Japanese registry for Mechanically Assisted Circulatory Support: First report

J-MACS investigators

Research output: Contribution to journalArticle

21 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1087-1096
Number of pages10
JournalJournal of Heart and Lung Transplantation
Volume36
Issue number10
DOIs
Publication statusPublished - Oct 2017

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Registries
Equipment and Supplies
Heart-Assist Devices
National Health Programs
Device Approval
Hospital Societies
Survival
Japan
Heart Failure
Transplantation
Demography
Transplants
Research
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

Cite this

Japanese registry for Mechanically Assisted Circulatory Support : First report. / J-MACS investigators.

In: Journal of Heart and Lung Transplantation, Vol. 36, No. 10, 10.2017, p. 1087-1096.

Research output: Contribution to journalArticle

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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.",
author = "{J-MACS investigators} and Takeshi Nakatani and Kazuhiro Sase and Hiroaki Oshiyama and Masatoshi Akiyama and Masao Horie and Kan Nawata and Tomohiro Nishinaka and Yoshihisa Tanoue and Koichi Toda and Masao Tozawa and Shunichi Yamazaki and Masanobu Yanase and Hiroshi Ohtsu and Michiko Ishida and Ayaka Hiramatsu and Kensuke Ishii and Soichiro Kitamura",
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AU - J-MACS investigators

AU - Nakatani, Takeshi

AU - Sase, Kazuhiro

AU - Oshiyama, Hiroaki

AU - Akiyama, Masatoshi

AU - Horie, Masao

AU - Nawata, Kan

AU - Nishinaka, Tomohiro

AU - Tanoue, Yoshihisa

AU - Toda, Koichi

AU - Tozawa, Masao

AU - Yamazaki, Shunichi

AU - Yanase, Masanobu

AU - Ohtsu, Hiroshi

AU - Ishida, Michiko

AU - Hiramatsu, Ayaka

AU - Ishii, Kensuke

AU - Kitamura, Soichiro

PY - 2017/10

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N2 - 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.

AB - 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.

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