Serious Adverse Events with Cyanoacrylate Closure of Varicose Veins: An Initial Report from a Large-Scale National Survey in Japan
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- Umetsu Michihisa
- Division of Vascular Surgery, Department of Surgery, Tohoku University Hospital, Sendai, Miyagi, Japan
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- Hirokawa Masayuki
- Ochanomizu Vascular and Vein Clinic, Tokyo, Japan
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- Fukaya Eri
- Division of Vascular Surgery, Stanford University School of Medicine, Palo Alto, CA, USA
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- Teshima Eiichi
- Vascular and Endovascular Surgery, Fukuoka Wajiro Hospital, Fukuoka, Fukuoka, Japan
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- Kusagawa Hitoshi
- Matsusaka Ohta Clinic, Matsusaka, Mie, Japan
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- Nishibe Toshiya
- Department of Medical Management and Informatics, Hokkaido Information University, Ebetsu, Hokkaido, Japan
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- Nemoto Hiroko
- Department of Surgery, Yokohama City University, Yokohama, Kanagawa, Japan
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- Mo Makoto
- Department of Surgery, Yokohama City University, Yokohama, Kanagawa, Japan Department of Cardiovascular Surgery, Yokohama Minami Kyosai Hospital, Yokohama, Kanagawa, Japan Japanese Society of Phlebology, Tokyo, Japan
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- Ogawa Tomohiro
- Department of Cardiovascular Surgery, Fukushima Dai-Ichi Hospital, Fukushima, Fukushima, Japan Japanese Regulatory Committee for Endovascular Treatment of Varicose Veins, Tokyo, Japan
抄録
<p>Objective: Cyanoacrylate closure (CAC) is a minimally invasive technique for the treatment of varicose veins. A recent paper reported serious adverse events (AEs) associated with this use. This triggered an urgent survey to determine the incidence of AEs in Japan.</p><p>Methods: The CAC-AE survey was sent to all 1,030 institutions authorized for CAC treatments. Cases performed between January 2020 and October 2023 were surveyed. Data on serious AEs and mortality were collected.</p><p>Results: There were 623 surveys returned. There were 16 cases of proximal deep vein thrombosis, 3 cases of pulmonary embolism (PE), and 0 cases of stroke. Deep vein occlusion due to cyanoacrylate extension was observed in 1 case. Vein resection due to infection was observed in 4 cases. There were 299 cases of localized phlebitis and/or allergic reactions requiring steroid administration. Systemic allergic reactions requiring steroid administration were observed in 66 cases. There was no anaphylaxis associated with cyanoacrylate. There was one postoperative death from PE.</p><p>Conclusion: This report’s intent is to provide real world data on serious AEs following CAC from Japan given current concern over these events. An extensive report investigation of individual complications with analysis including causality will be provided following a full investigation separately.</p>
収録刊行物
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- Annals of Vascular Diseases
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Annals of Vascular Diseases 17 (1), 21-24, 2024
Annals of Vascular Diseases 編集委員会
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詳細情報 詳細情報について
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- CRID
- 1390862545803551104
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- ISSN
- 18816428
- 1881641X
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- Crossref
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- 抄録ライセンスフラグ
- 使用不可