The FDA has issued a safety alert telling healthcare professionals, patients, and carers about potential serious adverse effects with left ventricular assist devices (LVADs). It says that these adverse events include an increased rate of pump thrombosis with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD. FDA adds that it is “also aware” of bleeding complications related to both devices.
According to the FDA, as reported in the alert, the benefits of these LVADs continue to outweigh the risks. However, the agency says that it also believes that healthcare professionals, patients, and carers should be “aware of this important information when considering the use of these devices”.
It recommends that healthcare professionals 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; and review the current device labelling prior to making treatment decisions if they are considering using either of the devices referenced in the alert. The FDA says that all explanted LVAD devices and components should be returned to their respective manufacturer, adding that manufacturer evaluation—in the case of LVAD-related pump thrombosis and other adverse events—of an affected device is critical to better understand the reasons for these adverse events.
The FDA also recommends that patients/carers openly discuss—and in detail—the benefits and risks of any therapy being considered by their heart failure specialist, cardiologist and surgical team.
The alert concludes: “Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”