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

VLACHOVSKÝ, Robert. Non-clinical study for the evaluation of novel vascular graft device (Prolong 2) in a porcine model; dead end? In AIVS 2010, Ischgl. 2010.

Basic information

• Original name: Non-clinical study for the evaluation of novel vascular graft device (Prolong 2) in a porcine model; dead end?
• Authors: VLACHOVSKÝ, Robert.
• Edition: AIVS 2010, Ischgl, 2010.

Other information

• Original language: English
• Type of outcome: Presentations at conferences
• Field of Study: 30200 3.2 Clinical medicine
• Country of publisher: Austria
• Confidentiality degree: is not subject to a state or trade secret
• Organization unit: Faculty of Medicine

Abstract

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.