Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- mitral valve replacement
Study Overview
Brief Summary
The purpose of this study is to evaluate the immediately clinic and ultramicroscopic myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested heart versus on-pump empty beating heart surgical techniques.
Detailed Description
During open-heart surgery prevention of ischemia and reperfusion following cardioplegic arrest are essential for myocardial protection. Beating heart surgery on normothermic bypass simulates physiologic cardiac status and is good method for myocardial protection. A comparison of both available techniques for valve replacement arrested heart versus on-pump empty beating heart of the clinical and ultramicroscopic myocardial alterations will allowed to better understand myocardial protection because eliminated the use of cardioplegia and the corollary risk of ischemic reperfusion injury.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patient included into the study were adults 18-60 years old,
- •with an echocardiography diagnosis of mitral and/or tricuspid valve disease due to inflammatory acquired diseases,
- •no previous history of cardiac surgery and d) elective indication for valve replacement.
Exclusion Criteria
- •with metabolic diseases such as diabetes mellitus and uremia,
- •with coronary artery diseases,
- •dilated myocardiopathy,
- •with severe chronic pulmonary obstructive diseases,
- •with present or past history of malignant diseases,
- •acute endocarditis
- •with severe pre-operatory laboratory parameters such as creatinine levels > 3mg/dL, Hemoglobin ≤ 7.0 g/dL, Prothrombin time/activity ≤ 70% and clotting time ≥ 10 minutes.
Outcomes
Primary Outcomes
mitral valve replacement
Time Frame: 1hour , 3 hours and 1 hour after surgery procedure
Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups with the beating heart also in the group B.
Secondary Outcomes
- Ultramicroscopic evidences of ischemia(1hour, 3 hours and 1 hour after aortic clamping)
Investigators
Clotario Neptali Carrasco Cueva
Medical Doctor , Profesor of Cardiac Surgery
Federal University of Bahia