15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Condition: Surgery; Survival, Prosthesis; Valve Heart Disease
MeSH terms: Heart Diseases; Heart Valve Diseases; Prosthesis Failure
Study type: Observational

Summary: 
      Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to
      national data of the Spanish Society of Thoracic and Cardiovascular Surgery).

      There is conflicting evidence regarding the long-term survival of patients aged 50-65 years
      with mechanical (M) or biological (B) aortic prostheses. General consensus of greater
      complications associated with the use of long-life anticoagulation in M and of reoperation in
      B.

      Similar survival with lower MACCE complications in bioprosthesis could reconsider their
      choice in patients aged 50-65 years, specially in the current TAVI era.

      The investigators are going to perform a multicentric retrospective observational study
      (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve
      Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 5 Cardiovascular Surgery
      Centers in Andalousia (south Spain)
    

Detailed description: 
      Objectives The main objective is to analyze long-term survival (15 years) and major
      cardiovascular complications (MACE, (death of any cause, neurological events (TIA / stroke),
      any prosthesis reoperation, and major bleeding), in patients aged 50-65 years who underwent
      isolated aortic valve replacement (AVR) due to severe aortic stenosis . Secondary objectives
      were to analyze the evolution of transprosthetic gradients by echocardiography, type of INR
      control, and degree of significant structural degeneration in bioprostheses.

      Material and Method: A retrospective analytical study of patients aged 50-65 years who
      underwent AVR surgery for stenosis between 2000-2015 in all centers with a Cardiovascular
      Surgery Dept. in Andalousia (SPAIN) as an inclusion criterion. As exclusion criteria,
      autonomic change of residence, need for concomitant surgery, previous cardiac interventions
      and endocarditis. Survival analysis and clinical data will be performed through the Diraya
      Health Care medical records (DAE), direct telephone contact with family and / or relatives, A
      crude analysis of the data and a posterior analysis by propensity score matching with the
      help of the Foundation for Biomedical Research of Malaga (IBIMA) with SPSS software will be
      carried out using a 1: 1 "nearest neighbour" matching protocol based on the Number of total
      bioprosthesis. A total sample of more than 1200 cases is expected, of which about 380 would
      be bioprostheses that would serve as a basis for the pairing. To find a 10% difference in the
      primary endpoint, two groups of 325 patients are required for a p = 0.05 and 80% for a
      bilateral contrast of two independent proportions. Sub-analysis will be performed by
      subgroups of age (50-59 vs. 60-65 years) and another according to the mark of the 2
      prostheses of each type most used. All statistical analyzes will be two-tailed with an alpha
      error of 0.05 to consider statistically significant data, and will be reviewed by IBIMA
      biostatistics.

      Conclusions: A positive result (similar survival and prosthetic durability in group B, with
      lower complications) could change the current indications of AVS in our environment, allowing
      the age of indication of bioprostheses to be reduced below 60 years.
    

Intervention name(s): bioprosthesis implantation between 2000-2015; mechanical prosthesis implantation between 2000-2015
Intervention type(s): Procedure; Procedure
Intervention description(s): Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass; Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe
        aortic stenosis from years 2000-2015 both inclusive, with bioprosthesis or mechanical
        prosthesis
      
Keywords: long-term survival; bioprosthesis; complications; anticoagulation; mechanichal prosthesis