3 results on '"Coscas R"'
Search Results
2. Preclinical and clinical evaluation of a novel synthetic bioresorbable, on-demand, light-activated sealant in vascular reconstruction.
- Author
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Pellenc Q, Touma J, Coscas R, Edorh G, Pereira M, Karp J, Castier Y, Desgranges P, and Alsac JM
- Subjects
- Acrylates adverse effects, Aged, Aged, 80 and over, Angioplasty instrumentation, Animals, Decanoates adverse effects, Endarterectomy, Carotid instrumentation, Female, Glycerol administration & dosage, Glycerol adverse effects, Humans, Male, Materials Testing, Middle Aged, Models, Animal, Polymers adverse effects, Prospective Studies, Sheep, Domestic, Time Factors, Tissue Adhesives adverse effects, Treatment Outcome, Acrylates administration & dosage, Angioplasty adverse effects, Aorta, Thoracic surgery, Carotid Arteries surgery, Decanoates administration & dosage, Endarterectomy, Carotid adverse effects, Glycerol analogs & derivatives, Hemorrhage prevention & control, Hemostatic Techniques adverse effects, Polymers administration & dosage, Tissue Adhesives administration & dosage
- Abstract
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.
- Published
- 2019
- Full Text
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3. Radial access for endovascular ilio-femoral procedures.
- Author
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Touma J, Coscas R, Ijaverliat I, Lamas H, Coggia M, and Goëau-Brissonniere O
- Subjects
- Anastomosis, Surgical methods, Humans, Radial Artery, Catheterization, Peripheral methods, Endovascular Procedures methods, Femoral Artery surgery, Iliac Artery surgery, Peripheral Arterial Disease surgery
- Abstract
Common femoral artery puncture for ilio-femoral angioplasty can be hazardous or cumbersome in specific situations that require upper limb access (presence of a hostile groin, previous femoral surgery, cross-over maneuver in the setting of bifurcated aortic graft or pre-existing iliac kissing stents). The brachial artery is an alternative access site that is burdened with significant local complication rates. As in the coronary setting, feasibility and safety of transradial peripheral angioplasty has been reported in the recent literature. Procedural success rates ranged from 87% to 100%. No major access site bleeding was observed. Procedure and fluoroscopy time were not substantially increased, and decreased along with the learning curve. The majority of reports were limited to iliac lesions treatment, due to the lack of long-shaft and dedicated devices. Our experience showed the feasibility of this technique in iliac lesions but also in superficial femoral and popliteal artery procedures. Radial access can be used in situations where femoral approach is unsuitable and as first-line approach in the setting of ambulatory procedures. Although devices evolve, main limitations remain related to the lack of longer introducer sheaths and the absence of specific rescue devices and drug-eluting balloons. As a conclusion, radial access for endovascular ilio-femoral procedures is currently a promising alternative to femoral and humeral access in selected patients with the possibility of same-day discharge, and could progressively be considered when planning peripheral procedures.
- Published
- 2016
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