Primary Outcome Measures:
- Collect and analyze clinical and laboratory data and tissue samples from patients who are receiving mechanical
circulatory support devices (MCSD) for end-stage heart failure. [ Time Frame: Collected as part of the registry ] [ Designated as safety issue: No ]
Biospecimen Description:
DNA sample collection is an optional portion of the project. Tissue and Blood specimens are collected at the time of implant, explant or exchange of the mechanical circulatory assist device.
Intervention Details:
Device: Mechanical Circulatory Support Device (MCSD)
INTERMACS is an observational registry of patients with end stage heart failure that receive a FDA approved Mechanical Circulatory Support Device
BACKGROUND:
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.
DESIGN NARRATIVE:
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 data and tissue/blood samples
- Analyze collected data
- Provide these resources to researchers outside the registry
- Publish and disseminate results
Purpose
