序贯混合消融与单独手术CryoMaze治疗心房颤动(SurHyb试验):多中心随机对照试验方案

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Alan Bulava, Ales Mokracek, Dan Wichterle, Petr Budera, Pavel Osmancik, Petr Kacer, Linda Veteskova, Petr Nemec, Tomas Skala, Petr Santavy, Jan Chovancik, Piotr Branny, Vitalii Rizov, Miroslav Kolesar, Marian Rybar
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引用次数: 0

摘要

背景:房颤在接受心脏手术的结构性心脏病患者中很常见。手术CryoMaze在几项试验中已被证明是一种有效的治疗方法,但成功率差异很大,在47-95%之间。序贯混合方法,结合手术CryoMaze和射频导管消融,可以实现房性心律失常的高度自由。然而,在合并手术治疗心房颤动的患者中,比较混合入路与单独CryoMaze的数据缺乏。方法:SurHyb研究设计为一项前瞻性、开放标签、多中心随机试验。计划行冠状动脉旁路移植术或瓣膜修复/置换术的非阵发性心房颤动患者被随机分为单独手术CryoMaze组或术后3个月手术CryoMaze联合射频导管消融组。主要结局指标是无心律失常生存期,不使用I类或III类抗心律失常药物,使用植入式心脏监护仪进行评估。结论:这是第一项随机研究,在严格的心律监测下,比较了非阵发性心房颤动患者单独联合手术CryoMaze与分阶段混合手术CryoMaze合并导管消融。该结果可能有助于优化房颤合并CryoMaze患者的治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Sequential hybrid ablation versus surgical CryoMaze alone for treatment of atrial fibrillation (SurHyb Trial): a protocol of the multicentre randomized controlled trial.

Background: Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between 47-95%. The sequential hybrid approach, combining surgical CryoMaze followed by radiofrequency catheter ablation, can achieve high freedom from atrial arrhythmias. However, in patients with concomitant surgical atrial fibrillation treatment, data comparing the hybrid approach to CryoMaze alone are lacking.

Methods: The SurHyb study was designed as a prospective, open-label, multicentre randomized trial. Patients with non-paroxysmal atrial fibrillation who were scheduled for coronary artery bypass grafting or valve repair/replacement were randomized to either surgical CryoMaze alone or surgical CryoMaze followed by radiofrequency catheter ablation 3 months post-surgery. The primary outcome measure was arrhythmia-free survival without class I or III antiarrhythmic drugs, which has been evaluated using implantable cardiac monitors.

Conclusions: This is the first randomized study that compares concomitant surgical CryoMaze alone with the staged hybrid surgical CryoMaze followed by catheter ablation, in patients with non-paroxysmal atrial fibrillation using rigorous rhythm monitoring. The results may contribute to the optimization of the treatment in patients undergoing concomitant CryoMaze for atrial fibrillation.

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来源期刊
Journal of applied biomedicine
Journal of applied biomedicine PHARMACOLOGY & PHARMACY-
CiteScore
2.40
自引率
7.70%
发文量
13
审稿时长
>12 weeks
期刊介绍: Journal of Applied Biomedicine promotes translation of basic biomedical research into clinical investigation, conversion of clinical evidence into practice in all medical fields, and publication of new ideas for conquering human health problems across disciplines. Providing a unique perspective, this international journal publishes peer-reviewed original papers and reviews offering a sensible transfer of basic research to applied clinical medicine. Journal of Applied Biomedicine covers the latest developments in various fields of biomedicine with special attention to cardiology and cardiovascular diseases, genetics, immunology, environmental health, toxicology, neurology and oncology as well as multidisciplinary studies. The views of experts on current advances in nanotechnology and molecular/cell biology will be also considered for publication as long as they have a direct clinical impact on human health. The journal does not accept basic science research or research without significant clinical implications. Manuscripts with innovative ideas and approaches that bridge different fields and show clear perspectives for clinical applications are considered with top priority.
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