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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Replacement; Diseases of Mitral Valves; Abnormality of Mitral Valve Annulus (Disorder)
• Intervention / Treatment: Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, +064
    • Suez Canal University
  • Ismailia, Egypt, 002-064
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group A; 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; St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts; Other Names: St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization; St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease
Other: Group B; 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; St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts; Other Names: St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization; St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Suez Canal University
• Collaborators: National Research Centre, Egypt
• Investigators: Study Director: Mohamed A. allaban, PhD, Suez Canal University, FOM- Research Ethics Committee

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: mitral valve replacement; : Preservation of mitral apparatus ,; Rheumatic valve disease and ischemia
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2796#

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by H. D. Elayouty, H. S. Hassan and S.A. Elhafeez. The first draft of the manuscript was written by A. H.Elayouty and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
• IPD Sharing Time Frame: Within 360 days
• IPD Sharing Access Criteria: h.dosoky@yahoo.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes