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 (original) (raw)
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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.
British Journal of Surgery, 2018
Background This was an 8-year follow-up of an RCT comparing ultrasound-guided foam sclerotherapy (UGFS) with high ligation and surgical stripping (HL/S) of the great saphenous vein (GSV). Methods Patients were randomized to UGFS or HL/S of the GSV. The primary outcome was the recurrence of symptomatic GSV reflux. Secondary outcomes were patterns of reflux according to recurrent varices after surgery, Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification, Venous Clinical Severity Score (VCSS) and EuroQol Five Dimensions (EQ-5D™) quality-of-life scores. Results Of 430 patients originally randomized (230 UGFS, 200 HL/S), 227 (52·8 per cent; 123 UGFS, 103 HL/S) were available for analysis after 8 years. The proportion of patients free from symptomatic GSV reflux at 8 years was lower after UGFS than HL/S (55·1 versus 72·1 per cent; P = 0·024). The rate of absence of GSV reflux, irrespective of venous symptoms, at 8 years was 33·1 and 49·7 per cent respectively (P = 0·009). M...
Ultrasonography-guided foam sclerotherapy in patients with small saphenous vein insufficiency
Journal of Vascular Surgery: Venous and Lymphatic Disorders, 2020
Purpose: Chronic venous insufficiency is an important health problem; small saphenous vein (SSV) insufficiency is one of the leading causes and may affect up to 20% of adults. In addition to conventional treatment methods, endovenous treatment techniques have become popular in treatment of varicose veins. Herein, we report the outcomes of ultrasound-guided foam sclerotherapy (UGFS) in patients with symptomatic SSV insufficiency. Methods: From January 2014 to June 2018, patients with primary SSV insufficiency treated with UGFS were followed to assess the effectiveness and safety of the procedure. A total of 31 lower limbs of 30 patients (18 females and 12 males), who attended control visits at 1 week, 1, 3, and 6 months, and yearly, after undergoing UGFS, were included in the study. The clinical results, occlusion rates, and the patients' preprocedure and postprocedure Venous Clinical Severity Scores were recorded. Results: The records show that, during the procedure, severe pain occurred at the time of injection in one patient (3%), vasovagal syncope in one patient (3%), hyperpigmentation in five patients (16%), and phlebitis in three patients (9%). It was also recorded that during follow-up 24 legs (78%) showed complete thrombosis and 7 legs (22%) had partial thrombosis. The mean Venous Clinical Severity Score for the patients before UGFS was 8.58 6 3.78, and 7.25 6 3.17 after the procedure. No major complications, including sural nerve injury and deep venous thrombosis, were seen during the follow-up period. Conclusions: The results of this study show that UGFS is a simple, safe, and effective procedure for treatment in patients with symptomatic SSV insufficiency with acceptable side effects.
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.
Improvement in Venous Clinical Severity Score Following Ultrasound Guided Foam Sclerotherapy
Journal of Imaging and Interventional Radiology, 2018
Title: Improvement in Venous Clinical Severity Score Following Ultrasound Guided Foam Sclerotherapy. Background: Ultrasound guided foam Sclerotherapy (UGFS) is a simple and cost effective procedure in the management of lower limb varicose vein with very few studies on Indian population. This study is focused on clinical improvement evaluated by venous clinical severity score (VCSS) at 2 months following UGFS, in a rural population in South Kerala. Objective: To assess improvement in Venous Clinical Severity Scoring (VCSS), two months following UGFS in lower limb varicose veins. Methods: A prospective, observational study of 58 cases was done between December 2015 and November 2016, in a rural population in Kerala. 58 patients underwent UGFS during the study and their pre UGFS VCSS score was documented. Of these, 49 patients came back for follow up at 2 months, for post UGFS VCSS and Duplex Doppler evaluation to assess the effectiveness of UGFS. Results: Pre procedure VCSS score of 49 patients, ranged between 3.0-19.0 (Mean=10.7) and post procedure VCSS were between 2-16 (Mean=7.6), which is statistically significant (P=0.01). Decrease in VCSS score by about 3-5 was noted in 44 out of the 49 patients who had successful outcome with no persistent reflux and clinical improvement was also seen in 5 patients with persistent reflux. Of the 19 patients with venous ulcer, there was healing of ulcer at 2 month post UGFS review. Conclusion: UGFS is a simple, cost effective procedure which leads to significant improvement in clinical symptoms and decreasing morbidity associated with chronic venous disease.
Foam treatment for varicose veins; efficacy and safety
Alexandria Journal of Medicine, 2013
Introduction: Lower extremity varicose vein is a common disease. Sclerotherapy can be used to treat truncal varices of the superficial venous system. This involves injecting a sclerosant intraluminally in order to cause fibrosis and eventual obliteration of the vein. Objective: To demonstrate the efficacy and safety of foam sclerotherapy in the treatment of great saphenous reflux measured against patient clinical examination and duplex scanning. Materials and methods: Fifty legs with varicose veins due to incompetent great saphenous vein were treated with ultrasound guided sclerosing foam prepared according to the Tessari method by mixing 3% polidocanol solution (Aethoxysclerol) with air using 2 disposable syringes and a three way tap producing high-quality micro-foam. Clinical examination and duplex scanning before and after the treatment with a mean follow up of 6 months were done to every patient. Results: An average of 10 ml of foam was required to close incompetent Great saphenous veins as defined by a reflux of more than 0.5 s documented by duplex scan. At the 6th month of follow up, patients felt that their legs were treated successfully with resolution of symptoms and complete resolution in 96%. Conclusion: Foam sclerotherapy is a safe and effective therapy in treating varicose veins with high patient satisfaction and improvement in quality of life.
Indian Journal of Vascular and Endovascular Surgery, 2015
Objective:The purpose of this study was to determine the outcome and rate of recurrence for varicose veins treated with ultrasound-guided foam sclerotherapy (UGFS). Methods: Data was collected from hospital records. Patients treated with UGFS for superficial venous insufficiency were included in the study. Total 361 legs in 241 patients, out of which 121 patients with unilateral limbs and 120 patients with bilateral limbs were found to be treated by this method. Results: Out of these 361 legs great saphenous vein (GSV) varicosity was found in 88 legs, short saphenous vein (SSV) in 76, GSV & SSV both in 63, others 134. 264 legs with primary varicosity while 97 were with recurrent. In 294 legs clinical CEAP was 2-3 while in 67 legs it was 4-6. Saphenofemoral junction (SFJ) incompetence was found 60 legs, saphenopopliteal junction (SPJ) incompetence in 68, only perforator's incompetence was in 56, SFJ with perforator's incompetence 61, SPJ with perforator's 29 and no incompetence was noted in 87 legs.Outcome at 6 months was 96.23% while treatment failure and recurrences were noted in 2.77 % of legs. Complications which were noted at 1 week were superficial skin necrosis in 3.04%, pain at injection sites in 15.23%, superficial thrombophlebitis in 16.62%, bruising in 12.18%, skin staining in 11.08%, superficial vein thrombosis (SVT) in 9.97% while no DVT was noted in any of the treated legs. Conclusion: On conclusion it was found that UGFS is a popular office based treatment modality, safe, effective, easy and improvement in venous signs and symptoms. Even on recurrence patients easily accepts retreatment with this method. Furthermore it is associated with lesser pain, anesthesia requirements; time off work and driving gives it additional advantages.
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.
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...