BAROSTIM NEO™ Reduces Heart Failure Symptoms for Patients with or without Atrial Fibrillation
Authors: Michael R. Zile, MD, JoAnn Lindenfeld, MD, William T. Abraham, MD, Fred A. Weaver, MD, Faiez Zannad, MD, Elizabeth Galle, MPH, Tyson Rogers, MS and Vijendra Swarup, MD
Background: Patients with heart failure (HF) with reduced ejection fraction (HFrEF) can have varying responses to device-based HF therapies particularly when comparing those with and without a history of atrial fibrillation (AF).
Objective: Evaluate the response to baroreflex activation therapy (BAT) at 6 months in subjects with and without AF.
Methods: A multicenter trial (BeAT-HF) conducted in subjects with HFrEF, currently or recently with NYHA class III symptoms, left ventricular ejection fraction (LVEF) ≤ 35%, stable optimal medical HF management for at least 4 weeks, no class-1 indication for cardiac resynchronization therapy, and NT-proBNP<1600pg/ml, randomized subjects 1:1 to receive BAROSTIM Therapy (BAT) or BAT plus guideline directed therapy (GDT) for HF. Change from baseline to 6 months data was collected in 120 BAT subjects and 125 BAT+GDT subjects for outcomes including: 6-minute hall walk distance (6MHW), Minnesota Living with HF Questionnaire (QOL), core lab read NT-proBNP and New York Functional Class (NYHA).
Results: A total of 87 (36%) of the 245 subjects had AF. A response to BAT was demonstrated with an improvement between the two arms for all endpoints as shown in the documents below.
Conclusion: Among subjects with symptomatic HFrEF, treatment with BAT plus GDT, compared with GDT alone, demonstrates improvement in 6MHW, QOL, NT-proBNP, and NYHA in subjects with and without a history of AF.