The team of Intermacs Investigators is comprised of heart failure physicians from the United States. In collaboration with federal partners, they established the registry aims, endpoints, protocol, and manual of operations.

Kirklin
James K. Kirklin, MD
Principal Investigator
The principal investigator for Intermacs, Dr. James Kirklin, and his team at the University of Alabama at Birmingham (UAB) have a long established track record in focused multi-institutional studies and databases in cardiac transplantation (via the Cardiac Transplant Research Database and the Pediatric Heart Transplant Study) and over the past decade in mechanical circulatory support.  Dr. Kirklin has dedicated a major portion of his professional career to the advancement of knowledge in the area of these surgical therapies for advanced heart failure and is a past President of the International Society for Heart and Lung Transplantation (ISHLT), the professional society which is the “home” for the majority of important presentations and publications regarding mechanical circulatory support.


Naftel
David C. Naftel, PhD
Co-Investigator
Dr. David C. Naftel is Professor of Surgery and Biostatistics and Co-Director of Cardiothoracic Surgery Research at the University of Alabama at Birmingham (UAB). He is an internationally recognized expert on outcomes research in cardiac surgery. He is the statistician on multi-institutional ongoing studies of outcome after heart transplantation, including the Pediatric Heart Transplant Study (36 institutions, 3,831 listed and 2,763 transplanted patients in the database) and an NIH sponsored study on quality of life after heart transplant (4 institutions, 600 patients). Dr. Naftel is chairperson of the Independent Expert Panel on Statistical Methods for the Analysis of Organ Transplantation Data created by the federal Department of Health and Human Services. He has worked with industry in analyzing studies for FDA medical device approval, including studies on prosthetic heart valves, cardiac conduits, coronary stents, atrial fibrillation ablation devices and vascular endografts. He has been instrumental in the development and clinical acceptance of parametric statistical methods for estimating time-related risk of clinical outcomes and their associated risk factors.


Young
James B. Young, MD
Study Chair
James B. Young, MD is Professor of Medicine and Executive Dean of the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Chairman of the Endocrinology and Metabolism Institute at Cleveland Clinic, and a founder of the Cleveland Clinic Kaufman Center for Heart Failure. He is the Study Chairman of the NIH, FDA, and CMS Interagency Registry for Mechanical Assist Circulatory Support (Intermacs). He has a joint appointment to the Multi-Organ Transplant Center. Dr. Young is board certified as a Diplomat of the American Board of Internal Medicine as well as in the subspecialty of cardiovascular disease.

Dr. Young’s clinical research activities began during his residency and fellowship training when he was a Lipid Research Clinic (LRC) physician. He subsequently focused his efforts on heart failure and cardiac transplant therapeutics including early experiences with dopamine receptor agonists, angiotensin-converting enzyme inhibitors, beta- blockers, calcium channel blockers, angiotensin receptor blockers, many new immunosuppressants, and a variety of parenteral inotropes and vasodilators. He has collaborated extensively with his basic science research associates in the Kaufman Center for Heart Failure and Multi-Organ Transplant Center on “bridging” and “translational” research focused primarily on the molecular biology of cardiac remodeling, allograft arteriopathy, and transplanted heart rejection. Dr. Young served as the United States Principal Investigator or Co-Principal Investigator for the HOPE, RESOLVED, SPICE, VMAC, MIRACLE-ICD, ONTARGET, TRANSCEND, and CHARM multicenter clinical trials.

Dr. Young has published almost 500 manuscripts and abstracts and several textbooks. Professionally, he is most proud of his contributions to the development and administration of organ procurement programs, his efforts to secure recognition for the newly emerging cardiology subspecialty of “Heart Failure and Cardiac Transplant Medicine”, and his collaborations with basic and clinical scientists.


Pagani
Francis Pagani, MD, PhD
Co-Investigator
Dr. Francis D. Pagani is the Otto Gago MD Professor of Surgery in the University of Michigan Medical School and is currently the Surgical Director of the Heart Transplant Program and Director of the Center for Circulatory Support in the Section of Cardiac Surgery. Dr. Pagani is an internationally-recognized leader in developing ventricular assist device therapy and an expert in the treatment of end-stage heart failure, with a vibrant research program supported by the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH), as well as corporate sponsors. The Center for Circulatory Support, under Dr. Pagani’s direction, is one of the most recognized and well-respected programs in the nation. His research focuses on the use of mechanical circulatory support in the treatment of end-stage heart disease and the use of cellular transplantation for myocardial regeneration.


Stevenson
Lynne W. Stevenson, MD
Co-Investigator
Dr. Stevenson is the Director of the Cardiomyopathy and Heart Failure Program at Brigham & Women’s Hospital in Boston, Massachusetts. She has been inspirational in the success of the Registry and she helped define the current Intermacs Patient Profiles used today. Dr. Stevenson was the Co-Chair of the Consensus Conference on Mechanical Cardiac Support in 2000, at which representatives of ISHLT, FDA, NHLBI, ACC, ASTS, STS, ACC, AHA, RFSA and industry met and identified the vital role of a MCSD Registry (as summarized in the Consensus Report in Circulation, Journal of American Cardiologists, Journal of Heart and Lung Transplant 2000). Her role in conceiving and completing this landmark collaborative conference exemplifies her commitment to uniting disparate groups with parallel goals. While on the Board of Directors of the ISHLT, she was integrally involved in the development of the preliminary MCSD database. She has participated in NHLBI special emphasis review panels, most recently in 2004, relating to artificial heart development. She was Chair of the Heart Failure and Cardiac Transplant Committee of the American College of Cardiology for 5 years. She participates regularly in consultation with the CDRH Branch of the FDA regarding trial design for new devices in heart failure. For 10 years, she has been on the Medicare (now CMS) review panel for certification of cardiac transplant centers, and serves on the NHLBI Heart Failure Task Force and is Chair of the new NHLBI working group on Cardio-Renal Interactions. Her particular expertise is in the medical therapy and evaluation for surgical therapy of patients with advance heart failure, participating in the original REMATCH design and serving as Chair of the Medical Management Committee for the successful trial of destination therapy, Chair the Registry Committee of the NHLBI-sponsored STICH trial, and Principal Investigator of the multi-center NHLBI-sponsored ESCAPE trial of patients hospitalized with advanced heart failure.


Kormos
Robert L. Kormos, MD
Co-Investigator
Dr. Robert L. Kormos is currently a professor with tenure specializing in cardiothoracic surgery at the University of Pittsburgh and is the director of UPMC’s Artificial Heart and Program and co-director of the Heart Transplant Program.

Dr. Kormos has been on the faculty at the University of Pittsburgh since 1987 after completion of two fellowships in research and transplant surgery. While at the University of Pittsburgh, his research and clinical interests have been focused on mechanical circulatory support, resulting in his authorship of over 250 published articles, 40 book chapters and a textbook on the subject. He is an associate editor for The Journal of Heart and Lung Transplantation, a member of more than 17 professional societies and is internationally regarded for his clinical and research work in organ transplantation and in the use of cardiac assist devices as temporary or permanent support for patients with end-stage heart disease. He has been an invited lecturer to more than 200 national and international meetings. He is a member of the STS/AATS Workforce on New Technology, the STS Workforces on Clinical Education, and Adult Cardiac and Vascular Surgery and a member of the joint STS-FDA pilot Network of Experts. He is the Co-Principle Investigator for the The Randomized Evaluation of VAD InterVEntion Before Inotropic Therapy (REVIVE-IT) trial. He was interim medical director of the mechanical circulatory support registry of the United Network of Organ Sharing and International Society for Heart and Lung Transplantation. He is the past Chair of the Society for Thoracic Surgeons Workforce on End-Stage Cardiopulmonary Disease.

Dr. Kormos is the recipient of multiple awards including the President's Award at the 7th Annual Scientific Session of the International Society for Heart and Lung Transplantation in 1987. He was also elected to serve as president of the International Society for Heart and Lung Transplantation from 1999-2000. As a further honor, Dr. Kormos has been listed for the past 10 years in the America's Top Doctors published by Castle Connolly Medical, Ltd.


Blume
Elizabeth Blume, MD
Co-Investigator
Dr. Blume is the Medical Director of the Advanced Cardiac Therapies Program at Boston Children’s Hospital and Associate Professor of Pediatrics at Harvard Medical School. She is responsible for the clinical, research, educational, and administrative duties of the cardiomyopathy, end-stage heart failure, mechanical support and heart transplant patients. She has served as the pediatric representative to the Heart Failure/Transplant Committee of the American College of Cardiology, Early Career Development Subcommittee of CDVY for the AHA, Region 1 representative to the UNOS Pediatric Committee as well as Past-President of the Pediatric Heart Transplant Study. Dr. Blume has contributed to multiple research projects involving children with heart failure, serving as the PI for an initial multi-center trial of carvedilol in children, as a member of the Steering Committee for the first randomized beta blocker trial in children. She is currently the site PI for the NIH funded Clinical Trials in Organ Transplant-Pediatric funded by NAIDK. She currently serves as a consultant to the NIH sponsored Pumpkin Trial, and recently has published on the care of children at end-of-life.