Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement
Phase: NA
Conditions: Diseases of Mitral Valves, Abnormality of Mitral Valve Annulus (Disorder), Mitral Valve Replacement
Sponsor: Suez Canal University

       
                            
  
 
Title: ~ Outcome of preservation of mitral valve apparatus during mitral valve    
             replacement for rheumatic versus valve lesions  with myocardial ischemia“. 
   
 
ID: 2796# 
    Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement 
 
 
 
 
 
 
 
 
 
 

                                              The visual abstract: 
Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among 
rheumatic and/or ischemic mitral lesions? 
There are some differences between the two groups that actually didn`t affect the one year- survival or 
reoperation rates. 
 Mitral valve replacement with preservation of leaflets, and added revascularization, when indicated, is a 
feasible and reproducible procedure.  
Thoracoscopic or minimally invasive techniques can be developed on these bases 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
Abstract 
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),  will be started in 2017 and expected to be terminated in 2020 at one center. All patients will 
have modified preservation of mitral apparatus during prosthetic mitral replacement. Additionally, group 
B patients had bypass grafts to left anterior descending and/or posterior descending / right coronary 
artery. Data were collected and analyzed. 
Results: Pre-operative clinical data didn`t show significant differences between groups (p>0.05.) except 
smoking index was much higher in group B. Results will be reported and analyzed to get the conclusions  
    
 Key wards: Preservation of mitral apparatus during mitral replacement, 

Intra-operative TEE during mitral replacement  
Mitral replacement with preservation of mitral apparatus for rheumatic mitral disease, 
Mitral replacement with preservation of mitral apparatus for ischemic mitral disease  
    
Introduction 
Rheumatic heart disease led to an estimation of 275100 deaths worldwide in 2013 [1].  Mitral valve 
disease comprises diverse etiologies e.g., rheumatic, degenerative or left ventricular ischemia.[2]. 
Rheumatic heart disease remains by far the most common manifestation of valve heart disease worldwide 
and affects approximately 41 million people.  
 Deaths due to coronary artery disease peaked in the mid -1960s and then, deaths decreased however, it 
still is the leading cause of death worldwide [3, 4]. 
 Early mortality after mitral valve replacement without preservation of the valve apparatus was 10.4 % 
[3].    
Mitral valve apparatus: The apparatus consists of the two leaflets, the annulus and the sub-valvular 
apparatus. The latter includes the left ventricular free wall, the two papillary muscles that give off the 
chordae tendineae. Carpentier, in 2010 reported that proper valve function is dependent on integrity and 
harmonious interplay of the components and disturbed integrity and harmony will produce valve 
incompetence and/or stenosis-dysfunction [5].    Functionally the apparatus is producing “ annulo-
ventricular continuity”. 
 The papillary muscles:  
 These small myocardial structures originate from the free wall of the left ventricle. They are attached to 
the trabecular carnea and covered by the endocardium: 
1- They contract to prevent inversion or prolapse of the leaflets, 
2- Hold the valve in place while the ventricle is pumping blood, 

3-   Draw the mitral ring toward the apex causing further shorting of the long axis of the contracting left 
ventricle thus, contributing to ejection of left ventricular blood through the aortic valve. They contract 
just before left ventricular wall contraction [5]. 
The posteromedial papillary muscle is supplied via the dominant right coronary artery or the circumflex 
(only one source) and the anterolateral is supplied by the LAD, Diagonal or marginal branch of 
circumflex artery (dual blood supply). 
Papillary muscle dysfunction (PMD) can be due to ischemia. This dysfunction syndrome can be evaluated 
with tissue Doppler strain imaging. Dysfunction is not an independent determinant of mitral regurgitation. 
Papillary muscle tethering distance is the final determinant of MR and PMD is one of the determinants of 
the tethering distance along with LV remodeling. As the papillary muscles contract during the isometric 
phase, the closed mitral valve is brought down into the left ventricle leading to a reduction of the 
longitudinal axis and increasing the short axis producing increased myocardial fiber stretch, greater wall 
tension, contraction and stroke volume. If the left ventricle dilates; wall tension increases as by Laplace`s 
law producing increased systolic wall stress that can be assessed with the echocardiogram. Interruption of 
the papillary –annular complex causes impairment of the normal left ventricular stress-strain patterns 
Revascularization of the viable adjacent left ventricular wall is expected to improve mitral apparatus 
`functions. Lillehei and others, in 1965 reported the continuity between mitral annulus and the papillary 
muscles, subsequently; they started preservation of the posterior leaflet [4].                            
 David and his colleagues in 1984, described mitral valve replacement with preservation of both leaflets 
Modifications were added to: prevent preserved tissues from affecting prosthetic valve function and 
adequate size of the prosthesis; also to prevent LV outflow tact obstruction [4-7]                                                                    
Functional ischemic mitral regurgitation is a complex disorder with a poor prognosis., it is known that 
post-infarction left ventricular remodeling is the most significant factor in the development of this mitral 
valve lesion. Echocardiography and magnetic resonance imaging have made significant contributions to 
clarifying the many mechanisms that progressively worsen mitral regurgitation [8] 

Left ventricular remodeling owing to severe myocardial infarction plays an important role in mitral valve 
lesion-development, although local involvement of the papillary muscles is also a factor. Annular dilation 
is not the direct cause of regurgitation, but the consequence of the different mechanisms leading to a lack 
of valve coaptation [9]                                                             
The ischemic origin of the severe ischemic mitral regurgitation is evident when the posterior papillary 
muscle appears to be elongated and presents a partial rupture.(12-15). Functional ischemic mitral 
regurgitation is currently one of the most widely investigated medical conditions at the international level 
[10-12]. 
In patients with non-ischemic mitral regurgitation, the abnormal valve structure leads to functional 
deterioration of the left ventricle because of dilation and, eventually, to ventricular dysfunction. In 
contrast, the ventricular dysfunction in coronary artery disease generates a series of changes in left 
ventricular geometry and in the various components of the mitral valve resulting in the functional 
anatomy of non-ischemic mitral regurgitation [13] The progressive increase in mitral 
regurgitation results in an increase in ventricular dilation and wall stress, thus establishing a 
vicious circle, with progressive deterioration of ventricular function [14-15].       There is still 
controversy about the best surgical approach, particularly with regard to whether to replace or 
repair the valve, the type and size of prosthesis to be used in mitral replacement for severe 
rheumatic and / or severe ischemic mitral valve disease [16]. 
 
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. 
Patients and Methods: 
This prospective cross-sectional comparative study included 50 patients with isolated rheumatic mitral 
valve disease (group A) and 50 patients with ischemic mitral disease (group B).  

The Institutional Review Board (IRB) or Ethics Committee (EC) and consent of each patient were 
obtained 
Criteria for inclusion of patients for mitral valve replacement according to the guide lines:  
For mitral stenosis: Mitral valve replacement is an option for treatment only if there is no other option and 
the patient has severe limiting symptoms [11]. Because the natural history of rheumatic MS is one of slow 
progression over decades, surgery should be delayed until the patient has severe limiting symptoms 
(NYHA class III or IV)-[17–20]. Patients who increase their trans-mitral gradients to >15 mm Hg with 
exercise have been shown to improve symptomatically after intervention. Intervention should be delayed 
until symptoms are severely limiting and cannot be managed with diuresis and heart rate control [.21]. 
For mitral regurgitation: most patients with acute severe MR require surgical correction for 
reestablishment of normal hemodynamics and for relief of symptoms [22].  
Chronic primary MR include infective endocarditis, connective tissue disorders, rheumatic heart disease, 
cleft mitral valve, and radiation heart disease Correction of the MR before irreversible changes occur can 
be curative. For mixed MS and MR: mitral valve replacement may be necessary if therapy with diuretics 
do not relieve symptoms, but it should be performed only in patients who have severe limiting symptoms. 
The selected surgical technique: 
The left atrial approach: mitral valve inspection: we incise any fused commissures towards the valve 
annulus, fused or thickened chordae were mobilized. Anterior leaflet was incised from its middle; the 
incision continued to the annulus, the middle was selected for incision as it is devoid of chordal 
attachment. TiCron sutures 2/0 with pledgets (non-absorbable, polyester braided sutures) were bitten from 
annulus thence; those were passed from the bottom to the tip of the leaflet.  Lastly, each suture was 
anchored to the bi-leaflet mitral prostheses (St. Jude bi-leaflet –low profile prostheses were used in all 
patients but, with different sizes (mostly 27-sized prosthesis). The posterior leaflet was preserved by 

leaflet plicating sutures. The prosthetic mechanical valve was placed perpendicularly to the original mitral 
valve orifice. Modifications were done to prevent the preserved tissue from interfering with prosthetic 
valve function, to implant an adequate size of valve and to prevent left ventricle outflow tract obstruction. 
For myocardial ischemia with valve lesions, arterial bypass grafts will have the priority above the venous 
grafts. 
Sample size 
The sample has been calculated according to the following formula (Shujuikuo et al., 2 018): 
N= (Z/D)^2p(1-p) 
N=is the sample size 
Z=is the standard normal deviate = 1.96 at confidence interval 90% 
D=is the desired confidence level (90% that the population proportion falls within 10% of the sample 
proportion) 
P=is the sample proportion =0.7 
Calculated number of patients= 46 patients. We will add 4 patients for possible incomplete study of 4 or 
less patients. Finally patients to be studied= 100 patients 
 
 
 
 
 
Ethical considerations: 

            The study protocol will be approved by the research ethics committee of the faculty of 
medicine, Suez Canal University and The Tumor- Hospital in Ismailia. 
            An informed consent for carrying out special investigations will be taken from patients 
undergoing this study. 
This consent is attached to protocol and contains: 
1. 
Explanation of aim, procedure, and potential benefits of the study  in a simple way easy 
to understand. 
2. 
No harmful maneuver will be used, potential risks will be minimized by performing the 
procedure under supervision of a qualified trained cardiologist.  
3. 
 All data will be considered confidential and will not be used outside this study without 
patient approval. 
4. 
Researcher phone number and all communicating methods will be identified to patient .  
5. 
Patients will be announced by results of study .  
6. 
Patient has the right to withdraw from this study at any time without affecting their 
routine medical care. 
7. 
Signature or finger prints of patients.                      
 
 
Data management and statistical analysis: 

     Data collected will be coded, entered, and analyzed using Microsoft excel program software. 
      Statistical package for social science (SPSS) will be used for data analysis. 
The independent data of study will be conducted and analyzed to identify rate of  
post-infusion Cardiovascular events and its relation to pre-infusion status , post- 
infusion status. 
The proper statistical tests will be used. 
 
 
Statistical analysis : 
Coefficient is positive, if one variable tends to increase as the other decreases.                                      
Coefficient is negative, if one variable tends to decrease as the other increases. 
We will do test for normalization of data, like Kolmogorov- Simirnove or Shapiro test because 
normally distributed data will be analyzed by non-parametric tests. 
Parameters at baseline and the end of every cycle of chemotherapy will be analyzed by linear 
mixed effects. COX regression analysis is needed to compare between patients affected by 
cardio-toxicity and non-affected patients.   
P. value is considered as significant when:  P < 0.05. 
Value of P  less than or equal  to 0.05 will be considered statistically significant. 

Time Table: 
 
August  2016 to 
September2016 
 
October  2016 to 
 November 2018 
 
Dec.  2018 
 to 
Jan.  2019  
 
Feb. 2019 
 to 
October  2020 
 
Preparatory 
period and 
protocol approval  
 
 
 
 
 
 
 
 
 
 
Data collection 
and field work 
 
 
 
 
 
 
 
 
 
 
 
 
Data management  
 
 
 
 
 
 
 
 
 
 
 
 

Finishing and 
printing  
 
 
 
 
 
 
 
 
Budget: 
Preparing protocol 
 
500  L.E 
Collecting    data  including  
Transplantation fees  
 
4000  L.E 
Echocardiographic assessment 
 
 9200 L.E 
Statistical analysis  
 
2000 L.E 
Printing and finishing  
 
1000 L.E 
Preparing thesis  
 
300 L.E 
Total 
 
 17000L.E 
 

 
 
 
 
 
 
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