Tags

Type your tag names separated by a space and hit enter

Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction.
Semin Thorac Cardiovasc Surg. 2016 Summer; 28(2):320-328.ST

Abstract

The purpose of this publication is to describe the intraoperative experience along with long-term safety and efficacy of the second-generation baroreflex activation therapy (BAT) system in patients with heart failure (HF) and reduced ejection fraction HF (HFrEF). In a randomized trial of New York Heart Association Class III HFrEF, 140 patients were assigned 1:1 to receive BAT plus medical therapy or medical therapy alone. Procedural information along with safety and efficacy data were collected and analyzed over 12 months. Within the cohort of 71 patients randomized to BAT, implant procedure time decreased with experience, from 106 ± 37 minutes on the first case to 83 ± 32 minutes on the third case. The rate of freedom from system- and procedure-related complications was 86% through 12 months, with the percentage of days alive without a complication related to system, procedure, or underlying cardiovascular condition identical to the control group. The complications that did occur were generally mild and short-lived. Overall, 12 months therapeutic benefit from BAT was consistent with previously reported efficacy through 6 months: there was a significant and sustained beneficial treatment effect on New York Heart Association functional Class, quality of life, 6-minute hall walk distance, plasma N-terminal pro-brain natriuretic peptide, and systolic blood pressure. This was true for the full trial cohort and a predefined subset not receiving cardiac resynchronization therapy. There is a rapid learning curve for the specialized procedures entailed in a BAT system implant. BAT system implantation is safe with the therapeutic benefits of BAT in patients with HFrEF being substantial and maintained for at least 1 year.

Authors+Show Affiliations

Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: fred.weaver@med.usc.edu.Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.Division of Cardiology, University of Mississippi Medical Center, Jackson, Mississippi.Department of Cardiology, Immanuel Heart Center Bernau-Medical School, Brandenburg, Bernau, Germany.Montreal Heart Institute, University of Montréal, Montreal, Quebec, Canada.Department of Internal Medicine III, University Hospital of Cologne, Cologne, Germany.Department of Cardiology, University Hospital, Lille, France.Department of Research, CVRx, Inc, Minneapolis, Minnesota.Department of Cardiothoracic Surgery, Cologne University Heart Centre, Cologne, Germany.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, German Cardiovascular Research Center (DZHK), University Medicine Göttingen, Göttingen, Germany.Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28043438

Citation

Weaver, Fred A., et al. "Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction." Seminars in Thoracic and Cardiovascular Surgery, vol. 28, no. 2, 2016, pp. 320-328.
Weaver FA, Abraham WT, Little WC, et al. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016;28(2):320-328.
Weaver, F. A., Abraham, W. T., Little, W. C., Butter, C., Ducharme, A., Halbach, M., Klug, D., Lovett, E. G., Madershahian, N., Müller-Ehmsen, J., Schafer, J. E., Senni, M., Swarup, V., Wachter, R., & Zile, M. R. (2016). Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Seminars in Thoracic and Cardiovascular Surgery, 28(2), 320-328. https://doi.org/10.1053/j.semtcvs.2016.04.017
Weaver FA, et al. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016;28(2):320-328. PubMed PMID: 28043438.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. AU - Weaver,Fred A, AU - Abraham,William T, AU - Little,William C, AU - Butter,Christian, AU - Ducharme,Anique, AU - Halbach,Marcel, AU - Klug,Didier, AU - Lovett,Eric G, AU - Madershahian,Navid, AU - Müller-Ehmsen,Jochen, AU - Schafer,Jill E, AU - Senni,Michele, AU - Swarup,Vijay, AU - Wachter,Rolf, AU - Zile,Michael R, Y1 - 2016/06/02/ PY - 2016/04/18/accepted PY - 2017/1/4/entrez PY - 2017/1/4/pubmed PY - 2017/6/14/medline KW - BAT KW - autonomic dysfunction KW - carotid sinus KW - heart failure SP - 320 EP - 328 JF - Seminars in thoracic and cardiovascular surgery JO - Semin. Thorac. Cardiovasc. Surg. VL - 28 IS - 2 N2 - The purpose of this publication is to describe the intraoperative experience along with long-term safety and efficacy of the second-generation baroreflex activation therapy (BAT) system in patients with heart failure (HF) and reduced ejection fraction HF (HFrEF). In a randomized trial of New York Heart Association Class III HFrEF, 140 patients were assigned 1:1 to receive BAT plus medical therapy or medical therapy alone. Procedural information along with safety and efficacy data were collected and analyzed over 12 months. Within the cohort of 71 patients randomized to BAT, implant procedure time decreased with experience, from 106 ± 37 minutes on the first case to 83 ± 32 minutes on the third case. The rate of freedom from system- and procedure-related complications was 86% through 12 months, with the percentage of days alive without a complication related to system, procedure, or underlying cardiovascular condition identical to the control group. The complications that did occur were generally mild and short-lived. Overall, 12 months therapeutic benefit from BAT was consistent with previously reported efficacy through 6 months: there was a significant and sustained beneficial treatment effect on New York Heart Association functional Class, quality of life, 6-minute hall walk distance, plasma N-terminal pro-brain natriuretic peptide, and systolic blood pressure. This was true for the full trial cohort and a predefined subset not receiving cardiac resynchronization therapy. There is a rapid learning curve for the specialized procedures entailed in a BAT system implant. BAT system implantation is safe with the therapeutic benefits of BAT in patients with HFrEF being substantial and maintained for at least 1 year. SN - 1532-9488 UR - https://www.unboundmedicine.com/medline/citation/28043438/Surgical_Experience_and_Long_term_Results_of_Baroreflex_Activation_Therapy_for_Heart_Failure_With_Reduced_Ejection_Fraction_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1043-0679(16)30045-4 DB - PRIME DP - Unbound Medicine ER -