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 hypertensi on is decreasing. While effective pharmacologic therapies have improved out comes for mild-moderate heart failure, the impact of newer therapies and me chanical circulatory support for advanced heart failure has not yet been re alized. Implantable devices have been shown to be safe and effective as bri dges to cardiac transplantation, but further work is needed to establish th e role of mechanical support for myocardial recovery and for long-term supp ort. This conference was held to assess current mechanical support applicat ions and future trial designs for investigation affecting this public healt h issue. The participants concluded that important differences between devices and d rugs may warrant novel study designs characterized by innovation and flexib ility. While the randomized clinical trial remains the most powerful tool f or unambiguous comparison of interventions, variations may include timed gr aduation from control to investigational therapies, assignment influenced b y patient risk or patient preferences and criteria for an optional crossove r to compassionate device use. A major impact would result from a national outcomes database for advanced heart failure that identifies high-risk popu lations with the greatest potential for benefit from newer therapies and th us facilitates the design of devices and device trials. A separate registry with industry of outcomes after device placement would help to identify "b reakthrough" device therapies and facilitate the refinement and acceptance of this new technology. As represented in this conference, progress in mech anical circulatory support will be accelerated by the continued coordinatio n of scientists, engineers, industry, clinical investigators and regulatory and payment agencies in prospective partnership.