PMID- 33992562
OWN - NLM
STAT- MEDLINE
DCOM- 20211028
LR  - 20220219
IS  - 2213-1787 (Electronic)
IS  - 2213-1779 (Print)
IS  - 2213-1779 (Linking)
VI  - 9
IP  - 6
DP  - 2021 Jun
TI  - Response by Sex in Patient-Centered Outcomes With Baroreflex Activation Therapy 
      in Systolic Heart Failure.
PG  - 430-438
LID - S2213-1779(21)00060-3 [pii]
LID - 10.1016/j.jchf.2021.01.012 [doi]
AB  - OBJECTIVES: The aim of this study was to assess sex differences in the efficacy 
      and safety of baroreflex activation therapy (BAT) in the BeAT-HF (Baroreflex 
      Activation Therapy for Heart Failure) trial. BACKGROUND: Patients were randomized 
      1:1 to receive guideline-directed medical therapy (GDMT) alone (control group) or 
      BAT plus GDMT. METHODS: Pre-specified subgroup analyses including change from 
      baseline to 6 months in 6-min walk distance (6MWD), quality of life (QoL) 
      assessed using the Minnesota Living With Heart Failure Questionnaire (MLWHQ), New 
      York Heart Association (NYHA) functional class, and N-terminal pro-B-type 
      natriuretic peptide (NT-proBNP) were conducted in men versus women. RESULTS: 
      Fifty-three women and 211 men were evaluated. Women had similar baseline 
      NT-proBNP levels, 6MWDs, and percentage of subjects with NYHA functional class 
      III symptoms but poorer MLWHQ scores (mean 62 +/- 22 vs. 50 +/- 24; p = 0.01) 
      compared with men. Women experienced significant improvement from baseline to 
      6 months with BAT plus GDMT relative to GDMT alone in MLWHQ score (-34 +/- 27 
      vs. -9 +/- 23, respectively; p < 0.01), 6MWD (44 +/- 45 m vs. -32 +/- 118 m; p < 0.01), 
      and improvement in NYHA functional class (70% vs. 27%; p < 0.01), similar to the 
      responses seen in men, with no significant difference in safety. Women receiving 
      BAT plus GDMT had a significant decrease in NT-proBNP (-43% vs. 7% with GDMT 
      alone; difference -48%; p < 0.01), while in men this decrease was -15% versus 2%, 
      respectively (difference -17%; p = 0.08), with an interaction p value of 0.05. 
      CONCLUSIONS: Women in BeAT-HF had poorer baseline QoL than men but demonstrated 
      similar improvements with BAT in 6MWD, QoL, and NYHA functional class. Women had 
      a significant improvement in NT-proBNP, whereas men did not. (Baroreflex 
      Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196).
CI  - Copyright (c) 2021. Published by Elsevier Inc.
FAU - Lindenfeld, JoAnn
AU  - Lindenfeld J
AD  - Division of Cardiology, Vanderbilt University Medical Center, Nashville, 
      Tennessee, USA. Electronic address: joann.lindenfeld@vumc.org.
FAU - Gupta, Richa
AU  - Gupta R
AD  - Division of Cardiology, Vanderbilt University Medical Center, Nashville, 
      Tennessee, USA.
FAU - Grazette, Luanda
AU  - Grazette L
AD  - Keck School of Medicine, University of Southern California, Los Angeles, 
      California, USA.
FAU - Ruddy, Jean Marie
AU  - Ruddy JM
AD  - Medical University of South Carolina, Charleston, South Carolina, USA.
FAU - Tsao, Lana
AU  - Tsao L
AD  - Saint Elizabeth's Medical Center, Boston, Massachusetts, USA.
FAU - Galle, Elizabeth
AU  - Galle E
AD  - CVRx, Minneapolis, Minnesota, USA.
FAU - Rogers, Tyson
AU  - Rogers T
AD  - NAMSA, Minneapolis, Minnesota, USA.
FAU - Sears, Samuel
AU  - Sears S
AD  - East Carolina State University, Greenville, North Carolina, USA.
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.
LA  - eng
SI  - ClinicalTrials.gov/NCT02627196
GR  - K08 HL143169/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210512
PL  - United States
TA  - JACC Heart Fail
JT  - JACC. Heart failure
JID - 101598241
RN  - 0 (Peptide Fragments)
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
SB  - IM
MH  - Baroreflex
MH  - *Electric Stimulation Therapy
MH  - Female
MH  - *Heart Failure/therapy
MH  - *Heart Failure, Systolic/therapy
MH  - Humans
MH  - Male
MH  - Natriuretic Peptide, Brain
MH  - Patient-Centered Care
MH  - Peptide Fragments
MH  - Quality of Life
MH  - Stroke Volume
PMC - PMC8852222
MID - NIHMS1774872
OTO - NOTNLM
OT  - baroreflex
OT  - congestive
OT  - heart failure
COIS- Funding Support and Author Disclosures This study was funded by CVRx. Drs. 
      Lindenfeld and Zannad have served as consultants to CVRx. Ms. Galle is an 
      employee of CVRx. Dr. Ruddy serves as a surgical proctor for CVRx. Mr. Rogers is 
      an employee of NAMSA; and serves as a consultant to CVRx. All other authors have 
      reported that they have no relationships relevant to the contents of this paper 
      to disclose.
EDAT- 2021/05/17 06:00
MHDA- 2021/10/29 06:00
PMCR- 2022/02/17
CRDT- 2021/05/16 20:33
PHST- 2020/11/02 00:00 [received]
PHST- 2021/01/04 00:00 [revised]
PHST- 2021/01/26 00:00 [accepted]
PHST- 2021/05/17 06:00 [pubmed]
PHST- 2021/10/29 06:00 [medline]
PHST- 2021/05/16 20:33 [entrez]
PHST- 2022/02/17 00:00 [pmc-release]
AID - S2213-1779(21)00060-3 [pii]
AID - 10.1016/j.jchf.2021.01.012 [doi]
PST - ppublish
SO  - JACC Heart Fail. 2021 Jun;9(6):430-438. doi: 10.1016/j.jchf.2021.01.012. Epub 
      2021 May 12.