Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device

Abstract

Continuous-flow left ventricular assist devices (LVADs) are becoming the standard of care for patients with refractory end-stage heart failure. We present the outcomes of patients enrolled in a prospective multicenter clinical study in Japan using the HeartMate II continuous-flow LVAD for bridge to transplantation. The study evaluated 6 inotrope-dependent heart failure patients failing on medical management (3 males and 3 females, age 44.7 ± 15.8 years, BSA 1.58 ± 0.17 m(2)) implanted with the HMII LVAD at 5 Japanese centers. Functional status, adverse events and outcomes were determined for the first 6 months with follow-up at 2 years. After implant, functional improvement was evident in 6-min walk distance which increased from 268 ± 92 m at baseline to 399 ± 105 m at 6 months, and 100% of patients were in NYHA class I or II at 6 months compared to 0% at baseline. Adverse events included localized non-device-related infection (4/6), arrhythmias (3/6) and percutaneous lead infection (1/6). There were no re-thoracotomies for bleeding and no strokes or pump replacements. All patients were alive at 6 months and all were transplanted after 1.96-3.58 years of LVAD support. The results in Japan of the HMII LVAD for BTT are consistent with results from the US pivotal clinical trial. The expanded use of this technology to Japanese heart failure patients is appropriate.