FDA Warns About Adverse Events in Conjunction With 2 LVADs

Recent reports have acknowledged the potential for serious adverse events in conjunction with 2 US Food and Drug Administration (FDA)-approved implantable left ventricular assist devices (LVADs) used by patients with advanced-stage heart failure, according to an FDA safety communication.

The FDA’s warning references 2 specific LVAD models. The HeartMate II Left Ventricular Assist System (Thoratec Corporation, Pleasanton, California) and the HeartWare Ventricular Assist System (HVAD; HeartWare, Inc., Framingham, Massachusetts) have raised concerns regarding safety issues since their initial FDA approval. The HeartMate II was approved for bridge-to-transplant (BTT) and destination therapy (DT) in 2008 and 2010, respectively. The HeartWare HVAD was approved for BTT in 2012.

“Adverse events include an increased rate of pump thrombosis with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices,” the FDA wrote. “We are also aware of bleeding complications associated with both devices.”

The FDA recognized that LVADs are “life-sustaining, life-saving devices for patients with advanced left ventricular heart failure. When used for the currently approved indications in appropriately selected patients, we believe the benefits of these LVADs continue to outweigh the risks,” the agency wrote.

Before prescribing an LVAD, health care providers should perform a thorough clinical evaluation and assess the benefit-risk profile of each patient. Risks should be considered for pump thrombosis, stroke, and bleeding in patients. If complications arise, all explanted LVADs should be returned to the manufacturer for a thorough evaluation. This evaluation is critical to better understand the cause of underlying adverse events.

Currently, Thoratec is conducting a prospective, multicenter, nonrandomized study to assess the incidence of HeartMate II pump thrombosis and identify risk factors associated with pump thrombosis events. HeartWare is conducting a prospective, randomized, controlled, unblinded, multicenter study to assess whether optimal blood pressure management can help lower the stroke incidence in DT patients implanted with an HVAD.

The FDA encouraged providers to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program, if they suspect or experience a problem with an LVAD.

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