Mid-Term Results of Cyanoacrylate Embolization of Saphenous Veins

Murzina, Elena; Lobastov, Kirill; Bargandzhiya, Astanda; Laberko, Leonid; Popov, I. B.

doi:10.17116/flebo202014041311

Cited by 8 publications

(3 citation statements)

References 29 publications

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“…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%

“…The published medical literature records a smaller number of significant complications that includes 1 death, 3 PEs, 10 DVTs, 93 endovenous glue-induced thromboses (EGIT), 1 temporary blindness, and 11 infections (Table 8). 16,[32][33][34][35][36][37][38] The discrepancy between the data available from the FDA TPLC with that reported by other regulatory agencies and that published in the medical literature (Table 8) is due to the FDA mandatory reporting requirements subject to the Federal Food, Drug and Cosmetic Act 1938 (Table 2). 40 Serious adverse events are defined as death, serious injuries, and device malfunction.…”

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: Medical Literaturementioning

confidence: 99%

Section: Medical Literaturementioning

confidence: 99%

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

View full text Add to dashboard Cite

show abstract

“…[1][2][3][4][5] According to individual studies, the incidence of asymptomatic thrombotic lesions may reach 5%-10% after thermal ablation, 2%-6% after cyanoacrylate glue ablation, and 20%-25% after sclerotherapy. 1,[6][7][8][9][10][11] However, the evidence on the usefulness of prophylactic anticoagulation in VV surgery is still conflicting. [12][13][14] An individual approach for VTE risk assessment and pharmacological prophylaxis is suggested by current guidelines.…”

Section: Introductionmentioning

confidence: 99%

The trends in venous thromboembolism occurrence and prevention after minimally invasive varicose vein surgery

Lobastov,

Shaldina,

Matveeva

et al. 2023

Phlebology

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Objectives To assess the trends of VTE occurrence and prevention in varicose vein surgery. Method The registry-based CAPSIVS trial (NCT03041805) analysis includes results in 1878 lower limbs. The primary outcome is a 28-day symptomatic or asymptomatic DVT revealed with duplex ultrasound. Results Any DVT, including EHIT, was observed in 3.4%, while symptomatic in 0.5%. Prophylactic anticoagulation was administrated in 20.4% with LMWH (13.2%) or DOAC (7.1%) for patients with higher VTE risk but did not reduce the events rate. With propensity score matching DOACs were superior to LMWHs (1.5% vs 9.8%). Duration of anticoagulation was essential: the lowest incidence (4.2%) was associated with prophylaxis for up to 7 days, while a single LMWH injection resulted in a DVT rate of 8.8%. With individual VTE history, any anticoagulation duration appeared insufficient. Conclusions Prophylactic anticoagulation after varicose vein surgery should be based on the individual VTE risk and provided for ≥7–30 days.

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Cyanoacrylate Adhesive Closure of Saphenous Veins

Shirinbek¹,

Odinokova²

2021

Flebol.

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Mid-Term Results of Cyanoacrylate Embolization of Saphenous Veins

Cited by 8 publications

References 29 publications

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

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

The trends in venous thromboembolism occurrence and prevention after minimally invasive varicose vein surgery

Cyanoacrylate Adhesive Closure of Saphenous Veins

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