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Francis Pagani
Francis Pagani

HVAD risks: What you need to know

Michigan Health 7/7/21

After a popular medical device for heart failure is taken off the market, a cardiac surgeon explains why most people won’t have theirs removed.

First, “Don’t panic.”

This is the advice of University of Michigan Health cardiac surgeon Francis Pagani, M.D., after medical device maker Medtronic announced an abrupt stop to new implantations of its Heartware Ventricular Assist Device, also commonly known as an HVAD. No one else will be given the device, but 4,000 people across the country already have one in their chest. People with heart failure have ventricular assist devices implanted to help pump blood through the body.

The problem reported with Medtronic’s Heartware is an increased risk of neurological events, such as stroke, and potential delays restarting or failure to restart altogether.

Although the concerns are important, Pagani says people whose devices are working properly will likely be able to continue using them. After all, switching it out for another VAD would mean another big heart surgery.

“There is no benefit to exchanging to the HeartMate 3 (an alternative commercial left ventricular assist device) if the HVAD device is functioning normally,” said Pagani, who sees patients at the Frankel Cardiovascular Center. “The data strongly suggests that those patients remain on the device.”