title: Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction.
abstract: OBJECTIVE
  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).
authors.affiliation: Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. Electronic address: william.abraham@osumc.edu.
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zile
authors.affiliation: Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, California.
authors.forename: Fred A
authors.initials: FA
authors.lastname: Weaver
authors.affiliation: Department of Cardiology, Immanuel Heart Center Bernau - Medical School Brandenburg, Bernau, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.affiliation: Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada.
authors.forename: Anique
authors.initials: A
authors.lastname: Ducharme
authors.affiliation: Department of Internal Medicine III, University Hospital of Cologne, Cologne, Germany.
authors.forename: Marcel
authors.initials: M
authors.lastname: Halbach
authors.affiliation: Department of Cardiology A, University Hospital, Lille, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Klug
authors.affiliation: Department of Research, CVRx, Inc., Minneapolis, Minnesota.
authors.forename: Eric G
authors.initials: EG
authors.lastname: Lovett
authors.affiliation: Department of Medicine, Asklepios Klinik Altona, Hamburg, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Müller-Ehmsen
authors.affiliation: Department of Statistics, NAMSA, Inc., Minneapolis, Minnesota.
authors.forename: Jill E
authors.initials: JE
authors.lastname: Schafer
authors.affiliation: Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Senni
authors.affiliation: Department of Electrophysiology, Arizona Heart Hospital, Phoenix, Arizona.
authors.forename: Vijay
authors.initials: V
authors.lastname: Swarup
authors.affiliation: Clinic for Cardiology and Pneumology, University Medicine Göttingen and German Cardiovascular Research Center, Göttingen, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Wachter
authors.affiliation: Division of Cardiology, University of Mississippi Medical Center, Jackson, Mississippi.
authors.forename: William C
authors.initials: WC
authors.lastname: Little
mesh_terms: D000368:Aged; D017704:Baroreflex / Q000502:physiology; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006333:Heart Failure; D006801:Humans; D008297:Male; D008875:Middle Aged; D019919:Prosthesis Implantation / Q000379:methods; D013318:Stroke Volume / Q000502:physiology; D016896:Treatment Outcome
keywords: autonomic nervous system; baroreflex; device; heart failure; randomized controlled trial