Japanese registry for Mechanically Assisted Circulatory Support: First report

Takeshi Nakatani; Kazuhiro Sase; Hiroaki Oshiyama; Masatoshi Akiyama; Masao Horie; Kan Nawata; Tomohiro Nishinaka; Yoshihisa Tanoue; Koichi Toda; Masao Tozawa; Shunichi Yamazaki; Masanobu Yanase; Hiroshi Ohtsu; Michiko Ishida; Ayaka Hiramatsu; Kensuke Ishii; Soichiro Kitamura; J-MACS investigators

doi:10.1016/j.healun.2017.08.002

Japanese registry for Mechanically Assisted Circulatory Support: First report

J Heart Lung Transplant. 2017 Oct;36(10):1087-1096. doi: 10.1016/j.healun.2017.08.002. Epub 2017 Aug 12.

Authors

Takeshi Nakatani¹, Kazuhiro Sase², Hiroaki Oshiyama³, Masatoshi Akiyama⁴, Masao Horie⁵, Kan Nawata⁶, Tomohiro Nishinaka⁷, Yoshihisa Tanoue⁸, Koichi Toda⁹, Masao Tozawa¹⁰, Shunichi Yamazaki¹¹, Masanobu Yanase¹², Hiroshi Ohtsu¹³, Michiko Ishida¹⁴, Ayaka Hiramatsu¹⁴, Kensuke Ishii¹⁴, Soichiro Kitamura¹⁵; J-MACS investigators

Affiliations

¹ Principal Investigator, Chair, J-MACS Operating Committee, Maki Hospital, Osaka, Japan. Electronic address: tnakatan@maki-group.jp.
² Co-principal Investigator, J-MACS Operating Committee, Juntendo University, Tokyo, Japan.
³ Co-principal Investigator, J-MACS Operating Committee, Medical Technology Association of Japan, Tokyo, Japan.
⁴ Investigator, J-MACS Operating Committee, Tohoku University, Miyagi, Japan.
⁵ Investigator, J-MACS Operating Committee, Nipro Corporation, Osaka, Japan.
⁶ Investigator, J-MACS Operating Committee, The University of Tokyo, Tokyo, Japan.
⁷ Investigator, J-MACS Operating Committee, Tokyo Women's Medical University, Tokyo, Japan.
⁸ Investigator, J-MACS Operating Committee, Kyushu University, Fukuoka, Japan.
⁹ Investigator, J-MACS Operating Committee, Osaka University, Osaka, Japan.
¹⁰ Investigator, J-MACS Operating Committee, Century Medical, Inc., Tokyo, Japan.
¹¹ Investigator, J-MACS Operating Committee, Sun Medical Technology Research Corp. Nagano, Japan.
¹² Investigator, J-MACS Operating Committee, National Cerebral and Cardiovascular Center, Osaka, Japan.
¹³ National Center for Global Health and Medicine, Tokyo, Japan.
¹⁴ Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
¹⁵ Chair, J-MACS Steering Committee, National Cerebral and Cardiovascular Center, Osaka, Japan.

PMID: 28942783
DOI: 10.1016/j.healun.2017.08.002

Abstract

Background: In Japan, ventricular assist devices (VADs) have been used for patients with severe heart failure as a bridge to transplantation (BTT) since 1992. However, it was not until 1997, when the Organ Transplant Law was enacted, that medical devices received approval by the national health insurance system for that use. To encourage research and development of innovative medical devices, the Pharmaceuticals and Medical Devices Agency has established a public-private partnership in collaboration with academic societies, hospitals and manufacturers.

Methods: The Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) is a prospective registry designed to be harmonized with the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS). Participation in J-MACS is mandatory for device manufacturers to meet the conditions of approval as well as for hospitals to obtain authorization for reimbursement from the national health insurance system.

Results: From June 2010 to April 2015, 476 patients were registered at 31 hospitals. Of these, analysis of primary VAD patients (n = 332) revealed that their overall 360-day survival was 91% (implantable 93%, extracorporeal 84%).

Conclusions: This initial report from J-MACS focuses on patients' demographics, device types, survival, competing outcomes, adverse events and successful examples of system failure detection.

Keywords: assist device; bridge to transplantation; mechanical circulatory support; registry; severe heart failure.

Publication types

Review

MeSH terms

Heart Failure / epidemiology
Heart Failure / surgery*
Heart-Assist Devices / statistics & numerical data*
Humans
Japan / epidemiology
Morbidity / trends
Registries*