Preclinical and clinical evaluation of a novel synthetic bioresorbable, on-demand, light-activated sealant in vascular reconstruction.

BACKGROUND: Synthetic vascular material use, particularly polytetrafluoroethylene- (PTFE) -based, can be associated with bleeding, which may increase operative time and blood loss. None of the commercially available sealants designed to ensure hemostasis combine bioresorption, high viscosity, hydrophobicity, and compliance with the underlying tissue and on-demand activation. METHODS: A study was designed to assess the biocompatibility and in-vivo performance and bioresorption of a new synthetic on-demand light-activated poly(glycerol-sebacate) acrylate- (PGSA) -based SETALIUM™ Vascular Sealant (TISSIUM, Paris, France) in three large animal studies of open vascular carotid and aortic surgery. The pre-clinical results were then translated into a clinical setting in a prospective, single-arm multicenter study in patients requiring carotid endarterectomy using an ePTFE patch. RESULTS: The biocompatibility testing showed that the PGSA-based SETALIUM™ Vascular Sealant did not induce any significant toxic reaction at a standard clinical dose nor at doses up to 40 times the equivalent intended clinical dose. The PGSA-based sealant was shown to be non-pyrogenic, non-sensitizing, non-irritant, non-clastogenic, and non-mutagenic. The animal studies showed excellent performance and safety results, with clinically significant hemostasis achieved in 100% of the animals in both carotid and aorta studies and excellent local tolerance. Histopathology and morphometric analyses showed surface-based gradual and sustained bioresorption of the PGSA-based sealant up to 86% at 12 months. In the clinical study, the application of the PGSA-based sealant resulted in good performance and safety, with immediate hemostasis achieved in 84% of the cases and no adverse event related to the sealant reported through the one-year follow-up. CONCLUSIONS: The new synthetic on-demand light activated PGSA-based SETALIUM™ Vascular Sealant investigated in our studies demonstrated good biocompatibility, sustained and gradual surface based bioresorption, and acceptable safety profile in animal studies. In addition, the first in-human use showed that the sealant is a safe and effective alternative to achieve fast and controlled hemostasis in vascular carotid reconstructions. A larger randomized controlled study will allow further validation of these encouraging preliminary results.

Ten-year results of ALIZE acetabular cup with hydroxyapatite coating and AURA hydroxyapatite-coated stem in total hip arthroplasty.

One hundred seven total hip arthroplasties were done between 1991 and 1992 with ALIZE acetabular cup with hydroxyapatite coating (Biomet France, Valence, France) and AURA hydroxyapatite-coated stem (Biomet France) in 107 patients. The articulation was ceramic on polyethylene for 102 patients and metal on polyethylene for the remaining 5 patients. The mean follow-up of the series was 8.4 +/- 2.5 years. The mean preoperative Merle d'Aubigné hip functional score was 10.6 +/- 3 vs 15.8 +/- 1.8 at the latest follow-up. Sixty-three patients were alive for the long-term follow-up at a mean of 9.67 +/- 0.25 years. Of the patients, 98.5% were satisfied or very satisfied at the latest follow-up. Five revisions were documented in these series: 1 for acetabular loosening, 2 for traumatic ceramic head fracture, 1 for polyethylene replacement, and 1 for stem replacement due to bone fracture. The mean wear rate was 0.076 +/- 0.043 mm/y (<0.1 mm/y considered as the normal wear rate). The overall survival rate at 10 years was 95.6% +/- 2.1% using revision of either component as the end point.