PMID- 25982108
OWN - NLM
STAT- MEDLINE
DCOM- 20160408
LR  - 20220318
IS  - 2213-1787 (Electronic)
IS  - 2213-1779 (Linking)
VI  - 3
IP  - 6
DP  - 2015 Jun
TI  - Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced 
      Ejection Fraction.
PG  - 487-496
LID - S2213-1779(15)00125-0 [pii]
LID - 10.1016/j.jchf.2015.02.006 [doi]
AB  - OBJECTIVES: The objective of this clinical trial was to assess the safety and 
      efficacy of carotid BAT in advanced HF. BACKGROUND: Increased sympathetic and 
      decreased parasympathetic activity contribute to heart failure (HF) symptoms and 
      disease progression. Baroreflex activation therapy (BAT) results in centrally 
      mediated reduction of sympathetic outflow and increased parasympathetic activity. 
      METHODS: Patients with New York Heart Association (NYHA) functional class III HF 
      and ejection fractions </=35% on chronic stable guideline-directed medical therapy 
      (GDMT) were enrolled at 45 centers in the United States, Canada, and Europe. They 
      were randomly assigned to receive ongoing GDMT alone (control group) or ongoing 
      GDMT plus BAT (treatment group) for 6 months. The primary safety end point was 
      system- and procedure-related major adverse neurological and cardiovascular 
      events. The primary efficacy end points were changes in NYHA functional class, 
      quality-of-life score, and 6-minute hall walk distance. RESULTS: One hundred 
      forty-six patients were randomized, 70 to control and 76 to treatment. The major 
      adverse neurological and cardiovascular event-free rate was 97.2% (lower 95% 
      confidence bound 91.4%). Patients assigned to BAT, compared with control group 
      patients, experienced improvements in the distance walked in 6 min (59.6 +/- 14 m 
      vs. 1.5 +/- 13.2 m; p = 0.004), quality-of-life score (-17.4 +/- 2.8 points vs. 2.1 +/- 
      3.1 points; p < 0.001), and NYHA functional class ranking (p = 0.002 for change 
      in distribution). BAT significantly reduced N-terminal pro-brain natriuretic 
      peptide (p = 0.02) and was associated with a trend toward fewer days hospitalized 
      for HF (p = 0.08). CONCLUSIONS: BAT is safe and improves functional status, 
      quality of life, exercise capacity, N-terminal pro-brain natriuretic peptide, and 
      possibly the burden of heart failure hospitalizations in patients with 
      GDMT-treated NYHA functional class III HF. (Barostim Neo System in the Treatment 
      of Heart Failure; NCT01471860; Barostim HOPE4HF [Hope for Heart Failure] Study; 
      NCT01720160).
CI  - Copyright (c) 2015 American College of Cardiology Foundation. Published by Elsevier 
      Inc. All rights reserved.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. 
      Electronic address: william.abraham@osumc.edu.
FAU - Zile, Michael R
AU  - Zile MR
AD  - Medical University of South Carolina, Charleston, South Carolina; Ralph H. 
      Johnson Department of Veterans Affairs Medical Center, Charleston, South 
      Carolina.
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, California.
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, Minnesota.
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, Minnesota.
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, Arizona.
FAU - Wachter, Rolf
AU  - Wachter R
AD  - Clinic for Cardiology and Pneumology, University Medicine Gottingen and German 
      Cardiovascular Research Center, Gottingen, Germany.
FAU - Little, William C
AU  - Little WC
AD  - Division of Cardiology, University of Mississippi Medical Center, Jackson, 
      Mississippi.
LA  - eng
SI  - ClinicalTrials.gov/NCT01471860
SI  - ClinicalTrials.gov/NCT01720160
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20150514
PL  - United States
TA  - JACC Heart Fail
JT  - JACC. Heart failure
JID - 101598241
SB  - IM
CIN - Rev Port Cardiol. 2015 Dec;34(12):795-7
CIN - Nat Rev Cardiol. 2015 May;12(5):258. PMID: 25824508
CIN - Rev Port Cardiol. 2015 Dec;34(12):795-7. PMID: 27099884
MH  - Aged
MH  - *Baroreflex/physiology
MH  - Electric Stimulation Therapy/*methods
MH  - Female
MH  - Heart Failure
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prosthesis Implantation/methods
MH  - Stroke Volume/physiology
MH  - Treatment Outcome
OTO - NOTNLM
OT  - autonomic nervous system
OT  - baroreflex
OT  - device
OT  - heart failure
OT  - randomized controlled trial
EDAT- 2015/05/20 06:00
MHDA- 2016/04/09 06:00
CRDT- 2015/05/19 06:00
PHST- 2015/02/06 00:00 [received]
PHST- 2015/02/24 00:00 [revised]
PHST- 2015/02/24 00:00 [accepted]
PHST- 2015/05/19 06:00 [entrez]
PHST- 2015/05/20 06:00 [pubmed]
PHST- 2016/04/09 06:00 [medline]
AID - S2213-1779(15)00125-0 [pii]
AID - 10.1016/j.jchf.2015.02.006 [doi]
PST - ppublish
SO  - JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 
      2015 May 14.