Myocardial Protection in Minimally Invasive Mitral Valve Surgery

Study Overview
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Brief Summary
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Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest. Aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair. A single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.

Official Title
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Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair: Outcome on Myocardial Pro-tection

Conditions
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Myocardial Protection, Minimally Invasive Surgery, Mitral Valve Prolapse

Intervention / Treatment
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* Device: Aortic clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgical indication for mitral valve repair. Right mini-thoracotomy approach. Retrograde arterial perfusion. Exclusion Criteria: Age more than 75 years. Cardiac ejection fraction lower than 40%. Previous cardiac surgery procedures for coronary artery bypass graft. Any degree of coronary artery disease. Severe peripheral vascular disease. Concomitant procedures for atrial fibrillation ablation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EAC<br>Patients undergoing surgery endo-aortic clamp. | Device: Aortic clamp<br>* In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.<br>|
| TTC<br>Patients undergoing surgery through trans-thoracic aortic clamp. | Device: Aortic clamp<br>* In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cTn-T levels immediately after surgery | Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping | Immediately after surgery | 
| CK-MB levels immediately after surgery | Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping | Immediately after the surgery | 
| cTn-T levels 6h | Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping | hour 6 after surgery | 
| CK-MB levels 6h | Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping | hour 6 after surgery | 
| cTn-T levels 12h | Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping | hour 12 after surgery | 
| CK-MB levels 12h | (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping | hour 12 after surgery | 
| cTn-T levels 24h | Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping | hour 24 after surgery | 
| CK-MB levels 24h | Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping | hour 24 after surgery |