Symptomatic endpoint responder rates to BAROSTIM Therapy
Abstract Background Patients with heart failure with reduced ejection fraction (HFrEF) have varying responses to symptomatic endpoints with device-based HF therapies. Purpose Evaluate the symptomatic response to baroreflex activation therapy (BAT) at six months. Methods In a trial of subjects with NYHA Class II (recently III) or III HFrEF, left ventricular EF≤35%, guideline directed medical HF therapy (GDMT), no indication for cardiac resynchronization therapy, and NT-proBNP<1600 pg/ml, 264 subjects were randomized to BAROSTIM therapy plus GDMT (BAT group) or GDMT alone (Control group). Six-minute hall walk (6MHW), Minnesota Living with HF (QOL) and NYHA Class were analyzed. Clinically relevant responders were defined by 6-month improvement in 6MHW>10%, QOL>5 points or improvement in at least one NYHA class; super responders were defined by 6-month improvement in 6MHW>20%, QOL>10 points or improvement to NYHA class I. Results Both clinically relevant and super responders were significantly higher in BAT versus Control subjects for all symptomatic endpoints. In BAT subjects, 72% had clinically relevant improvements in ≥2 endpoints compared to 29% of Control subjects (p<0.001), and 28% of BAT subjects had super responder improvements in ≥2 endpoints versus 10% of Control subjects (p<0.001). Conclusion Among subjects with symptomatic HFrEF, treatment with BAT resulted in clinically relevant and super responder rates. The BAT clinically relevant and super responder rates are similar to those seen with CRT, in CRT-indicated patients. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): CVRx, Inc.