PMID- 27099884
OWN - NLM
STAT- MEDLINE
DCOM- 20160421
LR  - 20191113
IS  - 2174-2030 (Electronic)
IS  - 0870-2551 (Linking)
VI  - 34
IP  - 12
DP  - 2015 Dec
TI  - Comment on "Baroreflex Activation Therapy for the Treatment of Heart Failure With 
      a Reduced Ejection Fraction".
PG  - 795-7
AB  - OBJECTIVES: The objective of this clinical trial was to assess the safety and 
      efficacy of carotid baroreflex activation therapy (BAT) in advanced heart failure 
      (HF). BACKGROUND: Increased sympathetic and decreased parasympathetic activity 
      contribute to HF symptoms and disease progression. 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.
FAU - Oliveira, Mario
AU  - Oliveira M
LA  - eng
PT  - Comment
PT  - Journal Article
PL  - Portugal
TA  - Rev Port Cardiol
JT  - Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de 
      Cardiologia = Portuguese journal of cardiology : an official journal of the 
      Portuguese Society of Cardiology
JID - 8710716
SB  - IM
CON - JACC Heart Fail. 2015 Jun;3(6):487-96. PMID: 25982108
MH  - *Baroreflex
MH  - Electric Stimulation Therapy/*methods
MH  - Female
MH  - Humans
MH  - Male
EDAT- 2016/04/22 06:00
MHDA- 2016/04/22 06:01
CRDT- 2016/04/22 06:00
PHST- 2016/04/22 06:00 [entrez]
PHST- 2016/04/22 06:00 [pubmed]
PHST- 2016/04/22 06:01 [medline]
AID - S0870-2551(15)00268-1 [pii]
AID - 10.1016/j.repce.2015.12.014 [doi]
PST - ppublish
SO  - Rev Port Cardiol. 2015 Dec;34(12):795-7. doi: 10.1016/j.repce.2015.12.014.