Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada; Toronto General Hospital, Toronto, Ontario, Canada.
J Am Coll Cardiol. 2010 Feb 23;55(8):774-82. doi: 10.1016/j.jacc.2009.11.029.
This study examined the predictors of early complications after defibrillator implantation.
Although implantable cardioverter-defibrillators are widely used, predictors of procedural complications and the consequences of these events have not been determined.
In a prospective, multicenter, population-based clinical outcomes registry of all newly implanted defibrillator patients at 18 centers in Ontario, Canada, we examined 45-day complications and all-cause mortality from February 2007 to May 2009. Complications were determined longitudinally and were categorized as direct implant-related or indirect events.
Among 3,340 patients (mean age 63.8 +/- 12.5 years, 78.5% men), major complications occurred in 4.1% of de novo procedures. Compared with those undergoing a single-chamber device, implantation of a cardiac resynchronization defibrillator (adjusted hazard ratio [HR]: 2.17, 95% confidence interval [CI]: 1.38 to 3.43, p < 0.001) or dual-chamber device (adjusted HR: 1.82, 95% CI: 1.19 to 2.79, p = 0.006) was associated with increased risk of major complications. Major complications were increased in women (adjusted HR: 1.49, 95% CI: 1.02 to 2.16, p = 0.037) and when left ventricular end-systolic dimension exceeded 45 mm (adjusted HR: 1.54, 95% CI: 1.08 to 2.20, p = 0.018). Major complications (excluding death) occurring early after defibrillator implantation were associated with increased adjusted risk of subsequent death up to 180 days after defibrillator implant (adjusted HR: 3.70, 95% CI: 1.64 to 8.33, p = 0.002). Direct implant-related complications were associated with increased risk of early death (adjusted HR: 24.89, p = 0.01), whereas indirect clinical complications conferred increased risk of near-term death (adjusted HR: 12.35, p < 0.001) after defibrillator implantation.
Complications after de novo defibrillator implantation were strongly associated with device type. Major complications were associated with increased risk of mortality.
本研究旨在探讨除颤器植入术后早期并发症的预测因素。
尽管植入式心脏复律除颤器（ICD）的应用已较为广泛，但目前仍未明确预测程序并发症的因素以及这些事件的后果。
在加拿大安大略省 18 个中心的一项前瞻性、多中心、基于人群的所有新植入 ICD 患者临床结局注册研究中，我们在 2007 年 2 月至 2009 年 5 月期间对 45 天内的并发症和全因死亡率进行了检测。并发症是通过纵向检测确定的，并分为直接与植入相关的并发症和间接并发症。
在 3340 例患者（平均年龄 63.8±12.5 岁，78.5%为男性）中，4.1%的患者在初次手术中出现了主要并发症。与植入单腔装置的患者相比，植入心脏再同步除颤器（校正后的危险比 [HR]：2.17，95%置信区间 [CI]：1.38 至 3.43，p＜0.001）或双腔装置（校正后的 HR：1.82，95%CI：1.19 至 2.79，p=0.006）与主要并发症风险增加相关。女性（校正后的 HR：1.49，95%CI：1.02 至 2.16，p=0.037）和左心室收缩末期直径＞45mm（校正后的 HR：1.54，95%CI：1.08 至 2.20，p=0.018）的患者主要并发症风险增加。除颤器植入后早期发生的主要并发症（不包括死亡）与植入除颤器后 180 天内死亡的校正后风险增加相关（校正后的 HR：3.70，95%CI：1.64 至 8.33，p=0.002）。与直接与植入相关的并发症相比，间接临床并发症与早期死亡风险增加相关（校正后的 HR：24.89，p=0.01），而与近期死亡风险增加相关（校正后的 HR：12.35，p＜0.001）。
初次植入除颤器后的并发症与装置类型密切相关。主要并发症与死亡率增加相关。
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