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二尖瓣修复术与置换术治疗重度缺血性二尖瓣反流的成本效益:心胸外科手术试验网络的一项随机临床试验

Cost-Effectiveness of Mitral Valve Repair Versus Replacement for Severe Ischemic Mitral Regurgitation: A Randomized Clinical Trial From the Cardiothoracic Surgical Trials Network.

作者信息

Ferket Bart S., Ailawadi Gorav, Gelijns Annetine C., Acker Michael, Hohmann Samuel F., Chang Helena L., Bouchard, Denis, Meltzer David O., Michler Robert E., Moquete Ellen G., Voisine Pierre, Mullen John C., Lala Anuradha, Mack Michael J., Gillinov A. Marc, Thourani Vinod H., Miller Marissa A., Gammie James S., Parides Michael K., Bagiella Emilia, Smith Robert L., Smith Peter K., Hung Judy W., Gupta Lopa N., Rose Eric A., O'Gara Patrick T., Moskowitz Alan J.

出版信息

Circ Cardiovasc Qual Outcomes. 2018 Nov 14;11(11):e004466. doi: 10.1161/CIRCOUTCOMES.117.004466.

Abstract

BACKGROUND

The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe ischemic mitral regurgitation (MR) randomized to mitral valve repair or replacement. However, replacement provided more durable correction of MR and fewer cardiovascular readmissions. Yet, costeffectiveness outcomes have not been addressed.

METHODS AND RESULTS

We conducted a cost-effectiveness analysis of the surgical treatment of ischemic MR based on the CTSN trial (n=126 for repair; n=125 for replacement). Patient-level data on readmissions, survival, qualityof- life, and US hospital costs were used to estimate costs and quality-adjusted life years per patient over the trial duration and a 10-year time horizon. We performed microsimulation for extrapolation of outcomes beyond the 2 years of trial data. Bootstrap and deterministic sensitivity analyses were done to address parameter uncertainty. In-hospital cost estimates were $78 216 for replacement versus $72 761 for repair (difference: $5455; 95% uncertainty interval [UI]: −7784–21 193) while 2-year costs were $97 427 versus $96 261 (difference: $1166; 95% UI: −16 253–17 172), respectively. Quality-adjusted life years at 2 years were 1.18 for replacement versus 1.23 for repair (difference: −0.05; 95% UI: −0.17 to 0.07). Over 5 and 10 years, the benefits of reduction in cardiovascular readmission rates with replacement increased, and survival minimally improved compared with repair. At 5 years, cumulative costs and quality-adjusted life years showed no difference on average, but by 10 years, there was a small, uncertain benefit for replacement: $118 023 versus $119 837 (difference: −$1814; 95% UI: −27 144 to 22 602) and qualityadjusted life years: 4.06 versus 3.97 (difference: 0.09; 95% UI: −0.87 to 1.08). After 10 years, the incremental cost-effectiveness of replacement continued to improve.

CONCLUSIONS

Our cost-effectiveness analysis predicts potential savings in cost and gains in quality-adjusted survival at 10 years when mitral valve replacement is compared with repair for severe ischemic MR. These projected benefits, however, were small and subject to variability. Efforts to further delineate predictors of long-term outcomes in patients with severe ischemic MR are needed to optimize surgical decisions for individual patients, which should yield more cost-effective care.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov. Unique identifier: NCT00807040.

摘要

背景

心胸外科手术试验网络(CTSN)最近报告称,在随机接受二尖瓣修复或置换的严重缺血性二尖瓣反流(MR)患者中,左心室收缩末期容积指数或2年生存率没有差异。然而,置换能更持久地纠正二尖瓣反流,且心血管再入院率更低。不过,成本效益结果尚未得到探讨。

方法与结果

我们基于CTSN试验(修复组n = 126;置换组n = 125)对缺血性二尖瓣反流的手术治疗进行了成本效益分析。使用患者层面的再入院、生存、生活质量和美国医院成本数据,来估计每位患者在试验期间及10年时间范围内的成本和质量调整生命年。我们进行了微观模拟,以推断超出试验数据2年的结果。进行了自抽样和确定性敏感性分析,以解决参数不确定性问题。住院成本估计置换组为78216美元,修复组为72761美元(差值:5455美元;95%不确定区间[UI]:-7784至21193美元),而2年成本分别为97427美元和96261美元(差值:1166美元;95% UI:-16253至17172美元)。2年时的质量调整生命年置换组为1.18,修复组为1.23(差值:-0.05;95% UI:-0.17至0.07)。在5年和10年时,置换组降低心血管再入院率的益处增加,与修复组相比,生存率略有提高。在5年时,累积成本和质量调整生命年平均无差异,但到10年时,置换组有微小的、不确定的益处:118023美元对119837美元(差值:-1814美元;95% UI:-27144至22602美元),质量调整生命年为4.06对

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