Safety Assessment of Cyanoacrylate Closure for Treatment of Varicose Veins in a Large-Scale National Survey in Japan.

Abstract

Objective: Cyanoacrylate closure (CAC) is a minimally invasive technique for treating axial venous reflux. However, the incidence of serious adverse events (AEs) related to CAC is concerning. With an increasing number of patients receiving CAC and insufficient safety data in Japan, this study aimed to investigate the safety profile of CAC, focusing on the types and incidence of AEs.

Methods: A nationwide survey was conducted by the Japanese Regulatory Committee for Endovascular Treatment of Varicose Veins between November 2023 and December 2023. Data were collected from 1,017 institutions, covering 24,209 patients who underwent CAC at 335 institutions between January 2020 and October 2023. Thromboembolism, phlebitis, hypersensitivity reactions, granuloma formation, infection, bleeding, death, and need for glue resection were documented as unfavorable events/outcomes.

Results: Venous thromboembolism (VTE) developed in 142 patients (0.59%). Pulmonary embolism, proximal deep vein thrombosis (DVT), and ablation-related thrombus extension (ARTE) developed in 3 (0.01%), 9 (0.04%), and 95 (0.39%) patients, respectively. Localized phlebitis that required additional treatment was observed in 1,656 patients (6.8%). Of the localized hypersensitivity cases, 960 (58%) required oral antihistamines and 268 (16%) required oral and/or intravenous steroids. Furthermore, 65 patients (0.27%) developed systemic hypersensitivity that required systemic steroids. No patients developed a stroke or anaphylaxis. One patient died due to pulmonary embolism. Glue resection was performed in nine patients with delayed infection (n = 4), hypersensitivity reactions (n = 4), or a foreign body granuloma (n = 1). The incidence of hypersensitivity reactions was similar among institutions. However, the incidence of thrombosis-related events significantly differed between the high-volume and low-volume institutions. The incidence of proximal DVT (0.13% vs. 0.01%; p < 0.001; odds ratio [OR], 12.5; 95% confidence interval [CI], 2.6-60.3) and ARTE (0.73% vs. 0.30%; p < 0.001; OR, 2.5; 95% CI, 1.66-3.77) was significantly higher in low-volume institutions than in high-volume centers.

Conclusions: A nationwide survey of CAC for varicose veins in Japan demonstrated that it was a safe procedure with a low rate of serious AEs, such as VTE. However, hypersensitivity reactions requiring steroid administration and systemic allergic reactions were observed in some patients.