Reversal of Severe Heart Failure With a Continuous-Flow Left Ventricular Assist Device and Pharmacological Therapy A Prospective Study

Background-We have previously shown that a specific combination of drug therapy and left ventricular assist device unloading results in significant myocardial recovery, sufficient to allow pump removal, in two thirds of patients with dilated cardiomyopathy receiving a Heartmate I pulsatile device. However, this protocol has not been used with nonpulsatile devices. Methods and Results-We report the results of a prospective study of 20 patients who received a combination of angiotensin-converting enzymes, beta-blockers, angiotensin II inhibitors, and aldosterone antagonists followed by the beta(2)-agonist clenbuterol and were regularly tested (echocardiograms, exercise tests, catheterizations) with the pump at low speed. Before left ventricular assist device insertion, patient age was 35.2+/-12.6 years (16 male patients), patients were on 2.0+/-0.9 inotropes, 7 (35%) had an intra-aortic balloon pump, 2 were hemofiltered, 2 were ventilated, 3 had a prior Levitronix device, and 1 had extracorporeal membrane oxygenation. Cardiac index was 1.39+/-0.43 L . min(-1) . m(-2), pulmonary capillary wedge pressure was 31.5+/-5.7 mm Hg, and heart failure history was 3.4+/-3.5 years. One patient was lost to follow-up and died after 240 days of support. Of the remaining 19 patients, 12 (63.2%) were explanted after 286+/-97 days. Eight had symptomatic heart failure for <= 6 months and 4 for >6 months (48 to 132 months). Before explantation, at low flow for 15 minutes, ejection fraction was 70+/-7%, left ventricular end-diastolic diameter was 48.6+/-5.7 mm, left ventricular end-systolic diameter was 32.3+/-5.7 mm, m(V) over dotO(2) was 21.6+/-4 mL . kg(-1) . min(-1), pulmonary capillary wedge pressure was 5.9+/-4.6 mm Hg, and cardiac index was 3.6+/-0.6 L . min(-1) . m(-2). Estimated survival without heart failure recurrence was 83.3% at 1 and 3 years. After a 430.7+/-337.1-day follow-up, surviving explants had an ejection fraction of 58.1+/-13.8%, left ventricular end-diastolic diameter of 59.0+/-9.3 mm, left ventricular end-systolic diameter of 42.0+/-10.7 mm, and m(V) over dotO(2) of 22.6+/-5.3 mL . kg(-1) . min(-1). Conclusions-Reversal of end-stage heart failure secondary to nonischemic cardiomyopathy can be achieved in a substantial proportion of patients with nonpulsatile flow through the use of a combination of mechanical and pharmacological therapy. (Circulation. 2011;123:381-390.)