Document Detail


Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure.
MedLine Citation:
PMID:  21030409     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
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.
Authors:
Gaetano M De Ferrari; Harry J G M Crijns; Martin Borggrefe; Goran Milasinovic; Jan Smid; Markus Zabel; Antonello Gavazzi; Antonio Sanzo; Robert Dennert; Juergen Kuschyk; Srdjan Raspopovic; Helmut Klein; Karl Swedberg; Peter J Schwartz;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-10-28
Journal Detail:
Title:  European heart journal     Volume:  32     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-04-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  847-55     Citation Subset:  IM    
Affiliation:
Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. g.deferrari@smatteo.pv.it
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00461019
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MeSH Terms
Descriptor/Qualifier:
Investigator
Investigator/Affiliation:
Peter J Schwartz / ; Gaetano M De Ferrari / ; Antonio Sanzo / ; Harry J G M Crijns / ; Robert Dennert / ; Martin Borggrefe / ; Juergen Kuschyk / ; Nina Schoene / ; Goran Milasinovic / ; Srdjan Raspopovic / ; Helmut Klein / ; Jan Smid / ; Markus Zabel / ; D Zenker / ; Antonello Gavazzi / ; Attilio Iacovoni /
Comments/Corrections
Comment In:
Eur Heart J. 2011 Apr;32(7):788-90   [PMID:  21088010 ]

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