Myocardial Protection in Minimally Invasive Mitral Valve Surgery

NCT04231903 | Completed

• 1 other identifier: 0063123
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Protection; Minimally Invasive Surgery; Mitral Valve Prolapse

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

EAC

Patients undergoing surgery endo-aortic clamp.

Device: Aortic clamp

TTC

Patients undergoing surgery through trans-thoracic aortic clamp.

Device: Aortic clamp

Interventions

Aortic clamp DEVICE

In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.

EAC; TTC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All comers at our Deparment with diagnosis of mitral valve disease with surgical indication for mitral valve repair through the right mini-thoracotomy approach and retrograde arterial perfusion.

You may qualify if:

• Surgical indication for mitral valve repair.
• Right mini-thoracotomy approach.
• Retrograde arterial perfusion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Cardio-thoracic Surgeon, Principal Investigator

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 18, 2020
• Study Start: June 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: January 18, 2020

Record last verified: 2020-01