WASHINGTON, DC — In its latest outcomes update from the ongoing postapproval study of the temporary Total Artificial Heart (TAH-t, SynCardia Systems), the FDA says there continues to be higher 3-month mortality for the subgroup of patients who required preimplantation circulatory rescue interventions using the pump’s Companion 2 (C2) Driver System[1].
The relative increase is compared with corresponding patients whose preimplantation rescue was achieved with an earlier generation of driver, the Circulatory Support System (CSS) console.
Three-month mortality continues to be similar for patients with either kind of driver system among those who didn’t require preimplantation circulatory rescue, according to the agency.
The new interim results[2], based on 42 months of follow-up and reported to the FDA on July 10, also show a higher 3-month rate of adverse neurologic events, apparently driven by cerebrovascular accidents (CVA: transient ischemic attacks, ischemic/embolic stroke, or hemorrhagic stroke) among patients initially supported using the C2 Driver System compared with the CSS Console.
“We also now have more information to share regarding reports of Freedom Driver malfunctions, including cessation of the TAH-t’s pumping without warning alarms or recognizable signs of impending malfunction,” the agency said, referring to the “serious, life-threatening” malfunctions described in its previous TAH-t update, released October 2016 and covered at that time by theheart.org | Medscape Cardiology.
The new update says, “These malfunctions appear to be mainly the result of dropping or rough handling the Freedom Driver, although FDA continues to work with SynCardia to fully assess these events and their possible root causes.”
For the comparison of patients who required preimplantation circulatory rescue interventions, 3-month mortality was 42% for those initially supported by the C2 Driver system but 21% for those supported by the CSS Console.
The corresponding rates were “similar,” at 30% and 24%, respectively, for the subgroup that did not require preimplantation circulatory rescue interventions.
The new 3-month rate of adverse neurologic events is 31% in patients initially supported by the C2 Driver System and 14% (P<0.0001) for those initially supported by the CSS Console.
The difference appears to be driven by CVAs (27% and 8%, respectively; P<0.0001) and not other components of the composite neurologic end point, which also included non-CVA strokes, confusion, seizures, encephalopathy, and “other events,” for which differences did not reach significance.
The FDA recommends that clinicians “carefully consider these mortality and neurological adverse event results and device-malfunction reports when making treatment decisions and device selection and discuss the risks and benefits of these devices with your patients.” It also asks that they report “any adverse events or suspected adverse events,” for example, through MedWatch.
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