Beating Versus Arrested Heart for Mitral Valve Replacement

Phase 4

Completed

• Conditions: Mitral Stenosis; Mitral Insufficiency

• Registration Number: NCT01641614
• Lead Sponsor: Federal University of Bahia

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2011-03
• Study Completion: 2012-01
• Status Verified: 2012-07
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mitral valve replacement	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 Outcome Measures

Name	Time	Method
Ultramicroscopic evidences of ischemia	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

Trial Locations

Locations (1)

Hospital Ana Neri; 🇧🇷 Salvador, Bahia, Brazil