MUSC doctors first at academic medical center to perform ‘game-changing’ new heart failure device procedure

April 09, 2022
two female doctors stand on either side of a patient in a procedure room bathed in fluorescent green light
Drs. Jean Marie Ruddy, left, and Anne Kroman perform the new method of implanting the heart failure device. Photos courtesy of CVRx

Two doctors at MUSC Health are the first at an academic medical center and only the second in the world to use a new, minimally invasive procedure to implant a heart failure treatment device – and, in an interesting turn of events, they’re both women in heavily male-dominated specialties.

Vascular surgeon Jean Marie Ruddy, M.D., is principal investigator at the MUSC site for the trial of this new implantation method for Barostim. Cardiac electrophysiologist Anne Kroman, D.O., Ph.D., is site co-principal investigator of the BATwire percutaneous implant study, using the Barostim Neo System.

headshot of a doctor with long brown hair 
Dr. Jean Marie Ruddy 
Dr. Anne Kroman 
Dr. Anne Kroman

Barostim won breakthrough device approval from the U.S. Food and Drug Administration in 2019 following successful trials that were led by MUSC Health cardiologist Michael Zile, M.D. The device uses electrical impulses to stimulate the nerve that regulates blood pressure, inducing the blood vessels to relax.

“When the blood vessels out in the periphery are relaxed, that makes for less work for the heart,” Ruddy said.

Although the device can’t reverse heart failure, it can improve patients’ quality of life. It’s intended for patients who are in that middle ground of not getting sufficient benefit from medication but not sick enough for a heart pump or heart transplant, said cardiologist Ryan Tedford, M.D., section chief of heart failure, medical director of cardiac transplantation and professor in the College of Medicine.

His patient became the first at MUSC Health to undergo the new method of implantation on Thursday.

The original method of implantation required a vascular surgeon to make an incision in the patient’s neck to insert the electrode. But in a “feat of engineering,” the new method being tested would enable the device to be implanted through a wire, Ruddy said. It’s similar to how pacemaker wires are currently inserted, Kroman added.

“This is what we call a ‘first-in-man study.’ It’s a new way to deliver the same technology but to save the patient from an incision in the side of the neck,” she explained.

Instead, using ultrasound, the doctors looked for the region of the blood vessel where the appropriate nerve is situated, then advanced a needle into place, through which they guided the wire. The entire procedure took about an hour and a half. It’s expected that this will become an outpatient procedure, but for the purposes of the trial, patients must be hospitalized overnight.

a surgical room is bathed in fluorescent green light as everyone in the room looks at a screen just out of camera range 
The doctors used ultrasound imaging to guide the wire to deliver the device.

Ruddy said the patient did well and returned home Friday.

Patients who’ve previously had the device implanted have seen their quality of life improve, Ruddy and Kroman said. Typically, before the procedure, patients are short of breath, even from walking around, and may have given up favorite activities – Ruddy mentioned a patient who was eager to return to fishing.

“They're often able to get back into those activities because their energy level is improved. And again, the energy part really goes back to – if you relax the blood vessels, the heart does not have to work so hard. And so therefore that feeds forward to the patient having less fatigue, a little bit more energy and, really, we're talking about quality of life,” Ruddy said.

Tedford said there are large numbers of patients who could benefit from this type of treatment, either because they’re not sick enough for more serious interventions or because they don’t meet the criteria for those surgeries.

CVRx, the company that created Barostim, expounded.

“There are millions of patients living with heart failure with reduced ejection fraction in the U.S. who may be able to benefit from Barostim. This new implantation method could eventually be used for most patients who may benefit from Barostim and represents a step forward in the evolution of the therapy to be even more simple to implant.”

Ruddy agreed that it potentially offers more options to patients and their doctors.

“I think that it opens up our opportunities to treat patients as individuals,” she said. “And so I believe there will still be patients who need to have the surgical implant, but this allows us to select patients with the appropriate anatomy to offer them a less invasive implantation of the device. As many fields have moved toward patient-specific decision-making, I think this is another example of how we can apply that to management of heart failure patients.”

And Kroman noted the significance of two women performing the procedures. About 14% of vascular surgeons are women, and 10% of cardiac electrophysiology fellows are women. She hopes that her and Ruddy’s visibility will encourage more women and girls to pursue these fields.

“It’s unique and it’s nice to have two women being co-principal investigators on such a new and exciting project with new technology,” Kroman said.

Electrophysiologist (EP) Jeffrey Winterfield, M.D., the section chief for cardiac electrophysiology, said this advancement articulates a number of momentous firsts, and he is ecstatic that MUSC Health is a world leader in bringing this innovative procedure to the fore.

“Being among the first to implant a novel device meant to modulate the heart's innervation from the autonomic nervous system is groundbreaking work,” he explained. “This is brand new science and a potential 'game-changer' in terms of how we manage arrhythmias and heart failure. The team implanting the device includes both a woman surgeon and a woman EP, unusual in and of itself, beyond the nature of this cutting-edge procedure. This is truly significant from a number of important perspectives.”