背景:LUX-Dx™是自2022年10月以来引入欧洲市场的新型可插入心脏监护仪(ICM)。
目的:本研究的目的是全面描述ICM在欧洲商业使用初期的植入经验。
方法:该系统包括切口工具和预加载有小ICM的单件式插入工具。植入手术包括切口,创建一个设备口袋,插入ICM,传感验证,和切口闭合。患者会收到带有预装App的移动设备,连接到他们的ICM并将数据传输到管理系统。在植入时和患者出院前分析在欧洲中心收集的数据。
结果:在23个中心共进行了368次植入手术。晕厥(235,64%)和隐源性中风(34,9%)是ICM最常见的适应症。大多数程序(338,92%)在电生理实验室进行。所有ICM均成功植入左胸骨旁区域,323名(88%)患者朝向45°。在对9例(2%)患者进行感知验证后,需要重新定位。未报告手术并发症,从皮肤切口到缝合的中位时间为4分钟(第25-75百分位数2-7)。在植入时,平均R波振幅为0.39±0.30mV,P波能见度为91±20%.传感参数保持稳定,直到出院前,并且不受患者特征或适应症的影响。程序时间很快,在患者组中表现出一致性,并在初步使用该系统后进行了改进。操作员对系统的反馈是积极的。患者报告说,使用App非常方便,植入后的不适程度很低。
结论:LUX-Dx™植入看起来既有效又简单,具有良好的植入后感知值,并与操作员和患者的积极反馈相关。
BACKGROUND: The LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022.
OBJECTIVE: The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use.
METHODS: The system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge.
RESULTS: A total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4 min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30 mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation.
CONCLUSIONS: LUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients.