Myocardial Protection in Minimally Invasive Mitral Valve Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Prolapse; Minimally Invasive Surgery; Myocardial Protection
• Intervention / Treatment: Device: Aortic clamp

• Study Type: Observational
• Enrollment (Actual): 116

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EAC; Patients undergoing surgery endo-aortic clamp.	Device: Aortic clamp; In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.
TTC; Patients undergoing surgery through trans-thoracic aortic clamp.	Device: Aortic clamp; In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Valve Prolapse; Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: 0063123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No