OPEN Research Support
head

Consultant
Sofie Laugesen
Department of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.11.2018  
Slut 01.01.2021  
 



Skeletonized versus pedicled internal tho-racic artery – A Randomized Study The Skeletonization trial (TST)

Short summary

Coronary artery bypass grafting (CABG) is one of the most commonly performed heart operation.

It is to date unknown whether skeletonized left internal thoracic artery (LIMA) is superior to pedicle har-vested LIMA, though some studies have shown improved flow-rates in the skeletonized graft and com-promised blood flow to the thoracic wall after pedicle harvested LIMA.

We expect that this study will provide important information that can lead to a better understanding of which method is the best technic to harvest the LIMA when undergoing CABG


Rationale

Background: It is to date unknown whether skeletonized left internal thoracic artery (LIMA) is superior to pedicle harvested LIMA, though some studies have shown improved flow-rates in the skeletonized graft and compromised blood flow to the thoracic wall after pedicle harvested LIMA. Thunderbeat© by Olym-pus offer yet another new tool for skeletonized dissection of LIMA, which might be even more beneficial in regards to the patency of the vessel, perfusion of the thoracic wall and increased flow rates.

Aim: The aim of this study is to compare the outcome in form of patency of LIMA, perfusion of the thorac-ic wall and flow rates in LIMA depending of the chosen method of harvesting LIMA: Pedicled (1) surgically skeletonized (2), skeletonized with Thunderbeat© (3). 

Method: Patients scheduled for elective CABG including LIMA-graft, will prior to surgery randomly be assigned to one of three groups: Pedicled (1), surgically skeletonized (2) skeletonized with Thunderbeat© (3). The study will be conducted as a prospective randomized non-blinded controlled study.   

We expect that this study will provide important information that can lead to a better understanding of which method is the best technic to harvest the LIMA when undergoing CABG.  Such optimization could improve the quality of life for each patient (prolonged life free of angina, less risk of mediastinitis, less nerve injury in the thoracic wall with better sensibility and less risk of permanent chest pain due to nerve injury), which may lower perioperative costs related to reoperations due to bleeding, graft failure and sternal infection



Description of the cohort

Patients enlisted for elective stand-alone CABG surgery with intended use of LIMA operated by one of the study's appointed heart surgeons on Odense University Hospital. 

• Stand-alone CABG (surgical removal of the left atrial appendage exclusion, LAAX. is accepted)  

• On-pump with cardioplegia

• Patients aged >18

• Elective surgery



Data and biological material

Pre-Operation:  Baseline characteristics that will be accounted for in this study will be:• Gender• Age• Smoking status• Diabetes – with or without insulin• Ventricular ejection fraction (EF)• Prior incidence of stroke• Atrial fibrillation (afib)• Hypertension• Hyper cholesterol• Obesity• Euroscore• Kidney counts • EQ-5D-5L standard survey (a survey regarding their own evaluation of function and pain prior to operation)Intraoperative:• Perioperative flow and pulsatility index measured in LIMA by systolic pressure of 100 mmHg.• Duration of cross-clamp and perfusion time.• Time to harvest LIMA (defined as time lap from the insertion to the removal of the LIMA-harvesting sternal retractor.  • Sternal perfusion measured perioperative before sternotomy and after sternal closure.• The use of sternal vax • Size of LIMA (eyeballing)  Postoperative:• Transfusion requirements • Bleeding complications and re-operation• Sternal wound impairment requiring surgical therapy• Duration of intensive care unit • Total days of hospitalization  • Completion of EQ-5D-5L standard survey on day 3 • Thoracic pain at day 3 including the amount of painkillers used.• Values of CRP, Leucocytes in blood work day 3• Perioperative values of troponin and CKMB 


Collaborating researchers and departments

Department of cardiothoracic surgery, Odense University hospital 

  • Intern Sofie Laugesen 
  • Consultant Poul Erik Mortensen
  • Consultant Søren Bak
  • Consultant Peter Pallesen
  • Consultant Bo Juel Kjeldsen