Left ventricular assist device (LVAD) hemodynamic and unloading support in patients with advanced severe congestive heart failure can significantly improve cardiac function, allowing the removal of LVAD. This prospective multicenter, nonrandomized study (RESTAGE-HF), aimed to investigate whether a standardized specific pharmacological therapy, combined with a protocol of optimized LVAD mechanical unloading, to induce regular testing of underlying myocardial function and reverse remodeling, could yield a greater incidence of LVAD explantation.
40 patients with CHF from nonischemic cardiomyopathy receiving the Heartmate II LVAD were enrolled from 6 centers. The primary endpoint was the proportion of patients with sufficient myocardial function improvement to reach the explantation criteria within 18 months with sustained remission from heart failure at 12 months. Before LVAD, age was 35 years, 67.5% were men, heart failure mean duration was 20 months, 95% required inotropic and 20% temporary mechanical support, left ventricular ejection fraction was 14%, the end-diastolic diameter was 7 cm, the end-systolic diameter was 6 cm, pulmonary artery saturations were 46%, and pulmonary capillary wedge pressure was 26 mm Hg. Overall, 40% of all enrolled patients achieved the primary endpoint, with 50% of patients receiving the protocol being explanted within 18 months. Overall, 19 patients were explanted. The 15 ongoing explanted patients are now 2.26 explant after explantation survival free from LVAD or transplantation was 90% at 1-year and 77% at 2 and 3 years.
In conclusion, this support strategy combined with a cardiac function monitoring protocol and standardized pharmacological therapy resulted in a high LVAD explantation rate occurring in all six participating sites.
Ref: https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.120.046415
