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Non-clinical study for the evaluation of novel vascular graft device (Prolong 2) in a porcine model; dead end?

VLACHOVSKÝ, Robert

Basic information

Original name

Non-clinical study for the evaluation of novel vascular graft device (Prolong 2) in a porcine model; dead end?

Authors

Edition

AIVS 2010, Ischgl, 2010

Other information

Language

English

Type of outcome

Prezentace na konferencích

Field of Study

30200 3.2 Clinical medicine

Country of publisher

Austria

Confidentiality degree

není předmětem státního či obchodního tajemství

Organization unit

Faculty of Medicine
Změněno: 20/1/2011 21:37, MUDr. Tomáš Novotný, Ph.D.

Abstract

V originále

Objective: The long-term patency rates of synthetic femoral bypass grafts remain poor. Abnormal hemodynamics is commonly agreed to be a major contributor to the development of disease at the junction. The computational and experimental studies propose a new vascular graft design - it consists of a normal straight bypass graft with a new distal bifurcation added to it. The purpose of the study was to evaluate the suitability of new vascular graft devices in an animal model. Method: The proximal graft end was implanted in the aorta, distal graft end was implanted in the common iliac artery. The host artery (below the proximal anastomosis) was ligated in order to simulate arterial occlusion. Six of the animals in this study were implanted with a new device and six animals had a conventional straight vascular graft in a suitable artery. Each pig was destroyed and evaluated 20 weeks after surgery, the device together with end sections of the aorta and iliac artery was excised for histological assessment. Results: In experimental group, significant, almost total obliteration of junction by fibrous tissue was revealed in all cases. Significant obliteration of both proximal and distal graft leg was demonstrated in all members of the experimental group. In control group, in all cases significant obliteration of junction by fibrous tissue was revealed. Conclusion: These results are not encouraging in that they show that the novel bypass graft design concept reduces the incidence of disturbed flow in the bypass anastomosis and improves long term patency rates. The study has proven that the device can be surgically implanted and can perform acceptably for a period of time following implantation, but probably for a shorter time. A less prolonged study with a statistically significant sample size or another type of experimental animal is necessary to definitely establish device efficacy.