Myocardial Protection in Minimally Invasive Mitral Valve Surgery
- Conditions
- Myocardial ProtectionMitral Valve ProlapseMinimally Invasive Surgery
- Interventions
- Device: Aortic clamp
- Registration Number
- NCT04231903
- Lead Sponsor
- University of Turin, Italy
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- Surgical indication for mitral valve repair.
- Right mini-thoracotomy approach.
- Retrograde arterial perfusion.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EAC Aortic clamp Patients undergoing surgery endo-aortic clamp. TTC Aortic clamp Patients undergoing surgery through trans-thoracic aortic clamp.
- Primary Outcome Measures
Name Time Method CK-MB levels immediately after surgery Immediately after the 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
cTn-T levels 6h hour 6 after surgery Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
cTn-T levels 12h hour 12 after surgery Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 6h hour 6 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
cTn-T levels immediately after surgery Immediately after surgery Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 12h hour 12 after surgery (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels 24h hour 24 after surgery Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 24h hour 24 after surgery Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
- Secondary Outcome Measures
Name Time Method