Proposition: the benefit of cardiac transplantation in stable outpatients with heart failure should be tested in a randomized trial.
Recent data suggest that cardiac transplantation is associated with a survival benefit only in patients at high risk for dying of advanced heart failure without this procedure. To test the hypothesis that survival and quality of life advantages associated with cardiac transplantation exist in stable outpatients, a 3-stage approach is proposed: 1). to establish a database within the International Society for Heart and Lung Transplantation/United Network for Organ Sharing/Eurotransplant infrastructure that will provide an estimate of the survival benefit of heart transplantation in various heart failure risk strata by prospectively following cohorts of patients listed for heart transplantation; 2). to organize an international consensus conference that will define, based on the review of the Stage 1 data, the feasibility of a prospective randomized trial; and 3). pending consensus, to perform a clinical trial, perhaps with an augmented, randomized design that allocates cardiac transplantation to all patients at high risk for dying of heart failure while randomizing patients at low risk to either conventional treatment or cardiac transplantation. Generating such scientific evidence is important in light of today's donor organ crisis and the associated difficulties of equitable resource allocation.
Deng
Mario C
MC
Division of Circulatory Physiology, Columbia University College of Physicians and Surgeons, New York, New York 10032, USA. md785@columbia.edu
Smits
Jaqueline M A
JM
Young
James B
JB
D015331:Cohort Studies; D003245:Consensus Statements as Topic; D016208:Databases, Factual; D006333:Heart Failure / Q000601:surgery*; D016027:Heart Transplantation; D006801:Humans; D010045:Outpatients; D011446:Prospective Studies; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018570:Risk Assessment; D015996:Survival Rate