3-year clinical outcomes of A Singapore VenaSeal™ real world post-market evaluation Study (ASVS) for varicose vein ablation.
Chronic venous insufficiency
Cyanoacrylate closure
Endovenous
Varicose vein
VenaSeal™ closure system
Journal
CVIR endovascular
ISSN: 2520-8934
Titre abrégé: CVIR Endovasc
Pays: Switzerland
ID NLM: 101738484
Informations de publication
Date de publication:
27 Apr 2024
27 Apr 2024
Historique:
received:
20
09
2023
accepted:
09
04
2024
medline:
28
4
2024
pubmed:
28
4
2024
entrez:
27
4
2024
Statut:
epublish
Résumé
Medium-term clinical outcome data are lacking for cyanoacrylate glue (CAG) ablation for symptomatic varicose veins, especially from the Asian population. Aim was to determine the 3-year symptomatic relief gained from using the VenaSeal™ device to close refluxing truncal veins from the Singaporean ASVS prospective registry. The revised Venous Clinical Severity Score (rVCSS) and three quality of life (QoL) questionnaires were completed to assess clinical improvement in venous disease symptoms along with a dedicated patient satisfaction survey. 70 patients (107 limbs; 40 females; mean age of 60.9 ± 13.6 years) were included at 3 years. At 3 years, rVCSS showed sustained improvement from baseline (5.00 to 0.00; p < 0.001) and 51/70 (72.9%) had improvement by at least 2 or more CEAP categories. Freedom from reintervention was 90% and 85.7% patients were extremely satisfied with the treatment outcome. No further reports of further hypersensitivity reactions after one year. The 3-year follow-up results of the ASVS registry demonstrated continued and sustained clinical efficacy with few reinterventions following CAG embolization in Asian patients with chronic venous insufficiency. ClinicalTrials.gov Registration: NCT03893201.
Identifiants
pubmed: 38676860
doi: 10.1186/s42155-024-00452-8
pii: 10.1186/s42155-024-00452-8
doi:
Banques de données
ClinicalTrials.gov
['NCT03893201']
Types de publication
Journal Article
Langues
eng
Pagination
41Informations de copyright
© 2024. The Author(s).
Références
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