Clinical Trial: Beating Versus Arrested Heart for Mitral Valve Replacement

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement

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 Summary: 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.
Sponsor: Federal University of Bahia

Current Primary Outcome: 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.


Original Primary Outcome: Cardiac dysfunction [ Time Frame: 1hour , 3 hours and 1 hour after surgery procedure ]

Echocardiogram was performed before and after the surgery procedure in both groups using a transthoracic technique to measure ejection fraction and the systolic pressure of pulmonary artery. Cardiac dysfunction New York Heart Association functional class protocol (NYHA) was adopted to classify the degree of cardiac dysfunction of each patient before and after surgery.


Current Secondary Outcome: Ultramicroscopic evidences of ischemia [ Time Frame: 1hour, 3 hours and 1 hour after aortic clamping ]

During the surgery myocardial biopsies were performed as full thickness transmural specimen of three small fragments for electromicrospic analysis


Original Secondary Outcome: Same as current

Information By: Federal University of Bahia

Dates:
Date Received: July 10, 2012
Date Started: April 2010
Date Completion:
Last Updated: July 17, 2012
Last Verified: July 2012