BAHMVR: Beating Versus Arrested Heart for Mitral Valve Replacement

Sponsor

Federal University of Bahia (Other)

Overall Status

Completed

CT.gov ID

NCT01641614

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Stenosis Mitral Insufficiency	Procedure: Mitral valve replacement Procedure: mitral valve replacement	Phase 4

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

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Beating heart surgery 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.	Procedure: Mitral valve replacement 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
Active Comparator: heart surgery Group B 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.	Procedure: mitral valve replacement 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

Arm

Intervention/Treatment

Experimental: Beating heart surgery

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.

Procedure: Mitral valve replacement

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

Active Comparator: heart surgery Group B

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.

Procedure: mitral valve replacement

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.