title: [Transcatheter aortic valve implantation: a systematic review of the literature on efficacy and safety data].
abstract: BACKGROUND
  Aortic stenosis is the most common valve disease and transcatheter aortic valve replacement is considered as an alternative to surgical valve replacement or to medical treatment in inoperable or high-risk patients, but it is not suitable for all patients with severe aortic stenosis, taking into account also the high cost associated.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) for aortic stenosis via percutaneous, (transfemoral, or endovascular approach) or surgically (transapical, or transventricular) approach.
  
  
  RESULTS
  The present review includes 10 randomized controlled trials (RCTs) and 29 observational studies. We combined the outcomes from the individual trials through meta-analysis where possible. We assessed the overall quality of the evidence for the primary outcome using the GRADE system. Regarding TAVI vs. standard surgery, there were no significant differences between TAVI and conventional surgery for mortality at 1 year or more, the frequency of stroke, and heart attack; for mortality at 30 days, no difference was observed in RCTs and the result was in favor of TAVI in observational studies. Another outcome in favor of TAVI was the frequency of major bleeding that was significantly lower in patients treated with TAVI. The quality of the evidence ranged from moderate to very low. Regarding TAVI vs. medical therapy, for the outcome death at 1 year or more, if we consider the RCTs, the results are favorable to TAVI, while in observational studies no significant differences were observed between the two interventions. In contrast, for the outcome mortality at 30 days, in RCTs no significant differences between the two interventions were observed, while the results were favorable to TAVI in observational studies. For the frequency of stroke in the single RCT that reported this outcome, it was significantly lower in patients treated with medical therapy, with no significant differences in the results of observational studies. The results related to the frequency of heart attack from observational studies are in favor of TAVI. The quality of the evidence ranged from low to very low.
  
  
  CONCLUSIONS
  Candidates for TAVI are those patients for which conventional open-heart surgery is not recommended because of the risk due to advanced age or important comorbidities.
authors.affiliation: Dipartimento di Epidemiologia del Sistema Sanitario Regionale del Lazio.
authors.forename: Laura
authors.initials: L
authors.lastname: Amato
authors.affiliation: Dipartimento di Epidemiologia del Sistema Sanitario Regionale del Lazio.
authors.forename: Elena
authors.initials: E
authors.lastname: Parmelli
authors.affiliation: Dipartimento di Epidemiologia del Sistema Sanitario Regionale del Lazio.
authors.forename: Simona
authors.initials: S
authors.lastname: Vecchi
authors.affiliation: Dipartimento di Epidemiologia del Sistema Sanitario Regionale del Lazio.
authors.forename: Silvia
authors.initials: S
authors.lastname: Minozzi
authors.affiliation: Dipartimento di Epidemiologia del Sistema Sanitario Regionale del Lazio.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Mitrova
authors.affiliation: Agenzia Sanitaria e Sociale, Regione Emilia-Romagna.
authors.forename: Rossana
authors.initials: R
authors.lastname: De Palma
authors.affiliation: Agenzia Sanitaria e Sociale, Regione Emilia-Romagna.
authors.forename: Elena
authors.initials: E
authors.lastname: Berti
authors.affiliation: Dipartimento di Epidemiologia del Sistema Sanitario Regionale del Lazio.
authors.forename: Marina
authors.initials: M
authors.lastname: Davoli
mesh_terms: D001024:Aortic Valve Stenosis / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D009203:Myocardial Infarction / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000379:methods*