FDA Warns of Continued High Death Rates with Syncardia Heart Transplant Devices

Washington, DC: The US Food and Drug Administration has issued an update to healthcare providers, informing them of the latest findings from the SynCardia TAH-t post-approval study. The results support earlier findings which show a continued 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 study is looking specifically at mortality and neurological adverse events associated with the TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems. These are devices used during heart transplant surgery.

On June 15, 2015, the FDA posted a letter informing the health care community that preliminary post-approval study information suggested a higher mortality rate in this subgroup of patients. This was backed up by findings sent out to the health care community on October 26, 2016, stating that additional interim post-approval study results continued to show a higher mortality rates, specifically, 39% mortality associated with the C2 driver system compared with a 25% mortality rate with the CSS console.

The letter also stated additional interim post-approval study results indicated a higher risk of neurological adverse events for patients supported by the C2 Driver System compared to patients supported by the CSS Console. These include: transient ischemic attacks, confusion, ischemic/embolic stroke, hemorrhagic stroke, strokes from other causes, seizures, encephalopathy, and other events.

The TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. There has continued to be a higher 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 were similar for the C2 Driver System compared to the CSS Console.

As a condition of approval of the C2 Driver System, the agency required SynCardia to conduct a post-approval study assessing post-market performance. The study relies on data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), and compares outcomes for patients who were initially supported with the C2 Driver System and the CSS Console during the same time period (implanted on June 20, 2012 or after).

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Published on Sep-27-17