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Pivotal trial shows HFrEF benefits from baroreceptor stimulation

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Promising results need confirmation

The results that Dr. Zile reported are obviously very promising. It was a huge step forward when researchers identified medical treatments that can safely manipulate the autonomic nervous system in patients with heart failure with reduced ejection fraction. Now we are asking what else we can do because we have run into limits on what we can accomplish with drugs alone. The BeAT-HF study is a step in that direction.

Dr. Andrew D. Krahn, professor of medicine, University of British Columbia; director of cardiology, St. Paul's Hospital, Vancouver Mitchel L. Zoler/MDedge News

Dr. Andrew D. Krahn

Over the past 20 years or so, electrophysiologists and heart failure physicians have worked together to develop implanted devices that can improve heart failure management. Despite this, many patients remain ineligible for existing devices. The evidence from BeAT-HF is a good start on documenting the benefit of a new option, and I’m encouraged that it’s on the right track, but I don’t think I’ll start using this device in patients this week.

Andrew D. Krahn, MD, is professor of medicine and head of cardiology at the University of British Columbia and St. Paul’s Hospital in Vancouver. He has been a consultant to Medtronic and he has received research funding from Boston Scientific and Medtronic. He made these comments as a discussant for BeAT-HF.


 

REPORTING FROM HEART RHYTHM 2019

– Baroreflex activation therapy met all four of its primary endpoints in its U.S. pivotal trial of 264 patients with advanced heart failure with reduced ejection fraction who were ineligible for cardiac resynchronization therapy.

Dr. Michael R. Zile, professor of Medicine, Medical College of South Carolina, Charleston; head of cardiology, VA Medical Center, Charleston, S.C. Mitchel L. Zoler/MDedge News

Dr. Michael R. Zile

The results showed that ongoing baroreflex activation therapy (BAT) via a single, stimulating electrode surgically placed on a patient’s carotid artery led to statistically significant and clinically meaningful improvements in quality of life and functional capacity while also reducing the level of a biomarker of heart failure severity in patients already on guideline-directed medical therapy, Michael R. Zile, MD, said at the annual scientific sessions of the Heart Rhythm Society. He estimated that the device is appropriate for perhaps a third or more of patients with heart failure with reduced ejection fraction (HFrEF), specifically patients with New York Heart Association functional class III disease who are not candidates for treatment with cardiac resynchronization therapy (CRT) and with a blood level of N-terminal pro–brain natriuretic peptide (NT-proBNP) of less than 1,600 pg/mL, a cutoff that excludes patients with very severe class III HFrEF and focuses on those who benefited in the study.

“To our knowledge, this is the first successful pivotal trial of device-based neuromodulation therapy in HFrEF patients,” said Dr. Zile, professor of medicine at the Medical University of South Carolina in Charleston. “We think that BAT fills an unmet need” in a large number of HFrEF patients. He stressed that the placement of the single, 2-mm, unilateral electrode on the baroreceptor-containing carotid sinus is an “extremely safe and simple” surgery. The electrode attaches to a small, subcutaneously placed generator.

Dr. Zile attributed the treatment’s success, in contrast to a prior, failed attempt to treat HFrEF by vagus nerve stimulation (J Am Coll Cardiol. 2016 Jul 12;68[2]:147-56) to BAT’s action via the patient’s brain, which processes the afferent signal it receives from stimulation to in turn inhibit sympathetic activation and upregulate parasympathetic innervation, with both actions benefiting HFrEF patients. “The integrated autonomic balance is the real difference with this device,” he said. Other helpful effects from BAT are reduced heart rate, reduced cardiac remodeling, increased vasodilation, a decrease in elevated blood pressure, increased diuresis, and a drop in renin secretion. The pivotal trial built on findings from a phase 2 study (JACC Heart Fail. 2015 Jun;3[6]:487-96).

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