To answer this question, the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) clinical trial was conducted. The Heartmate left ventricular assist (LVAD) system was used (Fig. A. 8). This trial was a true cooperative agreement based on mutual trust between academia, the private sector, and the government. This was a single blind trial, with the company and the principle investigator blinded to the aggregate results of the trial as it was underway. The NHLBI established a Data and Safety Monitoring Board (DSMB) to confidentially review the progress of the trial and evaluate every adverse event. At each meeting, the DSMB recommended to NHLBI if the trial should continue and what was needed to improve recruitment and the quality of the data. The final decisions about the conduct of the trial were made by the NHLBI.

Figure A.8. HeartMate IP and VE.

It should be noted here that the burden of heart failure on healthcare is increasing. Heart transplants provide remarkable survival and quality of life, but only for some patients, because the limited donor pool provides hearts for only about 2000 patients a year. Figure A. 9 is based on a registry of some 52,000 heart transplant patients. The mean survival is nine years, with some patients surviving fifteen years or more. These patients serve as the guideline for improved function, quality of life, and survival for alternative therapies (Fig. A. 9).

Years Post-Transplantation Figure A.9. Heart transplant survival.
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