Publications by authors named "Jeffrey Jacobs"

546 Publications

Current Status of Training and Certification for Congenital Heart Surgery Around the World: Proceedings of the Meetings of the Global Council on Education for Congenital Heart Surgery of the World Society for Pediatric and Congenital Heart Surgery.

World J Pediatr Congenit Heart Surg 2021 May;12(3):394-405

Division of Cardiovascular Surgery, Children's Minnesota, Minneapolis, MN, USA.

The optimal training of the highly specialized congenital heart surgeon is a long and complex process, which is a significant challenge in most parts of the world. The World Society for Pediatric and Congenital Heart Surgery (WSPCHS) has established the Global Council on Education for Congenital Heart Surgery as a nonprofit organization with the goal of assessing current training and certification and ultimately establishing standardized criteria for the training, evaluation, and certification of congenital heart surgeons around the world. The Global Council and the WSPCHS have reviewed the present status of training and certification for congenital cardiac surgery around the world. There is currently lack of consensus and standardized criteria for training in congenital heart surgery, with significant disparity between continents and countries. This represents significant obstacles to international job mobility of competent congenital heart surgeons and to the efforts to improve the quality of care for patients with Congenital Heart Disease worldwide. The purpose of this article is to summarize and document the present state of training and certification in congenital heart surgery around the world.
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http://dx.doi.org/10.1177/21501351211003520DOI Listing
May 2021

Pediatric Cardiac Surgical Patterns of Practice and Outcomes in Japan and Europe.

World J Pediatr Congenit Heart Surg 2021 May;12(3):312-319

Pediatric Cardiothoracic Surgery, Children's Memorial Health Institute, Warsaw, Poland.

Objectives: The Japan Cardiovascular Surgery Database-Congenital section (JCVSD-Congenital) and the European Congenital Heart Surgeons Association (ECHSA) Congenital Heart Surgery Database (CHSD) share the same nomenclature. We aimed at comparing congenital cardiac surgical patterns of practice and outcomes in Japan and Europe using the JCVSD-Congenital and ECHSA-CHSD.

Methods And Results: We examined Japanese (120 units, 63,365 operations) and European (96 units, 90,098 operations) data in JCVSD-Congenital and ECHSA-CHSD from 2011 to 2017. Patients' age and weight, periprocedural times, mortality at hospital discharge, and postoperative length of stay were calculated for ten benchmark operations. There was a significantly higher proportion of ventricular septal defect closures and Glenn operations and a significantly lower proportion of coarctation repairs, tetralogy of Fallot repairs, atrioventricular septal defect repairs, arterial switch operations, truncus repairs, Norwood operations, and Fontan operations in JCVSD-Congenital compared to ECHSA-CHSD. Postoperative length of stay was significantly longer following all benchmark operations in JCVSD-Congenital compared to ECHSA-CHSD. Mean STAT mortality score (Society of Thoracic Surgeons European Association for Cardio-Thoracic Surgery mortality score) was significantly higher in JCVSD-Congenital (0.78) compared to ECHSA-CHSD (0.71). Mortality at hospital discharge was significantly lower in JCVSD-Congenital (4.2%) compared to ECHSA-CHSD (6.0%, < .001).

Conclusions: The distribution of the benchmark procedures and age at the time of surgery differ between Japan and Europe. Postoperative length of stay is longer, and the mean complexity is higher in Japan compared to European data. These comparisons of patterns of practice and outcomes demonstrate opportunities for continuing bidirectional transcontinental collaboration and quality improvement.
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http://dx.doi.org/10.1177/2150135120988634DOI Listing
May 2021

Multi-institutional Analysis of 100 Consecutive Patients with COVID-19 and Severe Pulmonary Compromise Treated with Extracorporeal Membrane Oxygenation: Outcomes and Trends Over Time.

ASAIO J 2021 05;67(5):496-502

Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia.

The role of extracorporeal membrane oxygenation (ECMO) in the management of severely ill patients with coronavirus disease 2019 (COVID-19) continues to evolve. The purpose of this study is to review a multi-institutional clinical experience in 100 consecutive patients, at 20 hospitals, with confirmed COVID-19 supported with ECMO. This analysis includes our first 100 patients with complete data who had confirmed COVID-19 and were supported with ECMO. The first patient in the cohort was placed on ECMO on March 17, 2020. Differences by the mortality group were assessed using χ2 tests for categorical variables and Kruskal-Wallis rank-sum tests and Welch's analysis of variance for continuous variables. The median time on ECMO was 12.0 days (IQR = 8-22 days). All 100 patients have since been separated from ECMO: 50 patients survived and 50 patients died. The rate of survival with veno-venous ECMO was 49 of 96 patients (51%), whereas that with veno-arterial ECMO was 1 of 4 patients (25%). Of 50 survivors, 49 have been discharged from the hospital and 1 remains hospitalized at the ECMO-providing hospital. Survivors were generally younger, with a lower median age (47 versus 56.5 years, p = 0.014). In the 50 surviving patients, adjunctive therapies while on ECMO included intravenous steroids (26), anti-interleukin-6 receptor blockers (26), convalescent plasma (22), remdesivir (21), hydroxychloroquine (20), and prostaglandin (15). Extracorporeal membrane oxygenation may facilitate salvage and survival of selected critically ill patients with COVID-19. Survivors tend to be younger. Substantial variation exists in the drug treatment of COVID-19, but ECMO offers a reasonable rescue strategy.
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http://dx.doi.org/10.1097/MAT.0000000000001434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078020PMC
May 2021

Society of Thoracic Surgeons 2021 Adult Cardiac Surgery Risk Models for Multiple Valve Operations.

Ann Thorac Surg 2021 Apr 9. Epub 2021 Apr 9.

Duke University, Durham, North Carolina.

Background: The STS Quality Measurement Task Force has developed risk models and composite performance measures for isolated coronary artery bypass grafting surgery (CABG), isolated aortic valve replacement (AVR), isolated mitral valve replacement or repair (MVRR), AVR+CABG, and MVRR+CABG. To further enhance its portfolio of risk-adjusted performance metrics, STS has developed new risk models for multiple valve operations +/- CABG procedures.

Methods: Using July 2011 to June 2019 STS Adult Cardiac Surgery Database (ACSD) data, risk models for AVR+MVRR (n=31,968) and AVR+MVRR+CABG (n=12,650) were developed with the following endpoints: operative mortality, major morbidity (any one or more of the following: cardiac reoperation; deep sternal wound infection/mediastinitis; stroke; prolonged ventilation; and renal failure), and combined mortality and/or major morbidity. Data were divided into development (July 2011 - June 2017, n=35,109) and validation (July 2017 - June 2019, n=9,509) samples. Predictors were selected by assessing model performance and clinical face validity of full and progressively more parsimonious models. Performance of the resulting models was evaluated by assessing discrimination and calibration.

Results: C-statistics for the overall population of multiple valve +/- CABG procedures were 0.7086, 0.6734, and 0.6840 for mortality, morbidity, and combined mortality and/or morbidity in the development sample, and 0.6953, 0.6561, and 0.6634 for the same outcomes, respectively, in the validation sample.

Conclusions: New STS-ACSD risk models have been developed for multiple valve +/- CABG operations, and these models will be used in subsequent STS performance metrics.
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http://dx.doi.org/10.1016/j.athoracsur.2021.03.089DOI Listing
April 2021

Medical education and training within congenital cardiology: current global status and future directions in a post COVID-19 world.

Cardiol Young 2021 Apr 12:1-13. Epub 2021 Apr 12.

Department of Cardiology, Mazankowski Heart Institute, University of Alberta, Edmonton, Alberta, Canada.

Despite enormous strides in our field with respect to patient care, there has been surprisingly limited dialogue on how to train and educate the next generation of congenital cardiologists. This paper reviews the current status of training and evolving developments in medical education pertinent to congenital cardiology. The adoption of competency-based medical education has been lauded as a robust framework for contemporary medical education over the last two decades. However, inconsistencies in frameworks across different jurisdictions remain, and bridging gaps between competency frameworks and clinical practice has proved challenging. Entrustable professional activities have been proposed as a solution, but integration of such activities into busy clinical cardiology practices will present its own challenges. Consequently, this pivot towards a more structured approach to medical education necessitates the widespread availability of appropriately trained medical educationalists, a development that will better inform curriculum development, instructional design, and assessment. Differentiation between superficial and deep learning, the vital role of rich formative feedback and coaching, should guide our trainees to become self-regulated learners, capable of critical reasoning yet retaining an awareness of uncertainty and ambiguity. Furthermore, disruptive innovations such as "technology enhanced learning" may be leveraged to improve education, especially for trainees from low- and middle-income countries. Each of these initiatives will require resources, widespread advocacy and raised awareness, and publication of supporting data, and so it is especially gratifying that Cardiology in the Young has fostered a progressive approach, agreeing to publish one or two articles in each journal issue in this domain.
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http://dx.doi.org/10.1017/S1047951121001645DOI Listing
April 2021

Zero-Balance Ultrafiltration during Cardiopulmonary Bypass Is Associated with Decreased Urine Output.

J Extra Corpor Technol 2021 Mar;53(1):27-37

SpecialtyCare, Brentwood, Tennessee; Congenital Heart Center, UF Health Shands Hospital, University of Florida, and Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida.

Zero-balance ultrafiltration (ZBUF) during cardiopulmonary bypass (CPB) has been purported to reduce pro-inflammatory mediators during cardiac surgery. However, its clinical benefit is equivocal and its effect on renal function unknown. The purpose of this study was to examine the effect of ZBUF on urine output in adult patients undergoing CPB. Following institutional review board approval, 98,953 records from a national registry of adult patients at 215 U.S. hospitals between January 2016 and September 2019 were reviewed. Groups were stratified according to ZBUF use. Anuric patients were excluded from the study as they were patients with missing data on urine output, ultrafiltration use, or ZBUF volume. The primary endpoint was intraoperative urine output normalized to body weight and procedure duration (total operative time). Final analysis of this endpoint was carried out using a linear mixed-effects regression model adjusting for patient and procedural characteristics, as well as practice patterns associated with surgeons and perfusionists. There was a significant 16.1% reduction in median urine output for ZBUF patients (.94 [.54, 1.47] mL/kg/h) vs. the non-ZBUF group (1.12 [.70,-1.73] mL/kg/h), < .001. After statistically adjusting for patient and procedural characteristics, each liter of ZBUF volume was associated with an estimated change in intraoperative urine output of -.03 mL/kg/h (95% CI: [-.04 to -.02], < .001). The median ZBUF volume was 1,550 [1,000, 2,600] mL, and when ZBUF was used, conventional ultrafiltration (CUF) was more likely to be used as well (88.4% vs. 44.8%, < .001). ZBUF patients had median asanguineous volume and crystalloid cardioplegia nearly two times more than non-ZBUF patients, and had slightly higher red blood cell transfusions (17.6% vs. 16.3%, < .05). The application of ZBUF during CPB was associated with patients having lower urine output and significantly higher use of CUF. Further research is required to determine if these results are reproducible in prospective clinical studies.
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http://dx.doi.org/10.1182/ject-2000016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7995628PMC
March 2021

Long-term outcomes of aortic root operations in the United States among Medicare beneficiaries.

J Thorac Cardiovasc Surg 2021 Feb 25. Epub 2021 Feb 25.

Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC. Electronic address:

Objective: The best method of aortic root repair in older patients remains unknown given a lack of comparative effectiveness of long-term outcomes data. The objective of this study was to compare long-term outcomes of different surgical approaches for aortic root repair in Medicare patients using The Society of Thoracic Surgeons Adult Cardiac Surgery Database-Centers for Medicare & Medicaid Services-linked data.

Methods: A retrospective cohort study was performed by querying the Society of Thoracic Surgeons Adult Cardiac Surgery Database for patients aged 65 years or more who underwent elective aortic root repair with or without aortic valve replacement. Primary long-term end points were mortality, any stroke, and aortic valve reintervention. Short-term outcomes and long-term survival were compared among each root repair strategy. Additional risk factors for mortality after aortic root repair were assessed with a multivariable Cox proportional hazards model.

Results: A total of 4173 patients aged 65 years or more underwent elective aortic root repair. Patients were stratified by operative strategy: mechanical Bentall, stented bioprosthetic Bentall, stentless bioprosthetic Bentall, or valve-sparing root replacement. Mean follow-up was 5.0 (±4.6) years. Relative to mechanical Bentall, stented bioprosthetic Bentall (adjusted hazard ratio, 0.80; confidence interval, 0.66-0.97) and stentless bioprosthetic Bentall (adjusted hazard ratio, 0.70; confidence interval, 0.59-0.84) were associated with better long-term survival. In addition, stentless bioprosthetic Bentall (adjusted hazard ratio, 0.64; confidence interval, 0.47-0.80) and valve-sparing root replacement (adjusted hazard ratio, 0.51; confidence interval, 0.29-0.90) were associated with lower long-term risk of stroke. Aortic valve reintervention risk was 2-fold higher after valve-sparing root replacement compared with other operative strategies.

Conclusions: In the Medicare population, there was poorer late survival and greater late stroke risk for patients undergoing mechanical Bentall and a higher rate of reintervention for valve-sparing root replacement. Bioprosthetic Bentall may be the procedure of choice in older patients undergoing aortic root repair, particularly in the era of transcatheter aortic valve replacement.
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http://dx.doi.org/10.1016/j.jtcvs.2021.02.068DOI Listing
February 2021

Commentary: Failure to rescue: What does it really measure?

J Thorac Cardiovasc Surg 2021 Feb 5. Epub 2021 Feb 5.

Shands Jacksonville, University of Florida College of Medicine Jacksonville, Jacksonville, Fla.

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http://dx.doi.org/10.1016/j.jtcvs.2021.01.129DOI Listing
February 2021

The Michigan Appropriateness Guide for Intravenous Catheters in children with congenital heart disease: miniMAGIC-CHD.

Cardiol Young 2021 Mar 19:1-5. Epub 2021 Mar 19.

The Heart Institute, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.

Background: The approach to vascular access in children with CHD is a complex decision-making process that may have long-term implications. To date, evidence-based recommendations have not been established to inform this process.

Methods: The RAND/UCLA Appropriateness Method was used to develop miniMAGIC, including sequential phases: definition of scope and key terms; information synthesis and literature review; expert multidisciplinary panel selection and engagement; case scenario development; and appropriateness ratings by expert panel via two rounds. Specific recommendations were made for children with CHD.

Results: Recommendations were established for the appropriateness of the selection, characteristics, and insertion technique of intravenous catheters in children with CHD with both univentricular and biventricular physiology.

Conclusion: miniMAGIC-CHD provides evidence-based criteria for intravenous catheter selection for children with CHD.
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http://dx.doi.org/10.1017/S1047951121000962DOI Listing
March 2021

Postoperative Hematocrit and Adverse Outcomes in Pediatric Cardiac Surgery Patients: A Cross-Sectional Study From the Society of Thoracic Surgeons and Congenital Cardiac Anesthesia Society Database Collaboration.

Anesth Analg 2021 Mar 15. Epub 2021 Mar 15.

Department of Anesthesiology and Critical Care Medicine, Bloomberg Children's Hospital, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Background: We sought to examine potential associations between pediatric postcardiac surgical hematocrit values and postoperative complications or mortality.

Methods: A retrospective, cross-sectional study from the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) and Congenital Cardiac Anesthesia Society Database Module (2014-2019) was completed. Multivariable logistic regression models, adjusting for covariates in the STS-CHSD mortality risk model, were used to assess the relationship between postoperative hematocrit and the primary outcomes of operative mortality or any major complication. Hematocrit was assessed as a continuous variable using linear splines to account for nonlinear relationships with outcomes. Operations after which the oxygen saturation is typically observed to be <92% were classified as cyanotic and ≥92% as acyanotic.

Results: In total, 27,462 index operations were included, with 4909 (17.9%) being cyanotic and 22,553 (82.1%) acyanotic. For cyanotic patients, each 5% incremental increase in hematocrit over 42% was associated with a 1.31-fold (95% confidence interval [CI], 1.10-1.55; P = .003) increase in the odds of operative mortality and a 1.22-fold (95% CI, 1.10-1.36; P < .001) increase in the odds of a major complication. For acyanotic patients, each 5% incremental increase in hematocrit >38% was associated with a 1.45-fold (95% CI, 1.28-1.65; P < .001) increase in the odds of operative mortality and a 1.21-fold (95% CI, 1.14-1.29; P < .001) increase in the odds of a major complication.

Conclusions: High hematocrit on arrival to the intensive care unit (ICU) is associated with increased operative mortality and major complications in pediatric patients following cardiac surgery.
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http://dx.doi.org/10.1213/ANE.0000000000005416DOI Listing
March 2021

Updating an Empirically Based Tool for Analyzing Congenital Heart Surgery Mortality.

World J Pediatr Congenit Heart Surg 2021 Mar;12(2):246-281

Duke Clinical Research Institute, 12277Duke University School of Medicine, Durham, NC, USA.

Objectives: STAT Mortality Categories (developed 2009) stratify congenital heart surgery procedures into groups of increasing mortality risk to characterize case mix of congenital heart surgery providers. This update of the STAT Mortality Score and Categories is empirically based for all procedures and reflects contemporary outcomes.

Methods: Cardiovascular surgical operations in the Society of Thoracic Surgeons Congenital Heart Surgery Database (January 1, 2010 - June 30, 2017) were analyzed. In this STAT 2020 Update of the STAT Mortality Score and Categories, the risk associated with a specific combination of procedures was estimated under the assumption that risk is determined by the highest risk individual component procedure. Operations composed of multiple component procedures were eligible for unique STAT Scores when the statistically estimated mortality risk differed from that of the highest risk component procedure. Bayesian modeling accounted for small denominators. Risk estimates were rescaled to STAT 2020 Scores between 0.1 and 5.0. STAT 2020 Category assignment was designed to minimize within-category variation and maximize between-category variation.

Results: Among 161,351 operations at 110 centers (19,090 distinct procedure combinations), 235 types of single or multiple component operations received unique STAT 2020 Scores. Assignment to Categories resulted in the following distribution: STAT 2020 Category 1 includes 59 procedure codes with model-based estimated mortality 0.2% to 1.3%; Category 2 includes 73 procedure codes with mortality estimates 1.4% to 2.9%; Category 3 includes 46 procedure codes with mortality estimates 3.0% to 6.8%; Category 4 includes 37 procedure codes with mortality estimates 6.9% to 13.0%; and Category 5 includes 17 procedure codes with mortality estimates 13.5% to 38.7%. The number of procedure codes with empirically derived Scores has grown by 58% (235 in STAT 2020 vs 148 in STAT 2009). Of the 148 procedure codes with empirically derived Scores in 2009, approximately one-half have changed STAT Category relative to 2009 metrics. The New STAT 2020 Scores and Categories demonstrated good discrimination for predicting mortality in an independent validation sample (July 1, 2017-June 30, 2019; sample size 46,933 operations at 108 centers) with C-statistic = 0.791 for STAT 2020 Score and 0.779 for STAT 2020 Category.

Conclusions: The updated STAT metrics reflect contemporary practice and outcomes. New empirically based STAT 2020 Scores and Category designations are assigned to a larger set of procedure codes, while accounting for risk associated with multiple component operations. Updating STAT metrics based on contemporary outcomes facilitates accurate assessment of case mix.
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http://dx.doi.org/10.1177/2150135121991528DOI Listing
March 2021

In Memoriam: Paul Morris Weinberg, MD.

Cardiol Young 2021 Jan;31(1):1-10

Congenital Heart Center, Division of Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida, United States of America.

On 15 October, 2020, Dr. Paul M. Weinberg, a true giant in the field of paediatric cardiology, succumbed to a prolonged illness. Dr. Weinberg had a 43-year career and was described as a pillar of The Children's Hospital of Philadelphia and the spirit of the Division of Cardiology, a cherished and beloved teacher, and an outstanding clinician. His impact on the field and on the careers of his students will be remembered for generations to come.In 2019, Dr. Weinberg wrote for Jefferson Medical School's 50th year reunion memory book: "In the true spirit of Hippocrates, I seek to mentor the next generation as I was mentored by the last, without expectation of reward. I am forever indebted to these educators for all the knowledge they imparted to me and for the wisdom that I acquired under their tutelage." These words are a true reflection of his unassuming dedication to teaching the next generation of paediatric cardiologists. His legacy will continue to live on through these trainees and impact the field for generations to come.
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http://dx.doi.org/10.1017/S1047951121000123DOI Listing
January 2021

Publishing patterns and citation performance of manuscripts relating to paediatric cardiology and congenital heart disease: comparison of paediatric and adult cardiology journals.

Cardiol Young 2021 Feb 24:1-5. Epub 2021 Feb 24.

Department of Genetics, Cardiovascular Research Centre, Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, UK.

Background: Manuscripts pertaining to paediatric cardiology and CHD have been published in a variety of different journals. Some of these journals are journals dedicated to paediatric cardiology, while others are focused on adult cardiology. Historically, it has been considered that manuscripts published in journals devoted to adult cardiology have greater citation potential. Our objective was to compare citation performance between manuscripts related to paediatric cardiology and CHD published in paediatric as opposed to adult cardiology journals.

Methods: We identified manuscripts related to paediatric cardiology and CHD published in five journals of interest during 2014. Of these journals, two were primarily concerned with adult cardiology, while the other three focused on paediatric cardiology. The number of citations for these identified manuscripts was gathered from Google Scholar. We compared the number of citations (median, mean, and 25th, 75th, 90th, and 95th percentiles), the potential for citation, and the h-index for the identified manuscripts.

Results: We identified a total of 828 manuscripts related to paediatric cardiology and congenital heart as published in the 5 journals during 2014. Of these, 783 (95%) were published in journals focused on paediatric cardiology, and the remaining 45 (5%) were published in journals focused on adult cardiology. The median number of citations was 41 in the manuscripts published in the journals focused on adult cardiology, as opposed to 7 in journals focused on paediatric cardiology (p < 0.001). The h-index, however, was greater for the journals dedicated to paediatric cardiology (36 versus 27).

Conclusion: Approximately one-twentieth of the work relating to paediatric cardiology and CHD is published in journals that focus predominantly on adult cardiology. The median number of citations is greater when manuscripts concerning paediatric cardiology and CHD are published in these journals focused on adult cardiology. The h-index, however, is higher when the manuscripts are published in journals dedicated to paediatric cardiology. While such publications in journals that focus on adult cardiology tend to generate a greater number of citations than those achieved for works published in specialised paediatric cardiology journals, the potential for citation is no different between the journals. Due to the drastically lower number of manuscripts published in journals dedicated to adult cardiology, however, median performance is different.
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http://dx.doi.org/10.1017/S1047951121000597DOI Listing
February 2021

Quest for Biomarkers in Pediatric Cardiac Surgery.

Ann Thorac Surg 2021 Feb 16. Epub 2021 Feb 16.

Congenital Heart Center, University of Florida 1600 SW Archer Rd HD 314B.

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http://dx.doi.org/10.1016/j.athoracsur.2020.12.078DOI Listing
February 2021

2019 Presidential Address of The Southern Thoracic Surgical Association: "WHY".

Ann Thorac Surg 2021 May 3;111(5):1420-1434. Epub 2021 Feb 3.

Congenital Heart Center, Division of Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida. Electronic address:

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http://dx.doi.org/10.1016/j.athoracsur.2020.11.068DOI Listing
May 2021

Robotic Surgery for Pediatric and Congenital Cardiac Disease.

Ann Thorac Surg 2021 Feb 1. Epub 2021 Feb 1.

University of Florida Department of Surgery Division of Thoracic and Cardiovascular Surgery 1600 SW Archer Rd Gainesville, FL 32608; Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV.

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http://dx.doi.org/10.1016/j.athoracsur.2020.11.062DOI Listing
February 2021

Global Leadership in Paediatric and Congenital Cardiac Care: "Coding our way to improved care: an interview with Rodney C. G. Franklin, MBBS, MD, FRCP, FRCPCH".

Cardiol Young 2021 Jan;31(1):11-19

Congenital Heart Center, UF Health Shands Children's Hospital, Gainesville, FL, USA.

Dr Rodney Franklin is the focus of our third in a planned series of interviews in Cardiology in the Young entitled, "Global Leadership in Paediatric and Congenital Cardiac Care." Dr Franklin was born in London, England, spending the early part of his childhood in the United States of America before coming back to England. He then attended University College London Medical School and University College Hospital in London, England, graduating in 1979. Dr Franklin would then go on to complete his general and neonatal paediatrics training in 1983 at Northwick Park Hospital and University College Hospital in London, England, followed by completing his paediatric cardiology training in 1989 at Great Ormond Street Hospital for Children in London, England. During this training, he additionally would hold the position of British Heart Foundation Junior Research Fellow from 1987 to 1989. Dr Franklin would then complete his training in 1990 as a Senior Registrar and subsequent Consultant in Paediatric and Fetal Cardiology at Wilhelmina Sick Children's Hospital in Utrecht, the Netherlands. He subsequently obtained his research doctorate at University of London in 1997, consisting of a retrospective audit of 428 infants with functionally univentricular hearts.Dr Franklin has spent his entire career as a Consultant Paediatric Cardiologist at the Royal Brompton & Harefield Hospital NHS Foundation Trust, being appointed in 1991. He additionally holds honorary Consultant Paediatric Cardiology positions at Hillingdon Hospital, Northwick Park Hospital, and Lister Hospital in the United Kingdom, and Honorary Senior Lecturer at Imperial College, London. He has been the Clinical Lead of the National Congenital Heart Disease Audit (2013-2020), which promotes data collection within specialist paediatric centres. Dr Franklin has been a leading figure in the efforts towards creating international, pan European, and national coding systems within the multidisciplinary field of congenital cardiac care. These initiatives include but are not limited to the development and maintenance of The International Paediatric & Congenital Cardiac Code and the related International Classification of Diseases 11th Revision for CHD and related acquired terms and definitions. This article presents our interview with Dr Franklin, an interview that covers his experience in developing these important coding systems and consensus nomenclature to both improve communication and the outcomes of patients. We additionally discuss his experience in the development and implementation of strategies to assess the quality of paediatric and congenital cardiac care and publicly report outcomes.
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http://dx.doi.org/10.1017/S104795112000476XDOI Listing
January 2021

The Society of Thoracic Surgeons Intermacs 2020 Annual Report.

Ann Thorac Surg 2021 03 16;111(3):778-792. Epub 2021 Jan 16.

Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan. Electronic address:

The Society of Thoracic Surgeons (STS)-Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) 2020 Annual Report reviews outcomes on 25,551 patients undergoing primary isolated continuous-flow left ventricular assist device (LVAD) implantation between 2010 and 2019. In 2019, 3198 primary LVADs were implanted, which is the highest annual volume in Intermacs history. Compared with the previous era (2010-2014), patients who received an LVAD in the most recent era (2015-2019) were more likely to be African American (26.8% vs 22.9%, P < .0001) and more likely to be bridged to durable LVAD with temporary mechanical support devices (36.8% vs 26.0%, P < .0001). In 2019, 50% of patients were INTERMACS Profile 1 or 2 before durable LVAD, and 73% received an LVAD as destination therapy. Magnetic levitation technology has become the predominant design, accounting for 77% of devices in 2019. The 1- and 2-year survival in the most recent era has improved compared with 2010 to 2014 (82.3% and 73.1% vs 80.5% and 69.1%, respectively; P < .0001). Major bleeding and infection continue to be the leading adverse events. Incident stroke has declined in the current era to 12.7% at 1 year. STS-Intermacs research publications are highlighted, and the new quality initiatives are introduced.
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http://dx.doi.org/10.1016/j.athoracsur.2020.12.038DOI Listing
March 2021

Six-Year Neurodevelopmental Outcomes for Children With Single-Ventricle Physiology.

Pediatrics 2021 Feb 13;147(2). Epub 2021 Jan 13.

Pediatrics, Herma Heart Institute, Children's Wisconsin and Medical College of Wisconsin, Milwaukee, Wisconsin.

Objectives: To determine if neurodevelopmental deficits in children with single-ventricle physiology change with age and early developmental scores predict 6-year outcomes.

Methods: In the Single Ventricle Reconstruction Trial, Bayley Scales of Infant Development, Second Edition, were administered at 14 months of age, and parents completed the Behavior Assessment System for Children, Second Edition (BASC-2) annually from the ages of 2 to 6 years. Scores were classified as average, at risk, or impaired. We calculated sensitivities, specificities, and positive and negative predictive values of earlier tests on 6-year outcomes.

Results: Of 291 eligible participants, 244 (84%) completed the BASC-2 at 6 years; more Single Ventricle Reconstruction participants than expected on the basis of normative data scored at risk or impaired on the BASC-2 Adaptive Skills Index at that evaluation (28.7% vs 15.9%; < .001). Children with Adaptive Skills Composite scores <2 SD below the mean at the age of 6 were more likely to have had delayed development at 14 months, particularly on the Psychomotor Development Index (sensitivity of 79%). However, the positive predictive value of the 14-month Mental Development Index and Psychomotor Development Index for 6-year BASC-2 Adaptive Scores was low (44% and 36%, respectively). Adaptive Skills Composite score impairments at the age of 6 were poorly predicted by using earlier BASC-2 assessments, with low sensitivities at the ages of 3 (37%), 4 (48%), and 5 years (55%).

Conclusions: Many children with hypoplastic left heart syndrome who have low adaptive skills at the age of 6 years will not be identified by screening at earlier ages. With our findings, we highlight the importance of serial evaluations for children with critical congenital heart disease throughout development.
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http://dx.doi.org/10.1542/peds.2020-014589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7849196PMC
February 2021

Tracheal surgery for airway anomalies associated with increased mortality in pediatric patients undergoing heart surgery: Society of Thoracic Surgeons Database analysis.

J Thorac Cardiovasc Surg 2021 Mar 27;161(3):1112-1121.e7. Epub 2020 Nov 27.

Division of Cardiothoracic Surgery, Department of Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.

Objectives: Airway anomalies are common in children with cardiac disease but with an unquantified impact on outcomes. We sought to define the association between airway anomalies and tracheal surgery with cardiac surgery outcomes using the Society of Thoracic Surgery Congenital Heart Surgery Database.

Methods: Index cardiac operations in children aged less than 18 years (January 2010 to September 2018) were identified from the Society of Thoracic Surgery Congenital Heart Surgery Database. Patients were divided on the basis of reported diagnosis of an airway anomaly and subdivided on the basis of tracheal lesion and tracheal surgery. Multivariable analysis evaluated associations between airway disease and outcomes controlling for covariates from the Society of Thoracic Surgery Congenital Heart Surgery Database Mortality Risk Model.

Results: Of 198,674 index cardiovascular operations, 6861 (3.4%) were performed in patients with airway anomalies, including 428 patients (0.2%) who also underwent tracheal operations during the same hospitalization. Patients with airway anomalies underwent more complex cardiac operations (45% vs 36% Society of Thoracic Surgeons/European Association for Cardiothoracic Surgery Congenital Heart Surgery Mortality category ≥3 procedures) and had a higher prevalence of preoperative risk factors (73% vs 39%; both P < .001). In multivariable analysis, patients with airway anomalies had increased odds of major morbidity and tracheostomy (P < .001). Operative mortality was also increased in patients with airway anomalies, except those with malacia. Tracheal surgery within the same hospitalization increased the odds of operative mortality (adjusted odds ratio, 3.9; P < .0001), major morbidity (adjusted odds ratio, 3.7; P < .0001), and tracheostomy (adjusted odds ratio, 16.7; P < .0001).

Conclusions: Patients undergoing cardiac surgery and tracheal surgery are at significantly higher risk of morbidity and mortality than patients receiving cardiac surgery alone. Most of those with unoperated airway anomalies have higher morbidity and mortality, which makes it an important preoperative consideration.
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http://dx.doi.org/10.1016/j.jtcvs.2020.10.149DOI Listing
March 2021

Heart Transplantation for Pediatric and Congenital Cardiac Disease: A Comparison of Two Eras over 23 Years and 188 Transplants at a Single Institution.

World J Pediatr Congenit Heart Surg 2021 Jan;12(1):17-26

Congenital Heart Center, Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, FL, USA.

Background: To assess changes in patterns of practice and outcomes over time, we reviewed all patients who underwent heart transplantation (HTx) at our institution and compared two consecutive eras with significantly different immunosuppressive protocols (cohort 1 [80 HTx, June 1995-June 2006]; cohort 2 [108 HTx, July 2006-September 2018]).

Methods: Retrospective study of 180 patients undergoing 188 HTx (June 1995-September 2018; 176 first time HTx, 10 second HTx, and 2 third HTx). In 2006, we commenced pre-HTx desensitization for highly sensitized patients and started using tacrolimus as our primary postoperative immunosuppressive agent. The primary outcome was mortality. Survival was modeled by the Kaplan-Meier method. Univariable and multivariable Cox proportional hazard models were created to identify prognostic factors for survival.

Results: Our 188 HTx included 18 neonates, 85 infants, 83 children, and 2 adults (>18 years). Median age was 260.0 days (range: 5 days-23.8 years). Median weight was 7.5 kg (range: 2.2-113 kg). Patients in cohort 1 were less likely to have been immunosensitized preoperatively (12.5% vs 28.7%, = .017). Nevertheless, Kaplan-Meier analysis suggested superior survival in cohort 2 ( = .0045). Patients in cohort 2 were more likely to be alive one year, five years, and ten years after HTx. Multivariable analysis identified the earlier era (hazard ratio [HR] [95% confidence interval] for recent era = 0.32 [0.14-0.73]), transplantation after prior Norwood operation (HR = 4.44 [1.46-13.46]), and number of prior cardiac operations (HR = 1.33 [1.03-1.71]) as risk factors for mortality.

Conclusions: Our analysis of 23 years of pediatric and congenital HTx reveals superior survival in the most recent 12-year era, despite the higher proportion of patients with elevated panel reactive antibody in the most recent era. This improvement was temporally associated with changes in our immunosuppressive strategy.
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http://dx.doi.org/10.1177/2150135120954149DOI Listing
January 2021

The 2020 annual report of DataDerm: The database of the American Academy of Dermatology.

J Am Acad Dermatol 2021 Apr 13;84(4):1037-1041. Epub 2020 Dec 13.

American Academy of Dermatology, Rosemont, Illinois; University of Florida, Gainesville, Florida.

The American Academy of Dermatology launched DataDerm in 2016 as the clinical data registry platform of the American Academy of Dermatology. DataDerm is approved by the Centers for Medicare & Medicaid Services as a Qualified Clinical Data Registry for the Merit-Based Incentive Payment System. The ultimate purpose of DataDerm is to provide dermatologists with a registry and database that will serve as a vehicle to advance the specialty in the domains of science, discovery, education, quality assessment, quality improvement, advocacy, and practice management. DataDerm is currently the largest clinical registry and database of patients receiving dermatologic care in the world. As of December 31, 2019, DataDerm contained data from 10,618,879 unique patients and 32,309,389 unique patient visits. Depending on the reporting period, 800 to 900 practices (representing 2400-2600 clinicians) actively participate in DataDerm by submitting data. This article provides the first of a planned series of annual updates of the status of DataDerm. The purpose of this article is to present the rationale for the creation, maintenance, history, and current status of DataDerm, as well as the future plans for DataDerm.
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http://dx.doi.org/10.1016/j.jaad.2020.11.068DOI Listing
April 2021

The Cardiac Neurodevelopmental Outcome Collaborative: a new community improving outcomes for individuals with congenital heart disease.

Cardiol Young 2020 Nov;30(11):1595-1596

Department of Pediatrics, Northwestern University Feinberg School of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.

Improved survival of patients with paediatric and congenital cardiac disease has led to a heightened awareness of the cognitive, neurodevelopmental, psychosocial, and physical functioning deficits that limit health, academic functioning, adaptive functioning, behavioural and emotional outcomes, health-related quality of life, and well-being for children and adults with congenital heart disease. The Cardiac Neurodevelopmental Outcome Collaborative was founded in 2016; its mission is to determine and implement best practices of neurodevelopmental and psychosocial services for individuals with paediatric and congenital heart disease and their families through clinical, quality improvement, and research initiatives.Cardiology in the Young is devoted to cardiovascular issues affecting the young, and older patients with congenital heart disease, or with other cardiac diseases acquired during childhood. The journal serves the interests of all professionals concerned with these topics. By design, the journal is international and multidisciplinary in its approach, and members of the editorial board take an active role in its mission, helping to make it an indispensable reference for paediatric and congenital cardiac care. All aspects of paediatric and congenital cardiac care are covered in the journal. The content includes original articles, brief reports, editorials, reviews, and papers devoted to continuing professional development. High-quality colour figures are published on a regular basis, and without charge to the authors. Regular supplements are published containing the abstracts of the annual meetings of the Association for European Paediatric and Congenital Cardiology, along with other occasional supplements. These supplements are supplied free to subscribers.The vision of Cardiology in the Young is to use print and electronic media to improve paediatric and congenital cardiac care. The mission of Cardiology in the Young is to be a premier global journal for paediatric and congenital cardiac care - an essential journal that spans the domains of patient care, research, education, and advocacy, and also spans geographical, temporal, and subspecialty boundaries.Cardiology in the Young and the Cardiac Neurodevelopment Outcome Collaborative are pleased to announce that Cardiology in the Young will serve as the official journal of the Cardiac Neurodevelopment Outcome Collaborative. This new partnership between the Cardiac Neurodevelopmental Outcome Collaborative and Cardiology in the Young will facilitate the dissemination of knowledge and recommendations to the scientific, clinical, and patient advocacy communities, ultimately improving paediatric and congenital cardiac care and outcomes for individuals with paediatric and congenital heart disease and their families.
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http://dx.doi.org/10.1017/S1047951120003509DOI Listing
November 2020

Costs Associated with Lobectomy for Lung Cancer: a novel analysis merging STS and Medicare data.

Ann Thorac Surg 2020 Nov 11. Epub 2020 Nov 11.

Background: Costs related to care of patients who undergo lobectomy for lung cancer may vary depending on patient, disease, and treating facility characteristics. We aimed to identify underlying case mix factors that contribute to variability of 90-day costs of lobectomy for early stage lung cancer.

Methods: The Society of Thoracic Surgeons General Thoracic Surgery Database was queried for lobectomy for clinical stage I lung cancer (2008-2013). Demographics, clinical outcomes, and 90-day episode-of-care costs across all care settings were analyzed for patients successfully linked to Medicare data. Hospital costs were estimated from charges using cost-to-charge ratios. Comprehensive regression models were created to identify impact of preoperative patient factors and hospital characteristics on costs, and to delineate additive costs due to perioperative outcomes and complications.

Results: The mean 90-day cost for lobectomy was $45,080 ±$38,239. Variables associated with significant additive costs were age ≥75 years, ASA III or IV, FEV1 <80% predicted, BMI <18.5 or >35, current or past smoker, cerebrovascular disease, chronic kidney disease, impaired functional status, open thoracotomy, prolonged operative time, government hospitals, metropolitan setting, and geographic location. Patients with ≥1 postoperative complication resulted in an overall mean added cost of $27,259. Added costs increased with the number of complications; isolated recurrent laryngeal nerve paresis ($3,911) and respiratory failure ($35,011) were associated with the least and most additive cost, respectively.

Conclusions: Lobectomy is associated with substantial variability of episode-of-care costs. Variability is driven by patient demographic and clinical factors, hospital characteristics, and the occurrence and severity of complications.
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http://dx.doi.org/10.1016/j.athoracsur.2020.08.073DOI Listing
November 2020

The Society of Thoracic Surgeons Congenital Heart Surgery Database: 2020 Update on Outcomes and Research.

Ann Thorac Surg 2020 12 16;110(6):1809-1818. Epub 2020 Oct 16.

Heart Institute, Children's Hospital of Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California.

The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database (CHSD) continues to be a highly regarded, comprehensive clinical outcomes database that captures more than 90% of all congenital heart surgery cases in the United States and has more than 90% of all congenital heart surgery centers as participants. This report includes aggregate information on clinical outcomes evaluated at the aggregate and The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) category levels for the period July 1, 2015, through June 30, 2019. It also includes the published research activities that use data from the STS CHSD. Also included is information on the STS CHSD auditing function, a summary of the significant revisions to the data, which is collected on each patient, and an update on efforts to update the risk-adjustment methods for evaluation of the outcomes.
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http://dx.doi.org/10.1016/j.athoracsur.2020.10.004DOI Listing
December 2020

Successful mobile extracorporeal membrane oxygenator for COVID-19 severe respiratory failure.

J Card Surg 2020 Dec 10;35(12):3655-3657. Epub 2020 Oct 10.

Department of Cardiothoracic Surgery, Cleveland Clinic Florida, Weston, Florida, USA.

High volume extracorporeal membrane oxygenation (ECMO) centers have developed mobile ECMO programs in recent years to facilitate the implementation of ECMO support at hospitals with lower capabilities, and transfer these patients for further care. We report a case of mobile ECMO on a patient with coronavirus disease 2019-related acute respiratory distress syndrome, and discuss the potential application in the current severe acute respiratory syndrome coronavirus 2 pandemic.
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http://dx.doi.org/10.1111/jocs.15106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7675363PMC
December 2020

Fourth Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report.

Ann Thorac Surg 2020 12 8;110(6):1819-1831. Epub 2020 Oct 8.

Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

Background: The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), originally a National Institutes of Health-sponsored U.S. database, provides a platform to understand the population of children supported with ventricular assist devices (VADs) during this time of increasing numbers, new devices, expanding indications, and improved outcomes.

Methods: Between September 19, 2012, and December 31, 2019, 44 hospitals implanted 1031 devices in 856 patients under 19 years of age.

Results: Overall, diagnosis was cardiomyopathy in 497 (58%) patients, congenital heart disease (CHD) in 216 (25%), myocarditis in 85 (10%), and other in 58 (7%). Positive outcome (alive on device or bridge to transplantation and recovery) occurred in 82% at 6 months. The patient cohort for implantable continuous (IC) pumps (n = 365) (age 13.2 ± 3.9 years, 18% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 23% intubated at implantation, 16% with CHD) was significantly different from the paracorporeal continuous (PC) pump cohort (n = 212) (age 3.6 ± 4.9 years, 46% Intermacs profile 1, 81% intubated, 42% CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 230) (age 2.7 ± 3.5 years, 31% Intermacs profile 1, 76% intubated, 26% CHD). Consistent with their cohort composition, positive outcomes at 6 months based on device type were the following: IC, 92%; PC, 68%; and PP, 81%. The incidence of cerebrovascular accidents in the IC, PC, and PP cohorts was 7%, 14%, and 15%, respectively.

Conclusions: IC VADs, the most common VAD type placed in children, are associated with improved outcomes compared with PP and PC devices, though PP and PC devices are limited to supporting our most challenging patients. Noteworthy, the incidence of cerebrovascular accidents for pediatric VADs has significantly decreased and is now 11% overall. This report demonstrates again that although often attributed to age, size, or device type, much of the burden in mortality and adverse events is correlated to the patient's overall state at VAD implantation.
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http://dx.doi.org/10.1016/j.athoracsur.2020.09.003DOI Listing
December 2020

Initial and Longitudinal Cost of Surgical Resection for Lung Cancer.

Ann Thorac Surg 2020 Oct 5. Epub 2020 Oct 5.

Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.

Background: The longitudinal cost of treating patients with non-small cell lung cancer (NSCLC) undergoing surgical resection has not been evaluated. We describe initial and 4-year resource use and cost for NSCLC patients aged 65 years of age or greater who were treated surgically between 2008 and 2013.

Methods: Using clinical data for NSCLC resections from The Society of Thoracic Surgeons General Thoracic Surgery Database linked to Medicare claims, resource use and cost of preoperative staging, surgery, and subsequent care through 4 years were examined ($2017). Cost of hospital-based care was estimated using cost-to-charge ratios; professional services and care in other settings were valued using reimbursements. Inverse probability weighting was used to account for administrative censoring. Outcomes were stratified by pathologic stage and by surgical approach for stage I lobectomy patients.

Results: Resection hospitalizations averaged 6 days and cost $31,900. In the first 90 days, costs increased with stage ($12,430 for stage I to $26,350 for stage IV). Costs then declined toward quarterly means more similar among stages. Cumulative costs ranged from $131,032 (stage I) to $205,368 (stage IV). In the stage I lobectomy cohort, patients selected for minimally invasive procedures had lower 4-year costs than did thoracotomy patients ($120,346 versus $136,250).

Conclusions: The 4-year cost of surgical resection for NSCLC was substantial and increased with pathologic stage. Among stage I lobectomy patients, those selected for minimally invasive surgery had lower costs, particularly through 90 days. Potential avenues for improving the value of surgical resection include judicious use of postoperative intensive care and earlier detection and treatment of disease.
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http://dx.doi.org/10.1016/j.athoracsur.2020.07.048DOI Listing
October 2020