Serious Adverse Events with Cyanoacrylate Closure of Varicose Veins: An Initial Report from a Large-Scale National Survey in Japan

Michihisa Umetsu; Masayuki Hirokawa; Eri Fukaya; Eiichi Teshima; Hitoshi Kusagawa; Toshiya Nishibe; Hiroko Nemoto; Makoto Mo; Tomohiro Ogawa

doi:10.3400/avd.oa.23-00106

Original Article

Serious Adverse Events with Cyanoacrylate Closure of Varicose Veins: An Initial Report from a Large-Scale National Survey in Japan

Michihisa Umetsu, Masayuki Hirokawa , Eri Fukaya, Eiichi Teshima, Hitoshi Kusagawa, Toshiya Nishibe, Hiroko Nemoto, Makoto Mo, Tomohiro Ogawa

Author information

Michihisa Umetsu
https://orcid.org/0000-0002-1080-2491
Division of Vascular Surgery, Department of Surgery, Tohoku University Hospital, Sendai, Miyagi, Japan
Masayuki Hirokawa Corresponding author
Ochanomizu Vascular and Vein Clinic, Tokyo, Japan
Eri Fukaya
Division of Vascular Surgery, Stanford University School of Medicine, Palo Alto, CA, USA
Eiichi Teshima
Vascular and Endovascular Surgery, Fukuoka Wajiro Hospital, Fukuoka, Fukuoka, Japan
Hitoshi Kusagawa
Matsusaka Ohta Clinic, Matsusaka, Mie, Japan
Toshiya Nishibe
Department of Medical Management and Informatics, Hokkaido Information University, Ebetsu, Hokkaido, Japan
Hiroko Nemoto
Department of Surgery, Yokohama City University, Yokohama, Kanagawa, Japan
Makoto Mo
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
Tomohiro Ogawa
Department of Cardiovascular Surgery, Fukushima Dai-Ichi Hospital, Fukushima, Fukushima, Japan
Japanese Regulatory Committee for Endovascular Treatment of Varicose Veins, Tokyo, Japan

Keywords: adverse event, complication, cyanoacrylate closure, national survey, varicose vein

JOURNAL OPEN ACCESS

2024 Volume 17 Issue 1 Pages 21-24

DOI https://doi.org/10.3400/avd.oa.23-00106

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Abstract

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.

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.

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.

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.

Corresponding author

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