a Cardiovascular , CHU Nantes , France ;
b Health Economics, Stratégique Santé , Evry , France ;
J Med Econ. 2016 Jul;19(7):696-701. doi: 10.3111/13696998.2016.1157484. Epub 2016 Mar 22.
Introduction Mitral regurgitation is a heart condition resulting from blood flowing from the left ventricle towards the left atrium, increasing the risk of heart failure and mortality. While surgery can greatly reduce these risks, some patients are not eligible, resulting in medication being their only therapeutic alternative. The MitraClip (Abbot Vascular) is a medical device that is percutaneously implanted and designed to eliminate leaking of the mitral valve. Methods The efficacy of the MitraClip strategy vs medical management was assessed using a 4-state Markov model based on the mitral regurgitation grade (mitral regurgitation grade 0, I/II, and III/IV, and death). At each 1-month cycle, patients were or were not hospitalized. The model analyzed a fictional population of 1000 patients over a 5-year period from a national Health Insurance perspective. The primary end-point was the number of deaths avoided. Data from the EVEREST II High Risk Study patients were used along with a literature review. Results At 5 years, among the 1000 patients, 276 deaths were found to be avoidable with the MitraClip strategy. The incremental cost-effectiveness ratio (ICER) was €93,363 per death avoided. The annual ICER was calculated to take into consideration excess costs resulting from the MitraClip over the first year (€29,984 vs €8557 for the reference strategy) and the reduction of costs in following years (€3122 for MitraClip vs €8557 for reference strategy). Thus, the mean ICER was calculated to be €20,720 per death avoided. Conclusion The MitraClip is a novel alternative therapy for mitral insufficiency in patients ineligible for surgery that may offer a medico-economic advantage.
简介
二尖瓣反流是一种由于血液从左心室流向左心房而导致的心脏状况,增加了心力衰竭和死亡的风险。虽然手术可以大大降低这些风险,但有些患者不符合手术条件,导致药物治疗成为他们唯一的治疗选择。MitraClip(雅培血管)是一种经皮植入的医疗器械,旨在消除二尖瓣反流。
方法
使用基于二尖瓣反流程度(二尖瓣反流程度 0、I/II 和 III/IV 以及死亡)的 4 状态 Markov 模型评估 MitraClip 策略与药物治疗的疗效。在每个 1 个月的周期中,患者是否住院。该模型分析了一个虚构的 1000 名患者群体,从国家医疗保险的角度来看,为期 5 年。主要终点是避免死亡的人数。使用 EVEREST II 高危研究患者的数据,并结合文献综述。
结果
在 5 年内,在 1000 名患者中,发现 MitraClip 策略可避免 276 例死亡。增量成本效益比(ICER)为每避免 1 例死亡 93363 欧元。计算了每年的 ICER,以考虑第一年 MitraClip 带来的超额成本(29984 欧元与参考策略的 8557 欧元)和随后几年的成本降低(MitraClip 的 3122 欧元与参考策略的 8557 欧元)。因此,平均 ICER 计算为每避免 1 例死亡 20720 欧元。
结论
MitraClip 是一种治疗不符合手术条件的二尖瓣关闭不全患者的新型替代疗法,可能具有医疗经济优势。