1. In patients with end-stage heart failure on optimal medical therapy, treatment with a left ventricular assist device (LVAD) significantly reduced the risk of all-cause mortality when compared with medical therapy alone.
2. The difference in mortality was observed at 1 year, while no significant differences were observed at the 2-year mark.
Original Date of Publication: November 2001
Study Rundown: In patients with severe heart failure, cardiac transplantation has been shown to provide considerable benefit, though the supply of donor hearts is incredibly limited and has been approximated at about 3000 per year. As a result, much research has focused on mechanical means of improving myocardial function, and several such left ventricular assist devices (LVADs) have been developed through the National Institutes of Health artificial-heart program. Several devices have been previously approved by the Food and Drug Administration as bridging therapy to transplantation, though none have been studied as long-term alternatives to transplantation. The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial explored whether a specific type of LVAD, when used in the long-term, would reduce mortality in patients with end-stage heart failure who are not eligible for cardiac transplantation when compared with optimal medical therapy. In summary, this study found that treating end-stage heart failure patients with this LVAD significantly reduced the risk of mortality 1-year after randomization, though this difference was no longer seen at the 2-year mark.
In-Depth [randomized controlled trial]: This trial was conducted at 20 cardiac transplantation centres across the United States. A total of 129 patients were randomized to treatment with either LVAD or optimal medical therapy. Adults with chronic end-stage heart failure were eligible for the trial. End-stage heart failure was defined as New York Heart Association (NYHA) class IV sympoms for at least 90 days, left ventricular ejection fraction (LVEF) <25%, peak oxygen consumption <12 mL/kg/min or continued need for intravenous inotropes for symptomatic hypotension, or worsening renal function/pulmonary congestion. The inclusion criteria were subsequently broadened, though only 5 patients were included under these broader criteria. The primary endpoint was all-cause mortality.
The study was terminated when the predetermined threshold of 92 deaths was reached. The risk of mortality was significantly lower in the group that received LVAD when compared to those on medical therapy (RR 0.52; 95%CI 0.34-0.78). The Kaplan-Meier estimates of survival demonstrated significantly reduced mortality in the LVAD group at the 1-year mark (p=0.002), though this difference was not significant at the 2-year mark (p=0.09). Patients in the LVAD group were significantly more likely to experience a serious adverse event compared to those on medical therapy (RR 2.35; 95%CI 1.86-2.95), including nonneurologic bleeding, neurologic dysfunction, supraventicular arrhythmia, and peripheral embolic events.
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