Japanese registry for Mechanically Assisted Circulatory Support: First report

被引：54

作者：

Nakatani, Takeshi ^{[1
]}

Sase, Kazuhiro ^{[2
]}

Oshiyama, Hiroaki ^{[3
]}

Akiyama, Masatoshi ^{[4
]}

Horie, Masao ^{[5
]}

Nawata, Kan ^{[6
]}

Nishinaka, Tomohiro ^{[7
]}

Tanoue, Yoshihisa ^{[8
]}

Toda, Koichi ^{[9
]}

Tozawa, Masao ^{[10
]}

Yamazaki, Shunichi ^{[11
]}

Yanase, Masanobu ^{[12
]}

Ohtsu, Hiroshi ^{[13
]}

Ishida, Michiko

Hiramatsu, Ayaka

Ishii, Kensuke ^{[14
]}

Kitamura, Soichiro ^{[15
]}

机构：

[1] Maki Hosp, J MACS Operating Comm, Osaka, Japan

[2] Juntendo Univ, J MACS Operating Comm, Tokyo, Japan

[3] Med Technol Assoc Japan, J MACS Operating Comm, Tokyo, Japan

[4] Tohoku Univ, J MACS Operating Comm, Sendai, Miyagi, Japan

[5] Nipro Corp, J MACS Operating Comm, Osaka, Japan

[6] Univ Tokyo, J MACS Operating Comm, Tokyo, Japan

[7] Tokyo Womens Med Univ, J MACS Operating Comm, Tokyo, Japan

[8] Kyushu Univ, J MACS Operating Comm, Fukuoka, Japan

[9] Osaka Univ, J MACS Operating Comm, Osaka, Japan

[10] Century Med Inc, J MACS Operating Comm, Tokyo, Japan

[11] Sun Med Technology Res Corp, J MACS Operating Comm, Nagano, Japan

[12] Natl Cerebral & Cardiovasc Ctr, J MACS Operating Comm, Osaka, Japan

[13] Natl Ctr Global Hlth & Med, Tokyo, Japan

[14] Pharmaceut & Med Devices Agcy, Tokyo, Japan

[15] Natl Cerebral & Cardiovasc Ctr, J MACS Steering Comm, Osaka, Japan

来源：

JOURNAL OF HEART AND LUNG TRANSPLANTATION | 2017年 / 36卷 / 10期

关键词：

assist device; bridge to transplantation; mechanical circulatory support; registry; severe heart failure; ARTIFICIAL HEARTS; DEVICES; TRANSPLANTATION;

D O I：

10.1016/j.healun.2017.08.002

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (C) 2017 The Authors. Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation. All rights reserved.

引用

页码：1087 / 1096

页数：10

共 17 条

[1] Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States [J].