Doing the wrong thing for the right reasons: The demise of the HVAD

Abstract

Feature Editor's Introduction-The HeartWare HVAD System (Medtronic) was a durable left ventricular assist device (LVAD) approved for bridge to transplant and destination therapy indications and had been implanted in approximately 20,000 patients worldwide. The device From the Texas Heart Institute, Houston, Tex.

Commentary: Beyond data: Transparency and trust

“…In this month's issue, Drs Balachandran and colleagues 1 convey their perspective in their Expert Invited Opinion in "Doing the wrong thing for the right reasons: the demise of the HVAD," and outline the trials and tribulations of the Medtronic HeartWare HVAD left ventricular assist device (LVAD) and its removal from the world market earlier last year (August 12, 2021). Their perspective is insightful and enlightening, coming from one of the storied founding fathers of mechanical circulatory support (MCS) as well as a foundational thought leader.…”

“…In this piece, the authors describe the development of the HVAD and its progress through the bridge to transplant ADVANCE (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure) trial and the tiered destination therapy ENDURANCE (A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure) trial and the and post-approval data and regulatory challenges. 1 This story clearly showed increased neurological adverse events, and a high number of Food and Drug Administration (FDA) recalls before evidence of sudden pump stoppage delivered the coup de grace prompting HVAD's market removal. Although this story and these data belong to the HeartWare LVAD, a similar arc could have occurred with any LVAD, or even general cardiac surgical device, and our community should take note of this narrative.…”