Bypass Graft Occlusion, Coronary Arterial Disease (CAD)
Conditions
Brief summary
Coronary artery bypass graft surgery (CABG) is a preferred surgical treatment in patients with widespread coronary artery disease. However, studies have shown that up to one third of patients will have closure of at least one bypass graft (graft failure) after one year, which has prognostic implications. Since graft failure can partly be due to inappropriate placement of the distal graft anastomosis, there is a need to develop new surgical methods to ensure optimal placement of the grafts. Three-dimensional (3D) printing is a technique developed to transform digital objects into physical models. The method is widely used in orthopedic surgery and maxillofacial surgery, but has also gained interests in cardiology, and has proved usefull in the preparation for invasive interventions or surgery in patients with complicated anatomy, including congenital heart disease. The purpose of the study is to investigate, if a surgical strategy, based on a preoperative cardiac CT, including a patient-specific printed 3-D model of the coronary vessels, marked with optimal bypass graft insertion points, can reduce graft failure, assessed by a control cardiac CT examination performed 12 months after surgery. The hypothesis is that 3-D printing of coronary vessels determined from invasive coronary angiography and cardiac CT prior to CABG reduces graft failure 12 months after surgery.
Interventions
DIAGNOSTIC_TEST3D print of coronary arteries
Based on a pre-surgical cardiac CT the optimal graft insertions points on the target coronary arteries wil be marked and a patient-specific model of the coronary arteries will be 3D-printed and sterialized to be available during CABG to guide the placement of the distal graft anastomosis.
Sponsors
Rigshospitalet, Denmark
Jesper James Linde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for CABG (with or without valve-surgery), determined by heart team conference. The revascularization plan must include further grafting in addition LIMA to LAD.
Exclusion criteria
* Age \<18 years * Permanent atrial fibrillation * Renal failure (eGRF \< 30) * Known allergy to contrast material * Pregnant and/or breastfeeding * Indication for acute CABG * Patients who cannot tolerate premedication with nitroglycerin and beta blocker (including LVEF\<40%). This applies only to the pre-operative CT scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft failure | From surgery to the control cardiac CT performed at 12 months | Difference in the proportion of grafts with graft failure 12 months after surgery. Graft failure is defined as: 1) graft occlusion 2) graft stenosis \>50% 3) Graft anastomosis is placed on wrong vessels or proximal to the stenosis 4) String sign (radialis grafts) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft failure at a patient level | From surgery to the control cardiac CT performed at 12 months | Difference in the proportion of patients with graft failure at 12 months |
| Occluded grafts | From surgery to the control cardiac CT at 12 months | Difference in number of occluded grafts at 12 months (graft level and patient level) |
| Graft stenosis | From surgery to the control cardiac CT at 12 months | Difference in proportion of graft stenosis at 12 months (graft level and patient level) |
| Acute myocardial infarction or new revascularization | From surgery to the control cardiac CT at 12 months | Acute myocardial infarction or renewed revascularization at 12 months. |
| Hospitalization for chest pain, acute coronary disease, heart failure or death | From surgery to the control cardiac CT at 12 months | Hospitalization with chest pain, acute coronary disease, heart failure or death at 12 months |
| Grafts placed on wrong vessels or proximal to coronary stenosis | From surgery to the control cardiac CT at 12 months | Difference in the number of grafts placed on wrong vessels or proximal to coronary stenosis (graft level and patient level) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Myocardial perfusion | From surgery to the control Cardiac CT performed at 12 months | Difference in myocardial perfusion assessed by cardiac CT scan at 12 months. |
Countries
Denmark
Contacts
Primary ContactJesper J Linde, MD, PhD
Outcome results
None listed