Vascular Graft Storage Solution Preserves Endothelial Function

Study Overview
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Brief Summary
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Since Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function the main aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments 8 Remnants from the operation after trimming the bypass length), rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline.

Detailed Description
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Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function. Aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments, rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline. According to literature saline could have detrimental effects on the endothelium but data shows conflicting evidence. Duragraft a so called endothelial preservation solution should protect the human endothelium. Intent of this observational study was to study the effects of both solutions and compare them. Within 12 patients undergoing aortocoronary bypass surgery, left overs from saphenous vein graft segments were randomized to DuraGraft© (n=12/6) or saline (n=12/6) solution before intraoperative storage. These segments as well as rat aortic segments underwent assessment of vascular function in a multichamber isometric myograph system in comparison to Krebs-Henseleit solution (KHS), a physiologic organ buffer solution. Additionally, human umbilical vein endothelial cells (HUVECs) were used for cell viability tests.

Official Title
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Vascular Graft Storage Solution Preserves Endothelial Function

Conditions
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Vein Injury

Intervention / Treatment
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* Other: ex vivo organ bath testing, preservation of vein sections without contact to patient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts Patient is ≥18 years of age Patient (or a legally authorized representative) is willing and able to provide consent DuraGraft® is being used for the CABG procedure Exclusion Criteria: Participation in a device study or receiving active drug product in an investigational study within one month (30 days) prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A( saline)<br>The vein piece 1 cm is taken from one patient, then the piece is divided and assigned to saline or the specific solution. | Other: ex vivo organ bath testing, preservation of vein sections without contact to patient<br>* 1 piece of vein is separated during surgical bypass procedure, then randomized and put ex vivo in two solutions: saline and specific solution, then tested in the organ bath<br>* Other names: organ bath ex vivo comparing saline vs specific solution;|
| B specific solution<br>The vein piece 1 cm is taken from one patient, then the piece is divided and assigned to saline or the specific solution. | Other: ex vivo organ bath testing, preservation of vein sections without contact to patient<br>* 1 piece of vein is separated during surgical bypass procedure, then randomized and put ex vivo in two solutions: saline and specific solution, then tested in the organ bath<br>* Other names: organ bath ex vivo comparing saline vs specific solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vessel function organ bath assessment | defines significant contraction or relaxation between the two solutions, a myograph will be used, every change above 5 nM will be seen as significant. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cell viability testing | shows significant difference between the two solutions, cell number of living cells will be simply counted and compared between the two solutions using a standard microscope and counting chamber | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vein, preservation, endothelium