Early results of an Asian prospective multicenter VenaSeal real-world postmarket evaluation to investigate the efficacy and safety of cyanoacrylate endovenous ablation for varicose veins

Tang, Tjun Yip; Yap, Charyl Jia Qi; Chan, Sze Ling; Soon, Shereen Xue Yun; Yap, Hao Yun; Lee, Shaun Qing Wei; Choke, Edward Tieng Chek; Chong, Tze Tec

doi:10.1016/j.jvsv.2020.03.020

Cited by 21 publications

(16 citation statements)

References 28 publications

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“…AEs from the index procedure to the three month visit have previously been reported. 13 There were no cases of infections, which required readmission for intravenous antibiotics. As previously reported, two patients had thrombus extension that protruded 5 mm into the saphenofemoral junction at the two-week Duplex ultrasound visit.…”

Section: Resultsmentioning

confidence: 91%

“…The primary objective of the study was to determine technical success – this was 100% and there was immediate truncal vein occlusion after the procedure. 13…”

Section: Discussionmentioning

confidence: 99%

“…Study design, inclusion, exclusion criteria and outcomes through three months have been described in detail previously. 13 The study’s primary endpoints evaluated the technical, anatomical and clinical performance of VSCS, performed on multiple truncal varicose veins. The target population was adult patients with symptomatic venous reflux disease in the GSV, small saphenous vein (SSV) and/or anterior accessory saphenous vein (AASV) with associated moderate to severe varicosities (CEAP classification C2–C5).…”

Section: Methodsmentioning

confidence: 99%

“…Patients also completed a brief questionnaire about treatment satisfaction and whether they would have the operation again if required to, which has been previously described in detail. 13…”

Section: Methodsmentioning

confidence: 99%

“…ASVS showed that the technology was safe in 100 Asian patients and was associated with high efficacy in term of truncal closure, technical success and patient satisfaction at the two weeks and three-month follow-up timepoints. 13 The aim of this publication is to report six- and twelve months outcomes.…”

Section: Introductionmentioning

confidence: 99%

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One-year outcome using cyanoacrylate glue to ablate truncal vein incompetence: A Singapore VenaSeal™ real-world post-market evaluation study (ASVS)

et al. 2021

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Objective We present 12 months efficacy data from A Singapore VenaSeal™ real-world post-market evaluation Study (ASVS), a prospective single-arm Asian population registry aimed to evaluate cyanoacrylate glue (CAG) closure of refluxing truncal veins. Methods Duplex ultrasound was used to assess truncal vein closure. The revised Venous Clinical Severity Score (rVCSS) and three quality of life (QoL) questionnaires were completed to assess improvement in venous disease symptoms. Results 90/100 (90%) patients (136 legs; 140 truncal veins) completed evaluation at 6- and 12 months. The truncal closure rates at 6 and 12 months were 139/140 (99.3%) and 137/140 (97.9%), respectively. rVCSS and QoL questionnaires scores were sustained from the 3 to 12 months visits, although there were no futher significant improvement. No serious adverse events were reported between 3 and 12 months. Conclusions CAG remains a safe and efficacious venous ablative technology at 12 months and is associated with a high rate of target vein occlusion and sustained QoL improvement.

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Section: Resultsmentioning

confidence: 91%

“…The primary objective of the study was to determine technical success – this was 100% and there was immediate truncal vein occlusion after the procedure. 13…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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