Heart Failure -> Heart Failure Management: -> Clinical Trials D-AB30 - Clinical Trials: Heart Failure and Implantable Devices (ID 37) Abstract Plus

D-AB30-02 - Response To Barostim Therapy By Atrial Fibrillation Status (ID 814)

  M.R. Zile: Honoraria/Speaking/Consulting Fee - CVRx Inc.. Research (Contracted Grants for PIs and Named Investigators only) - CVRx Inc..


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<1600 pg/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 Table 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.