Outcomes of cyanoacrylate closure of the truncal varicose vein insufficiency: A comparison between young and elderly patients

Yiğit, Görkem

doi:10.1177/02683555221150147

Cited by 7 publications

(4 citation statements)

References 34 publications

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“…There was one report of death from Turkey with the use of VenaBlock, 39 three reported cases of PE, and ten cases of deep vein thrombosis (DVT). 32–39 Septicaemia was reported in one patient 16 and temporary blindness in another case.…”

Section: Resultsmentioning

confidence: 99%

“…There was one Cochrane review on different interventions for great saphenous vein (GSV) incompetence which included cyanoacrylate glue. 31 There was one report of death from Turkey with the use of VenaBlock, 39 three reported cases of PE, and ten cases of deep vein thrombosis (DVT). [32][33][34][35][36][37][38][39] Septicaemia was reported in one patient 16 and temporary blindness in another case.…”

Section: Medical Literaturementioning

confidence: 99%

“…31 There was one report of death from Turkey with the use of VenaBlock, 39 three reported cases of PE, and ten cases of deep vein thrombosis (DVT). [32][33][34][35][36][37][38][39] Septicaemia was reported in one patient 16 and temporary blindness in another case. The most common reported adverse events were phlebitis, type IV hypersensitivity allergic reaction, foreignbody granuloma formation, and endovenous glue-induced thrombosis (EGIT).…”

Section: Medical Literaturementioning

confidence: 99%

“…Only till recently, there were no published cases of death in patients undergoing CAC till this year's publication by Yigit. 39 Thirteen cases of death, however, have been registered with the FDA and one incident is recorded by the MHRA. The reported causes of death are summarised in Table 9.…”

Section: Medical Literaturementioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%