Hospital-based health technology assessment on the use of mitral clips in the treatment of mitral regurgitation

Article type: Research Article

Authors: Miniati, Roberto^{a; *} | Cecconi, Giulio^a | Dori, Fabrizio^a | Marchetti, Matteo^a | Gentili, Guido Biffi^a | Porchia, Barbara^b | Presicce, Giorgio^c | Franchi, Sara^c | Gusinu, Roberto^d

Affiliations: [a] Department of Information Engineering, Biomedical Lab. University of Florence, Florence, Italy | [b] School of hygiene and public health at the Florence teaching Hospital AOU Careggi, Florence, Italy | [c] Florence teaching hospital AOU Careggi, General Direction Office, Florence, Italy | [d] Head of Health Technology Assessment unit at the Florence teaching hospital AOU Careggi, Largo Brambilla 3, Florence, Italy

Correspondence: [*] Corresponding author: Roberto Miniati, Department of Information Engineering, Biomedical Lab. University of Florence, Via S. Marta 3, 50139 Florence, Italy. E-mail: roberto.miniati@unifi.it.

Abstract: Background: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. Objective: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. Methods: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. Results: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. Conclusion: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.

Keywords: Health technology assessment, hospital based, mitral regurgitation, mitral clips

DOI: 10.3233/THC-130756

Journal: Technology and Health Care, vol. 21, no. 6, pp. 535-546, 2013