BioMonitor 2植入式心脏监测仪：新型植入式心脏监测仪的临床经验
The BioMonitor 2 insertable cardiac monitor: Clinical experience with a novel implantable cardiac monitor.
作者信息
Reinsch Nico, Ruprecht Ute, Buchholz Jochen, Diehl Rolf R, Kälsch Hagen, Neven Kars
机构信息
Department of Electrophysiology, Alfried Krupp Krankenhaus, Essen, Germany; Witten/Herdecke University, Witten, Germany.
Department of Electrophysiology, Alfried Krupp Krankenhaus, Essen, Germany; Department of Cardiology, Evangelisches Krankenhaus Werden, Essen, Germany; Witten/Herdecke University, Witten, Germany.
出版信息
J Electrocardiol. 2018 Sep-Oct;51(5):751-755. doi: 10.1016/j.jelectrocard.2018.05.017. Epub 2018 May 29.
INTRODUCTION
Implantable loop recorders (ILR) are leadless subcutaneous devices that allow cardiac monitoring for up to 3 years and are a valuable tool in the diagnosis of arrhythmias, cryptogenic stroke and unexplained syncope. The Biotronik BioMonitor 2 is a novel, insertable ILR allowing long-term continuous monitoring with wireless telemetry options.
METHODS
A single-center, prospective, observational study investigating the reliability of sensing quality and detection performance in the BioMonitor 2 ILR, as well as post-implantation patient satisfaction. R-wave amplitude was recorded immediately post implantation and 1 day post implantation, followed by extensive patient instruction. Follow-up was scheduled after 3 months, or after an event. Data from the ILR were retrieved, with documentation of all episodes, R-wave amplitude and noise burden. The anatomical position of the ILR was determined 1 day post implantation and after 3 months. A patient questionnaire was conducted after 3 months.
RESULTS
30 consecutive patients (mean age 71 ± 12 years, 56% male) were analyzed. Indications for ILR implantation were: unexplained syncope (n = 24, 80%), suspected atrial fibrillation (n = 4, 13%), cryptogenic stroke (n = 1, 3%) and palpitations (n = 1, 3%). Median time from skin cut to suture was 8 min. No complications occurred. Mean R-wave amplitude at implantation was 0.84 ± 0.32 mV, at day 1 post implantation 0.96 ± 0.31 mV, and after a mean follow-up of 85 ± 24 days 1.02 ± 0.47 mV (p = 0.01). The mean noise burden was 1.4 ± 2%.
CONCLUSION
Implantation of the novel BioMonitor 2 ILR is fast and uncomplicated. Initial sensing values are good and improve over time.
引言
植入式循环记录仪（ILR）是一种无导线皮下装置，可进行长达3年的心脏监测，是诊断心律失常、隐匿性卒中及不明原因晕厥的重要工具。百多力BioMonitor 2是一款新型可插入式ILR，具备无线遥测功能，可实现长期连续监测。
方法
一项单中心、前瞻性观察性研究，旨在调查BioMonitor 2 ILR的感知质量和检测性能的可靠性，以及植入后患者的满意度。在植入后即刻和植入后1天记录R波振幅，随后对患者进行全面指导。随访安排在3个月后或事件发生后。检索ILR的数据，记录所有发作情况、R波振幅和噪声负荷。在植入后1天和3个月确定ILR的解剖位置。3个月后进行患者问卷调查。
结果
对30例连续患者（平均年龄71±12岁，56%为男性）进行了分析。植入ILR的适应证为：不明原因晕厥（n = 24，80%）、疑似心房颤动（n = 4，13%）、隐匿性卒中（n = 1，3%）和心悸（n = 1，3%）。从皮肤切开到缝合的中位时间为8分钟。未发生并发症。植入时平均R波振幅为0.84±0.32 mV，植入后1天为0.96±0.31 mV，平均随访85±24天后为1.02±0.47 mV（p = 0.01）。平均噪声负荷为1.4±2%。
结论
新型BioMonitor 2 ILR的植入快速且简单。初始感知值良好，且随时间推移有所改善。
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