Department of Cardiovascular Medicine, Cleveland Clinic, Ohio, USA.
Am J Cardiol. 2012 May 1;109(9):1326-33. doi: 10.1016/j.amjcard.2011.12.030. Epub 2012 Feb 13.
Comparisons between transcatheter aortic valve implantation without replacement (TAVI) and tissue aortic valve replacement (AVR) in clinical trials might not reflect the outcomes in standard clinical practice. This could have important implications for the relative cost-effectiveness of these alternatives for management of severe aortic stenosis in high-risk patients for whom surgery is an option. The mean and variance of risks, transition probabilities, utilities, and cost of TAVI, AVR, and medical management derived from observational studies were entered into a Markov model that examined the progression of patients between relevant health states. The outcomes and cost were derived from 10,000 simulations. Sensitivity analyses were based on variations in the likelihood of mortality, stroke, and other commonly observed outcomes. Both TAVI and AVR were cost-effective compared to medical management. In the reference case (age 80 years, the perioperative TAVI and AVR mortality was 6.9% vs 9.8%, and annual mortality was 21% vs 24%), the utility of TAVI was greater than that of AVR (1.78 vs 1.72 quality-adjusted life years) and the lifetime cost of TAVI exceeded that of AVR ($59,503 vs $56,339). The incremental cost-effectiveness ratio was $52,773/quality-adjusted life years. Threshold analyses showed that variation in the probabilities of perioperative and annual mortality after AVR and after TAVI and annual stroke after TAVI were important determinants of the favored strategy. Sensitivity analyses defined the thresholds at which TAVI or AVR was the preferred strategy with regard to health outcomes and cost. In conclusion, TAVI satisfies current metrics of cost-effectiveness relative to AVR and might provide net health benefits at acceptable cost for selected high-risk patients among whom AVR is the current procedure of choice.
在临床试验中,经导管主动脉瓣植入术(TAVI)与组织主动脉瓣置换术(AVR)的比较结果可能无法反映标准临床实践中的结果。这对于这些替代方案治疗高危主动脉瓣狭窄患者的相对成本效益可能具有重要意义,因为手术是一种选择。从观察性研究中得出的 TAVI、AVR 和药物治疗的风险平均值和方差、转移概率、效用和成本被输入到一个马尔可夫模型中,该模型检查了相关健康状态之间的患者进展情况。结果和成本来自 10000 次模拟。敏感性分析基于死亡率、中风和其他常见观察结果的可能性变化。与药物治疗相比,TAVI 和 AVR 均具有成本效益。在参考病例中(80 岁,围手术期 TAVI 和 AVR 死亡率为 6.9%比 9.8%,年死亡率为 21%比 24%),TAVI 的效用大于 AVR(1.78 比 1.72 个质量调整生命年),并且 TAVI 的终身成本超过了 AVR(59503 美元比 56339 美元)。增量成本效益比为 52773 美元/质量调整生命年。阈值分析表明,AVR 和 TAVI 后的围手术期和年度死亡率以及 TAVI 后年度中风的概率变化是决定首选策略的重要决定因素。敏感性分析确定了 TAVI 或 AVR 在健康结果和成本方面具有优势的阈值。总之,与 AVR 相比,TAVI 符合当前的成本效益标准,并且可能为选定的高危患者提供可接受成本的净健康收益,其中 AVR 是当前的首选手术。