Health officials are warning physicians and patients about a potential risk of death and stroke associated with the SynCardia System’s Temporary Total Artificial Heart (TAH-t), after a new post approval study found increased adverse health events and problems with the new generation driver systems.
The FDA issued a SynCardia TAH-t warning on August 17, indicating that data suggests the new generation driver increases patients’ risk of stroke and decrease their rate of survival.
The SynCardia TAH-t systems function as a bridge to a heart transplant for patients who suffer from heart failure with bi-ventricle failure. The implantable devices are designed to completely take over pumping of the blood to both the pulmonary and systemic circulation. The systems are powered by an external driver that activates the implanted devices.
The warning letter informs healthcare providers and patients of a new study that found patients using the new generation C2 Driver Systems had a 12 and 14.2 percent lower survival rate at three and six months post implant, when compared to the original CSS Console driver approved by the FDA in 2004.
The study also found patients using the new C2 Driver Systems had an 18.6 and 19.1 percent higher rates of stroke at three and six month post implant intervals when compared to the original CSS Console.
In 2014, the FDA approved the new SynCardia C2 Driver Systems under the condition the manufacturer conduct a post-approval study assessing its safety and performance. Since the study commenced, the FDA has been informed of three separate sets of interim data indicating the new drivers have increased mortality rates and increased the risk of strokes.
In 2015, the FDA published a letter indicating the interim data suggested a higher mortality rate for a subgroup of patients that required pre-implant circulatory rescue interventions when using the C2 Drivers. An updated letter was issued in October 2016, indicating the rates of mortality when using the C2 Driver were still increasing.
The third update in September 2017, warned the health care community of higher incidents of patients suffering strokes when using C2 Driver systems.
Healthcare professionals are being instructed to carefully consider the risk of mortality and stroke results from the TAH-t post approval study when recommending treatment, and to inform patients of the risks and benefits prior to using the devices.
The FDA is asking any SynCardia devices and drivers suspected to be associated with any adverse health consequences be returned to the manufacturer and reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program to help better understand the issue.