BAROSTIM THERAPY: Integrated Autonomic Neuromodulation for Heart Failure and Hypertension

BAROSTIM THERAPY is a unique neuromodulation therapy that addresses derangements in both sympathetic and parasympathetic nervous system activity and associated neurohormonal abnormalities in chronic cardiovascular conditions. In patients with hypertension (HTN), BAROSTIM THERAPY reduces excessive blood pressure (BP). In patients with reduced-ejection fraction heart failure (HFrEF), it improves quality of life (QOL), functional capacity and plasma biomarkers – in particular for those patients who are ineligible for treatment with cardiac resynchronization therapy (CRT). Long term data in both indications continue to accrue. In HTN, 5- and 6-year results show persistent BP reductions of -38 / -21 mmHg (n=143) and -34 / -17 mmHg (n=48), respectively (all p<0.001), and comparative efficacy between the second and first generation BAROSTIM THERAPY devices (BAROSTIM NEO vs. Rheos) has been confirmed with both office-based and ambulatory BP measures. In HFrEF, 12-month follow up of a randomized controlled trial (RCT) demonstrated continued improvements in NT-proBNP (-163 pg/ml), 6 minute hall walk distance (53 m), QOL (-11 MLHF points) and NYHA Class (OR=3.73) (n= 71-98, all p<0.01). In non-CRT patients, improvements were -160 pg/ml, 77 m, -17 points and 2.98, respectively (all p≤0.01). Long term safety in both indications remains excellent. BeAT-HF, a prospective, outcomes RCT of BAROSTIM THERAPY for non-CRT eligible HFrEF patients, is currently enrolling under the FDA Expedited Access Pathway program, an initiative to accelerate approval of novel therapies targeting an unmet need for life-threatening conditions. Key elements of BeAT-HF’s unique study design will be presented.