Venous malformation of the tongue in a child treated by sclerotherapy with ethanolamine oleate: a case report

We describe a 3-year-old boy with a huge venous malformation (VM) in the tongue, which was treated by direct injection of ethanolamine oleate (EO). After the injection of 5% EO, the VM shrank and good tongue movement was obtained without problematic side effects. Our findings in this case suggest that sclerotherapy with EO is a safe and effective method for treating VM in the oral region.     

Ultrasound-guided foam sclerotherapy as a therapeutic modality in venous ulceration

ObjectivesThe objective of this systematic review and meta-analysis was to evaluate rates of ulcer healing following ultrasound-guided foam sclerotherapy (UGFS).MethodsThe MEDLINE, CENTRAL and Embase databases were used to search for relevant studies using the terms ' (sclerotherapy AND ulcer) OR (vein AND ulcer) OR (sclerotherapy AND vein)'. Heterogeneity between studies was quantified using the I² statistic. A random effects model was used to calculate risk ratios where substantial heterogeneity was found.ResultsThe initial search yielded 8266 articles. 8 studies were included in the qualitative synthesis and 3 in the meta-analysis. Superior complete ulcer healing rates were noted in patients treated with foam sclerotherapy versus compression therapy alone (pooled OR 6.41, 95% CI = 0.3–148.2, p = 0.246, random effects method). A marked degree of heterogeneity was observed between studies (I² = 81%).ConclusionA prospective, trial is warranted in order to determine the true merits of UGFS in the setting of venous ulceration.     

Three-Dimensional Volumetric Analysis of Venous Malformations for Assessing the Effectiveness of Percutaneous Sclerotherapy

BACKGROUNDPercutaneous sclerotherapy can be used to successfully treat venous malformations (VMs) of the head, neck, and limbs. However, the standard curative effect of sclerotherapy has rarely been analyzed, and there is currently no accurate statistical method to measure the volume of VMs after sclerotherapy. Here, we propose a novel three-dimensional (3D) reconstruction method to evaluate this effect.OBJECTIVETo test the feasibility of 3D software (MIMICS 19.0) to evaluate the treatment effect of sclerotherapy.METHODSThis retrospective study included patients with VMs on the head, neck, and limbs who were treated with ethanol sclerotherapy or foam sclerotherapy every 8 weeks. MIMICS 19.0 was used to calculate the performance of the lesion after treatment and measure the VM volumes before and after the treatment. The effect of the clinical treatment dose on the lesion was evaluated, and the treatment effect of each patient was recorded. The relationship between the number of treatments and the reduced volume of VMs was analyzed.RESULTSBased on the MIMICS-calculated regions of interest (ROI), we found that 1 mL of ethanol reduced the lesion by 473 mm³ and that one dosage of foam (1 mL of polidocanol and 4 mL air content) reduced the lesion by 2 138 mm³, demonstrating that the foam sclerosing agent exhibited greater efficacy in this study.CONCLUSIONSThe MIMICS 3D volume reconstruction method can effectively and safely evaluate the efficacy of sclerotherapy and provide a preoperative evaluation. This method is simple, accurate, and feasible.     

以栓塞硬化为主综合治疗会阴部静脉畸形

目的：探讨治疗会阴部海绵状静脉畸形的安全有效方法。方法：用栓塞硬化注射术,或结合手术切除部分硬化瘤体,治疗会阴部海绵状静脉畸形。结果：治疗患者33例,其中20例只进行栓塞硬化治疗。13例栓塞硬化后手术切除治疗。所有患者治疗后会阴部瘤体缩小,未出现并发症。23例完全治愈,随访6个月至4年,治疗部位无复发,局部功能形态良好。结论：以栓塞硬化为主综合治疗会阴部海绵状静脉畸形,简便有效,创伤小,不易复发。     

Advanced management of venous malformation with ethanol sclerotherapy: mid-term results

PURPOSE: This paper is an update of previously published data on the basis of a retrospective review of midterm results of ethanol sclerotherapy on 87 patients (January 1995 to December 2000) for assessment of its efficacy as an improved treatment method for venous malformation (VM). According to this assessment, VMs were defined with a new classification and studied with advanced diagnostic technology and an advanced care system. METHODS: The average follow-up period was 24 months after completion of a multisession treatment (mean, 8.2 months). Classification of VM was based on a modification of the Hamburg classification. Advanced diagnostic technology, mostly noninvasive, was used on 226 of 520 patients with congenital vascular malformation registered at the Congenital Vascular Malformation Clinic at the Samsung Medical Center. Of the 226 patients with VM, 87 with infiltrating extratruncular lesions had a total of 399 sessions of sclerotherapy. Follow-up assessment with periodic clinical examinations by the multidisciplinary team was supplemented with body blood pool scans, duplex scans, and magnetic resonance imaging, according to protocol, once the multisession therapy was completed. Angiographic assessment was seldom included. The endpoint of this phase II study was 24 months. RESULTS: Of 399 sessions, initial success was seen in 379 sessions (95.0%) and failure was seen in 20 sessions (5%). This was mostly caused by forced abandonment from technical difficulty in delivering ethanol safely to the lesion (eg, direct drainage of VM into normal deep vein system). Later results after completion of the multisession therapy with a minimum follow-up of 24 months on 71 VMs have shown no evidence of recurrence. Eighty-seven patients have shown the same results without recurrence on an average of 18.2 months of follow-up. Fifty-one minor to major complications, mostly skin damage, developed after 47 sessions among the 379 sessions (12.4% in 24/87 patients; 27.9%). However, complications resolved spontaneously or were managed successfully, except for one permanent facial nerve palsy and one peroneal nerve palsy. CONCLUSION: Absolute ethanol sclerotherapy can deliver excellent results as an independent therapy to the infiltrating type of extratruncular form of VM, which was once taboo because of prohibitively high morbidity. Absolute ethanol may be accepted as an effective treatment method because no recurrence has been observed in the relatively long-term observation period and the morbidity has been acceptable. However, it should be reserved only for individuals and centers with expertise. The morbidity involved should be clearly understood and accepted by the patient or family, and the risk of acute and chronic complications, both major or minor, should be explained to the patient. Long-term assessment of the complication's sequelae is warranted.     

Healing and Recurrence Rates Following Ultrasound-guided Foam Sclerotherapy of Superficial Venous Reflux in Patients with Chronic Venous Ulceration

ObjectivesTo determine healing and recurrence rates following ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR) in patients with healed (clinical, etiologic, anatomic and pathophysiologic (CEAP) classification, C5) and open (C6) chronic venous ulceration (CVU).MethodsBetween 1 March 2005 and 31 December 2009, 130 consecutive patients (132 limbs, 49 CEAP C5, 83 C6) of median age 70 (interquartile range (IQR) 56–76) years underwent UGFS as part of their treatment for CVU.ResultsThe median (IQR) follow-up time was 16 (12–32) months. One C6 patient moved abroad 1 week after UGFS and was lost to follow-up. Healing was observed in 67/82 (82%) remaining C6 patients at a median (IQR) of 1 (1–2) month following their first UGFS treatment. In 49 limbs originally treated for C5 disease, and in 67 limbs treated for C6 that healed following UGFS, there were five recurrent ulcers during the follow-up period, giving a 4.9% Kaplan–Meier estimate of recurrence at 2 years. In legs treated for C6 and C5 disease, the median (IQR) ulcer-free periods were 22 (IQR 9–32) and 14 (IQR 8–36) months, respectively.DiscussionHealing rates following UGFS for CVU are comparable to those reported after surgery but recurrence may be lower. UGFS is a safe, clinically effective and, thus, highly attractive minimally invasive alternative to surgery in patients with C5 and C6 disease.     

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.     

Ultrasound-guided foam sclerotherapy for the treatment of varicose veins

BACKGROUND: The aim was to assess the early efficacy and complications of ultrasound-guided foam sclerotherapy (UGFS) in a cohort of patients with varicose veins. METHODS: Of 192 consecutive patients referred with varicose veins over 15 months, only 11 chose surgery; the rest underwent UGFS treatment. Polidocanol was foamed 1 : 3 with air. Under ultrasound control via butterfly or Seldinger cannulation, 1 per cent foam was injected into superficial veins and 3 per cent foam into saphenous trunks, up to a total volume of 14 ml. Outcome was defined as complete when occlusion of the saphenous trunk and/or over 85 per cent of the varicosities was achieved, and partial closure when less. RESULTS: In 163 legs, complete occlusion occurred after one intervention, a further 32 after a second, and one after a third (overall 91 per cent). Of the remainder, all other legs achieved partial occlusion after up to three interventions, apart from two legs with great saphenous vein (GSV) incompetence, which failed. All 23 legs with small saphenous veins had complete occlusion after one intervention compared with 64 of 97 legs with GSV incompetence (P < 0.010). Occlusion rates were also higher when the GSV was cannulated directly: 56 of 70 versus 8 of 27 (P < 0.001). CONCLUSIONS: UGFS achieved early complete occlusion safely in over 90 per cent of legs with varicose veins.     

Transrectal ultrasound-guided puncture,drainage, and minocycline hydrochloride sclerotherapy for the symptomatic prostatic cyst

PURPOSE: We treated three patients who had symptomatic prostatic cysts by transrectal ultrasound-guided puncture, drainage, and sclerotherapy. The procedure and the results are described in this report. MATERIALS AND METHODS: The patients were 60, 73, and 78 years old and complained of difficult voiding. With local anesthesia, transrectal ultrasound-guided puncture and drainage were performed, and then 100 mg of minocycline hydrochloride was infused into the cavity of the cyst. We evaluated the International Prostate Symptom Score (IPSS), urodynamic data, volume of residual urine, complications, and recurrence. RESULTS: There were no complications, and improvements of voiding symptoms were experienced without any recurrences within the 2 years or more of follow-up. CONCLUSION: This minimally invasive treatment by transrectal ultrasound-guided puncture, drainage, and minocycline hydrochloride sclerotherapy is suggested to be promising for the symptomatic prostatic cyst.     

超声引导下经皮肝穿抽吸硬化介入治疗肝包虫囊肿

目的探讨超声引导下经皮肝穿抽吸硬化治疗肝包虫囊肿的应用价值。方法在超声引导下对38例肝包虫囊肿患者行经皮肝囊肿穿刺抽吸囊液,抽尽后向囊内注入20%～25%无菌高渗盐水或95%无水乙醇,注入量约为抽出量的25%～50%,保留5～15 min后全部抽出,再注入5～10 ml予以保留,术前术后结合口服抗包虫药阿苯达唑30～50mg/kg治疗。术后定期行超声随访,1年内3个月复查1次,1年后每年复查1次。结果治疗中1次穿刺成功率100%,6个月后16例囊肿缩小50%、22例缩小30%。1年后34例治愈,3例显效,1例好转。其后囊肿逐渐缩小,直至钙化,治愈率达100%。结论超声引导下经皮肝穿抽吸硬化治疗肝包虫囊肿是一种安全、有效、可靠的方法。     

Transrectal ultrasound-guided ethanol sclerotherapy for Müllerian duct cyst accompanied with ejaculatory duct obstruction]

OBJECTIVE: To evaluate the efficacy and safety of transrectal ultrasound-guided ethanol sclerotherapy in the treatment of Müllerian duct cyst accompanied with ejaculatory duct obstruction. METHODS: Under the transrectal ultrasound guidance, 3 cases of prostate Müllerian duct cyst were treated by 20 G needle puncture and ethanol injection, and closely followed up by ultrasonic monitored on follow-up examinations. RESULTS: All the cysts involuted completely 6 months after the treatment. Symptoms caused by ejaculatory duct obstruction were relieved in all the patients. No severe complications occurred. CONCLUSION: Transrectal ultrasound-guided ethanol sclerotherapy is an effective and safe method for the treatment of Müllerian duct cyst accompanied with ejaculatory duct obstruction.     

超声引导下泡沫硬化治疗四肢血管瘤

目的探讨超声引导下注射泡沫硬化剂治疗四肢血管瘤的疗效。方法收集经超声确诊的四肢血管瘤患者30例,于超声引导下向血管瘤腔内注射聚桂醇泡沫硬化剂,随访8个月,观察治疗后血管瘤体积变化和临床症状改善情况,评价疗效,观察治疗相关并发症。结果对13例进行1次治疗、12例进行2次治疗、3例进行3次治疗、2例进行4次治疗;血管瘤体积缩小≥60%19例、缩小30%~59%7例、缩小1%~29%2例、无明显变化2例,临床症状消失14例、明显好转11例,症状无明显变化5例;25例治疗有效,有效率为83.33%(25/30)。所有患者均未发生严重并发症。结论超声引导下聚桂醇泡沫硬化剂治疗四肢血管瘤费用低廉、安全、有效,值得临床推广与应用。     

泡沫硬化剂注射治疗下肢慢性静脉功能不全

目的 探讨泡沫硬化剂注射治疗下肢慢性静脉功能不全(CVI)的临床疗效.方法 2011年3月至2012年1月,对我院行泡沫硬化剂注射治疗的95例CVI患者(131条患肢,CEAP分级为C2～5级)的临床资料进行回顾性分析.结果 131条患肢均成功治疗,平均每条肢体应用泡沫硬化剂15.5 ml.31条(23.7％)肢体于治疗后2周复诊时实施了第2次注射治疗,其中3条(2.3％)肢体于治疗后1个月复诊时实施了第3次注射治疗.无严重并发症发生.结论 泡沫硬化疗法对各种类型的下肢CVI都有效,且简单易行,应扩大其临床适应证.     

Nd:YAG lasers (1,064 nm) in the treatment of venous malformations of the face and neck: challenges and benefits

Neodymium:yttrium aluminum garnet (Nd:YAG) laser therapy for venous malformations (VMs) of the head and neck is a rather new therapeutical option in addition to sclerotherapy and surgery. One hundred forty-six patients (age 2 months to 77.5 years) with VMs in the head/neck (localized, diffuse, and multifocal) were retrospectively analyzed with regard to number and quality of treatments and laser parameters used. Of these patients, 72 had no prior treatment of any kind, and 74 were pretreated. Laser treatment of mucosa and tongue was done with a mean fluence of 103.1 J/cm², of skin with 90.7 J/cm², and of glomuvenous malformations with 81.2 J/cm². Complex VM can mostly be controlled but rarely cured. Initial Nd:YAG laser therapy is important in the treatment of VMs regarding shrinkage of the tissue, discoloration, and induction of the desired dermal fibrosis that facilitates the surgical handling of the skin and reduces the risk of skin loss in surgery and sclerotherapy.     

超声引导下介入治疗周围软组织静脉畸形

目的 探讨超声引导下介入治疗周围软组织静脉畸形的有效性和安全性.方法 2004年3月至2007年10月收治静脉畸形患者32例,在实时超声引导下视病灶情况(病灶的部位、深浅与重要组织的毗邻关系等)分别选择缓慢推注无水酒精+博来霉素和单纯博来霉素,3周后若患者未达治愈可重复治疗.患者术后随访6个月-2年.结果 所有患者治疗1-6次,平均3次,操作可在门诊进行,不影响工作和生活.治愈27例(84.4%)、好转5例(15.6%)、无效0例.无异位栓塞等严重并发症发生.结论 超声引导下介入治疗静脉畸形是一种微创、疗效高、可重复、不良反应少、操作简便的方法 .     

Outcome of ultrasound-guided sclerotherapy for varicose veins: medium-term results assessed by ultrasound surveillance.

OBJECTIVE: To estimate medium-term success after a technique for ultrasound-guided sclerotherapy for superficial chronic venous disease. DESIGN: A prospective study in a single unit with ultrasound surveillance after treatment. MATERIALS: Results after 1189 treatment sessions for 807 venous saphenous veins and related tributaries or non-saphenous tributaries in 489 patients. METHODS: Univariate life table analysis determined primary and secondary success rates. Multivariate Cox regression analysis detected covariates that affected outcome. RESULTS: Primary and secondary success rates at 36 months for all veins were 52.4% (95%CI 46-58%) and 76.8% (95%CI 71-82%). Cox regression analysis for primary success for all veins showed significantly worse results for saphenous veins compared to tributaries (HR 3.72 - 95%CI 1.9 to 7.3). Cox regression for all saphenous veins showed independently worse results for patients less than 40 years age (HR 2.16 - 95%CI 1.27-3.66), small compared to great saphenous veins (HR 1.58 - 95%CI 1.11-2.24), veins greater than 6mm diameter compared to smaller veins (HR 2.22 - 95%CI 1.40-3.50), liquid compared to foam sclerotherapy (HR 2.20 - 95%CI 1.28-3.78), lower volumes of sclerosant compared to volumes greater than 12 ml (HR 0.51 - 95%CI 0.33-0.81) and highly diluted compared to concentrated sclerosant (HR 2.05 - 95%CI 1.21-3.46) with worse results using highly diluted or undiluted 3% sclerosant compared to a 1.5% concentration. There were no significant differences for primary success for saphenous veins for date of procedure, sex, side, primary or recurrent varicose veins, or commercial type of sclerosant. CONCLUSIONS: Ultrasound-guided sclerotherapy gives satisfactory results if it is accepted that treatment may need to be repeated to achieve secondary success. Results provide a basis for further research to explore factors that might affect outcome. Younger patients with larger diameter saphenous veins may warrant alternative forms of treatment, particularly for small saphenous reflux.     

Efficacy of percutaneous ethanol sclerotherapy for venous malformation in lower extremities: a retrospective review of 21 cases

Background

Venous malformations (VM) of lower extremities have characteristic symptoms, especially swelling, pain at rest or with dependence, or in the morning, or with exertion. Sclerotherapy has been applied and has been showed to alleviate the associated signs and symptoms. The aim of this study is to evaluate the outcomes of ethanol sclerotherapy for VM of lower extremities.

Methods

The 21 patients of intramuscular VM of the lower extremities, who received percutaneous sclerotherapy using absolute ethanol in our institute, were reviewed retrospectively. The average age at the time of the initial diagnosis was 18.6 years, and average follow-up period after last sclerotherapy is 19.4?±?13.5 months. The postinterventional changes of the associated signs and symptoms were evaluated by utilizing original VM scoring system.

Results

The average number of sclerotherapy sessions was 2.6 times per case. The average total amount of ethanol used in each patient was 41.3 ml. Sclerotherapy reduced the associated signs and symptoms in many of the patients (n?=?19/21). Preinterventional VM score as the overall baseline status was 10, and the average VM score after sclerotherapy was 4.1. There was no inverse correlation between the amount of ethanol used and the VM score. In seven cases treated more than three times, reverse correlation between the “VM score” and the number of sclerotherapy sessions was demonstrated (p?<?0.05, ρ?=?0.8214).

Conclusions

The characteristic symptoms and signs of the VM were improved by sclerotherapy. More than three sessions of ethanol sclerotherapy improved the overall status of extensive intramuscular VM in lower extremities. Level of Evidence: Level IV, therapeutic study.     

Blocking the Saphenofemoral Junction During Ultrasound-Guided Foam Sclerotherapy – Assessment of a Presumed Safety-measure Procedure

ObjectivesUltrasound-guided foam sclerotherapy (UGFS) is a technique in which a mixture of sclerosing drug and gas is used to treat varicose veins. Several authors have demonstrated transient systemic effects after UGFS. These effects are not well understood but probably originate from a systemic distribution of the sclerosing foam. Therefore, safety measures have been developed to prevent foam from flowing into the deep venous system. The aim of the study is to evaluate whether blockage of the saphenofemoral (SF) junction by either manual compression or surgical ligation prevents microbubbles from leaking into the deep venous circulation.MethodsTo detect the distribution of microbubbles, radioactive pertechnetate (^99mTcO₄^?) was added to the foam solution. Initially, in vitro trials were performed in the laboratory to investigate the effect of ^99mTc on foam stability. The time taken for foam to liquefy was measured for foam alone and for the mixture with ^99mTc. In subsequent research, eight varicose great saphenous veins (GSVs) were treated by UGFS. In three patients, this treatment was preceded by surgical ligation of the SF junction. In three patients, the groin was manually compressed during UGFS. In two patients, UGFS was performed without compression of the groin.ResultsIn vitro, ^99mTc did not influence foam stability; after 2.6 min all foam had reduced to liquid, regardless of whether ^99mTc had been added or not. In vivo trials showed that all patients showed a decrease in the cumulative amount of ^99mTc detected in the GSV following polidocanol-^99mTc mixture injection. However, the decrease of radioactivity was slightly reduced when compression or ligation of the SF junction was performed.ConclusionsBlocking the SF junction during UGFS using either manual compression or ligation does not prevent, but may reduce the flow of foam into the femoral vein.     

Comparative Study of Outcome of Duplex Ultrasound-Guided,Catheter-Directed Foam Sclerotherapy and Radio-frequency Ablation in the Management of Great Saphenous Varicose Veins

Chronic venous insufficiency of lower limbs is a common problem in adults. We compared the two modalities, namely duplex ultrasound-guided, catheter-directed foam sclerotherapy (UGFS) and radio-frequency ablation (RFA), in the management of great saphenous varicose veins using clinical assessment (Venous Clinical Severity Score, Venous Disability Score) and duplex imaging. Patients presenting with great saphenous vein (GSV) varicosity due to incompetent saphenofemoral junction (SFJ) were selected and randomly assigned in each arm, i.e., duplex UGFS group and RFA group. Patients were assessed on days 7, 30, and 90 both clinically and sonologically. Clinical assessment was based on the Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS). Obliteration of the treated GSV segment was noted in all the limbs of the RFA group (31/31) on duplex sonography on days 7, 30, and 90, while in the UGFS group, out of 30 limbs, obliteration was successful in 28 (28/30) and 2 had treatment failure. However, outcome of both the groups were statistically comparable (P value?>?0.05). After the procedure, improvement in the VCSS was noted in both the study arms in every follow-up and both the modalities were found to be equally effective. Improvement in the Venous Disability Score was there on every follow-up, but maximum improvement was seen on the second visit, i.e., post-treatment day 30. Improvement was statistically significant and equal in both arms after the initial 1 week. Foam sclerotherapy, especially catheter-directed, is as effective as radio-frequency ablation in achieving anatomical obliteration and yielding relief in clinical signs and symptoms in patients with GSV varicosity with SFJ incompetence.     

Comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-blind trial with 2 year-follow-up. "The 3/1 Study".

OBJECTIVES: To compare 1% and 3% POL foam in treating the great saphenous vein (GSV) by ultrasound guided sclerotherapy. DESIGN: Multicentre, prospective, randomised, double-blind trial with 2 year-follow-up. PATIENTS AND METHODS: 148 patients with GSV reflux (saphenous trunk diameter 4-8 mm) were randomised to undergo ultrasound guided foam sclerotherapy using either 1% or 3% POL foam in a single session. Foam production was standardised using a sterile disposable syringe kit including sterile air and the Turbofoam machine. Duplex ultrasonography was used to assess the outcome at 3 weeks, 6 months, 1 year, 18 months and 2 years. The main criterion of success was the disappearance of the venous reflux. The length of occlusion of the vein (only measured at 3 week-echography assessment) was a secondary criterion. Side effects were assessed. RESULTS: 74 patients were included in each group. The mean volume of foam injected was 4.4 ml for the 3% group and 4.6 ml for the 1% group. After 3 weeks, reflux was abolished in 96% (71 patients) of the 3% group and 88% (68 patients) of the 1% group (NS). The mean occlusion length of the vein was 38 cm for the 3% group and 34 for the 1% group (NS). After 2-years, reflux was absent in 69% of the 3% group and 68% of the 1% group (NS). 14 patients were lost to follow-up at 2 years. CONCLUSION: This study demonstrates equivalent efficacy for 1% POL and 3% POL foam in sclerotherapy of the GSV where the trunk is less than 8 mm in diameter. These data obtained two years of follow-up confirm our previously reported 6 month-follow-up data published in 2005.