Document Detail


Safety and biocompatibility of a novel self-expanding nitinol carotid stent with hybrid cell design in a porcine model of neointimal hyperplasia.
MedLine Citation:
PMID:  25371312     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: Stent design may influence the outcomes, suggesting that adverse events rates vary according to free cell area and cell design. Open cell design technology of self expandable stents, dedicated for carotid revascularization has better deliverability nonetheless closed cell technology is expected to cause less thromboembolic events.
AIM: The purpose of this study was to evaluate the feasibility and vascular response of a novel, hybrid cell, self-expandable nitinol stents (MER®, Balton, Poland) implanted into porcine carotid arteries. Hybrid cell design combines open and closed cell technology.
METHODS: All tested stents were implanted with 10% overstretch into 10 carotid segments of polish domestic pigs. Control angiography was obtained immediately before and after vascular interventions as well as 28 days after the procedure. Thereafter, animals were sacrificed, treated segments were harvested and evaluated in the independent histopathology laboratory.
RESULTS: All stents were easily introduced and implanted, showing good angiographic acute outcome. At 28 days, in the angiography all vessels were patent, with no signs of thrombi and excessive neointimal formation with the late lumen loss of -0,11 ± 0,3 mm and percent diameter stenosis (10.18 ± 8.1 %). There was a 10% increase in the vessel reference diameter when compared to baseline (4,57 ± 0,5 vs. 4.96 ± 0.3 mm, p<0,01). In the histopathology mean area stenosis was 17.4% and mean intimal thickness of 0.20mm. At histopathology, the mean injury, inflammation and fibrin scores were low. Endothelialization was complete in all stents and neointimal tissue appeared moderately mature as shown by the moderate mean neointimal smooth muscle score. Nonetheless, histopathology shows one stent affected by peri-strut granulomas and one stent affected by marked mineralization.
CONCLUSIONS: The novel Polish self- expandable nitinol carotid stent with hybrid cells technology shows optimal biocompatibility and vascular healing profile and therefore may be introduced into first in man application.
Authors:
Adam Janas; Krzysztof Milewski; Piotr P Buszman; Przemysław Nowakowski; Michał Jelonek; Bartłomiej Orlik; Agata Krauze; Stefan Samborski; Diane Beaudry; Guy Lecelrc; Marek Król; Jean Martin Lapointe; Wojciech Wojakowski; Anna Turek; Radosław Stefan Kiesz; Paweł E Buszman
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-11-05
Journal Detail:
Title:  Kardiologia polska     Volume:  -     ISSN:  0022-9032     ISO Abbreviation:  Kardiol Pol     Publication Date:  2014 Nov 
Date Detail:
Created Date:  2014-11-5     Completed Date:  -     Revised Date:  2014-11-6    
Medline Journal Info:
Nlm Unique ID:  0376352     Medline TA:  Kardiol Pol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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