Thijssen Joep, van den Akker van Marle M Elske, Borleffs C Jan Willem, van Rees Johannes B, de Bie Mihály K, van der Velde Enno T, van Erven Lieselot, Schalij Martin J
Department of Cardiology.
Pacing Clin Electrophysiol. 2014 Jan;37(1):25-34. doi: 10.1111/pace.12238. Epub 2013 Sep 2.
Although randomized trials have shown the beneficial effect on survival of an implantable cardioverter defibrillator (ICD) as primary prevention therapy in selected patients, data concerning the cost-effectiveness in routine clinical practice remain scarce. Accordingly, the purpose of this study was to assess the cost-effectiveness of primary prevention ICD implantation in the real world.
Patients receiving primary prevention single-chamber or dual-chamber ICD implantation at the Leiden University Medical Center were included in the study. Using a Markov model, lifetime cost, life years (LYs), and gained quality-adjusted life years (QALYs) were estimated for device recipients and control patients. Data on mortality, complication rates, and device longevity were retrieved from our center and entered into the Markov model. To account for model assumptions, one-way deterministic and probabilistic sensitivity analyses were performed. Importantly, calculations for the estimated incremental cost-effectiveness rate (ICER) per QALY gained are based on several numbers of assumptions, and accordingly findings may have over- or underestimated the cost-effectiveness of ICD therapy.
Primary prevention ICD implantation adds an estimated mean of 2.07 LYs and 1.73 QALYs. Increased lifetime cost for single-chamber and dual-chamber ICD recipients were estimated at €60,788 and €64,216, respectively. This resulted for single-chamber ICD recipients, in an estimated ICER of €35,154 per QALY gained. In dual-chamber ICD recipients, an estimated ICER of €37,111 per QALY gained was calculated. According to the probabilistic sensitivity analysis, estimated cost per QALY gained are €35,837 (95% confidence interval [CI]: €28,368-€44,460) for single-chamber and €37,756 (95% CI: €29,055-€46,050) for dual-chamber ICDs.
On the basis of data and detailed costs, derived from routine clinical practice, ICD therapy in selected patients with a reduced left ventricular ejection fraction appears to be cost-effective.
尽管随机试验已表明，植入式心脏复律除颤器（ICD）作为特定患者的一级预防治疗手段，对生存率有益，但关于其在常规临床实践中的成本效益数据仍然匮乏。因此，本研究旨在评估现实世界中一级预防ICD植入的成本效益。
纳入在莱顿大学医学中心接受一级预防单腔或双腔ICD植入的患者。使用马尔可夫模型，估计了器械接受者和对照患者的终身成本、生命年（LYs）以及获得的质量调整生命年（QALYs）。从我们中心获取了死亡率、并发症发生率和器械使用寿命的数据，并输入马尔可夫模型。为考虑模型假设，进行了单向确定性和概率敏感性分析。重要的是，每获得一个QALY的估计增量成本效益率（ICER）的计算基于若干假设，因此研究结果可能高估或低估了ICD治疗的成本效益。
一级预防ICD植入估计平均增加2.07个生命年和1.73个QALY。单腔和双腔ICD接受者的终身成本增加估计分别为60,788欧元和64,216欧元。这导致单腔ICD接受者每获得一个QALY的估计ICER为35,154欧元。在双腔ICD接受者中，计算出每获得一个QALY的估计ICER为37,111欧元。根据概率敏感性分析，单腔ICD每获得一个QALY的估计成本为35,837欧元（95%置信区间[CI]：28,368欧元 - 44,460欧元），双腔ICD为37,756欧元（95%CI：29,055欧元 - 46,050欧元）。
基于常规临床实践得出的数据和详细成本，对于左心室射血分数降低的特定患者，ICD治疗似乎具有成本效益。
