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

Andrew J.S. Coats, William T. Abraham, Michael R. Zile, Joann A. Lindenfeld, Fred A. Weaver, Marat Fudim, Johann Bauersachs, Sue Duval, Elizabeth Galle, Faiez Zannad

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1 Scopus citations

Abstract

Aims: 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. Methods and results: An individual patient data (IPD) meta-analysis was performed on all eligible trials that randomized HFrEF patients to BAT + guideline-directed medical therapy (GDMT) or GDMT alone (open label). Endpoints included 6-month changes in 6-min hall walk (6MHW) distance, Minnesota Living With Heart Failure (MLWHF) QoL score, NT-proBNP, and New York Heart Association (NYHA) class in all patients and three subgroups. A total of 554 randomized patients were included. In all patients, BAT provided significant improvement in 6MHW distance of 49 m (95% confidence interval [CI] 33, 64), MLWHF QoL of −13 points (95% CI −17, −10), and 3.4 higher odds of improving at least one NYHA class (95% CI 2.3, 4.9) when comparing from baseline to 6 months. These improvements were similar, or better, in patients who had baseline NT-proBNP <1600 pg/ml, regardless of the cardiac resynchronization therapy indication status. Conclusion: An IPD meta-analysis suggests that BAT improves exercise capacity, NYHA class, and QoL in HFrEF patients receiving GDMT. These clinically meaningful improvements were consistent across the range of patients studies. BAT was also associated with an improvement in NT-proBNP in subjects with a lower baseline NT-proBNP.

Original languageEnglish (US)
JournalEuropean Journal of Heart Failure
DOIs
StateAccepted/In press - 2022

Bibliographical note

Funding Information:
A.J.S.C. declares having received honoraria and/or lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Menarini, Novartis, Nutricia, Servier, Vifor, Abbott, Actimed, Arena, Cardiac Dimensions, Corvia, CVRx, Enopace, ESN Cleer, Faraday, Gore, Impulse Dynamics, Respicardia. M.F. was supported by the National Heart, Lung, and Blood Institute (NHLBI) (K23HL151744), the American Heart Association (20IPA35310955), Mario Family Award, Duke Chair's Award, Translating Duke Health Award, Bayer, Bodyport and BTG Specialty Pharmaceuticals; he receives consulting fees from AxonTherapies, Bodyport, Boston Scientific, CVRx, Daxor, Edwards LifeSciences, Fire1, Inovise, NXT Biomedical, Viscardia, Zoll. All other authors have nothing to disclose. J.B. receives consulting fees from Amgen, Astra Zeneca, Bayer, BMS, Boehringer, Ingelheim, Cardoir, Corvia, CVRX, Novartis, Pfizer and Virfor. M.R.Z., J.A.L, F.A.W. and M.F. declare having received consulting fees from CVRx. EG is an employee of CVRx. F.Z. receives consulting fees from Bayer, Boehringer, CVRx, Merck AG, Novartis, Vifor Fresenius. W.T.A. declares personal fees from Respicardia, Cardionomic, Wite Swell, AquaPass, Cordio, Vectorius, Impulse Dynamics and Edwards Lifesciences and personal equity in V‐Wave Medical. Conflict of interest:

Publisher Copyright:
© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Keywords

  • Autonomic nervous system
  • Baroreflex
  • Heart failure
  • Meta-analysis
  • Randomized controlled trials

PubMed: MeSH publication types

  • Journal Article

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