Serious Adverse Events Seen with Implantable Heart Failure Devices

The FDA is alerting health care professionals about serious adverse effects reported with implantable left ventricular assist devices (LVADs).

To date, 2 implantable LVADs are approved for bridge-to-transplant (BTT) or destination therapy (DT) in patients with advanced heart failure. Thoratec Corporation’s HeartMate II Left Ventricular Assist

System was approved for BTT in 2008 and DT in 2010, and HeartWare Inc’s HeartWare Ventricular Assist System HVAD was approved only for BTT in 2012.

Since approval, the HeartMate II device has been linked with an increased rate of pump thrombosis, while the HeartWare device has been associated with a high rate of stroke. The FDA is also aware of bleeding complications associated with both devices.

“When used for the currently approved indications in appropriately selected patients, FDA believes the benefits of these LVADs continue to outweigh the risks,” the agency wrote in its warning.

“However, the FDA also believes it is important for health care providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients.”

The FDA is now advising health care professionals to:

· Review the labeling of these devices before making treatment decisions.

· Perform thorough clinical evaluations weighing the risks and benefits of LVADs with each patient.

· Consider the risks for pump thrombosis, stroke, and bleeding with LVAD use.

The FDA encourages health care professionals and patients to report any adverse events associated with LVAD use to its MedWatch Safety Information and Adverse Event Reporting Program.