Type IV Hypersensitivity Reaction after Cyanoacrylate Venous Closure

O’Banion, Leigh Ann; Shao, Michael Y.; Ali, Amna; Kochubey, Mariya; Yan, Yueqi; Fallentine, Joshua; Oh, Jae Hak; Patel, Harik R.; Agrawal, Nishant; Carmona, Emely; Hager, Eric; Kiguchi, Misaki M.

doi:10.1016/j.avsg.2023.06.002

Cited by 2 publications

(1 citation statement)

References 22 publications

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“…Multivariate analysis revealed that suprafascial saphenous vein with a subcutaneous distance between the anterior vein wall and skin of <1 cm and saphenous vein diameter >8 mm were independent factors associated with the CHAIR phenomenon. O’Banion et al [ 23 ] conducted a retrospective review of patients who underwent CAC at four tertiary United States institutions between 2012 and 2022. Among the 595 patients who underwent 881 CAC procedures, there were 92 (10.4%) cases of CHAIR in 79 patients (13%).…”

Section: Possible Risk Factorsmentioning

confidence: 99%

Complex Hypersensitivity and Irritation Reaction (CHAIR) Phenomenon after Cyanoacrylate Closure of Varicose Vein

Joh,

Joo

2023

Vasc Specialist Int

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Cyanoacrylate glue is a non-thermal, non-tumescent agent used to treat saphenous reflux. It was introduced to overcome heat-related discomfort and complications. Multiple randomized controlled trials using this therapy have demonstrated excellent clinical outcomes at long-term follow-up. However, diffuse injection-site inflammation and systemic urticaria are worrisome complications. In preclinical studies, serial histopathological findings demonstrated acute inflammatory reaction, subacute vasculitis, chronic granulomatous foreign body reaction, fibrotic changes with partial vascular recanalization, and chronic foreign body-type inflammatory response. While the exact nature of this unique complication remains undefined, complex hypersensitivity and irritation reaction phenomena have been suggested based on reported clinical presentations. The incidence of this complication has been reported as ranging from 0.3%-25.4%. Typically, erythematous reactions can occur near treatment sites, with symptoms ranging from mild pruritus and/or erythema that resolves without treatment to recurrent severe inflammation and pruritus requiring nonsteroidal anti-inflammatory drugs, antihistamines, and/or corticosteroids. Surgical excision has been rarely reported in patients with severe intractable inflammation or treatment-site infections. Although several anecdotal studies reported on using antihistaminics or corticosteroids, no effective strategies have been established to prevent this complication.

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Section: Possible Risk Factorsmentioning

confidence: 99%

Complex Hypersensitivity and Irritation Reaction (CHAIR) Phenomenon after Cyanoacrylate Closure of Varicose Vein

Joh,

Joo

2023

Vasc Specialist Int

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899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure

Parsi,

Zhang,

Whiteley

et al. 2023

Phlebology

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Objective The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies. Methods The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data. Results The TPLC contained 899 reports which included 13 cases of death, 7 strokes, 211 thromboembolic events, and 482 immune reactions. The DAEN recorded three reportable adverse events, and the MHRA recorded seven adverse incidents including one death. Conclusion CAC is associated with serious adverse events including death. These events are under-reported in the medical literature and only sub-optimally reported to the regulatory agencies.

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Type IV Hypersensitivity Reaction after Cyanoacrylate Venous Closure

Cited by 2 publications

References 22 publications

Complex Hypersensitivity and Irritation Reaction (CHAIR) Phenomenon after Cyanoacrylate Closure of Varicose Vein

Complex Hypersensitivity and Irritation Reaction (CHAIR) Phenomenon after Cyanoacrylate Closure of Varicose Vein

899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure

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