Departments of Community and Preventive Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Am J Cardiovasc Drugs. 2009;9(6):393-400. doi: 10.2165/11317980-000000000-00000.
While implantable cardioverter-defibrillators (ICDs) improve survival, their benefit in terms of health-related quality of life (HRQOL) is negligible. To examine how shocks and congestive heart failure (CHF) mediate the effect of ICDs on HRQOL. The US patients from the MADIT-II (Multicenter Automatic Defibrillator Trial-II) trial (n = 983) were randomized to receive an ICD or medical treatment only. HRQOL was assessed using the Health Utility Index 3 at baseline and 3, 12, 24, and 36 months following randomization. Logistic regressions were used to test for the effect of ICDs on the CHF indicator, and linear regressions were used to examine the effect of ICD shocks and CHF on HRQOL in living patients. We used a Monte Carlo simulation and a parametric Weibull distribution survival model to test for the effect of selective attrition. Observations were clustered by patients and robust standard errors (RSEs) were used to control for the non-independence of multiple observations provided by the same patient. Patients in the ICD arm had 41% higher odds of experiencing CHF since their last assessment compared with those in the control arm (RSE = 0.19, p = 0.01). Developing CHF reduced HRQOL at the subsequent visit by 0.07 (p < 0.01). Having ICD shocks reduced overall HRQOL by 0.04 (p = 0.04) at the subsequent assessment. The negative effect of ICD firing on HRQOL was an order of magnitude greater than the effect of CHF. A higher prevalence of CHF and shocks among patients with ICDs and their negative effect on HRQOL may partially explain the lack of HRQOL benefit of ICD therapy.
尽管植入式心脏复律除颤器（ICD）可提高生存率，但它们对健康相关生活质量（HRQOL）的益处可忽略不计。为了研究电击和充血性心力衰竭（CHF）如何调节 ICD 对 HRQOL 的影响。来自 MADIT-II（多中心自动除颤器试验-II）试验的美国患者（n = 983）被随机分配接受 ICD 或仅接受药物治疗。HRQOL 使用健康效用指数 3 在随机分组后 3、12、24 和 36 个月进行评估。使用逻辑回归检验 ICD 对 CHF 指标的影响，使用线性回归检验 ICD 电击和 CHF 对存活患者 HRQOL 的影响。我们使用蒙特卡罗模拟和参数 Weibull 分布生存模型检验选择性缺失的影响。观察结果按患者聚类，并使用稳健标准误差（RSE）控制来自同一患者的多个观察结果的非独立性。与对照组相比，ICD 组的患者自上次评估以来发生 CHF 的可能性高 41%（RSE = 0.19，p = 0.01）。发生 CHF 会使下一次就诊的 HRQOL 降低 0.07（p < 0.01）。在随后的评估中，ICD 电击降低了整体 HRQOL 0.04（p = 0.04）。ICD 放电对 HRQOL 的负面影响是心力衰竭的影响的一个数量级。ICD 患者中 CHF 和电击的发生率较高及其对 HRQOL 的负面影响可能部分解释了 ICD 治疗对 HRQOL 无益处的原因。
