The Food and Drug Administration (FDA) is alerting healthcare providers, patients, and caregivers on serious adverse events linked to left ventricular assist devices (LVADs): the HeartMate II Left Ventricular Assist System (Thoratec Corporation) and the HeartWare Ventricular Assist System (HVAD) manufactured by HeartWare, Inc. LVADs are indicated for bridge-to-transplant (BTT) or destination therapy (DT). In addition, the FDA is also aware of bleeding complications related to both devices though the cause of bleeding is not fully understood. A possible factor may be modification to anticoagulant therapy in an attempt to reduce the risk of pump thrombosis and embolic stroke.
Adverse events include an increased rate of pump thrombosis with the HeartMate II device and a high rate of stroke with the HeartWare HVAD.
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The FDA recommends the following for healthcare providers:
- Perform a thorough clinical evaluation, assessing the benefit-risk profile of each patient in determining the most appropriate treatment plan and, if necessary, selecting a device.
- Consider the risks for pump thrombosis, stroke, and bleeding when determining the appropriate therapy for individual patients.
- Review the current device labeling prior to making treatment decisions if you are considering using either of these devices.
- Return all explanted LVAD devices and components to their respective manufacturer. In the case of LVAD-related pump thrombosis and other adverse events, manufacturer evaluation of the affected device is critical to better understand the reasons for these adverse events.
A thorough review of available data suggests the benefits of the device continue to outweigh the risks for the currently approved indications.
For more information call (888) 463-6332 or visit FDA.gov.