Skeletonised Versus Pedicled Internal Thoracic Artery

Summary

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.

Conditions

• Heart Diseases

Interventions

PROCEDURE

Pedicled

Surgical procedure: A prior marking was made on both sides of the LIMA and its veins with bi-polar technique. Hereafter the LIMA and its veins were dissected free with scissor and forceps. Clips were added to all side branches. When the full length of LIMA was obtained, the LIMA and its veins were divided distally by adding clips on the peripheral part of the vessels and proximately dividing by scissor. A vessel-clamp was placed distally and the pedicled LIMA placed in the jugular cavity with a cloth containing papaverine.

PROCEDURE

Surgical skeletonised

Surgical procedure: The fascia of the LIMA was opened with a scissor. Hereafter the LIMA was dissected free with scissor and forceps, clips on all LIMA side-branches and divided by scissor. When the full length of LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.

PROCEDURE

Thunderbeat skeletonised

Surgical procedure: With Thunderbeat the fascia of LIMA was opened. The LIMA was dissected free with Thunderbeat including all side-branches. When the full length of the LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.

Sponsors & Collaborators

• Odense Patient Data Explorative Network

  collaborator OTHER

• GCP-unit at Odense University Hospital

  collaborator UNKNOWN

• Lars Peter Riber

  lead OTHER

Principal Investigators

• Lars P Riber, MD, Ph.D. DMSc · Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2021-04-30

Completion

2021-11-30

Countries

• Denmark

Study Locations