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Cardiac Transplantation Research in the Next Decade: A Goal to Evidence-Based Outcomes
The National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group (WG) on August 5-6, 2010 in Bethesda, MD to discuss future directions of research in cardiac transplantation. The WG was composed of researchers with expertise in the basic science, clinical science, and epidemiological aspects of advanced heart failure and cardiac transplantation. These experts were asked to identify the highest priority research gaps in the field and make recommendations for future research strategies that would address those gaps. The WG was also asked to include approaches that capitalize on current scientific opportunities and focus on areas which required unique NHLBI leadership. Finally, the WG was charged with developing recommendations that were both visionary and practical, and that would have both short and long-term impact on the field of cardiac transplantation.
Cardiac transplantation is considered the gold standard treatment for patients with advanced heart failure who are refractory to management with medical therapy and mechanical circulatory support. However, clinical care in cardiac transplantation is dominated by group consensus based on anecdotal experience rather than strong scientific evidence. Progress in the pharmacological and device-based management of heart failure has led to longer survival of patients with advanced heart failure, creating a potential recipient pool in the United States of greater than 50,000 patients annually. Yet, the number of cardiac transplants performed in this country has remained relatively fixed at 2200 per year, a number that has not changed for a decade. Also, advances in immunosuppression and a better understanding of how to treat cardiac allograft rejection have led to improved 1 year cardiac allograft survival. However, late outcomes in this population remain dismal with a median cardiac allograft survival of 11 years, a statistic that has also not improved in over a decade. Thus, there is an urgent need for innovative clinical and basic research to develop evidence-based therapies and standard approaches that will expand the donor pool and prolong the survival of cardiac transplant recipients.
The WG participants reviewed key areas in cardiac transplantation and identified the most urgent knowledge gaps. These gaps were then organized into the following four specific research directions: 1) Enhanced phenotypic characterization of the pre-transplant population – including the prediction and management of renal impairment and recovery, the impact of nutrition, pulmonary hypertension, and mechanical circulatory support on late allograft outcomes, and the characterization and management of sensitization; 2) Donor-recipient optimization strategies – including the evaluation of donor-recipient interactions, standards for utilizing donor hearts, and optimization of donor outcomes by limiting ischemia-reperfusion injury; 3) Individualized immunosuppression therapy – including the use of pharmacogenomics and pattern-integrated biosignatures; and, 4) Investigations of immune and non-immune factors affecting late cardiac allograft outcomes – including a better understanding of antibody mediated rejection, measures to predict and induce clinical allograft tolerance, and prevention and management of complications of the cardio-metabolic syndrome in the cardiac transplant recipient. Finally, because the cardiac transplant population is relatively small compared to other patient groups, the WG strongly urged concerted efforts to enroll every transplant recipient into a clinical study in order to optimize research in this field.
A report is planned for publication in a peer-reviewed journal.
Monica R. Shah, MD, MHS, MSJ
Lisa Schwartz Longacre, PhD
Lynn Rundhaugen, MPH
Working Group Members
Last Updated: September 2010