Japanese Multicenter Outcomes With the HeartMate II Left Ventricular Assist Device in Patients With Small Body Surface Area

• Published in: Circulation Journal 2016/08/25, Vol.80(9), pp.1931-1936
• Main Authors: Ono, Minoru, Sawa, Yoshiki, Nakatani, Takeshi, Tominaga, Ryuji, Matsui, Yoshiro, Yamazaki, Kenji, Saiki, Yoshikatsu, Niinami, Hiroshi, Matsumiya, Goro, Arai, Hirokuni, on behalf of Japanese HeartMate II Investigators
• Format: Article
• Language: English
• Subjects: Adult; Age Factors; Aged; Body Surface Area; Disease-Free Survival; Female; Heart failure; Heart-Assist Devices; Humans; Intracranial Embolism - etiology; Intracranial Embolism - mortality; Intracranial Hemorrhages - etiology; Intracranial Hemorrhages - mortality; Japan - epidemiology; Male; Middle Aged; Multicenter registry; Registries; Sex Factors; Stroke; Survival Rate; Ventricular assist device
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-16-0203

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 m2. 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