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 language | English |
|---|---|
| Pages (from-to) | 1087-1096 |
| Number of pages | 10 |
| Journal | Journal of Heart and Lung Transplantation |
| Volume | 36 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Oct 2017 |
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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 journal › Article
}
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
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.
UR - http://www.scopus.com/inward/record.url?scp=85030236700&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85030236700&partnerID=8YFLogxK
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 -