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Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction.
JACC Heart Fail. 2015 Jun; 3(6):487-496.JH

Abstract

OBJECTIVES

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+Show Affiliations

Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio. Electronic address: william.abraham@osumc.edu.Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina.Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, California.Department of Cardiology, Immanuel Heart Center Bernau - Medical School Brandenburg, Bernau, Germany.Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada.Department of Internal Medicine III, University Hospital of Cologne, Cologne, Germany.Department of Cardiology A, University Hospital, Lille, France.Department of Research, CVRx, Inc., Minneapolis, Minnesota.Department of Medicine, Asklepios Klinik Altona, Hamburg, Germany.Department of Statistics, NAMSA, Inc., Minneapolis, Minnesota.Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.Department of Electrophysiology, Arizona Heart Hospital, Phoenix, Arizona.Clinic for Cardiology and Pneumology, University Medicine Göttingen and German Cardiovascular Research Center, Göttingen, Germany.Division of Cardiology, University of Mississippi Medical Center, Jackson, Mississippi.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

25982108

Citation

Abraham, William T., et al. "Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction." JACC. Heart Failure, vol. 3, no. 6, 2015, pp. 487-496.
Abraham WT, Zile MR, Weaver FA, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015;3(6):487-496.
Abraham, W. T., Zile, M. R., Weaver, F. A., Butter, C., Ducharme, A., Halbach, M., Klug, D., Lovett, E. G., Müller-Ehmsen, J., Schafer, J. E., Senni, M., Swarup, V., Wachter, R., & Little, W. C. (2015). Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC. Heart Failure, 3(6), 487-496. https://doi.org/10.1016/j.jchf.2015.02.006
Abraham WT, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015;3(6):487-496. PubMed PMID: 25982108.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. AU - Abraham,William T, AU - Zile,Michael R, AU - Weaver,Fred A, AU - Butter,Christian, AU - Ducharme,Anique, AU - Halbach,Marcel, AU - Klug,Didier, AU - Lovett,Eric G, AU - Müller-Ehmsen,Jochen, AU - Schafer,Jill E, AU - Senni,Michele, AU - Swarup,Vijay, AU - Wachter,Rolf, AU - Little,William C, Y1 - 2015/05/14/ PY - 2015/02/06/received PY - 2015/02/24/revised PY - 2015/02/24/accepted PY - 2015/5/19/entrez PY - 2015/5/20/pubmed PY - 2016/4/9/medline KW - autonomic nervous system KW - baroreflex KW - device KW - heart failure KW - randomized controlled trial SP - 487 EP - 496 JF - JACC. Heart failure JO - JACC Heart Fail VL - 3 IS - 6 N2 - OBJECTIVES: 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). SN - 2213-1787 UR - https://www.unboundmedicine.com/medline/citation/25982108/Baroreflex_Activation_Therapy_for_the_Treatment_of_Heart_Failure_With_a_Reduced_Ejection_Fraction_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2213-1779(15)00125-0 DB - PRIME DP - Unbound Medicine ER -