Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement (EarlyOutcome)
Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ismailia, Egipto, +064
- Suez Canal University
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Ismailia, Egipto, 002-064
- Suez Canal University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador falso: Group A
50 patients with isolated rheumatic mitral valve disease (group A)
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St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Otros nombres:
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Otro: Group B
50 patients with mitral disease and myocardial ischemia (group B)
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St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Smoking index
Periodo de tiempo: One week before surgery(or during first clinical visit) .
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Number of Packs every day X number of years of smoking= Pack.year,
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One week before surgery(or during first clinical visit) .
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Age and gender for each participant
Periodo de tiempo: One week before surgery .
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Males above 40 years and Females above 45 years need pre-operative coronary angio-graph
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One week before surgery .
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For each participant: pathological:type of mitral valve lesion
Periodo de tiempo: Seven days before surgery .
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severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions
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Seven days before surgery .
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For each participant: etiological :type of mitral valve lesion
Periodo de tiempo: Seven days before surgery .
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Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
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Seven days before surgery .
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For each participant: etiological :type of mitral valve lesion
Periodo de tiempo: Seven days before surgery- echo-cardiograph.
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Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
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Seven days before surgery- echo-cardiograph.
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For each participant:, assessing sub-valvular apparatus
Periodo de tiempo: One week before surgery. with Echo-cardiograph.
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Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.
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One week before surgery. with Echo-cardiograph.
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Abascal echo-cardiographic mitral valve score (Wilkins score)
Periodo de tiempo: One week before surgery.with Echo-cardiograph
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: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
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One week before surgery.with Echo-cardiograph
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left ventricular wall motion abnormality
Periodo de tiempo: one week before surgery - with an echo-cardiograph
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hypokinesia, Akinesia, Dyskinesia of certain segment(s)
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one week before surgery - with an echo-cardiograph
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Number of participants with Signs of left ventricular dysfunction
Periodo de tiempo: seven days before surgery echo-cardiograph examination
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low ejection fraction <52%, low stroke volume< 70 ml, low cardiac output <5 litres per minute
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seven days before surgery echo-cardiograph examination
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Number of participants with pre-operative coronary artery disease
Periodo de tiempo: seven days before surgery, coronary angio-graph
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Expected on clinical bases and .proved
by Echo-cardiograph-findings
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seven days before surgery, coronary angio-graph
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Number of participants with pre-operative ischemic complications
Periodo de tiempo: seven days before surgery echo-cardiograph examination
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left ventricular thrombi, septal and left ventricular wall thickness in mm .
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seven days before surgery echo-cardiograph examination
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Assessment of any evolving new prosthetic valve dysfunction
Periodo de tiempo: intra-operative trans-esophageal echo-cardiograph examination
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Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus
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intra-operative trans-esophageal echo-cardiograph examination
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Change in post-operative left ventricular functions
Periodo de tiempo: 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
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: Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume
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5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
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Change of Prosthetic mitral valve functions
Periodo de tiempo: Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
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Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus
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Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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changes on Clinical examination
Periodo de tiempo: Monthly up to 12 months after surgery)
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local and general Examination,: a new murmur, evolving heart failure
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Monthly up to 12 months after surgery)
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Changes in Results of Prothrombin time, concentration and.International normalized ratio
Periodo de tiempo: .Monthly through study completion up to 12 months.
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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.
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.Monthly through study completion up to 12 months.
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Mortality and Morbidity
Periodo de tiempo: Monthly through study completion up to 12 months.
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cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation
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Monthly through study completion up to 12 months.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Mohamed A. allaban, PhD, Suez Canal University, FOM- Research Ethics Committee
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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Enviado por primera vez
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Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Palabras clave
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Otros números de identificación del estudio
- 2796#
Plan de datos de participantes individuales (IPD)
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- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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