Baroreflex activation therapy with the Barostim™ device in patients with heart failure with reduced ejection fraction: a patient level meta‐analysis of randomized controlled trials

Abstract

Heart failure with reduced ejection fraction (HFrEF) remains associated with high morbidity and mortality, poor quality of life (QoL) and significant exercise limitation. Sympatho-vagal imbalance has been shown to predict adverse prognosis and symptoms in HFrEF, yet it has not been specifically targeted by any guideline-recommended device therapy to date. Barostim™, which directly addresses this imbalance, is the first Food and Drug Administration approved neuromodulation technology for HFrEF. We aimed to analyse all randomized trial evidence to evaluate the effect of baroreflex activation therapy (BAT) on heart failure symptoms, QoL and N-terminal pro-brain natriuretic peptide (NT-proBNP) in HFrEF.

Baroreflex activation therapy in advanced heart failure therapy: insights from a real‐world scenario

“…Nevertheless, the authors of a current meta-analysis including the HOPE4HF as well as the BeAT-HF cohort of patients report on clinical meaningful improvements consequent across the range of patients studied including CRT patients. 32 These results are in line with our results. In our study, most patients were CRT non-responders (Table 1).…”

“…These findings act in concert with a prior study. 32,34 However, our BAT group is certainly too small to reveal minor statistical differences.…”

“…13 The rationale is that CRT per se may influence sympathovagal balance to the heart and vessels and thus affects the potential benefit of BAT. [28][29][30][31][32][33] DeMazumder et al 33 and Gademan et al 31 have demonstrated that CRT has salutary effects on both the sympathetic and parasympathetic nervous systems, which act to restore the sympathovagal balance in patients with HFrEF.…”

Baroreflex activation therapy in heart failure: targeting the right patient

“…8 Similarly, in the BeAT-HF trial, BAT improved quality of life, exercise tolerance, and NT-proBNP level, without any significant safety concern. 9 The positive findings of these trials are further confirmed by the individual-patient meta-analysis published in this issue of the Journal by Coats et al 10 Putting together the populations of the HOPE4HF and BeAT-HF (for a total of 554 randomized patients), the authors confirmed that BAT provided significant improvement in exercise capacity, quality of life, NYHA class, and plasma NT-proBNP concentration. Interestingly, the larger number of patients included in this meta-analysis allowed subgroup analyses, showing greater beneficial effects of BAT in patients with NT-proBNP level <1600 ng/L and without a clear indication for CRT, as well as in female sex, with no influence of age or presence of atrial fibrillation.…”

Current and future use of neuromodulation in heart failure

“… 23 A recent meta-analysis confirmed consistent results and clinically meaningful improvement throughout the trials using BAT in patients with HFrEF. 24 …”