TY - JOUR
T1 - Japanese registry for Mechanically Assisted Circulatory Support
T2 - First report
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
N1 - Funding Information:
H.O., M.T., M.H. and S.Y. are employees of Terumo Heart KK, Century Medical, Inc., Nipro Corporation and Sun Medical Technology Research Corp., respectively. The remaining authors have no conflicts of interest to disclose. The J-MACS registry is a pilot project of the PMDA established for gathering and evaluating data regarding the use of medical devices. It is funded by post-marketing safety measure contributions from authorized marketing holders and also sponsored by Terumo Heart K.K, Century Medical, Inc., Nipro Corporation and Sun Medical Technology Research Corp. for use in post-marketing surveillance. These companies had no influence on the design of the present study, nor on data collection, analysis and interpretation. This study was supported by the Intramural Research Fund for Cardiovascular Diseases of the National Cerebral and Cardiovascular Center (Grant 25-4-1 to T.N.) and by JSPS KAKENHI (Grant 25350585 to K.S.). The authors thank all of the participating hospitals ( Appendix 1 ), J-MACS project members ( Appendix 2 ) and cooperating academic societies ( Appendix 3 ) for their advice and help with data collection. We also thank Dr. Bram D. Zuckerman and Dr. Eric A. Chen for their support as part of the United States–Japan Harmonization by Doing program. We are also grateful for the support and encouragement of Dr. James K. Kirklin, Dr. David C. Naftel and the INTERMACS investigators.
Publisher Copyright:
© 2017 The Authors
PY - 2017/10
Y1 - 2017/10
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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U2 - 10.1016/j.healun.2017.08.002
DO - 10.1016/j.healun.2017.08.002
M3 - Article
C2 - 28942783
AN - SCOPUS:85030236700
VL - 36
SP - 1087
EP - 1096
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
SN - 1053-2498
IS - 10
ER -