title: Post-approval study of a highly pulsed, low-shear-rate, continuous-flow, left ventricular assist device, EVAHEART: a Japanese multicenter study using J-MACS.
abstract: 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.
authors.affiliation: Department of Cardiovascular Surgery, Tokyo Women's Medical University, Tokyo. Electronic address: ssaitos@hij.twmu.ac.jp.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Saito
authors.affiliation: Department of Cardiovascular Surgery, Tokyo Women's Medical University, Tokyo.
authors.forename: Kenji
authors.initials: K
authors.lastname: Yamazaki
authors.affiliation: Department of Cardiovascular Surgery, Tokyo Women's Medical University, Tokyo.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nishinaka
authors.affiliation: Department of Cardiovascular Surgery, Tokyo Women's Medical University, Tokyo.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ichihara
authors.affiliation: Department of Cardiothoracic Surgery, University of Tokyo, Tokyo.
authors.forename: Minoru
authors.initials: M
authors.lastname: Ono
authors.affiliation: Department of Cardiothoracic Surgery, University of Tokyo, Tokyo.
authors.forename: Syunei
authors.initials: S
authors.lastname: Kyo
authors.affiliation: Department of Cardiothoracic Surgery, University of Tokyo, Tokyo.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nishimura
authors.affiliation: Department of Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Osaka.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nakatani
authors.affiliation: Osaka University, Osaka.
authors.forename: Koichi
authors.initials: K
authors.lastname: Toda
authors.affiliation: Osaka University, Osaka.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Sawa
authors.affiliation: Kyushu University, Fukuoka.
authors.forename: Ryuji
authors.initials: R
authors.lastname: Tominaga
authors.affiliation: Kyushu University, Fukuoka.
authors.forename: Tadahisa
authors.initials: T
authors.lastname: Tanoue
authors.affiliation: Department of Cardiovascular Surgery, Tohoku University.
authors.forename: Yoshikatsu
authors.initials: Y
authors.lastname: Saiki
authors.affiliation: Department of Cardiovascular Surgery, Hokkaido University, Sapporo.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Matsui
authors.affiliation: Department of Cardiovascular Surgery, Saku Central Hospital, Saku.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Takemura
authors.affiliation: Department of Cardiovascular Surgery, Saitama Medical University, Saitanma.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Niinami
authors.affiliation: Department of Cardiovascular Surgery, Chiba University, Chiba, Japan.
authors.forename: Goro
authors.initials: G
authors.lastname: Matsumiya
mesh_terms: D000328:Adult; D015331:Cohort Studies; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects* / Q000706:statistics & numerical data; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011788:Quality of Life; D012042:Registries; D016019:Survival Analysis
keywords: EVAHEART LVAS; J-MACS; bridge to transplantation; continuous flow; heart failure; survival; ventricular assist device