Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
J Thorac Cardiovasc Surg. 2013 Jul;146(1):52-60.e3. doi: 10.1016/j.jtcvs.2012.06.018. Epub 2012 Jul 11.
The primary analysis estimated the cost-effectiveness of transfemoral transcatheter aortic valve implantation (Edwards SAPIEN heart valve; Edwards Lifesciences LLC, Irvine, Calif) compared with standard management in inoperable patients with severe, symptomatic aortic stenosis. The secondary analysis estimated the cost-effectiveness of transcatheter aortic valve implantation (transfemoral or transapical approaches) (SAPIEN heart valve) compared with surgical aortic valve replacement in operable patients with severe, symptomatic aortic stenosis.
A combined decision tree and Markov model was developed to compare costs, life-years, and quality-adjusted life-years over a 20-year time horizon from the Canadian health-care payer perspective. The Placement of Aortic Transcatheter Valves trial provided rates of postoperative complications and mortality. Costs were derived from the Ontario Case Costing Initiative. Comprehensive sensitivity analyses were used to explore the impact of uncertainty on the cost-effective estimates.
In the primary analysis, comparing transfemoral transcatheter aortic valve implantation and standard management resulted in incremental cost-effectiveness ratios of $36,458/life-year and $51,324/quality-adjusted life-year. In the secondary analysis, transcatheter aortic valve implantation (transfemoral or transapical) and surgical aortic valve replacement were compared, resulting in an incremental cost-effectiveness ratio of $870,143/life-year and transcatheter aortic valve implantation being dominated by surgical aortic valve replacement when comparing quality-adjusted life-years. Deterministic sensitivity analysis for the primary analysis identified the procedural costs and 1-year mortality rates of both transfemoral transcatheter aortic valve implantation and standard management to be the most sensitive parameters in the model, whereas results from the secondary analysis were largely unchanged. Removal of long-term complications in both analyses led to more favorable incremental cost-effectiveness ratios for transcatheter aortic valve implantation.
This economic evaluation suggested that transfemoral transcatheter aortic valve implantation was a cost-effective option compared with standard management for inoperable patients with severe, symptomatic aortic stenosis, but it might not be a cost-effective treatment compared with surgical aortic valve replacement for operable patients.
主要分析估计了经股动脉经导管主动脉瓣植入术（爱德华兹 SAPIEN 心脏瓣膜；爱德华生命科学公司，加利福尼亚州欧文）与无法手术的严重症状性主动脉瓣狭窄患者的标准治疗相比的成本效益。次要分析估计了经股动脉或经心尖途径的经导管主动脉瓣植入术（SAPIEN 心脏瓣膜）与可手术的严重症状性主动脉瓣狭窄患者的外科主动脉瓣置换术相比的成本效益。
从加拿大医疗保健支付者的角度出发，开发了一个联合决策树和马尔可夫模型，以比较 20 年时间内的成本、生命年和质量调整生命年。放置主动脉经导管瓣膜试验提供了术后并发症和死亡率的发生率。成本来自安大略省病例成本倡议。综合敏感性分析用于探讨不确定性对成本效益估计的影响。
在主要分析中，经股动脉经导管主动脉瓣植入术与标准治疗相比，增量成本效益比为 36458 美元/生命年和 51324 美元/质量调整生命年。在次要分析中，经导管主动脉瓣植入术（经股动脉或经心尖）与外科主动脉瓣置换术进行了比较，结果显示增量成本效益比为 870143 美元/生命年，而经导管主动脉瓣植入术在比较质量调整生命年时被外科主动脉瓣置换术所主导。主要分析的确定性敏感性分析确定了股动脉经导管主动脉瓣植入术和标准治疗的手术成本和 1 年死亡率是模型中最敏感的参数，而次要分析的结果基本不变。在两项分析中去除长期并发症会使经导管主动脉瓣植入术的增量成本效益比更为有利。
这项经济评估表明，经股动脉经导管主动脉瓣植入术与无法手术的严重症状性主动脉瓣狭窄患者的标准治疗相比是一种具有成本效益的选择，但与可手术的严重症状性主动脉瓣狭窄患者的外科主动脉瓣置换术相比，它可能不是一种具有成本效益的治疗方法。
