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Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction

2016; Elsevier BV; Volume: 28; Issue: 2 Linguagem: Inglês

10.1053/j.semtcvs.2016.04.017

1532-9488

Fred A. Weaver, William T. Abraham, William C. Little, Christian Butter, Anique Ducharme, Marcel Halbach, Didier Klug, Eric G. Lovett, Navid Madershahian, Jochen Müller‐Ehmsen, Jill Schafer, Michele Senni, Vijay Swarup, Rolf Wachter, Michael R. Zile,

Cardiac Arrest and Resuscitation

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. 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. Central MessageBAT system implantation is safe with the therapeutic benefits in heart failure being substantial and maintained for at least 1 year. BAT system implantation is safe with the therapeutic benefits in heart failure being substantial and maintained for at least 1 year. Perspective StatementBAT system and implant techniques have evolved in a significantly positive direction from the first generation. With a pacemaker-like safety profile and therapeutic benefits in HFrEF sustained after 1 year, the necessary conditions are in place for an outcomes trial. A pivotal outcomes trial of BAT in HFrEF is expected to begin in 2016. BAT system and implant techniques have evolved in a significantly positive direction from the first generation. With a pacemaker-like safety profile and therapeutic benefits in HFrEF sustained after 1 year, the necessary conditions are in place for an outcomes trial. A pivotal outcomes trial of BAT in HFrEF is expected to begin in 2016. See Editorial Commentary pages 329-330. See Editorial Commentary pages 329-330.