BACKGROUND: The HeartMate II (HMII) continuous-flow LVAD was approved for Japanese health insurance coverage in April 2013 as a bridge to transplantation (BTT). We report on post-approval Japanese multicenter outcomes, and a comparison between patients with low and high body surface area (BSA). METHODS AND RESULTS: HMII LVAD was implanted in 104 consecutive patients at 15 Japanese centers between April 2013 and July 2014. Perioperative data were submitted to the Japanese Registry for Mechanically Assisted Circulatory Support. Patients were divided into 2 groups on the basis of BSA less or greater than 1.5 m(2). Survival outcomes, New York Heart Association functional class, and adverse event rates were compared between the 2 groups. Preoperative hemodynamics and INTERMACS profiles were similar between groups. There were more females and younger patients in the low BSA group. The respective 6-month and 1-year death- or pump exchange-free survival rates were excellent: 90% and 90% in the BSA <1.5 group vs. 90% and 85% in the BSA ≥1.5 group. In the BSA <1.5 group, occurrence of hemorrhagic stroke was 10% and occurrence of embolic stroke was 0%, vs. 12% and 8% in BSA ≥1.5 group. Driveline infection was encountered more frequently in the BSA <1.5 group. CONCLUSIONS: Results for HMII LVAD as BTT in the post-approval era showed excellent survival and functional capacity improvement. Of particular interest to the Japanese patient population are the excellent results in patients with small BSA. (Circ J 2016; 80: 1931-1936).
BACKGROUND: The HeartMate II (HMII) continuous-flow LVAD was approved for Japanese health insurance coverage in April 2013 as a bridge to transplantation (BTT). We report on post-approval Japanese multicenter outcomes, and a comparison between patients with low and high body surface area (BSA). METHODS AND RESULTS: HMII LVAD was implanted in 104 consecutive patients at 15 Japanese centers between April 2013 and July 2014. Perioperative data were submitted to the Japanese Registry for Mechanically Assisted Circulatory Support. Patients were divided into 2 groups on the basis of BSA less or greater than 1.5 m(2). Survival outcomes, New York Heart Association functional class, and adverse event rates were compared between the 2 groups. Preoperative hemodynamics and INTERMACS profiles were similar between groups. There were more females and younger patients in the low BSA group. The respective 6-month and 1-year death- or pump exchange-free survival rates were excellent: 90% and 90% in the BSA <1.5 group vs. 90% and 85% in the BSA ≥1.5 group. In the BSA <1.5 group, occurrence of hemorrhagic stroke was 10% and occurrence of embolic stroke was 0%, vs. 12% and 8% in BSA ≥1.5 group. Driveline infection was encountered more frequently in the BSA <1.5 group. CONCLUSIONS: Results for HMII LVAD as BTT in the post-approval era showed excellent survival and functional capacity improvement. Of particular interest to the Japanese patient population are the excellent results in patients with small BSA. (Circ J 2016; 80: 1931-1936).