Journal of Vascular Surgery: Venous and Lymphatic Disorders
Clinical research studySuperficial venous diseaseThree-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins
Graphical Abstract
Section snippets
Methods
The European Sapheon Closure System Observational ProspectivE (eSCOPE) study was an international, prospective, single-arm, observational, postmarket cohort study carried out in seven centers that specialize in the diagnosis and treatment of peripheral venous diseases in four European countries. Each site obtained local ethics committee approval before initiation, and all participants signed an ethics committee-approved, study-specific informed consent form before participation.
Patient
Baseline demographics
Between December 2011 and July 2012, 70 patients (55 women and 15 men) with a mean age of 48.4 years (range, 22-72 years) and mean body mass index of 25.7 (range, 18.9-43.3) were enrolled. Each patient had one solitary refluxing GSV; no deep vein reflux was observed in the study leg.
Risk factors included a family history of venous disease (30%, n = 21) and obesity (5.71%, n = 4). Other vascular risk factors included cigarette smoking (12.8%, n = 9), hypertension (7.14%, n = 5), abnormal blood
Discussion
The 3-year clinical follow-up of this eSCOPE study confirmed the continued efficacy of the studied CAC system.
Although 3-year occlusion rates are comparable with other nonthermal nontumescent technologies, when seen in context of more recent studies with this CAC system, this rate seems to be slightly lower, particularly if regarding the fact that recanalization was defined in the present study by a recanalized vein segment of at least 10 cm in length. The available clinical studies with
Conclusions
The 3-year follow-up results of the prospective, multicenter eSCOPE study demonstrated the continued efficacy of a CAC system over an extended follow-up period. The anatomic and clinical efficacy outcomes corroborate other long-term studies on the same CAC system. The study treatment is a valid option for treatment of refluxing saphenous veins without the use of tumescent local anesthesia and postinterventional use of medical compression stockings.
Author contributions
Conception and design: TP, AD
Analysis and interpretation: TP, JA, SD, LR, MW, JL, AD
Data collection: TP, JA, SD, LR, MW, JL, AD
Writing the article: TP, JA, SD, LR, MW, JL, AD
Critical revision of the article: TP, JA, SD, LR, MW, JL, AD
Final approval of the article: TP, JA, SD, LR, MW, JL, AD
Statistical analysis: Not applicable
Obtained funding: Not applicable
Overall responsibility: TP
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A systematic review on ablation techniques for larger saphenous veins in patients with symptomatic superficial venous disease
2024, Journal of Vascular Surgery: Venous and Lymphatic DisordersCyanoacrylate glue reactions: A systematic review, cases, and proposed mechanisms
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2023, Journal of Vascular Surgery: Venous and Lymphatic DisordersCitation Excerpt :Nonthermal ablations include UGFS with physician-compounded foam using the Tessari technique98,99 or the use of PEM (Varithena).100 Other nonthermal ablation techniques include CAC12,90,91 using the VenaSeal system (Medtronic) or the Turkish glue kit (VariClose Vein Sealing System; Biolas) and mechanicochemical ablation, such as the MOCA procedure.94-97 All nonthermal ablations can be performed without the need for tumescent anesthesia.
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2022, Journal of Vascular Surgery: Venous and Lymphatic DisordersCitation Excerpt :Therefore, the stump length should be kept as short as possible. The initial position of the catheter tip for glue injection was 5 cm distal to the junction in other studies.13-15 There have been a variety of reported stump lengths between different published trials.
Hypersensitivity reaction after cyanoacrylate closure of incompetent saphenous veins in patients with chronic venous disease: A retrospective study
2021, Journal of Vascular Surgery: Venous and Lymphatic DisordersCitation Excerpt :Gibson et al10 reported HSR in 6% of US patients. Proebstle et al16 reported HSR in 11% of European patients. There seems to be a higher incidence of HSR in Asians when compared with Caucasian patients.
Author conflict of interest: All authors or their institutions received research support associated with the reported study. In addition, T.P., J.L., and J.A. are consultants to the sponsor. T.P., S.D. and J.A. have been stock owners of the original sponsor.
The original sponsor of the European Sapheon Closure System Observational ProspectivE (eSCOPE) trial was Sapheon. Sapheon was acquired by Covidien Ltd, which was then acquired by Medtronic, Inc. (Santa Rosa, Calif).
The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
This trial (NCT01570101) was registered on clinicaltrials.gov.