University of Michigan Tests Tests New Mechanical Heart Pump in Clinical Trial

University of Michigan Tests Tests New Mechanical Heart Pump in Clinical Trial

A cardiac surgery and heart failure team at the University of Michigan implanted a novel mechanical heart pump into a patient as part of a clinical trial that will compare it to the only device currently used to treat end-stage heart failure.

This trial will allow you to evaluate novel technology as we investigate a potential new treatment for advanced heart failure - a life-threatening disease with extremely limited therapeutic options. “

Francis Pagani, M.D., Ph.D., national lead investigator for the trial and cardiac surgeon at the UM Health Frankel Cardiovascular Center

Of the 6 million Americans with heart failure, thousands are either waiting for a heart transplant or need a transplant but are ineligible.

Doctors often treat these patients with a ventricular assist device, an implantable heart pump that helps the weak muscle of the heart's left ventricle pump blood throughout the body. Once used as a stophap before transplantation, VADs are now increasingly being used as an alternative long-term therapy in place of heart transplantation.

The study, called Innovation (investigating a novel, magnetically levitated VAD for the treatment of refractory left ventricular heart failure), is the first test of the Briovad, an LVAD developed by Briohealth Solutions, Inc.

The first patient to receive the Briovad at UM was a woman from Monroe, Mich.

The study aims to enroll participants with heart failure whose left ventricles have weakened to 25% or less of normal blood packing capacity - a measure called left ventricular ejection fraction. To qualify, patients must have deteriorating heart failure despite optimal medication treatment.

Two-thirds of participants will be randomly assigned to receive the Briovad, while one-third will receive Abbott's Heartmate 3, which is the only device regularly offered to patients as a short- and long-term treatment at this time.

The Herzmate 3 was first approved by the US Food and Drug Administration in 2017. The Briovad received an investigational device exemption from the FDA for use in the Innovate study, which directly compared the two devices, and has been approved for commercial use in China.

Abbott announced in January 2024 that it would stop producing its other FDA-approved LVAD, the Herzmate II, by 2026.

"It's not ideal for patients to have just one device on the market for one condition," said Abbas Bitar, MD, principal investigator for the study and clinical assistant professor of internal medicine-cardiology at UM Medical School.

"If a malfunction or supply chain issue were to occur, patients would be left without an option. Having other choices available to our patients during this event is critical."

Both the Briovad and Herzmate 3 use technology that magnetically levitates a rotor in the pump housing to reduce damage while it turns and pumps blood to the body. The new device spins at a slightly slower speed to further reduce blood flow, according to Briohealth Solutions.

The Briovad pump is about 20% smaller than the Herzmate 3 and has a slightly narrower drive element, the cable that runs from the pump over the skin to the battery, which is worn outside the body.

Heartmate 3's pairs of batteries provide up to 17 hours of continuous power. Briovad offers up to 12 hours of charges; However, only one battery is used and is less burdensome for the patient to carry.

In April 2024, the U.S. Food and Drug Administration recalled Heartmate II and Heartmate 3 due to a buildup of biological material that caused blockages as blood exited the device pump.

“Despite the recall, Heartmate 3 has achieved the best results for patients without other treatment and has set new, higher standards of patient outcomes to compare with all future devices,” Pagani said.

“It has a very low rate of adverse outcomes compared to previous VADs, which have traditionally had high complication burdens, including drive infections and strokes.”

Ultimately, up to 40 U.S. health systems are expected to participate in the trial. The goal is to have a total of 780 participants innovate.

“While the use of VADS has grown over the years, the therapy has still not been as widely adopted as possible,” said Robert B. Hawkins, M.Sc., assistant professor of cardiac surgery at UM Medical School.

“We look forward to evaluating this new technology against the current standard to improve lives for patients across the country.”

Briohealth Solutions sponsors the Innovate Clinical Study. For the role of Dr. Paganis, as a national principal investigator, will receive funding from the University of Michigan from Briohealth Solutions to support his time with the innovative clinical trial.

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