Skeletonized vs Non-Skeletonized LIMA for Graft Patency
(COMFORT pilot Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods for harvesting the Left Internal Mammary Artery (LIMA) for heart bypass surgery. The non-skeletonized method takes the artery with surrounding tissue, while the skeletonized method isolates the artery without extra tissues. The trial aims to determine which method keeps the artery open longer after surgery. Individuals planning heart bypass surgery who need a LIMA graft may be suitable for this study. Participants will undergo a follow-up scan a year after surgery to assess the artery's condition. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially enhance future heart bypass procedures.
What prior data suggests that these harvesting techniques are safe for coronary artery bypass grafting?
Research has shown that using the skeletonized method to harvest the left internal mammary artery (LIMA) can yield mixed results. Some studies suggest this method might increase the risk of artery blockage. However, other research indicates that the skeletonized approach can reduce the risk of decreased blood flow to the breastbone and inflammation in the chest area.
The non-skeletonized technique, the standard method, involves taking the artery along with some surrounding tissue. Although detailed safety data for this method is not provided, it is widely used and considered reliable.
Both methods appear to maintain artery patency and function well, with success rates over 95% within three years, according to some studies. This suggests that both techniques have generally been well-tolerated in past procedures.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it compares two techniques for harvesting the left internal mammary artery (LIMA) used in coronary artery bypass grafting, a common heart surgery. The skeletonized technique focuses on isolating just the artery, potentially reducing trauma to surrounding tissues and preserving more blood supply, which could improve graft patency and healing. On the other hand, the non-skeletonized technique involves taking the artery along with surrounding structures, which is the traditional approach. By comparing these methods, researchers aim to determine which technique offers better long-term outcomes for patients, potentially leading to improved surgical practices.
What evidence suggests that this trial's techniques could be effective for graft patency?
This trial will compare skeletonized harvesting with non-skeletonized harvesting of the left internal mammary artery (LIMA) for graft patency. Research has shown that skeletonized harvesting of the LIMA can lead to more artery blockages compared to the traditional non-skeletonized method. One study found that this technique was linked to worse long-term results for patients. However, some newer methods, like the Thunderbeat technique, seem promising as effective alternatives. Despite these findings, the traditional non-skeletonized method remains the standard due to its reliable track record. While skeletonized harvesting is being explored in this trial, current evidence suggests the traditional method may be more dependable for keeping arteries open after surgery.13678
Who Is on the Research Team?
Fraser Rubens, MD, MSc.
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
This trial is for adults scheduled to have heart bypass surgery using the left internal mammary artery. Specific inclusion and exclusion criteria are not listed, but generally applies to those eligible for this type of heart surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pilot Phase
Evaluation of feasibility of implementing the study protocol, including patient screening, recruitment, and intraoperative documentation
Treatment
Participants undergo randomized study procedures for LIMA harvesting using either skeletonized or non-skeletonized techniques
Follow-up
Participants are monitored for safety and effectiveness, including completion of CTA at 1 year and follow-up until 2 years post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Non-skeletonized harvesting of the left internal mammary artery
- Skeletonized harvesting of the left internal mammary artery
Trial Overview
The study compares two ways of preparing an artery used in heart bypass: one method removes just the artery (skeletonized), while the other takes it with surrounding tissue (non-skeletonized). The goal is to see which method leads to better outcomes like fewer infections or blockages.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
LIMA is harvested using the skeletonized harvesting technique. This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
LIMA is harvested using the non-skeletonized harvesting technique. This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor
Population Health Research Institute
Collaborator
Citations
Skeletonized vs Pedicled Internal Mammary Artery Graft ...
In this study, skeletonized harvesting of the internal mammary artery was associated with a higher rate of occlusion and worse clinical outcomes.
Skeletonized Versus Pedicled Harvesting of the Internal ...
Recent evidence suggests that skeletonized ITA harvesting yields long‐term outcomes inferior to those of pedicled harvesting.
Safety and resource utilisation efficiency of semi-skeletonised ...
Safety and resource utilisation efficiency of semi-skeletonised versus skeletonised left internal mammary artery harvesting techniques: The BANGABANDHU study.
4.
ctsnet.org
ctsnet.org/article-video/left-internal-mammary-artery-harvesting-skeletonization-technique/Left Internal Mammary Artery Harvesting
Skeletonization is an advanced technique of graft harvesting for coronary artery bypass grafting (CABG), and while it requires meticulous ...
How to harvest the left internal mammary artery—a ...
However, non-touch skeletonized LIMA harvesting with Thunderbeat seems to be an effective alternative to traditional surgical skeletonized LIMA.
Skeletonized vs Pedicled Internal Mammary Artery Graft ...
In this study, skeletonized harvesting of the internal mammary artery was associated with a higher rate of occlusion and worse clinical outcomes.
Skeletonized or Pedicled Harvesting of Left Internal ...
We sought to compare clinical outcomes in skeletonized versus pedicled left internal mammary artery (LIMA) grafts in elective coronary artery bypass grafting ...
Selecting conduits for coronary artery bypass grafting
After a lengthy angiographic follow-up of 5.4 years, graft failure rates were 2.3% (21/921) for LIMA, 9.4% (67/710) for radial artery, 13.5% (10 ...
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