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.

Autor: Coats AJS; University of Warwick, Coventry, UK., Abraham WT; Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA., Zile MR; The Medical University of South Carolina and the RHJ Department of Veterans Affairs Medical Center, Charleston, SC, USA., Lindenfeld JA; Vanderbilt Heart and Vascular Institute, Nashville, TN, USA., Weaver FA; Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA., Fudim M; Duke University Medical Center, Durham, NC, USA.; Duke Clinical Research Institute, Durham, NC, USA., Bauersachs J; Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany., Duval S; Cardiovascular Division, University of Minnesota Medical School, Minneapolis, MN, USA., Galle E; CVRx®, Inc., Minneapolis, MN, USA., Zannad F; Université de Lorraine, Inserm Centre d'Investigation, CHU, Université de Lorraine, Nancy, France.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2022 Sep; Vol. 24 (9), pp. 1665-1673. Date of Electronic Publication: 2022 Jul 03.
DOI: 10.1002/ejhf.2573
Abstrakt: 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.
(© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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