Characterization of Post Coronary Artery Bypass Grafting Atrial Fibrillation Patterns (CABG-AF):A Feasibility Study

根据目前的文献，冠状动脉旁路移植术（CABG）后早期心房颤动（AF）的发生率约为29%。由于使用间歇性节律检测方法（Holter），调查这一问题的研究未能提供有效的数据。以前的研究表明，使用这种方法无法检测到高达48%的房颤复发。因此，我们假设在这一患者群体中，房颤的发生率被严重低估。在CABG-AF研究中，我们的目标是使用连续节律监测策略确定CABG后前6个月的“真实”AF发生率（敏感度为> 96%）。CABG结束时植入可插入式心脏监护仪，连续收集数据6个月。收集的数据将提供关于主要终点的见解：房颤发生率，以及其他次要终点，如房颤负担和密度。完整的CABG-AF研究将包括总共320例患者，并对这些患者进行长达3年的随访；目前的提案旨在为一项涉及25名患者、为期6个月的数据收集的试点研究获得资金。试点研究将用一年时间完成，其目标是证明方法的可行性，提供初步结果和发展研究基础设施。在CABG- af试验结束时，我们期望提供影响CABG后心律管理指南的结果。

According to current literature the incidence of atrial fibrillation (AF) in the early phase after coronary artery bypass graft surgery (CABG) lies at ~ 29 %. Studies which have investigated this issue fail to provide valid data due to the use of intermittent rhythm detection methods (Holter). It has previously been shown that up to 48 % of AF recurrence is not detected using such methods. We thus hypothesize that the incidence of AF is severely underestimated in this patient population. In the CABG-AF study we aim to determine the “true” AF incidence in the first 6 months after CABG using a continuous rhythm monitoring strategy (sensitivity of >96 %). Insertable Cardiac Monitors will be implanted at the end of CABG and data will be collected continuously for 6 months. The data collected will provide insights on the primary endpoint: incidence of AF, as well as further secondary endpoints such as AF burden and density. The complete CABG-AF study will include a total of 320 patients and follow these patients for up to 3 years; the current proposal aims to secure funding for a pilot study involving 25 patients with 6 months of data collection. The pilot study will take 1 year until completion and has the goal of demonstrating the feasibility of the methodology, providing preliminary results and developing study infrastructure. At the end of the CABG-AF trial we expect to provide results which will influence guidelines on rhythm management after CABG.