SAN FRANCISCO — Results from three small, foreign trials of an experimental heart pump were good enough to prompt a U.S. feasibility study, and two U.S. trials are planned, Dr. Donald S. Esmore said at the annual meeting of the International Society for Heart and Lung Transplantation.
In the three foreign studies, the VentrAssist left ventricular assist device was implanted either as destination therapy or as a bridge to transplant. In the U.S. feasibility study, which began in 2005, 10 patients out of a planned total of 30 have had the device implanted as a bridge to transplant, he said.
Dr. Esmore is a cardiothoracic surgeon at Alfred Hospital, Melbourne, and a consultant to Ventracor, the company that makes the heart pump. Ventracor plans to begin separate U.S. pivotal trials for destination therapy and for bridge to transplant this year, he said.
The initial pilot trial in Australia found no device-related deaths and a low rate of adverse events in nine patients who received the device, four as destination therapy and five as a bridge to transplant. The mean length of support on the device was 297 days.
A subsequent phase II trial in 33 patients who received the heart pump as a bridge to transplant at multiple centers outside the United States showed that 27 (82%) survived and either underwent heart transplantation within 154 days or were alive and capable of being transplanted, reported Dr. Esmore and his associates.
The median time to transplant for those who got new hearts was 95 days (range 32–306 days). The bridge time on the heart pump was a median of 167 days, reaching 486 days.
Five patients died during the study—two of them (6%) within 30 days of transplantation—for an overall survival rate of 85%.
The rate of serious adverse events was similar to rates seen with other heart pumps, Dr. Esmore said. There were 10 local infections, 8 cases of systemic sepsis, and 6 device malfunctions. Two patients died of a cerebrovascular accident; 14 had neurologic embolic events but experienced no major disability and progressed to successful transplantation.
The third foreign trial has enrolled 12 of an expected 15 patients to get the device as destination therapy. The mean time on the pump has been 378 days. Seven patients remain alive on the pump, and one has had a heart transplant.
The combined results from these studies show that close to 60% of patients survived in the 2 years after getting the pump, he said.