BACKGROUND: Over the last two decades, mechanical circulatory support devices have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, occasionally, a bridge to recovery, and most recently as permanent implantation or "destination therapy" for intractable heart failure. Although cardiac transplantation offers life saving therapy for selected patients, its use is limited by a supply of donor organs which currently meets less than one-tenth the need. As a consequence, the number of mechanical circulatory support device implantations has increased in recent years and this trend is expected to continue especially in view of the October 1, 2003 decision of the Centers for Medicare and Medicaid Services (CMS) to provide reimbursement for mechanical circulatory support device implantation surgery.

Despite favorable survival and quality of life outcomes, mechanical circulatory support devices do have severe and sometimes life-threatening complications associated with infection, thrombosis, and device failure. The development of new procedures and devices to reduce these complications will be expedited by the work of the registry involving the systematic, independent analysis of mechanical circulatory support device implantation procedures and outcomes. NHLBI will collaborate with the CMS and the Food and Drug Administration in monitoring the work of the registry to permit the development of standard reporting of patient characteristics, indications, implantation procedures, and adverse events.

DESIGN NARRATIVE: The registry will: 1) develop standard methods to collect data and specimens used to characterize heart failure patients receiving mechanical circulatory support devices, demographics of device use patient outcomes; 2) collect, process, and store patients'''' clinical data and tissue/blood samples; 3) analyze data collected; 4) provide these resources to researchers outsie the registry; 5) publish and disseminate results.