Japanese registry for Mechanically Assisted Circulatory Support: First report.

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.

Clinical Application of a Newly Developed Autoflow Control System for the Terumo Centrifugal Pump: From External Control to Built-in Direct Control.

We have developed an autoflow control system for the Terumo Capiox centrifugal pump, the SP-101. First, we made an external control system regulated by a personal computer through a serial communications line. Although an in vivo experiment using a goat showed excellent performance in regulating the flow, a communication error that caused an abrupt and instantaneous flow fluctuation was noted occasionally. Therefore, we incorporated a check-sum function to solve this problem. After this improvement, 5 patients safely underwent cardiopulmonary bypass using a pump having this autoflow control. As the next step for more practical usage, we developed a built-in autoflow control system in which the control device is entirely incorporated into the console without a communications line. This system demonstrated better response and reliability than the external control system and was applied successfully in 3 patients. In conclusion, this autoflow mode will expand the usage of centrifugal pumps through improved handling.