title: Hospital-based health technology assessment on the use of mitral clips in the treatment of mitral regurgitation.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Information Engineering, Biomedical Lab. University of Florence, Florence, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Miniati
authors.affiliation: Department of Information Engineering, Biomedical Lab. University of Florence, Florence, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Cecconi
authors.affiliation: Department of Information Engineering, Biomedical Lab. University of Florence, Florence, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Dori
authors.affiliation: Department of Information Engineering, Biomedical Lab. University of Florence, Florence, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Marchetti
authors.affiliation: Department of Information Engineering, Biomedical Lab. University of Florence, Florence, Italy.
authors.forename: Guido Biffi
authors.initials: GB
authors.lastname: Gentili
authors.affiliation: School of hygiene and public health at the Florence teaching Hospital AOU Careggi, Florence, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Porchia
authors.affiliation: Florence teaching hospital AOU Careggi, General Direction Office, Florence, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Presicce
authors.affiliation: Florence teaching hospital AOU Careggi, General Direction Office, Florence, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Franchi
authors.affiliation: Head of Health Technology Assessment unit at the Florence teaching hospital AOU Careggi, Largo Brambilla 3, Florence, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Gusinu
mesh_terms: D006348:Cardiac Surgical Procedures / Q000191:economics / Q000295:instrumentation* / Q000379:methods; D017721:Hospital Costs / Q000706:statistics & numerical data*; D006801:Humans; D007558:Italy; D019060:Minimally Invasive Surgical Procedures / Q000191:economics / Q000295:instrumentation* / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000191:economics / Q000601:surgery*; D013525:Surgical Instruments / Q000191:economics / Q000592:standards*; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000379:methods / Q000592:standards*
keywords: Health technology assessment; hospital based; mitral clips; mitral regurgitation