Comparison of the Mammary Harvesting Technique

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06464354
• Other study ID #: KCHC-01-mammary artery
• Secondary ID: SGS25/LF/2023
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.
• The mammary harvesting using the skeletonization technique
The mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group.
• No intervention
No intervention was used in the control study group.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravial-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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