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Temporary autonomic modulation with botulinum toxin type A to reduce atrial fibrillation after cardiac surgery.

Abstract：

BACKGROUND:Postoperative atrial fibrillation (POAF) frequently complicates cardiac surgery and is associated with worse outcomes. The cardiac autonomic nervous system is implicated in the pathogenesis of POAF. OBJECTIVE:The purpose of this study was to determine the efficacy and safety of selective cardiac autonomic modulation in preventing POAF. METHODS:In this randomized, double-blind, placebo-controlled trial, adults undergoing cardiac surgery were randomized 1:1 to intraoperative injection of 250 units onabotulinumtoxinA (botulinum toxin type A [BoNTA]) or placebo into epicardial fat pads. The study was powered to detect a 40% reduction in relative risk of POAF. Time to first episode of in-hospital POAF was the primary outcome, evaluated in patients receiving injection. Additionally, incidence of POAF, length of stay (LOS), and adverse events were examined. RESULTS:The trial assigned 145 patients to injection, 15 of whom were dropped before treatment, leaving 130 patients for analysis. Overall, 36.5% (23/63) of BoNTA-treated patients developed POAF compared with 47.8% (32/67) of placebo-treated patients. The time-to-event analysis revealed a hazard ratio of 0.69 (95% confidence interval 0.41-1.19; P = .18) for the BoNTA vs placebo arm. There were no significant differences in postoperative hospital LOS (median [interquartile range] 6.0 [3.4] vs 6.2 [3.7] days; P = .51) or adverse events prolonging LOS (27/63 [42.9%] vs 30/67 [44.8%]; P = .83) in patients receiving BoNTA vs placebo. CONCLUSION:Epicardial injection of onabotulinumtoxinA was without discernible adverse effects, but we failed to detect a significant difference in risk of POAF. Future large-scale studies of epicardial onabotulinumtoxinA injection as a potential POAF prevention strategy should be designed to study smaller, but clinically meaningful, treatment effects.

journal_name

Heart Rhythm

journal_title

Heart rhythm

authors

Waldron NH,Cooter M,Haney JC,Schroder JN,Gaca JG,Lin SS,Sigurdsson MI,Fudim M,Podgoreanu MV,Stafford-Smith M,Milano CA,Piccini JP,Mathew JP

doi

10.1016/j.hrthm.2018.08.021

subject

Has Abstract

pub_date

2019-02-01 00:00:00

pages

178-184

issue

eissn

1547-5271

issn

1556-3871

pii

S1547-5271(18)30822-1

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Temporary autonomic modulation with botulinum toxin type A to reduce atrial fibrillation after cardiac surgery.