PMID- 36202286 OWN - NLM STAT- MEDLINE DCOM- 20240216 LR - 20240314 IS - 1873-2615 (Electronic) IS - 1050-1738 (Linking) VI - 34 IP - 2 DP - 2024 Feb TI - Non-pharmacologic autonomic neuromodulation for treatment of heart failure: A systematic review and meta-analysis of randomized controlled trials. PG - 101-107 LID - S1050-1738(22)00124-4 [pii] LID - 10.1016/j.tcm.2022.09.007 [doi] AB - Treatment strategies that modulate autonomic tone through interventional and device-based therapies have been studied as an adjunct to pharmacological treatment of heart failure with reduced ejection fraction (HFrEF). The main objective of this study was to perform a meta-analysis of randomized controlled trials which evaluated the efficacy of device-based autonomic modulation for treatment of HFrEF. All randomized-controlled trials testing autonomic neuromodulation device therapy in HFrEF were included in this trial-level analysis. Autonomic neuromodulation techniques included vagal nerve stimulation (VNS), baroreflex activation (BRA), spinal cord stimulator (SCS), and renal denervation (RD). The prespecified primary endpoints included mean change and 95% confidence intervals (CI) of left ventricular ejection fraction (LVEF), NT pro-B-type natriuretic peptide (NT-proBNP), and quality of life (QOL) measures including 6-minute hall walk distance (6-MHWD), and Minnesota Living with Heart Failure Questionnaire (MLHFQ). New York Heart Association (NYHA) functional class improvement was reported as odds ratios and 95% CI of improvement by at least 1 functional class. Eight studies were identified that included 1037 participants (2 VNS, 2 BRA, 1 SCS, and 3 RD trials). This included 6 open-label, 1 single-blind, and 1 sham-controlled, double-blind study. The mean age (+/-SD) was 61 (+/-9.3) years. The mean follow-up time was 7.9 months. Twenty percent of the total patients were female, and the mean BMI (+/-SD) was 29.86 (+/-4.12). Autonomic neuromodulation device therapy showed a statistically significant improvement in LVEF (4.02%; 95% CI 0.24,7.79), NT-proBNP (-219.80 pg/ml; 95% CI -386.56, -53.03), NYHA functional class (OR 2.32; 95% CI 1.76, 3.07), 6-MHWD (48.39 m; 95% CI 35.49, 61.30), and MLHFQ (-12.20; 95% CI -19.24, -5.16) compared to control. In patients with HFrEF, the use of autonomic neuromodulation device therapy is associated with improvement in LVEF, reduction in NT-proBNP, and improvement in patient-centered QOL outcomes in mostly small open-label trials. Large, double-blind, sham-controlled trials designed to detect differences in hard cardiovascular outcomes are needed before widespread use and adoption of autonomic neuromodulation device therapies in HFrEF. CI - Copyright (c) 2022. Published by Elsevier Inc. FAU - Ahmed, Mohammad AU - Ahmed M AD - Department of Internal Medicine, Penn State Hershey Medical Center, Hershey, PA 17033, United States of America. FAU - Nudy, Matthew AU - Nudy M AD - Division of Cardiology, Penn State Hershey Medical Center, Heart and Vascular Institute, Hershey, PA 17033, United States of America. FAU - Bussa, Rahul AU - Bussa R AD - Department of Internal Medicine, Penn State Hershey Medical Center, Hershey, PA 17033, United States of America. FAU - Weigel, Frank AU - Weigel F AD - Department of Internal Medicine, Penn State Hershey Medical Center, Hershey, PA 17033, United States of America. FAU - Naccarelli, Gerald AU - Naccarelli G AD - Division of Cardiology, Penn State Hershey Medical Center, Heart and Vascular Institute, Hershey, PA 17033, United States of America. FAU - Maheshwari, Ankit AU - Maheshwari A AD - Division of Cardiology, Penn State Hershey Medical Center, Heart and Vascular Institute, Hershey, PA 17033, United States of America. Electronic address: amaheshwari@pennstatehealth.psu.edu. LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20221004 PL - United States TA - Trends Cardiovasc Med JT - Trends in cardiovascular medicine JID - 9108337 SB - IM MH - Humans MH - Female MH - Middle Aged MH - Aged MH - Male MH - *Heart Failure/therapy/drug therapy MH - Stroke Volume MH - Ventricular Function, Left MH - Quality of Life MH - Single-Blind Method MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - Autonomic neuromodulation OT - Baroreflex activation OT - Heart failure with reduced ejection fraction OT - Renal denervation OT - Spinal cord stimulation OT - Vagal nerve stimulation EDAT- 2022/10/07 06:00 MHDA- 2024/02/16 06:42 CRDT- 2022/10/06 19:24 PHST- 2022/07/10 00:00 [received] PHST- 2022/09/08 00:00 [revised] PHST- 2022/09/23 00:00 [accepted] PHST- 2024/02/16 06:42 [medline] PHST- 2022/10/07 06:00 [pubmed] PHST- 2022/10/06 19:24 [entrez] AID - S1050-1738(22)00124-4 [pii] AID - 10.1016/j.tcm.2022.09.007 [doi] PST - ppublish SO - Trends Cardiovasc Med. 2024 Feb;34(2):101-107. doi: 10.1016/j.tcm.2022.09.007. Epub 2022 Oct 4.