Abnormality of Mitral Valve Annulus (Disorder), Diseases of Mitral Valves, Mitral Valve Replacement
Conditions
Keywords
: Preservation of mitral apparatus ,, mitral valve replacement, Rheumatic valve disease and ischemia
Brief 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.
Interventions
DEVICESt.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Sponsors
National Research Centre, Egypt
Suez Canal University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
All roles were unmasked
Intervention model description
both groups of patients received surgical treatment parallel to each other.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Prosthetic mitral valve functions | Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph | Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus |
| Number of participants with pre-operative ischemic complications | seven days before surgery echo-cardiograph examination | left ventricular thrombi, septal and left ventricular wall thickness in mm . |
| Assessment of any evolving new prosthetic valve dysfunction | intra-operative trans-esophageal echo-cardiograph examination | Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus |
| Change in post-operative left ventricular functions | 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph | : Low Fractional Shortening \< 28% , Ejection fraction \< 40%,, increased left ventricular dimensions and volume |
| Smoking index | One week before surgery(or during first clinical visit) . | Number of Packs every day X number of years of smoking= Pack.year, |
| Age and gender for each participant | One week before surgery . | Males above 40 years and Females above 45 years need pre-operative coronary angio-graph |
| For each participant: pathological:type of mitral valve lesion | Seven days before surgery . | severe stenosis with mitral area \< 1 cm square, severe regurgitation, or mixed lesions |
| For each participant: etiological :type of mitral valve lesion | Seven days before surgery . | Rheumatic: distorted thickened leaflets,thickened fibrosed chordae |
| For each participant:, assessing sub-valvular apparatus | One week before surgery. with Echo-cardiograph. | Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall. |
| Abascal echo-cardiographic mitral valve score (Wilkins score) | One week before surgery.with Echo-cardiograph | :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 |
| left ventricular wall motion abnormality | one week before surgery - with an echo-cardiograph | hypokinesia, Akinesia, Dyskinesia of certain segment(s) |
| Number of participants with Signs of left ventricular dysfunction | seven days before surgery echo-cardiograph examination | low ejection fraction \<52%, low stroke volume\< 70 ml, low cardiac output \<5 litres per minute |
| Number of participants with pre-operative coronary artery disease | seven days before surgery, coronary angio-graph | Expected on clinical bases and .proved by Echo-cardiograph-findings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Results of Prothrombin time, concentration and.International normalized ratio | .Monthly through study completion up to 12 months. | 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. |
| Mortality and Morbidity | Monthly through study completion up to 12 months. | cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation |
| changes on Clinical examination | Monthly up to 12 months after surgery) | local and general Examination,: a new murmur, evolving heart failure |
Countries
Egypt
Outcome results
None listed