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NCT Number: NCT05562908

Skeletonised Versus Pedicled Internal Thoracic Artery

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.

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Key information

Conditions

Heart Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardio, Vascular and Thoracic Surgery

Odense, Region Syddanmark, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pedicled

Procedure

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.

Surgical skeletonised

Procedure

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.

Thunderbeat skeletonised

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Re-operation due to bleeding

    Time frame: Up to 48 hours calculated from the end of primaery surgery

    Number of patients in each group

  3. Re-operation due to ischemia

    Time frame: Up to 48 hours calculated from the end of primaery surgery

    Number of patients in each group

  4. Pleurocentesis

    Time frame: Up to 10 days calculated from the end of primaery surgery

    Number of patients in each group

  5. Myocardial injury - creatine kinase-MB (CK-MB)

    Time frame: Routine bloodsample measured four hours after aortic cross clamp removal.

    Unit: (µg/L)

  6. Myocardial injury - cardiac troponin (cTn)

    Time frame: Routine bloodsample measured four hours after aortic cross clamp removal.

    Unit: (ng/L)

  7. 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)

  8. Length of stay on ICU

    Time frame: Day of surgery to the day of discharge from ICU. Up to 52 weeks

    Unit: Days

  9. Length of stay in hospital

    Time frame: Day of surgery to the day of discharge from hospital. Up to 52 weeks

    Unit: Days

  10. 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.

  11. 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)

  12. 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

  13. 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

  14. 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

  15. Rate of mortality due to cardiac event - Early

    Time frame: Early (≤30 days)

    Number of deaths in each group

  16. Rate of mortality due to cardiac event - Intermediate

    Time frame: Intermediate (≤180 days)

    Number of deaths in each group

  17. Rate of mortality due to cardiac event - Iong

    Time frame: Long (≤2 years)

    Number of deaths in each group

  18. Rate of all-cause mortality - Early

    Time frame: Early (≤30 days)

    Number of deaths in each group

  19. Rate of all-cause mortality - Intermediate

    Time frame: Intermediate (≤180 days)

    Number of deaths in each group

  20. Rate of all-cause mortality - long

    Time frame: Long (≤ 2 years)

    Number of deaths in each group

Sponsors and collaborators

Lead sponsor

Lars Peter Riber

Other

Collaborators

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

Registry information

Official study title

Skeletonised Versus Pedicled Internal Thoracic Artery - A Randomised Study

Acronym: TST

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2022
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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