Over the last two decades, MCSDs have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, occasionally as a bridge to recovery, and most recently as permanent implantation or "destination therapy" for intractable heart failure. Although heart transplantation offers life-saving therapy for selected patients, its use is limited by a supply of donor organs that currently meets less than one-tenth the need. As a consequence, the number of MCSD implantations has increased in recent years, and this trend is expected to continue especially in light of the October 1, 2003 decision of the Centers for Medicare and Medicaid Services (CMS) to provide reimbursement for MCSD implantation surgery.
Despite favorable survival and quality of life outcomes, MCSDs do have severe and sometimes life-threatening complications, including 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 MCSD implantation procedures and outcomes. The National Heart, Lung, and Blood Institute (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.
The goals of the registry include the following:
- Develop standard methods to collect data and specimens used to characterize heart failure patients receiving MCSDs, and develop methods of collecting demographic data of device use patient outcomes
- Collect, process, and store patients' clinical
|age group:||0 to 99 years
||trial start date:||February 16, 2007
||Trial End Date:|| November 1, 2015
Jennifer Franzwa, RN at firstname.lastname@example.org
Julie Shepherd, RN at email@example.com
|Keywords: ||Cardiomyopathy ; Cardiovascular Diseases ; CMTP ; Heart ; Heart Diseases ; Heart Failure ; Mechanical Circulatory Support ; Ventricular Assist Device (VAD)