Skeletonised Versus Pedicled Internal Thoracic Artery (TST)

October 3, 2022 updated by: Lars Peter Riber

Skeletonised Versus Pedicled Internal Thoracic Artery - A Randomised Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Of Southern Denmark
      • Odense, Region Of Southern Denmark, Denmark, 5000
        • Department of Cardio, Vascular and Thoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pedicled
Harvesting of LIMA with its surrounding tissue: fascia, veins, etc
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.
Active Comparator: Surgical skeletonised
Harvesting of LIMA in a "naked" fashion where you dissect the artery free of the surrounding tissue.
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.
Active Comparator: Skeletonised with Thunderbeat
Same as Surgical skeletonised but instead of closing the side branches with clips a surgical tool is used for coagulation of the side-branches.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in flow in LIMA and pulssatility index between the three groups.
Time Frame: Perioperative - After weaning off the extracorporeal circulation just before closing the thorax
mL/ min With transit time flowmetry (Sono TT flowlab), the graft flow and peripheral index (PI) are measured after weaning off the extracorporeal circulation with a systolic pressure aimed at 100 mmHg. The measurements are done with probe size 3 or 4.
Perioperative - After weaning off the extracorporeal circulation just before closing the thorax

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative bleeding
Time Frame: Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit
Unit: mL
Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit
Re-operation due to bleeding
Time Frame: Up to 48 hours calculated from the end of primaery surgery
Number of patients in each group
Up to 48 hours calculated from the end of primaery surgery
Re-operation due to ischemia
Time Frame: Up to 48 hours calculated from the end of primaery surgery
Number of patients in each group
Up to 48 hours calculated from the end of primaery surgery
Pleurocentesis
Time Frame: Up to 10 days calculated from the end of primaery surgery
Number of patients in each group
Up to 10 days calculated from the end of primaery surgery
Myocardial injury - creatine kinase-MB (CK-MB)
Time Frame: Routine bloodsample measured four hours after aortic cross clamp removal.
Unit: (µg/L)
Routine bloodsample measured four hours after aortic cross clamp removal.
Myocardial injury - cardiac troponin (cTn)
Time Frame: Routine bloodsample measured four hours after aortic cross clamp removal.
Unit: (ng/L)
Routine bloodsample measured four hours after aortic cross clamp removal.
Differences in pre and post operative regional oxygen saturation on the thorax.
Time Frame: Measured 7 days prior to surgery and again 3 days after surgery
Unit: oxygen saturation (rSO2)
Measured 7 days prior to surgery and again 3 days after surgery
Length of stay on ICU
Time Frame: Day of surgery to the day of discharge from ICU. Up to 52 weeks
Unit: Days
Day of surgery to the day of discharge from ICU. Up to 52 weeks
Length of stay in hospital
Time Frame: Day of surgery to the day of discharge from hospital. Up to 52 weeks
Unit: Days
Day of surgery to the day of discharge from hospital. Up to 52 weeks
EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups
Time Frame: Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.
Developed by the EURO-QoF group in 1990 to describe five dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems and a visual analogue scale recording the patient's self-rated health.
Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.
Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision.
Time Frame: 180 ± 7 days calculated from the date of surgery.
All questions are closed questions and qualitative variables (yes/no)
180 ± 7 days calculated from the date of surgery.
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early
Time Frame: Early (≤30 days)
Number of deaths in each group
Early (≤30 days)
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Intermediate
Time Frame: Intermediate (≤180 days)
Number of deaths in each group
Intermediate (≤180 days)
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Long
Time Frame: Long (≤2 years)
Number of deaths in each group
Long (≤2 years)
Rate of mortality due to cardiac event - Early
Time Frame: Early (≤30 days)
Number of deaths in each group
Early (≤30 days)
Rate of mortality due to cardiac event - Intermediate
Time Frame: Intermediate (≤180 days)
Number of deaths in each group
Intermediate (≤180 days)
Rate of mortality due to cardiac event - Iong
Time Frame: Long (≤2 years)
Number of deaths in each group
Long (≤2 years)
Rate of all-cause mortality - Early
Time Frame: Early (≤30 days)
Number of deaths in each group
Early (≤30 days)
Rate of all-cause mortality - Intermediate
Time Frame: Intermediate (≤180 days)
Number of deaths in each group
Intermediate (≤180 days)
Rate of all-cause mortality - long
Time Frame: Long (≤ 2 years)
Number of deaths in each group
Long (≤ 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Peter Riber

Collaborators

Odense Patient Data Explorative Network
GCP-unit at Odense University Hospital

Investigators

  • Study Director: Lars P Riber, MD, Ph.D. DMSc, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP_764
  • S-20180083 (Registry Identifier: The Danish ethical committee - region of southern Denmark)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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