Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suez Canal University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Smoking index
Study Overview
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::
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
All roles were unmasked
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group A
50 patients with isolated rheumatic mitral valve disease (group A)
Intervention: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets (Device)
Group B
50 patients with mitral disease and myocardial ischemia (group B)
Intervention: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets (Device)
Outcomes
Primary Outcomes
Smoking index
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Seven days before surgery- echo-cardiograph.
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
For each participant:, assessing sub-valvular apparatus
Time Frame: 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)
Time Frame: 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
Time Frame: one week before surgery - with an echo-cardiograph
hypokinesia, Akinesia, Dyskinesia of certain segment(s)
Number of participants with Signs of left ventricular dysfunction
Time Frame: 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
Time Frame: seven days before surgery, coronary angio-graph
Expected on clinical bases and .proved by Echo-cardiograph-findings
Number of participants with pre-operative ischemic complications
Time Frame: 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
Time Frame: 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
Time Frame: 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
Change of Prosthetic mitral valve functions
Time Frame: 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
For each participant: etiological :type of mitral valve lesion
Time Frame: Seven days before surgery .
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
Secondary Outcomes
- changes on Clinical examination(Monthly up to 12 months after surgery))
- Changes in Results of Prothrombin time, concentration and.International normalized ratio(.Monthly through study completion up to 12 months.)
- Mortality and Morbidity(Monthly through study completion up to 12 months.)
Investigators
Hamdy Dosoky Ibraheem Elayouty
Prof. of Cardio-thoracic Surgery
Suez Canal University