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Safety and efficacy of baroreflex activation therapy for heart failure with reduced ejection fraction: a rapid systematic review.

Abstract

To retrieve and assess the available data in the literature about the safety and efficacy of baroreflex activation therapy (BAT) in heart failure with reduced ejection fraction (HFrEF) patients, through a rapid systematic review of clinical studies. Rapid systematic review of literature. Searched electronic databases included PubMed, EMBASE, CENTRAL, Scopus, and Web of Science using Mesh and free terms for heart failure and BAT. No language restriction was used for the searches. We included full peer reviewed publications of clinical studies (randomized or not), including patients with HFrEF undergoing BAT, with or without control group, assessing safety and efficacy outcomes. One reviewer conducted the analysis of the selected abstracts and the full-text articles, performed data extraction, and evaluated the methodological quality of the selected articles. The methodological quality was assessed according to the Cochrane Collaboration instruments. A descriptive summary of the results is provided. Of the 441 citations screened, 10 publications were included (three were only conference abstracts), reporting data from three studies. Only one study was a randomized clinical trial. Two studies reported a 6 month following, and the other study analysed outcomes up to 41 months. The procedure seems to be safe when performed by a well-trained multi-professional team. An 86% rate of system and procedure-related complication-free was reported, with no cranial nerve injuries. Improvements in New York Heart Association class of heart failure, quality of life, 6 min walk test, and hospitalization rates, as well as in muscle sympathetic nerve activity. No meta-analysis was conducted because of the lack of homogeneity across studies; the results from each study are reported individually. BAT procedure seems to be safe if appropriate training is provided. Improvements in clinical outcomes were described in all included studies. However, several limitations do not allow us to make conclusive statements on the efficacy of BAT for HFrEF. New well-designed trials are still needed.

Authors+Show Affiliations

Heart Institute (InCor), Medical School, University of Sao Paulo, Sao Paulo, Brazil. Institute for Neuro-Immune Medicine, Nova Southeastern University, Fort Lauderdale, FL, USA. Miami Veterans Affairs Healthcare System, Miami, FL, USA.Global Research and Innovation Network (GRINN), Joinville, Santa Catarina, Brazil.Institute for Neuro-Immune Medicine, Nova Southeastern University, Fort Lauderdale, FL, USA, (W.O.C.).Heart Institute (InCor), Medical School, University of Sao Paulo, Sao Paulo, Brazil.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31965746

Citation

Schmidt, Rodrigo, et al. "Safety and Efficacy of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction: a Rapid Systematic Review." ESC Heart Failure, 2020.
Schmidt R, Rodrigues CG, Schmidt KH, et al. Safety and efficacy of baroreflex activation therapy for heart failure with reduced ejection fraction: a rapid systematic review. ESC Heart Fail. 2020.
Schmidt, R., Rodrigues, C. G., Schmidt, K. H., & Irigoyen, M. C. C. (2020). Safety and efficacy of baroreflex activation therapy for heart failure with reduced ejection fraction: a rapid systematic review. ESC Heart Failure, doi:10.1002/ehf2.12543.
Schmidt R, et al. Safety and Efficacy of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction: a Rapid Systematic Review. ESC Heart Fail. 2020 Jan 21; PubMed PMID: 31965746.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of baroreflex activation therapy for heart failure with reduced ejection fraction: a rapid systematic review. AU - Schmidt,Rodrigo, AU - Rodrigues,Clarissa Garcia, AU - Schmidt,Kelen Heinrich, AU - Irigoyen,Maria Claudia Costa, Y1 - 2020/01/21/ PY - 2019/02/11/received PY - 2019/09/10/revised PY - 2019/09/23/accepted PY - 2020/1/23/entrez KW - Baroreflex activation therapy KW - Heart failure KW - Rapid review JF - ESC heart failure JO - ESC Heart Fail N2 - To retrieve and assess the available data in the literature about the safety and efficacy of baroreflex activation therapy (BAT) in heart failure with reduced ejection fraction (HFrEF) patients, through a rapid systematic review of clinical studies. Rapid systematic review of literature. Searched electronic databases included PubMed, EMBASE, CENTRAL, Scopus, and Web of Science using Mesh and free terms for heart failure and BAT. No language restriction was used for the searches. We included full peer reviewed publications of clinical studies (randomized or not), including patients with HFrEF undergoing BAT, with or without control group, assessing safety and efficacy outcomes. One reviewer conducted the analysis of the selected abstracts and the full-text articles, performed data extraction, and evaluated the methodological quality of the selected articles. The methodological quality was assessed according to the Cochrane Collaboration instruments. A descriptive summary of the results is provided. Of the 441 citations screened, 10 publications were included (three were only conference abstracts), reporting data from three studies. Only one study was a randomized clinical trial. Two studies reported a 6 month following, and the other study analysed outcomes up to 41 months. The procedure seems to be safe when performed by a well-trained multi-professional team. An 86% rate of system and procedure-related complication-free was reported, with no cranial nerve injuries. Improvements in New York Heart Association class of heart failure, quality of life, 6 min walk test, and hospitalization rates, as well as in muscle sympathetic nerve activity. No meta-analysis was conducted because of the lack of homogeneity across studies; the results from each study are reported individually. BAT procedure seems to be safe if appropriate training is provided. Improvements in clinical outcomes were described in all included studies. However, several limitations do not allow us to make conclusive statements on the efficacy of BAT for HFrEF. New well-designed trials are still needed. SN - 2055-5822 UR - https://www.unboundmedicine.com/medline/citation/31965746/Safety_and_efficacy_of_baroreflex_activation_therapy_for_heart_failure_with_reduced_ejection_fraction:_a_rapid_systematic_review L2 - https://doi.org/10.1002/ehf2.12543 DB - PRIME DP - Unbound Medicine ER -