FDA Warns of Deaths, Stroke Due to Power System Problems With Total Artificial Heart System

The US Food and Drug Administration (FDA) is warning physicians and patients about the risk of death and stroke in patients implanted with SynCardia System’s Temporary Total Artificial Heart (TAH-t), based on a problem with the newest-generation driver system that powers the device. The warning comes after a review of final data from a postapproval study.

“Carefully consider these mortality and stroke results from the TAH-t postapproval study when making treatment decisions, and discuss the risks and benefits of the C2 Driver System with patients,” reads an FDA letter to Health Care Providers issued today.

Used as a bridge to heart transplant, SynCardia’s TAH-t functions is intended for a small population of heart failure patients with severe biventricular failure, replacing a patient's native ventricles and valves “to completely take over pumping of blood to both the pulmonary and systemic circulation,” the FDA says. The Companion 2 (C2) Driver System is one of the available external pneumatic drivers used to activate the TAH-t device. Over 600 patients worldwide have used the C2 device to support their temporary artificial heart, according to SynCardia’s website.

The TAH-t Circulatory Support System (CSS) Console was originally approved by the FDA in 2004, and the smaller C2 Driver System received approval in 2012.

In the postapproval study following 289 patients that inspired the FDA’s letter, patients with the C2 Driver System had a 12% and 14.2% lower survival rates at 3 and 6 months postimplant, respectively, compared to patients with the CSS Console. C2 Driver System patients also had a 18.6% and 19.1% higher rate of stroke than CSS Console patients 3- and 6-months postimplant.

Earlier FDA letters informing clinicians of interim data showing increased risk of stroke and mortality were released on June 15, 2015; October 26, 2016, and September 25, 2017.

The agency is now recommending that providers seriously consider risks of mortality and stroke and discuss these risks and benefits with patients before making treatment decisions.

“We recognize that the CSS Console is no longer available as a driver option for TAH-t patients, and that consequently, physicians may determine that the C2 Driver System is the most appropriate option for patients with severe biventricular failure in need of mechanical circulatory support,” the alert states.

The FDA encourages providers, patients, and user facilities to report any suspected adverse events related to the SynCardia TAH-t and Driver Systems. Voluntarily reports of adverse events related to the device can be submitted through MedWatch.

“The FDA will continue to work with SynCardia to ensure that the product labeling addresses the postapproval study findings,” the agency says. “We will continue to keep the public informed if new or additional information becomes available.”