Background: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).Methods: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.Results: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 (R² = 0.85 and interclass correlation coefficient = 0.91 for serial [3] 14-day ECG monitors versus ICM).Conclusions: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.

中文翻译：

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监测策略对消融成功评估和消融后心房颤动负担评估的影响：对实践和临床试验设计的影响

背景：在评估心房颤动 (AF) 的药物和侵入性治疗干预的试验中，各种无创间歇性节律监测策略已被用于评估心律失常复发。我们确定是否可以确定无创心律监测的频率和持续时间，以准确检测心律失常复发，并近似使用植入式心脏监测器 (ICM) 持续监测产生的 AF 负担。方法：参加 CIRCA- 的 346 名患者的心律史重建了 DOSE 试验（冷冻球囊与接触力灌注射频导管消融术）。使用计算机模拟，我们评估了一系列无创监测策略的无事件生存率、敏感性、阴性预测值和 AF 负担，包括在当代 AF 消融试验中使用的那些。结果：分析中包括总共 126 290 个监测日。根据 ICM 的记录，在 12 个月时，164 名患者经历了房性心律失常复发（1 年无事件生存率，52.6%）。房颤消融试验中使用的大多数无创监测策略对检测心律失常复发的敏感性较差。灵敏度随着监测强度的增加而增加，连续 (3) 个短期监测器（24 小时/48 小时心电图监测器）错过了很大一部分复发（灵敏度，15.8% [95% CI，8.9%–20.7%] 和24.5% [95% CI, 16.2%–30.6%]）。系列 (3) 长期监测器（14 天心电图监测器）更接近黄金标准 ICM（灵敏度，64.6% [95% CI，53.6%–74.3%]）。来自短期监测的 AF 负担显着高估了复发患者的真实 AF 负担。增加监测持续时间可改善侵入性 AF 负担的无创估计值之间的相关性和一致性。R ² = 0.85 和组间相关系数 = 0.91 对于串行 [3] 14 天心电图监测与 ICM）。结论：观察到的消融后房性快速心律失常复发率高度依赖于所采用的心律失常监测策略。结果的试验间差异可能反映了不同的监测方案。根据一致性测量，连续长期（7-14 天）间歇监测累积至少 28 天的年度监测提供与 ICM 相当的 AF 负担估计值。然而，ICM 在心律失常检测方面优于间歇监测，应被视为临床试验的黄金标准。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT01913522。