The FDA warned transplant surgeons and cardiologists of higher rates of death and strokes associated with SynCardia Systems’ Companion 2 pneumatic driver system for its Temporary Total Artificial Heart, approved in 2012, which serves as a bridge for patients with severe bi-ventricular failure to a heart transplant.
The system replaces a patient’s ventricles and valves with an implanted device, taking over the pumping of blood to the lungs and body and powered by an external pneumatic driver.
The results of a postmarket study conducted by the company showed higher mortality rates with the C2 system compared to the previous-generation external driver, the Circulatory Support System Console approved in 2004, the FDA said in its letter to physicians.
In patients who did not require pre-implant circulatory interventions—such as an intra-aortic balloon pump or extracorporeal membrane oxygenation—there was a higher mortality rate at six months following the implant for C2 Driver System patients, at 36.6%, compared to CSS Console patients at 24.4%, the agency wrote.
Among patients that did receive interventions, mortality rates were higher with the C2 Driver system after both three and six months, at 41.6% and 44.2%, respectively, compared to the CSS Console’s 20.8% and 27.1%.
Out of all patients, 27% had strokes while using the C2 Driver, versus 7.9% with the CSS Console at six months.
The FDA urged providers to carefully consider the mortality and stroke data when making treatment decisions and to discuss the risks and benefits of the C2 Driver System with patients, as well as to report any suspected adverse events.