The Food and Drug Administration (FDA) in the U.S. has published a letter warning surgeons and cardiologists of high stroke and mortality rates associated with the Temporary Total Artificial Heart (TAH-t) Companion 2 (C2) Driver System from SynCardia Systems.
Results from a post-approval study revealed that stroke rates were more than threefold higher (26.5%) for the C2 Driver System versus the previous generation driver, the Circulatory Support System (CSS) Console (7.9%). In addition, mortality rates at three months were higher for the C2 Driver system compared to the CSS Console (34.5% versus 22.5%), with 6-month survival rates showing a similar pattern (60% for the C2 Driver System versus 74.2% for CSS Console).
The TAH-t offers a bridge to heart transplant in small populations of heart failure patients with severe biventricular failure. The system, which replaces the native ventricles and valves completely, requires an external pneumatic driver for blood flow. The TAH-t and the CSS Console driver were approved by the FDA in 2004, with the newer C2 Driver System being cleared for use in 2012 with the provision that a post-market study would be initiated to assess performance.
Given the new insights gleaned from the study, the FDA’s letter makes several key recommendations going forward: “Carefully consider these mortality and stroke results from the TAH-t post-approval study when making treatment decisions, and discuss the risks and benefits of the C2 Driver System with patients.”
“Return all devices associated with, or suspected to be associated with, any adverse events to the manufacturer for evaluation to help them and the FDA better understand the issue. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”