Korean Circulation Journal

  • 제54권8호
  • /
  • Pages.499-512
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  • 2024
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  • 1738-5520(pISSN)
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  • 1738-5555(eISSN)
대한심장학회 (The Korean Society of Cardiology)
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Serial Vascular Responses of Balloon-Expandable Stent With Biodegradable Film-Type Graft in a Rabbit Iliac Artery Dissection Model (BioGard Study)

  • Sang Min Park (Division of Cardiology, Nowon Eulji Medical Center, Eulji University School of Medicine) ;
  • Kyung-Chan Choi (Department of Pathology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Byeong Han Lee (Laboratory Animal Center, Osong Medical Innovation Foundation) ;
  • Sang Yol Yoo (Department of Radiology, H Plus Yangji Hospital) ;
  • Christopher Y. Kim (Utah Cardiology)
  • 투고 : 2024.02.01
  • 심사 : 2024.05.07
  • 발행 : 2024.08.01
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초록

Background and Objectives: Arterial dissection during endovascular therapy rarely occurs but can be lethal. A fabric-based covered graft stents yield poor clinical outcomes. A novel balloon-expandable stent with biodegradable film graft for overcoming these issues was evaluated in a rabbit iliac artery model. Method: Eighteen rabbits with iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0×24 mm). Subsequently, survived twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year. Results: There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2 weeks, 26.1 at 1 month, 29.7 at 3 months, 49.2 at 9 months, and 51.0 at 1 year), along with mild peri-strut inflammatory response (Grade: 1-2 at mid-term and 0-1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2 weeks, 12.3 at 1 month, 14.2 at 3 months, 25.1 at 9 months, and 26.6 at 1 year). Conclusions: The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model.

키워드

과제정보

Authors thank to In Kwon Jung, PhD and Mr. Jung Sun Jang at R&D Center of Genoss for their technical support.

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