Prospective randomised comparative study of visual foam sclerotherapy alone or in combination with ultrasound-guided foam sclerotherapy for treatment of superficial venous insufficiency: preliminary report

ObjectiveThe aim of the study is to compare ultrasound-guided foam sclerotherapy (UGFS: injection of foam sclerosant under ultrasound guidance) of the great saphenous vein (GSV) combined with visual foam sclerotherapy (VFS: injection of foam sclerosant under visual control) for varicose tributary veins and VFS alone in the treatment of GSV reflux.Design and methodsA total of 133 limbs in 97 patients with GSV reflux were randomised to receive either VFS alone or VFS combined with UGFS. In both groups, 1% polidocanol foam was used. Assessments included duplex ultrasonography, evaluation of Venous Clinical Severity Scores (VCSS) and CEAP (clinical, etiologic, anatomic, and pathophysiologic) scores. Ultrasonographic inspection of the foam in the GSV was carried out during 5 min before compression was applied. The primary ‘end’ point of the study was obliteration of the GSV at 6 months.ResultsA total of 51 limbs in 48 patients were treated with UGFS + VFS and the remaining 52 limbs in 49 patients were treated with VFS alone. There were no significant inter-group differences in patient age, male: female ratio, height, weight, body mass index, CEAP clinical scores or VCSS. The GSV diameter was 6.0 ± 1.7 mm (median ± interquartile range) in the UGFS + VFS group and 5.7 ± 1.6 mm in the VFS group (p = 0.419). The mean injected volume of foam for varicose tributary veins was 4 ± 2 ml in the UGFS + VFS group and 6 ± 2 ml in the VFS group, a significantly higher amount of foam being used in the latter (p < 0.001). However, the mean total amount of foam was greater in limbs treated with UFGS + VFS than in those treated with VFS alone (p = 0.017). Ultrasonographic inspection revealed complete vasospasm of the GSV in 37 (72.5%) limbs in the UGFS + VFS group and 29 (55.8%) in the VFS group during sclerotherapy (p = 0.097). At 6-month follow-up, complete occlusion was found in 23 limbs (45.1%) treated with UGFS + VFS and in 22 limbs (42.3%) treated with VFS. The difference between the two groups was not significant (p = 0.775). Reflux was absent in 30 limbs (58.8%) treated with UGFS + VFS and in 37 (71.2%) treated with VFS (p = 0.190). There was no inter-group difference in post-treatment VCSS (p = 0.223).ConclusionsThese results show that UGFS + VFS and VFS are equally effective for the treatment of GSV reflux, despite the lower volume of foam used for VFS alone.     

Duplex ultrasound scan findings two years after great saphenous vein radiofrequency endovenous obliteration

OBJECTIVE: To assess the clinical and duplex ultrasound scan findings in the groin and thigh 2 years after great saphenous vein (GSV) radiofrequency endovenous obliteration (RFO). METHODS: Sixty-three limbs in 56 patients with symptomatic varicose veins and GSV incompetence were treated with RFO, usually with adjunctive stab-avulsion phlebectomies, and examined at a median follow-up of 25 months, by using a color-coded, duplex sonography protocol that mandated views in at least two planes of the saphenofemoral junction (SFJ) and its tributaries and at three GSV levels in the thigh. RESULTS: The commonest duplex finding in the groin was an open, competent, SFJ with a < or =5-cm patent terminal GSV segment conducting prograde tributary flow through the SFJ (82%). Despite the presence of a total of 104 patent junctional tributaries, SFJ reflux was uncommon, affecting only five limbs. GSV truncal occlusion was observed in 90% of treated GSVs. Limited segmental treatment was successful in three limbs with a midthigh reflux source well below competent terminal and subterminal valves. Six GSV trunks had partial or no occlusion, but only one refluxed. These were anatomical RFO failures (9.5%) but were clinically improved, including the refluxing limb. Neovascularity was not identified in any groin. Thigh varicosities were observed in 12 limbs, including telangiectasias and isolated small tributary branches. New varicosities, linked to refluxing thigh perforators (two), or patent SFJ tributaries (three), were present in five limbs. CONCLUSION: RFO is the ideological opposite of high ligation without GSV stripping. It leaves physiologic tributary flow relatively undisturbed, does not incite groin neovascularity, eliminates the GSV as a refluxing conduit in >90% of limbs and has a 2-year, postadjunctive phlebectomy varicosity prevalence of 7.9%, with symptom score improvement in 95% of limbs with an initial score higher than zero.     

Defining the role of extended saphenofemoral junction ligation: a prospective comparative study

OBJECTIVE: This study explores the added effect of extended saphenofemoral junction (SFJ) ligation when the greater saphenous vein (GSV) has been eliminated from participating in thigh reflux by means of endovenous obliteration. GSV obliteration, unlike surgical stripping, can be done with or without SFJ ligation to isolate and study SFJ ligation's specific contribution to treatment results. METHODS: Sixty limbs treated with SFJ ligation and 120 limbs treated without high ligation were selected from an ongoing, multicenter, endovenous obliteration trial on the basis of their having primary varicose veins, GSV reflux, and early treatment dates. RESULTS: Five (8%) high-ligation limbs and seven (6%) limbs without high ligation with patent veins at 6 weeks or less were excluded as unsuccessful obliterations. Treatment significantly reduced symptoms and CEAP clinical class in both groups (P =.0001). Recurrent reflux developed in one (2%) of 49 high-ligation limbs and eight (8%) of 97 limbs without high ligation by 6 months (P =.273). New instances of reflux did not appear thereafter in 57 limbs followed to 12 months. Recurrent varicose veins occurred in three high-ligation limbs and four limbs without high ligation by 6 months and in one additional high-ligation limb and two additional limbs without high ligation by 12 months. Actuarial recurrence curves were not statistically different with or without SFJ ligation (P >.156), predicting greater than 90% freedom from recurrent reflux and varicosities at 1 year for both groups. CONCLUSION: These early results suggest that extended SFJ ligation may add little to effective GSV obliteration, but our findings are not sufficiently robust to warrant abandonment of SFJ ligation as currently practiced in the management of primary varicose veins associated with GSV vein reflux.     

泡沫硬化剂注射术与大隐静脉剥脱术的近期疗效对照研究

目的 评价泡沫硬化剂注射术联合高位结扎术治疗下肢大隐静脉曲张的近期临床效果.方法 55例(55条肢体)下肢大隐静脉曲张患者随机分为两组:传统大隐静脉剥脱术组(A组,23例);大隐静脉高位结扎联合泡沫硬化剂注射术组(B组,32例),比较两组手术前后CEAP分级及静脉临床严重程度评分(VCSS)的变化.结果 A、B两组手术...     

Endovenous ablation of the great saphenous vein may avert phlebectomy for branch varicose veins

BACKGROUND: Endovenous ablation of the great saphenous vein (GSV) may be performed simultaneously with stab phlebectomy of branch varicose veins or as a stand-alone procedure. A clinical approach of performing radiofrequency ablation (RFA) alone as initial treatment for varicose veins was reviewed. METHODS: Patients with duplex ultrasound-documented reflux in the GSV and CEAP clinical stage 2 to 6 were selected for RFA. Patients were examined within a week preoperatively with duplex ultrasound imaging. Patients were seen within a week postoperatively and again at 2 to 3 months to ascertain if further treatment was required. A retrospective review of the initial 184 procedures in a series from June 2002 through February 2005 was performed, allowing for a 9-month follow-up period. RESULTS: Three procedures were performed under general anesthesia and 181 with intravenous sedation and tumescent anesthesia. Postoperative duplex scans showed total occlusion or partial patency of <10 cm in 155 limbs. Seven (4.5%) had concomitant stab phlebectomy, seven subsequently had sclerotherapy, and 39 (25.2%) underwent subsequent stab phlebectomy of persistent symptomatic varicosities. In 101 limbs (65.1%), symptoms resolved and had no further therapy, and 24 limbs had a GSV that was patent for >10 cm on postoperative duplex imaging. Nine limbs had no further therapy (37.5%), eight (33.3%) had subsequent stab phlebectomy, and three had stripping of the GSV and stab phlebectomy. Four limbs had a redo RFA, four limbs had an aborted RFA procedure, and one limb was lost to follow-up. Failure of total GSV occlusion was more often associated with use of a 6F catheter. Complications were generally mild, and there was no postoperative deep vein thrombosis. CONCLUSION: Endovenous ablation of the GSV can be performed safely and effectively as the initial treatment for lower extremity varicose veins. Because most patients show clinical improvement after RFA, an algorithm of reassessment of the limb and branch varicose veins several months post-RFA allows most patients to defer stab phlebectomy.     

导管引导下泡沫硬化剂疗法治疗大隐静脉曲张

目的 探讨导管引导下的泡沫硬化剂疗法治疗下肢静脉曲张的临床效果.方法 选择2008年4月至8月间有微创治疗意愿的30例(条)中重度下肢静脉曲张患者.其中男性11例,女性19例;年龄34-85岁,平均年龄52岁.病史2～30年,平均20年.对其进行导管引导下患肢大隐静脉主干内注射1%聚桂醇泡沫硬化剂,观察大隐静脉主干的闭合情况.结果 30条患肢均在导管引导下成功注射硬化剂,平均每条患肢应用6.2 ml泡沫硬化剂,27条(90%)大隐静脉主干治疗后即刻可见反流消失.术后早期大隐静脉走行轻微浅静脉炎5例(条),2周内自行缓解,无严重的并发症发生.平均随访3个月,27例患者下肢活动后酸胀、乏力感消失,下肢明显的曲张畸形静脉消失;27条患肢(90%)于治疗后2周、3个月后复诊血管超声时大隐静脉主干闭塞.4例(条)患者(15%)仅有小腿局限的轻度曲张.结论 导管引导的泡沫硬化剂疗法治疗下肢静脉曲张的大隐静脉主干闭合率较高,是微创治疗下肢静脉曲张有效的新方法.     

Foam sclerotherapy combined with surgical treatment for recurrent varicose veins: short term results.

OBJECTIVE: To study the short term results of combined peroperative foam sclerotherapy (PFS) and surgical treatment for recurrent varicose veins. METHODS: PFS was used to treat 129 limbs with recurrent varices: 100 great saphenous (GSV), 29 small saphenous veins (SSV). Foam was prepared with 1% polidocanol mixed with 4 times its volume of air. The 100 GSVs comprised 28 trunks directly connected with the femoral vein, 28 connected to a lymph node venous network, 11 associated with perforators and 33 isolated trunks. The 29 SSVs comprised 4 trunks directly connected to the popliteal vein, 7 isolated trunks, 15 popliteal perforators and 3 recanalisations after SSV stripping. All operations included phlebectomies. In twenty limbs re-ligation of the SFJ and 4 SPJs was carried out. All were performed under local anaesthesia in an ambulatory setting. Patients were assessed clinically and by colour duplex ultrasound after 3 and 40 days follow-up. RESULTS: 120 patients (93%) showed complete obliteration of saphenous trunks, junctions and varices. The 9 incomplete obliterations were 3 venous recanalisations in the SSV compartment and 6 perforators (4 popliteal and 2 femoral). Two asymptomatic deep venous thromboses were detected by colour duplex 3 days after operation. CONCLUSION: PFS facilitates surgical treatment of recurrent varicose veins. There is a small risk of post-operative deep vein thrombosis.     

大隐静脉传统剥脱术与泡沫硬化剂注射术的随机对照研究

目的 比较大隐静脉传统剥脱术与泡沫硬化剂注射联合高位结扎术治疗大隐静脉曲张的临床效果.方法 本研究为单中心前瞻性随机对照研究.2009年3月至11月,连续录入60例大隐静脉曲张患者,其中男性26例,女性34例,年龄37～66岁,中位年龄49岁.随机分为两组,每组30例,一组行大隐静脉剥脱术(手术组),另一组行高位结扎联合泡沫硬化剂注射治疗(硬化剂组).主要临床观察指标为患者术后恢复时间、术后疼痛程度和术后复发率,次要观察指标为围手术期并发症发生率.结果 1例患者术前退出研究,余59例手术按计划完成.硬化剂组手术时间短于手术组(43 min比65 min,P＜0.01),术后镇痛药应用少于手术组,术后平均恢复时间也少于手术组(3 d比6 d,P＜0.01).术后3个月随访,两组CEAP分级为C1,均较术前的C4明显改善(P＜0.01).术后6个月随访,硬化剂组大隐静脉闭塞率80.0%,手术组为89.5%,差异无统计学意义(P＞0.05).结论 与大隐静脉剥脱术相比,大隐静脉高位结扎联合泡沫硬化剂注射术可以缩短手术时间,减少术后疼痛和术后恢复时间.     

Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.

AIM: This study is a prospective randomised controlled trial comparing sapheno-femoral ligation, great saphenous stripping and multiple avulsions with sapheno-femoral ligation and ultrasound guided foam sclerotherapy to the saphenous vein. Primary end points were patient recovery period and quality of life and secondary end points frequency of complications on the two arms of the trial and the cost of the treatment. MATERIAL AND METHOD: Sixty patients with primary varicose veins due to GSV incompetence and suitable for day case surgery were randomly allocated to undergo ultrasound-guided sclerotherapy with sapheno-femoral ligation under local anaesthesia (n=30) or sapheno-femoral ligation, stripping and multiple avulsions under general anaesthesia (n=30). The study protocol included history, physical examination, assignment of CEAP class and assessment venous clinical severity score (VCSS), completion of the aberdeen vein questionnaire (AVQ) and colour duplex ultrasound. RESULTS: All treatments were completed as intended. Median time to return to normal activities was significantly reduced in the foam sclerotherapy group (2 days) compared to the surgical group (8 days) (p<0.001, Mann-Whitney). AVQ score was also significantly reduced at 3 months by 46% in the sclerotherapy group, and by 40% in the conventional surgery group (p<0.001, Wilcoxon). The time taken to complete treatment was shorter in the foam sclerotherapy plus SFJ ligation group: 45 vs. 85 min (p<0.001, Mann-Whitney). The overall cost of the procedure in the sclerotherapy group ( 672.97 pounds) was significantly less compared to conventional surgery ( 1120.64 pounds). At 3 weeks, there was no statistical difference in the complication rate between the two groups. At 3 months, median CEAP class dropped from four pre-operatively to one following treatment in both groups and the median VCSS score dropped from five to one in group one and from seven to three in group two (p<0.001, Wilcoxon test). In group one four patients (13%) had a recanalised vein which needed further sessions of foam sclerotherapy, resulting in a short-term closure rate of 87%. CONCLUSION: Ultrasound guided sclerotherapy combined with sapheno-femoral ligation was less expensive, involved a shorter treatment time and resulted in more rapid recovery compared to sapheno-femoral ligation, saphenous stripping and phlebectomies.     

Validation of a new duplex derived haemodynamic effectiveness score, the saphenous treatment score, in quantifying varicose vein treatments

ObjectivesTo evaluate a duplex-derived score for varicose vein treatments using numerical values of haemodynamic effectiveness.DesignThe saphenous treatment score (STS) was developed prospectively to compare the effect of endovenous treatments on reflux within saphenous segments.PatientsSixty-six patients were randomised to endovenous laser ablation (EVLA) or ultrasound-guided foam sclerotherapy (UGFS) to the great saphenous vein (GSV).MethodsAssessments included the Aberdeen varicose vein severity score (AVVSS), the venous clinical severity score (VCSS), the venous filling index (VFI) and the STS.ResultsA mean STS of 5.70 decreased to 3.30, P < .0005, post-treatment. The median (IQR) AVVSS, VCSS and VFI (ml/sec) decreased from 21.52(15.48) to 18.86(11.27), P = .14, from 6(4) to 3(4), P < .0005 and from 7.1(6.9) to 1.9(.9) P < .0005, respectively. In 15 patients requiring additional UGFS the mean STS values decreased from 5.8 to 4.13 and then to 2.6 P < .0005, respectively. The individual above and below knee mean treatment differences in STS on 38 EVLA and 28 UGFS patients were 1.92 and .87 (EVLA) compared to 1.57and .29 (UGFS) P = .001, respectively.ConclusionsThe STS has been shown to grade the haemodynamic effects of different treatments as well as ongoing treatments on the GSV.     

CHIVA与闭合治疗非隐来源下肢静脉曲张的疗效比较

背景与目的：非隐反流来源下肢静脉曲张血流动力学类型复杂,传统隐静脉主干闭合或抽剥可能遗漏反流静脉造成高复发率,目前常用治疗方法以射频消融术（RFA）、激光及硬化剂闭合为主,但未形成共识。本研究旨在探讨对比血流动力学纠正术（CHIVA）和RFA联合超声引导泡沫硬化剂（UGFS）闭合治疗非隐来源下肢静脉曲张的安全性和有效性。方法：选取2019年7月—2021年12月中南大学湘雅三医院连续收治并定期随访的非隐反流来源下肢静脉曲张患者共95例。其中41例行CHIVA治疗（CHIVA组）,54例行RFA联合UGFS闭合（闭合组）。收集患者数据包括人口特征、反流静脉类型、分流通路类型、围术期情况、术后疗效、并发症、静脉临床严重程度评分（VCSS）。结果：CHIVA组平均手术时间明显少于闭合组（61.36 min vs. 78.15 min,P=0.000 5）、平均术中出血量明显少于闭合组（4.07 mL vs. 8.52 mL,P<0.000 1）、术中切口个数明显少于闭合组（1.58个vs. 3.65个,P<0.000 1）;两组平均住院时间无明显差异（P>0.05）。CHI...     

Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efficacy and complications

BACKGROUND: Endovenous laser therapy (EVLT) and radiofrequency ablation (RFA) are new, minimally invasive percutaneous endovenous techniques for ablation of the incompetent great saphenous vein (GSV). We have performed both procedures at the Mayo Clinic during two different consecutive periods. At the time of this report, no single-institution report has compared RFA with EVLT in the management of saphenous reflux. To evaluate early results, we reviewed saphenous closure rates and complications of both procedures. METHODS: Between June 1, 2001, and June 25, 2004, endovenous GSV ablation was performed on 130 limbs in 92 patients. RFA was the procedure of choice in 53 limbs over the first 24-month period of the study. This technique was subsequently replaced by EVLT, which was performed on the successive 77 limbs. The institutional review board approved the retrospective chart review of patients who underwent saphenous ablation. According to the CEAP classification, 124 limbs were C2-C4, and six were C5-C6. Concomitant procedures included avulsion phlebectomy in 126 limbs, subfascial endoscopic perforator surgery in 10, and small saphenous vein ablation in 4 (EVLT in 1, ligation in 1, stripping in 2). Routine postoperative duplex scanning was initiated at our institution only after recent publications reported thrombotic complications following RFA. This was obtained in 65 limbs (50%) (54/77 [70%] of the EVLT group and 11/53 [20.8%] of the RFA group) between 1 and 23 days (median, 7 days). RESULTS: Occlusion of the GSV was confirmed in 93.9% of limbs studied (94.4% in the EVLT [51/54] and 90.9% in the RFA group [10/11]). The distance between the GSV thrombus and the common femoral vein (CFV) ranged from -20 mm (protrusion in the CFV) to +50 mm (median, 9.5 mm) and was similar between the two groups (median, 9.5 mm vs 10 mm). Thrombus protruded into the lumen of the CFV in three limbs (2.3%) after EVLT. All three patients were treated with anticoagulation. One received a temporary inferior vena cava filter because of a floating thrombus in the CFV. Duplex follow-up scans of these three patients performed at 12, 14, and 95 days, respectively, showed that the thrombus previously identified at duplex scan was no longer protruding into the CFV. No cases of pulmonary embolism occurred. The distance between GSV thrombus and the saphenofemoral junction after EVLT was shorter in older patients (P = .006, r(2) = 0.13). The overall complication rate was 15.4% (20.8% in the EVLT and 7.6% in the RFA group, P =.049) and included superficial thrombophlebitis in 4, excessive pain in 6 (3 in the RFA group), hematoma in 1, edema in 3 (1 in the RFA group), and cellulitis in 2. Except for two of the three patients with thrombus extension into the CFV, none of these adverse effects required hospitalization. CONCLUSION: GSV occlusion was achieved in >90% of cases after both EVLT and RFA at 1 month. We observed three cases of thrombus protrusion into the CFV after EVLT and recommend early duplex scanning in all patients after endovenous saphenous ablations. DVT prophylaxis may be considered in patients >50 years old. Long-term follow-up and comparison with standard GSV stripping are required to confirm the durability of these endovenous procedures.     

Sapheno-femoral Junction Reflux in Patients with a Normal Saphenous Trunk

OBJECTIVE: To determine the patterns and clinical importance of saphenofemoral junction (SFJ) reflux in patients with chronic venous disease (CVD) and a normal great saphenous vein (GSV) trunk. METHODS: Fifteen hundred consecutive patients were examined using duplex ultrasound (DU) in three centres. Patients with reflux involving the SFJ and/or its tributaries only were included and its prevalence and patterns were studied. Patients with GSV trunk reflux or in any other veins were excluded. The SFJ diameter was categorised as normal, dilated or varicose. The results of surgery were evaluated by DU in 42 patients 1 year after the procedure. RESULTS: SFJ area incompetence with a competent GSV trunk occurred in 8.8% of limbs. It was significantly more common in CEAP class 2, 13.6% compared to class 3, 8.2% (p=0.03), class 1, 2.7%, class 4, 4.4% and classes 5 and 6 together, 1.5% (p<0.001 for all). The SFJ had a normal diameter in 21%, dilated in 62% and varicose in 17%. Reflux was seen in 39% of limbs with a normal SFJ diameter, in 85% of those with a dilated SFJ and in all varicose SFJs. Of the 42 operated limbs, 27 had ligation and division of the SFJ and tributary phlebectomies. Fifteen had tributary phlebectomies only, leaving the SFJ intact. At one-year follow-up, SFJ area reflux was found in six limbs (14.3%), involving the SFJ alone in 1, a main tributary in 1 and 4 small tributaries. No reflux was found in the GSV trunk. All but two of the 42 patients were satisfied with the results. CONCLUSIONS: SFJ reflux with tributary involvement and sparing of the GSV trunk occurs in 8.8% of CVD patients. Such reflux is found in the entire spectrum of CVD, but it is more common in class 2. Local surgery with or without SFJ ligation has very good results at 1 year. DU scanning prior to treatment is important in all patients so that the intact GSV can be spared.     

Comparison of manual compression release with distal pneumatic cuff maneuver in the ultrasonic evaluation of superficial venous insufficiency.

BACKGROUND: Venous reflux can be elicited either manually or by pneumatic tourniquet, and previous studies did not indicate any significant difference between these manoeuvres in patients with superficial venous insufficiency (SVI). PURPOSE: To investigate if two methods correlate in patients with CVI. MATERIALS AND METHODS: Venous reflux was studied in 94 venous segments of 57 limbs in 52 consecutive patients with SVI. Limbs were divided into two groups: group I (CEAP C2-C3) and group II (CEAP C4-C6). A colour duplex scanner was used to determine quantitative venous reflux at the sapheno-femoral junction (SFJ), at the sapheno-popliteal junction (SPJ), and in the greater saphenous vein in the thigh (GSV). Patients received both manual compression and cuff deflation method in eliciting venous reflux. The parameters assessed were the duration of reflux (second) and the peak reflux velocity (cm/s). STATISTICS: Paired t-test was used to evaluate differences between the two methods. Statistical significance was recorded when the p-value was <0.05. Bland and Altman plot was also used to assess the agreement of the same measurement. RESULTS: There were 58 venous segments in group I and 36 in group II. In group I, there were no significant differences in the duration of reflux at the SFJ, SPJ, and in the GSV. On the contrary, peak reflux velocity was found to be significantly higher at the SFJ and in the GSV (p=0.022 and 0.006, respectively). In group II, there was no significant difference in the duration of reflux at the SFJ and SPJ between the two methods. On the contrary, manual compression maneuver produced significantly higher peak reflux velocity than at the SFJ and in the GSV (p=0.023 and 0.002, respectively). Bland and Altman plot analysis, manual compression method displayed a relatively good agreement with cuff deflation manoeuvre both in group I and group II. In contrast, concerning the peak reflux velocity, relative wide limits of agreement were found between the two methods. CONCLUSIONS: Unlike previously published reports, our results lead to apparent discrepancies in the quantitative evaluation of venous reflux using different methodology.     

Great Saphenous Vein Stripping with Liberal Use of Subfascial Endoscopic Perforator Vein Surgery (SEPS)

This study is based on a unique registry of 632 patients who underwent great saphenous vein (GSV) stripping and liberal use of subfascial endoscopic perforator vein surgery (SEPS) for minimal to severe lower limb venous insufficiency. Clinical examinations and color-coded duplex scanning were performed on a randomly selected, manageable sample of 170 limbs to assess the affect of early SEPS on junctional (saphenofemoral [SFJ] and/or saphenopopliteal [SPJ]) and perforator vein (PV) insufficiencies and superficial varicosities at a median of 6.5 years. PV incompetence was present in 68 legs (40%), as the sole transfascial insufficiency in 28 limbs and combined with SFJ or SPJ incompetence in 40 limbs. Junction incompetence alone characterized an additional 38 limbs, bringing the total transfascial insufficiency prevalence to 62%. Superficial varicosities affected 46% of limbs. Overall CEAP clinical class was unimproved beyond preoperative values. PV incompetence was associated with higher CEAP and clinical venous severity scores than were junctional insufficiencies alone. We concluded that PV incompetence alone or combined with junctional insufficiency is associated with increased symptoms and disease progression. The prevalence of SFJ, SPJ, and PV incompetence (62%) and recurrent varicosities (46%) suggests that early use of SEPS does not prevent disease progression and offers no benefit over GSV stripping in the absence of deep vein insufficiency or threatened ulceration.     

Clinical significance of ostial great saphenous vein reflux.

PURPOSE: To evaluate anatomical and haemodynamic differences in patients with great saphenous vein (GSV) insufficiency by duplex scanning and air plethysmography. MATERIAL AND METHODS: Duplex scanning and air plethysmography examination were undertaken. One hundred and twenty-one limbs in 91 patients were selected prospectively and divided into three groups: group A consisted of 27 controls; group B consisted of 25 limbs with GSV reflux and normal saphenous femoral junction (SFJ) and group C consisted of 69 limbs of patients with GSV and SFJ reflux. The presence of reflux and GSV diameter (SFJ, proximal and medial thirds of the thigh, the knee and medial and distal thirds of the calf) were assessed by duplex scanning. Air plethysmography was used to evaluate haemodynamic parameters: total venous volume (VV), venous filling index (VFI), residual volume fraction (RVF) and ejection fraction (EF). RESULTS: There was a significant difference in GSV diameter among the three groups in almost all segments evaluated (e.g. medial thigh group A = 2.4 SD 0.3 mm; B = 3.2 SD 0.7 mm; C = 5.9 SD 2.2mm p<0.001, Anova). A significant difference in VFI was found among the groups (group A = 1.2 SD 0.5; B = 2.0 SD 1.4; C = 4.0 SD 2.5 p<0.05, Anova). VV was statistical different between groups A and C (p = 0.004) and B and C(p = 0.03). EF and RVF were comparable in all groups. The VFI was normal in 68% in group B comparing with only 14.5% in group C patients, finding a reflux more than 5ml/s (determined by VFI) in 26.1% of the group C patients, comparing with only 4% of group B patients (p<0.05). CONCLUSION: We have shown that in patients with GSV reflux those with incompetence of the ostial valve of the GSV show greater venous reflux and dilatation of the saphenous trunk than those in whom the ostial valve is competent.     

Endovenous saphenous ablation corrects the hemodynamic abnormality in patients with CEAP clinical class 3-6 CVI due to superficial reflux

This investigation was designed to determine whether minimally invasive radiofrequency or laser ablation of the saphenous vein corrects the hemodynamic impact and clinical symptoms of chronic venous insufficiency (CVI) in CEAP clinical class 3-6 patients with superficial venous reflux. Patients with CEAP clinical class 3-6 CVI were evaluated with duplex ultrasound and air plethysmography (APG) to determine anatomic and hemodynamic venous abnormalities. Patients with an abnormal (>2 mL/second) venous filling index (VFI) and superficial venous reflux were included in this study. Saphenous ablation was performed utilizing radiofrequency (RF) or endovenous laser treatment (EVLT). Patients were reexamined within 3 months of ablation with duplex to determine anatomic success of the procedure, and with repeat APG to determine the degree of hemodynamic improvement. Venous clinical severity scores (VCSS) were determined before and after saphenous ablation. Eighty-nine limbs in 80 patients were treated with radiofrequency ablation (RFA) (n = 58), or EVLT (n = 31). The average age of patients was 55 years and 66% were women. There were no significant differences in preoperative characteristics between the groups treated with RFA or EVLT. Postoperatively, 86% of limbs demonstrated near total closure of the saphenous vein to within 5 cm of the saphenofemoral junction. Eight percent remained open for 5-10 cm from the junction, and 6% demonstrated minimal or no saphenous ablation. The VFI improved significantly after ablation in both the RF and EVLT groups. Postablation, 78% of the 89 limbs were normal, with a VFI <2 mL/second, and 17% were moderately abnormal, between 2 and 4 mL/second. VCSS scores (11.5 +/-4.5 preablation) decreased significantly after ablation to 4.4 +/-2.3. Minimally invasive saphenous ablation, using either RFA or EVLT, corrects or significantly improved the hemodynamic abnormality and clinical symptoms associated with superficial venous reflux in more than 90% of cases. These techniques are useful for treatment of patients with more severe clinical classes of superficial CVI.     

Reflux elimination without any ablation or disconnection of the saphenous vein. A haemodynamic model for venous surgery.

OBJECTIVES: to investigate the possibility of the haemodynamic suppression of reflux in the greater saphenous vein (GSV) without any high ligation and/or stripping procedure. DESIGN: prospective study; single group of patients. MATERIALS: forty patients affected by primary chronic venous insufficiency of all clinical classes, with demonstrated duplex incompetence both of the sapheno-femoral junction (SFJ) and the GSV trunk, with the re-entry perforator located on a GSV tributary. The re-entry point was defined as the perforator, whose finger compression of the superficial vein above its opening eliminates reflux in the GSV. METHODS: air-plethysmographic parameters as well as duplex scanning were performed both preoperatively, and 1 and 6 months later, respectively. Operation consisted in flush ligation and division from the GSV of the tributary containing the re-entry perforating vein. RESULTS: duplex investigation demonstrated both a forward flow and reflux disappearance in the GSV in 100% and 85% of the cases after 1 and 6 months, respectively. All air-plethysmographic parameters, with the exception of Ejection Fraction, improved significantly: Venous Volume changed from 150+/-9 ml to 114+/-7 ml (p <0.0001), Venous Filling Index from 4.9+/-0.5 ml/s to 2.3+/-0.2 ml/s ( p <0.0001), and Residual Volume Fraction from 42+/-3 ml to 30+/-2 ml ( p <0.0001). CONCLUSIONS: this study demonstrates that reflux in the GSV system is supported by a gradient of pressure between the anatomical point of reflux and the point of re-entry in the deep veins. Disconnection of the flow to the re-entry perforator without high ligation of the sapheno-femoral junction suppresses GSV reflux.     

Real-time color duplex scanning after sclerotherapy of the greater saphenous vein

A color real-time duplex scanner was used to scan the greater saphenous vein in 89 limbs of 55 patients to study the efficacy of prior greater saphenous vein sclerotherapy. The greater saphenous vein was insonated from the saphenofemoral junction to the knee to evaluate both reflux to a standardized 30 mm Hg Valsalva maneuver and evidence of greater saphenous vein obliteration by sclerotherapy. These data were correlated with the number of sclerosing injections used (mean, 1.8; range, 1 to 6), time from the last injection (mean, 27.5 mo.; range, 3 to 55 mo), and concentration of injectant used (0.5% to 3% sodium tetradecyl sulfate). Fifty-one of 89 injected limbs (57%) demonstrated reflux through the saphenofemoral junction, and reflux down the more distal greater saphenous vein was found in 67 of 89 injected limbs (75%). Greater saphenous vein obliteration was noted in only 18 of 89 injected limbs (20%); two were totally obliterated, and 16 were partially obliterated. The greater saphenous vein was obliterated in 6% below a refluxing saphenofemoral junction and in 40% below a nonrefluxing junction. A greater saphenous vein obliteration rate of 9% was found with a refluxing greater saphenous vein, and 50% in a nonrefluxing greater saphenous vein. Femoral vein reflux was identified in 11 of the 110 limbs (10%) and in every case was associated with both saphenofemoral junction and greater saphenous vein reflux. We noted a trend toward more successful results with more concentrated injectate (3% sodium tetradecyl sulfate). Fifty percent of patients reported improvement in symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)     

The effect of ultrasound-guided sclerotherapy of incompetent perforator veins on venous clinical severity and disability scores

PURPOSE: Current techniques to treat venous ulcerations and patients with severe lipodermatosclerosis include the elimination of incompetent perforator veins by open surgical ligation and division or by subfascial endoscopic perforator surgery. An alternative and less invasive means to obliterate perforator veins is ultrasound-guided sclerotherapy (UGS). We hypothesize that UGS is a clinically effective means of eliminating perforator veins and results in improvement of the clinical state (scores) without the complications associated with other more invasive methods. METHODS: Between January 2000 and March 2004, UGS was used to treat chronic venous insufficiency in 80 limbs of 68 patients. This was a clinical series of patients who had perforator incompetence and no previous surgery for venous disease < or = 2 years of their UGS procedure. Most had perforator disease without coexisting axial reflux of the saphenous or deep venous systems. Color flow duplex scanning was used to identify incompetent perforator veins in the calf, and duplex guidance was used to inject each perforator with the liquid sclerosant sodium morrhuate (5%). Patients were restudied by duplex scanning up to 5 years after treatment. Clinical results were determined by Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS) before and after treatment. RESULTS: Of the 80 limbs treated with UGS, 98% of incompetent perforators were successfully obliterated at the time of treatment, and 75% of limbs showed persistent occlusion of perforators and remained clinically improved with a mean follow-up of 20.1 months. According to the CEAP classification, there were 46.2% with limb ulceration or C6, 1.2% C5, 28.7% C4, 17.5% C3, and 6.2% C2 with pain isolated to the site of the perforator(s). Of those who returned for follow-up, the VCSSs changed from a median of 8 before treatment (95% confidence interval [CI], 3 to 15) to a median of 2 after treatment (95% CI, 0 to 7) (P < .01). Likewise, VDSs dropped from a median of 4 before treatment (95% CI, 1 to 3) to 1 after treatment (95% CI, 0 to 2) (P < .01). There were no cases of deep vein thrombosis involving the deep vein adjacent to the perforator injected. One patient had skin complications with skin necrosis. Perforator recurrence was found more frequently in those with ulcerations than those without. CONCLUSION: UGS is an effective and durable method of eliminating incompetent perforator veins and results in significant reduction of symptoms and signs as determined by venous clinical scores. As an alternative to open interruption or subfascial endoscopic perforator surgery, UGS may lead to fewer skin and wound healing complications. Perforator recurrence occurs particularly in those with ulcerations, and therefore, surveillance duplex scanning after UGS and repeat injections may be needed.