The University of Michigan’s cardiac surgery and heart failure team has begun testing a new mechanical heart pump in a clinical trial. This device, known as BrioVAD, is being compared to the only current device used to treat end-stage heart failure. With 6 million Americans living with heart failure, thousands are either waiting for a heart transplant or are not eligible for one.
For these patients, doctors often use a ventricular assist device (VAD), an implantable heart pump that helps the left ventricle of the heart pump blood. Initially, VADs were used as temporary solutions before a heart transplant. However, they are increasingly being used as long-term alternatives to heart transplantation.
The clinical trial, named INNOVATE (Investigation of a Novel, MagNetically Levitated VAD for the Treatment of Refractory Left Ventricular Heart Failure), is the first to test the BrioVAD. This left ventricular assist device (LVAD) was developed by BrioHealth Solutions, Inc. The first patient to receive the BrioVAD at the University of Michigan was a woman from Monroe, Michigan.
The trial aims to enroll patients with heart failure whose left ventricles are functioning at 25% or less of their normal capacity—a measure called left ventricular ejection fraction. To be eligible, patients must have worsening heart failure despite optimal treatment with medications.
Two-thirds of the trial participants will receive the BrioVAD, while one-third will be treated with Abbott’s HeartMate 3, the current standard device for both short- and long-term treatment of heart failure. The HeartMate 3 was approved by the U.S.
Food and Drug Administration (FDA) in 2017. The BrioVAD has received an investigational device exemption from the FDA for the INNOVATE trial, and it has been approved for commercial use in China.
In January 2024, Abbott announced it would stop producing the HeartMate II by 2026, another FDA-approved LVAD. Abbas Bitar, M.D., principal investigator for the trial and clinical assistant professor at the U-M Medical School, emphasized the need for multiple device options for patients. “Having only one device on the market for any condition is not ideal for patients,” Bitar said. “If a malfunction or supply chain issue were to arise, patients would be left without an option. It’s important to have other choices available for patients in that event.”
Both the BrioVAD and HeartMate 3 feature magnetically levitated rotors that reduce friction and damage as they pump blood. The BrioVAD spins at a slower speed than the HeartMate 3 to further reduce blood damage. The BrioVAD is also smaller, approximately 20% smaller than the HeartMate 3, with a narrower driveline—the cable that connects the pump to the battery pack worn outside the body.
While the HeartMate 3’s two batteries provide up to 17 hours of power, the BrioVAD uses a single battery with a charge duration of up to 12 hours. The BrioVAD’s one-battery system makes it more convenient for patients to carry.
In April 2024, the FDA recalled both the HeartMate II and HeartMate 3 due to issues with biological material buildup, which caused blockages as blood exited the pump. Despite the recall, Dr. Pagani noted that the HeartMate 3 has achieved the best outcomes for patients with no other treatment options and has set a new standard for patient outcomes. The device has a low rate of adverse outcomes, such as infections and strokes, compared to previous VADs.
The trial is expected to include up to 40 U.S. health systems, with a goal of enrolling 780 participants in total. Robert B. Hawkins, M.D., M.Sc., assistant professor of cardiac surgery at U-M Medical School, acknowledged that while the use of VADs has grown over the years, the therapy has not been as widely adopted as it could be.
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