Cited by 523Vagus Nerve Stimulation ResearchCardiac pacing and defibrillation studiesHeart Rate Variability and Autonomic Control

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Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure

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De Ferrari, Gaetano M., Crijns, Harry J.G.M., Borggrefe, Martin, Milasinovic, Goran, Smid, Jan, Zabel, Markus, Gavazzi, Antonello, Sanzo, Antonio, Dennert, Robert, Kuschyk, Juergen, Raspopovic, Srdjan, Klein, Helmut, Swedberg, Karl, Schwartz, Peter J.·2011·European Heart Journal

DOI 10.1093/eurheartj/ehq391

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Abstract

AIMS: In chronic heart failure (CHF), reduced vagal activity correlates with increased mortality and acute decompensation. Experimentally, chronic vagus nerve stimulation (VNS) improved left ventricular (LV) function and survival; clinically, it is used for the treatment of drug-refractory epilepsy. We assessed safety and tolerability of chronic VNS in symptomatic CHF patients, using a novel implantable nerve stimulation system. The secondary goal was to obtain preliminary data on clinical efficacy. METHODS AND RESULTS: This multi-centre, open-label phase II, two-staged study (8-patient feasibility phase plus 24-patient safety and tolerability phase) enrolled 32 New York Heart Association (NYHA) class II-IV patients [age 56 ± 11 years, LV ejection fraction (LVEF) 23 ± 8%]. Right cervical VNS with CardioFit (BioControl Medical) implantable system started 2-4 weeks after implant, slowly raising intensity; patients were followed 3 and 6 months thereafter with optional 1-year follow-up. Overall, 26 serious adverse events (SAEs) occurred in 13 of 32 patients (40.6%), including three deaths and two clearly device-related AEs (post-operative pulmonary oedema, need of surgical revision). Expected non-serious device-related AEs (cough, dysphonia, and stimulation-related pain) occurred early but were reduced and disappeared after stimulation intensity adjustment. There were significant improvements (P < 0.001) in NYHA class quality of life, 6-minute walk test (from 411 ± 76 to 471 ± 111 m), LVEF (from 22 ± 7 to 29 ± 8%), and LV systolic volumes (P = 0.02). These improvements were maintained at 1 year. CONCLUSIONS: This open-label study shows that chronic VNS in CHF patients with severe systolic dysfunction may be safe and tolerable and may improve quality of life and LV function. A controlled clinical trial appears warranted.

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Authors: De Ferrari, G. M., Crijns, H. J. G. M., Borggrefe, M., Milasinovic, G., Smid, J., Zabel, M., Gavazzi, A., Sanzo, A., Dennert, R., Kuschyk, J., Raspopovic, S., Klein, H., Swedberg, K., & Schwartz, P. J.
Affiliations: Maastricht University Medical Centre (NL)
University Medical Centre Mannheim (DE)
University Hospital Magdeburg (DE)
Universitätsmedizin Göttingen (DE)
Policlinico San Matteo Fondazione (IT)
Univerzitetski Klinički Centar Srbije (RS)
University of Rochester Medicine (US)
University of Gothenburg (SE)
University of Cape Town (ZA)
ORCID: Crijns, Harry J.G.M.
Borggrefe, Martin
Zabel, Markus
Gavazzi, Antonello
Sanzo, Antonio
Kuschyk, Juergen
Klein, Helmut
Swedberg, Karl
Schwartz, Peter J.
Venue: European Heart Journal
Publisher: Oxford University Press (OUP)
Published: 2010-10-28
Volume: 32
Issue: 7
Pages: 847-855
ISSN: 0195-668X (ISSN-L)
1522-9645
DOI: 10.1093/eurheartj/ehq391
OpenAlex: W2120723181
Cited by: 523
References: 29
Citations by year: 2026: 13 · 2025: 24 · 2024: 25 · 2023: 29 · 2022: 32 · 2021: 29 · 2020: 24 · 2019: 23 · 2018: 28 · 2017: 51 · 2016: 44 · 2015: 51 · 2014: 46 · 2013: 37 · 2012: 44
FWCI: 19.71
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: European Heart Journal (publishedVersion)
PubMed (publishedVersion)
Research Publications (Maastricht University) (submittedVersion, other-oa)
Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
GRO (submittedVersion)
Topics: Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
Keywords: chronic heart failure, safety and tolerability, left ventricular ejection fraction, left ventricular systolic function, NYHA functional class, 6-minute walk test, quality of life, device-related adverse events, parasympathetic activity
MeSH terms: Aged, Chronic Disease, Exercise Test, Feasibility Studies, Female, Heart Failure, Heart Rate, Humans, Length of Stay, Male, Middle Aged, Stroke Volume, Treatment Outcome, Prosthesis Implantation, Vagus Nerve Stimulation, Implantable Neurostimulators

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Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure

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