PMID- 32616150
OWN - NLM
STAT- MEDLINE
DCOM- 20210112
LR  - 20210112
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 76
IP  - 1
DP  - 2020 Jul 7
TI  - Baroreflex Activation Therapy in Patients With Heart Failure With Reduced 
      Ejection Fraction.
PG  - 1-13
LID - S0735-1097(20)35298-0 [pii]
LID - 10.1016/j.jacc.2020.05.015 [doi]
AB  - BACKGROUND: This study demonstrated the safety and effectiveness of baroreflex 
      activation therapy (BAT) in patients with heart failure with reduced ejection 
      fraction (HFrEF). OBJECTIVES: The BeAT-HF (Baroreflex Activation Therapy for 
      Heart Failure) trial was a multicenter, prospective, randomized, controlled 
      trial; subjects were randomized 1:1 to receive either BAT plus optimal medical 
      management (BAT group) or optimal medical management alone (control group). 
      METHODS: Four patient cohorts were created from 408 randomized patients with 
      HFrEF using the following enrollment criteria: current New York Heart Association 
      (NYHA) functional class III or functional class II (patients who had a recent 
      history of NYHA functional class III); ejection fraction </=35%; stable medical 
      management for >/=4 weeks; and no Class I indication for cardiac resynchronization 
      therapy. Effectiveness endpoints were the change from baseline to 6 months in 
      6-min hall walk distance (6MHW), Minnesota Living with HF Questionnaire 
      quality-of-life (QOL) score, and N-terminal pro-B-type natriuretic peptide 
      (NT-proBNP) levels. The safety endpoint included the major adverse neurological 
      or cardiovascular system or procedure-related event rate (MANCE). RESULTS: 
      Results from, timeline and rationale for, cohorts A, B, and C are presented in 
      detail in the text. Cohort D, which represented the intended use population that 
      reflected the U.S. Food and Drug Administration-approved instructions for use 
      (enrollment criteria plus NT-proBNP <1,600 pg/ml), consisted of 245 patients 
      followed-up for 6 months (120 in the BAT group and 125 in the control group). BAT 
      was safe and significantly improved QOL, 6MHW, and NT-proBNP. In the BAT group 
      versus the control group, QOL score decreased (Delta = -14.1; 95% confidence interval 
      [CI]: -19 to -9; p < 0.001), 6MHW distance increased (Delta = 60 m; 95% CI: 40 to 80 
      m; p < 0.001), NT-proBNP decreased (Delta = -25%; 95% CI: -38% to -9%; p = 0.004), 
      and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001). CONCLUSIONS: 
      BAT was safe and significantly improved QOL, exercise capacity, and NT-proBNP. 
      (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196).
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.
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. Electronic address: zilem@musc.edu.
FAU - Lindenfeld, JoAnn
AU  - Lindenfeld J
AD  - Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.
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 - Zannad, Faiez
AU  - Zannad F
AD  - Inserm Centre d'Investigation, CHU de Nancy, Institute Lorrain du Coeur et des 
      Vaisseaux, Universite de Lorraine, Nancy, France.
FAU - Galle, Elizabeth
AU  - Galle E
AD  - CVRx, Inc., Minneapolis, Minnesota.
FAU - Rogers, Tyson
AU  - Rogers T
AD  - NAMSA, Inc., Minneapolis, Minneapolis.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.
LA  - eng
SI  - ClinicalTrials.gov/NCT02627196
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
SB  - IM
CIN - J Am Coll Cardiol. 2020 Jul 7;76(1):14-16. PMID: 32616157
MH  - Aged
MH  - Baroreflex/*physiology
MH  - Electric Stimulation Therapy/*methods
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure/physiopathology/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Stroke Volume/*physiology
MH  - Ventricular Function, Left/*physiology
OTO - NOTNLM
OT  - autonomic nervous system
OT  - baroreflex
OT  - device
OT  - heart failure
OT  - randomized controlled trial
EDAT- 2020/07/04 06:00
MHDA- 2021/01/13 06:00
CRDT- 2020/07/04 06:00
PHST- 2020/04/01 00:00 [received]
PHST- 2020/05/04 00:00 [accepted]
PHST- 2020/07/04 06:00 [entrez]
PHST- 2020/07/04 06:00 [pubmed]
PHST- 2021/01/13 06:00 [medline]
AID - S0735-1097(20)35298-0 [pii]
AID - 10.1016/j.jacc.2020.05.015 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015.