1. Frequency and severity of hypersensitivity reactions in patients after VenaSeal™ cyanoacrylate treatment of superficial venous insufficiency
- Author
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Elena Rinehardt, Renee Minjarez, Brian L. Ferris, and Kathleen Gibson
- Subjects
Adult ,Male ,medicine.medical_specialty ,Time Factors ,030204 cardiovascular system & hematology ,Severity of Illness Index ,law.invention ,Erythematous rash ,Varicose Veins ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,law ,Varicose veins ,Hypersensitivity ,medicine ,Humans ,Saphenous Vein ,In patient ,Cyanoacrylates ,Prospective Studies ,030212 general & internal medicine ,Aged ,Retrospective Studies ,business.industry ,Endovascular Procedures ,General Medicine ,Middle Aged ,Surgery ,Treatment Outcome ,Cyanoacrylate adhesive ,Venous Insufficiency ,Erythema ,Cyanoacrylate ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Venous disease ,business - Abstract
Objective Hypersensitivity reaction presenting as a distinctive erythematous rash has been reported following VenaSeal™ cyanoacrylate adhesive closure. We report the frequency of hypersensitivity reactions, time to onset, duration, and severity of symptoms in patients treated with cyanoacrylate adhesive closure at a single institution. Patient and procedural factors associated with hypersensitivity reactions were evaluated. Methods A combined retrospective/prospective review of cyanoacrylate adhesive closure-treated patients was conducted over five years. Data collected from electronic medical records were reviewed for the presence of hypersensitivity reactions along with the time of onset, duration of symptoms, and severity of reaction. Severity was classified as mild if no treatment or over the counter medication was provided, moderate if steroids were required, and severe if the reaction lasted >30 days or required vein excision. Results Three hundred and seventy-nine limbs were treated in 286 patients (313 treatment days). Hypersensitivity reactions occurred in 18 patients (5.8% treatments, 6.3% patients). Thirteen were mild (4.2%), four were moderate (1.3%), and one was severe (0.3%). No patient or procedural predictive factors for hypersensitivity reaction were identified other than a trend towards decreased hypersensitivity reactions in patients with Clinical, Etiologic, Anatomic, Pathophysiologic (CEAP) clinical class C4–C6 (p = .06). Second limb treatment on a subsequent day was performed in 27 patients, and no hypersensitivity reactions occurred. Symptom onset time ranged from 1 to 23 days, with a mean of 13 days (confidence interval (CI) ±3.5 days). Duration of symptoms ranged from 3 to 28 days (mean 10.8 CI ±4.9 days). Conclusions Hypersensitivity reactions occurred in 6.0% of patients treated with cyanoacrylate adhesive closure, but most were mild and self-limited. Severe reactions were uncommon. No predictive patient or procedural factors were found to be associated with hypersensitivity reactions other than a trend towards decreased risk in patients with advanced CEAP clinical class. Previous cyanoacrylate adhesive closure treatment was not a predictive factor for hypersensitivity reaction in patients undergoing treatment at a later date.
- Published
- 2019