Comparison of the Mammary Harvesting Technique

NCT06464354 | Completed

• 2 other identifiers: KCHC-01-mammary arterySGS25/LF/2023
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The skeletonization technique of left internal artery (LIMA) harvesting is reported as more spar-ing to the vascular supply of the sternum. Some studies report a greater length and greater flow of the graft additionally. The aim of our study was to measure the difference in post-op sternal blood supply compared to the pedicle harvesting technique and to measure the length and flow of the LIMA graft.

Conditions

Ischemic Heart Disease

Keywords

sternotomy; thermography; coronary bypass; LIMA; skeletonization technique

Outcome Measures

Primary Outcomes (1)

• Rewarming time difference

  Duration of spontaneous rewarming of the skin surface of the caudal sternum after a cold stimulus, measured from 24°C to 27°C. Unit: seconds (s)

  first preoperatively and on 4th postoperative day

Secondary Outcomes (3)

• Duration of the mammary graft harvesting

  during surgery, immediately after the graft harvesting

• Length of the mammary artery graft

  during surgery, immediately after the graft harvesting

• Free outflow of the mammary artery

  during surgery, just before the graft use

Study Arms (3)

LIMA - pedicle

Procedure: The mammary artery harvesting by the pedicle technique

LIMA - skeletonised

Procedure: The mammary harvesting using the skeletonization technique

Control group - LIMA not harvested

Procedure: No intervention

Interventions

The mammary artery harvesting by the pedicle technique PROCEDURE

The mammary artery harvesting by the pedicle technique was used in the LIMA pedicle study group.

LIMA - pedicle

The mammary harvesting using the skeletonization technique PROCEDURE

The mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group.

LIMA - skeletonised

No intervention PROCEDURE

No intervention was used in the control study group.

Control group - LIMA not harvested

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery via sternotomy

You may qualify if:

• Elective cardiac surgery procedure via median sternotomy
• The left mammary artery (LIMA) harvesting for coronary bypass planned as a part of the operation - Group 1 and 2
• Other cardiac surgery procedures without the LIMA harvesting (valve surgery for instance) - Control group
• Signing of the informed consent

You may not qualify if:

• Emergent surgery
• Re-operation
• Re-sternotomy
• Thoracotomy approach
• Harvesting of both mammary arteries (BIMA)
• Endocarditis
• Ongoing non-cardiac infection
• Fever
• Circulatory failure
• Ongoing administration of catecholamines to patient
• Unsigned informed consent

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravial-Silesian Region, 70852, Czechia

Location

Related Publications (3)

• Cheng K, Rehman SM, Taggart DP. A Review of Differing Techniques of Mammary Artery Harvesting on Sternal Perfusion: Time for a Randomized Study? Ann Thorac Surg. 2015 Nov;100(5):1942-53. doi: 10.1016/j.athoracsur.2015.06.087. Epub 2015 Sep 26.

  PMID: 26410160 BACKGROUND

• Alom S, Yang N, Bin Saeid J, Zeinah M, Harky A. Harvesting internal mammary artery: a narrative review. J Cardiovasc Surg (Torino). 2020 Dec;61(6):790-801. doi: 10.23736/S0021-9509.20.11216-3. Epub 2020 Sep 4.

  PMID: 32885924 BACKGROUND

• Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686.

  PMID: 34132753 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Radim Brát, Assoc.Prof.,MD,PhD,MBA

  University Hospital Ostrava

  STUDY CHAIR

• Jiří Sieja, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)