Post-approval study of a highly pulsed, low-shear-rate, continuous-flow, left ventricular assist device, EVAHEART: A Japanese multicenter study using J-MACS

摘要

Background The EVAHEART left ventricular assist device was approved in 2010 by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for bridge to heart transplantation (BTT). However, its effectiveness has not been evaluated since approval. In this study we evaluated the EVAHEART device in a commercial setting in Japan. Methods Ninety-six consecutive patients enrolled in the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS), who were listed for transplant or likely to be listed and who received an EVAHEART device, were enrolled from 2011 to 2013 at 14 Japanese centers. Patients' survival rates, adverse events and quality-of-life data were obtained from the J-MACS Registry. Results Patients' median age was 43 years (85% male). The Interagency Registry for Mechanically Assisted Circulatory Support profiles revealed 12 patients in Level 1, 45 in Level 2, 37 in Level 3 and 1 in Level 4. The mean support duration was 384.7 days, with a cumulative duration of 101.2 years. The Kaplan-Meier survival rate during support was 93.4% at 6 months, 87.4% at 1 year and 87.4% at 2 years. Seventy-seven patients (80.2%) currently remain on support, 7 received a transplant and 10 died during support. Major adverse events included drive-line infection (14.6%) and neurologic events such as ischemic stroke (17.7%), hemorrhage (13.5%), transient ischemic attack (3.1%), pump thrombosis (1%) and hemolysis (1%). There was no gastrointestinal (GI) bleeding or right heart failure requiring right ventricular assist device (RVAD). There was no pump exchange due to mechanical failure. Conclusions The EVAHEART device provides safe, reliable and long-term circulatory support with improved survival in commercial settings of BTT in Japan, where the transplant waiting period is much longer. Incidences of GI bleeding, hemolysis, right ventricular failure, device thrombosis and mechanical failure were extremely rare in patients on EVAHEART devices.