Clinical trial NCT06464354: Comparison of the Mammary Harvesting Technique
Official title: Comparison of the Effect of Mammary Artery Harvesting Technique to Sternal Blood Supply Using Non-contact Dynamic Thermography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Keywords: sternotomy
thermography
coronary bypass
LIMA
skeletonization technique
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective cardiac surgery via sternotomy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rewarming time difference
timeFrame: first preoperatively and on 4th postoperative day
Secondary outcomes:
measure: Duration of the mammary graft harvesting
timeFrame: during surgery, immediately after the graft harvesting
measure: Length of the mammary artery graft
timeFrame: during surgery, immediately after the graft harvesting
measure: Free outflow of the mammary artery
timeFrame: during surgery, just before the graft use
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravial-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Radim Brát, Assoc.Prof.,MD,PhD,MBA
role: STUDY_CHAIR
affiliation: University Hospital Ostrava
name: Jiří Sieja, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.