The emergence of a baroreflex activation therapy device for heart failure patients is drawing in the assistance of the open surgical expertise of vascular surgeons in the arena of the carotid bulb— and drawing attention to a need for “clear and well-defined guidelines.”
Discussion was stirred after the delivery of a case experience from the University of Miami, Florida, during the 2023 Eastern Vascular Society (EVS) annual meeting (Sept. 7–9) in Washington, D.C., in which presenter Christopher Chow, MD, a vascular surgery resident at the institution, raised the possibility of a randomized controlled trial comparing the Barostim device (CVRx) to a sham therapy.
Chow described the University of Miami experience working with his institution’s heart failure-cardiology team who identify patients who would benefit.
He reported successful intraoperative therapy among all patients treated, many of whom returned home the same day. “Patients by and large tolerate the procedure without significant complications,” he told EVS 2023. “Discomfort associated with device activity is actually a common complaint, known as extraneous stimulations. It’s been described as stimulations of the nerves around the carotid bulb.” They can take the form of headaches and a painful buzzing sensation in the chest, Chow added.
The baroreflex activation therapy device is an implantable pulse generator designed to deliver continuous electrical stimulation to carotid baroreceptors through a lead sewn into the adventitia of the carotid bulb, with a subsequent increase in parasympathetic outflow and a reduction in symptoms of heart failure, Chow said.
“There have been some early studies that it may be beneficial,” Chow said. “The implantation of the device is very neatly suited for the skillset of vascular surgeons. It requires a small carotid cutdown at the carotid bulb through ultrasound identification and then sewing of the lead onto the adventitia of the bulb.”
But Chow emphasized a need for clearer guidelines.
“Further research is definitely needed, such as a randomized controlled trial—we would suggest a sham device therapy,” he said. “Vascular surgeons are very keen on generating this data. We should continue working with heart and cardiovascular teams to find the best practice guidelines for Barostim therapy.”
Under audience questioning, Chow underscored the point: “In general, I would say there is really no clear and well-defined guidelines about who would actually benefit from this therapy, and that is actually one of the aims of this discussion—to try to foster that conversation,” he said.
The baroreflex activation technology is relatively new but is gaining traction, Chow observed, with work already starting on a percutaneous approach. “You can imagine what that may imply for future carotid interventions,” he added.
