What is the role of Baroreceptor Activation Therapy (BAT) in the management of Heart Failure (HF)?

From the Guidelines

Baroreceptor activation therapy (BAT) should be considered for heart failure patients with NYHA class III symptoms, left ventricular ejection fraction ≤35%, and who are on stable guideline-directed medical therapy, as it has been associated with improvements in quality of life, exercise capacity, and NT-proBNP levels, as seen in a prospective, multicenter, RCT with 408 patients 1.

Key Points

• BAT involves implanting a device that electrically stimulates the carotid baroreceptors to restore autonomic balance.
• The therapy has been FDA-approved for heart failure with reduced ejection fraction and has shown clinical benefits in improving exercise capacity, quality of life, and functional status.
• Typical candidates for BAT include patients with NYHA class III heart failure, left ventricular ejection fraction ≤35%, and who are on stable guideline-directed medical therapy.
• The procedure involves surgical implantation of an electrode on the carotid sinus and a pulse generator in the chest wall, similar to a pacemaker implantation.

Clinical Benefits and Side Effects

• Clinical benefits of BAT include improved exercise capacity, quality of life, and functional status, with some studies suggesting potential reductions in heart failure hospitalizations.
• Side effects are generally mild and include temporary pain at the implantation site, transient bradycardia during titration, and rarely, infection.
• BAT works by counteracting the pathological sympathetic overactivation seen in heart failure, which contributes to disease progression.

Recommendation

• BAT should be considered as part of a comprehensive heart failure management strategy rather than a replacement for established therapies.
• The decision to implant a BAT device should be made on a case-by-case basis, taking into account the individual patient's symptoms, medical history, and response to other treatments.
• Further research is needed to fully understand the long-term benefits and risks of BAT in heart failure patients.

From the Research

Baroreceptor Activation Therapy in Heart Failure

• Baroreceptor activation therapy (BAT) is a promising approach for the management of resistant hypertension and heart failure, characterized by pronounced sympathetic overactivity 2.
• The pathophysiological background of heart failure renders carotid baroreceptor stimulation a potential treatment candidate for the disease, with available data from animal models pointing towards significant cardioprotective benefits 2.
• BAT has been evaluated in clinical trials for resistant hypertension, with relevant outcomes regarding safety and efficacy of the technique 2, 3.

Efficacy and Safety of BAT

• The double-blind, randomized Rheos Pivotal Trial demonstrated a blood pressure lowering effect in patients with resistant hypertension for the first-generation BAT device 4.
• A smaller randomized study in heart failure showed that the Barostim Neo system is safe and can improve heart failure symptoms and decrease neuroendocrine activation 4.
• However, large randomized trials showing reduction of blood pressure and cardiovascular events are still lacking, and therefore, BAT's efficacy and safety cannot be conclusively assessed 4.

Long-term Effects of BAT

• A long-term follow-up study found that BAT provides symptomatic relief, improvement in left ventricular function, and reduction of cardiac biomarkers in patients with heart failure with reduced ejection fraction (HFrEF) 5.
• The study showed that BAT reduced NYHA classification in 52% of patients after 1 year, with significant improvement in LVEF and reduction in NT-proBNP levels 5.
• The findings highlight the long-term efficacy and potential benefits of BAT as a therapeutic intervention for patients with HFrEF 5.

Mechanism of Action

• Baroreflex activation therapy works by generating a centrally mediated reduction of sympathetic outflow and increasing parasympathetic activity to the heart via a physiological reflex pathway 6.
• This approach rebalances the unbalanced autonomic nervous system via a specific path, providing a new approach to the management of advanced heart failure with reduced ejection fraction 6.