Experimental Non-Inferiority Trial of Synthetic Small-calibre Biodegradable vs. Stable Vascular GraftsDepartments of 1Cardiovascular Surgery, 3Pathology and 4Radiology University Hospital of Geneva; Dept. of 2Pharmaceutics & Biopharmaceutics EPGL, University of Geneva; Switzerland.1Beat H. WALPOTH, MD FAHA

Damiano Mugnai1, Sarra de Valence2, Wojciech Mrowczynski1, Jean-Christophe Tille3, Xavier Montet4, Robert Gurny2, Michael Moeller2, Afksendiyos Kalangos1

OBJECTIVES: There is a big need for shelf-ready, synthetic, small calibre prostheses for cardiovascular revascularisation procedures. Biodegradable scaffolds resistant to degradation-induced aneurysm formation in the systemic arterial circulation have been developed for :

in vivo vascular tissue-engineering

Our aim is to assess the long-term results of synthetic, biodegradable, electrospun, small-calibre vascular grafts compared to ePTFE for aortic replacement in the rat model.

Vascular Tissue Engineering:Manufacturing of scaffoldsBiodegradable grafts (polycaprolactone = PCL) were produced by random nano-fibre electro-spinning (porosity 80%)Modern BARBAPAPA technique to create novel vascular grafts

METHODS - I: 14 anaesthetised Sprague Dawley rats (male, 275g), received an infrarenal aortic graft (8 biodegradable; 6 ePTFE) replacement (end-to-end; 2mm ID; 20mm long) and 6 rats (same age) served as sham (controls)PCL graftQuality and patency control after surgery with transit time flowmeter2 mmePTFE graft

METHODS - II: After 15 months survival in vivo high resolution ultra-sonography (Visualsonics) and angiography were performed to assess patency, stenosis, aneurysm formation, intimal hyperplasia and compliance. After explantation micro CT calcification quantification, histology, immuno-histology, scanning electron microscopy (SEM) and morphometry were carried out.

RESULTS:PCL vs. ePTFE grafts at 15 months

PCL ( n=8)ePTFE (n=6)P