Left ventricular assist devices as destination therapy for end-stage heart failure

Abstract

Clinical scenario You admit a 67-year-old man with a history of ischemic cardiomyopathy, 3-vessel coronary artery bypass graft surgery, and a left ventricular ejection fraction of 25% with New York Heart Association (NYHA) Class IV heart failure symptoms. The patient states that over the past few months he has had a gradual decline in his functional status despite maximal medical therapy. He already has a biventricular implantable cardioverter/defibrillator (ICD) in place, and is transferred to your service with a blood pressure of 88/60, on dopamine and dobutamine drips, with a sodium of 120 and a creatinine of 0.9. His coronary anatomy is not suitable for revascularization. Because of progressive diabetes with end organ damage (retinopathy) and his advanced age, he is not considered an ideal transplant candidate. You wonder how he might fare with destination left ventricular assist device (LVAD) therapy. Literature search Combining the keywords heart failure (heart failure, congestive), heart assist devices, and survival analysis, Medline provides 27 references. You choose the following article: Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. For the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. N Engl J Med 2001;345:1435 43. Question What is the overall survival and quality of life for patients receiving destination LVAD therapy? Design The study was a randomized, unblinded trial of patients with Class IV heart failure who were not transplant candidates and who continued with maximal medical therapy or received destination LVAD therapy with a HeartMate device (Thoratec, Pleasanton, Calif). Patients A total of 129 patients with NYHA Class IV heart failure who were not candidates for cardiac transplantation were enrolled in the study. Patients had been treated with angiotensin-converting enzyme inhibitors, diuretics, and digoxin, had a left ventricular ejection fraction ≤25%, and a maximal oxygen uptake ≤12 mL/kg/min or the need for continuous inotropic support. Patients were allowed to remain on β-blockers if they had received them for at least 60 of the 90 days before randomization. The patients had an average age of 68 years in the medical therapy group and 66 years in the LVAD group. Intervention Patients were randomized to continue with maximal medical therapy or receive the HeartMate left ventricular assist device. Main outcome measures The primary end point was death from any cause. Secondary end points included serious adverse events, the number of days spent in the hospital, quality of life, depression, and functional status. Main results At 1 year, 25% of patients in the medical therapy group were still alive, compared with 52% of patients in the LVAD group (P =.002). Median survival was 150 days in the medically-treated group compared with 408 days in the LVAD group. At 2 years, 8% of the medically-treated group was still alive compared with 23% of the LVAD group (P =.09). Whereas the medically-treated group died primarily of progressive pump failure, patients in the LVAD group died from sepsis (41% of deaths) or device failure (17%). Quality of life was significantly better in the LVAD group, with higher scores on the SF-36 physical scale (46 vs 21, P =.01), the SF-36 emotional scale (64 vs 17, P =.03), the Beck Depression Inventory (8 vs 13, P =.04), and lower NYHA class (II vs IV, P <.001). Commentary Destination LVAD therapy provides improved survival and quality of life for patients with Class IV heart failure compared with maximal medical therapy. 1 Although survival was longer at 1 year with the LVAD, by 2 years most patients in both arms of the study had died. The patients in the LVAD arm of this trial died primarily from device-related issues such as mechanical failure, sepsis, and stroke, all of which are potentially modifiable with technical improvements. In fact