The rate of adverse events, predominantly bleeding, was 9.9 per patient-year in the first month after implantation and 2.5 per patient-year thereafter.
There were three deaths due to perioperative complications; two were related to bleeding, and one was related to a stroke after administration of two doses of vitamin K.
Taken together, the adverse events and deaths "remind us that this is still a surgical procedure, and patients are exposed to certain risks," he said.
Dr. Burkhoff disclosed that he is medical director of and a stockholder in CircuLite. Dr. Kormos disclosed that he receives research support from HeartWare. The study was sponsored by CircuLite.