Mechanical Cardiac Support 2000: Current Applications and Future Trial Design - June 15-16, 2000 - Bethesda, Maryland

Heart failure presents an increasing public health burden of morbidity and mortality even as the mortality from coronary artery disease and hypertension is decreasing. While effective pharmacologic therapies have improved outcomes for mild-moderate heart failure, the impact of newer therapies and mechanical circulatory support for advanced heart failure has not yet been realized. Implantable devices have been shown to be safe and effective as bridges to cardiac transplantation, but further work is needed to establish the role of mechanical support for myocardial recovery and for long-term support. This conference was held to assess current mechanical support applications and future trial designs for investigation affecting this public health issue. The participants concluded that important differences between devices and drugs may warrant novel study designs characterized by innovation and flexibility. While the randomized clinical trial remains the most powerful tool for unambiguous comparison of interventions, variations may include timed graduation from control to investigational therapies, assignment influenced by patient risk or patient preferences and criteria for an optional crossover to compassionate device use. A major impact would result from a national outcomes database for advanced heart failure that identifies high-risk populations with the greatest potential for benefit from newer therapies and thus facilitates the design of devices and device trials. A separate registry with industry of outcomes after device placement would help to identify "breakthrough" device therapies and facilitate the refinement and acceptance of this new technology. As represented in this conference, progress in mechanical circulatory support will be accelerated by the continued coordination of scientists, engineers, industry, clinical investigators and regulatory and payment agencies in prospective partnership.