PMID- 26011593
OWN - NLM
STAT- MEDLINE
DCOM- 20160809
LR  - 20151029
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 17
IP  - 10
DP  - 2015 Oct
TI  - Baroreflex activation therapy for the treatment of heart failure with a reduced 
      ejection fraction: safety and efficacy in patients with and without cardiac 
      resynchronization therapy.
PG  - 1066-74
LID - 10.1002/ejhf.299 [doi]
AB  - AIMS: Increased sympathetic and decreased parasympathetic activity contribute to 
      heart failure (HF) symptoms and disease progression. Carotid baroreceptor 
      stimulation (baroreflex activation therapy, BAT) results in centrally mediated 
      reduction of sympathetic and increase in parasympathetic activity. Because 
      patients treated with cardiac resynchronization therapy (CRT) may have less 
      sympathetic/parasympathetic imbalance, we hypothesized that there would be 
      differences in the response to BAT in patients with CRT vs. those without CRT. 
      METHODS AND RESULTS: New York Heart Association (NYHA) Class III patients with an 
      ejection fraction (EF) </=35% were randomized (1 : 1) to ongoing guideline-directed 
      medical and device therapy (GDMT, control) or ongoing GDMT plus BAT. Safety 
      endpoint was system-/procedure-related major adverse neurological and 
      cardiovascular events (MANCE). Efficacy endpoints were Minnesota Living with 
      Heart Failure Quality of Life (QoL), 6-min hall walk distance (6MHWD), N-terminal 
      pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction 
      (LVEF), and HF hospitalization rate. In this sample, 146 patients were randomized 
      (70 control; 76 BAT) and were 140 activated (45 with CRT and 95 without CRT). 
      MANCE-free rate at 6 months was 100% in CRT and 96% in no-CRT group. At 6 months, 
      in the no-CRT group, QoL score, 6MHWD, LVEF, NT-proBNP and HF hospitalizations 
      were significantly improved in BAT patients compared with controls. Changes in 
      efficacy endpoints in the CRT group favoured BAT; however, the improvements were 
      less than in the no-CRT group and were not statistically different from control. 
      CONCLUSIONS: BAT is safe and significantly improved QoL, exercise capacity, 
      NTpro-BNP, EF, and rate of HF hospitalizations in GDMT-treated NYHA Class III HF 
      patients. These effects were most pronounced in patients not treated with CRT.
CI  - (c) 2015 The Authors European Journal of Heart Failure (c) 2015 European Society of 
      Cardiology.
FAU - Zile, Michael R
AU  - Zile MR
AD  - Division of Cardiology, Department of Medicine, Medical University of South 
      Carolina, 114 Doughty Street, Thurmond/Gazes, 323, Charleston, SC 29425, USA and 
      Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, 
      USA.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, 
      USA.
FAU - Weaver, Fred A
AU  - Weaver FA
AD  - Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, 
      University of Southern California, Los Angeles, CA, USA.
FAU - Butter, Christian
AU  - Butter C
AD  - Department of Cardiology, Immanuel Heart Center Bernau-Medical School 
      Brandenburg, Bernau, Germany.
FAU - Ducharme, Anique
AU  - Ducharme A
AD  - Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada.
FAU - Halbach, Marcel
AU  - Halbach M
AD  - Department of Internal Medicine III, University Hospital of Cologne, Cologne, 
      Germany.
FAU - Klug, Didier
AU  - Klug D
AD  - Department of Cardiology A, University Hospital, Lille, France.
FAU - Lovett, Eric G
AU  - Lovett EG
AD  - Department of Research, CVRx, Inc., Minneapolis, MN, USA.
FAU - Muller-Ehmsen, Jochen
AU  - Muller-Ehmsen J
AD  - Department of Medicine, Asklepios Klinik Altona, Hamburg, Germany.
FAU - Schafer, Jill E
AU  - Schafer JE
AD  - Department of Statistics, NAMSA, Inc., Minneapolis, MN, USA.
FAU - Senni, Michele
AU  - Senni M
AD  - Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
FAU - Swarup, Vijay
AU  - Swarup V
AD  - Department of Electrophysiology, Arizona Heart Hospital, Phoenix, AZ, USA.
FAU - Wachter, Rolf
AU  - Wachter R
AD  - Clinic for Cardiology and Pneumology, University Medicine Gottingen and German 
      Cardiovascular Research Center (DZHK), Gottingen, Germany.
FAU - Little, William C
AU  - Little WC
AD  - Division of Cardiology, University of Mississippi Medical Center, Jackson, MS, 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01471860
SI  - ClinicalTrials.gov/NCT01720160
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150610
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
CIN - Eur J Heart Fail. 2015 Oct;17(10):1000-2. PMID: 26417677
MH  - Aged
MH  - *Baroreflex/physiology
MH  - Cardiac Resynchronization Therapy
MH  - *Electric Stimulation Therapy
MH  - Female
MH  - Heart Failure/physiopathology/*therapy
MH  - Humans
MH  - Implantable Neurostimulators
MH  - Male
MH  - Middle Aged
MH  - Stroke Volume
MH  - Ventricular Function, Left
OTO - NOTNLM
OT  - Autonomic nervous system
OT  - Baroreflex
OT  - Heart failure
OT  - Randomized controlled trial
OT  - Resynchronization
EDAT- 2015/05/27 06:00
MHDA- 2016/08/10 06:00
CRDT- 2015/05/27 06:00
PHST- 2015/04/23 00:00 [received]
PHST- 2015/05/13 00:00 [revised]
PHST- 2015/05/14 00:00 [accepted]
PHST- 2015/05/27 06:00 [entrez]
PHST- 2015/05/27 06:00 [pubmed]
PHST- 2016/08/10 06:00 [medline]
AID - 10.1002/ejhf.299 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 
      10.