用于静脉曲张消融的 A Singapore VenaSeal™ 真实世界上市后评估研究 (ASVS) 的 3 年临床结果

IF 1.2 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS CVIR Endovascular Pub Date : 2024-04-27 DOI:10.1186/s42155-024-00452-8
Tjun Yip Tang, Charyl Jia Qi Yap, Sze Ling Chan, Shereen Xue Yun Soon, Vanessa Bao Xian Khoo, Edward Choke, Tze Tec Chong
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引用次数: 0

摘要

目前尚缺乏氰基丙烯酸酯胶(CAG)消融术治疗症状性静脉曲张的中期临床结果数据,尤其是来自亚洲人群的数据。本研究的目的是根据新加坡ASVS前瞻性登记数据,确定使用VenaSeal™装置闭合反流的躯干静脉3年后症状缓解的情况。患者填写了静脉临床严重程度评分(rVCSS)修订版和三份生活质量(QoL)问卷,以评估静脉疾病症状的临床改善情况,并进行了专门的患者满意度调查。70 名患者(107 条肢体;40 名女性;平均年龄为 60.9 ± 13.6 岁)接受了为期 3 年的治疗。3 年后,rVCSS 与基线相比有持续改善(从 5.00 降至 0.00;p < 0.001),51/70(72.9%)名患者的症状至少改善了 2 个或更多 CEAP 类别。90%的患者无须再次干预,85.7%的患者对治疗效果非常满意。一年后,没有再出现过敏反应的报告。ASVS登记的3年随访结果表明,CAG栓塞术对亚洲慢性静脉功能不全患者具有持续的临床疗效,很少出现再次干预的情况。ClinicalTrials.gov 注册:NCT03893201。
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3-year clinical outcomes of A Singapore VenaSeal™ real world post-market evaluation Study (ASVS) for varicose vein ablation
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.
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来源期刊
CVIR Endovascular
CVIR Endovascular Medicine-Radiology, Nuclear Medicine and Imaging
CiteScore
2.30
自引率
0.00%
发文量
59
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