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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Suez Canal University
Ismailia, Egypt
Suez Canal University
Ismailia, Egypt
Smoking index
Number of Packs every day X number of years of smoking= Pack.year,
Time frame: One week before surgery(or during first clinical visit) .
Age and gender for each participant
Males above 40 years and Females above 45 years need pre-operative coronary angio-graph
Time frame: One week before surgery .
For each participant: pathological:type of mitral valve lesion
severe stenosis with mitral area \< 1 cm square, severe regurgitation, or mixed lesions
Time frame: Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
Time frame: Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
Time frame: Seven days before surgery- echo-cardiograph.
For each participant:, assessing sub-valvular apparatus
Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.
Time frame: One week before surgery. with Echo-cardiograph.
Abascal echo-cardiographic mitral valve score (Wilkins score)
:if score is 8 or less it is good for balloon valvo-plasty, if \> 8 surgery is recommended ( leaflet mobility, thickness and calcification. Fourthly, sub-valvular thickening., higher scores = more deterioration
Time frame: One week before surgery.with Echo-cardiograph
left ventricular wall motion abnormality
hypokinesia, Akinesia, Dyskinesia of certain segment(s)
Time frame: one week before surgery - with an echo-cardiograph
Number of participants with Signs of left ventricular dysfunction
low ejection fraction \<52%, low stroke volume\< 70 ml, low cardiac output \<5 litres per minute
Time frame: seven days before surgery echo-cardiograph examination
Number of participants with pre-operative coronary artery disease
Expected on clinical bases and .proved by Echo-cardiograph-findings
Time frame: seven days before surgery, coronary angio-graph
Number of participants with pre-operative ischemic complications
left ventricular thrombi, septal and left ventricular wall thickness in mm .
Time frame: seven days before surgery echo-cardiograph examination
Assessment of any evolving new prosthetic valve dysfunction
Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus
Time frame: intra-operative trans-esophageal echo-cardiograph examination
Change in post-operative left ventricular functions
: Low Fractional Shortening \< 28% , Ejection fraction \< 40%,, increased left ventricular dimensions and volume
Time frame: 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
Change of Prosthetic mitral valve functions
Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus
Time frame: Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
changes on Clinical examination
local and general Examination,: a new murmur, evolving heart failure
Time frame: Monthly up to 12 months after surgery)
Changes in Results of Prothrombin time, concentration and.International normalized ratio
Adjust dose of oral anticoagulant.( between double and half to three times the control) Dose usually ranges between 1 and 11 mg warfarin tablet daily.
Time frame: .Monthly through study completion up to 12 months.
Mortality and Morbidity
cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation
Time frame: Monthly through study completion up to 12 months.
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