Background: Implantable left ventricular assist devices (LVADs) have been used primarily as bridges to cardiac transplantation, although some patients have been maintained long term on these devices and a few have recovered enough to be weaned. This trial was designed to evaluate their suitability as long-term myocardial replacement therapy in patients who are ineligible for cardiac transplantation.
Methods and results: One hundred twenty-nine patients with end-stage heart failure who were ineligible for cardiac transplantation were randomly assigned to receive an LVAD (Thoratec HeartMate; Thoratec, Pleasanton, CA) or optimal medical therapy, with a primary end point of all-cause mortality. To be eligible, patients had to have New York Heart Association (NYHA) class IV heart failure for at least 90 days despite attempted therapy with an angiotensin-converting enzyme inhibitor, diuretics, and digoxin; an ejection fraction </=25%; and an exercise peak O(2) uptake </=12 mL. kg(-1). min(-1) (later increased to 14 mL. kg(-1). min(-1)). Patient eligibility was approved by a gatekeeper at the coordinating center.
Results: Survival was significantly improved from 25% at 1 year in the medical therapy group to 52% in the LVAD group (relative risk, 0.52; 95% confidence interval, 0.34-0.78; P = 0.001). However, at 2 years only 23% in the LVAD group were alive (compared with 8% in the medical group). Fifty of 54 deaths in the medical group were caused by left ventricular dysfunction; in the LVAD group, of the 41 total deaths, 17 were caused by sepsis, 7 by LVAD failure, 4 by cerebrovascular disease, 2 by pulmonary embolus, and only 1 by left ventricular dysfunction. Serious adverse events were 2.35 times as frequent in the LVAD group, predominately caused by infection, bleeding, neurologic dysfunction, and device malfunction. NYHA class improved in all LVAD survivors at 1 year. Quality of life was significantly improved more compared with the medical therapy group by some indices, but not by the Minnesota Living With Heart Failure Questionnaire.
Conclusions: The use of an LVAD resulted in improved survival and quality of life in patients with extremely severe heart failure (75% 1-year mortality in the medical control group). However, only 23% of LVAD patients survived to 2 years and complications were frequent.