Safety and biocompatibility of a novel self-expanding nitinol carotid stent with hybrid cell design in a porcine model of neointimal hyperplasia

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 S. Kiesz, Paweł E. Buszman

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: Stent design may infuence the outcomes, suggesting that adverse event rates vary according to free cell area and cell design. Open cell design technology of self-expandable stents, dedicated for carotid revascularisation has better deliverability, although closed cell technology is expected to cause fewer thromboembolic events. Aim: To evaluate the feasibility and vascular response of 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 sacrifced, and the 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 or excessive neointimal formation, with the late lumen loss of -0.11 ± 0.3 mm and percentage 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 was 0.20 mm. At histopathology, the mean injury, infammation, and fbrin scores were low. Endothelialisation 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 mineralisation. Conclusions: The novel Polish self-expandable nitinol carotid stent with hybrid cell technology shows optimal biocompatibility and a vascular healing profle, and therefore may be introduced for frst-in-man application.

Original languageEnglish (US)
Pages (from-to)240-245
Number of pages6
JournalKardiologia Polska
Volume73
Issue number4
DOIs
StatePublished - Jan 1 2015
Externally publishedYes

Keywords

  • Carotid stenting
  • New technologies
  • Pre-clinical study

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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