HVAD risks: What you need to know

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.

11:38 AM

Author | Jane Racey Gleeson

surgeons doing procedure close up
File photo: Cardiac surgeons Francis Pagani, M.D., and Jonathan Haft, M.D., in the operating room. Credit: Leisa Thompson Photography

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."

MORE FROM MICHIGAN: Sign up for our weekly newsletter

(Pagani recently moderated a webinar about this topic with the Society of Thoracic Surgeons, as seen in the video above.)

University of Michigan Health patients implanted with the HVAD have been sent information about the device, including a request for them to contact their health care provider with any immediate concerns.

"We recommend that patients continue with their regularly scheduled follow up appointments with their heart failure cardiologists and the U-M Health VAD Team care providers," Pagani said.

In June, Medtronic issued an Urgent Medical Device Communication Notification to inform health care providers that the company had decided to stop selling and distributing the HVAD system because of the safety concerns. People who need a VAD device moving forward will be offered a different one instead.

What if I already have one of these Medtronic HVAD devices that's been taken off of the shelves?

For the approximately 4,000 patients who currently have a Medtronic HVAD nationwide, the company shared these recommendations regarding the device:

  • Continue to follow up regularly with your surgeon, physician or VAD coordinator and follow your health care provider's advice and directions. 

  • Medtronic is developing a support program that will include financial assistance for eligible patients. 

  • Medtronic will provide ongoing product support for the HVAD System and will ensure continued availability of batteries and a controller.

  • Never disconnect your HVAD pump from two power sources at the same time and always have a back-up controller and fully charged spare batteries available.

If you are a U-M patient and would like to speak with a member of the Michigan Medicine staff about the Medtronic device and this issue, please call 734-647-7321 and select option 2.

Like Podcasts? Add the Michigan Medicine News Break on iTunes, Google Podcasts or anywhere you listen to podcasts


More Articles About: Health Management Diagnosis of Heart Condition Interventional cardiology Cardiovascular: Diseases & Conditions Cardiovascular: Preventive Cardiology LVADs, VADs and Other Assist Devices Cardiovascular: Diagnostics & Procedures
Health Lab word mark overlaying blue cells
Health Lab

Explore a variety of healthcare news & stories by visiting the Health Lab home page for more articles.

Media Contact Public Relations

Department of Communication at Michigan Medicine

[email protected]

734-764-2220

Stay Informed

Want top health & research news weekly? Sign up for Health Lab’s newsletters today!

Subscribe
Featured News & Stories smart watch on wrist
Health Lab
Clinical smart watch finds success at identifying atrial fibrillation
A Michigan Medicine research team developed a prescription wristwatch that continuously monitors the wearer’s heart rhythm and uses a unique algorithm to detect atrial fibrillation. The clinical-grade device, called the Verily Study Watch, proved very accurate at identifying atrial fibrillation in participants.
supar molecule teal blue yellow red
Health Lab
Immune protein suPAR links viral infection as possible cause of kidney disease
Through a series of experiments in non-human primates, mice and humans, a multi-institutional team led by researchers from Michigan Medicine and Rush University found that the immune protein soluble urokinase plasminogen activator receptor, or suPAR, is an important link between viral infections and proteinuria; the elevation of protein in the urine is known to cause glomerulopathy, a common form of kidney disease.
heart organ yellow blue
Health Lab
Irregular heartbeat after valve surgery increases risk of stroke, death
Postoperative atrial fibrillation, commonly known as Afib, has traditionally been viewed as benign and limited. But a study led by researchers at the University of Michigan Health Frankel Cardiovascular Center finds that postoperative atrial fibrillation increases the risk of strokes and permanent Afib — and is linked to worse long term survival — after heart valve surgery.
human organ for transplant
Health Lab
Findings shed light on how a pediatric heart surgery complication impacts heart transplant survival
Patients who experience this condition following the Fontan continue to have a high risk of death from the time they’re waitlisted for a new heart through receiving the transplant, according to a 20-center study led by Michigan Medicine. And one specific complication called cyanosis – or experiencing less than normal oxygen blood levels – was associated with worsened survival.
Brain image highlighting areas
Health Lab
Women stroke survivors believe they will receive worse care in the emergency room
National study examined health care perceptions of approximately 3,500 women, including those with and without a history of stroke
surgeons in OR with blue and teal scrubs with screen on and patient under teal sheet
Health Lab
Treating heart valve disease: What are your options?
Michigan Medicine’s head of cardiac surgery, Gorav Ailawadi, M.D, M.B.A., answers questions about different treatment options for heart valve disease.