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The role of clinically-relevant parameters on the cohesiveness of sclerosing foams in a biomimetic vein model

The role of clinically-relevant parameters on the cohesiveness of sclerosing foams in a biomimetic vein model
The role of clinically-relevant parameters on the cohesiveness of sclerosing foams in a biomimetic vein model
We have recently reported on the development of a biomimetic vein model to measure the performance of sclerosing foams. In this study we employed the model to compare the commercially-available Varithena(®) (polidocanol injectable foam) 1 % varicose vein treatment (referred to as polidocanol endovenous microfoam, or PEM) with physician compounded foams (PCFs) made using different foam generation methods (Double Syringe System and Tessari methods) and different foam formulations [liquid to gas ratios of 1:3 or 1:7; gas mixtures composed of 100 % CO2, various CO2:O2 mixtures and room air (RA)]. PCFs produced using the DSS method had longer dwell times (DTs) (range 0.54-2.21 s/cm in the 4 mm diameter vein model) than those of the corresponding PCFs produced by the Tessari technique (range 0.29-0.94 s/cm). PEM had the longest DT indicating the best cohesive stability of any of the foams produced (2.92 s/cm). Other biomimetic model variables investigated included effect of vessel size, delayed injection and rate of plug formation (injection speed). When comparing the 4 and 10 mm vessel diameters, the DTs seen in the 10 mm vessel were higher than those observed for the 4 mm vessel, as the vein angle had been reduced to 5° to allow for foam plug formation. PCF foam performance was in the order RA > CO2:O2 (35:65) ? CO2:O2 (65:35) > CO2; PEM had a longer DT than all PCFs (22.10 s/cm) except that for RA made by DSS which was similar but more variable. The effect of delayed injection was also investigated and the DT for PEM remained the longest of all foams with the lowest percentage deviation with respect to the mean values, indicating a consistent foam performance. When considering rate of plug formation, PEM consistently produced the longest DTs and this was possible even at low plug expansion rates (mean 29.5 mm/s, minimum 20.9 mm/s). The developed vein model has therefore demonstrated that PEM consistently displays higher foam stability and cohesiveness when compared to PCFs, over a range of clinically-relevant operational variables.
0957-4530
1-10
Carugo, Dario
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Ankrett, Dyan
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O'Byrne, Vincent
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Wright, David
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Lewis, Andrew
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Hill, Martyn
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Zhang, Xunli
d7cf1181-3276-4da1-9150-e212b333abb1
Carugo, Dario
0a4be6cd-e309-4ed8-a620-20256ce01179
Ankrett, Dyan
28cc6a0a-52dd-45a7-a64c-e67c0c9837de
O'Byrne, Vincent
f9a573d5-6e2d-4d67-9478-dcfc161d79e6
Wright, David
b82e86cd-3f68-4e1e-a140-4cd9a1ed0d42
Lewis, Andrew
8d08a0a8-aba0-4de3-b4b2-b7aeb15b9e04
Hill, Martyn
0cda65c8-a70f-476f-b126-d2c4460a253e
Zhang, Xunli
d7cf1181-3276-4da1-9150-e212b333abb1

Carugo, Dario, Ankrett, Dyan, O'Byrne, Vincent, Wright, David, Lewis, Andrew, Hill, Martyn and Zhang, Xunli (2015) The role of clinically-relevant parameters on the cohesiveness of sclerosing foams in a biomimetic vein model. Journal of Materials Science: Materials in Medicine, 26 (11), 1-10. (doi:10.1007/s10856-015-5587-z). (PMID:26449448)

Record type: Article

Abstract

We have recently reported on the development of a biomimetic vein model to measure the performance of sclerosing foams. In this study we employed the model to compare the commercially-available Varithena(®) (polidocanol injectable foam) 1 % varicose vein treatment (referred to as polidocanol endovenous microfoam, or PEM) with physician compounded foams (PCFs) made using different foam generation methods (Double Syringe System and Tessari methods) and different foam formulations [liquid to gas ratios of 1:3 or 1:7; gas mixtures composed of 100 % CO2, various CO2:O2 mixtures and room air (RA)]. PCFs produced using the DSS method had longer dwell times (DTs) (range 0.54-2.21 s/cm in the 4 mm diameter vein model) than those of the corresponding PCFs produced by the Tessari technique (range 0.29-0.94 s/cm). PEM had the longest DT indicating the best cohesive stability of any of the foams produced (2.92 s/cm). Other biomimetic model variables investigated included effect of vessel size, delayed injection and rate of plug formation (injection speed). When comparing the 4 and 10 mm vessel diameters, the DTs seen in the 10 mm vessel were higher than those observed for the 4 mm vessel, as the vein angle had been reduced to 5° to allow for foam plug formation. PCF foam performance was in the order RA > CO2:O2 (35:65) ? CO2:O2 (65:35) > CO2; PEM had a longer DT than all PCFs (22.10 s/cm) except that for RA made by DSS which was similar but more variable. The effect of delayed injection was also investigated and the DT for PEM remained the longest of all foams with the lowest percentage deviation with respect to the mean values, indicating a consistent foam performance. When considering rate of plug formation, PEM consistently produced the longest DTs and this was possible even at low plug expansion rates (mean 29.5 mm/s, minimum 20.9 mm/s). The developed vein model has therefore demonstrated that PEM consistently displays higher foam stability and cohesiveness when compared to PCFs, over a range of clinically-relevant operational variables.

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Accepted/In Press date: 25 September 2015
e-pub ahead of print date: 8 October 2015
Published date: 26 November 2015
Organisations: Bioengineering Group, Mechatronics, Engineering Science Unit, Faculty of Engineering and the Environment

Identifiers

Local EPrints ID: 383605
URI: http://eprints.soton.ac.uk/id/eprint/383605
ISSN: 0957-4530
PURE UUID: e7bee0a4-4c03-41b1-92ef-26e2230c9f7a
ORCID for Martyn Hill: ORCID iD orcid.org/0000-0001-6448-9448
ORCID for Xunli Zhang: ORCID iD orcid.org/0000-0002-4375-1571

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Date deposited: 24 Nov 2015 11:45
Last modified: 26 Nov 2019 02:05

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Contributors

Author: Dario Carugo
Author: Dyan Ankrett
Author: Vincent O'Byrne
Author: David Wright
Author: Andrew Lewis
Author: Martyn Hill ORCID iD
Author: Xunli Zhang ORCID iD

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