A Novel Resorbable Embolization Microsphere for Transient Uterine Artery Occlusion: A Comparative Study with Trisacryl-Gelatin Microspheres in the Sheep Model |
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| Affiliation: | 1. Occlugel SAS, Jouy en Josas;2. Department of Radiology, Centre Hospitalier Universitaire de Caen, Caen;3. Department of Pathology, APHP, Hôpital Lariboisière, 2 rue Ambroise Paré, 75010 Paris, France;4. Department of Interventional Neuroradiology, APHP, Hôpital Lariboisière, 2 rue Ambroise Paré, 75010 Paris, France;5. UMR CNRS 8612 Institut Galien Paris-Sud, Chatenay Malabry;6. Université René Diderot, Paris;7. Laboratoire MSC, Paris, France.;1. School of Pharmaceutical Sciences, University of Geneva, 30, quai Ernest Ansermet, 1211 Geneva;2. Department of Radiology and Interventional Radiology, CHUV University of Lausanne, Lausanne, Switzerland;3. Department of Visceral Surgery, CHUV University of Lausanne, Lausanne, Switzerland;1. College of Marine Life Science, Ocean University of China, Qingdao 266003, China;2. Key Laboratory for Nano-Bio Interface Research, Suzhou Key Laboratory for Nanotheranostics, Division of Nanobiomedicine, Suzhou Institute of Nano-Tech and Nano-Bionics, Chinese Academy of Sciences, Suzhou 215123, China;3. College of Life Science and Bioengineering, Beijing University of Technology, Beijing 100022, China;1. Department of Biomedical Engineering/Biomaterials Science, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands;2. Department of Physiology, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands;3. Interfacultary Research Centre on Biomaterials (CEIB), University of Liège, Chemistry Institute B6C, B-4000 Liege (Sart-Tilman), Belgium;4. Faculty of Humanities and Sciences, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands;5. INterface BIOmaterials B.V, Van Iterson Building (Chemelot Campus), Burgemeester Lemmensstraat 364, 6163 JT Geleen, The Netherlands;6. Department of Biomedical Engineering, Faculty of Engineering, University of Malaya, Jalan Universiti, 50603 Kuala Lumpur, Malaysia;1. Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan;2. Department of Biomaterials, Field of Tissue Engineering, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan;1. Department of Radiology, University of Minnesota, Minneapolis, MN 55455, USA;2. Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN 55455, USA;3. North American Science Associates Inc., Brooklyn Park, MN 55443, USA |
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| Abstract: | PurposeTo evaluate angiographic recanalization, inflammatory reaction, and uterine damage after sheep uterine artery embolization (UAE) with a novel calibrated resorbable embolization microsphere (REM) and compare the results with control nonresorbable microspheres.Materials and MethodsSix hormonally artificially cycled sheep underwent bilateral UAE until stasis with either REM or trisacryl-gelatin microspheres (TGMS). At 7 days, control angiograms were obtained to assess the residual vascularization at arterial and parenchymal phases. The animals were then sacrificed for analysis of the presence of microspheres, inflammatory foreign body reaction, and surface areas of uterine damage.ResultsMean volume of microspheres injected per uterine artery (UA) or per animal did not differ between groups. At day 7, the flow was normal for six of six UAs that received embolization with REM versus only three of six UAs with TGMS (P = .0455, χ2 test). Uterine parenchymography showed no defects in six UAs in the REM group versus five defects in six UAs in the TGMS group (P = .0060, χ2 test). No REM or residual fragments of microspheres were observed on histologic analysis. TGMS were observed in tissues and accompanied by a mild inflammatory response. Necrosis rates were not significantly different between the two products, either in endometrium (REM 23.5% ± 28.8% [median 8.1%] vs TGMS 21.8% ± 23.7% [median 14.6%]) or in myometrium (REM 8.2% ± 22.7% [median 0.0%] vs TGMS 8.8% ± 20.8% [median 0.9%]). Endometrium alteration rate was lower with REM than with TGMS (39.7% ± 25.7% [median 34%] vs 60.6% ± 27.1% [median 71%]; P = .0060, Mann-Whitney test). Myometrium alteration rates were not significantly different between REM (45.7% ± 37.1% [median 63.0%]) and TGMS (37.8% ± 34.0% [median 19.1%]).ConclusionsAt 1 week after sheep UAE with REM, the recanalization was complete, the microspheres were completely degraded, and there was no remnant inflammatory response. |
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| Keywords: | IRFB" },{" #name" :" keyword" ," $" :{" id" :" key0090" }," $$" :[{" #name" :" text" ," _" :" inflammatory reaction of foreign body type PEG" },{" #name" :" keyword" ," $" :{" id" :" key0010" }," $$" :[{" #name" :" text" ," _" :" polyethylene glycol PLGA" },{" #name" :" keyword" ," $" :{" id" :" key0020" }," $$" :[{" #name" :" text" ," _" :" polylactic-glycolic acid REM" },{" #name" :" keyword" ," $" :{" id" :" key0030" }," $$" :[{" #name" :" text" ," _" :" resorbable embolization microsphere TGMS" },{" #name" :" keyword" ," $" :{" id" :" key0040" }," $$" :[{" #name" :" text" ," _" :" trisacryl-gelatin microspheres UA" },{" #name" :" keyword" ," $" :{" id" :" key0050" }," $$" :[{" #name" :" text" ," _" :" uterine artery UAE" },{" #name" :" keyword" ," $" :{" id" :" key0060" }," $$" :[{" #name" :" text" ," _" :" uterine artery embolization |
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