Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2015 |
| Start Date: | October 2010 |
| End Date: | June 2014 |
OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
The purpose of this study is to demonstrate improved vein graft patency rates at 12 months
for endoscopically harvested saphenous vein grafts. The study will evaluate use
modifications to existing techniques in vein graft handling during harvests. A secondary
aim is to develop a standardized approach for harvesting, handling, and preparing vein
grafts in the endoscopic approach.
for endoscopically harvested saphenous vein grafts. The study will evaluate use
modifications to existing techniques in vein graft handling during harvests. A secondary
aim is to develop a standardized approach for harvesting, handling, and preparing vein
grafts in the endoscopic approach.
Available data supports two facts: 1) Saphenous vein graft failure rates may be as high as
47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic
vein-graft harvesting is independently associated with vein-graft failure and adverse
clinical outcomes.
Multiple factors may contribute to the lower long term patency rates of endoscopically
harvested grafts. Summarized, the two major contributing factors are theorized to be
harvesting techniques and vein trauma during harvesting.
With recognized disadvantages of open vessel harvesting including higher incidence of
infection, longer incisions, greater potential for poor healing, and longer length of
hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of
utmost importance.
It is our hypothesis that modification of existing harvesting techniques can improve vein
graft patency in endoscopic vein graft harvesting so that patency rates comparable to open
vessel harvesting can be obtained.
In this prospective, multi-center non-randomized, observational study, 100 patients will
undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone
coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using
best harvesting practices. As a part of routine postoperative care, patients will be
prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of
dual-antiplatelet therapy will be monitored.
Vein graft patency will be evaluated:
1. Intra-operatively by transit time graft flow measurements.
2. Post-operative Day 30 through Cardiac CT Angiography.
3. Post-operative Month 12 through Cardiac CT Angiography.
47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic
vein-graft harvesting is independently associated with vein-graft failure and adverse
clinical outcomes.
Multiple factors may contribute to the lower long term patency rates of endoscopically
harvested grafts. Summarized, the two major contributing factors are theorized to be
harvesting techniques and vein trauma during harvesting.
With recognized disadvantages of open vessel harvesting including higher incidence of
infection, longer incisions, greater potential for poor healing, and longer length of
hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of
utmost importance.
It is our hypothesis that modification of existing harvesting techniques can improve vein
graft patency in endoscopic vein graft harvesting so that patency rates comparable to open
vessel harvesting can be obtained.
In this prospective, multi-center non-randomized, observational study, 100 patients will
undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone
coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using
best harvesting practices. As a part of routine postoperative care, patients will be
prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of
dual-antiplatelet therapy will be monitored.
Vein graft patency will be evaluated:
1. Intra-operatively by transit time graft flow measurements.
2. Post-operative Day 30 through Cardiac CT Angiography.
3. Post-operative Month 12 through Cardiac CT Angiography.
Inclusion Criteria:
- Males and females at least 18 years of age and able to sign consent
- Undergoing CABG surgery
- Eligible for endoscopic saphenous vein harvesting
- A minimum of two non-sequential vein grafts will be performed
- Subject willing to comply with the requirements of the protocol
Exclusion Criteria:
1. Previous CABG
2. Previous or concomitant valve surgery
3. Any other concomitant cardiac procedure other than surgical ablation or incidental
PFO repair
4. Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
5. Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
6. Abnormal platelet level defined as Plt Count >400,000
7. Abnormal platelet function (hypercoagulable state) as evidenced by TEG
testing
8. Allergy to or presence of a condition that the investigator feels may prevent safe
administration of ASA or Plavix post-operatively.
9. Patient has a co-morbid condition that in the opinion of the investigator poses undue
risk for successful endovascular harvesting of the vein
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