Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement
Condition: Diseases of Mitral Valves; Abnormality of Mitral Valve Annulus (Disorder); Mitral Valve Replacement
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Are there differences in outcome of mitral valve replacement with preservation of mitral
      apparatus among rheumatic and/or ischemic mitral lesions?.

      Mitral valve replacement with preservation of leaflets, and added coronary artery-bypass
      surgery, when indicated, is it a feasible and reproducible procedure?.

      The study was designed to compare outcome after prosthetic mitral replacement with
      preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for
      ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical
      assessment. and echo-cardiograph.
    

Detailed description: 
      Objectives: The aim is to compare outcome of modified preservation of mitral valve apparatus
      during prosthetic mitral replacement for rheumatic versus myocardial ischemia &mitral valve
      disease.

      Methods ;This prospective cross-sectional comparative study will include 50 patients with
      isolated rheumatic mitral valve disease (group A) and 50 patients with mitral disease and
      myocardial ischemia (group B), surgery is expected to be performed between 2017 and 2020 at
      one center. All patients will have modified preservation of mitral apparatus during
      prosthetic mitral replacement. Additionally, group B patients will have bypass grafts to left
      anterior descending and/or posterior descending / right coronary artery. Data will be
      collected and analyzed.

      The Institutional Review Board (IRB), Ethics Committee (EC)-approval and consent of each
      patient were obtained.

      Criteria for inclusion of patients and exclusion of others were determined according to the
      guide lines.

      Statistical analysis::

      Qualitative variables and their association among both groups were studied by applying
      Chi-square test and Fisher Exact test. Quantitative variables among both groups were compared
      by applying independent samples t-test. P < 0.05 values mean statistically-significant
      results.
    

Intervention name(s): St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
Intervention type(s): Device
Intervention description(s): St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Other intervention name(s): St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization; St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: both groups of patients received surgical treatment parallel to each other.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: : Preservation of mitral apparatus ,; mitral valve replacement; Rheumatic valve disease and ischemia