Michael R. Zile
SAN FRANCISCO — In certain patients with HF with reduced ejection fraction, baroreflex activation therapy was associated with improvements in N-terminal pro-B natriuretic peptide levels, quality of life and functional outcomes, according to the results of the final design of the BeAT-HF trial.
The device (Barostim Neo, CVRx Inc.) uses carotid baroreceptor stimulation to produce an afferent signal to inhibit sympathetic activity and enhance parasympathetic activity, Michael R. Zile, MD, professor of medicine and Endowed Chair, Charles Ezra Daniel for Cardiology at Medical University of South Carolina, said during a presentation at the Heart Rhythm Society Annual Scientific Sessions.
“Baroreflex activation is produced by surgically placing a 2-mm electrode on the carotid sinus and attaching this electrode to a subcutaneously implanted pulse generator,” he said.
In the initial design of the BeAT-HF trial, the device met most of its endpoints but did not reduce NT pro-BNP at 6 months, Zile said.
However, he said the device appeared to reduce NT pro-BNP in patients with levels < 1,600 pg/mL at baseline. For the final BeAT-HF analysis, the researchers analyzed the 162 patients from the initial trial with NT pro-BNP < 1,600 pg/mL plus a second cohort of 102 patients all with levels below the threshold. Among these 264 patients, 130 received the device plus optimal medical management (mean age, 62 years; 19% women) and 134 received optimal medical management alone (mean age, 63 years; 22% women), he said.
In the combined cohort, the device group had a reduction of 21% in NT pro-BNP at 6 months compared with a gain of 3.3% for the control group (difference, –24.6%; P = .004), Zile said.
The device group also had greater improvement in Minnesota Living with Heart Failure Questionnaire quality of life score and functional capacity score at 6 months (P < .001 for both) compared with the control group, according to the researchers.
“To our knowledge, this is the first successful pivotal trial of a device-based neuromodulation therapy in HFrEF patients,” Zile said during the presentation. – by Erik Swain
Zile MR, et al. LBCT01-04. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 8-11, 2019; San Francisco.
Disclosure: The study was sponsored by CVRx Inc. Zile reports he has financial ties with CVRx Inc.