Beating Versus Arrested Heart for Mitral Valve Replacement

Phase 4

Completed

• Conditions: Mitral Stenosis; Mitral Insufficiency
• Interventions: Procedure: mitral valve replacement

• 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

Arm && Interventions

Group	Intervention	Description
Beating heart surgery	mitral valve replacement	Group A (Beating heart) surgery was performed under normal temperature (36⁰ C) ,once CPB was established, the patient was placed in Trendelenburg position and a retrograde perfusion catheter was inserted into the coronary sinus and ligated by a simple suture line. Aorta cross clamping was immediately established and blood was oxygenated and delivered continuously through a catheter Mitral valve was exposed using the left atrial retractor. Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture De Vegas' technique.
heart surgery Group B	mitral valve replacement	Group B (arrested heart) surgery was performed under moderate hypothermia (32⁰C) as technique requirement (3). After cardiac arrest, during the period of cross clamping, the aortic root was perfused through the cardioplegias's cannula with oxygenated blood at a rate between 200 mL/min to 300 mL/min for 2 minutes with 15 minutes intervals.Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture De Vegas' technique.

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