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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Chronic vagus nerve stimulation: A new and promising therapeutic approach for chronic heart failure
European Heart Journal, Volume 32, No. 7, Year 2011
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Description
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 resultsThis 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 IIIV patients [age 56 ± 11 years, LV ejection fraction (LVEF) 23 ± 8]. Right cervical VNS with CardioFit (BioControl Medical) implantable system started 24 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. ConclusionsThis 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. © 2011 The Author.
Authors & Co-Authors
De Ferrari, Gaetano Maria
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Crijns, Harry JGM
Netherlands, Maastricht
Maastricht Universitair Medisch Centrum+
Borggrefe, Martin M.
Germany, Mannheim
Universitätsklinikum Mannheim
Milasinovic, Goran
Serbia, Belgrade
Klinicki Centar Srbije
Smid, Jan
Germany, Magdeburg
Otto-von-guericke-universität Magdeburg
Zabel, Markus
Germany, Gottingen
Universitätsmedizin Göttingen
Gavazzi, Antonello
Italy, Bergamo
Ospedali Riuniti Di Bergamo
Sanzo, Antonio
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Dennert, Robert
Germany, Mannheim
Universitätsklinikum Mannheim
Kuschyk, Juergen
Serbia, Belgrade
Klinicki Centar Srbije
Raspopovic, Srdjan
Germany, Magdeburg
Otto-von-guericke-universität Magdeburg
Klein, Helmut
Germany, Gottingen
Universitätsmedizin Göttingen
United States, Rochester
University of Rochester
Swedberg, Karl B.
Sweden, Gothenburg
Göteborgs Universitet
Schwartz, Peter J.
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Italy, Pavia
Università Degli Studi Di Pavia
Italy, Milan
Irccs Istituto Auxologico Italiano
Saudi Arabia, Riyadh
College of Medicine
South Africa, Cape Town
University of Cape Town
Statistics
Citations: 465
Authors: 14
Affiliations: 13
Identifiers
Doi:
10.1093/eurheartj/ehq391
ISSN:
0195668X
e-ISSN:
15229645
Research Areas
Disability
Health System And Policy
Study Design
Cohort Study