Korean Circulation Journal

  • 제54권8호
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  • 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.

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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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