The BeAT-HF trial evaluated the Barostim extravascular, implantable neuromodulation device. Dr. Michael Zile, professor of cardiology at the Medical University of South Carolina, presented findings at the second annual Technology and Heart Failure (HF) Therapeutics (THT) conference in Boston.
Trial details
Zile said that the trial evaluated 323 randomized patients with a median follow-up of 3.6 years. The study of the FDA breakthrough device spanned 103 U.S. centers and five UK centers.
Findings included 97% freedom from major adverse neurological or cardiovascular (MANCE) system or procedure-related events. Long-term symptom improvement compared to control included a 44-meter improvement in a six-minute hall walk at 12 months. Quality of Life improved by 10 points on the Minnesota Living with Heart Failure Questionnaire at 24 months. NYHA Class improved in 27% more Barostim patients at 24 months, Zile said.
The trial observed no statistically significant difference in mortality and morbidity. It saw a 34% relative reduction in all-cause mortality for Barostim patients compared to control. The “win ratio” — a composite of cardiovascular death, LVAD, heart transplant, HF hospitalization and quality of life — favored Barostim at a total of 1.26.
Conclusions
Zile concluded that the “totality of evidence indicates that BAT is a safe, effective and durable treatment for patients with heart failure with reduced ejection fraction.”
Minneapolis-based CVRx said the executive steering committee intends to submit the full results of the trial for publication in one or more peer-reviewed journals. The company anticipates regulatory submission to the FDA for expanded labeling in the coming months.
“We are happy to see the significant long-term data that favored Barostim,” Nadim Yared, president and CEO of CVRx, said in a news release. “Interest and adoption of the therapy continue to expand based on the previously-approved claims, and now we look forward to submitting this new data to the FDA to pursue expanded labeling for Barostim. We are forever grateful to the patients, investigators, nurses, and research staff involved in the study.”
About the CVRx Barostim system
Barostim delivers electrical pulses to baroreceptors in the wall of the carotid artery. These activate the body’s baroreflex, triggering an autonomic response to the heart. CVRx designed the therapy to restore balance to the autonomic nervous system, reducing the symptoms of heart failure.
The system holds FDA breakthrough device designation and FDA approval for use in heart failure patients in the U.S. It also holds CE mark approval for heart failure and resistant hypertension in Europe.
