Two MUSC Health doctors 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 all both of women in strongly masculine specialties.
Vascular surgeon Jean Marie Ruddy, MD, is the principal investigator at the MUSC site for the trial of this new method of implanting Barostim. Cardiac Electrophysiologist Anne Kroman, DO, Ph.D., is co-principal investigator of the BATwire percutaneous implant study, using the Barostim Neo system.
Barostim gained approval for the breakthrough device from the United States Food and Drug Administration in 2019 following successful trials led by MUSC Health cardiologist Michael Zile, MD. The device uses electrical impulses to stimulate the nerve that regulates blood pressure, prompting blood vessels to relax.
“When the peripheral blood vessels are relaxed, it does less work for the heart,” Ruddy said.
Although the device cannot reverse heart failure, it can improve patients’ quality of life. It’s for patients who don’t get enough benefit from the drugs but aren’t sick enough for a heart pump or heart transplant, said cardiologist Ryan Tedford, MD, heart failure section chief, medical director of the heart transplant and professor in the faculty of medicine.
His patient became the first at MUSC Health to undergo the new implantation method 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 allow the device to be implanted through a wire, Ruddy said. It’s similar to how pacemaker leads are currently inserted, Kroman added.
“This is what we call a ‘first in man study’. It’s a new way of offering the same technology but saving the patient from an incision on the side of the neck,” she explained.
Instead, using ultrasound, doctors searched for the region of the blood vessel where the appropriate nerve was located, then advanced a needle into place, through which they guided the wire. The whole procedure took about an hour and a half. It is expected to become an outpatient procedure, but for the purposes of the trial, patients must be hospitalized overnight.
Ruddy said the patient was fine and returned home on Friday.
Patients who have already 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 when walking around, and may have given up on favorite activities – Ruddy mentioned one patient who was eager to get back to fishing.
“They are often able to return to these activities because their energy levels have improved. And again, the energy part really comes down to – if you relax the blood vessels, the heart doesn’t have to work so hard. And so, it allows the patient to have less fatigue, a bit more energy and, really, we’re talking about quality of life,” Ruddy said.
Tedford said a large number of patients could benefit from this type of treatment, either because they are not sick enough for more serious procedures or because they do not meet the criteria for these surgeries.
CVRx, the company that created Barostim, explained.
“There are millions of heart failure patients with reduced ejection fraction in the United States who could benefit from Barostim. This new method of implantation could eventually be used for most patients who would benefit from Barostim. and represents a step forward in the evolution of therapy to be even easier to implement.
Ruddy agreed that it potentially gives patients and their doctors more options.
“I think it opens up our possibilities of treating patients as individuals,” she said. “And so I think there will always be patients who need to have the surgical implant, but it allows us to select patients with the appropriate anatomy to offer them a less invasive implantation of the device. As many fields have moved towards patient-specific decision-making, I think this is another example of how we can apply it to the management of patients with heart failure.
And Kroman noted the importance of two women performing the procedures. About 14% of vascular surgeons are women and 10% of cardiac electrophysiology fellows are women. She hopes 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 female co-PIs on such a new and exciting project with new technology,” Kroman said.
Electrophysiologist (EP) Jeffrey Winterfield, MD, Chief of the Cardiac Electrophysiology Section, said this breakthrough articulates a number of momentous firsts, and he is thrilled that MUSC Health is a world leader in bringing this innovative procedure to the foreground.
“To be among the first to implant a new device intended to modulate the innervation of the heart from the autonomic nervous system is groundbreaking work,” he explained. “This is brand new science and potentially ‘game changing’ in terms of managing arrhythmias and heart failure. The team implanting the device includes both a female surgeon and a female EP, which is unusual in itself, beyond the nature of this cutting-edge procedure. It’s really significant from a number of important points of view.