Miniati Roberto, Cecconi Giulio, Dori Fabrizio, Marchetti Matteo, Gentili Guido Biffi, Porchia Barbara, Presicce Giorgio, Franchi Sara, Gusinu Roberto
Department of Information Engineering, Biomedical Lab. University of Florence, Florence, Italy.
School of hygiene and public health at the Florence teaching Hospital AOU Careggi, Florence, Italy.
Technol Health Care. 2013;21(6):535-46. doi: 10.3233/THC-130756.
This study, carried out at the Florence Teaching Hospital Careggi (AOUC), reports the technological evaluation, through the use of Health Technology Assessment (HTA), on the application of mitral clips in the treatment of mitral insufficiency.
The assessment, carried out by analyzing the clinical, technological, social, procedural, safety and economic elements, sought to answer the following research questions: Evaluation of the general technological status of the mitral clips in the treatment process of mitral regurgitation, with particular reference to traditional methods; and contextualisation of the analyses within the hospital structure, by identifying criticality issues and improvements.
The methodology was based on the following steps: technological description; areas of evaluation and the selection of Key Performance Indicators; research of scientific facts and the collection of expert opinions; evaluation and reporting of findings.
The results are based on an analysis which included a total of 50 indicators, effectively evaluating 86.5% of them, from the least from the clinical sector (80%) to the most in the areas of procedure, safety and social (100%). Traditional surgery (repair or valve replacement) still represents the gold standard for the treatment of mitral regurgitation due to its maturity both on a technological and clinical level. The minimally invasive procedures which use the mitral clips present interesting opportunities both on a social level (minimum stay in hospital and no post-operative rehabilitation) and clinical level, especially as an alternative to medication, even if they are still at an emergent level (the long-term results are unknown) and complex to use. From the clinical point of view they show some interesting findings related to immediate and post-operative mortality (none during the operation and a minor and equal amount 30 days and 12 months later in comparison to traditional methods) whilst economically, despite the fact that the cost of the device is greater than those used in traditional interventions, the cost-refund relationship does not show significant differences compared to the traditional types of treatment.
The HTA evaluation of minimally invasive technologies that use clips for the treatment of mitral regurgitation shows, in the hospital setting, very interesting results, particularly for inoperable patients, where the clinical and social improvements are significant compared to pharmacological treatments, whilst for 'operable' patients, the traditional techniques are still the most appropriate.
本研究在佛罗伦萨卡雷吉教学医院（AOUC）开展，通过卫生技术评估（HTA）对二尖瓣夹在二尖瓣关闭不全治疗中的应用进行技术评估。
通过分析临床、技术、社会、程序、安全和经济因素进行评估，旨在回答以下研究问题：评估二尖瓣夹在二尖瓣反流治疗过程中的总体技术状况，尤其参照传统方法；通过识别关键问题和改进措施，将分析置于医院结构背景中。
该方法基于以下步骤：技术描述；评估领域及关键绩效指标的选择；科学事实研究及专家意见收集；结果评估与报告。
结果基于一项分析，该分析共纳入50项指标，有效评估了其中的86.5%，从临床领域最少的（80%）到程序、安全和社会领域最多的（100%）。传统手术（修复或瓣膜置换）因其在技术和临床层面的成熟度，仍是二尖瓣反流治疗的金标准。使用二尖瓣夹的微创手术在社会层面（住院时间最短且无需术后康复）和临床层面都呈现出有趣的机遇，特别是作为药物治疗的替代方案，即便它们仍处于新兴阶段（长期结果未知）且使用复杂。从临床角度看，它们显示出一些与术中及术后死亡率相关的有趣发现（术中无死亡，30天及12个月后与传统方法相比死亡率轻微且相当），而在经济方面，尽管该设备成本高于传统干预所用设备，但成本效益关系与传统治疗类型相比并无显著差异。
在医院环境中，对使用夹子治疗二尖瓣反流的微创技术进行的HTA评估显示出非常有趣的结果，特别是对于无法手术的患者，与药物治疗相比，临床和社会改善显著，而对于“可手术”患者，传统技术仍是最合适的。
