Borisenko Oleg, Haude Michael, Hoppe Uta C, Siminiak Tomasz, Lipiecki Janusz, Goldberg Steve L, Mehta Nawzer, Bouknight Omari V, Bjessmo Staffan, Reuter David G
Synergus AB, Svardvagen 19, 182 33, Danderyd, Sweden.
Medical Clinic I, Neuss City Clinic, Lukas Krankenhaus GmbH, Preußenstraße 84, 41464, Neuss, Germany.
BMC Cardiovasc Disord. 2015 May 14;15:43. doi: 10.1186/s12872-015-0039-8.
To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT).
Cost-utility analysis using a combination of a decision tree and Markov process was performed. The clinical effectiveness was determined based on the results of the Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) trial. The mean age of the target population was 62 years, 77% of the patients were males, 64% of the patients had severe FMR and all patients had New York Heart Association functional class III. The epidemiological, cost and utility data were derived from the literature. The analysis was performed from the German statutory health insurance perspective over 10-year time horizon.
Over 10 years, the total cost was €36,785 in the PMVR arm and €18,944 in the OMT arm. However, PMVR provided additional benefits to patients with an 1.15 incremental quality-adjusted life years (QALY) and an 1.41 incremental life years. The percutaneous procedure was cost-effective in comparison to OMT with an incremental cost-effectiveness ratio of €15,533/QALY. Results were robust in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis with a willingness-to-pay threshold of €35,000/QALY, PMVR had a 84 % probability of being cost-effective.
Percutaneous mitral valve repair may be cost-effective in inoperable patients with FMR due to heart failure.
为了确定与延长最佳药物治疗(OMT)相比,使用Carillon®二尖瓣轮廓系统®(美国华盛顿州柯克兰市心脏维度公司)对伴有中重度功能性二尖瓣反流(FMR)的充血性心力衰竭患者进行经皮二尖瓣修复(PMVR)的成本效益。
采用决策树和马尔可夫过程相结合的方法进行成本效用分析。临床疗效基于Carillon二尖瓣环成形装置经导管植入(TITAN)试验的结果确定。目标人群的平均年龄为62岁,77%的患者为男性,64%的患者有严重FMR,所有患者均为纽约心脏协会心功能Ⅲ级。流行病学、成本和效用数据均来自文献。分析是从德国法定医疗保险的角度在10年的时间范围内进行的。
在10年期间,PMVR组的总成本为36,785欧元,OMT组为18,944欧元。然而,PMVR为患者带来了额外的益处,质量调整生命年(QALY)增加了1.15,生命年增加了1.41。与OMT相比,经皮手术具有成本效益,增量成本效益比为15,533欧元/QALY。在确定性敏感性分析中结果稳健。在支付意愿阈值为35,000欧元/QALY的概率敏感性分析中,PMVR具有成本效益的概率为84%。
对于因心力衰竭导致FMR且无法手术的患者,经皮二尖瓣修复可能具有成本效益。