Japanese Experience of EVAHEART TM Left Ventricular Assist System

Abstract

Purpose The EVAHEART(Sun Medical Technology Research Co, JAPAN) is centrifugal left ventricular assist system providing highly pulsed flow designed for long-term circulatory support. We report the clinical outcomes of 85 patients implanted with the EVAHEART as a bridge to cardiac transplantation in JAPAN. Methods and Materials Eighty-five patients with advanced heart failure (INTERMACS profile I-III, eligible for heart transplantation, who was eligible for cardiac transplantation) were implanted with the EVAHEART between 2006 and Oct 2012 in 13 clinical site. Median age was 43 (range: 18-60) and 18 of these patients received the device as a part of the Japanese multi-center clinical trial. Survival analyses and other safety and performance data were analyzed. Adverse events data were collected from Japanese Registry for Mechanical Assisted Circulatory Support (J-MACS). Results Mean support duration was 407.8days with a cumulative duration of 95.0 Patient-years. Sixty-three patients (74%) remain ongoing, 11 transplanted, and 11 died during support. The Kaplan-Meier survival rate during support was 94.8% at 6months, 89.4% at 1 year, and 83.5% at 3year. Major adverse events in pos PMDA approval study included drive line infection (19.4%), Cerebral infarction (19.4%), and right heart failure requiring RVAD (0.0%), GI bleeding (1.5%)and pump thrombosis (1.5%). There was no incidence of pump exchange for mechanical failure. Conclusions 1. The EVAHEART was able to provide safe and reliable long-term circulatory support with an improved survival in advanced heart failure patients in Japan where waiting period for transplantation is extremely longer. 2. The incidence of RV failure, GI bleeding, and mechanical failure was extremely rare in patients with highly pulsatile implantable centrifugal pump.