Dipartimento di Cardiologia, Fondazione IRCCS Policlinico San Matteo, P.le Golgi 2, 27100, Pavia, Italy.
Circulation. 2011 Jun 7;123(22):2526-35. doi: 10.1161/CIRCULATIONAHA.110.015024. Epub 2011 May 16.
Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome.
We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P=0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P=0.682).
In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01007474.
接受心脏再同步治疗除颤器（CRT-D）的患者的设备相关不良事件的长期数据缺乏。我们量化了当前临床实践中重复侵入性程序的频率和长期并发症的性质，并检查了设备相关事件的可能预测因素及其与长期患者预后的关系。
我们分析了 3253 名患者的数据，这些患者在意大利 117 个中心成功植入了新的 CRT-D，并进行了中位数为 18 个月（25%至 75%：9 至 30）的随访。416 名患者报告了设备相关事件，具体而言，390 名患者因系统修订而接受了手术干预。植入后 4 年，50%的患者因电池耗尽而接受手术修订，14%的患者因意外事件而接受手术修订。相比之下，在研究中心，4 年后，电池耗尽的单腔和双腔除颤器患者分别为 10%和 13%，意外事件分别为 4%和 9%。在 CRT-D 中，感染的发生率为 1.0%/年，且在更换设备后感染的风险增加（危险比，2.04；95%置信区间，1.01 至 4.09；P=0.045）。左心室导联脱位的发生率为 2.3%/年，与植入时较长的透视时间和较高的起搏阈值有关。设备相关事件与较差的临床结局无关；事实上，接受手术修订和未接受手术修订的患者的死亡风险相似（危险比，0.90；95%置信区间，0.56 至 1.47；P=0.682）。
在当前的临床实践中，CRT-D 中的设备相关事件比单腔或双腔除颤器更频繁，并且经常通过系统修订的手术干预来处理。然而，这些事件与更差的临床结局无关。
