Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein (original) (raw)
Related papers
Phlebology: The Journal of Venous Disease, 2020
Objectives To compare the effectiveness of two foam sclerotherapy techniques of the great saphenous vein. Methods Fifty subjects with varicose veins, edema, and great saphenous vein incompetence (diameter 6–10 mm) were randomly categorized into two equal groups and were treated with different foam sclerotherapy techniques: A (usual ultrasound-guided) and B (catheter-directed with tumescence). Concomitant phlebectomy was performed in all patients. Patients were seen on days 7 and 28, and at six and 12 months. The primary outcomes were the full success rate of the treated great saphenous vein and the number of patients who required retreatment sessions performed at 28-day follow-up. The secondary-assisted outcomes were the full success rates of the treated great saphenous vein after the retreatment sessions at six- and 12-month follow-up. Secondary outcomes were changes in quality of life and side effects and complications of the intervention. In case of reflux, retreatment sessions w...
Journal of Vascular Surgery, 2006
Objective: To identify patient and physician-controlled treatment variables that might predict the persistence or redevelopment of saphenofemoral junction (SFJ) reflux. Methods: Thirteen European centers, with substantial lower extremity venous disease practices, examined their experience with SFJ ligation and GSV stripping for primary varicose veins in patients followed for >2 years, entering their data into a protocol-driven matrix that stipulated duplex Doppler imaging as an essential component of follow-up examinations and required a complete review of all peri-operative examinations, as well as all operative procedure and anesthesia notes. Matrix entries were centrally audited for consistency and credibility, and queried for correction or clarification before being accepted into the study database. Presence or absence of Doppler-detectable SFJ reflux was the dependent variable and principal outcome measure.
Vascular Health and Risk Management, 2021
This study assessed the outcomes and impact on the quality of life following one-step outpatient radiofrequency ablation (RFA) and ultrasound guided foam sclerotherapy (USGFS) for large reflux with varicosities in the great saphenous vein (GSV). Design: Prospective, single-centre, analytical cohort. Materials and Methods: Thirty symptomatic patients having reflux in the GSV and varicosities (CEAP C3 to C6) were treated with RFA and USGFS simultaneously, in a singlestep procedure, from March 2016 to December 2016. They were followed up at 1 week, 6 months, 1 and 3 years. Clinical outcomes, changes in the Quality of Life (QOL) questionnaires SF-36™, VCSS and AVVQ, evolutive vein occlusion rates were assessed by duplex ultrasound, and ulcer closure was checked. Results: The sample was divided into two groups: (Group 1) GSV diameter ≥13.0 mm (median 19.0 [14-24]), 17 subjects, and (Group 2) GSV diameter ≤12.9 mm (median 10.3 [10-12]), 16 subjects. No major adverse event was observed, and the postoperative minor adverse event rates were similar between the two groups. A significant improvement was observed in VCSS and AVVQ from the preoperative levels to the sixth month and the third-year follow-up. Twelve of 13 ulcers had healed at 1 year and remained closed until 3 years. The entire sample had a significant increase in all short form 36 domains, except for mental health in the Group 2 (GSV ≥ 13.0 mm). Overall first week occlusion rate for the whole sample was 90.9% and 69.7% at the 3-year follow-up. No difference in occlusion rate was observed between the two groups at any time. Conclusion: Exclusively outpatient combined techniques were safe and feasible in this study with no major adverse events, despite the large diameters of the GSV or ulcer presence. Within 3 years, both diameter groups showed equivalent improvement in all QOL parameters, satisfactory axial occlusion, and maintained ulcer closure.
Benha Medical Journal
Background: To find out outcomes of the day-case MOCA in the management of great saphenous vein (GSV) reflux. There is a rapid change in the management of great saphenous vein reflux in recent years. MOCA being minimal invasive instead of vein surgery, can be performed by percutaneous catheter ablation without incisions. Patients and methods: This prospective randomized controlled study was conducted on 78 cases (93 limbs); 63 cases with unilateral limb and 15 cases with bilateral limbs with GSV reflux. All patients were treated with MOCA using the Flebogrif catheter using duplex guidance without tumescent anesthesia. Follow-up period was for 6-months. Results: There was satisfactory results and marked improvement of patients' symptoms. Patients experienced significantly less postoperative pain at 1st 2 days (VAS: 1.9 ± 0.6). Patients were discharged within hours and returned back to work within few days. There were 1-week PO minor complications that disappeared by time except only 1 (3.3%) limb of DVT was treated conservatively. At 3-6 months there was residual varicosities only in 6 (6.6%) and treated by foam sclerotherapy. Conclusions: MOCA utilizing Flebogrif catheter and completion foam sclerotherapy are considered very promising interventions to treat GSV reflux; being less invasive, highly effective with good quality of life, less pain, satisfactory cosmoses and rapid return to work.
Journal of Vascular Surgery, 2008
and is commonly responsible for varicose veins of the lower extremity. This non-randomized prospective controlled study was designed to test the hypothesis that 1) endovenous laser treatment is more effective than foam sclerotherapy in the closure of the refluxing GSV (as measured by degree of great saphenous vein reflux and venous clinical severity score changes) and 2) to record the associated complications of echo-guided endovenous chemical ablation with foam and endovenous laser therapy for the treatment of great saphenous vein reflux and to further identify risk factors associated with treatment failure. Methods: Between January 1, 2006 and June 25, 2006, patients seeking treatment of varicose veins at a private practice of vascular medicine were assessed for the study. Inclusion criteria were: 1) presence of great saphenous vein reflux and 2) C2-6, Epr, A s, according to the CEAP classification. The selected patients consented into the study and were allowed to choose between foam (53 patients) or laser (45 patients) treatment. Duplex examinations were performed prior to treatment and at seven and 14 days, four weeks, six months, and one year after treatment. Venous clinical severity score was assessed pre-treatment and at one year post-procedure. Results: The cohorts showed no statistically significant differences in age, sex, clinical and anatomical presentation, great saphenous vein diameter, and venous clinical severity score before the treatments. After one year follow up, occlusion of the great saphenous vein was confirmed in 93.4% (42/45) of limbs studied in the laser group and 77.4% (41/53) of limbs in the foam group (P < .0465). Venous clinical severity score significantly improved in both groups (P < .0001). Procedure associated pain was higher in the laser group (P < .0082). Induration, phlebitis, and ecchymosis were the most common complications. Logistical regression and subgroups analysis shown that a larger great saphenous vein diameter measured before treatment was associated with treatment failure in the foam (odds ratio 1.68, 95% CI 1.24-2.27, P < .0008) and in the laser group (odds ratio 1.91, 95% CI 1.02-3.59, P < .0428). A 90% treatment success is predicted for veins <6.5 mm in the foam group versus veins <12 mm in the laser group. Conclusions: Overall, endovenous laser ablation achieved higher occlusion rates than echo-guided chemical ablation with foam after one year follow-up. Matching the patient to the technique based on great saphenous vein diameter measured before treatment may assist in boosting the treatment success rate to >90%. A larger patient cohort followed and compared over a longer period of time would be required to confirm these findings. ( J Vasc Surg 2008;48:940-6.) From the Clínica de Várices Doctor González Folch a and the Programa de Fisiopatología, Instituto de Ciencias Biomédicas, Faculdad de Medicina, Universidad de Chile. b Competition of interest: none.
European Journal of Vascular and Endovascular Surgery, 2012
Objective: The 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 methods: A 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. Results: A total of 51 limbs in 48 patients were treated with UGFS þ 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 AE 1.7 mm (median AE interquartile range) in the UGFS þ VFS group and 5.7 AE 1.6 mm in the VFS group (p ¼ 0.419). The mean injected volume of foam for varicose tributary veins was 4 AE 2 ml in the UGFS þ VFS group and 6 AE 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 þ VFS than in those treated with VFS alone (p ¼ 0.017). Ultrasonographic inspection revealed complete vasospasm of the GSV in 37 (72.5%) limbs in the UGFS þ VFS group and 29 (55.8%) in the VFS group during sclerotherapy (p ¼ 0.097). At 6-month follow-up, complete occlusion was found in 23 limbs (45.1%) treated with UGFS þ VFS and in 22 limbs (42.3%) treated with VFS. The difference between the two groups was not significant (p ¼ 0.775). Reflux was absent in 30 limbs (58.8%) treated with UGFS þ VFS and in 37 (71.2%) treated with VFS (p ¼ 0.190). There was no inter-group difference in post-treatment VCSS (p ¼ 0.223). Conclusions: These results show that UGFS þ VFS and VFS are equally effective for the treatment of GSV reflux, despite the lower volume of foam used for VFS alone.
Veins and Lymphatics, 2013
Ultrasound guided foam sclerotherapy (UGFS) constitutes a valid ablative treatment for superficial vein diseases for the great saphenous vein (GSV), but no standardized protocol for its execution has yet been defined. Different variable factors involved in this procedure influence the final outcome and clinical results. The aim of our study was to analyze the respective influence on efficacy and side effects of three variable factors (foam volume, foam concentration, and contact time between the foam and the endothelium) for UGFS procedures for GSV insufficiency in order to select the best protocol for treatment. A retrospective analysis was made of UGFS procedures (190 patients, 201 legs) performed for GSV insufficiency in our institute from January 2007 to January 2010. All great saphenous veins included in our study exhibited a trans-ostial reflux and caliber range was 7-11 mm. In all cases, foam was prepared according to the Tessari method, using polidocanol (POL) and a gas mixture of CO 2 (70%) and filtered room air (30%), in a proportion of 1:4. A single injection procedure in the GSV was performed under Doppler ultrasound guidance at mid to lower third of the thigh. Legs were randomly assigned to one of three different treatment protocols:-Group A (71 legs): POL 3%, mean foam volume 4.5 cc, intermittent groin pressure 5 min, supine bed rest 10 min;-Group B (61 legs): POL 2%, mean foam volume 9 cc, intermittent groin pressure 5 min, supine bed rest 10 min;-Group C (69 legs): POL 2%, mean foam volume 9 cc, continuous groin pressure 5 min followed by intermittent groin pressure 5 min, continuous leg compression 5 min, supine bed rest 10 min. Efficacy of treatment and occurrence of side effects were evaluated in each group at two weeks and again at two years after the procedure and the cumulative results compared. Analysis of outcomes did not show any significant difference between the complete obliteration rate (P=0.825) or occurrence of local inflammatory reactions (P=0.883) between legs in Group A and in Group B. However, a significantly better outcome was observed between the complete obliteration rates and the local inflammatory reaction for legs in Group C compared to both legs in Group A (P=0.020 and P=0.015, respectively) and legs in Group B (P=0.013 and P=0.018, respectively). The type of procedure did not seem to have any effect on the extent of recanalization (over or less than 50% of the original lumen). No major adverse events such as deep vein thrombosis, significant allergic reactions, or serious neurological events occurred in any patient in any group. Further studies are still necessary to identify the best concentration ratios, volumes and length of contact time between foam and endothelium according to class size of specific veins to promote possible standardization of the procedure. However, measures to increase the contact time between foam and endothelium were shown to improve late results. In addition, the same efficacy and side effects are observed with lower POL concentration if foam volumes are increased.
European Journal of Vascular and Endovascular Surgery
This paper adds information on a new, effective, and safe approach in varicose vein treatment, which is based on duplex guided foam sclerotherapy, with additional use of a catheter to release the foam, perivenous tumescence infiltration, and flushing of the vein before foam injection. The inclusion of these three technical additions to the usual foam sclerotherapy (mostly performed by direct injection or cannula) significantly improved clinical and duplex based outcomes up to 3 years after treatment. Objectives: This was a prospective observational study to assess the short-to mid-term efficacy and safety of catheter foam sclerotherapy (CFS) of the great saphenous vein (GSV), including peri-saphenous tumescence infiltration (PST) and intra-saphenous saline irrigation (ISI), in combination with phlebectomy of the varicose tributaries. Methods: Eighty-eight limbs in 82 patients (19 male, 63 female, mean age 55.7 years) affected by varices related to GSV incompetence were submitted to CFS of the refluxing GSV segment after PST and ISI, combined with phlebectomy of the varicose tributaries. Sodium tetradecylsulfate (STS) 3% þ CO 2 /O 2 sclerosant foam (SF) (median 7 mL) was injected in the GSV trunk (median caliber 7.1 mm) by means of a 4F catheter. Clinical and colour duplex ultrasound (CDU) investigation was performed pre-operatively, and 40 days, 6, 12, and 36 months post-operatively. A visual analogue scale (VAS) was used to assess procedure related symptoms and venous symptoms before and 40 days after the treatment. Results: Clinical recurrence (visible varices) at 40 days, 6 and 12 months was 0%, whereas at 36 months it was 4.7%; VAS pre-operative score of heaviness, pain, and cramps/paraesthesiae decreased from 6 (IQR 6e8) to 1 (IQR 0e3), from 3 (IQR 0e7) to 0 (IQR 0e1), and from 3 (IQR 0e7) to 0 (IQR 0e1) respectively at 40 days. The CDU based occlusion rate at 40 days, 6, 12, and 36 months was 100% (88/88), 100% (88/88), 94.3% (83/88), and 89.4% (76/85) respectively. Six of the nine patent saphenous veins (average diameter 1.4 mm) had anterograde flow (overall 96.5% reflux free GSVs). One superficial venous thrombosis was recorded without any further relevant complication. Conclusions: GSV treatment by means of CFS and adjuvant PST þ ISI, combined with phlebectomy of varicose tributaries, proved to be safe and effective in terms of clinical and duplex based outcomes at short/mid-term follow-up.
BMJ Open, 2019
IntroductionEndovenous ablations are the new standard procedures for treatment of great saphenous vein reflux including endovenous laser ablation (EVLA), radio frequency ablation (RFA), endovenous steam ablation (EVSA), mechanochemical ablation (MOCA), cyanoacrylate injection and ultrasound-guided foam sclerotherapy (UGFS). EVLA and RFA have demonstrated similar anatomical success for short-term outcome, but results are controversial for longer term (≥5 years). Additional evidences from randomised controlled trials have been published. This study is, therefore, conducted to, directly and indirectly, compare outcomes among all procedures stratifying by short-term and long-term follow-up.Methods and analysisMedline and Scopus will be searched from 2000 to September 2018 with predefined search strategy. Interventions of interest are open surgery (ie, saphenofemoral or high ligation (HL) with stripping) and endovenous ablations (ie, EVLA, RFA, EVSA, MOCA, cyanoacrylate injection and UGF...