Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction
William T Abraham1, Michael R Zile2, Fred A Weaver3
1Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.
Insights
Baroreflex activation therapy (BAT) is a safe and effective treatment for advanced heart failure (HF), improving exercise capacity and quality of life in patients with New York Heart Association functional class III HF.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Heart failure (HF) is characterized by increased sympathetic and decreased parasympathetic activity.
- Baroreflex activation therapy (BAT) modulates autonomic function, reducing sympathetic outflow and enhancing parasympathetic activity.
Purpose of the Study:
- To evaluate the safety and efficacy of carotid baroreflex activation therapy (BAT) in patients with advanced heart failure (HF).
Main Methods:
- A randomized controlled trial involving 146 patients with NYHA class III HF and ejection fraction ≤35%.
- Participants received either guideline-directed medical therapy (GDMT) alone or GDMT plus BAT for 6 months.
- Primary endpoints included safety (adverse events) and efficacy (NYHA class, quality of life, 6-minute hall walk distance).
Main Results:
- BAT was associated with a high rate of safety (97.2% event-free).
- Significant improvements were observed in the BAT group for 6-minute hall walk distance, quality-of-life scores, and NYHA functional class.
- BAT also led to a reduction in N-terminal pro-brain natriuretic peptide levels and a trend toward fewer HF hospitalizations.
Conclusions:
- Baroreflex activation therapy (BAT) is safe for patients with advanced, GDMT-treated NYHA class III heart failure.
- BAT significantly improves functional status, quality of life, and exercise capacity.
- BAT may also reduce heart failure hospitalizations and lower biomarker levels.
Objectives:
The objective of this clinical trial was to assess the safety and efficacy of carotid BAT in advanced HF.
Background:
Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Baroreflex activation therapy (BAT) results in centrally mediated reduction of sympathetic outflow and increased parasympathetic activity.
Methods:
Patients with New York Heart Association (NYHA) functional class III HF and ejection fractions ≤35% on chronic stable guideline-directed medical therapy (GDMT) were enrolled at 45 centers in the United States, Canada, and Europe. They were randomly assigned to receive ongoing GDMT alone (control group) or ongoing GDMT plus BAT (treatment group) for 6 months. The primary safety end point was system- and procedure-related major adverse neurological and cardiovascular events. The primary efficacy end points were changes in NYHA functional class, quality-of-life score, and 6-minute hall walk distance.
Results:
One hundred forty-six patients were randomized, 70 to control and 76 to treatment. The major adverse neurological and cardiovascular event-free rate was 97.2% (lower 95% confidence bound 91.4%). Patients assigned to BAT, compared with control group patients, experienced improvements in the distance walked in 6 min (59.6 ± 14 m vs. 1.5 ± 13.2 m; p = 0.004), quality-of-life score (-17.4 ± 2.8 points vs. 2.1 ± 3.1 points; p < 0.001), and NYHA functional class ranking (p = 0.002 for change in distribution). BAT significantly reduced N-terminal pro-brain natriuretic peptide (p = 0.02) and was associated with a trend toward fewer days hospitalized for HF (p = 0.08).
Conclusions:
BAT is safe and improves functional status, quality of life, exercise capacity, N-terminal pro-brain natriuretic peptide, and possibly the burden of heart failure hospitalizations in patients with GDMT-treated NYHA functional class III HF. (Barostim Neo System in the Treatment of Heart Failure; NCT01471860; Barostim HOPE4HF [Hope for Heart Failure] Study; NCT01720160).
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