Comparison of the Mammary Harvesting Technique

Comparison of the Effect of Mammary Artery Harvesting Technique to Sternal Blood Supply Using Non-contact Dynamic Thermography

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Procedure: The mammary artery harvesting by the pedicle technique; Procedure: The mammary harvesting using the skeletonization technique; Procedure: No intervention

Detailed Description

A total of 90 patients were examined in a prospective randomized study. In 60 patients referred for coronary artery bypass grafting (CABG), LIMA was harvested, one-half (n=30) skeletonized, and one-half (n=30) with a pedicle. Thirty patients operated via sternotomy without LIMA harvesting (other procedures, for instance, valve surgery) were the control group. In patients undergoing LIMA harvest, harvest duration, graft length, and graft free flow were measured at defined arterial pressure. In all patients, the sternal blood flow was examined by active dynamic thermography (DIRT): first preoperatively and on 4th postoperative day. During this, the time of spontaneous rewarming of the skin surface after the application of a cold stimulus was measured in the caudal part of the sternum. The difference between postoperative and preoperative time was calculated and compared between groups.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Czechia
  • Moravial-Silesian Region
    • Ostrava, Moravial-Silesian Region, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery via sternotomy

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LIMA - pedicle	Procedure: The mammary artery harvesting by the pedicle technique; The mammary artery harvesting by the pedicle technique was used in the LIMA pedicle study group.
LIMA - skeletonised	Procedure: The mammary harvesting using the skeletonization technique; The mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group.
Control group - LIMA not harvested	Procedure: No intervention; No intervention was used in the control study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the mammary graft harvesting	Time from the start of the harvesting to complete graft release. Unit: minute (min).	during surgery, immediately after the graft harvesting
Length of the mammary artery graft	Length from the distance of the graft from the chest wall to its distal end. Unit: millimeter (mm).	during surgery, immediately after the graft harvesting
Free outflow of the mammary artery	After trimming the distal clip on the graft at an arterial pressure of 70 mmHg, free flow for 30 seconds, then multiplied by two. Unit: millilitre per minute (ml/min).	during surgery, just before the graft use

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Study Chair: Radim Brát, Assoc.Prof.,MD,PhD,MBA, University Hospital Ostrava; Principal Investigator: Jiří Sieja, MD, University Hospital Ostrava

Publications and helpful links

General Publications

• 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. Erratum In: JAMA Cardiol. 2021 Aug 18;:null.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: sternotomy; thermography; coronary bypass; LIMA; skeletonization technique
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: KCHC-01-mammary artery; SGS25/LF/2023 (Other Grant/Funding Number: University of Ostrava)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No