Objective: To investigate the accuracy of arrhythmia detection algorithm and the effectiveness of Reveal LINQ insertable cardiac monitor (ICM). Methods: This single-center, descriptive, non-controlled clinical study was designed to enroll consecutive patients who were implanted with Reveal LINQ ICM in Minneapolis Veterans Affairs Medical Center from June 19, 2014 to April 18, 2017. The safety of implant procedure, the accuracy of automatic arrhythmia detection algorithm and the clinical effectiveness were evaluated and validated independently by two physicians. Results: Sixty patients with average age of (65±13) years (30-89 years) were enrolled and the follow-up duration was 466 days (30-1 072 days). Of these, 57 patients are male. The indications of ICM implantation were unexplained syncope in 35 cases, cryptogenic stroke in 13 cases, atrial fibrillation (AF) management in 5 cases, and palpitations in 7 cases. The implantation procedure was safe and successful in all patients without complications. The detection accuracy of arrhythmia algorithm was 86% (620/723), 82% (2 369/2 876), and 30% (411/1 380) for tachycardia, bradycardia, and pause events, respectively. The detection accuracy of arrhythmia algorithm for AF was 17% (5/30), 60% (1 569/2 632) and 69% (172/251) for cryptogenic stroke, unexplained syncope, and AF management, respectively. Important clinical findings were observed in 15% (9/60) patients. Only 5% (3/60) patients had important findings based on the intended clinical indications. Conclusion: The Reveal LINQ ICM is a safe, simple, and effective procedure for the detection of tachycardia and bradycardia events. However, the automatic AF and pause events detection algorithm had high false positive rate which requires further improvement.
目的： 探讨新一代插入式心电监测器Reveal LINQ的心律失常算法识别准确性和植入患者的临床有效性。 方法： 单中心、前瞻性、非对照临床研究设计，连续入选自2014年6月19日至2017年4月18日在美国明尼苏达大学退役军人中心医院植入插入式心电监测器Reveal LINQ的患者，评价植入该心电监测器的安全性（手术成功率和出血、感染及其他并发症的发生率）、心律失常事件报告率、心律失常识别算法准确性和植入患者的临床获益。临床获益的评价结果包括：有基于植入目的发现并改变临床治疗以及没有基于植入目的发现但有其他重要意义的发现并改变了临床治疗。植入适应证分别为：不明原因晕厥35例、不明原因卒中13例、心房颤动（房颤）管理5例及心悸7例。 结果： 共入选60例患者，男性57例，女性3例，年龄30~89（65±13）岁，患者中位随访时间466（30，1 072）d。全部患者临床植入操作安全，未发生并发症。心动过速事件和心动过缓事件算法识别准确率分别为86%（620/723）和82%（2 369/2 876）；心脏停搏事件算法识别准确准确率为30%（411/1 380）；在不明原因卒中、晕厥和房颤管理患者房颤算法识别的准确率分别为17%（5/30）、60%（1 569/2 632）和69%（172/251）。15%（9/60）植入患者获得了有临床意义的发现并改变了临床治疗，其中5%（3/60）的患者获得了基于植入目的发现。 结论： 新一代插入式心电监测器Reveal LINQ临床植入操作安全、简便、有效，心动过速和心动过缓算法识别准确率较高，心脏停搏和房颤的算法识别准确率尚有待提高。.
Keywords: Arrhythmia; Atrial fibrillation; Insertable cardiac monitor; Stroke; Syncope.