Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Cardiol J. 2011;18(5):503-14. doi: 10.5603/cj.2011.0005.
Randomized clinical trials (RCTs) have demonstrated the efficacy of implantable cardioverter-defibrillators (ICDs) in reducing sudden cardiac death (SCD) in specific patient populations. However, patients ≥ 65 years were under-represented in these trials and the overall benefit of ICDs may be diminished in older patients due to competing risks for death. We evaluate the published data on ICD efficacy at reducing all-cause mortality in patients ≥ 65 years and in patients ≥ 75 years.
We searched MEDLINE to identify RCTs and observational studies of ICDs that provided age-based outcome data for primary prevention of SCD. The primary endpoint was mortality evaluated by a meta-analysis of the RCTs using a random-effects model. Secondary endpoints included operative mortality, long-term complications and quality of life.
The enrollment of patients ≥ 65 years in RCTs was limited (range: 33% in DEFINITE to 56% in MUSTT). Combining data from four RCTs (n = 3,562) revealed that primary prevention ICD therapy is efficacious in reducing all-cause mortality in patients ≥ 65 years (HR 0.66; 95% CI 0.50-0.87; test of heterogeneity: X(2) = 5.26; p = 0.15). For patients ≥ 75 years, combining data from four RCTs (n = 579) revealed that primary prevention ICD therapy remains efficacious in reducing all-cause mortality (HR 0.73; 95% CI 0.51-0.974; p = 0.03). There appears to be no difference in ICD-related, operative, in-hospital, or long- -term complications among older patients compared to younger patients, although it remains unclear if older patients have a better quality of life with an ICD than younger patients.
Although the overall evidence regarding ICD efficacy in patients ≥ 65 years is limited and divergent, and the evidence available for patients ≥ 75 years is even more sparse, our meta-analysis suggests that primary prevention ICDs may be beneficial in older patients. Our findings need to be validated by future studies, particularly ones examining ICD complications and quality of life.
随机临床试验（RCTs）已经证明了植入式心脏复律除颤器（ICD）在降低特定患者群体中心源性猝死（SCD）方面的有效性。然而，这些试验中年龄在 65 岁以上的患者代表性不足，由于死亡的竞争风险，ICD 的总体益处可能会降低老年患者。我们评估了关于 ICD 降低年龄在 65 岁以上和年龄在 75 岁以上的患者全因死亡率的有效性的已发表数据。
我们在 MEDLINE 上搜索了提供 ICD 用于 SCD 一级预防的年龄相关结果数据的 RCT 和观察性研究。主要终点是通过随机效应模型对 RCT 进行荟萃分析评估死亡率。次要终点包括手术死亡率、长期并发症和生活质量。
RCT 中年龄在 65 岁以上的患者的入组人数有限（范围：DE-FINIT 为 33%，MUSTT 为 56%）。将来自四项 RCT（n = 3562）的数据结合起来，发现初级预防 ICD 治疗对降低年龄在 65 岁以上的患者的全因死亡率有效（HR 0.66；95%CI 0.50-0.87；异质性检验：X(2) = 5.26；p = 0.15）。对于年龄在 75 岁以上的患者，将来自四项 RCT（n = 579）的数据结合起来，发现初级预防 ICD 治疗仍然可以降低全因死亡率（HR 0.73；95%CI 0.51-0.974；p = 0.03）。与年轻患者相比，老年患者的 ICD 相关、手术、住院和长期并发症似乎没有差异，尽管尚不清楚老年患者是否比年轻患者的生活质量更好。
尽管关于年龄在 65 岁以上患者的 ICD 有效性的总体证据有限且存在差异，并且关于年龄在 75 岁以上患者的证据更加缺乏，但我们的荟萃分析表明，初级预防 ICD 可能对老年患者有益。我们的发现需要通过未来的研究来验证，特别是那些检查 ICD 并发症和生活质量的研究。
