Beating Versus Arrested Heart for Mitral Valve Replacement (BAHMVR)

Federal University of Bahia

Status and phase: Completed; Phase 4

Conditions: Mitral Insufficiency; Mitral Stenosis

Treatments: Procedure: mitral valve replacement; Procedure: Mitral valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT01641614

REQ:690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Beating heart surgery

Experimental group

Description:

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.

Treatment:

Procedure: Mitral valve replacement

heart surgery Group B

Active Comparator group

Description:

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.

Treatment:

Procedure: mitral valve replacement