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Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure
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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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“Many studies in animal models and clinical patients have shown that the decrease in HR plays a notable role in the treatment of HF (18, 52).”
From Climbing-inspired twining electrodes using shape memory for peripheral nerve stimulation and recording (2019) · cites this paper as [52]
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Metadata
- 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
- 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
- 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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