Division of Cardiology The Children's Hospital of Philadelphia PA.
Department of Pediatrics The Perelman School of Medicine at The University of Pennsylvania Philadelphia PA.
J Am Heart Assoc. 2022 Aug 16;11(16):e024112. doi: 10.1161/JAHA.121.024112. Epub 2022 Aug 5.
Background Insertable cardiac monitors (ICMs) are effective in the detection of paroxysmal arrhythmias. In 2014, the first miniaturized ICM was introduced with a less invasive implant technique. The impact of this technology on ICM use in pediatric patients has not been evaluated. We hypothesized an increase in annual pediatric ICM implants starting in 2014 attributable to device miniaturization. Methods and Results A retrospective observational study was conducted using administrative claims from MarketScan Medicaid and commercial insurance claims databases. Use of ICM between January 2013 and December 2018 was measured (normalized to the total enrolled population ≤18 years) and compared with balancing measures (Holter ambulatory monitors, cardiac event monitors, encounters with syncope diagnosis, implantation of implantable cardioverter-defibrillator/pacemaker). Secondary analyses included evaluations of subsequent interventions and complications. The study cohort included 33 532 185 individual subjects, of which 769 (0.002%) underwent ICM implantation. Subjects who underwent ICM implantation were 52% male sex, with a median age of 16 years (interquartile range, 10-17 years). A history of syncope was present in 71%, palpitations in 43%, and congenital heart disease in 28%. Following release of the miniaturized ICM, use of ICMs increased from 5 procedures per million enrollees in 2013 to 11 per million between 2015 and 2018 (<0.001), while balancing measures remained static. Of 394 subjects with ≥1 year of follow-up after implantation, interventions included catheter ablation in 24 (6%), pacemaker implantation in 15 (4%), and implantable cardioverter-defibrillator implantation in 7 (2%). Conclusions Introduction of the miniaturized ICM was followed by a rapid increase in pediatric use. The effects on outcomes and value deserve further attention.
背景 可植入式心脏监测器(ICM)在检测阵发性心律失常方面非常有效。2014 年,推出了首款微创型 ICM,其植入技术的侵入性更小。但这项技术对儿科患者中 ICM 使用的影响尚未得到评估。我们假设,由于设备的小型化,2014 年开始,儿科患者每年的 ICM 植入量将会增加。
方法和结果 本研究使用 MarketScan Medicaid 和商业保险理赔数据库中的行政索赔数据进行了回顾性观察研究。测量了 2013 年 1 月至 2018 年 12 月期间 ICM 的使用情况(按 ≤18 岁的总登记人口进行标准化),并与平衡措施(动态心电图监测、事件监测、晕厥就诊、植入式心脏复律除颤器/起搏器)进行了比较。次要分析包括对后续干预和并发症的评估。研究队列包括 33532185 名个体,其中 769 人(0.002%)接受了 ICM 植入。接受 ICM 植入的患者中,52%为男性,中位年龄为 16 岁(四分位间距,10-17 岁)。71%的患者有晕厥史,43%的患者有心悸史,28%的患者有先天性心脏病史。微创型 ICM 推出后,2013 年每百万登记患者中 ICM 的使用量为 5 例,2015 年至 2018 年增至 11 例(<0.001),而平衡措施保持不变。在 394 名植入后随访至少 1 年的患者中,干预措施包括导管消融 24 例(6%)、起搏器植入 15 例(4%)、植入式心脏复律除颤器植入 7 例(2%)。
结论 微创型 ICM 的推出后,儿科患者的使用量迅速增加。其对结果和价值的影响值得进一步关注。