Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Canada (M.A., L.M., P.K., J.G.A.).
Department of Medicine, University of British Columbia, Vancouver, Canada (M.W.D., R.Y., N.H., J.G.A.).
Circulation. 2022 Jan 4;145(1):21-30. doi: 10.1161/CIRCULATIONAHA.121.056109. Epub 2021 Nov 24.
Various noninvasive intermittent rhythm monitoring strategies have been used to assess arrhythmia recurrences in trials evaluating pharmacological and invasive therapeutic interventions for atrial fibrillation (AF). We determined whether a frequency and duration of noninvasive rhythm monitoring could be identified that accurately detects arrhythmia recurrences and approximates the AF burden derived from continuous monitoring using an implantable cardiac monitor (ICM).
The rhythm history of 346 patients enrolled in the CIRCA-DOSE trial (Cryoballoon Versus Contact-Force Irrigated Radiofrequency Catheter Ablation) was reconstructed. Using computer simulations, we evaluated event-free survival, sensitivity, negative predictive value, and AF burden of a range of noninvasive monitoring strategies, including those used in contemporary AF ablation trials.
A total of 126 290 monitoring days were included in the analysis. At 12 months, 164 patients experienced atrial arrhythmia recurrence as documented by the ICM (1-year event-free survival, 52.6%). Most noninvasive monitoring strategies used in AF ablation trials had poor sensitivity for detecting arrhythmia recurrence. Sensitivity increased with the intensity of monitoring, with serial (3) short-duration monitors (24-/48-hour ECG monitors) missing a substantial proportion of recurrences (sensitivity, 15.8% [95% CI, 8.9%-20.7%] and 24.5% [95% CI, 16.2%-30.6%], respectively). Serial (3) longer-term monitors (14-day ECG monitors) more closely approximated the gold standard ICM (sensitivity, 64.6% [95% CI, 53.6%-74.3%]). AF burden derived from short-duration monitors significantly overestimated the true AF burden in patients with recurrences. Increasing monitoring duration resulted in improved correlation and concordance between noninvasive estimates of the invasive AF burden ( = 0.85 and interclass correlation coefficient = 0.91 for serial [3] 14-day ECG monitors versus ICM).
The observed rate of postablation atrial tachyarrhythmia recurrence is highly dependent on the arrhythmia monitoring strategy employed. Between-trial discrepancies in outcomes may reflect different monitoring protocols. On the basis of measures of agreement, serial long-term (7-14 day) intermittent monitors accumulating at least 28 days of annual monitoring provide estimates of AF burden comparable with ICM. However, ICMs outperform intermittent monitoring for arrhythmia detection, and should be considered the gold standard for clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01913522.
在评估药物和介入治疗房颤（AF）的临床试验中，已经使用了各种非侵入性间歇节律监测策略来评估心律失常复发。我们确定是否可以确定一种非侵入性节律监测的频率和持续时间，该监测可以准确检测心律失常复发，并近似于使用植入式心脏监测器（ICM）获得的 AF 负担。
重建了参加 CIRCA-DOSE 试验（冷冻球囊与接触力灌流射频导管消融）的 346 名患者的节律史。通过计算机模拟，我们评估了一系列非侵入性监测策略的无事件生存、敏感性、阴性预测值和 AF 负担，包括当代 AF 消融试验中使用的监测策略。
共纳入 126290 天的监测数据进行分析。在 12 个月时，164 名患者出现了 ICM 记录的房性心律失常复发（1 年无事件生存率为 52.6%）。AF 消融试验中使用的大多数非侵入性监测策略检测心律失常复发的敏感性均较差。随着监测强度的增加，敏感性增加，连续（3）个短持续时间监测器（24/48 小时心电图监测器）遗漏了很大一部分复发（敏感性分别为 15.8%[95%CI，8.9%-20.7%]和 24.5%[95%CI，16.2%-30.6%]）。连续（3）个较长时间的监测器（14 天心电图监测器）更接近金标准 ICM（敏感性为 64.6%[95%CI，53.6%-74.3%]）。来自短持续时间监测器的 AF 负担显著高估了有复发患者的真实 AF 负担。增加监测持续时间可改善非侵入性估计与侵入性 AF 负担之间的相关性和一致性（连续[3]14 天 ECG 监测器与 ICM 之间的 = 0.85 和组内相关系数 = 0.91）。
术后房性快速性心律失常复发的观察发生率高度依赖于所使用的心律失常监测策略。试验之间的结果差异可能反映了不同的监测方案。基于一致性衡量标准，累积至少 28 天年度监测的连续长期（7-14 天）间歇性监测器提供的 AF 负担估计与 ICM 相当。然而，ICM 在心律失常检测方面优于间歇性监测，应被视为临床试验的金标准。
