title: Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction.
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.affiliation: 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.
authors.forename: Fred A
authors.initials: FA
authors.lastname: Weaver
authors.affiliation: Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.affiliation: Division of Cardiology, University of Mississippi Medical Center, Jackson, Mississippi.
authors.forename: William C
authors.initials: WC
authors.lastname: Little
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 Montréal, 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, 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 Cardiothoracic Surgery, Cologne University Heart Centre, Cologne, Germany.
authors.forename: Navid
authors.initials: N
authors.lastname: Madershahian
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, German Cardiovascular Research Center (DZHK), University Medicine Göttingen, Göttingen, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Wachter
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
mesh_terms: D017704:Baroreflex; D015415:Biomarkers / Q000097:blood; D002346:Carotid Sinus / Q000294:innervation*; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000295:instrumentation; D017079:Exercise Tolerance; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D058542:Implantable Neurostimulators; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D011183:Postoperative Complications / Q000209:etiology; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation; D011788:Quality of Life; D020127:Recovery of Function; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left
chemical_list: D015415:Biomarkers; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain
keywords: BAT; autonomic dysfunction; carotid sinus; heart failure