Tamana Alozai, Sharon Oud, Céline A M Eggen, Renee Pullens, Michiel A Schreve, Çağdaş Ünlü, Michael C Mooij, Clarissa J van Vlijmen
{"title":"一项随机、单盲、对照试验，比较冲洗静脉内激光消融与标准静脉内激光消融对大隐静脉的影响。","authors":"Tamana Alozai, Sharon Oud, Céline A M Eggen, Renee Pullens, Michiel A Schreve, Çağdaş Ünlü, Michael C Mooij, Clarissa J van Vlijmen","doi":"10.1016/j.ejvs.2025.01.014","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to compare anterior accessory saphenous vein (AASV) reflux after standard endovenous laser ablation (EVLA) vs. flush EVLA (fEVLA) of the great saphenous vein (GSV).</p><p><strong>Methods: </strong>This was as randomised, single blind, controlled trial (Dutch Trial Register, NL5283). Patients with GSV and saphenofemoral junction incompetence and competent AASV were randomised to standard EVLA or fEVLA using a 1 470 nm radial fibre. Treatment was blinded both for patients and phlebologists. The primary outcome was AASV reflux assessed at one week and six, twelve, and twenty four months. Secondary outcomes included GSV occlusion, stump length, endovenous heat induced thrombus (EHIT), complications, pain, time to return to daily activities, Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score, cosmetic results, and re-interventions.</p><p><strong>Results: </strong>In total, 52 patients were randomised to standard EVLA and 49 to fEVLA. After twenty four months, AASV reflux occurred in 21% after standard EVLA and 30% after fEVLA (risk ratio 1.53, 95% confidence interval 0.64 - 3.66; p = .34). Freedom from AASV reflux was 81% after standard EVLA vs. 74% after fEVLA (log rank test, χ<sup>2</sup> = 0.68, 1 df, p = .41). The GSV occlusion rate was 98% vs. 100%, respectively (p = .33). Mean stump length ± standard deviation was longer after standard EVLA (8 ± 4 mm vs. 4 ± 4 mm; p < .001). EHIT 1 occurred more frequently after fEVLA (57% vs. 17%; p < .001). EHIT 2 was seen in 2% vs. 6%, respectively (p = .34). The superficial vein thrombosis rate was 2% after standard EVLA (p = .33) and the paraesthesia rate was 4% after fEVLA (p = .23). Pain levels, time to return to daily activities, and cosmetic results were comparable, as were VCSS and AVVQ scores.</p><p><strong>Conclusion: </strong>FEVLA of the GSV using a radial two ring laser does not reduce AASV reflux at twenty four months compared with standard EVLA.</p>","PeriodicalId":55160,"journal":{"name":"European Journal of Vascular and Endovascular Surgery","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Randomised, Single Blind, Controlled Trial Comparing Flush Endovenous Laser Ablation with Standard Endovenous Laser Ablation of the Great Saphenous Vein.\",\"authors\":\"Tamana Alozai, Sharon Oud, Céline A M Eggen, Renee Pullens, Michiel A Schreve, Çağdaş Ünlü, Michael C Mooij, Clarissa J van Vlijmen\",\"doi\":\"10.1016/j.ejvs.2025.01.014\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The aim of this study was to compare anterior accessory saphenous vein (AASV) reflux after standard endovenous laser ablation (EVLA) vs. flush EVLA (fEVLA) of the great saphenous vein (GSV).</p><p><strong>Methods: </strong>This was as randomised, single blind, controlled trial (Dutch Trial Register, NL5283). Patients with GSV and saphenofemoral junction incompetence and competent AASV were randomised to standard EVLA or fEVLA using a 1 470 nm radial fibre. Treatment was blinded both for patients and phlebologists. The primary outcome was AASV reflux assessed at one week and six, twelve, and twenty four months. Secondary outcomes included GSV occlusion, stump length, endovenous heat induced thrombus (EHIT), complications, pain, time to return to daily activities, Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score, cosmetic results, and re-interventions.</p><p><strong>Results: </strong>In total, 52 patients were randomised to standard EVLA and 49 to fEVLA. After twenty four months, AASV reflux occurred in 21% after standard EVLA and 30% after fEVLA (risk ratio 1.53, 95% confidence interval 0.64 - 3.66; p = .34). Freedom from AASV reflux was 81% after standard EVLA vs. 74% after fEVLA (log rank test, χ<sup>2</sup> = 0.68, 1 df, p = .41). The GSV occlusion rate was 98% vs. 100%, respectively (p = .33). Mean stump length ± standard deviation was longer after standard EVLA (8 ± 4 mm vs. 4 ± 4 mm; p < .001). EHIT 1 occurred more frequently after fEVLA (57% vs. 17%; p < .001). EHIT 2 was seen in 2% vs. 6%, respectively (p = .34). The superficial vein thrombosis rate was 2% after standard EVLA (p = .33) and the paraesthesia rate was 4% after fEVLA (p = .23). Pain levels, time to return to daily activities, and cosmetic results were comparable, as were VCSS and AVVQ scores.</p><p><strong>Conclusion: </strong>FEVLA of the GSV using a radial two ring laser does not reduce AASV reflux at twenty four months compared with standard EVLA.</p>\",\"PeriodicalId\":55160,\"journal\":{\"name\":\"European Journal of Vascular and Endovascular Surgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2025-01-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Vascular and Endovascular Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ejvs.2025.01.014\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Vascular and Endovascular Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ejvs.2025.01.014","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
摘要
目的：本研究的目的是比较大隐静脉（GSV）标准静脉内激光消融（EVLA）与冲洗EVLA （fEVLA）后的前副隐静脉（AASV）反流。方法：随机、单盲、对照试验（荷兰试验登记，NL5283）。GSV、隐股连接处不全和正常AASV患者随机分为标准EVLA或使用1470 nm径向纤维的fEVLA。对患者和血液学家进行盲法治疗。主要结局是在1周、6个月、12个月和24个月时评估AASV反流。次要结果包括GSV阻塞、残端长度、静脉内热致血栓（EHIT）、并发症、疼痛、恢复日常活动时间、静脉临床严重程度评分（VCSS）、阿伯丁静脉曲张问卷（AVVQ）评分、美容结果和再干预。结果：52例患者随机分为标准EVLA组，49例患者随机分为fEVLA组。24个月后，标准EVLA后出现AASV反流的比例为21%，fEVLA后出现AASV反流的比例为30%(风险比1.53,95%可信区间0.64 - 3.66；P = .34)。标准EVLA后的AASV返流自由度为81%，而fEVLA后为74%（对数秩检验，χ2 = 0.68, 1 df, p = 0.41）。GSV闭塞率分别为98%和100% （p = 0.33）。标准EVLA后残肢平均长度±标准差更长（8±4 mm vs. 4±4 mm）；P < 0.001)。EHIT 1在fEVLA后发生的频率更高(57% vs. 17%；P < 0.001)。EHIT 2分别为2%和6% （p = .34）。标准EVLA术后浅静脉血栓形成率为2% (p = 0.33)， fEVLA术后感觉异常率为4% （p = 0.23）。疼痛程度、恢复日常活动的时间和美容结果具有可比性，VCSS和AVVQ评分也具有可比性。结论：与标准EVLA相比，径向双环激光对GSV的FEVLA在24个月时不能减少AASV反流。
A Randomised, Single Blind, Controlled Trial Comparing Flush Endovenous Laser Ablation with Standard Endovenous Laser Ablation of the Great Saphenous Vein.
Objective: The aim of this study was to compare anterior accessory saphenous vein (AASV) reflux after standard endovenous laser ablation (EVLA) vs. flush EVLA (fEVLA) of the great saphenous vein (GSV).
Methods: This was as randomised, single blind, controlled trial (Dutch Trial Register, NL5283). Patients with GSV and saphenofemoral junction incompetence and competent AASV were randomised to standard EVLA or fEVLA using a 1 470 nm radial fibre. Treatment was blinded both for patients and phlebologists. The primary outcome was AASV reflux assessed at one week and six, twelve, and twenty four months. Secondary outcomes included GSV occlusion, stump length, endovenous heat induced thrombus (EHIT), complications, pain, time to return to daily activities, Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score, cosmetic results, and re-interventions.
Results: In total, 52 patients were randomised to standard EVLA and 49 to fEVLA. After twenty four months, AASV reflux occurred in 21% after standard EVLA and 30% after fEVLA (risk ratio 1.53, 95% confidence interval 0.64 - 3.66; p = .34). Freedom from AASV reflux was 81% after standard EVLA vs. 74% after fEVLA (log rank test, χ2 = 0.68, 1 df, p = .41). The GSV occlusion rate was 98% vs. 100%, respectively (p = .33). Mean stump length ± standard deviation was longer after standard EVLA (8 ± 4 mm vs. 4 ± 4 mm; p < .001). EHIT 1 occurred more frequently after fEVLA (57% vs. 17%; p < .001). EHIT 2 was seen in 2% vs. 6%, respectively (p = .34). The superficial vein thrombosis rate was 2% after standard EVLA (p = .33) and the paraesthesia rate was 4% after fEVLA (p = .23). Pain levels, time to return to daily activities, and cosmetic results were comparable, as were VCSS and AVVQ scores.
Conclusion: FEVLA of the GSV using a radial two ring laser does not reduce AASV reflux at twenty four months compared with standard EVLA.
期刊介绍：
The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles.
Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.
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