the robotic system were chosen by thermal modeling to support smooth, repeated injections on an ex vivo heart. Injections at predefined locations and depth were confirmed in an infarcted porcine model. CONCLUSIONS: A coupled thermoresponsive hydrogel and robotic injection system incorporating a temperature-controlled injectate line was capable of targeted injections and amenable to use with a subxiphoid transepicardial approach for hydrogel injection after myocardial infarction. The confirmation of precise location and depth injections would facilitate a patient-specific planning strategy to optimize injection patterning to maximize the mechanical benefits of hydrogel placement. %B Ann Thorac Surg %V 102 %P 780-786 %8 2016 Sep %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/27154150?dopt=Abstract %R 10.1016/j.athoracsur.2016.02.082 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2015 %T An artificial system for selecting the optimal surgical team %A Saberi, Nahid %A Mahvash, Mohsen %A Zenati, Marco %K Artificial Intelligence %K General Surgery %K Humans %K Models, Statistical %K Surgeons %K Treatment Outcome %K Workforce %X We introduce an intelligent system to optimize a team composition based on the team's historical outcomes and apply this system to compose a surgical team. The system relies on a record of the procedures performed in the past. The optimal team composition is the one with the lowest probability of unfavorable outcome. We use the theory of probability and the inclusion exclusion principle to model the probability of team outcome for a given composition. A probability value is assigned to each person of database and the probability of a team composition is calculated from them. The model allows to determine the probability of all possible team compositions even if there is no recoded procedure for some team compositions. From an analytical perspective, assembling an optimal team is equivalent to minimizing the overlap of team members who have a recurring tendency to be involved with procedures of unfavorable results. A conceptual example shows the accuracy of the proposed system on obtaining the optimal team. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2015 %P 218-21 %8 2015 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/26736239?dopt=Abstract %R 10.1109/EMBC.2015.7318339 %0 Journal Article %J Clin Cardiol %D 2014 %T Choice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial %A Zenati, Marco A %A Gaziano, J Michael %A Collins, Joseph F %A Biswas, Kousick %A Gabany, Jennifer M %A Quin, Jacquelyn A %A Bitondo, Jerene M %A Bakaeen, Faisal G %A Kelly, Rosemary F %A Shroyer, A Laurie %A Bhatt, Deepak L %K Adult %K Coronary Artery Bypass %K Endoscopy %K Humans %K Research Design %K Saphenous Vein %K Tissue and Organ Harvesting %X The Randomized Endo-vein Graft Prospective (REGROUP) trial (ClinicalTrials.gov NCT01850082) is a randomized, intent-to-treat, 2-arm, parallel-design, multicenter study funded by the Cooperative Studies Program (CSP No. 588) of the US Department of Veterans Affairs. Cardiac surgeons at 16 Veterans Affairs (VA) medical centers with technical expertise in performing both endoscopic vein harvesting (EVH) and open vein harvesting (OVH) were recruited as the REGROUP surgeon participants. Subjects requiring elective or urgent coronary artery bypass grafting using cardiopulmonary bypass with use of ≥1 saphenous vein graft will be screened for enrollment using pre-established inclusion/exclusion criteria. Enrolled subjects (planned N = 1150) will be randomized to 1 of the 2 arms (EVH or OVH) after an experienced vein harvester has been assigned. The primary outcomes measure is the rate of major adverse cardiac events (MACE), including death, myocardial infarction, or revascularization. Subject assessments will be performed at multiple times, including at baseline, intraoperatively, postoperatively, and at discharge (or 30 days after surgery, if still hospitalized). Assessment of leg-wound complications will be completed at 6 weeks after surgery. Telephone follow-ups will occur at 3-month intervals after surgery until the participating sites are decommissioned after the trial's completion (approximately 4.5 years after the full study startup). To assess long-term outcomes, centralized follow-up of MACE for 2 additional years will be centrally performed using VA and non-VA clinical and administrative databases. The primary MACE outcome will be compared between the 2 arms, EVH and OVH, at the end of the trial duration. %B Clin Cardiol %V 37 %P 325-30 %8 2014 Jun %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/24633760?dopt=Abstract %R 10.1002/clc.22267 %0 Journal Article %J BMJ Case Rep %D 2014 %T Post occlusive left atrial appendage thrombosis with extension into the left atrium %A Shalaby, Alaa %A Refaat, Marwan %A Lacomis, Joan %A Zenati, Marco %K Aged %K Atrial Appendage %K Atrial Fibrillation %K Echocardiography, Transesophageal %K Humans %K Male %K Mitral Valve Insufficiency %K Postoperative Complications %K Thrombosis %K Tomography, X-Ray Computed %X A 67-year-old man underwent left atrial appendage (LAA) exclusion concomitant with mitral valve surgery and radiofrequency ablation maze procedure. On transoesophageal echocardiography anticipating ablation for left atrial tachycardia, an echodense thrombus was visualised in the LAA location with apparent intracavitary extension into the left atrium. Based on CT imaging findings, the echo represented thrombosis of a large left atrial appendage with probable extension into the left atrium. %B BMJ Case Rep %V 2014 %8 2014 May 21 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/24850549?dopt=Abstract %R 10.1136/bcr-2013-200969 %0 Journal Article %J Semin Thorac Cardiovasc Surg %D 2013 %T Conduits in coronary artery bypass grafting %A Bakaeen, Faisal G %A Zenati, Marco A %A Bhatt, Deepak L %K Coronary Artery Bypass %K Gastroepiploic Artery %K Humans %K Internal Mammary-Coronary Artery Anastomosis %K Practice Guidelines as Topic %K Practice Patterns, Physicians' %K Radial Artery %K Saphenous Vein %K Treatment Outcome %X Modern cardiac practice in the United States is conservative when it comes to using bilateral internal mammary or radial artery grafts in coronary artery bypass surgery. Here, we examine the evidence regarding using other arterial grafts instead of veins as a complement to left internal mammary artery in surgical revascularization. In addition, we put our report in perspective relative to prevailing practice, professional societal guidelines, and future directions in coronary artery bypass grafting. %B Semin Thorac Cardiovasc Surg %V 25 %P 273-9 %8 2013 Winter %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/24673955?dopt=Abstract %R 10.1053/j.semtcvs.2014.01.002 %0 Journal Article %J Crit Pathw Cardiol %D 2013 %T Evaluation and management of the atrial fibrillation patient: a report from the Society of Cardiovascular Patient Care %A Steinberg, Benjamin A %A Beckley, Philip D %A Deering, Thomas F %A Clark, Carol L %A Amin, Alpesh N %A Bauer, Kenneth A %A Cryer, Byron %A Mansour, Moussa %A Scheiman, James M %A Zenati, Marco A %A Newby, L Kristin %A Peacock, W Frank %A Bhatt, Deepak L %K Accreditation %K Anticoagulants %K Atrial Fibrillation %K Continuity of Patient Care %K Critical Care %K Critical Pathways %K Hemorrhage %K Humans %K Quality of Health Care %K Thromboembolism %X Atrial fibrillation (AF) is the most common cardiac dysrhythmia, and its prevalence is growing. The care of patients with AF is complex and involves multiple specialties and venues of care. Guideline recommendations are available for AF therapy; however, their implementation can be challenging. The Society of Cardiovascular Patient Care has developed an accreditation program, formulated by an expert committee on AF. Accreditation is based on specific criteria in 7 domains: (1) community outreach, (2) prehospital care, (3) early stabilization, (4) acute care, (5) transitions of care, (6) clinical quality measures, and (7) governance. This document presents the rationale, discussion, and supporting evidence for these criteria, in an effort to maximize effective and efficient AF care. %B Crit Pathw Cardiol %V 12 %P 107-15 %8 2013 Sep %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/23892939?dopt=Abstract %R 10.1097/HPC.0b013e31829834ed %0 Journal Article %J Rep U S %D 2013 %T Space-Time Localization and Registration on the Beating Heart %A Wood, Nathan A %A Waugh, Kevin %A Liu, Tian Yu Tommy %A Zenati, Marco A %A Riviere, Cameron N %X This paper presents a framework for localizing a miniature epicardial crawling robot, HeartLander, on the beating heart using only 6-degree-of-freedom position measurements from an electromagnetic position tracker and a dynamic surface model of the heart. Using only this information, motion and observation models of the system are developed such that a particle filter can accurately estimate not only the location of the robot on the surface of the heart, but also the pose of the heart in the world coordinate frame as well as the current physiological phase of the heart. The presented framework is then demonstrated in simulation on a dynamic 3-D model of the human heart and a robot motion model which accurately mimics the behavior of the HeartLander robot. %B Rep U S %V 2012 %P 3792-3797 %8 2013 Dec 31 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/24511430?dopt=Abstract %R 10.1109/IROS.2012.6386009 %0 Journal Article %J AJR Am J Roentgenol %D 2013 %T Static and cine CT imaging to identify and characterize mediastinal adhesions as a potential complication for patients underdoing "redo sternotomy" %A Malguria, Nagina %A Hanley, Michael %A Steigner, Michael %A Kumamaru, Kanako K %A Wake, Nicole %A Zenati, Marco %A Rybicki, Frank J. %K Aged %K Heart Diseases %K Humans %K Male %K Mediastinal Diseases %K Middle Aged %K Postoperative Complications %K Radiographic Image Interpretation, Computer-Assisted %K Reoperation %K Sternotomy %K Tissue Adhesions %K Tomography, X-Ray Computed %X OBJECTIVE: The purpose of this article is to describe the image acquisition, identification, and reporting of postoperative adhesions in patients undergoing CT for "redo sternotomy" surgical planning. CONCLUSION: Adhesions appear as linear fibrous bands that join structures in the mediastinum viewed on static images. Confirmation by cine imaging shows deformation of mediastinal structures. Identification and reporting of adhesions will likely guide surgeons to safer interventions. %B AJR Am J Roentgenol %V 201 %P W72-4 %8 2013 Jul %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/23789699?dopt=Abstract %R 10.2214/AJR.12.9406 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2012 %T Predictors and impact of postoperative atrial fibrillation on patients' outcomes: a report from the Randomized On Versus Off Bypass trial %A Almassi, G Hossein %A Pecsi, Sharon A %A Collins, Joseph F %A Shroyer, A Laurie %A Zenati, Marco A %A Grover, Frederick L %K Aged %K Atrial Fibrillation %K Coronary Artery Bypass %K Coronary Artery Bypass, Off-Pump %K Female %K Humans %K Male %K Middle Aged %K Prognosis %K Prospective Studies %K Single-Blind Method %K Survival Rate %K Treatment Outcome %X OBJECTIVE: The study objective was to determine the predictors of postoperative atrial fibrillation (POAF) in patients randomized to conventional coronary artery bypass graft (on-pump coronary artery bypass [ONCAB]) versus beating heart coronary surgery (off-pump coronary artery bypass [OPCAB]). METHODS: The subgroup of 2103 patients (of 2203 enrollees) in the Randomized On Versus Off Bypass trial with no POAF was studied (1056 patients in the ONCAB group and 1047 patients in the OPCAB group). Univariate and multivariate analyses were used to identify the predictors of POAF and the impact of POAF on outcomes. RESULTS: Use of ONCAB versus OPCAB was not associated with increased rates of POAF. Older age (P < .0001), white race (P < .001), and hypertension (P < .002) were predictors of POAF on multivariate analysis. In general, POAF led to a higher rates of reintubation (ONCAB: 6.3% vs 0.8% no POAF, P < .001; OPCAB: 7.4% vs 1.8% no POAF, P < .0001) and prolonged ventilatory support (ONCAB: 7.1% vs 2.3% no POAF, P = .001; OPCAB: 9.2% vs 3.4% no POAF, P = .0003). The rate of any early adverse outcome was higher in patients with POAF (all patients: 10% POAF vs 4.7% no POAF, P < .0001; ONCAB: 9% POAF vs 4.3% no POAF, P = .008; OPCAB: 11% POAF vs 5.1% no POAF, P = .001). The 1-year all cause mortality was higher with POAF for both groups (ONCAB: 5.4% POAF vs 2% no POAF, P = .009; OPCAB: 5.1% POAF vs 2.6% no POAF, P = .07). POAF was independently associated with early composite end point (odds ratio [OR], 2.23; confidence interval [CI], 1.55-3.22; P < .0001), need for new mechanical support (OR, 3.25; CI, 1.39-7.61; P = .007), prolonged ventilatory support (OR, 2.93; CI, 1.89-4.55; P < .0001), renal failure (OR, 5.42; CI, 1.94-15.15; P = .001), and mortality at 12 months (OR, 1.94; CI, 1.14-3.28; P = .01). CONCLUSIONS: In the Randomized On Versus Off Bypass trial, the strategy of revascularization did not affect the rate of POAF. Age, race, and hypertension were predictors of POAF. POAF was independently associated with a higher short-term morbidity and higher 1-year mortality rates. %B J Thorac Cardiovasc Surg %V 143 %P 93-102 %8 2012 Jan %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/22054659?dopt=Abstract %R 10.1016/j.jtcvs.2011.10.003 %0 Journal Article %J IFMBE Proc %D 2012 %T A Study Ex Vivo of the Effect of Epicardial Fat on the HeartLander Robotic Crawler %A Patronik, N A %A Zenati, M A %A Riviere, C N %X A tethered epicardial crawling robot known as HeartLander has been developed for minimally-invasive surgery on the beating heart. The crawler has been tested in vivo many times in a porcine model, a model which provides generally authentic conditions in many ways; however, the pigs tested generally have little epicardial fat, whereas the epicardial fat in human patients will be considerable. As a result, it is necessary to determine the effect of such fat on the performance of the crawler. In one experiment, using fresh ovine hearts ex vivo, clogging of the suction chambers of the crawler during sliding over tissue with active suction was investigated for a variety of thicknesses of epicardial fat. In a second experiment, the maximum traction force during each step was measured when sliding with active suction repeatedly over the same location for a variety of fat thicknesses. The clogging experiment showed accumulation of fat in the suction chamber, with the amount dependent on the state of the epicardial membrane, but the suction line did not clog. The traction experiment showed that traction was maintained in all cases except when the epicardial membrane was excised completely. %B IFMBE Proc %V 37 %P 227-230 %8 2012 %G eng %N Part 1, Part 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/22866058?dopt=Abstract %R 10.1007/978-3-642-23508-5_60 %0 Journal Article %J Int J Med Robot %D 2012 %T Synchronization of epicardial crawling robot with heartbeat and respiration for improved safety and efficiency of locomotion %A Patronik, Nicholas A %A Ota, Takeyoshi %A Zenati, Marco A %A Riviere, Cameron N %K Acceleration %K Algorithms %K Animals %K Equipment Design %K Heart %K Heart Rate %K Humans %K Locomotion %K Minimally Invasive Surgical Procedures %K Pericardium %K Reproducibility of Results %K Respiration %K Robotics %K Swine %X BACKGROUND: HeartLander is a miniature mobile robot designed to navigate over the epicardium of the beating heart for minimally invasive therapy. This paper presents a technique to decrease slippage and improve locomotion efficiency by synchronizing the locomotion with the intrapericardial pressure variations of the respiration and heartbeat cycles. METHODS: Respiratory and heartbeat phases were detected in real time using a chest-mounted accelerometer during locomotion in a porcine model in vivo. Trials were conducted over the lateral aspect of the heart surface to test synchronized locomotion against an unsynchronized control. RESULTS: Offline evaluation showed that the respiration and heartbeat algorithms had accuracies of 100% and 88%, respectively. Synchronized trials exhibited significantly lower friction, higher efficiency, and greater total distance traveled than control trials. CONCLUSION: Synchronization of the locomotion of HeartLander with respiration and heartbeat is feasible and results in safer and more efficient travel on the beating heart. %B Int J Med Robot %V 8 %P 97-106 %8 2012 Mar %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/22009934?dopt=Abstract %R 10.1002/rcs.442 %0 Journal Article %J Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron %D 2012 %T Toward Onboard Estimation of Physiological Phase for an Epicardial Crawling Robot %A Wood, Nathan A %A Schwartzman, David %A Zenati, Marco A %A Riviere, Cameron N %X HeartLander is a miniature mobile robot which adheres to and crawls over the surface of the beating heart to provide therapies in a minimally invasive manner. Although HeartLander inherently provides a stable operating platform, the motion of the surface of the heart remains an important factor in the operation of the robot. The quasi-periodic motion of the heart due to physiological cycles, respiration and the heartbeat, affects the ability of the robot to move, as well as localize accurately. In order to improve locomotion efficiency, as well as register different locations on the heart in physiological phase, two methods of identifying physiological phases are presented: sliding-window-based and model-based. In the sliding-window-based approach a vector of previous measurements is compared to previously learned motion templates to determine the current physiological phases, while the model-based approach learns a Fourier series model of the motion, and uses this model to estimate the current physiological phases using an Extended Kalman Filter (EKF). The two methods, while differing in approach, produce similarly accurate results on data recorded from animal experiments in vivo. %B Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron %V 2012 %P 6290716 %8 2012 Dec 31 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/24634894?dopt=Abstract %R 10.1109/BioRob.2012.6290716 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2012 %T Towards localizing on the surface of the beating heart %A Wood, Nathan A %A Liu, Tian Yu Tommy %A Waugh, Kevin %A Zenati, Marco A %A Riviere, Cameron N %K Cardiovascular Surgical Procedures %K Computer Simulation %K Heart %K Humans %K Image Processing, Computer-Assisted %K Miniaturization %K Models, Cardiovascular %K Myocardial Contraction %K Robotics %K Surgery, Computer-Assisted %X This paper presents preliminary work toward localizing on a surface which undergoes periodic deformation, as an aspect of research on HeartLander, a miniature epicardial crawling robot. Using only position measurements from the robot, the aim of this work is to use the nonuniform movements of the heart as features to aid in localization. Using a particle filter, with motion and observation models which accurately model the robotic system, registration and localization parameters can be quickly and accurately identified. The presented framework is demonstrated in simulation on dynamic 2-D models which approximate the deformation of the surface of the heart. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2012 %P 1413-6 %8 2012 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/23366165?dopt=Abstract %R 10.1109/EMBC.2012.6346204 %0 Journal Article %J Laryngoscope %D 2012 %T A transoral highly flexible robot: Novel technology and application %A Rivera-Serrano, Carlos M %A Johnson, Paul %A Zubiate, Brett %A Kuenzler, Richard %A Choset, Howie %A Zenati, Marco %A Tully, Stephen %A Duvvuri, Umamaheswar %K Adult %K Cadaver %K Equipment Design %K Feasibility Studies %K Humans %K Larynx %K Microsurgery %K Mouth %K Otorhinolaryngologic Surgical Procedures %K Robotics %X OBJECTIVES/HYPOTHESIS: Organ preservation surgery is a major focus in head and neck oncology. Current approaches are aimed toward improving quality of life and decreasing treatment-related morbidity. Transoral robotic surgery was developed to overcome the limitations of traditional surgical approaches. The most widely used robotic system is the da Vinci Surgical System. Although the da Vinci offers clear surgical advantages over traditional approaches, its rigid operative arms prevent complex maneuverability in three-dimensional space. The ideal surgical robot would configure to the anatomy of the patient and maneuver in narrow spaces. We present the first cadaveric trials of the use of a highly flexible robot able to traverse the nonlinear upper aerodigestive tract and gain physical and visual access to important anatomical landmarks without laryngeal suspension. STUDY DESIGN: Feasibility. METHODS: Using human cadavers, we investigated the feasibility of visualizing the endolarynx transorally with a highly flexible robot without performing suspension of the larynx. Two fresh and four preserved human specimens were used. RESULTS: Unhampered visualization of the endolarynx was achieved in all specimens without performing laryngeal suspension. Standard mouth retractors facilitated the delivery of the robot into the endolarynx. CONCLUSIONS: The flexible robot technology mitigates laryngeal suspension and the limitations of current robotic surgery with rigid line-of-sight-directed instruments. Having demonstrated the feasibility of physical and visual access to the endolarynx, future work will study the feasibility of using the highly flexible robot in transoral robotic procedures with flexible instrumentation placed in the robot's available working ports. %B Laryngoscope %V 122 %P 1067-71 %8 2012 May %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/22447466?dopt=Abstract %R 10.1002/lary.23237 %0 Journal Article %J Heart Rhythm %D 2011 %T Conservative management of pericardial-esophageal fistula complicating robotic atrial fibrillation ablation %A Shalaby, Alaa %A Refaat, Marwan %A Sebastien, Gilbert %A Zenati, Marco %K Adult %K Atrial Fibrillation %K Catheter Ablation %K Drainage %K Esophageal Fistula %K Esophagoscopy %K Fistula %K Heart Diseases %K Humans %K Male %K Pericardium %K Robotics %K Tomography, X-Ray Computed %B Heart Rhythm %V 8 %P 905-8 %8 2011 Jun %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/21278000?dopt=Abstract %R 10.1016/j.hrthm.2011.01.035 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2011 %T Fourier modeling of porcine heartbeat and respiration in vivo for synchronization of HeartLander robot locomotion %A Wood, Nathan A %A Patronik, Nicholas A %A Zenati, Marco A %A Riviere, Cameron N %K Algorithms %K Animals %K Cardiology %K Equipment Design %K Fourier Analysis %K Heart %K Heart Rate %K Locomotion %K Models, Statistical %K Motion %K Movement %K Reproducibility of Results %K Respiration %K Robotics %K Swine %X HeartLander is a small mobile robot which adheres to and navigates over the surface of the heart to provide therapies in a minimally invasive manner. HeartLander's ability to efficiently operate in this dynamic environment is greatly affected by physiological motion, namely the cardiac and respiration cycles. Synchronization of robot motion with minimal intrapericardial pressure results in safer and more efficient travel. The work presented models the physiological components of motion using Fourier series and estimates their parameters using an Extended Kalman Filter. Using the Fourier series parameters, estimates of physiological phase values are calculated to be used for step synchronization. The proposed methods are demonstrated on data from a HeartLander animal study for four locations on the heart. Mean respiration phase estimates are shown to be within 5% of the true respiration phases, while mean cardiac phase estimates are shown to have a minimum error of 11%. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2011 %P 7041-4 %8 2011 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/22255960?dopt=Abstract %R 10.1109/IEMBS.2011.6091780 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2011 %T Impact of endoscopic versus open saphenous vein harvest technique on late coronary artery bypass grafting patient outcomes in the ROOBY (Randomized On/Off Bypass) Trial %A Zenati, Marco A %A Shroyer, A Laurie %A Collins, Joseph F %A Hattler, Brack %A Ota, Takeyoshi %A Almassi, G Hossein %A Amidi, Morteza %A Novitzky, Dimitri %A Grover, Frederick L %A Sonel, Ali F %K Aged %K Chi-Square Distribution %K Coronary Angiography %K Coronary Artery Bypass %K Coronary Artery Bypass, Off-Pump %K Coronary Artery Disease %K Endoscopy %K Female %K Graft Occlusion, Vascular %K Humans %K Logistic Models %K Male %K Middle Aged %K Risk Assessment %K Risk Factors %K Saphenous Vein %K Single-Blind Method %K Time Factors %K Tissue and Organ Harvesting %K Treatment Outcome %K United States %K Vascular Patency %X OBJECTIVE: In the Randomized On/Off Bypass (ROOBY) Trial, the efficacy of on-pump versus off-pump coronary artery bypass grafting was evaluated. This ROOBY Trial planned subanalysis compared the effects on postbypass patient clinical outcomes and graft patency of endoscopic vein harvesting and open vein harvesting. METHODS: From April 2003 to April 2007, the technique used for saphenous vein graft harvesting was recorded in 1471 cases. Of these, 894 patients (341 endoscopic harvest and 553 open harvest) also underwent coronary angiography 1 year after coronary artery bypass grafting. Univariate and multivariable analyses were used to compare patient outcomes in the endoscopic and open groups. RESULTS: Preoperative patient characteristics were statistically similar between the endoscopic and open groups. Endoscopic vein harvest was used in 38% of the cases. There were no significant differences in both short-term and 1-year composite outcomes between the endoscopic and open groups. For patients with 1-year catheterization follow-up (n=894), the saphenous vein graft patency rate for the endoscopic group was lower than that in the open harvest group (74.5% vs 85.2%, P<.0001), and the repeat revascularization rate was significantly higher (6.7% vs 3.4%, P<.05). Multivariable regression documented no interaction effect between endoscopic approach and off-pump treatment. CONCLUSIONS: In the ROOBY Trial, endoscopic vein harvest was associated with lower 1-year saphenous vein graft patency and higher 1-year revascularization rates, independent of the use of off-pump or on-pump cardiac surgical approach. %B J Thorac Cardiovasc Surg %V 141 %P 338-44 %8 2011 Feb %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/21130476?dopt=Abstract %R 10.1016/j.jtcvs.2010.10.004 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2011 %T Outcomes of coronary artery bypass grafting and reduction annuloplasty for functional ischemic mitral regurgitation: a prospective multicenter study (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) %A Grossi, Eugene A %A Woo, Y Joseph %A Patel, Nirav %A Goldberg, Judith D %A Schwartz, Charles F %A Subramanian, Valavanur A %A Genco, Christopher %A Goldman, Scott M %A Zenati, Marco A %A Wolfe, Alan J %A Mishra, Yugal K %A Trehan, Naresh %K Aged %K Coronary Artery Bypass %K Early Termination of Clinical Trials %K Heart Valve Prosthesis Implantation %K Humans %K Middle Aged %K Mitral Valve Annuloplasty %K Mitral Valve Insufficiency %K Myocardial Ischemia %K Proportional Hazards Models %K Prospective Studies %K Recovery of Function %K Reoperation %K Risk Assessment %K Risk Factors %K Severity of Illness Index %K Stroke Volume %K Time Factors %K Treatment Outcome %K Ultrasonography %K United States %K Ventricular Function, Left %K Ventricular Remodeling %X OBJECTIVE: Functional ischemic mitral regurgitation is a complication of ventricular remodeling; standard therapy is reduction annuloplasty and coronary artery bypass grafting. Unfortunately, outcomes are retrospective and contradictory. We report a multicenter study that documents the outcomes of reduction annuloplasty for functional ischemic mitral regurgitation. METHODS: Twenty-one centers randomized 75 patients to the coronary artery bypass grafting + reduction annuloplasty subgroup that was the control arm of the Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve trial. Entry criteria included patients requiring revascularization, patients with severe or symptomatic moderate functional ischemic mitral regurgitation, an ejection fraction 25% or greater, a left ventricular end-diastolic dimension 7.0 cm or less, and more than 30 days since acute myocardial infarction. All echocardiograms were independently scored by a core laboratory. Reduction annuloplasty was achieved by device annuloplasty. Two patients underwent immediate intraoperative conversion to a valve replacement because reduction annuloplasty was unable to correct mitral regurgitation; as-treated results are presented. RESULTS: Thirty-day mortality was 4.1% (3/73). Patients received an average of 2.8 bypass grafts. Mean follow-up was 24.6 months. Mitral regurgitation was reduced from 2.6 ± 0.8 preoperatively to 0.3 ± 0.6 at 2 years. Freedom from death or valve reoperation was 78% ± 5% at 2 years. There was significant improvement in ejection fraction and New York Heart Association class with reduction of left ventricular end-diastolic dimension. Cox regression analyses suggested that increasing age (P = .001; hazard ratio, 1.16 per year; 95% confidence interval, 1.06-1.26) and renal disease (P = .018; hazard ratio, 3.48; 95% confidence interval, 1.25-9.72) were associated with decreased survival. CONCLUSIONS: Coronary artery bypass grafting + reduction annuloplasty for functional ischemic mitral regurgitation predictably reduces mitral regurgitation and relieves symptoms. This treatment of moderate to severe mitral regurgitation is associated with improved indices of ventricular function, improved New York Heart Association class, and excellent freedom from recurrent mitral insufficiency. Although long-term prognosis remains guarded, this multicenter study delineates the intermediate-term benefits of such an approach. %B J Thorac Cardiovasc Surg %V 141 %P 91-7 %8 2011 Jan %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/21168015?dopt=Abstract %R 10.1016/j.jtcvs.2010.08.057 %0 Journal Article %J Rep U S %D 2011 %T Position Estimation of an Epicardial Crawling Robot on the Beating Heart by Modeling of Physiological Motion %A Wood, Nathan A %A Del Agua, Diego Moral %A Zenati, Marco A %A Riviere, Cameron N %X HeartLander, a small mobile robot designed to provide treatments to the surface of the beating heart, overcomes a major difficulty of minimally invasive cardiac surgery, providing a stable operating platform. This is achieved inherently in the way the robot adheres to and crawls over the surface of the heart. This mode of operation does not require physiological motion compensation to provide this stable environment; however, modeling of physiological motion is advantageous in providing more accurate position estimation as well as synchronization of motion to the physiological cycles. The work presented uses an Extended Kalman Filter framework to estimate parameters of non-stationary Fourier series models of the motion of the heart due to the respiratory and cardiac cycles as well as the position of the robot as it moves over the surface of the heart. The proposed method is demonstrated in the laboratory with HeartLander operating on a physiological motion simulator. Improved performance is demonstrated in comparison to the filtering methods previously used with HeartLander. The use of detected physiological cycle phases to synchronize locomotion of HeartLander is also described. %B Rep U S %V 2011 %P 4522-4527 %8 2011 Dec 05 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/23066511?dopt=Abstract %R 10.1109/IROS.2011.6095084 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2011 %T Toward a hybrid snake robot for single-port surgery %A Mahvash, Mohsen %A Zenati, Marco %K Computer-Aided Design %K Equipment Design %K Equipment Failure Analysis %K Minimally Invasive Surgical Procedures %K Robotics %X We propose a new snake-like robot for use in single-port minimally invasive surgery. The snake robot is made of a concentric tube robot and a highly articulated robotic probe. The probe operates as a stiff shield for the concentric tube robot. Consequently, the snake robot provides simultaneously high tip stiffness and dexterity that cannot be obtained by the single use of any of two robots. A critical design challenge is achieving a small radius of curvature for the hybrid snake. A mechanic model is presented for computing the minimum achievable radius of curvature for the hybrid snake. Experiments validate the mechanic model. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2011 %P 5372-5 %8 2011 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/22255552?dopt=Abstract %R 10.1109/IEMBS.2011.6091329 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2010 %T Application of the HeartLander crawling robot for injection of a thermally sensitive anti-remodeling agent for myocardial infarction therapy %A Chapman, Michael P %A Lopez Gonzalez, Jose L %A Goyette, Brina E %A Fujimoto, Kazuro L %A Ma, Zuwei %A Wagner, William R %A Zenati, Marco A %A Riviere, Cameron N %K Animals %K Chickens %K Hydrogel, Polyethylene Glycol Dimethacrylate %K Injections %K Motion %K Myocardial Infarction %K Robotics %K Temperature %K Ventricular Remodeling %X The injection of a mechanical bulking agent into the left ventricular (LV) wall of the heart has shown promise as a therapy for maladaptive remodeling of the myocardium after myocardial infarct (MI). The HeartLander robotic crawler presented itself as an ideal vehicle for minimally-invasive, highly accurate epicardial injection of such an agent. Use of the optimal bulking agent, a thermosetting hydrogel developed by our group, presents a number of engineering obstacles, including cooling of the miniaturized injection system while the robot is navigating in the warm environment of a living patient. We present herein a demonstration of an integrated miniature cooling and injection system in the HeartLander crawling robot, that is fully biocompatible and capable of multiple injections of a thermosetting hydrogel into dense animal tissue while the entire system is immersed in a 37°C water bath. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2010 %P 5428-31 %8 2010 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/21096276?dopt=Abstract %R 10.1109/IEMBS.2010.5626518 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2010 %T Evaluation in vitro of a treatment planning algorithm for an epicardial crawling robot %A Goyette, Brina E %A Becker, Brian C %A Zenati, Marco A %A Riviere, Cameron N %K Algorithms %K Biosensing Techniques %K Cardiac Surgical Procedures %K Equipment Design %K Heart %K Humans %K In Vitro Techniques %K Models, Statistical %K Motion %K Pericardium %K Robotics %K Surgery, Computer-Assisted %K Time Factors %K Treatment Outcome %X HeartLander is a small, mobile robot designed to assist surgical procedures on the surface of the heart. It crawls within the pericardial sac surrounding the heart. Numerous potential clinical uses for HeartLander involve injections or other interventions at multiple locations on the epicardial surface. To minimize treatment time, we have developed an algorithm that optimizes a plan for reaching a given set of treatment targets. Results from in vitro evaluation on a beating heart model show improvement over a greedy technique. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2010 %P 2275-8 %8 2010 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/21097014?dopt=Abstract %R 10.1109/IEMBS.2010.5627690 %0 Journal Article %J Innovations (Phila) %D 2010 %T Impact of Subxiphoid Video Pericardioscopy with a Rigid Shaft on Cardiac Hemodynamics in a Porcine Model %A Yokota, Takenori %A Ota, Takeyoshi %A Schwartzman, David %A Zenati, Marco A %X OBJECTIVE: Single-port subxiphoid videopericardioscopy with a rigid shaft is useful for left atrial exclusion, left ventricular pacing lead implantation, and epicardial mapping, but it may interfere with the cardiac rhythm and adversely alter hemodynamics. We examined the impact of this technique on hemodynamic indices in a porcine model. METHODS: The videopericardioscopy device was introduced into the pericardial space of 5 pigs (35-45 kg) via a subxiphoid approach and navigated to 6 anatomical targets (right atrial appendage, superior vena cava, ascending aorta, left atrial appendage (anterior and posterior approaches), transverse sinus, and atrioventricular groove). After successful target acquisition, the device was withdrawn through the subxiphoid port. When the hemodynamics stabilized, the device was navigated to another target. The heart rate, arterial blood pressure, central venous pressure, pulmonary arterial pressure, and mixed venous oxygen saturation were measured at every pre-target (subxiphoid incision) and target point. After the navigation trials, the animals were sacrificed and the mediastinum space was examined for procedure-related injuries. RESULTS: The device afforded a good view, and the navigation trials were successfully performed on the beating heart. Four animals tolerated the procedures, while 1 died of device-induced ventricular fibrillation after the trials. Hemodynamics were severely compromised at all anatomical targets except the left atrial appendage (anterior approach). CONCLUSIONS: Subxiphoid videopericardioscopy significantly interferes with the cardiac rhythm, causing life-threatening arrhythmia and hemodynamic compromise, when the target is located deep and far from the pericardiotomy. A flexible or highly articulated device would enable intrapericardial navigation without hemodynamic compromise. %B Innovations (Phila) %V 5 %P 51-54 %8 2010 Jan %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/20401174?dopt=Abstract %R 10.1097/IMI.0b013e3181ceef8a %0 Journal Article %J J Am Coll Cardiol %D 2010 %T Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) %A Grossi, Eugene A %A Patel, Nirav %A Woo, Y Joseph %A Goldberg, Judith D %A Schwartz, Charles F %A Subramanian, Valavanur %A Feldman, Ted %A Bourge, Robert %A Baumgartner, Norbert %A Genco, Christopher %A Goldman, Scott %A Zenati, Marco %A Wolfe, Alan J %A Mishra, Yugal K %A Trehan, Naresh %A Mittal, Sanjay %A Shang, Shulian %A Mortier, Todd J %A Schweich, Cyril J %K Aged %K Female %K Follow-Up Studies %K Heart Ventricles %K Heart-Assist Devices %K Humans %K Male %K Middle Aged %K Mitral Valve Insufficiency %K Treatment Outcome %X OBJECTIVES: we sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota). BACKGROUND: FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies. METHODS: RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping). RESULTS: the study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p < 0.001); Coapsys provided a greater decrease in LV end-diastolic dimension (p = 0.021). Control had lower MR grades during follow-up (p = 0.01). Coapsys showed a survival advantage compared with control at 2 years (87% vs. 77%) (hazard ratio: 0.421; 95% confidence interval: 0.200 to 0.886; stratified log-rank test; p = 0.038). Complication-free survival (including death, stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019). CONCLUSIONS: analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276). %B J Am Coll Cardiol %V 56 %P 1984-93 %8 2010 Dec 07 %G eng %N 24 %1 http://www.ncbi.nlm.nih.gov/pubmed/21126639?dopt=Abstract %R 10.1016/j.jacc.2010.06.051 %0 Journal Article %J Ann Thorac Surg %D 2010 %T Severe functional mitral regurgitation arising from isolated annular dilatation %A Kilic, Arman %A Schwartzman, David S %A Subramaniam, Kathirvel %A Zenati, Marco A %K Atrial Fibrillation %K Catheter Ablation %K Dilatation, Pathologic %K Heart Atria %K Heart Valve Prosthesis Implantation %K Humans %K Male %K Middle Aged %K Mitral Valve %K Mitral Valve Insufficiency %K Tricuspid Valve Insufficiency %X Functional mitral regurgitation or functional tricuspid regurgitation most commonly result from maladaptive remodeling due to ischemic heart disease or idiopathic dilatative cardiomyopathy. We report a case of significant functional mitral regurgitation and functional tricuspid regurgitation arising from isolated annular dilatation secondary to atrial fibrillation and associated atrial remodeling. The patient underwent successful mitral and tricuspid valve repair and a bi-atrial Maze procedure. %B Ann Thorac Surg %V 90 %P 1343-5 %8 2010 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/20868842?dopt=Abstract %R 10.1016/j.athoracsur.2010.03.026 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2010 %T Subxiphoid epicardial left ventricular pacing lead placement is feasible %A Ota, Takeyoshi %A Schwartzman, David %A Zenati, Marco A %K Aged %K Female %K Heart Ventricles %K Humans %K Pacemaker, Artificial %K Pericardium %K Prosthesis Implantation %K Xiphoid Bone %B J Thorac Cardiovasc Surg %V 139 %P 1661-2 %8 2010 Jun %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/19818457?dopt=Abstract %R 10.1016/j.jtcvs.2009.06.031 %0 Journal Article %J Ann Thorac Surg %D 2009 %T A highly articulated robotic surgical system for minimally invasive surgery %A Ota, Takeyoshi %A Degani, Amir %A Schwartzman, David %A Zubiate, Brett %A McGarvey, Jeremy %A Choset, Howie %A Zenati, Marco A %K Animals %K Cardiac Surgical Procedures %K Minimally Invasive Surgical Procedures %K Robotics %K Swine %X PURPOSE: We developed a novel, highly articulated robotic surgical system (CardioARM) to enable minimally invasive intrapericardial therapeutic delivery through a subxiphoid approach. We performed preliminary proof of concept studies in a porcine preparation by performing epicardial ablation. DESCRIPTION: CardioARM is a robotic surgical system having an articulated design to provide unlimited but controllable flexibility. The CardioARM consists of serially connected, rigid cyclindrical links housing flexible working ports through which catheter-based tools for therapy and imaging can be advanced. The CardioARM is controlled by a computer-driven, user interface, which is operated outside the operative field. EVALUATION: In six experimental subjects, the CardioARM was introduced percutaneously through a subxiphoid access. A commercial 5-French radiofrequency ablation catheter was introduced through the working port, which was then used to guide deployment. In all subjects, regional ("linear") left atrial ablation was successfully achieved without complications. CONCLUSIONS: Based on these preliminary studies, we believe that the CardioARM promises to enable deployment of a number of epicardium-based therapies. Improvements in imaging techniques will likely facilitate increasingly complex procedures. %B Ann Thorac Surg %V 87 %P 1253-6 %8 2009 Apr %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/19324161?dopt=Abstract %R 10.1016/j.athoracsur.2008.10.026 %0 Journal Article %J IEEE Trans Robot %D 2009 %T A Miniature Mobile Robot for Navigation and Positioning on the Beating Heart %A Patronik, Nicholas A %A Ota, Takeyoshi %A Zenati, Marco A %A Riviere, Cameron N %X Robotic assistance enhances conventional endoscopy; yet, limitations have hindered its mainstream adoption for cardiac surgery. HeartLander is a miniature mobile robot that addresses several of these limitations by providing precise and stable access over the surface of the beating heart in a less-invasive manner. The robot adheres to the heart and navigates to any desired target in a semiautonomous fashion. The initial therapies considered for HeartLander generally require precise navigation to multiple surface targets for treatment. To balance speed and precision, we decompose any general target acquisition into navigation to the target region followed by fine positioning to each target. In closed-chest, beating-heart animal studies, we demonstrated navigation to targets located around the circumference of the heart, as well as acquisition of target patterns on the anterior and posterior surfaces with an average error of 1.7 mm. The average drift encountered during station-keeping was 0.7 mm. These preclinical results demonstrate the feasibility of precise semiautonomous delivery of therapy to the surface of the beating heart using HeartLander. %B IEEE Trans Robot %V 25 %P 1109-1124 %8 2009 %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/20179783?dopt=Abstract %R 10.1109/tro.2009.2027375 %0 Journal Article %J J Interv Cardiol %D 2008 %T Feasibility of myxomatous mitral valve repair using direct leaflet and chordal radiofrequency ablation %A Williams, Jeffrey L %A Toyoda, Yoshiya %A Ota, Takeyoshi %A Gutkin, Dmitry %A Katz, William %A Zenati, Marco %A Schwartzman, David %K Animals %K Catheter Ablation %K Disease Models, Animal %K Dogs %K Echocardiography %K Mitral Valve Insufficiency %K Mitral Valve Prolapse %K Pennsylvania %K Treatment Outcome %X OBJECTIVE: Minimally invasive repair of mitral valve prolapse (MVP) causing severe mitral regurgitation (MR) should reduce MR and have chronic durability. Our ex vivo, acute in vivo, and chronic in vivo studies suggest that direct application of radiofrequency ablation (RFA) to mitral leaflets and chordae can effect these repair goals to decrease MR. METHODS: A total of seven canines were studied to assess the effects of RFA on mitral valve structure and function. RFA was applied ex vivo (n = 1), acutely in vivo using a right lateral thoracotomy and cardiopulmonary bypass (n = 3), and chronically in vivo using percutaneous access to the heart (n = 3). RFA was applied to the mitral valve and its associated chordae. Mitral valve structure and function (in vivo preparations) were then assessed. RESULTS: Ex vivo application of RFA resulted in qualitative reduction in mitral leaflet surface area and chordal length. Acute in vivo application of RFA to canines found to have MVP causing severe MR demonstrated a 43.7-60.7% statistically significant (P = 0.039) reduction in postablation MR. Chronic, in vivo, percutaneous application of RFA was found to be feasible and the engendered alterations durable. CONCLUSION: These data suggest that myxomatous mitral valve repair using radiofrequency energy delivered via catheter is feasible. %B J Interv Cardiol %V 21 %P 547-54 %8 2008 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/18973508?dopt=Abstract %R 10.1111/j.1540-8183.2008.00398.x %0 Journal Article %J J Thorac Cardiovasc Surg %D 2008 %T A fusion protein of hepatocyte growth factor enhances reconstruction of myocardium in a cardiac patch derived from porcine urinary bladder matrix %A Ota, Takeyoshi %A Gilbert, Thomas W %A Schwartzman, David %A McTiernan, Charles F %A Kitajima, Takashi %A Ito, Yoshihiro %A Sawa, Yoshiki %A Badylak, Stephen F %A Zenati, Marco A %K Actins %K Animals %K Capillaries %K Collagen %K Electromagnetic Phenomena %K Extracellular Matrix %K Hepatocyte Growth Factor %K Immunohistochemistry %K Myocardium %K Polyethylene Terephthalates %K Recombinant Fusion Proteins %K Reverse Transcriptase Polymerase Chain Reaction %K Swine %K Tissue Engineering %K Urinary Bladder %X OBJECTIVE: We sought to promote myocardial repair using urinary bladder matrix incorporated with a fusion protein that combined hepatocyte growth factor and fibronectin collagen-binding domain in a porcine model. Collagen-binding domain acted as an intermediary to promote hepatocyte growth factor binding and enhance hepatocyte growth factor stability within urinary bladder matrix. METHODS: Urinary bladder matrix incorporated with collagen-binding domain and hepatocyte growth factor was implanted into the porcine right ventricular wall (F group) to repair a surgically created defect. Untreated urinary bladder matrix patches (U group) and Dacron patches (D group) served as controls (N = 5/group). Electromechanical mapping was performed 60 days after surgery. Linear local shortening was used to assess regional contractility, and electrical activity was recorded. RESULTS: Linear local shortening was significantly improved in the F group compared with controls (F: 0.51% +/- 1.57% [P < .05], U: -1.06% +/- 1.84%, D: -2.72% +/- 2.59%), whereas it was inferior to the normal myocardium (13.7% +/- 4.3%; P < .05). Mean electrical activity was 1.49 +/- 0.82 mV in the F group, which was statistically greater than in the control groups (U: 0.93 +/- 0.71 mV; D: 0.30 +/- 0.22 mV; P < .05) and less than the normal myocardium (8.24 +/- 2.49 mV; P < .05). Histologic examination showed predominant alpha-smooth muscle actin positive cells with the F group showing the thickest layer and the D group showing the thinnest layer, with an endocardial endothelial monolayer. Scattered isolated islands of alpha-actinin positive cells were observed only in the F group, but not in the controls, suggesting the presence of cardiomyocytes. CONCLUSION: The collagen-binding domain/hepatocyte growth factor/urinary bladder matrix patch demonstrated increased contractility and electrical activity compared with urinary bladder matrix alone or Dacron and facilitated a homogeneous repopulation of host cells. Urinary bladder matrix incorporated with collagen-binding domain and hepatocyte growth factor may contribute to constructive myocardial remodeling. %B J Thorac Cardiovasc Surg %V 136 %P 1309-17 %8 2008 Nov %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/19026821?dopt=Abstract %R 10.1016/j.jtcvs.2008.07.008 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2008 %T Highly articulated robotic probe for minimally invasive surgery %A Degani, Amir %A Choset, Howie %A Zubiate, Brett %A Ota, Takeyoshi %A Zenati, Marco %K Animals %K Cardiac Surgical Procedures %K Equipment Design %K Female %K Humans %K Male %K Minimally Invasive Surgical Procedures %K Pericardium %K Robotics %K Surgery, Computer-Assisted %K Swine %X We have developed a novel highly articulated robotic probe (HARP) that can thread through tightly packed volumes without disturbing the surrounding tissues and organs. We use cardiac surgery as the focal application of this work. As such, we have designed the HARP to enter the pericardial cavity through a subxiphoid port. The surgeon can effectively reach remote intrapericardial locations on the epicardium and deliver therapeutic interventions under direct control. Our device differs from others in that we use conventional actuation and still have great maneuverability. We have performed proof-of-concept clinical experiments to give us preliminary validation of the ideas presented here. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2008 %P 3273-6 %8 2008 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/19163406?dopt=Abstract %R 10.1109/IEMBS.2008.4649903 %0 Journal Article %J Ann Thorac Surg %D 2008 %T Highly fenestrated septum primum leads to failure of Amplatzer septal defect closure %A McGarvey, Jeremy %A Ota, Takeyoshi %A Anderson, William %A Katz, William %A Zenati, Marco A %K Animals %K Bioprosthesis %K Cattle %K Echocardiography, Transesophageal %K Female %K Heart Septal Defects %K Humans %K Middle Aged %K Pericardium %K Prostheses and Implants %K Prosthesis Failure %K Reoperation %X A patient presenting with a history of transient ischemic attacks was initially diagnosed with a large secundum-type atrial septal defect by transesophageal echocardiography. Subsequent attempts to percutaneously repair the defect using an Amplatzer septal occlude device (AGA Medical, Plymouth, MN) failed to position correctly on multiple attempts. At the time of surgery, a largely deficient and highly fenestrated septum primum was found, which was likely the cause of the Amplatzer device (AGA Medical) failure. The defect was then definitively repaired using a bovine pericardial patch without incident. %B Ann Thorac Surg %V 86 %P 998-1000 %8 2008 Sep %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/18721601?dopt=Abstract %R 10.1016/j.athoracsur.2008.02.077 %0 Journal Article %J Ann Thorac Surg %D 2008 %T Long-term outcome of lung and heart-lung transplantation for idiopathic pulmonary arterial hypertension %A Toyoda, Yoshiya %A Thacker, Jnanesh %A Santos, Ricardo %A Nguyen, Duc %A Bhama, Jay %A Bermudez, Christian %A Kormos, Robert %A Johnson, Bruce %A Crespo, Maria %A Pilewski, Joseph %A Teuteberg, Jeffrey %A Alvarez, Rene %A Mathier, Michael %A McNamara, Dennis %A McCurry, Kenneth %A Zenati, Marco %A Hattler, Brack %K Adolescent %K Adult %K Age Factors %K Aged %K Analysis of Variance %K Cohort Studies %K Female %K Follow-Up Studies %K Graft Rejection %K Graft Survival %K Heart-Lung Transplantation %K Humans %K Hypertension, Pulmonary %K Logistic Models %K Lung Transplantation %K Male %K Middle Aged %K Multivariate Analysis %K Postoperative Complications %K Probability %K Retrospective Studies %K Risk Assessment %K Severity of Illness Index %K Sex Factors %K Survival Rate %K Time Factors %K Treatment Outcome %X BACKGROUND: The survival after lung and heart-lung transplantation for idiopathic pulmonary arterial hypertension has been reportedly the lowest among the major diagnostic categories of lung transplant recipients. METHODS: Retrospective analysis was performed for lung and heart-lung transplant recipients for idiopathic pulmonary arterial hypertension from 1982 to 2006. The patients were divided into 2 groups, based on the era; group 1: 1982 to 1993, and group 2: 1994 to 2006. Since 1994, we have introduced our current protocols including prostaglandin E1 and nitroglycerin for donor lung preservation, and lung protection with cold and terminal warm blood pneumoplegia as well as immunosuppression with alemtuzumab induction. These modifications were introduced in different years over a wide span of time (1994 to 2003). RESULTS: Group 1 had 59 patients (35 +/- 1 years old, ranging 15 to 53, 20 male and 39 female) with 7 single lung, 11 double lung, and 41 heart-lung, whereas group 2 had 30 (43 +/- 2 years old, ranging 17 to 65, 9 male and 21 female) with 2 single, 20 double, and 8 heart-lung transplantations. The recipient age was significantly (p = 0.004) higher in group 2, and group 2 had significantly older (35 +/- 3 vs 26 +/- 1, p = 0.002) and more female donors (73% vs 41%, p = 0.007) compared with group 1. The actuarial survival was significantly (p = 0.004) better in group 2 with 86% at 1 year, 75% at 5 years, and 66% at 10 years compared with group 1 with 58% at 1 year, 39% at 5 years, and 27% at 10 years. CONCLUSIONS: With our current pulmonary protection and immunosuppression, the long-term outcome of lung and heart-lung transplantation for idiopathic pulmonary arterial hypertension is excellent. %B Ann Thorac Surg %V 86 %P 1116-22 %8 2008 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/18805144?dopt=Abstract %R 10.1016/j.athoracsur.2008.05.049 %0 Journal Article %J Circulation %D 2008 %T Minimally invasive epicardial injections using a novel semiautonomous robotic device %A Ota, Takeyoshi %A Patronik, Nicholas A %A Schwartzman, David %A Riviere, Cameron N %A Zenati, Marco A %K Animals %K Coloring Agents %K Electromagnetic Phenomena %K Equipment Design %K Injections %K Minimally Invasive Surgical Procedures %K Myocardial Contraction %K Pericardium %K Pressure %K Robotics %K Swine %K Vacuum %K Xiphoid Bone %X BACKGROUND: We have developed a novel miniature robotic device (HeartLander) that can navigate on the surface of the beating heart through a subxiphoid approach. This study investigates the ability of HeartLander to perform in vivo semiautonomous epicardial injections on the beating heart. METHODS AND RESULTS: The inchworm-like locomotion of HeartLander is generated using vacuum pressure for prehension of the epicardium and drive wires for actuation. The control system enables semiautonomous target acquisition by combining the joystick input with real-time 3-dimensional localization of the robot provided by an electromagnetic tracking system. In 12 porcine preparations, the device was inserted into the intrapericardial space through a subxiphoid approach. Ventricular epicardial injections of dye were performed with a custom injection system through HeartLander's working channel. HeartLander successfully navigated to designated targets located around the circumference of the ventricles (mean path length=51+/-25 mm; mean speed=38+/-26 mm/min). Injections were successfully accomplished following the precise acquisition of target patterns on the left ventricle (mean injection depth=3.0+/-0.5 mm). Semiautonomous target acquisition was achieved within 1.0+/-0.9 mm relative to the reference frame of the tracking system. No fatal arrhythmia or bleeding was noted. There were no histological injuries to the heart due to the robot prehension, locomotion, or injection. CONCLUSIONS: In this proof-of-concept study, HeartLander demonstrated semiautonomous, precise, and safe target acquisition and epicardial injection on a beating porcine heart through a subxiphoid approach. This technique may facilitate minimally invasive cardiac cell transplantation or polymer therapy in patients with heart failure. %B Circulation %V 118 %P S115-20 %8 2008 Sep 30 %G eng %N 14 Suppl %1 http://www.ncbi.nlm.nih.gov/pubmed/18824742?dopt=Abstract %R 10.1161/CIRCULATIONAHA.107.756049 %0 Journal Article %J Ann Thorac Surg %D 2008 %T Minimally invasive epicardial left atrial ablation and appendectomy for refractory atrial tachycardia %A McGarvey, Jeremy R %A Schwartzman, David %A Ota, Takeyoshi %A Zenati, Marco A %K Atrial Appendage %K Atrial Fibrillation %K Catheter Ablation %K Combined Modality Therapy %K Electrocardiography %K Female %K Follow-Up Studies %K Humans %K Middle Aged %K Minimally Invasive Surgical Procedures %K Risk Assessment %K Severity of Illness Index %K Tachycardia, Supraventricular %K Treatment Outcome %X Surgical removal or epicardial radiofrequency ablation of the left atrial appendage (LAA) is occasionally required when endocardial ablations fail. We report a modified minimally invasive surgical approach for elimination of recurrent atrial arrhythmias arising from the LAA, including both radiofrequency ablation and appendectomy. Ablation of the LAA base was performed using the Medtronic Cardioblate bipolar radiofrequency device (Medtronic, Minneapolis, MN), and left atrial appendectomy was then completed using the EndoGIA stapling system (US Surgical, Norwalk, CT). This procedure successfully isolated and removed the tachycardia focus, and normal sinus rhythm was restored. Elimination of LAA arrhythmias using a combination of epicardial radiofrequency ablation and appendectomy ensures electrical isolation while minimizing surgical invasiveness. %B Ann Thorac Surg %V 86 %P 1375-7 %8 2008 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/18805205?dopt=Abstract %R 10.1016/j.athoracsur.2008.04.006 %0 Journal Article %J Annu Int Conf IEEE Eng Med Biol Soc %D 2008 %T A novel highly articulated robotic surgical system for epicardial ablation %A Ota, Takeyoshi %A Degani, Amir %A Schwartzman, David %A Zubiate, Brett %A McGarvey, Jeremy %A Choset, Howie %A Zenati, Marco A %K Animals %K Cardiovascular Surgical Procedures %K Catheter Ablation %K Equipment Design %K Equipment Failure Analysis %K In Vitro Techniques %K Pericardium %K Reproducibility of Results %K Robotics %K Sensitivity and Specificity %K Surgery, Computer-Assisted %K Swine %K User-Computer Interface %X We have developed a novel, highly articulated robotic surgical system to enable minimally invasive intrapericardial interventions through a subxiphoid approach and have performed preliminary tests of epicardial left atrial ablation in porcine (N=3) and human cadaver (N=2) preparations. In this study, the novel highly articulated robotic surgical system successfully provided safe epicardial ablations to the left atrium in porcine beating heart models via a subxiphoid approach. We have also performed complex guidance of the robot and subsequent ablation in a cadaveric preparation for successful pulmonary vein isolation. %B Annu Int Conf IEEE Eng Med Biol Soc %V 2008 %P 250-3 %8 2008 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/19162640?dopt=Abstract %R 10.1109/IEMBS.2008.4649137 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2007 %T Electromechanical characterization of a tissue-engineered myocardial patch derived from extracellular matrix %A Ota, Takeyoshi %A Gilbert, Thomas W %A Badylak, Stephen F %A Schwartzman, David %A Zenati, Marco A %K Animals %K Disease Models, Animal %K Electrocardiography %K Extracellular Matrix %K Heart %K Myocardium %K Regeneration %K Swine %K Tissue Engineering %K Ventricular Remodeling %X OBJECTIVE: Extracellular matrix scaffolds have been successfully used for myocardial wall repair. However, regional functional evaluation (ie, contractility, electrical conductivity) of the extracellular matrix scaffold during the course of remodeling has been limited. In the present study, we evaluated the remodeled scaffold for evidence of electrical activation. METHODS: The extracellular matrix patch was implanted into the porcine right ventricular wall (n = 5) to repair an experimentally produced defect. Electromechanical mapping was performed with the NOGA system (Biosense Webster Inc, Diamond Bar, Calif) 60 days after implantation. Linear local shortening was recorded to assess regional contractility. After sacrifice, detailed histologic examinations were performed. RESULTS: Histologic examinations showed repopulation of the scaffold with cells, including a monolayer of factor VIII-positive cells in the endocardial surface and multilayered alpha-smooth muscle actin-positive cells beneath the monolayer cells. The alpha-smooth muscle actin-positive cells tended to be present at the endocardial aspect of the remodeled scaffold and at the border between the remodeled scaffold and the normal myocardium. Electromechanical mapping demonstrated that the patch had low-level electrical activity (0.56 +/- 0.37 mV; P < .0001) in most areas and moderate activity (2.20 +/- 0.70 mV; P < .0001) in the margin between the patch and the normal myocardium (7.58 +/- 2.23 mV). CONCLUSIONS: The extracellular matrix scaffolds were repopulated by alpha-smooth muscle actin-positive cells 60 days after implantation into the porcine heart. The presence of the cells corresponded to areas of the remodeling scaffold that showed early signs of electrical conductivity. %B J Thorac Cardiovasc Surg %V 133 %P 979-85 %8 2007 Apr %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/17382638?dopt=Abstract %R 10.1016/j.jtcvs.2006.11.035 %0 Journal Article %J Ann Thorac Surg %D 2007 %T Epicardial left ventricular mapping using subxiphoid video pericardioscopy %A Zenati, Marco A %A Shalaby, Alaa %A Eisenman, Gregory %A Nosbisch, John %A McGarvey, Jeremy %A Ota, Takeyoshi %K Body Surface Potential Mapping %K Catheter Ablation %K Endoscopy %K Humans %K Male %K Middle Aged %K Pericardium %K Tachycardia, Ventricular %K Xiphoid Bone %X We report a novel subxiphoid video pericardioscopy approach for epicardial mapping that allows direct visualization of the epicardium with minimal use of fluoroscopy. The FLEXview system (Boston Scientific Cardiac Surgery, Santa Clara, CA), which is capable of a free navigation around the heart owing to its flexible neck, was inserted into the pericardial space through a small subxiphoid incision. A commercially available mapping catheter advanced through the working port of the device could be navigated around virtually the entire biventricular epicardial surface. The subxiphoid video pericardioscopy approach using the FLEXview system provided adequate visualization and access to the epicardium of both ventricles for electroanatomic mapping while minimizing surgical invasiveness. %B Ann Thorac Surg %V 84 %P 2106-7 %8 2007 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/18036952?dopt=Abstract %R 10.1016/j.athoracsur.2007.07.032 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2007 %T Impact of beating heart left atrial ablation on left-sided heart mechanics %A Ota, Takeyoshi %A Schwartzman, David %A Francischelli, David %A Hettrick, Douglas A %A Zenati, Marco A %K Analysis of Variance %K Animals %K Atrial Fibrillation %K Atrial Function, Left %K Catheter Ablation %K Echocardiography %K Electrophysiologic Techniques, Cardiac %K Female %K Swine %K Ventricular Function, Left %X OBJECTIVE: The cut-and-sew Cox-Maze procedure is the gold standard for surgical treatment of atrial fibrillation, but it is associated with long-term impairment of left atrial mechanical function. We developed a bipolar, irrigated radiofrequency ablation device. We hypothesized that beating heart radiofrequency left atrial ablation would result in minimal acute changes in left atrial hemodynamics. METHODS: Six healthy subjects were studied. Combination pressure-conductance catheters were inserted into the left atrium and ventricle. With the use of the device, atrial ablation was performed on the beating heart without cardiopulmonary bypass, including electrical isolation of the posterior left atrium and atrial appendage myocardium. Simultaneous left-sided heart pressure-volume and intracardiac echocardiography data were acquired before ablation, after left atrial appendage ablation alone, and after all ablation (with and without appendage occlusion). The derived indices of left-sided heart mechanical function were examined. RESULTS: Relative to baseline, no significant diminishment in pressure-volume or intracardiac echocardiography-derived indices of global left-sided heart mechanical function were observed after ablation, with or without appendage occlusion. Mitral valve morphology and function were not significantly altered. A significant diminishment of atrial appendage systolic flow was noted after appendage ablation in association with spontaneous echocardiographic contrast in this region. CONCLUSIONS: In this model, ablation does not seem to compromise global left-sided heart mechanical function. However, these findings mask regional diminishment in atrial appendage systolic function. This observation demonstrates that electrical isolation of the appendage should be accompanied by its occlusion or excision. Appendage occlusion after ablation does not seem to compromise left-sided heart mechanical function. %B J Thorac Cardiovasc Surg %V 134 %P 982-8 %8 2007 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/17903518?dopt=Abstract %R 10.1016/j.jtcvs.2007.04.063 %0 Journal Article %J Innovations (Phila) %D 2006 %T Epicardial Atrial Ablation Using a Novel Articulated Robotic Medical Probe Via a Percutaneous Subxiphoid Approach %A Ota, Takeyoshi %A Degani, Amir %A Zubiate, Brett %A Wolf, Alon %A Choset, Howie %A Schwartzman, David %A Zenati, Marco A %X OBJECTIVE: Minimally invasive epicardial atrial ablation to cure atrial fibrillation through the use of a percutaneous subxiphoid approach currently has a lack of dedicated technology for intrapericardial navigation around the beating heart. We have developed a novel articulated robotic medical probe and performed preliminary experiments in a porcine preparation. METHODS: In five large, healthy pigs, the teleoperated robotic system was introduced inside the pericardial space through a percutaneous subxiphoid approach. Secondary visualization of the left atrium and left atrial appendage was achieved with the use of a 5-mm scope inserted through a left thoracic port. The operator actively controlled the path of the robot by using a master manipulator. The catheter, with an irrigated radiofrequency tip, was guided through the working port of the robot to achieve epicardial ablation of the left atrium. RESULTS: Access to the pericardial space and progression around the left atrium was successful in all cases, with no interference with the beating heart such as a fatal arrhythmia, unexpected bleeding, and hypotension. Epicardial ablation was successfully performed in all five cases. No adverse hemodynamic or electrophysiological events were noted during the trials. When the animals were killed, there was no visually detected injury on the surrounding mediastinal structures caused by ablation. Transmural ablation was confirmed by histopathology of the left atrium. CONCLUSIONS: We have developed a dedicated articulated robotic medical probe and successfully performed epicardial left atrial radiofrequency ablation. Based on the feedback from these preliminary experiments, the radius of curvature and proper visualization of the device are being improved in the next generation prototype. %B Innovations (Phila) %V 1 %P 335-340 %8 2006 %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/17895961?dopt=Abstract %R 10.1097/imi.0b013e31802f43b1 %0 Journal Article %J Conf Proc IEEE Eng Med Biol Soc %D 2006 %T Highly Articulated Robotic Probe for Minimally Invasive Surgery %A Degani, Amir %A Choset, Howie %A Zubiate, Brett %A Ota, Takeyoshi %A Zenati, Marco %X We have developed a novel highly articulated robotic probe (HARP) that can thread through tightly packed volumes without disturbing the surrounding tissues and organs. We use cardiac surgery as the focal application of this work. As such, we have designed the HARP to enter the pericardial cavity through a subxiphoid port. The surgeon can effectively reach remote intrapericardial locations on the epicardium and deliver therapeutic interventions under direct control. Our device differs from others in that we use conventional actuation and still have great maneuverability. We have performed proof-of-concept clinical experiments to give us preliminary validation of the ideas presented here. %B Conf Proc IEEE Eng Med Biol Soc %V 2006 %P 4167-4172 %8 2006 %G eng %N 1642343 %1 http://www.ncbi.nlm.nih.gov/pubmed/20725532?dopt=Abstract %R 10.1109/ROBOT.2006.1642343 %0 Journal Article %J Conf Proc IEEE Eng Med Biol Soc %D 2006 %T Improved traction for a mobile robot traveling on the heart %A Patronik, N A %A Ota, T %A Zenati, M A %A Riviere, C N %K Animals %K Cardiovascular Surgical Procedures %K Equipment Design %K Equipment Failure Analysis %K Friction %K Minimally Invasive Surgical Procedures %K Motion %K Pericardium %K Robotics %K Sheep %X This document describes the effects of several design parameters on the traction generated by the suction pads of a mobile robot that walks on the surface of the heart. HeartLander is a miniature mobile robot that adheres to the epicardial surface of the heart using suction, and can travel to any desired location on the heart to administer therapeutic applications. To maximize the effectiveness of locomotion, the gripper pads must provide sufficient traction to avoid slipping. Our testing setup measured the force applied to the gripper pad adhering to ovine epicardial tissue, and recorded overhead video for tracking of the pad and tissue during an extension. By synchronizing the force and video data, we were able to determine the point at which the pad lost traction and slipped during the extension. Of the pads tested, the pad with no suction grate achieved maximum traction. Increasing the extension speed up to 20 mm/s resulted in a corresponding increase in traction. Increasing the vacuum pressure also improved the traction, but the magnitude of the effect was less than the improvement gained from increasing extension speed. %B Conf Proc IEEE Eng Med Biol Soc %V 2006 %P 339-42 %8 2006 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/17946816?dopt=Abstract %R 10.1109/IEMBS.2006.259532 %0 Journal Article %J Innovations (Phila) %D 2006 %T Patency outcomes of aortic connectors %A Zenati, Marco A %A Sonel, Ali %A Hattler, Brack %A Shroyer, A Laurie %A Collins, Joseph %A Messenger, John %A Baltz, Janet H %A Mohr, Lisa M %A Gabany, Jennifer M %A Novitsky, Dimitri %A Grover, Frederick %X OBJECTIVE: : Controlled outcome analysis of mechanical aortic connectors for proximal saphenous vein bypass graft anastomosis is lacking. We report the clinical and angiographic outcome of patients receiving the Symmetry aortic connector (St. Jude Medical, Inc St. Paul, MN, US) within a multicenter, prospective, randomized study. METHODS: : Twenty-five patients at 3 study sites received aortic connectors at the time of coronary artery bypass surgery. Protocol-defined angiographic follow-up was completed in 19 of 25 patients (76%) at time-points up to 14 months postoperatively; 32 connector anastomoses were evaluated in these 19 patients. Beating heart surgery was performed in 17 patients, and 2 were performed with cardiopulmonary bypass. Age was 69.7 ± 8.1 year; all patients were males. RESULTS: : The connector anastomosis patency rate was 15.6% (5/32). There were no deaths during the follow-up period. Four patients (21%) suffered myocardial infarction and 2 additional patients (10.5%) required percutaneous coronary interventions; one of who required 3 percutaneous coronary interventions, the other received one percutaneous coronary intervention. CONCLUSIONS: : In this nonrandomized cohort of patients, occlusion rate with Symmetry connectors was significantly greater than anticipated. Patients who have received these connectors during coronary artery bypass surgery may require closer follow-up and evaluation. While the manufacturer has stopped producing this device, there has been no recall of the product, clinical support remains ongoing, and next generation connectors have now been marketed. Consideration should be given to discontinuation of the clinical use of Symmetry connectors. %B Innovations (Phila) %V 1 %P 255-7 %8 2006 Fall %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/22436755?dopt=Abstract %R 10.1097/01.IMI.0000229898.22601.55 %0 Journal Article %J Innovations (Phila) %D 2006 %T Percutaneous subxiphoid access to the epicardium using a miniature crawling robotic device %A Ota, Takeyoshi %A Patronik, Nicholas A %A Riviere, Cameron N %A Zenati, Marco A %X BACKGROUND: : To expand minimally invasive beating-heart surgery, we have developed a miniature 2-footed crawling robot (HeartLander) that navigates on the epicardium. This paradigm obviates mechanical stabilization and lung deflation, and avoids the access limitations of current approaches. We tested the locomotion of the device on a beating porcine heart accessed through a closed-chest subxiphoid approach. METHODS: : HeartLander consists of 2 modules that are connected by an extensible midsection. It adheres to the epicardium using suction pads. Locomotion and turning are accomplished by moving the 2 modules in an alternating fashion using wires that run through the midsection between them. After a preliminary test with a plastic beating-heart model, we performed a porcine study in vivo. The device was inserted into the pericardial space through a subxiphoid incision, while the test was observed using a left thoracoscopy. The blood pressure and electrocardiogram were monitored, and vacuum pressure and driving forces on the wires were recorded. RESULTS: : HeartLander traveled across the anterior and lateral surfaces of the beating heart without restriction, including locomotion forward, backward, and turning. The vacuum pressure was kept below 450 mm Hg at all times. The average maximum force during elongation was 1.86 ± 0.97 N, and during retraction was 1.24 ± 0.33 N. No adverse hemodynamic or electrophysiologic events were noted during the trial. No epicardial damage was found on the excised heart after the porcine trial. CONCLUSIONS: : The current HeartLander prototype demonstrated safe and successful locomotion on a beating porcine heart through a closed-chest subxiphoid approach. %B Innovations (Phila) %V 1 %P 227-31 %8 2006 Fall %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/22436750?dopt=Abstract %R 10.1097/01.IMI.0000240673.14388.fc %0 Journal Article %J Pacing Clin Electrophysiol %D 2006 %T Robotic implantation of a multichamber cardiac resynchronization therapy defibrillator %A Shalaby, Alaa %A Sharma, Mahesh S %A Zenati, Marco A %K Defibrillators, Implantable %K Electrodes, Implanted %K Heart Failure %K Humans %K Male %K Middle Aged %K Prosthesis Implantation %K Robotics %K Surgery, Computer-Assisted %K Treatment Outcome %X Transvenous implantation of a cardiac resynchronization therapy defibrillator (CRT-D) may not be feasible due to anatomic constraints. One of the most notable advances in minimal-access heart surgery has been the introduction of robotic telemanipulation systems. We present a challenging case in which a CRT-D system was implanted using a robotic approach. Feasibility of such an approach expands the horizons for delivery of CRT-D therapy. %B Pacing Clin Electrophysiol %V 29 %P 906-9 %8 2006 Aug %G eng %N 8 %1 http://www.ncbi.nlm.nih.gov/pubmed/16923009?dopt=Abstract %R 10.1111/j.1540-8159.2006.00418.x %0 Journal Article %J Conf Proc IEEE Eng Med Biol Soc %D 2005 %T A miniature cable-driven robot for crawling on the heart %A Patronik, N A %A Zenati, M A %A Riviere, C N %X This document describes the design and preliminary testing of a cable-driven robot for the purpose of traveling on the surface of the beating heart to administer therapy. This methodology obviates mechanical stabilization and lung deflation, which are typically required during minimally invasive cardiac surgery. Previous versions of the robot have been remotely actuated through push-pull wires, while visual feedback was provided by fiber optic transmission. Although these early models were able to perform locomotion in vivo on porcine hearts, the stiffness of the wire-driven transmission and fiber optic camera limited the mobility of the robots. The new prototype described in this document is actuated by two antagonistic cable pairs, and contains a color CCD camera located in the front section of the device. These modifications have resulted in superior mobility and visual feedback. The cable-driven prototype has successfully demonstrated prehension, locomotion, and tissue dye injection during in vitro testing with a poultry model. %B Conf Proc IEEE Eng Med Biol Soc %V 2005 %P 5771-4 %8 2005 %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/17281569?dopt=Abstract %R 10.1109/IEMBS.2005.1615799 %0 Journal Article %J Comput Aided Surg %D 2005 %T Preliminary evaluation of a mobile robotic device for navigation and intervention on the beating heart %A Patronik, N A %A Zenati, M A %A Riviere, C N %K Animals %K Cardiac Surgical Procedures %K Equipment Design %K Laparoscopes %K Minimally Invasive Surgical Procedures %K Pericardium %K Robotics %K Swine %K Video-Assisted Surgery %X This article describes the development and preliminary testing of a mobile robotic device to facilitate minimally invasive beating-heart intrapericardial intervention. The HeartLander robot will be introduced beneath the pericardium via subxiphoid incision, adhere to the epicardium, navigate to any location, and administer therapy under the control of the physician. As compared to current robotic cardiac surgical techniques, this novel paradigm obviates immobilization of the heart and eliminates access limitations. Furthermore, it does not require lung deflation and differential ventilation and thus could enable outpatient cardiac surgery. The current HeartLander prototypes use suction to maintain prehension of the epicardium and wire actuation to perform locomotion. A fiber optic videoscope displays visual feedback to the physician, who controls the device through a joystick interface. The initial prototype demonstrated successful prehension, turning, and locomotion on open-chest, beating-heart porcine models where the pericardium was removed (N = 3). A smaller second-generation prototype with an injection system demonstrated locomotion and myocardial injection of dye, both performed with the pericardium intact (N = 3). These trials illustrate the feasibility of using a miniature mobile robot to navigate upon the beating heart and perform intrapericardial therapy. %B Comput Aided Surg %V 10 %P 225-32 %8 2005 Jul %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/16393791?dopt=Abstract %R 10.3109/10929080500230197 %0 Journal Article %J Pacing Clin Electrophysiol %D 2005 %T Utility of echocardiographic tissue synchronization imaging to redirect left ventricular lead placement for improved cardiac resynchronization therapy %A Dohi, Kaoru %A Suffoletto, Matthew %A Ganz, Leonard %A Zenati, Marco %A Gorcsan, John %K Aged %K Bundle-Branch Block %K Cardiac Pacing, Artificial %K Cardiomyopathies %K Echocardiography, Doppler %K Female %K Humans %X An 80-year-old woman with severe symptomatic heart failure (ejection fraction of 13%), and left bundle branch block (QRS duration of 160 ms) underwent cardiac resynchronization therapy (CRT). She had significant baseline dyssynchrony with a septal to posterior wall delay of 160 ms by echocardiographic tissue synchronization imaging (TSI). Despite exhaustive efforts, a stable posterior-lateral coronary vein lead position could not be achieved with the standard percutaneous approach, resulting in anterior coronary vein lead placement. This resulted in no improvement in the patient's symptoms or ventricular function. Follow-up TSI revealed earlier activation of the anteroseptal site and worsened dyssynchrony with septal to posterior wall delay of now 290 ms. This information prompted surgical revision of the left ventricular (LV) lead position via limited thoracotomy and posterior-lateral epicardial lead implantation. Pacing at the new lead site resulted in a 30% increase in stroke volume and symptomatic improvement. TSI in this case redirected lead position in a clinical nonresponder, resulting in a favorable response to CRT. %B Pacing Clin Electrophysiol %V 28 %P 461-5 %8 2005 May %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/15869683?dopt=Abstract %R 10.1111/j.1540-8159.2005.40056.x %0 Journal Article %J J Cardiovasc Surg (Torino) %D 2004 %T Emergent off-pump complete myocardial revascularization in dextrocardia %A Bonanomi, G %A Kostov, D %A Zenati, M A %K Acute Disease %K Aged %K Angioplasty, Balloon, Coronary %K Cardiac Catheterization %K Cardiopulmonary Bypass %K Coronary Artery Bypass %K Coronary Disease %K Dextrocardia %K Echocardiography %K Electrocardiography %K Emergencies %K Female %K Heart Failure %K Hepatitis C, Chronic %K Humans %K Hyperparathyroidism, Secondary %K Hypertension %K Kidney Failure, Chronic %K Myocardial Infarction %K Radiography %K Saphenous Vein %K Situs Inversus %K Stroke Volume %K Treatment Outcome %K Ventricular Dysfunction, Left %X Dextrocardia is a rare condition not spared by coronary artery disease. We report the case of a 72-year-old patient with dextrocardia associated with situs inversus totalis who presented to our Institution with acute myocardial infarction complicated by congestive heart failure. Due to the severe general conditions of the patient, an emergent off-pump complete myocardial revascularization was undertaken. The patient tolerated the procedure well and was asymptomatic at discharge. The technical aspects encountered in the setting of mirror-image anatomy and the advantages of off-pump myocardial revascularization in the critically ill patient are discussed. %B J Cardiovasc Surg (Torino) %V 45 %P 31-3 %8 2004 Feb %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/15041933?dopt=Abstract %0 Journal Article %J Heart Surg Forum %D 2004 %T Prototype epicardial crawling device for intrapericardial intervention on the beating heart %A Riviere, Cameron N %A Patronik, Nicholas A %A Zenati, Marco A %K Animals %K Endoscopes %K Equipment Design %K Equipment Failure Analysis %K Feasibility Studies %K Minimally Invasive Surgical Procedures %K Motion %K Pericardiectomy %K Pilot Projects %K Robotics %K Swine %X The development and preliminary testing of a device for facilitating minimally invasive beating-heart intrapericardial interventions are described. We propose the concept of an endoscopic robotic device that adheres to the epicardium by suction and navigates by crawling like an inchworm to any position on the surface under the control of a surgeon. This approach obviates cardiac stabilization, lung deflation, differential lung ventilation, and reinsertion of laparoscopic tools for accessing different treatment sites, thus offering the possibility of reduced trauma to the patient. The device has a working channel through which various tools can be introduced for treatment. The current prototype demonstrated successful prehension, turning, and locomotion on beating hearts in a limited number of trials in a porcine model. %B Heart Surg Forum %V 7 %P E639-43 %8 2004 %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/15769699?dopt=Abstract %R 10.1532/HSF98.20041057 %0 Journal Article %J J Heart Lung Transplant %D 2004 %T Serial dobutamine stress echocardiography with Doppler assessment of the left internal thoracic artery graft after minimally invasive bypass for a patient with an orthotopic heart transplant %A Grewal, Harpreet Singh %A Zenati, Marco A %A Kormos, Robert %A Murali, Srinivas %A Katz, William E %K Aged %K Coronary Artery Bypass %K Coronary Disease %K Echocardiography, Stress %K Heart Transplantation %K Humans %K Male %K Minimally Invasive Surgical Procedures %K Postoperative Complications %K Thoracic Arteries %X Select patients who have undergone orthotopic heart transplantation with proximal left anterior disease may be candidates for minimally invasive direct coronary artery bypass surgery. Combining left internal thoracic artery transthoracic Doppler flow assessment with wall motion assessment during dobutamine stress echocardiography adds to the utility of this test by focusing attention on the graft's status as well as detecting ischemia due to cardiac allograft vasculopathy. %B J Heart Lung Transplant %V 23 %P 256-9 %8 2004 Feb %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/14761775?dopt=Abstract %R 10.1016/S1053-2498(03)00146-3 %0 Journal Article %J J Cardiovasc Electrophysiol %D 2003 %T Epicardium-based left atrial ablation: impact on electromechanical properties %A Schwartzman, David %A Bonanomi, Gianluca %A Zenati, Marco A %K Animals %K Atrial Function, Left %K Body Surface Potential Mapping %K Catheter Ablation %K Female %K Heart Atria %K Male %K Myocardial Contraction %K Pericardium %K Pulmonary Veins %K Swine %X UNLABELLED: Epicardium-Based LA Ablation. INTRODUCTION: An important developmental task for surgical ablation of atrial fibrillation is simplification. A significant step would be the development of tools that create satisfactory ablation lesions without necessitating cardiopulmonary bypass or atriotomy. Optimally, these lesions would have no adverse impact on atrial electromechanical properties. METHODS AND RESULTS: We sought to characterize left atrial (LA) lesions created by a bipolar ablation device without cardiopulmonary bypass or atriotomy and to assess their impact on LA electromechanical properties. In each of five pigs, lesions were delivered to the epicardium of the beating heart, and encircled and connected right and left pulmonary vein vestibules and the atrial appendage. Before and after ablation, LA electromechanical properties were assessed using endocardial electromechanical mapping and intracardiac echocardiography. Postmortem histologic analysis also was performed. Each lesion was thrombus-free and barotrauma-free, histologically transmural, and a complete conduction barrier. Although a large aggregate area (24% +/- 6%) of LA myocardium was excluded, there was no significant change in global electromechanical properties. However, marked diminishment in appendage function was observed. CONCLUSION: Epicardium-based LA ablation in a beating heart could be achieved successfully without cardiopulmonary bypass or atriotomy. Although there was no adverse impact on global electromechanical properties, there was evidence of important regional diminishment. %B J Cardiovasc Electrophysiol %V 14 %P 1087-92 %8 2003 Oct %G eng %N 10 %1 http://www.ncbi.nlm.nih.gov/pubmed/14521663?dopt=Abstract %R 10.1046/j.1540-8167.2003.03230.x %0 Journal Article %J J Am Coll Cardiol %D 2003 %T Left atrial appendectomy and maze %A Bonanomi, Gianluca %A Zenati, Marco A %A Schwartzman, David %K Anticoagulants %K Atrial Fibrillation %K Cardiac Surgical Procedures %K Heart Atria %K Humans %K Intracranial Embolism %K Stroke %K Treatment Outcome %K Warfarin %B J Am Coll Cardiol %V 41 %P 170; author reply 170-1 %8 2003 Jan 01 %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/12570963?dopt=Abstract %R 10.1016/s0735-1097(02)02671-2 %0 Journal Article %J J Cardiovasc Electrophysiol %D 2003 %T Left heart pacing lead implantation using subxiphoid videopericardioscopy %A Zenati, Marco A %A Bonanomi, Gianluca %A Chin, Albert K %A Schwartzman, David %K Animals %K Cardiac Pacing, Artificial %K Electrodes, Implanted %K Endoscopy %K Feasibility Studies %K Female %K Male %K Pericardium %K Surgery, Computer-Assisted %K Swine %K Television %K Xiphoid Bone %X INTRODUCTION: Recent clinical data support the utility of left heart pacing. The transvenous approach for left heart pacing lead implantation is imperfect. A direct epicardial approach may have advantages, but heretofore its utility has been limited because of the requirement for thoracotomy. We sought to examine the feasibility of a method for epicardial lead implantation that did not require thoracotomy. METHODS AND RESULTS: In five large swine, percutaneous access to the epicardium was achieved with subxiphoid videopericardioscopy, using a device that marries endoscopy with a port through which pacing leads could be introduced. In each animal, standard, active fixation pacing leads were implanted onto the left atrium and ventricle. The atrial lead was implanted at the base of the appendage. The ventricular lead was implanted on the anterior, lateral, and inferior walls. Continuous direct visualization of the epicardium provided guidance for lead localization and fixation, including avoidance of complications such as trauma to epicardial coronary vessels. Capture thresholds were uniformly low. Postmortem examination demonstrated anatomically accurate, uncomplicated lead fixation. CONCLUSION: Using subxiphoid videopericardioscopy, uncomplicated, anatomically accurate left heart epicardial pacing lead implantation can be achieved without thoracotomy. %B J Cardiovasc Electrophysiol %V 14 %P 949-53 %8 2003 Sep %G eng %N 9 %1 http://www.ncbi.nlm.nih.gov/pubmed/12950539?dopt=Abstract %R 10.1046/j.1540-8167.2003.03255.x %0 Journal Article %J J Thorac Cardiovasc Surg %D 2003 %T Microelectromechanical systems for endoscopic cardiac surgery %A Bonanomi, Gianluca %A Rebello, Keith %A Lebouitz, Kyle %A Riviere, Cameron %A Di Martino, Elena %A Vorp, David %A Zenati, Marco A %K Animals %K Cardiac Surgical Procedures %K Electricity %K Endoscopy %K Equipment Design %K Mechanics %K Miniaturization %K Swine %B J Thorac Cardiovasc Surg %V 126 %P 851-2 %8 2003 Sep %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/14502165?dopt=Abstract %R 10.1016/s0022-5223(03)00393-3 %0 Journal Article %J J Thorac Cardiovasc Surg %D 2003 %T A new device for beating heart bipolar radiofrequency atrial ablation %A Bonanomi, Gianluca %A Schwartzman, David %A Francischelli, David %A Hebsgaard, Kim %A Zenati, Marco A %K Animals %K Cardiac Pacing, Artificial %K Catheter Ablation %K Echocardiography %K Electrocardiography %K Electrophysiologic Techniques, Cardiac %K Heart Atria %K Swine %X OBJECTIVE: A technique for mimicking left atrial atriotomies using an ablation device that can be deployed without cardiopulmonary bypass has been developed. METHODS: In 12 healthy large (35-50 kg) adult pigs, maze-like ablation lesions were directly applied to the left atrial epicardium on the beating heart. The ablation device is irrigated, with a bipolar "hemostat" morphology, utilizing radiofrequency energy. Prior to and after ablation, left atrial electromechanical properties were measured during sinus rhythm in the latest 5 pigs using percutaneous endocardial catheter electromechanical mapping and intracardiac echocardiography. Pathologic analysis was performed acutely. RESULTS: All ablation lesions demonstrated conduction block along their entire course. Global left atrial conduction time (49.4 +/- 8.8 milliseconds before vs 58.8 +/- 9 milliseconds after) and pattern were not significantly altered. Although a significant amount (17.12% +/- 9%) of myocardium was either ablated or electrically isolated, ablation was not associated with significant alterations in global left atrial mechanics (left atrium ejection fraction 19% before vs 17% after; pulmonary vein peak flow velocity 1.22 m/s before vs 1.38 m/s after; peak mitral inflow velocity 2.34 m/s before vs 2.64 m/s after), mitral valve function, nor left ventricular function. There was no evidence of atrial thrombus formation. Transmurality was achieved in most lesions with no evidence of charring or barotrauma. CONCLUSIONS: Utilizing this ablation device, atrial lesions similar to the left component of the Maze procedure were deployed with uniform success in a beating heart without cardiopulmonary bypass or atriotomy and without adverse effects on left atrial electromechanics. %B J Thorac Cardiovasc Surg %V 126 %P 1859-66 %8 2003 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/14688697?dopt=Abstract %R 10.1016/s0022-5223(03)01305-9 %0 Journal Article %J Comput Aided Surg %D 2002 %T Experimental off-pump coronary bypass using a robotic telemanipulation system %A Zenati, Marco A %A Nichols, Larry %A Bonanomi, Gianluca %A Griffith, Bartley P %K Anastomosis, Surgical %K Animals %K Cardiopulmonary Bypass %K Coronary Artery Bypass %K Coronary Vessels %K Endoscopy %K Female %K Male %K Mammary Arteries %K Models, Animal %K Robotics %K Swine %K Telemedicine %X We hypothesized that a high-quality anastomosis between the left internal thoracic artery and the left anterior descending coronary artery could be constructed off-pump using a 4-degrees-of-freedom robotic telemanipulation system, endoscopic myocardial stabilization, and two-dimensional visualization. Nine swine were used. Three ports were created on the left chest for the endoscope and the two robotic arms, and another port was created on the right chest for the endostabilizer. Quality of anastomosis was assessed by angiography, analysis of flow, survival after proximal coronary ligation, and histopathology. All nine anastomoses were completed successfully in 22 +/- 3.6 minutes without the need for repair stitches. Left internal thoracic artery flow was 21.6 +/- 2.5 ml/min with diastolic dominant pattern. Eight animals (89%) survived for 60 minutes with the proximal left anterior descending coronary ligated. Angiographic patency was 100% with Fitzgibbon grade A in all. Histopathology of the anastomosis demonstrated minor changes in the integrity of the endothelium and the internal elastic lamina and absence of medial necrosis. We have demonstrated in our robotic off-pump coronary bypass model that a high-quality anastomosis can be constructed between the left internal thoracic artery and the left anterior descending coronary artery. These results support continued research towards robotic endoscopic off-pump CABG. %B Comput Aided Surg %V 7 %P 248-53 %8 2002 %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/12454895?dopt=Abstract %R 10.1002/igs.10045 %0 Journal Article %J Circulation %D 2002 %T Images in cardiovascular medicine. Fulminant Clostridium septicum aortitis %A Zenati, Marco A %A Bonanomi, Gianluca %A Kostov, Dean %A Lee, Robert %K Aged %K Aorta, Thoracic %K Aortitis %K Clostridium %K Humans %K Male %K Tomography, X-Ray Computed %B Circulation %V 105 %P 1871 %8 2002 Apr 16 %G eng %N 15 %1 http://www.ncbi.nlm.nih.gov/pubmed/11956133?dopt=Abstract %R 10.1161/01.cir.0000016163.45584.a1 %0 Journal Article %J Heart Surg Forum %D 2002 %T A new live animal training model for off-pump coronary bypass surgery %A Zenati, Marco A %A Bonanomi, Gianluca %A Kostov, Dean %A Svanidze, Oleg %K Anastomosis, Surgical %K Animals %K Cardiac Surgical Procedures %K Clinical Competence %K Coronary Artery Bypass %K Disease Models, Animal %K Education, Medical %K Models, Anatomic %K Robotics %K Swine %X Training models are needed to perform accurate off-pump coronary artery bypass (OPCAB) surgery and to test evolving new technologies like minimally invasive devices and robotics. We describe a simple, effective and reproducible live animal training model to perform multiple arterial anastomoses on the beating heart that would maximize the use of available resources for training purposes. %B Heart Surg Forum %V 5 %P 150-1 %8 2002 %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/12114129?dopt=Abstract %0 Journal Article %J Ann Thorac Surg %D 2002 %T Outcomes of lung volume reduction surgery followed by lung transplantation: a matched cohort study %A Burns, Karen E A %A Keenan, Robert J %A Grgurich, Wayne F %A Manzetti, Jan D %A Zenati, Marco A %K Aged %K Cohort Studies %K Female %K Follow-Up Studies %K Humans %K Lung Transplantation %K Male %K Middle Aged %K Pneumonectomy %K Postoperative Complications %K Pulmonary Emphysema %K Spirometry %K Survival Rate %X BACKGROUND: Lung volume reduction surgery (LVRS) has been demonstrated to provide symptomatic relief and to improve lung function in patients with end-stage emphysema. The goal of this study was to assess the additional morbidity associated with lung transplantation after LVRS for end-stage emphysema with regard to immediate postoperative outcomes, longitudinal spirometry, and survival rates compared to an age-, gender-, procedure-matched, and transplant time-matched cohort that had lung transplantation alone. METHODS: We compared the postoperative and long-term outcomes of a sequential procedure cohort to a matched cohort to assess the possible added post-transplant morbidity. RESULTS: Fifteen patients who underwent sequential LVRS (including 11 unilateral LVRS, 4 bilateral LVRS) and lung transplantation (ipsilateral in 7 and contralateral in 8) on average 28.1 +/- 17.2 months (median, 27.4 months; range, 3.7 to 61.7 months) later were assessed. No significant differences were noted in pretransplant demographics, post-transplant variables, longitudinal spirometric indices, or survival. A trend toward a lower pretransplant arterial carbon dioxide tension was apparent in the sequential procedure cohort. Group analysis revealed a significant increase in the number of patients requiring transfusion and in the total number of units transfused in patients undergoing ispsilateral transplantation after LVRS; a significant increase in the length of intensive care unit stay; and a trend toward an increase in the duration of hospital stay in patients undergoing lung transplantation within 18 months of LVRS. CONCLUSIONS: In appropriate candidates, LVRS bridged the time to transplantation by an average of 28.1 +/- 17.2 months (median, 27.4 months; range, 3.7 to 61.7 months) without significantly increasing post-transplant morbidity or mortality. Furthermore, bilateral LVRS bridged the time to transplantation to a greater extent than unilateral LVRS (34.9 +/- 29.8 months; median, 32.1 months versus 25.4 +/- 16.3 months; median, 22.3 months; p = 0.23). %B Ann Thorac Surg %V 73 %P 1587-93 %8 2002 May %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/12022555?dopt=Abstract %R 10.1016/s0003-4975(02)03499-9 %0 Journal Article %J Heart Surg Forum %D 2001 %T Hybrid strategies in minimally invasive revascularization %A Zenati, M A %K Coronary Disease %K Humans %K Mammary Arteries %K Minimally Invasive Surgical Procedures %K Myocardial Revascularization %K Treatment Outcome %B Heart Surg Forum %V 4 %P 328-30 %8 2001 %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/11827862?dopt=Abstract %0 Journal Article %J Ann Thorac Surg %D 2001 %T Minimally invasive coronary bypass without general endotracheal anesthesia %A Zenati, M A %A Paiste, J %A Williams, J P %A Strindberg, G %A Dumouchel, J P %A Griffith, B P %K Anesthesia, Endotracheal %K Anesthesia, Epidural %K Coronary Artery Bypass %K Graft Occlusion, Vascular %K Humans %K Male %K Middle Aged %K Minimally Invasive Surgical Procedures %K Reoperation %K Stents %X This report describes the case of a 51-year-old man with myocardial ischemia resulting from in-stent restenosis of the left anterior descending coronary artery who underwent a minimally invasive direct coronary artery bypass using thoracic epidural analgesia while awake, without general endotracheal anesthesia. %B Ann Thorac Surg %V 72 %P 1380-2 %8 2001 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/11603472?dopt=Abstract %R 10.1016/s0003-4975(00)02474-7 %0 Journal Article %J Anesth Analg %D 2001 %T Minimally invasive direct coronary artery bypass surgery under high thoracic epidural %A Paiste, J %A Bjerke, R J %A Williams, J P %A Zenati, M A %A Nagy, G E %K Anesthesia, Epidural %K Coronary Artery Bypass %K Humans %K Male %K Middle Aged %K Minimally Invasive Surgical Procedures %X IMPLICATIONS: This report describes the use of high-thoracic epidural anesthesia for a patient undergoing minimally invasive direct coronary artery bypass. %B Anesth Analg %V 93 %P 1486-8, table of contents %8 2001 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/11726428?dopt=Abstract %R 10.1097/00000539-200112000-00028 %0 Journal Article %J Cardiol Rev %D 2001 %T Robotic heart surgery %A Zenati, M A %K Cardiac Surgical Procedures %K Heart Diseases %K Humans %K Patient Care %K Robotics %X Advances in computer and robotic technology are transforming cardiac surgery, overcoming the limitations of conventional endoscopic tools. Using minimal access through 5 millimeter ports, computer-enhanced instruments provide superhuman dexterity through tremor filtration and motion scaling, and are capable of precise manipulation in confined body cavities. Using these technologies, endoscopic beating heart coronary bypass surgery as well as complex mitral valve repairs have been performed in the last few years. However, the current world experience with robotic heart surgery is mostly anecdotal, retrospective, and noncontrolled. Results of rigorous prospective randomized studies in the United States under Food and Drug Administration approved protocols, are awaited. The use of robotic telemanipulation technology for heart surgery is restricted in the United States to patients enrolled in clinical studies in a few elite centers. Further refinement in robotic and image-guided technology for cardiac surgery may further expand the use of computer enhanced instrumentation in the near future. %B Cardiol Rev %V 9 %P 287-94 %8 2001 Sep-Oct %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/11520453?dopt=Abstract %R 10.1097/00045415-200109000-00009 %0 Journal Article %J J Heart Lung Transplant %D 2001 %T Ten year experience of FK 506 for adult cardiac transplantation at a single institution %A Sakai, T %A Kormos, R L. %A Mccurry, K R. %A Ristich, J %A Hattler, B G. %A Zenati, M %A Griffith, B P. %B J Heart Lung Transplant %V 20 %P 191-192 %8 2001 Feb %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/11250326?dopt=Abstract %R 10.1016/s1053-2498(00)00400-9 %0 Journal Article %J J Thorac Cardiovasc Surg %D 1999 %T Alternative approach to multivessel coronary disease with integrated coronary revascularization %A Zenati, M %A Cohen, HA %A Griffith, B P %K Aged %K Aged, 80 and over %K Angioplasty, Balloon, Coronary %K Coronary Artery Bypass %K Coronary Disease %K Female %K Follow-Up Studies %K Humans %K Male %K Middle Aged %K Minimally Invasive Surgical Procedures %K Myocardial Revascularization %K Postoperative Complications %K Retreatment %K Thoracic Arteries %X OBJECTIVE: Integrated coronary revascularization combines minimally invasive coronary artery bypass grafting (MICABG) with left internal thoracic artery-left anterior descending artery grafting and percutaneous coronary intervention. We hypothesized that integrated coronary revascularization could result in successful revascularization in suitable patients with multivessel coronary artery disease. METHODS: Between September 1996 and January 1998, 31 consecutive patients underwent integrated coronary revascularization. Twenty-two were male; mean age was 69 years (46-86 years) and 42% were older than 75 years. Eight patients (26%) had a Parsonnet score greater than 20%. Left ventricular ejection fraction was 46.3% +/- 12%; 6 patients (19%) had a left ventricular ejection fraction less than 35%. RESULTS: The anastomosis time for MICABG with the internal thoracic artery was 14.6 +/- 5.2 minutes and the operating time was 105 +/- 20 minutes; 28 patients (90%) were extubated in the operating room. The internal thoracic artery anastomosis was patent in all 31 patients (100%). Percutaneous coronary intervention was performed before MICABG in 2 patients (7%), on the same day of MICABG in 16 patients (52%), on postoperative day 1 in 3 patients (9%), and on postoperative days 2 to 4 in 10 patients (32%). Postprocedure length of stay in the hospital was 2.7 +/- 1.0 days and 13 patients (42%) were discharged home on postoperative day 1 or 2. Three patients (9.6%) required repeat target vessel revascularization in the distribution of the previous percutaneous coronary intervention. All patients are alive without angina at a follow-up of 10.8 +/- 3.8 months. CONCLUSION: Our early results demonstrate that integrated coronary revascularization can be performed safely and effectively. Long-term results will be available from a prospective randomized trial now underway to compare integrated coronary revascularization with coronary artery bypass grafting for multivessel coronary artery disease. %B J Thorac Cardiovasc Surg %V 117 %P 439-44; discussion 444-6 %8 1999 Mar %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/10047645?dopt=Abstract %R 10.1016/s0022-5223(99)70322-3 %0 Journal Article %J Curr Interv Cardiol Rep %D 1999 %T Alternative Approaches to Coronary Revascularization %A Cohen, HA %A Zenati, M %B Curr Interv Cardiol Rep %V 1 %P 138-146 %8 1999 Jul %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/11096618?dopt=Abstract %0 Journal Article %J Am J Cardiol %D 1999 %T Assessment of left internal mammary artery graft patency and flow reserve after minimally invasive direct coronary artery bypass %A Katz, W E %A Zenati, M %A Mandarino, W A %A Cohen, HA %A Gorcsan, J %K Adenosine %K Aged %K Analysis of Variance %K Blood Flow Velocity %K Coronary Angiography %K Coronary Artery Bypass %K Coronary Disease %K Coronary Vessels %K Echocardiography, Doppler %K Female %K Humans %K Internal Mammary-Coronary Artery Anastomosis %K Linear Models %K Male %K Mammary Arteries %K Middle Aged %K Minimally Invasive Surgical Procedures %K Regional Blood Flow %K Thoracotomy %K Vascular Patency %K Vasodilator Agents %X Despite its merits, minimally invasive direct coronary artery bypass surgery (MIDCAB) has been criticized for variable left internal mammary artery (LIMA) graft patency rates, prompting the frequent use of postoperative LIMA angiography. Noninvasive transthoracic Doppler interrogation of LIMA grafts has recently been shown to have utility for assessing patency and flow reserve after conventional bypass surgery, but data after MIDCAB has been limited. The objective of this study was to assess LIMA graft anatomy and physiology in 54 patients after MIDCAB using angiography and noninvasive LIMA Doppler imaging. The right internal mammary artery (RIMA) was studied as a control. LIMA flow reserve in response to adenosine was evaluated in a subgroup of 18 randomly chosen patients with patent grafts. LIMA angiographic patency was 93%. Forty-four patients (81%) had obtainable LIMA Doppler data. Patent grafts had a diastolic dominant flow pattern with a peak diastolic/systolic velocity ratio of 1.3 +/- 0.6 and a percent diastolic time-velocity integral (TVI) of 70 +/- 11%. These data were significantly different than the RIMA control values of 0.2 +/- 0.1 and 30 +/- 10%, respectively (p <0.05). Occluded grafts had absent flow or a systolic dominant pattern. Adenosine-induced increases in LIMA peak diastolic velocity from 48 +/- 20 to 105 +/-28 cm/s (p <0.05 vs baseline) and diastolic TVI from 21 +/- 10 to 37 +/- 19 cm (p <0.05 vs baseline), yielding adenosine/baseline ratios of 2.4 +/- 0.9 and 2.0 +/- 0.7, respectively, which was consistent with normal flow reserve. The diastolic flow velocity reserve response was inversely related to baseline diastolic flow (r = -0.69). In conclusion, MIDCAB can be associated with a high rate of LIMA potency and favorable physiologic Doppler flow patterns. Correlation of these findings to long-term patient outcome after MIDCAB is warranted. %B Am J Cardiol %V 84 %P 795-801 %8 1999 Oct 01 %G eng %N 7 %1 http://www.ncbi.nlm.nih.gov/pubmed/10513776?dopt=Abstract %R 10.1016/s0002-9149(99)00439-7 %0 Journal Article %J J Thorac Cardiovasc Surg %D 1999 %T Emerging new concepts of myocardial laser revascularization %A Zenati, M %A Cohen, HA %B J Thorac Cardiovasc Surg %V 118 %P 977-8 %8 1999 Nov %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/10534811?dopt=Abstract %R 10.1016/s0022-5223(99)70082-6 %0 Journal Article %J J Invasive Cardiol %D 1999 %T Integrated coronary revascularization %A Cohen, HA %A Zenati, M %K Adult %K Aged %K Aged, 80 and over %K Angioplasty, Balloon, Coronary %K Clinical Trials as Topic %K Coronary Angiography %K Coronary Artery Bypass %K Coronary Artery Disease %K Female %K Humans %K Male %K Myocardial Revascularization %B J Invasive Cardiol %V 11 %P 184-90; discussion 190-1 %8 1999 Mar %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/10745509?dopt=Abstract %0 Journal Article %J Dimens Crit Care Nurs %D 1999 %T Minimally invasive coronary artery bypass grafting: a kinder cut %A Koncsol, K %A DeVoogd, K %A Hravnak, M %A Zenati, M %K Coronary Artery Bypass %K Critical Care %K Humans %K Minimally Invasive Surgical Procedures %K Patient Discharge %K Patient Selection %K Postoperative Care %X Minimally invasive coronary artery bypass graft (CABG) surgery is a promising variation on traditional CABG, avoiding the risks of sternotomy and cardiopulmonary bypass. This article describes the procedure, patient-selection criteria, and postoperative care. %B Dimens Crit Care Nurs %V 18 %P 21-3 %8 1999 Mar-Apr %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/10640005?dopt=Abstract %R 10.1097/00003465-199903000-00004 %0 Journal Article %J Ann Thorac Surg %D 1999 %T Transmyocardial laser revascularization in the patient with unmanageable unstable angina %A Hattler, B G %A Griffith, B P %A Zenati, M A %A Crew, J R %A Mirhoseini, M %A Cohn, L H %A Aranki, S F %A Frazier, O H %A Cooley, D A %A Lansing, A M %A Horvath, K A %A Fontana, G P %A Landolfo, K P %A Lowe, J E %A Boyce, S W %K Adult %K Aged %K Aged, 80 and over %K Angina, Unstable %K Follow-Up Studies %K Heart Ventricles %K Humans %K Laser Therapy %K Male %K Middle Aged %K Myocardial Revascularization %K Postoperative Complications %K Reoperation %K Survival Rate %K Treatment Outcome %X BACKGROUND: Transmyocardial laser revascularization (TMR) provides relief for patients with chronic angina, nonamenable to direct coronary revascularization. Unmanageable, unstable angina (UUA) defines a subset of patients with refractory angina who are at high risk for myocardial infarction and death. Patients were classified in the UUA group when they had been admitted to the critical care unit with unstable angina for 7 days with three failed attempts at weaning them off intravenous antianginal medications. METHODS: Seventy-six treated patients were analyzed to determine if TMR is a viable option for patients with unmanageable unstable angina. These patients were compared with 91 routine protocol patients (protocol group [PG]) undergoing TMR for chronic angina not amenable to standard revascularization. The procedure was performed through a left thoracotomy without cardiopulmonary bypass. These patients were followed for 12 months after the TMR procedure. Both unmanageable and chronic angina patients had a high incidence of at least one prior surgical revascularization (87% and 91%, respectively). RESULTS: Perioperative mortality (< or = 30 days post-TMR) was higher in the UUAG versus PG (16% vs 3%, p = 0.005). Late mortality, up to 1 year of follow-up, was similar (13% vs 11%, UUAG vs PG; p = 0.83). A majority of the adverse events in the UUAG occurred within the first 3 months post-TMR, and patients surviving this interval did well, with reduced angina of at least two classes occurring in 69%, 82%, and 82% of patients at 3, 6, and 12 months, respectively. The percent improvement in angina class from baseline was statistically significant at 3, 6, and 12 months. A comparable improvement in angina was found in the protocol group of patients. CONCLUSIONS: TMR carried a significantly higher risk in unmanageable, unstable angina than in patients with chronic angina. In the later follow-up intervals, however, both groups demonstrated similar and persistent improvement in their angina up to 12 months after the procedure. TMR may be considered in the therapy of patients with unmanageable, unstable angina who otherwise have no recourse to effective therapy in the control of their disabling angina. %B Ann Thorac Surg %V 68 %P 1203-9 %8 1999 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/10543480?dopt=Abstract %R 10.1016/s0003-4975(99)00972-8 %0 Journal Article %J Ann Thorac Surg %D 1998 %T Abciximab and excessive bleeding in patients undergoing emergency cardiac operations %A Gammie, J S %A Zenati, M %A Kormos, R L %A Hattler, B G %A Wei, L M %A Pellegrini, R V %A Griffith, B P %A Dyke, C M %K Abciximab %K Adult %K Aged %K Antibodies, Monoclonal %K Blood Loss, Surgical %K Cardiac Surgical Procedures %K Emergency Treatment %K Female %K Humans %K Immunoglobulin Fab Fragments %K Male %K Middle Aged %K Platelet Aggregation Inhibitors %K Postoperative Hemorrhage %X BACKGROUND: Abciximab (ReoPro; Eli Lilly and Co, Indianapolis, IN) is a monoclonal antibody that binds to the platelet glycoprotein IIb/IIIa receptor and produces powerful inhibition of platelet function. Clinical trials of abciximab in patients undergoing coronary angioplasty have demonstrated a reduction in thrombotic complications and have encouraged the widespread use of this agent. We have observed a substantial incidence of excessive bleeding among patients who receive abciximab and subsequently require emergency cardiac operations. METHODS: The records of 11 consecutive patients who required emergency cardiac operations after administration of abciximab and failed angioplasty or stent placement were reviewed. RESULTS: The interval from the cessation of abciximab administration to operation was critical in determining the degree of coagulopathy after cardiopulmonary bypass. The median values for postoperative chest drainage (1,300 versus 400 mL; p < 0.01), packed red blood cells transfused (6 versus 0 U; p = 0.02), platelets transfused (20 versus 0 packs; p = 0.02), and maximum activated clotting time (800 versus 528 seconds; p = 0.01) all were significantly greater in the early group (cardiac operation < 12 hours after abciximab administration; n = 6) compared with the late (cardiac operation >12 hours after abciximab administration; n = 5) group. CONCLUSIONS: This report suggests that the antiplatelet agent abciximab is associated with substantial bleeding when it is administered within 12 hours of operation. %B Ann Thorac Surg %V 65 %P 465-9 %8 1998 Feb %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/9485247?dopt=Abstract %R 10.1016/s0003-4975(97)01299-x %0 Journal Article %J Circulation %D 1998 %T Feasibility of combined percutaneous transluminal angioplasty and minimally invasive direct coronary artery bypass in patients with multivessel coronary artery disease %A Cohen, HA %A Zenati, M %A Smith, A J %A Lee, J S %A Chough, S %A Jafar, Z %A Counihan, P %A Izzo, M %A Burchenal, J E %A Feldman, A M %A Griffith, B %K Angioplasty, Balloon, Coronary %K Coronary Artery Bypass %K Coronary Disease %K Coronary Vessels %K Humans %K Minimally Invasive Surgical Procedures %K Retrospective Studies %K Stents %K Treatment Outcome %X BACKGROUND: Angioplasty has become an accepted treatment of patients with coronary artery disease and is now commonly used to treat patients with multivessel disease. The major disadvantage of angioplasty has been restenosis requiring repeat interventions with resultant loss of initial cost savings. Compared with the right and the circumflex coronary arteries, the left anterior descending artery (LAD) has been more adversely affected by restenosis. Recently, minimally invasive direct coronary artery bypass (MIDCAB) to the LAD through a small left anterior thoracotomy using the left internal mammary artery has been performed in some centers with excellent early results and with reduced costs compared with standard bypass surgery. METHODS AND RESULTS: We retrospectively reviewed the first 31 consecutive patients treated in our institution with integrated coronary revascularization (ICR): MIDCAB to the LAD combined with PTCA of the other diseased vessels in patients with multivessel disease. Postoperative angiography in 84% of patients revealed a patent anastomosis and normal flow in the graft and bypassed vessel. Thirty-eight (97%) of 39 vessels were successfully treated percutaneously. At a mean follow-up of 7 months, all patients are currently asymptomatic. There have been 2 adverse clinical events, both related to angioplasty and not to MIDCAB. The average length of stay at the hospital after MIDCAB was 2.79+/-1.05 days. CONCLUSIONS: These preliminary results with ICR are encouraging and suggest that a randomized, prospective clinical trial comparing ICR with standard coronary artery bypass surgery for the revascularization of symptomatic patients with multivessel disease involving the LAD is warranted. %B Circulation %V 98 %P 1048-50 %8 1998 Sep 15 %G eng %N 11 %1 http://www.ncbi.nlm.nih.gov/pubmed/9736589?dopt=Abstract %R 10.1161/01.cir.98.11.1048 %0 Journal Article %J Eur J Cardiothorac Surg %D 1998 %T Lung volume reduction or lung transplantation for end-stage pulmonary emphysema? %A Zenati, M %A Keenan, R J %A Courcoulas, A P %A Griffith, B P %K Aged %K alpha 1-Antitrypsin Deficiency %K Endoscopy %K Female %K Humans %K Lung Transplantation %K Male %K Middle Aged %K Pneumonectomy %K Pulmonary Emphysema %K Respiratory Mechanics %K Thoracoscopy %K Treatment Outcome %X OBJECTIVE: As the waiting period for lung transplant (LT) candidates with end-stage pulmonary emphysema (COPD) continues to increase, there is a need for alternative treatments to reduce the morbidity and mortality associated with COPD. We hypothesized that lung reduction (LR) may avoid the need for subsequent LT in patients on the waiting list that are also candidates for LR. METHODS: From July 1994 to December 1995, 20 patients received LR as alternative to LT. The average age was 58 +/- 7 years; 11 were males. Eighteen patients had primary COPD and two had alpha-1 antitrypsin deficiency. Eighteen LRs were thoracoscopic (two bilateral and 16 unilateral) and two were done through a median sternotomy. RESULTS: At a follow-up of 32 +/- 4 months, 19 patients are alive (19/20 = 95%). Fifteen patients (15/20 = 75%) are currently off the LT list and doing well: FEV1 is 40 +/- 18% predicted at 2 years compared with 22.7 +/- 6% before LR (P < 0.001); FVC is 84 +/- 13% at 2 years compared with 55 +/- 7% (P < 0.001) and the RV is 145 +/- 59% compared with 270 +/- 58% (P < 0.001). One patient (5%) required extra-corporeal membrane oxygenation (ECMO) after LR to the contralateral side of the first procedure and subsequently died. Two patients (10%) are currently listed for LT because of persistent symptoms. One patient (5%) in whom deterioration was secondary to exposure to toxic fumes, underwent successful LT. One patient (5%) is doing well from the pulmonary standpoint but is being worked up for new severe coronary artery disease (CAD). The freedom from LT is 95% (19/20) and the freedom from repeat LR is 85% (17/20). CONCLUSIONS: LR has the potential to offer an effective palliative alternative to LT in 75% of selected patients up to 32 months of follow-up. Widespread use of bilateral LR is anticipated to further improve the results. %B Eur J Cardiothorac Surg %V 14 %P 27-31; discussion 31-2 %8 1998 Jul %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/9726611?dopt=Abstract %R 10.1016/s1010-7940(98)00132-8 %0 Journal Article %J Eur J Cardiothorac Surg %D 1998 %T MIDCAB characteristics and results: the CardioThoracic Systems (CTS) registry %A Holubkov, R %A Zenati, M %A Akin, J J %A Erb, L %A Courcoulas, A %K Coronary Artery Bypass %K Female %K Humans %K Internal Mammary-Coronary Artery Anastomosis %K Male %K Middle Aged %K Minimally Invasive Surgical Procedures %K Postoperative Complications %K Registries %K Time Factors %K Treatment Outcome %K Vascular Patency %X OBJECTIVE: The CardioThoracic Systems (CTS) registry of minimally invasive direct coronary artery bypass (MIDCAB) was established to examine baseline characteristics of patients undergoing this surgical procedure, document details of the procedures including grafting techniques and post-operative complication rates, and assess post-operative graft patency. METHODS: A total of 508 consecutive patients who had MIDCAB using CTS instrumentation between April 1996 and March 1997 at 35 international centers were analyzed. RESULTS: The mean age of patients, 27% of whom were women, was 63 years. Eight percent had previous coronary artery bypass surgery. While nearly all patients had significant stenoses in the left anterior descending artery, 23% had disease in two vessels and 9% in three vessels. Almost all procedures used the left internal mammary artery, with 7% employing multiple or sequential grafts. The entire surgical procedure lasted on average 135 min (median 2 h), with a mean time of 14 min to perform anastomosis. Surgical approaches, including anastomosis technique and method used to maintain bloodless field, varied widely across clinical centers. In-hospital complication rates were relatively low, with 0.6% mortality (0% perioperative), 1.2% conversion to sternotomy with cardiopulmonary bypass, 1.4% conversion to sternotomy without bypass, and 5.5% redo or reintervention. In total, 92% of patients were free from all of these events at hospital discharge; women showed a strong trend toward increased risk for major in-hospital events compared with men. Rib fracture was the most common complication, reported in 12% of patients. Post-operative angiography, performed in 83 patients at an average 2.2 days post-procedure, found full patency in 78 (94%). CONCLUSIONS: The CTS registry data indicates that in the great majority of patients, MIDCAB using CTS instrumentation was performed safely and with acute success. Comparative studies, most importantly clinical trials, are needed to determine the types of patients who benefit most from this procedure, as well as its longer-term outcome. %B Eur J Cardiothorac Surg %V 14 Suppl 1 %P S25-30 %8 1998 Oct %G eng %1 http://www.ncbi.nlm.nih.gov/pubmed/9814788?dopt=Abstract %R 10.1016/s1010-7940(98)00100-6 %0 Journal Article %J J Thorac Cardiovasc Surg %D 1998 %T Preoperative risk models for minimally invasive coronary bypass: a preliminary study %A Zenati, M %A Cohen, HA %A Holubkov, R %A Smith, A J %A Boujoukos, A J %A Caldwell, J %A Firestone, L %A Griffith, B P %K Aged %K Aged, 80 and over %K Angioplasty, Balloon, Coronary %K Cause of Death %K Cerebrovascular Disorders %K Combined Modality Therapy %K Coronary Artery Bypass %K Coronary Disease %K Female %K Hospital Mortality %K Humans %K Length of Stay %K Male %K Middle Aged %K Minimally Invasive Surgical Procedures %K Postoperative Complications %K Risk Assessment %K Stents %K Treatment Outcome %X OBJECTIVE: Available risk assessment models are designed for standard coronary artery bypass grafting. We hypothesized that minimally invasive coronary bypass could improve on predicted outcome in extremely high-risk patients (Parsonnet score > 20%) by the current risk models. METHODS: From September 1996 to September 1997, 27 consecutive extremely high-risk patients underwent minimally invasive coronary bypass. Seventeen patients were male; age was 73 +/- 12 years, and 63% of patients were older than 75 years. Left ventricular ejection fraction was 33.7% +/- 15% and 63% had an ejection fraction of less than 35%. The predicted 30-day mortality according to the System 97 model was 25.6% +/- 11.3%. The Parsonnet risk score was 36.2% +/- 11%; the predicted length of stay in the hospital was 15.3 +/- 3 days. The predicted risk of stroke according to the Multicenter Perioperative Stroke Risk Index was 22.3% +/- 11.7%. RESULTS: Minimally invasive coronary bypass was isolated in 20 patients and integrated with angioplasty and stenting in 7 patients. The observed 30-day mortality was 0% (P < .01 vs predicted): at an average follow-up of 10.8 +/- 4.1 months, 26 patients (96.3%) are alive without angina; one patient with acquired immunodeficiency syndrome died on postoperative day 40 of acute pancreatitis. No patient had a stroke or neurologic deficit (P < .01 vs predicted). Patency of internal thoracic artery anastomosis was confirmed by angiography in all 27 patients. No patient required reoperation. Eighteen patients (67%) were extubated in the operating room. The observed length of hospital stay after minimally invasive coronary bypass was 3.8 +/- 2.6 days (P < .01 vs predicted). CONCLUSION: On the basis of our results on a relatively small series of patients, we suggest that risk models geared for standard coronary bypass grafting may not be appropriate for minimally invasive coronary bypass. %B J Thorac Cardiovasc Surg %V 116 %P 584-9 %8 1998 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/9766586?dopt=Abstract %R 10.1016/s0022-5223(98)70164-3 %0 Journal Article %J J Thorac Cardiovasc Surg %D 1998 %T Resident training and minimally invasive cardiac surgery %A Zenati, M %A Spier, L %A Gammie, J S %A Griffith, B P %K Cardiac Surgical Procedures %K Cardiology %K Coronary Artery Bypass %K Education %K Humans %K Internship and Residency %K Minimally Invasive Surgical Procedures %B J Thorac Cardiovasc Surg %V 115 %P 1390 %8 1998 Jun %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/9628687?dopt=Abstract %R 10.1016/s0022-5223(98)70228-4 %0 Journal Article %J Ann Thorac Surg %D 1997 %T Lung transplantation for respiratory failure resulting from systemic disease %A Pigula, F A %A Griffith, B P %A Zenati, M A %A Dauber, J H %A Yousem, S A %A Keenan, R J %K Adult %K Female %K Graft Rejection %K Graft vs Host Disease %K Humans %K Hypertension, Pulmonary %K Immunosuppression Therapy %K Infections %K Lung %K Lung Neoplasms %K Lung Transplantation %K Lymphangiomyoma %K Male %K Postoperative Care %K Postoperative Complications %K Recurrence %K Respiratory Insufficiency %K Retrospective Studies %K Sarcoidosis, Pulmonary %K Scleroderma, Systemic %X BACKGROUND: Lung transplantation for pulmonary failure resulting from systemic disease is controversial. We reviewed our transplant experience in patients with sarcoidosis, scleroderma, lymphangioleiomyomatosis, and graft-versus-host disease. METHODS: This retrospective review examined the outcome of 23 patients who underwent pulmonary transplantation for these systemic diseases. Group 1 included 15 patients with pulmonary hypertension who underwent transplantation (9 for sarcoidosis, 6 for scleroderma), and group 2 included 8 patients with normal pulmonary artery pressures who underwent transplantation (5 for lymphangioleiomyomatosis, 3 for graft-versus-host disease). The incidences of infection and rejection, pulmonary function, and survival were measured and compared with those of patients who underwent transplantation for isolated pulmonary disease. RESULTS: Although there were no differences in the rate of infection between patients who underwent transplantation for systemic versus isolated disease, patients with pulmonary hypertension who underwent transplantation for systemic disease had significantly lower rates of rejection. Four patients with sarcoidosis and 2 with lymphangioleiomyomatosis demonstrated recurrence in the allograft. Survival was similar between patients who underwent transplantation for systemic versus isolated disease. CONCLUSIONS: Patients with respiratory failure resulting from these systemic diseases can undergo transplantation with outcomes comparable to those obtained in patients who undergo transplantation for isolated pulmonary disease. %B Ann Thorac Surg %V 64 %P 1630-4 %8 1997 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/9436547?dopt=Abstract %R 10.1016/s0003-4975(97)00930-2 %0 Journal Article %J Ann Thorac Surg %D 1997 %T Resource utilization for minimally invasive direct and standard coronary artery bypass grafting %A Zenati, M %A Domit, T M %A Saul, M %A Gorcsan, J %A Katz, W E %A Hudson, M %A Courcoulas, A P %A Griffith, B P %K Aged %K Blood Transfusion %K Coronary Artery Bypass %K Female %K Health Care Costs %K Health Resources %K Humans %K Intensive Care Units %K Length of Stay %K Male %K Middle Aged %K Minimally Invasive Surgical Procedures %K Stroke Volume %X BACKGROUND: Minimally invasive direct coronary artery bypass grafting (MIDCABG) has been recently reintroduced into the cardiac surgical armamentarium for selected patients with suitable coronary anatomy. We hypothesized that MIDCABG had the potential for similar immediate results with decreased perioperative morbidity and decreased resource utilization compared with standard coronary artery bypass grafting (CABG). METHODS: From January 1996 to August 1996, 17 MIDCABG patients were compared with 33 patients with left ventricular ejection fraction greater than 0.50 who underwent CABG with standard technique. No significant differences were observed between the two groups for preoperative variables that are known to affect cost and resource utilization. Length of stay in the hospital was 2.5 +/- 0.8 days for MIDCABG and 5.9 +/- 2 days for CABG (p < 0.0001); length of stay in the intensive care unit was 12.3 +/- 3.3 hours for MIDCABG compared to 32.3 +/- 12.6 hours for the CABG group (p < 0.0001). RESULTS: Forty-one percent of MIDCABG patients were extubated in the operating room and 59% were discharged home on the first or second postoperative day versus none in the CABG group (p < 0.0001). Significantly less morbidity was observed in the MIDCABG group compared with CABG. Total ratio of cost-to-charge was $12,885 +/- $1,511 for MIDCABG and $21,260 +/- $5,497 for CABG (p < 0.0001), with an average savings of $8,375. CONCLUSIONS: Minimally invasive CABG is associated with significant reduction of resource utilization and morbidity related to inital hospitalization compared with CABG. %B Ann Thorac Surg %V 63 %P S84-7 %8 1997 Jun %G eng %N 6 Suppl %1 http://www.ncbi.nlm.nih.gov/pubmed/9203606?dopt=Abstract %R 10.1016/s0003-4975(97)00324-x %0 Journal Article %J Transpl Int %D 1996 %T Extracorporeal membrane oxygenation for lung transplant recipients with primary severe donor lung dysfunction %A Zenati, M %A Pham, S M %A Keenan, R J %A Griffith, B P %K Adult %K Cardiopulmonary Bypass %K Extracorporeal Membrane Oxygenation %K Female %K Follow-Up Studies %K Graft Rejection %K Humans %K Ischemia %K Lung %K Lung Transplantation %K Male %K Middle Aged %K Postoperative Complications %K Reperfusion Injury %K Risk Factors %K Time Factors %K Tissue Donors %K Transplantation, Homologous %X Primary severe donor lung dysfunction (DLD) is a significant complication after lung transplantation (LTx), and a high mortality is reported with conventional therapy. The purpose of this report is to review the experience of the University of Pittsburgh with extracorporeal membrane oxygenation (ECMO) for primary severe DLD after LTx. From September 1991 to May 1995, 220 LTx were performed at our center. Eight patients (8/220 = 3.6%) with severe DLD after LTx required ECMO support. The age of LTx recipients was 44 +/- 5 years (mean +/- SD); seven patients were female and one was male. Indications for LTx were: chronic obstructive pulmonary disease in four patients, bronchiectasis in two, and pulmonary hypertension in two. There were three single LTx and five bilateral LTx. The interval from LTx to institution of ECMO was 5.6 +/- 3.2 h (range 0-10 h). Three patients were supported with veno-venous (v-v) ECMO and five had veno-arterial (v-a) ECMO. The duration of ECMO support was 7.3 +/- 4.8 days (range 3-15 days). activated glotting time (ACT) was maintained between 110 and 180 s with intermittent use of heparin. Seven patients (7/8 = 87%) were successfully weaned from ECMO and six patients (6/8 = 75%) were discharged home; they are currently alive after a follow-up of 17 +/- 10.1 months. One patient died on ECMO support for refractory DLD and another died 2 months after ECMO wean from multisystem organ failure. At 6 months follow-up, forced expiratory volume in 1 s (FEV1) is 2.35 +/- 0.91 (75% +/- 17.4% predicted) and mean forced vital capacity (FVC) is 2.53 +/- 0.81 (64% +/- 14% predicted). We conclude that ECMO can be lifesaving when instituted early after primary severe DLD. The v-v ECMO support is preferred when the patient is hemodynamically stable and adequate long-term function of the allograft is anticipated. %B Transpl Int %V 9 %P 227-30 %8 1996 %G eng %N 3 %1 http://www.ncbi.nlm.nih.gov/pubmed/8723191?dopt=Abstract %R 10.1007/BF00335390 %0 Journal Article %J Ann Thorac Surg %D 1996 %T Role of lung reduction in lung transplant candidates with pulmonary emphysema %A Zenati, M %A Keenan, R J %A Sciurba, F C %A Manzetti, J D %A Landreneau, R J %A Griffith, B P %K Adult %K Aged %K Endoscopy %K Female %K Humans %K Lung %K Lung Transplantation %K Male %K Middle Aged %K Pulmonary Emphysema %K Respiratory Mechanics %K Thoracoscopy %X BACKGROUND: The average waiting time for candidates for lung transplantation (LTx) with end-stage emphysema is 21 months with a 15% mortality. We hypothesized that lung reduction might offer an alternative to LTx. METHODS: Of 95 patients with end-stage emphysema evaluated by our LTx program, 45 were accepted for both lung reduction and LTx and 35 underwent lung reduction. RESULTS: All 35 patients survived lung reduction. Thirty patients had a follow-up of 3 months. There was a significant improvement (p < 0.05) of forced expiratory volume in 1 second (0.64 to 0.97 L), forced vital capacity (2.12 to 2.76 L), residual volume (5.62 to 4.26 L), maximum voluntary ventilation (28.1 to 38.5 L/min), 6-minute walk (904 to 1,012 feet), Borg dyspnea index (3.7 to 2.4), and arterial carbon dioxide tension (44.9 to 41.6 mm Hg). Twenty patients (66%) were removed from the LTx list due to their significant improvement (group A). Compared with the remaining 10 patients with 3 months of follow-up (group B), percent increase in forced expiratory volume in 1 second (70% in group A versus 27% in group B) and in forced vital capacity (41% group A versus 18% group B) and percent decrease in residual volume (26% group A versus 1.5% group B) were significantly better in group A (p < 0.01). Seven patients in group B were bridged to LTx; 6 of these patients (86%) had hypercarbia before lung reduction compared with 8 (40%) in group A (p < 0.05). All are alive after LTx: the forced expiratory volume in 1 second is 53% and the forced vital capacity is 64% of predicted. CONCLUSIONS: Lung reduction is safe and effective in selected LTx candidates with end-stage emphysema and has the potential to provide an alternative to LTx. Long-term follow-up is warranted to confirm these results. %B Ann Thorac Surg %V 62 %P 994-9 %8 1996 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/8823078?dopt=Abstract %R 10.1016/0003-4975(96)00535-8 %0 Journal Article %J J Thorac Cardiovasc Surg %D 1995 %T Infections and pathologic factors in the donor lung %A Dowling, R D %A Williams, P %A Zenati, M %A Griffith, B P %A Hardesty, R L %K Anti-Bacterial Agents %K Humans %K Lung %K Lung Transplantation %K Pneumonia, Bacterial %K Postoperative Complications %K Tissue Donors %B J Thorac Cardiovasc Surg %V 109 %P 1263-4 %8 1995 Jun %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/7776700?dopt=Abstract %R 10.1016/S0022-5223(95)70222-9 %0 Journal Article %J Ann Thorac Surg %D 1995 %T Lung reduction as bridge to lung transplantation in pulmonary emphysema %A Zenati, M %A Keenan, R J %A Landreneau, R J %A Paradis, I L %A Ferson, P F %A Griffith, B P %K Humans %K Laser Therapy %K Lung Transplantation %K Male %K Middle Aged %K Pneumonectomy %K Pulmonary Emphysema %K Radiography %K Thoracoscopy %K Video Recording %K Waiting Lists %X We present a case of bridging to lung transplantation by means of laser ablation of emphysematous bullae in a lung transplant candidate. The patient underwent successful left single-lung transplantation 17 months after lung reduction. He is now well 3 months after transplantation. %B Ann Thorac Surg %V 59 %P 1581-3 %8 1995 Jun %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/7771852?dopt=Abstract %R 10.1016/0003-4975(95)00082-v %0 Journal Article %J J Card Surg %D 1995 %T Surgical management of mobile aortic atheroma diagnosed by intraoperative transesophageal echocardiography %A Zenati, M %A Madia, C L %A De Nino, L A %A Payne, D N %K Aged %K Aortic Diseases %K Arteriosclerosis %K Calcinosis %K Coronary Disease %K Echocardiography, Transesophageal %K Humans %K Intraoperative Care %K Male %K Myocardial Revascularization %K Saphenous Vein %K Ultrasonography, Interventional %B J Card Surg %V 10 %P 608-10 %8 1995 Sep %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/7488789?dopt=Abstract %R 10.1111/j.1540-8191.1995.tb00643.x %0 Journal Article %J J Cardiovasc Surg (Torino) %D 1994 %T Results of heart transplantation by extending recipient selection criteria %A Livi, U %A Milano, A %A Bortolotti, U %A Casula, R %A Zenati, M %A Casarotto, D %K Adult %K Contraindications %K Female %K Heart Transplantation %K Humans %K Immunosuppression Therapy %K Italy %K Male %K Middle Aged %K Patient Selection %K Postoperative Care %K Postoperative Complications %K Risk Factors %K Statistics as Topic %K Survivors %X From November 1985 to July 1993, 29 out of 241 patients (12%) who underwent heart transplantation (HTx) at our institution had one or more "classical" contraindications to HTx: age > or = 60 years (20 patients); insulin-dependent diabetes mellitus (5 patients); irreversible renal failure requiring combined heart-kidney transplantation (2 patients); previous surgery for malignancy (1 patient); familial hypercholesterolemia (1 patient) and active systemic infection (1 patient). The main indication for HTx was ischemic cardiomyopathy (21 patients, 61%). Immunosuppression regimen consisted of Cyclosporine and Azathioprine, oral prednisone being subsequently added in 6 patients because of persistent rejection. There were 2 perioperative deaths and one late death. Follow-up ranged from 1 to 88 months (mean, 28 +/- 20) with an actuarial survival at 5 years of 85 +/- 8%. Annual cardiac catheterization demonstrated normal graft function and coronary arteries in all. No significant differences in survival, incidence of rejection and infection, renal function and duration of hospitalization were found when these patients were compared with those with no contraindications to HTx. In conclusion, HTx can be performed with good early clinical results in selected patients with "classical" contraindications to HTx; longer follow-up, however, is needed to confirm whether extension of the recipient selection criteria justified. %B J Cardiovasc Surg (Torino) %V 35 %P 377-82 %8 1994 Oct %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/7995827?dopt=Abstract %0 Journal Article %J J Heart Lung Transplant %D 1994 %T Successful treatment of disseminated infection with Listeria monocytogenes in a heart transplant recipient %A Zenati, M %A Milano, A %A Livi, U %A Cattelan, A %A Casarotto, D %K Ampicillin %K Cardiomyopathy, Dilated %K Drug Therapy, Combination %K Heart Transplantation %K Humans %K Listeria monocytogenes %K Male %K Meningitis, Listeria %K Middle Aged %K Netilmicin %K Opportunistic Infections %K Postoperative Complications %B J Heart Lung Transplant %V 13 %P 345-6 %8 1994 Mar-Apr %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/8031822?dopt=Abstract %0 Journal Article %J Transplant Proc %D 1993 %T Influence of marginal donors on early results after heart transplantation %A Milano, A %A Livi, U %A Casula, R %A Bortolotti, U %A Gambino, A %A Zenati, M %A Valente, M %A Angelini, A %A Thiene, G %A Casarotto, D %K Actuarial Analysis %K Adolescent %K Adult %K Age Factors %K Child %K Child, Preschool %K Echocardiography %K Female %K Heart Arrest %K Heart Transplantation %K Humans %K Immunosuppression Therapy %K Infant %K Male %K Middle Aged %K Resuscitation %K Retrospective Studies %K Survival Rate %K Tissue and Organ Procurement %K Tissue Donors %B Transplant Proc %V 25 %P 3158-9 %8 1993 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/8266498?dopt=Abstract %0 Journal Article %J J Thorac Cardiovasc Surg %D 1992 %T Donor-transmitted pneumonia in experimental lung allografts. Successful prevention with donor antibiotic therapy %A Dowling, R D %A Zenati, M %A Yousem, S A %A Pasculle, A W %A Kormos, R L %A Armitage, J A %A Griffith, B P %A Hardesty, R L %K Administration, Inhalation %K Animals %K Anti-Bacterial Agents %K Dogs %K Female %K Infusions, Intravenous %K Lung Transplantation %K Pneumonia, Pneumococcal %K Tissue Donors %K Transplantation, Homologous %X Bacterial pneumonia is the most common cause of early morbidity and mortality (less than 2 weeks) after heart-lung transplantation. The majority (76%) of cultures taken from human donor tracheas at the time of explant grew bacteria. The abnormal immune response of the lung allograft and the common finding of bacterial contamination of lung donors led us to hypothesize that clinically silent bacterial contamination of the donor lung progresses to pneumonia in the recipient and that antibiotic treatment of donors will prevent the development of pneumonia in the recipient. Inocula of Streptococcus pneumoniae were instilled into the left middle lobe of normal and donor dogs to identify the number of bacteria that would result in pneumonia in a normal animal and the amount that, when given to a donor, would result in pneumonia in the recipient. Initial studies established that inocula of 10(4) colony-forming units of S. pneumoniae did not result in pneumonia in normal or immunosuppressed animals. When 10(4) colony-forming units or as few as 10(2) were instilled into the left middle lobe of donors 24 hours before explantation and use of the lung for transplantation, severe acute bronchopneumonia developed in all 18 recipients. Treatment of donors with aerosol and intravenous antibiotics, but not with either alone, prevented pneumonia in the recipients. We conclude that bacterial contamination of the donor lung leads to pneumonia in recipients. Intravenous and aerosol antibiotic treatment of donors with bacterial contamination prevents pneumonia in canine lung recipients. Treatment of human donors with this antibiotic regimen may decrease the prevalence of early bacterial pneumonia. %B J Thorac Cardiovasc Surg %V 103 %P 767-72 %8 1992 Apr %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/1548919?dopt=Abstract %0 Journal Article %J Transplantation %D 1992 %T Improved immunosuppression with aerosolized cyclosporine in experimental pulmonary transplantation %A Keenan, R J %A Duncan, A J %A Yousem, S A %A Zenati, M %A Schaper, M %A Dowling, R D %A Alarie, Y %A Burckart, G J %A Griffith, B P %K Aerosols %K Animals %K Cyclosporine %K Graft Rejection %K Graft Survival %K Lung Transplantation %K Male %K Rats %K Transplantation, Homologous %X Rejection remains a major obstacle to long-term success of pulmonary transplantation. Direct delivery of cyclosporine to lung allografts may produce better control of rejection by generating high intragraft concentrations of drug with decreased systemic delivery and toxicity. The efficacy of inhaled cyclosporine in preventing allograft rejection was compared with systemic delivery by intramuscular injections in a rat model of lung transplantation (Brown-Norway to Lewis). Group 1 animals were given no immunosuppression. Group 2 received a single i.m. injection of 25 mg/kg CsA on the day of operation while group 3 received daily doses on postoperative days 0-3. Groups 4-7 received aerosolized CsA daily for seven days. The aerosol generator produced an airborne concentration of CsA of 180 mg/m3 with a mean particle size of 0.7 mu and estimated pulmonary depositions of CsA of 0.98-3.6 mg/kg/day. Animals were killed on POD 7, and the transplanted lungs graded histologically in a blinded fashion. All control animals showed destructive grade 4 changes by POD 7. Animals receiving high-dose aerosolized CsA (groups 6 and 7) showed minimal changes with a mean rejection grade of 1.3. A single i.m. dose of CsA (group 2) failed to prevent rejection; the mean grade was 2.2. Animals given four i.m. doses of CsA had a mean grade of 1.8. Aerosolized CsA provided significantly better control of rejection than did systemic CsA (groups 6 and 7 vs. groups 2 and 3; P less than 0.0002 and less than 0.0054, respectively). Local delivery of CsA by aerosol inhalation is effective in limiting acute rejection of the rat lung allograft. %B Transplantation %V 53 %P 20-5 %8 1992 Jan %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/1733067?dopt=Abstract %R 10.1097/00007890-199201000-00003 %0 Journal Article %J J Thorac Cardiovasc Surg %D 1992 %T Pulmonary atresia and intact ventricular septum associated with pulmonary artery sling %A Zenati, M %A del Nonno, F %A Marino, B %A di Carlo, D C %K Abnormalities, Multiple %K Heart Defects, Congenital %K Heart Septum %K Humans %K Infant, Newborn %K Male %K Pulmonary Artery %B J Thorac Cardiovasc Surg %V 104 %P 1755-6 %8 1992 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/1453746?dopt=Abstract %0 Journal Article %J J Heart Lung Transplant %D 1991 %T Cytomegalovirus infection and survival in lung transplant recipients %A Duncan, A J %A Dummer, J S %A Paradis, I L %A Dauber, J H %A Yousem, S A %A Zenati, M A %A Kormos, R L %A Griffith, B P %K Actuarial Analysis %K Adolescent %K Adult %K Child %K Child, Preschool %K Cytomegalovirus Infections %K Female %K Heart-Lung Transplantation %K Humans %K Incidence %K Lung Transplantation %K Male %K Middle Aged %K Pneumonia %K Postoperative Complications %K Superinfection %K Survival Rate %K Tissue Donors %K Transfusion Reaction %X Fifty-nine patients who survived more than 30 days after lung transplantation (52 heart-lung, seven double lung, and two single lung) were studied for mortality and morbidity related to cytomegalovirus (CMV) infection. CMV infection developed in 32 patients (54%) and was more common in the preoperatively CMV seropositive group (95%) as compared with the seronegative group (38%). Symptomatic infections, pneumonitis, and CMV-related mortality, however, were higher in the seronegative (primary infection) group and actuarial survival was worse in these patients (40% and 23% at 1 and 5 years, respectively). Transplantation of CMV-seropositive donor organs was associated with a significantly higher incidence of primary infection and use of seronegative blood products led to a decrease in the primary CMV infection rate. The mortality of primary CMV infection was 54% and this was associated with a significantly higher rate of pulmonary superinfections in the first year after transplantation. The incidence of late pulmonary infections was associated with the development of chronic rejection rather than CMV status. We conclude that primary CMV infection has a major impact on the outcome after lung transplantation. The high mortality of primary infections justifies an aggressive approach to prevention and treatment in the at-risk seronegative group. %B J Heart Lung Transplant %V 10 %P 638-44; discussion 645-6 %8 1991 Sep-Oct %G eng %N 5 Pt 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/1659899?dopt=Abstract %0 Journal Article %J Eur J Cardiothorac Surg %D 1991 %T Immunosuppression with aerosolized cyclosporine for prevention of lung rejection in a rat model %A Zenati, M %A Duncan, A J %A Burckart, G J %A Schaper, M %A Yousem, S A %A Griffith, B P %A Casarotto, D %K Aerosols %K Animals %K Cyclosporins %K Graft Rejection %K Lung %K Lung Transplantation %K Rats %K Rats, Inbred BN %X The efficacy of local delivery of aerosol cyclosporine (CsA) for prevention of lung rejection was compared with the intramuscular route (IM) in a fully allogeneic rat model (BN/LEW) of lung transplantation (LTx). Control rats (group 1, n = 6) received no CsA after LTx. Rats in group 2 (n = 10) received 4 doses of CsA in olive oil (25 mg/kg) intramuscularly starting on postoperative day (POD) 0. Group 3 (n = 9) was treated with aerosolized CsA for 3 h/day for 7 days starting on POD 0. All animals were sacrificed on POD 6. Transplanted lungs were graded histologically in a blind manner on a 0-4 scale. Control animals all showed grade 4 rejection. i.m. CsA therapy reduced lung rejection with a rejection grade of 1.8 +/- 0.35 (mean +/- SD) but was associated with a 50% incidence of pneumonia. Aerosol CsA provided better control of rejection with a rejection grade of 1.2 +/- 0.4 (group 3 vs. group 2: P less than 0.05 Wilcoxon) and none of these animals had penumonia. Trough blood levels of CsA were significantly lower in the group treated with aerosolized CsA when compared with the IM group (P less than 0.05). Therefore we conclude that: (1) aerosol CsA is effective in preventing lung allograft rejection following lung transplantation in rats, and (2) local delivery of aerosol CsA is superior to the i.m. route because better control of rejection is achieved with a lower systemic delivery of CsA. %B Eur J Cardiothorac Surg %V 5 %P 266-71; discussion 272 %8 1991 %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/1859667?dopt=Abstract %R 10.1016/1010-7940(91)90175-j %0 Journal Article %J Surgery %D 1990 %T Aerosolized cyclosporine as single-agent immunotherapy in canine lung allografts %A Dowling, R D %A Zenati, M %A Burckart, G J %A Yousem, S A %A Schaper, M %A Simmons, R L %A Hardesty, R L %A Griffith, B P %K Aerosols %K Animals %K Cyclosporins %K Dogs %K Graft Rejection %K Immunotherapy %K Lung Transplantation %K Transplantation, Homologous %X Current systemic immunosuppressive regimens are unable to prevent lung allograft rejection consistently and are associated with significant morbidity and death. Acute rejection has occurred in 40% and chronic rejection in 50% of our lung recipients. We hypothesized that regional immunotherapy with aerosolized cyclosporine would prevent or reduce lung allograft rejection while allowing for low systemic drug delivery. In a canine model of unilateral lung allotransplantation, aerosolized cyclosporine was delivered directly to the allograft. Acute rejection was prevented or reduced in all treated recipients. All control animals had severe acute rejection. Intragraft cyclosporine concentration was high and systemic drug delivery was low, as evidenced by low whole-blood cyclosporine levels and low tissue cyclosporine levels in skeletal muscle. Ninety-five percent of whole-blood trough cyclosporine levels were less than 150 ng/ml. Aerosolized cyclosporine was able to prevent or reduce acute pulmonary rejection and resulted in minimal systemic drug delivery. %B Surgery %V 108 %P 198-204; discussion 204-5 %8 1990 Aug %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/2382220?dopt=Abstract %0 Journal Article %J Ann Thorac Surg %D 1990 %T Disruption of the aortic anastomosis after heart-lung transplantation %A Dowling, R D %A Baladi, N %A Zenati, M %A Dummer, J S %A Kormos, R L %A Armitage, J M %A Yousem, S A %A Hardesty, R L %A Griffith, B P %K Adolescent %K Adult %K Anastomosis, Surgical %K Aneurysm, Infected %K Aorta %K Aortic Aneurysm %K Aortic Diseases %K Candidiasis %K Child %K Child, Preschool %K Female %K Heart-Lung Transplantation %K Humans %K Male %K Middle Aged %K Rupture, Spontaneous %K Trachea %X Disruption of the aorta at the anastomotic site occurred in 4 of 66 consecutive heart-lung transplant recipients and was associated with a 100% mortality. In 3 of these patients, Candida either was cultured from the suture line or was seen in the wall of the aorta at postmortem examination. In 2 of these 3 patients, cultures of material from the donor trachea taken at the time of explanation grew Candida species. Two patients were seen with sudden massive hemorrhage on postoperative day 26 and postoperative day 28. One patient experienced acute decompensation due to right ventricular outflow tract obstruction on postoperative day 30, and the remaining patient was seen 7 months postoperatively with obstruction of both the left main bronchus and the right pulmonary artery caused by extrinsic compression by an aortic pseudoaneurysm. A high index of suspicion should be maintained when transplanting lungs containing Candida species, as we believe there is substantial evidence of donor transmission of the fungal agents. We now include amphotericin B in our antibiotic prophylactic regimen in an attempt to prevent fungal infection because previous treatment has been uniformly unsuccessful. Furthermore, we wrap both the trachea and the aorta with omentum to lessen the likelihood of mediastinal spread of infection to the aortic suture line. %B Ann Thorac Surg %V 49 %P 118-22 %8 1990 Jan %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/2297258?dopt=Abstract %R 10.1016/0003-4975(90)90368-g %0 Journal Article %J Transplantation %D 1990 %T HLA-class II antigen expression in human heart-lung allografts %A Yousem, S A %A Curley, J M %A Dauber, J %A Paradis, I %A Rabinowich, H %A Zeevi, A %A Duquesnoy, R %A Dowling, R %A Zenati, M %A Hardesty, R %K Bronchiolitis Obliterans %K Heart-Lung Transplantation %K HLA-D Antigens %K Humans %K Immunoenzyme Techniques %K Lung %X Long-term survival in heart-lung transplantation has ben hindered by the development of bronchiolitis obliterans (OB), which is believed to be a manifestation of chronic rejection of the lung. Since HLA-class II antigens are involved in the rejection response, the distribution of the class II products HLA-DR, HLA-DQ, and HLA-DP were studied in normal lung, and in transplanted lung with and without OB, utilizing frozen-section immunohistochemical techniques. All three allelic products are usually expressed on the epithelial, endothelial, and mesenchymal components of the lung. Sequential transbronchial biopsies from 4 recipients before and concurrent with the diagnosis of OB were stained with serial dilutions of monoclonal antibodies to assess the level of expression of the above class II products. Increased levels of HLA-DR and HLA-DP antigens may be seen on the bronchial and bronchiolar epithelium during OB, but the changes are subtle and complicated by many other variables. Additional studies are needed to confirm these preliminary results. %B Transplantation %V 49 %P 991-5 %8 1990 May %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/2186527?dopt=Abstract %R 10.1097/00007890-199005000-00030 %0 Journal Article %J J Heart Transplant %D 1990 %T Influence of the donor lung on development of early infections in lung transplant recipients %A Zenati, M %A Dowling, R D %A Dummer, J S %A Paradis, I L %A Arena, V C %A Armitage, J M %A Kormos, R L %A Hardesty, R L %A Griffith, B P %K Adolescent %K Adult %K Candidiasis %K Female %K Humans %K Lung %K Lung Transplantation %K Male %K Mediastinitis %K Pneumonia %K Postoperative Complications %K Pseudomonas Infections %K Regression Analysis %K Survival Analysis %K Time Factors %K Tissue Donors %K Trachea %X Infection of the lung allograft is the greatest cause of morbidity and mortality after heart-lung transplantation. To better understand the pathogenesis of these infections, we compared the results from cultures of the donor tracheas with the type and prevalence of early intrathoracic infections in the recipients. In the last 37 recipients, intrathoracic infections occurred within 2 weeks of operation in 16 (43%). Organisms isolated from the donor tracheal cultures were different from those associated with early infections, except for three of four recipients with heavy growth of Candida in donor tracheal cultures, in whom fatal invasive candidiasis developed caused by the same species of Candida isolated from the donor culture. Comparisons were made between recipients with (n = 16) and without early infection (n = 21) for age of donors and recipients, ischemic time, length of donor stay in an intensive care unit, donor arterial oxygen pressure, duration of recipient intubation, sterile donor tracheal culture or culture with presence of mouth flora, bacterial pathogens, or Candida, method of lung preservation, and antibiotic prophylaxis of donor. The only factor significantly associated with the onset of early infection was the presence of mouth flora in the donor tracheal culture (p = 0.004, Fisher's exact test, two sided). Multiple logistic regression was performed to test the additional contribution of other covariates after adjusting for the presence of mouth flora. None of the other covariates contributed to the occurrence of early infection. Recipients with early infection had a significantly lower survival compared with those without early infection (p = 0.04) by the Kaplan-Meier survival analysis.(ABSTRACT TRUNCATED AT 400 WORDS) %B J Heart Transplant %V 9 %P 502-8; discussion 508-9 %8 1990 Sep-Oct %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/2231088?dopt=Abstract %0 Journal Article %J Transplantation %D 1990 %T Primary graft failure following pulmonary transplantation %A Zenati, M %A Yousem, S A %A Dowling, R D %A Stein, K L %A Griffith, B P %K Adult %K Female %K Humans %K Ischemia %K Lung %K Lung Transplantation %K Male %B Transplantation %V 50 %P 165-7 %8 1990 Jul %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/2368141?dopt=Abstract %R 10.1097/00007890-199007000-00034 %0 Journal Article %J Pediatr Med Chir %D 1990 %T [Psycho-affective and relational aspects of children with congenital cardiopathy] %A Russo, E %A Zenati, M %A Morelli, D %A Beduschi, M %A Casarotto, D %A Marelli, D %A Casarotti, D %K Adolescent %K Child %K Child, Preschool %K Heart Defects, Congenital %K Humans %K Infant %K Infant, Newborn %K Mother-Child Relations %K Parent-Child Relations %K Physician-Patient Relations %X The psychological and relational problems present in pediatric patients with congenital cardiac anomalies and in their families are reviewed based on an analysis of the current literature and on the personal experience of the authors. The need for all caretakers, especially the cardiologist and the cardiac surgeon, to be aware of these critical aspects is emphasized. The psychological experience of the patient and of his family is thoroughly addressed. Moreover, the complex relationship that developed between the family and the physician as a result of the family's expectations, requests and unconscious projections are discussed. %B Pediatr Med Chir %V 12 %P 81-4 %8 1990 Jan-Feb %G ita %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/2198551?dopt=Abstract %0 Journal Article %J Clin Chest Med %D 1990 %T The pulmonary donor %A Griffith, B P %A Zenati, M %K Adult %K Humans %K Lung %K Lung Diseases %K Lung Transplantation %K Middle Aged %K Tissue and Organ Procurement %K Tissue Donors %X This article discusses the Pittsburgh experience with the pulmonary donor and provides guidelines for the maintenance and selection of appropriate donor lungs. Criteria for the selection of the pulmonary donor include absence of radiographic abnormality, minimal ventilation-perfusion mismatch, and an absence of identifiable infection. Because early thoracic infections result in a high mortality, donors are excluded if white cells, fungi, or bacteria are noted in samples obtained from tracheal aspirates or bronchoscopic examination. A number of techniques for the procurement of donor lungs are currently satisfactory and include core cooling with the use of cardiopulmonary bypass and different hypothermic pulmonary artery flush solutions. Other clinical preservation techniques are discussed, including autoperfusion and the use of blood-based pulmoplegia and University of Wisconsin storage solution. Because so much of the outcome following pulmonary allografting is based on the quality of the donor lungs, much of the future direction in pulmonary transplantation must be directed toward a continuing investigation of better methods for selection and maintenance of the donor and ex vivo preservation. %B Clin Chest Med %V 11 %P 217-26 %8 1990 Jun %G eng %N 2 %1 http://www.ncbi.nlm.nih.gov/pubmed/2189657?dopt=Abstract %0 Journal Article %J Curr Surg %D 1989 %T Experimental donor-transmitted pneumonia in a model of canine orthotopic unilateral lung allotransplantation %A Dowling, R D %A Zenati, M %A Pasculle, A W %A Yousem, S A %A Griffith, B P %A Hardesty, R L %K Animals %K Dogs %K Female %K Lung %K Lung Transplantation %K Pneumonia, Pneumococcal %K Streptococcus pneumoniae %K Tissue Donors %K Transplantation, Homologous %B Curr Surg %V 46 %P 464-7 %8 1989 Nov-Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/2620535?dopt=Abstract %0 Journal Article %J J Thorac Cardiovasc Surg %D 1989 %T Infections in mortally ill cardiac transplant recipients %A Hsu, J %A Griffith, B P %A Dowling, R D %A Kormos, R L %A Dummer, J S %A Armitage, J M %A Zenati, M %A Hardesty, R L %K Adult %K Cardiotonic Agents %K Heart Diseases %K Heart Transplantation %K Heart, Artificial %K Humans %K Infection Control %K Infections %K Intra-Aortic Balloon Pumping %K Retrospective Studies %X A total of 351 cardiac transplantations performed between June 1, 1980, and Sept. 30, 1987, were reviewed to determine if infectious complications were more frequent in those patients requiring preoperative intravenous inotropic support, placement of an intraaortic balloon pump, or mechanical support with a left ventricular assist device or total artificial heart. One hundred forty-nine transplants (45%) were performed in these mortally ill patients. There was no statistically significant difference between patients with and without infection within each support group for the following: the number of in-patient days awaiting a donor heart, the number of days receiving support, the percent of patients with preoperative tracheal intubation, the length of the operation, and the percent of patients requiring reoperation for bleeding. The need for invasive methods of support (intraaortic balloon pump, left ventricular assist device, or total artificial heart) in patients awaiting heart transplantation increases the prevalence of perioperative nonviral infection. Preoperative mechanical support with a left ventricular assist device or total artificial heart significantly increases the risk of infection-related mortality. %B J Thorac Cardiovasc Surg %V 98 %P 506-9 %8 1989 Oct %G eng %N 4 %1 http://www.ncbi.nlm.nih.gov/pubmed/2507825?dopt=Abstract %0 Journal Article %J G Ital Cardiol %D 1989 %T [New trends in combined transplantation of the heart and lungs] %A Zenati, M %A Dowling, R D %A Yousem, S A %A Hardesty, R L %A Griffith, B P %A Casarotto, D %K Heart-Lung Transplantation %K Humans %X Heart-lung transplantation is a surgical alternative for patients with end-stage lung disease with associated right heart failure. While the procedure is very promising, the morbidity and mortality remain high. The current understanding of the proper selection of candidates, procurement and preservation of donor organs, operative procedure and postoperative care continues to evolve. At the University of Pittsburgh, 70 heart-lung transplantations have been performed since 1982. Early infection and chronic rejection are the major factors influencing survival. Early (less than 2 weeks) intrathoracic infection occurred in 43% of heart-lung transplant recipients, with pneumonia being the most frequent infection. The incidence of pneumonia in heart-lung transplant recipients is twice that in a comparable group of heart recipients. Subclinical pneumonitis in the donor lung, abnormal muco-ciliary clearance and altered allogenic response in the transplanted lung are significant factors associated with the increased incidence of early infections. Chronic rejection, manifested as bronchiolitis obliterans, has occurred in 54% of heart-lung transplantation recipients. Infection caused by cytomegalovirus, Epstein-Barr virus and Pneumocystis carinii have been shown to increase the incidence of bronchiolitis obliterans, as have episodes of acute rejection. Recent reports of a 61% 2-year survival rate represent a substantial improvement over earlier trials. With a better understanding of the pathogenesis of infection in the transplanted lung as well as improved immunosuppressive agents, further improvements in survival can be expected. %B G Ital Cardiol %V 19 %P 913-22 %8 1989 Oct %G ita %N 10 %1 http://www.ncbi.nlm.nih.gov/pubmed/2693175?dopt=Abstract %0 Journal Article %J Ann Thorac Surg %D 1989 %T Organ procurement for pulmonary transplantation %A Zenati, M %A Dowling, R D %A Armitage, J M %A Kormos, R L %A Dummer, J S %A Hardesty, R L %A Griffith, B P %K Graft Survival %K Heart-Lung Transplantation %K Humans %K Lung Transplantation %K Organ Preservation %K Pennsylvania %K Postoperative Complications %K Tissue and Organ Procurement %K Tissue Donors %X Selection of suitable donors is critical to the success of clinical pulmonary transplantation. Requirements for lung donors, management before explantation, and methods of preservation were reviewed for the 70 heart-lung, eight double-lung, and two single-lung transplantations performed at the University of Pittsburgh since 1982. Careful observation of trends of hyperoxygenation studies, chest roentgenograms, and Gram stain and culture results of tracheal secretions, as well as findings on bronchoscopy, can help identify which lungs not only have adequate function but are acceptable for transplantation. In spite of the rigid criteria used, 76% of tracheal cultures from donors deemed acceptable grew organisms. The presence of oropharyngeal flora has been shown to correlate with the development of early intrathoracic infections in the recipient. Prophylactic broad-spectrum antibiotic treatment of the donor is desirable to treat microbial contamination that could cause focal injury to the donor lung and predispose to infection in the recipient. Acceptance of less than ideal donors is ill-advised even though rejection of such donors conflicts with the current shortage of organs. %B Ann Thorac Surg %V 48 %P 882-6 %8 1989 Dec %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/2596931?dopt=Abstract %R 10.1016/0003-4975(89)90696-6 %0 Journal Article %J Pediatr Radiol %D 1988 %T Acro-mesomelic dysplasia--a new type. Report of two siblings %A Brahimi, L %A Bacha, L %A Kozlowski, K %A Massen, R %A Zenati, M %K Child %K Female %K Humans %K Male %K Osteochondrodysplasias %K Radiography %K Syndrome %X Two siblings who represent a new type of acro-mesomelic dysplasia are reported. The unique pattern of the acro-mesomelic hypoplastic/dysplastic changes allows us to designate them as a new syndrome. %B Pediatr Radiol %V 18 %P 67-9 %8 1988 %G eng %N 1 %1 http://www.ncbi.nlm.nih.gov/pubmed/3340435?dopt=Abstract %R 10.1007/BF02395764 %0 Journal Article %J G Ital Cardiol %D 1988 %T [Elements for an analysis of psychosocial indicators and psychological intervention in heart transplantation] %A Zenati, M %A Morelli, D %A Fabbri, A %A Casarotto, D %K Family %K Follow-Up Studies %K Heart Transplantation %K Humans %K Patient Compliance %K Psychology %K Quality of Life %K Social Adjustment %X It is now accepted that cardiac transplantation is a viable therapeutic alternative for patients with end-stage heart disease. The most recent data offer a favourable short and medium term prognosis. Retrospective studies suggest that transplantation is associated with a good quality of life and tolerance of the side effects of the medication. Even if cardiac transplantation does not appear to be associated with serious psychological morbidity, it is important to assess the recipient's anxiety, depression, body image and his subjective quality of life, including satisfaction with his family and marital life, to prevent postoperative psychologic distress and enhance the patient's coping abilities. The family is the patient's chief buffer against stress but it is also under stress and needs to be aided through this process. The psychosocial themes that appear prominently at the different stages of the transplant process are somewhat predictable. These can be used to help the patient and family anticipate stress and deal with these issues in a way that enhances mastery of a difficult situation. The heart transplant team faces difficult ethical issues regarding patient selection and informed consent. Public input on these issues is needed, especially since more patients elect to receive heart transplants and the donor supply is likely to remain the same, thereby making donor hearts less available to those who could derive benefit from them. %B G Ital Cardiol %V 18 %P 479-84 %8 1988 Jun %G ita %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/3063570?dopt=Abstract %0 Journal Article %J G Ital Cardiol %D 1985 %T [Cardiac failure due to isolated pulmonary sequestration. Description of a clinical case in the neonatal period] %A Casarotto, D %A Fabbri, A %A Motta, A %A Rebonato, M %A Zenati, M %A Consolaro, G %K Bronchopulmonary Sequestration %K Heart Failure %K Humans %K Infant, Newborn %K Infant, Premature, Diseases %K Male %K Radiography %X Pulmonary Sequestration is a congenital anomaly rarely seen in the pediatric age. Clinical manifestations commonly appear with a respiratory symptomatology and less frequently with cardiac signs especially in the case of an associated congenital heart disease. In the presented case, isolated Pulmonary Sequestration manifested itself as a congestive heart failure, and a diastolic overloading of the left ventricle. After surgical removal of the Sequestration was demonstrated a normalization of both clinical and haemodynamic findings. %B G Ital Cardiol %V 15 %P 725-8 %8 1985 Jul %G ita %N 7 %1 http://www.ncbi.nlm.nih.gov/pubmed/4076708?dopt=Abstract