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Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure
- De Ferrari, G. M. (author)
- Crijns, H. J. (author)
- Borggrefe, M. (author)
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- Milasinovic, G. (author)
- Smid, J. (author)
- Zabel, M. (author)
- Gavazzi, A. (author)
- Sanzo, A. (author)
- Dennert, R. (author)
- Kuschyk, J. (author)
- Raspopovic, S. (author)
- Klein, H. (author)
- Schwartz, P. J. (author)
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- (creator_code:org_t)
- 2010-10-28
- 2011
- English.
- In: European heart journal. - : Oxford University Press (OUP). - 1522-9645 .- 0195-668X. ; 32:7, s. 847-855
- Journal article (peer-reviewed)
Abstract
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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.
Keyword
- Heart failure
- Autonomic nervous system
- Non-pharmacologic therapy
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- ref (subject category)
- art (subject category)
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- Crijns, H. J.
- Borggrefe, M.
- Milasinovic, G.
- Smid, J.
- Zabel, M.
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- Gavazzi, A.
- Sanzo, A.
- Dennert, R.
- Kuschyk, J.
- Raspopovic, S.
- Klein, H.
- Swedberg, Karl, ...
- Schwartz, P. J.
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