Certain patients who undergo heart transplants using a Temporary Total Artificial Heart (TAH-t) by SynCardia System Inc., are at greater risk of death during the three months following the procedure, the Food and Drug Administration (FDA) announced in a Safety Communication.
The announcement was an update to an October 2016 letter to health care providers informing them of recent adverse events with the device as well as the Companion 2 Driver System (C2 Driver System) compared to the CSS Console, as well as recent events with an additional SynCardia pneumatic driver system, the Freedom Driver System.
The TAH-t device functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. The agency said recent data shows there continues to be a higher three-month mortality rate for the subgroup of patients requiring pre-implant circulatory rescue interventions when using the C2 Driver System compared to those using the CSS Console.
The mortality rates for patients who did not require pre-implant circulatory rescue interventions continued to be similar for the C2 Driver System compared to the CSS Console.
The agency also found a higher neurological adverse event rate in the first three months post-implant for patients initially supported with the C2 Driver System compared to patients initially supported with the CSS Console. The rate was attributed mostly to the difference in the rate of cerebrovascular accidents between the two groups.
The neurological adverse event rate involves several separate adverse events including cerebrovascular accidents (transient ischemis attacks, ischemic/embolic stroke, and hemorrhagic stroke), strokes from other causes, confusion, seizures, encephalopathy, and other events.
When the C2 Driver System was approved by the FDA, the agency required SynCardia to conduct a post-marketing study assessing post-market performance. The study relies on data from the Interagency Registry for Mechanically Assisted Circulatory Support and compares outcomes for patients who were initially supported with the C2 Driver System and the CSS Console during the same time period – with implantation on June 20, 2012, or later.
The FDA’s evaluation and the TAH-t post-approval study are ongoing. In the interim, the agency says it recognizes that physicians may determine that the C2 Driver System may be the best and possibly only option for circulatory support for some patients. The FDA said it expects to receive final post-approval study results by the end of 2017 for further review.
The agency says it also has more information to share regarding reports of Freedom Driver malfunctions, including the cessation of the TAH-t’s pumping without warning alarms or recognizable signs of impending malfunction. “The sudden loss of circulatory support may lead to serious adverse health consequences or death,” the agency said, adding that these malfunctions appear to be mainly the result of dropping or rough handling of the Freedom Driver.
Any adverse events related to these devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Safety Communication