Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency

Study Overview
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Brief Summary
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The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis (>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment. Patency will be assessed with a new fluorescence angiography technique as well as ultrasonic transit-time flow measurement. We hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of graft occlusion at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We also hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of 50-99% stenoses at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We expect both groups will experience similar perioperative outcomes but hypothesize that patients receiving a strategy of intraoperative patency assessment and graft revision will experience improved long-term graft patency and freedom from late clinical events at 5-6 years post-operatively.

Detailed Description
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The immediate and long term success of coronary surgery is dependent on the construction of a high quality anastomosis with a durable conduit to an appropriate target coronary vessel. Significant advances in medical therapy including early post-operative aspirin administration and increased use of arterial grafting have improved early, midterm and late graft patency. However, modern coronary bypass series continue to report perioperative graft occlusions rates as high as 11%. These very early graft failures have been predominantly ascribed to technical problems at graft anastomosis sites and may be preventable. New intraoperative graft assessment technologies have recently become available which can identify technical problems such that they can be repaired in the operating room. However, these techniques increase the length of the bypass operation and may have false positives, which may lead to unnecessary and potentially damaging graft revisions. The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis(>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment.

Official Title
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Graft Imaging to Improve Patency (GRIIP)

Conditions
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Coronary Disease

Intervention / Treatment
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* Procedure: Indocyanine green intraoperative angiogram and transit-time flowmetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: isolated aortocoronary bypass surgery left ventricular ejection fraction >20% expect at least 2 bypass grafts Exclusion Criteria: renal insufficiency (creatinine >180 umol/L) known allergy to indocyanine green contrast dye severe peripheral vascular disease precluding femoral access known allergy to radiographic contrast media women of childbearing potential co-morbid illness which precludes the use of follow-up angiography geographically inaccessible for follow-up angiography
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Graft patency assessment by routine clinical assessment with/without intraluminal coronary probe | |
| Experimental: 2<br>Graft patency assessment by indocyanine green angiography and transit-time flowmetry | Procedure: Indocyanine green intraoperative angiogram and transit-time flowmetry<br>* ICG graft angiography following each distal anastomosis, and imaging of proximal anastomoses after all grafts completed. transit time flowmetry performed on all grafts after all grafts completed.<br>* Other names: Medtronic Medistem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft occlusion determined by conventional angiography or CT angiography |  | 4 days to 4 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50-99% graft stenosis on postoperative graft angiography |  | 4 day to 4 months postoperatively | 
| Mortality, myocardial infarction, low output syndrome |  | Perioperatively | 
| Major cardiac adverse events |  | 1 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary disease, angiography, intraoperative care, vascular patency