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一项关于新加坡VenaSeal™ 静脉曲张消融术真实世界上市后评估研究(ASVS)的3年临床结果

3-year clinical outcomes of A Singapore VenaSeal™ real world post-market evaluation Study (ASVS) for varicose vein ablation.

作者信息

Tang Tjun Yip, Yap Charyl Jia Qi, Chan Sze Ling, Soon Shereen Xue Yun, Khoo Vanessa Bao Xian, Choke Edward, Chong Tze Tec

机构信息

The Vascular & Endovascular Clinic, Gleneagles Medical Centre, 6 Napier Road #08-08, Sinagpore, 258499, Singapore.

Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.

出版信息

CVIR Endovasc. 2024 Apr 27;7(1):41. doi: 10.1186/s42155-024-00452-8.

Abstract

INTRODUCTION

Medium-term clinical outcome data are lacking for cyanoacrylate glue (CAG) ablation for symptomatic varicose veins, especially from the Asian population.

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov Registration: NCT03893201.

摘要

引言

对于症状性静脉曲张的氰基丙烯酸酯胶水(CAG)消融术,缺乏中期临床结果数据,尤其是来自亚洲人群的数据。

目的

旨在确定使用VenaSeal™装置闭合来自新加坡前瞻性ASVS登记处反流主干静脉后3年的症状缓解情况。

方法

完成修订的静脉临床严重程度评分(rVCSS)和三份生活质量(QoL)问卷,以评估静脉疾病症状的临床改善情况,并进行专门的患者满意度调查。3年时纳入70例患者(107条肢体;40名女性;平均年龄60.9±13.6岁)。

结果

3年时,rVCSS显示从基线持续改善(从5.00降至0.00;p<0.001),51/70(72.9%)患者的CEAP分级至少改善2级或更多。无需再次干预的比例为90%,85.7%的患者对治疗结果极为满意。一年后未再有进一步过敏反应的报告。

结论

ASVS登记处的3年随访结果表明,对于亚洲慢性静脉功能不全患者,CAG栓塞术后临床疗效持续且持久,再次干预较少。

试验注册

ClinicalTrials.gov注册编号:NCT03893201。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f75/11055841/233830e61b75/42155_2024_452_Fig1_HTML.jpg

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本文引用的文献

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