FDA Warns Heart Failure Patients of Serious Adverse Events with Left Ventricular Assist Devices

The Food and Drug Administration (FDA) has issued a safety alert for left ventricular assist devices (LVADs) manufactured by Thoratec Corporation and HeartWare Inc. because of serious adverse events in patients who have received the devices.

The August 5 alert involves the HeartMate II Left Ventricular Assist System manufactured by Thoratec Corporation and the HeartWare Ventricular Assist System HVAD manufactured by HeartWare, Inc.

LVADs are implantable devices that help the left ventricle (the main pumping chamber of the heart) circulate blood in patients with advanced heart failure. The pump is implanted inside a patient’s body and attached to the heart’s left ventricle and to the aorta. The power pack and controller are connected to the blood pump and carried by the patient outside the body. LVADs are approved for bridge-to-transplant (BTT)—providing circulatory support to a patient at risk of imminent death from non-reversible left ventricular heart failure until a donor heart becomes available for transplant—or for destination therapy (DT)—providing circulatory support to a patient with end-stage left ventricular heart failure who is not candidate for a heart transplant.

The FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These events include an increased rate of pump thrombosis (blood clots inside the pump) with the HeartMate II and a high rate of stroke with the HeartWare HVAD. The agency said is it also aware of bleeding complications with both devices. Despite these risks, the FDA feels that when the devices are used for the approved indications in “appropriately selected patients,” the benefits continue to outweigh the risks. But the agency also believes health care providers and patients must be aware of risk information when considering the use of these devices.

The FDA advises health care providers to perform a thorough clinical evaluation of each patient to determine the most appropriate treatment plan and, if necessary, to select an LVAD device. The doctor should consider the risks for pump thrombosis, stroke, and bleeding and review the current device labeling prior to making treatment decisions if considering using either of these devices. In addition, health facilities are asked to return all removed devices to the manufacturer. In particular, when there has been LVAD-related pump thrombosis or other adverse events, it is important that the manufacturer evaluate the affected device in order to better understand the reasons for the adverse events.

Patients and caregivers should have a thorough discussion of the risks and benefits of any treatment before settling on a medical or surgical treatment or device. The patient should ask about his or her risk of an adverse event like a blood clot or stroke and the potential side effects if there is such an event. The patient should also ask how the LVAD compares to non-LVAD medical therapies.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.

 

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