Japanese registry for Mechanically Assisted Circulatory Support: First report

Abstract

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