Skeletonised Versus Pedicled Internal Thoracic Artery (TST)

Lars Peter Riber

Status: Completed

Conditions: Heart Diseases

Treatments: Procedure: Thunderbeat skeletonised; Procedure: Surgical skeletonised; Procedure: Pedicled

Study type: Interventional

Funder types: Other

Identifiers

NCT05562908

S-20180083 (Registry Identifier)

OP_764

Details and patient eligibility

About

It is to date unknown whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonisation is superior to pedicle harvested LIMA. Though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall after pedicle harvested LIMA.

The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.

The aim of this study is to compare three groups of LIMA harvesting techniques: Pedicled, surgical skeletonised and skeletonised with Thunderbeat to determine the best way to harvest LIMA during CABG operations.

The study design is an experimental randomized controlled trial in a single centre.

Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.

Study Unit: Test-days within subject and subject

The study will address two main hypotheses in CABG patients:

1. That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).
2. Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)
• On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)
• Patients aged >18
• Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)

Exclusion criteria

• CABG combined with other heart surgery, except from LAAX
• Previous heart surgery
• LVEF < 40% (there is a known higher risk of postoperative complications with low LVEF)
• Known cancers (there is a known higher risk of postoperative complication)
• Thoracic radiation therapy (there is a known higher risk of postoperative complication)
• Severe chronic obstructive pulmonary disease (COPD) (there is a known higher risk of postoperative complication)
• Patients not able to understand written consent
• Urgent and emergent surgery (there is a known higher risk of postoperative complication)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 3 patient groups

Pedicled

Active Comparator group

Description:

Harvesting of LIMA with its surrounding tissue: fascia, veins, etc

Treatment:

Procedure: Pedicled

Surgical skeletonised

Active Comparator group

Description:

Harvesting of LIMA in a "naked" fashion where you dissect the artery free of the surrounding tissue.

Treatment:

Procedure: Surgical skeletonised

Skeletonised with Thunderbeat

Active Comparator group

Description:

Same as Surgical skeletonised but instead of closing the side branches with clips a surgical tool is used for coagulation of the side-branches.

Treatment:

Procedure: Thunderbeat skeletonised