PMID- 21030409
OWN - NLM
STAT- MEDLINE
DCOM- 20111227
LR  - 20220408
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 32
IP  - 7
DP  - 2011 Apr
TI  - Chronic vagus nerve stimulation: a new and promising therapeutic approach for 
      chronic heart failure.
PG  - 847-55
LID - 10.1093/eurheartj/ehq391 [doi]
AB  - 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.
FAU - De Ferrari, Gaetano M
AU  - De Ferrari GM
AD  - Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 
      g.deferrari@smatteo.pv.it
FAU - Crijns, Harry J G M
AU  - Crijns HJ
FAU - Borggrefe, Martin
AU  - Borggrefe M
FAU - Milasinovic, Goran
AU  - Milasinovic G
FAU - Smid, Jan
AU  - Smid J
FAU - Zabel, Markus
AU  - Zabel M
FAU - Gavazzi, Antonello
AU  - Gavazzi A
FAU - Sanzo, Antonio
AU  - Sanzo A
FAU - Dennert, Robert
AU  - Dennert R
FAU - Kuschyk, Juergen
AU  - Kuschyk J
FAU - Raspopovic, Srdjan
AU  - Raspopovic S
FAU - Klein, Helmut
AU  - Klein H
FAU - Swedberg, Karl
AU  - Swedberg K
FAU - Schwartz, Peter J
AU  - Schwartz PJ
CN  - CardioFit Multicenter Trial Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00461019
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20101028
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
SB  - IM
CIN - Eur Heart J. 2011 Apr;32(7):788-90. PMID: 21088010
MH  - Aged
MH  - Chronic Disease
MH  - Exercise Test
MH  - Feasibility Studies
MH  - Female
MH  - Heart Failure/physiopathology/*therapy
MH  - Heart Rate
MH  - Humans
MH  - Implantable Neurostimulators
MH  - Length of Stay
MH  - Male
MH  - Middle Aged
MH  - Prosthesis Implantation/methods
MH  - Stroke Volume
MH  - Treatment Outcome
MH  - Vagus Nerve Stimulation/adverse effects/*methods
FIR - Schwartz, Peter J
IR  - Schwartz PJ
FIR - De Ferrari, Gaetano M
IR  - De Ferrari GM
FIR - Sanzo, Antonio
IR  - Sanzo A
FIR - Crijns, Harry J G M
IR  - Crijns HJ
FIR - Dennert, Robert
IR  - Dennert R
FIR - Borggrefe, Martin
IR  - Borggrefe M
FIR - Kuschyk, Juergen
IR  - Kuschyk J
FIR - Schoene, Nina
IR  - Schoene N
FIR - Milasinovic, Goran
IR  - Milasinovic G
FIR - Raspopovic, Srdjan
IR  - Raspopovic S
FIR - Klein, Helmut
IR  - Klein H
FIR - Smid, Jan
IR  - Smid J
FIR - Zabel, Markus
IR  - Zabel M
FIR - Zenker, D
IR  - Zenker D
FIR - Gavazzi, Antonello
IR  - Gavazzi A
FIR - Iacovoni, Attilio
IR  - Iacovoni A
EDAT- 2010/10/30 06:00
MHDA- 2011/12/28 06:00
CRDT- 2010/10/30 06:00
PHST- 2010/10/30 06:00 [entrez]
PHST- 2010/10/30 06:00 [pubmed]
PHST- 2011/12/28 06:00 [medline]
AID - ehq391 [pii]
AID - 10.1093/eurheartj/ehq391 [doi]
PST - ppublish
SO  - Eur Heart J. 2011 Apr;32(7):847-55. doi: 10.1093/eurheartj/ehq391. Epub 2010 Oct 
      28.