Reynolds Matthew R, Lei Yang, Wang Kaijun, Chinnakondepalli Khaja, Vilain Katherine A, Magnuson Elizabeth A, Galper Benjamin Z, Meduri Christopher U, Arnold Suzanne V, Baron Suzanne J, Reardon Michael J, Adams David H, Popma Jeffrey J, Cohen David J
Harvard Clinical Research Institute, Boston, Massachusetts; Department of Cardiology, Lahey Hospital and Medical Center, Burlington, Massachusetts.
Saint Luke's Mid America Heart Institute, Kansas City, Kansas; University of Kansas School of Medicine, Kansas City, Kansas.
J Am Coll Cardiol. 2016 Jan 5;67(1):29-38. doi: 10.1016/j.jacc.2015.10.046.
Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.
The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk.
We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S.
Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained.
In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S.
With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).
以往关于经导管主动脉瓣置换术（TAVR）成本效益的研究主要基于单一的球囊扩张系统。
本研究的目的是评估对于严重主动脉瓣狭窄且手术风险高的患者，使用自膨胀式人工瓣膜进行TAVR与外科主动脉瓣置换术（SAVR）相比的成本效益。
我们基于CoreValve美国高危关键试验中个体患者层面的数据进行了正式的经济分析。使用关于2年生存期和生活质量以及12个月内医疗资源使用和医院成本的实证数据来预测预期寿命、质量调整预期寿命和终身医疗成本，以便从美国角度估计TAVR相对于SAVR的增量成本效益。
相对于SAVR，TAVR平均缩短初始住院时间4.4天，减少出院后康复服务需求，并带来更好的1个月生活质量。TAVR的首次住院和预计终身成本高于SAVR（每位患者分别相差11,260美元和17,849美元），而TAVR预计可带来0.32个质量调整生命年（[QALY]；0.41个生命年[LY]）的终身收益，贴现率为3%。终身增量成本效益比为每获得1个QALY 55,090美元，每获得1个LY 43,114美元。敏感性分析表明，TAVR初始成本降低约1,650美元将导致增量成本效益比<每获得1个QALY 50,000美元。
在高危临床试验人群中，与SAVR相比，使用自膨胀式人工瓣膜进行TAVR提供了有意义的临床益处，增量成本按美国现行标准认为是可接受的。
随着TAVR首次住院成本预期适度降低，在该患者人群中TAVR相对于SAVR的价值将变得更高。（美敦力CoreValve系统治疗需要主动脉瓣置换的高危和极高危有症状严重主动脉瓣狭窄患者的安全性和有效性研究[美敦力CoreValve美国关键试验]；NCT01240902）
