Cleveland Clinic, Cleveland, OH, USA.
Ann Cardiothorac Surg. 2012 Jul;1(2):145-55. doi: 10.3978/j.issn.2225-319X.2012.06.12.
The incremental cost-effectiveness of transapical transcatheter aortic valve implantation (TAVI) is ill-defined in high-risk patients where aortic valve replacement (AVR) is an option, and has not been ascertained outside a randomized controlled trial.
We developed a Markov model to examine the progression of patients between health states, defined as peri- and post-procedural, post-complication, and death. The mean and variance of risks, transition probabilities, utilities and cost of transapical TAVI, high-risk AVR, and medical management were derived from analysis of relevant registries. Outcome and cost were derived from 10,000 simulations. Sensitivity analyses further evaluated the impact of mortality, stroke, and other commonly observed outcomes.
In the reference case, both transapical TAVI and high-risk AVR and TAVI were cost-effective when compared to medical management ($44,384/QALY and $42,637/QALY, respectively). Transapical TAVI failed to meet accepted criteria for incremental cost-effectiveness relative to AVR, which was the dominant strategy. In sensitivity analyses, the mortality rates related to the two strategies, the utilities post-AVR and post-transapical TAVI, and the cost of transapical TAVI, were the main drivers of model outcome.
Transapical TAVI did not satisfy current metrics of incremental cost-effectiveness relative to high-risk AVR in the reference case. However, it may provide net health benefits at acceptable cost in selected high-risk patients among whom AVR is the standard intervention.
在主动脉瓣置换术(AVR)是一种选择的高危患者中,经心尖经导管主动脉瓣植入术(TAVI)的增量成本效益尚不清楚,并且尚未在随机对照试验之外确定。
我们开发了一个马尔可夫模型来检查患者在健康状态之间的进展情况,这些健康状态定义为围手术期和术后、并发症后和死亡。经相关注册分析得出 TAVI、高危 AVR 和药物治疗的风险、转移概率、效用和成本的平均值和方差。从 10,000 次模拟中得出结果和成本。敏感性分析进一步评估了死亡率、中风和其他常见观察结果的影响。
在参考案例中,与药物治疗相比,经心尖 TAVI 和高危 AVR 和 TAVI 均具有成本效益(分别为 44,384/QALY 和 42,637/QALY)。经心尖 TAVI 相对于 AVR 没有达到增量成本效益的可接受标准,AVR 是主导策略。在敏感性分析中,两种策略的死亡率、AVR 和经心尖 TAVI 后的效用以及经心尖 TAVI 的成本是模型结果的主要驱动因素。
在参考案例中,与高危 AVR 相比,经心尖 TAVI 不符合当前增量成本效益的标准。然而,它可能在接受 AVR 作为标准干预的高危患者中以可接受的成本提供净健康效益。