Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement

Conditions
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Diseases of Mitral Valves, Abnormality of Mitral Valve Annulus (Disorder), Mitral Valve Replacement

Intervention / Treatment
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* Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:: Mitral stenosis (MS) symptoms are severely limiting and cannot be managed with diuresis and heart rate control. Mitral regurgitation(MR): * acute severe MR require surgical correction for hemo-dynamics and relief of symptoms . Chronic primary mitral regurgitation: * rheumatic heart disease: replacement before irreversible changes occur can be curative. Mixed Mitral Stenosis and Mitral Regurgitation: If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms. Myocardial ischemia associating or complicated with miral valve disease. Exclusion criteria Patients showing good response to medical therapy, and Cases complicated by: ineffective endocarditis, previous myocardial re-vascularization ischemic ventricular septal defect, left ventricular aneurysm, Ruptured papillary muscles of mitral apparatus.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: both groups of patients received surgical treatment parallel to each other.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group A<br>50 patients with isolated rheumatic mitral valve disease (group A) | Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets<br>* St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts<br>* Other names: St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease;|
| Other: Group B<br>50 patients with mitral disease and myocardial ischemia (group B) | Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets<br>* St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts<br>* Other names: St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking index | Number of Packs every day X number of years of smoking= Pack.year, | 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 | 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 | Seven days before surgery . | 
| For each participant: etiological :type of mitral valve lesion | Rheumatic: distorted thickened leaflets,thickened fibrosed chordae | Seven days before surgery . | 
| For each participant: etiological :type of mitral valve lesion | Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence | 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. | 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 | One week before surgery.with Echo-cardiograph | 
| left ventricular wall motion abnormality | hypokinesia, Akinesia, Dyskinesia of certain segment(s) | 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 | 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 | 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 . | 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 | 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 | 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 | Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes on Clinical examination | local and general Examination,: a new murmur, evolving heart failure | 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. | .Monthly through study completion up to 12 months. | 
| Mortality and Morbidity | cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation | Monthly through study completion up to 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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: Preservation of mitral apparatus ,, mitral valve replacement, Rheumatic valve disease and ischemia