Type IV Hypersensitivity Reaction after Cyanoacrylate Venous Closure.

BACKGROUND: Nonthermal endovenous closure techniques are routinely utilized to treat superficial axial venous reflux. Cyanoacrylate closure is a safe and effective modality implemented for truncal closure. However, an adverse reaction of type IV hypersensitivity (T4H), unique to cyanoacrylate, is a known risk. This study aims to evaluate the real-world incidence of T4H and examine risk factors that may predispose its development. METHODS: A retrospective review between 2012- and 2022 was performed at four tertiary US institutions to examine patients who underwent cyanoacrylate vein closure of their saphenous veins. Patient demographics, comorbidities, CEAP (Clinical [C], Etiological [E], Anatomical [A], and Pathophysiological [P]) classification, and periprocedural outcomes were included. The primary endpoint was development of T4H post procedure. Logistic regression analysis for risk factors predictive of T4H was performed. Variables with a P-value of <0.05 were deemed significant. RESULTS: 595 patients underwent 881 cyanoacrylate venous closures. Mean age was 66.2 ± 14.9, and 66% of patients were female. There were 92 (10.4%) T4H events in 79 (13%) patients. Oral steroids were administered to 23% for persistent and/or severe symptoms. There were no systemic allergic reactions to cyanoacrylate. Multivariate analysis revealed younger age (P = 0.015), active smoking status (P = 0.033), and CEAP 3 (P < 0.001) and 4 (P = 0.005) classifications as independent risk factors associated with development of T4H. CONCLUSIONS: This real-world multicenter study shows the overall incidence of T4H to be 10%. CEAP 3 and 4 patients of younger age and smokers predicted a higher risk of T4H to cyanoacrylate.

Thrombotic complications after radiofrequency and cyanoacrylate endovenous ablation: Outcomes of a multicenter real-world experience.

OBJECTIVE: Chronic venous insufficiency (CVI) affects >40% of the U.S. population; thus, intervention for symptomatic venous disease comprises a large portion of many vascular practices. The treatment of superficial CVI has evolved from open surgical treatment to minimally invasive endovenous closure, including both thermal and nonthermal techniques. Thrombotic complications of thermal ablation have been well reported, with an overall complication rate of <2%. However, a paucity of high-powered, real-world data is available on the thrombotic outcomes of nonthermal techniques. In the present study, we compared the incidence of endovenous heat-induced thrombosis (EHIT) and endovenous glue-induced thrombosis (EGIT) in a large cohort of patients with CVI. METHODS: A retrospective review was conducted at two tertiary-level institutions of patients who had undergone superficial endovenous ablation from 2018 to 2021. The patient demographics, comorbidities, and periprocedural outcomes were collected through medical record review. A Caprini risk assessment model score was assigned using the information available from the electronic medical records. The patients were categorized by procedure type (ClosureFast [Medtronic Inc, Minneapolis, MN] radiofrequency ablation [RFA] vs VenaSeal [Medtronic Inc] cyanoacrylate glue closure [CAG]). The primary end point was the incidence of EHIT or EGIT. The secondary end point was the incidence of deep vein thrombosis and/or pulmonary embolism. RESULTS: A total of 803 patients had undergone 1096 procedures during the study period. Their mean age was 62 ± 15 years, and 67% were women. Of the 1096 procedures, 700 were RFA and 396 were CAG procedures, with a combined closure rate of 98% by postprocedure duplex ultrasound at 7 days. The average Caprini score was 5.2 ± 1.8 (RFA, 5.0; vs CAG, 5.4; P < .001). The incidence of EHIT and EGIT was 1.9% and 1.3%, respectively (P = .57). The deep vein thrombosis rate was 0.1% in the RFA cohort and 0.3% in the CAG cohort (P = .81). A comparative analysis of thermal vs nonthermal techniques was performed. A univariate analysis of the risk factors for EHIT and EGIT revealed no significant factors predisposing to thrombotic events. CONCLUSIONS: The results from the present study have demonstrated the safety of RFA and CAG closure techniques for CVI, with lower thrombotic rates than previously reported. Further work might help to identify how these results can be achieved across all venous ablative techniques for CVI, even for patient populations with advanced venous disease and possibly a greater than average risk of thrombotic events.