Vascular Graft Storage Solution Preserves Endothelial Function (VGE)

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.

Study Overview

• Status: Completed
• Conditions: Vein Injury
• Intervention / Treatment: Other: ex vivo organ bath testing, preservation of vein sections without contact to patient

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1230
    • KH North Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing bypass surgery exluding emergency cases

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A( saline); 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; 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; Other Names: organ bath ex vivo comparing saline vs specific solution
B specific solution; 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; 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; Other Names: organ bath ex vivo comparing saline vs specific solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Klinikum Floridsdorf
• Investigators: Principal Investigator: Bernhard Winkler, Associate Professor Priv. Doz. DDR., Klinikum Floridsdorf

Publications and helpful links

General Publications

• Santoli E, Di Mattia D, Boldorini R, Mingoli A, Tosoni A, Santoli C. University of Wisconsin solution and human saphenous vein graft preservation: preliminary anatomic report. Eur J Cardiothorac Surg. 1993;7(10):548-52. doi: 10.1016/1010-7940(93)90055-g.
• Winkler B, Reineke D, Heinisch PP, Schonhoff F, Huber C, Kadner A, Englberger L, Carrel T. Graft preservation solutions in cardiovascular surgery. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):300-9. doi: 10.1093/icvts/ivw056. Epub 2016 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: endothelium; preservation; vein
• Other Study ID Numbers: A2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only during publication or manuscript preparation data will be shared but no patients names or data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No