Section of Cardiac Electrophysiology, Department of Cardiology, University of Colorado, Aurora, Colorado.
Section of Cardiac Electrophysiology, Department of Cardiology, University of Colorado, Aurora, Colorado; University of Colorado Denver, VA Eastern Colorado Health Care System, Denver, Colorado; Colorado Cardiovascular Outcomes Research (CCOR) Group, Denver, Colorado.
Am J Cardiol. 2014 Aug 1;114(3):419-26. doi: 10.1016/j.amjcard.2014.05.010. Epub 2014 May 16.
Repeat implantable cardioverter defibrillator (ICD) procedures are increasing and may be associated with higher risks for complications. To provide more information for clinical decision making, especially in light of recent defibrillator advisories, we examined a large national cohort to characterize repeat ICD procedural outcomes. Using data from the National Cardiovascular Data Registry (ICD Registry), we compared patient characteristics, reasons for ICD implantation, and associated in-hospital adverse events among 92,751 patients receiving their first device and 81,748 patients who underwent repeat procedures with (n = 31,057) and without (n = 50,691) lead involvement. Hierarchical multivariable logistic regression was used to determine the predictors of in-hospital complications. Complication rates were higher in those who underwent repeat ICD procedures with lead involvement (lead implantation or revision), compared with patients who underwent initial implants (3.2% vs 2.6%, p <0.001) or versus those with pocket-only (e.g., generator change only) procedures (3.2% vs 0.6%, p <0.001). There were significantly more in-hospital deaths, lead dislodgements, and infections requiring antibiotics in the lead involvement cohort. Compared with those who had a pocket-only procedure, the multivariable adjusted odds ratio of any complication were increased at 4.20 (95% confidence interval: 3.66 to 4.82, p <0.001) in patients who underwent repeat procedures with lead involvement excluding lead extraction or 7.11 (95% confidence interval: 5.96 to 8.48, p <0.001) in procedures involving lead extractions. In conclusion, repeat ICD procedures, when involving the addition or revision of a lead with or without concurrent lead extraction, are associated with higher complication rates compared with initial implants and with those who underwent pocket-only procedures.
重复植入式心律转复除颤器(ICD)程序正在增加,并且可能与更高的并发症风险相关。为了为临床决策提供更多信息,特别是鉴于最近的除颤器咨询意见,我们检查了一个大型全国队列,以描述重复 ICD 程序的结果。使用来自全国心血管数据注册(ICD 注册)的数据,我们比较了首次接受设备的 92751 名患者和重复程序的 81748 名患者(n=31057 例伴导线植入或修订,n=50691 例无导线植入或修订)的患者特征、ICD 植入原因和相关院内不良事件。使用分层多变量逻辑回归确定院内并发症的预测因素。与初次植入患者(2.6%,p<0.001)或仅进行囊袋手术(例如仅更换发生器)患者(0.6%,p<0.001)相比,进行重复 ICD 手术伴导线植入或修订的患者(导线植入或修订)的并发症发生率更高(3.2%,p<0.001)。在伴有导线植入或修订的患者中,院内死亡率、导线脱位和需要抗生素治疗的感染明显更高。与仅进行囊袋手术的患者相比,在不包括导线拔除的重复伴有导线植入或修订的手术中,任何并发症的多变量校正比值比增加了 4.20(95%置信区间:3.66 至 4.82,p<0.001),在伴有导线拔除的手术中增加了 7.11(95%置信区间:5.96 至 8.48,p<0.001)。总之,与初次植入和仅进行囊袋手术的患者相比,重复 ICD 手术(伴有或不伴有导线同时拔除)时,由于导线的添加或修订,并发症发生率更高。