Bleeding and Blood Transfusion in MVR

Study Overview
=================
Brief Summary
-----------------
To identify the best approach for mitral valve replacement to decrease risk of bleeding and restrict blood transfusion and its complication.

Detailed Description
-----------------
Mitral valve disease is the most common form of the valvular heart disorders including mitral regurgitation and mitral stenosis. Surgical treatment includes repair and replacement with different approaches as conventional median sternotomy or minimally invasive approaches. Since minimally invasive mitral valve surgery (MMVS) was first described in the mid-to-late 1990s by pioneer surgeons Alain Carpentier and Randolph Chitwood, the techniques have evolved to include mini-thoracotomy, port-access thoracoscopic, partial sternotomy, and robotic. Right lateral mini-thoracotomy has become the standard approach for mitral valve surgery in many centers. These approaches may result in less surgical trauma, blood transfusions, and pain, thereby leading to a shorter hospital stay and faster return to daily activities. A reduction in postoperative hemorrhage and transfusion requirements have been suggested as a potential advantage of minimally invasive valve surgery. This benefit is important given the significant morbidity and mortality associated with transfusions and re-exploration for bleeding. Observational studies suggested that patients undergoing MMVS required fewer units of pRBCs transfused per patient and patients were at lower risk of transfusion. RCTs did not reach statistical significance. So, more studies were required to reach a definite conclusion. Through this study our aim is to evaluate postoperative bleeding and needs for blood transfusion in conventional median sternotomy mitral valve replacement in comparison to minimally invasive approach.

Official Title
-----------------
Bleeding and Needs for Blood Transfusion in Mitral Valve Replacement, Comparison Between Median Sternotomy and Minimally Invasive Approach.

Conditions
-----------------
Mitral Valve Disease

Intervention / Treatment
-----------------
* Procedure: Mitral valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing mitral valve replacement through minimally invasive or median sternotomy at Assiut Cardiothoracic surgery department. Exclusion Criteria: Patients refused to be enrolled in research. Emergency, redo procedures, active infectious endocarditis, and combined surgery (valve surgery and coronary artery bypass graft).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MVR through Median sternotomy<br> | Procedure: Mitral valve replacement<br>* Mitral valve replacement through median sternotomy and minimally invasive approach<br>|
| MVR through Minimally invasive approach<br> | Procedure: Mitral valve replacement<br>* Mitral valve replacement through median sternotomy and minimally invasive approach<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding | Amount of post operative bleeding per drains | Baseline | 
| Blood transfusion | Amount of blood products transfused | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reexploration | Number of patients re-explored due to massive bleeding | Baseline | 
| Complications of blood transfusion | Complications of blood transfusion | Baseline | 
| ICU stay | Numbered of days patient stayed in ICU | Baseline | 
| Cost effectiveness | Financial aspect | Baseline |