Skeletonised Versus Pedicled Internal Thoracic Artery

NCT05562908 | Completed DMC

• 2 other identifiers: OP_764S-20180083
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

coronary artery diseases; left internal mammary artery; LIMA harvesting; flow; quality of life

Outcome Measures

Primary Outcomes (1)

• Differences in flow in LIMA and pulssatility index between the three groups.

  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 Outcomes (20)

• Postoperative bleeding

  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

  Up to 48 hours calculated from the end of primaery surgery

• Re-operation due to ischemia

  Up to 48 hours calculated from the end of primaery surgery

• Pleurocentesis

  Up to 10 days calculated from the end of primaery surgery

• Myocardial injury - creatine kinase-MB (CK-MB)

  Routine bloodsample measured four hours after aortic cross clamp removal.

Study Arms (3)

Pedicled

ACTIVE COMPARATOR

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

Procedure: Pedicled

Surgical skeletonised

ACTIVE COMPARATOR

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

Procedure: Surgical skeletonised

Skeletonised with Thunderbeat

ACTIVE COMPARATOR

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

Interventions

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.

Pedicled

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.

Surgical skeletonised

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.

Skeletonised with Thunderbeat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lars Peter Riber: lead
• Odense Patient Data Explorative Network: collaborator
• GCP-unit at Odense University Hospital: collaborator

Study Sites (1)

Department of Cardio, Vascular and Thoracic Surgery

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (19)

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• Sa MP, Cavalcanti PE, Santos HJ, Soares AF, Miranda RG, Araujo ML, Lima RC. Flow capacity of skeletonized versus pedicled internal thoracic artery in coronary artery bypass graft surgery: systematic review, meta-analysis and meta-regression. Eur J Cardiothorac Surg. 2015 Jul;48(1):25-31. doi: 10.1093/ejcts/ezu344. Epub 2014 Sep 15.

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• Kamiya H, Akhyari P, Martens A, Karck M, Haverich A, Lichtenberg A. Sternal microcirculation after skeletonized versus pedicled harvesting of the internal thoracic artery: a randomized study. J Thorac Cardiovasc Surg. 2008 Jan;135(1):32-7. doi: 10.1016/j.jtcvs.2007.09.004.

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• Markman PL, Rowland MA, Leong JY, Van Der Merwe J, Storey E, Marasco S, Negri J, Bailey M, Rosenfeldt FL. Skeletonized internal thoracic artery harvesting reduces chest wall dysesthesia after coronary bypass surgery. J Thorac Cardiovasc Surg. 2010 Mar;139(3):674-9. doi: 10.1016/j.jtcvs.2009.03.066. Epub 2009 Sep 22.

  PMID: 19775705 BACKGROUND

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• Lee SW, Jo JY, Kim WJ, Choi DK, Choi IC. Patient and haemodynamic factors affecting intraoperative graft flow during coronary artery bypass grafting: an observational pilot study. Sci Rep. 2020 Jul 31;10(1):12968. doi: 10.1038/s41598-020-69924-w.

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• Mannacio V, Di Tommaso L, De Amicis V, Stassano P, Vosa C. Randomized flow capacity comparison of skeletonized and pedicled left internal mammary artery. Ann Thorac Surg. 2011 Jan;91(1):24-30. doi: 10.1016/j.athoracsur.2010.06.131.

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• Mazur P, Litwinowicz R, Tchantchaleishvili V, Natorska J, Zabczyk M, Bochenek M, Przybylski R, Iwaniec T, Kedziora A, Filip G, Kapelak B. Left Internal Mammary Artery Skeletonization Reduces Bleeding-A Randomized Controlled Trial. Ann Thorac Surg. 2021 Sep;112(3):794-801. doi: 10.1016/j.athoracsur.2020.10.024. Epub 2020 Nov 7.

  PMID: 33171172 BACKGROUND

• Ben-Yehuda O, Chen S, Redfors B, McAndrew T, Crowley A, Kosmidou I, Kandzari DE, Puskas JD, Morice MC, Taggart DP, Leon MB, Lembo NJ, Brown WM, Simonton CA, Dressler O, Kappetein AP, Sabik JF, Serruys PW, Stone GW. Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial. Eur Heart J. 2019 Jun 21;40(24):1930-1941. doi: 10.1093/eurheartj/ehz113.

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• Laugesen S, Krasniqi L, Benhassen LL, Mortensen PE, Pallesen PA, Bak S, Kjelsen BJ, Riber LP. How to harvest the left internal mammary artery-a randomized controlled trial. Interdiscip Cardiovasc Thorac Surg. 2024 May 2;38(5):ivae102. doi: 10.1093/icvts/ivae102.

  PMID: 38775645 DERIVED

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Study Officials

• Lars P Riber, MD, Ph.D. DMSc

  Odense University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After randomisation, the attending consultant informed the patient of the harvesting method. Data collector and outcome adjudicator were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Associate Professor, Ph.D., DMSc

Model Details: Randomised trial

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: April 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DK (1)