Department of Cardiology, Herlev-Gentofte University Hospitals, Kildegaardsvej 28,2900 Hellerup, Denmark.
Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen, Denmark.
Europace. 2019 Aug 1;21(8):1211-1219. doi: 10.1093/europace/euz121.
The safety of omitting implantable cardioverter-defibrillator (ICD) generator replacement in patients with no prior appropriate therapy, comorbid conditions, and advanced age is unclear. The aim was to investigate incidence of appropriate ICD therapy after generator replacement.
We identified patients implanted with a primary prevention ICD (n = 4630) from 2007 to 2016, who subsequently underwent an elective ICD generator replacement (n = 670) from the Danish Pacemaker and ICD Register. The data were linked to other databases and evaluated the outcomes of appropriate therapy and death. Predictors of ICD therapy were identified using multivariate Cox regression analyses. A total of 670 patients underwent elective ICD generator replacement. Of these, 197 (29.4%) patients had experienced appropriate therapy in their 1st generator period. During follow-up of 2.0 ± 1.6 years, 95 (14.2%) patients experienced appropriate therapy. Predictors of appropriate therapy in 2nd generator period was low initial left ventricular ejection fraction (≤25%) [hazard ratio (HR) 1.87, confidence interval (CI) 1.13-1.95] and appropriate therapy in 1st generator period (HR 3.95, CI 2.57-6.06). For patients with appropriate therapy in 1st generator period, 4-year incidence of appropriate therapy was 50.6% vs. 16.4% in those without (P < 0.001). Among patients >80 years with no prior appropriate therapy 8.8% of patients experienced appropriate therapy after replacement. Comorbidity burden and advanced age were associated with reduced device utilization after replacement and a high competing risk of death without preceding appropriate therapy.
A significant residual risk of appropriate therapy in the 2nd generator was present even among patients with advanced age and with a full prior generator period without any appropriate ICD events.
对于既往无适当治疗、合并症和高龄的患者，省略植入式心脏复律除颤器（ICD）除颤器更换是否安全尚不清楚。本研究旨在探讨更换除颤器后 ICD 适当治疗的发生率。
我们从丹麦起搏器和 ICD 登记处确定了 2007 年至 2016 年植入原发性预防 ICD（n=4630）的患者，随后对其中 670 例进行了选择性 ICD 除颤器更换（n=670）。这些数据与其他数据库相关联，并评估了适当治疗和死亡的结果。使用多变量 Cox 回归分析确定 ICD 治疗的预测因素。共有 670 例患者接受了选择性 ICD 除颤器更换。其中，197 例（29.4%）患者在首次除颤器治疗期间经历了适当治疗。在 2.0±1.6 年的随访期间，95 例（14.2%）患者经历了适当治疗。在第二次除颤器治疗期间，适当治疗的预测因素为初始左心室射血分数较低（≤25%）[危险比（HR）1.87，置信区间（CI）1.13-1.95]和首次除颤器治疗期间发生适当治疗（HR 3.95，CI 2.57-6.06）。在首次除颤器治疗期间发生适当治疗的患者中，4 年时适当治疗的发生率为 50.6%，而未发生适当治疗的患者为 16.4%（P<0.001）。在既往无适当治疗且年龄>80 岁的患者中，更换后有 8.8%的患者经历了适当治疗。合并症负担和高龄与更换后设备使用率降低相关，且在无先前适当治疗的情况下，死亡的竞争风险较高。
即使在高龄患者和既往无任何适当 ICD 事件的完整除颤器治疗期间，更换除颤器后也存在明显的适当治疗残留风险。
