PMID- 35713888
OWN - NLM
STAT- MEDLINE
DCOM- 20221011
LR  - 20230106
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 24
IP  - 9
DP  - 2022 Sep
TI  - Baroreflex activation therapy with the Barostim device in patients with heart 
      failure with reduced ejection fraction: a patient level meta-analysis of 
      randomized controlled trials.
PG  - 1665-1673
LID - 10.1002/ejhf.2573 [doi]
AB  - AIMS: Heart failure with reduced ejection fraction (HFrEF) remains associated 
      with high morbidity and mortality, poor quality of life (QoL) and significant 
      exercise limitation. Sympatho-vagal imbalance has been shown to predict adverse 
      prognosis and symptoms in HFrEF, yet it has not been specifically targeted by any 
      guideline-recommended device therapy to date. Barostim, which directly addresses 
      this imbalance, is the first Food and Drug Administration approved 
      neuromodulation technology for HFrEF. We aimed to analyse all randomized trial 
      evidence to evaluate the effect of baroreflex activation therapy (BAT) on heart 
      failure symptoms, QoL and N-terminal pro-brain natriuretic peptide (NT-proBNP) in 
      HFrEF. METHODS AND RESULTS: An individual patient data (IPD) meta-analysis was 
      performed on all eligible trials that randomized HFrEF patients to 
      BAT + guideline-directed medical therapy (GDMT) or GDMT alone (open label). 
      Endpoints included 6-month changes in 6-min hall walk (6MHW) distance, Minnesota 
      Living With Heart Failure (MLWHF) QoL score, NT-proBNP, and New York Heart 
      Association (NYHA) class in all patients and three subgroups. A total of 554 
      randomized patients were included. In all patients, BAT provided significant 
      improvement in 6MHW distance of 49 m (95% confidence interval [CI] 33, 64), MLWHF 
      QoL of -13 points (95% CI -17, -10), and 3.4 higher odds of improving at least 
      one NYHA class (95% CI 2.3, 4.9) when comparing from baseline to 6 months. These 
      improvements were similar, or better, in patients who had baseline NT-proBNP 
      <1600 pg/ml, regardless of the cardiac resynchronization therapy indication 
      status. CONCLUSION: An IPD meta-analysis suggests that BAT improves exercise 
      capacity, NYHA class, and QoL in HFrEF patients receiving GDMT. These clinically 
      meaningful improvements were consistent across the range of patients studies. BAT 
      was also associated with an improvement in NT-proBNP in subjects with a lower 
      baseline NT-proBNP.
CI  - (c) 2022 The Authors. European Journal of Heart Failure published by John Wiley 
      & Sons Ltd on behalf of European Society of Cardiology.
FAU - Coats, Andrew J S
AU  - Coats AJS
AD  - University of Warwick, Coventry, UK.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, 
      USA.
FAU - Zile, Michael R
AU  - Zile MR
AD  - The Medical University of South Carolina and the RHJ Department of Veterans 
      Affairs Medical Center, Charleston, SC, USA.
FAU - Lindenfeld, Joann A
AU  - Lindenfeld JA
AD  - Vanderbilt Heart and Vascular Institute, Nashville, TN, 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 - Fudim, Marat
AU  - Fudim M
AD  - Duke University Medical Center, Durham, NC, USA.
AD  - Duke Clinical Research Institute, Durham, NC, USA.
FAU - Bauersachs, Johann
AU  - Bauersachs J
AD  - Department of Cardiology and Angiology, Hannover Medical School, Hannover, 
      Germany.
FAU - Duval, Sue
AU  - Duval S
AD  - Cardiovascular Division, University of Minnesota Medical School, Minneapolis, MN, 
      USA.
FAU - Galle, Elizabeth
AU  - Galle E
AD  - CVRx(R), Inc., Minneapolis, MN, USA.
FAU - Zannad, Faiez
AU  - Zannad F
AD  - Universite de Lorraine, Inserm Centre d'Investigation, CHU, Universite de 
      Lorraine, Nancy, France.
LA  - eng
GR  - K23 HL151744/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20220703
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (Peptide Fragments)
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
SB  - IM
CIN - Eur J Heart Fail. 2022 Sep;24(9):1674-1676. PMID: 35851979
MH  - Baroreflex/physiology
MH  - *Electric Stimulation Therapy/methods
MH  - *Heart Failure/diagnosis/therapy
MH  - Humans
MH  - Natriuretic Peptide, Brain
MH  - Peptide Fragments
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Stroke Volume/physiology
PMC - PMC9796660
OTO - NOTNLM
OT  - Autonomic nervous system
OT  - Baroreflex
OT  - Heart failure
OT  - Meta-analysis
OT  - Randomized controlled trials
EDAT- 2022/06/18 06:00
MHDA- 2022/10/12 06:00
PMCR- 2022/12/28
CRDT- 2022/06/17 11:25
PHST- 2022/06/04 00:00 [revised]
PHST- 2022/02/07 00:00 [received]
PHST- 2022/06/06 00:00 [accepted]
PHST- 2022/06/18 06:00 [pubmed]
PHST- 2022/10/12 06:00 [medline]
PHST- 2022/06/17 11:25 [entrez]
PHST- 2022/12/28 00:00 [pmc-release]
AID - EJHF2573 [pii]
AID - 10.1002/ejhf.2573 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2022 Sep;24(9):1665-1673. doi: 10.1002/ejhf.2573. Epub 2022 Jul 
      3.