Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence

2014 ◽  
Vol 30 (6) ◽  
pp. 397-404 ◽  
Author(s):  
Jose I Almeida ◽  
Julian J Javier ◽  
Edward G Mackay ◽  
Claudia Bautista ◽  
Daniel J Cher ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Duplex Ultrasound ◽  
Clinical Severity ◽  
Leg Pain ◽  
Compression Stockings ◽  
Saphenous Veins ◽  
Kaplan Meier ◽  
Venous Clinical Severity Score ◽  
Human Use

Objectives To evaluate the safety and effectiveness of endovenous cyanoacrylate-based embolization of incompetent great saphenous veins. Methods Incompetent great saphenous veins in 38 patients were embolized by cyanoacrylate bolus injections under ultrasound guidance without the use of perivenous tumescent anesthesia or graduated compression stockings. Follow-up was performed over a period of 24 months. Result Of 38 enrolled patients, 36 were available at 12 months and 24 were available at 24 months follow-up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all patients except for one complete and two partial recanalizations observed at, 1, 3 and 6 months of follow-up, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836–1.0) at 24 months follow-up. Venous Clinical Severity Score improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.3 ± 1.1, 1.5 ± 1.4 and 2.7 ± 2.5 at 6, 12 and 24 months, respectively ( p < .0001). Edema improved in 89% of legs (n = 34) at 48 hours follow-up. At baseline, only 13% were free from pain. At 6, 12 and 24 months, 84%, 78% and 64% were free from leg pain, respectively. Conclusions The first human use of endovenous cyanoacrylate for closure of insufficient great saphenous veins proved to be feasible, safe and effective. Clinical efficacy was maintained over a period of 24 months.

Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study)

Vascular ◽  
2016 ◽  
Vol 25 (2) ◽  
pp. 149-156 ◽  
Author(s):  
Kathleen Gibson ◽  
Brian Ferris
Keyword(s):  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Duplex Ultrasound ◽  
Side Branch ◽  
Clinical Severity ◽  
Pain Rating ◽  
Compression Stockings ◽  
Post Procedure ◽  
Saphenous Veins ◽  
Venous Clinical Severity Score

Purpose Cyanoacrylate closure of the great saphenous vein with the VenaSeal™ Closure System is a relatively new modality. Studies have been limited to moderate-sized great saphenous veins and some have mandated postoperative compression stockings. We report the results of a prospective study of cyanoacrylate closure for the treatment of great saphenous vein, small saphenous veins, and/or accessory saphenous veins up to 20 mm in diameter. Methods Fifty subjects with symptomatic great saphenous vein, small saphenous veins, and/or accessory saphenous veins incompetence were each treated at a single session. Compression stockings were not used post-procedure. Subjects returned to clinic at week 1 and again at one month. Post-procedure evaluations were performed at seven days and one month and included numerical pain rating score, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire score, and time to return to work and normal activities. Duplex ultrasound was performed at each visit. Findings Procedural pain was mild (numerical pain rating scale 2.2 ± 1.8). All treated veins (48 great saphenous vein, 14 accessory saphenous veins, and 8 small saphenous veins) had complete closure by duplex ultrasound at seven days and one month. Mean time to return to work and normal activities was 0.2 ± 1.1 and 2.4 ± 4.1 days, respectively. The revised venous clinical severity score was improved to 1.8 ± 1.4 ( p < .001) and Aberdeen Varicose Vein Questionnaire score to 8.9 ± 6.6 ( p < .001) at one month. Phlebitis in the treatment area or side branches occurred in 10 subjects (20%) and completely resolved in all but one subject (2%) by one month; 98% of subjects were “completely” or “somewhat” satisfied, and 2% “unsatisfied” with the procedure at one month, despite the protocol disallowance of concomitant side branch treatment. Conclusions Cyanoacrylate closure is safe and effective for the treatment of one or more incompetent saphenous or accessory saphenous veins. Closure rates were high even in the absence of the use of compression stockings or side branch treatment. Time back to work or normal activities was short and improvements in venous severity scores and QOL were significant, comparing favorably with alternative treatment methods.

Long-term results of endovenous laser ablation of saphenous vein reflux: Up to nine years of follow-up

2020 ◽  
pp. 026835552093974
Author(s):  
Boutros Karam ◽  
Moustafa Moussally ◽  
Hussein Nassar ◽  
Karim Ataya ◽  
Rola Jaafar ◽  
...  
Keyword(s):  
Laser Ablation ◽  
Saphenous Vein ◽  
Clinical Severity ◽  
Long Term Results ◽  
Endovenous Laser Ablation ◽  
Saphenous Veins ◽  
Venous Clinical Severity Score ◽  
Vein Reflux

Introduction Endovenous laser ablation (EVLA) has become the gold standard for the treatment of saphenous vein reflux. We report the long-term clinical and ultrasound results of EVLA. Methods This study is a retrospective review of patients who underwent EVLA of saphenous vein over four years. Clinical results were assessed using venous clinical severity score (VCSS), and ultrasound results were classified according to Bush classification. Results Over a median follow-up time of 4.4 years, 168 EVLA-treated patients showed a drop in VCSS from 4.38 to 1.39. Ultrasound results of 140 treated great saphenous veins showed that 64% had one or more cause of recurrence. The presence of neovascularization correlated well with the lack of improvement of VCSS. Conclusion EVLA resulted in drop in VCSS from 4.38 to 1.39. Among 140 treated great saphenous veins, reflux in the anterior accessory saphenous vein was the primary cause (23.5%) of recurrence.

Need for adjunctive procedures following cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of postprocedure compression: Three-month data from a postmarket evaluation of the VenaSeal System (the WAVES Study)

2018 ◽  
Vol 34 (4) ◽  
pp. 231-237 ◽  
Author(s):  
Kathleen Gibson ◽  
Renee Minjarez ◽  
Krissa Gunderson ◽  
Brian Ferris
Keyword(s):  
Saphenous Vein ◽  
Varicose Vein ◽  
Severity Score ◽  
Rating Scale ◽  
Great Saphenous Vein ◽  
Clinical Severity ◽  
Compression Stockings ◽  
Saphenous Veins ◽  
Clinical Severity Score ◽  
Venous Clinical Severity Score

Purpose Studies examining cyanoacrylate closure of saphenous veins with the VenaSeal™ System have not allowed concomitant procedures for tributaries at the time of the index procedure. Outside of clinical trials, however, concomitant procedures are frequently performed in conjunction with endovenous ablation. We report on the frequency of need for saphenous tributary treatment three months after cyanoacrylate closure of the treatment of great saphenous vein, small saphenous vein, and/or accessory saphenous vein. Methods Fifty subjects with symptomatic great saphenous vein, small saphenous vein, and/or accessory saphenous vein incompetence were treated with no postprocedure compression stockings. Concomitant procedures were not allowed. Treating physicians predicted the type and nature of any concomitant procedures that they would usually perform at the time of ablation, if not limited by the constraints of the study. Evaluations were performed at one week, one and three months and included duplex ultrasound, numeric pain rating scale, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire, and time to return to work and normal activities. At the three-month visit, the need for and type of adjunctive procedures were recorded. Results Complete closure at three months was achieved in 70 (99%) of the treated veins (48 great saphenous veins, 14 accessory saphenous veins, eight small saphenous veins). Revised venous clinical severity score improved from 6.4 ± 2.2 to 1.8 ± 1.5 (P < .001) and Aberdeen Varicose Vein Questionnaire from 17.3 ± 7.9 to 6.5 ± 7.2 (P < .0001). Sixty-six percent of patients underwent tributary treatment at three months. The percentage of patients who required adjunctive treatments at three months was lower than had been predicted by the treating physicians (65% versus 96%, p=.0002). Conclusions Closure rates were high in the absence of the use of compression stockings or side branch treatment. Improvement in quality of life was significant, and the need for and extent of concomitant procedures was significantly less than had been predicted by the treating physicians.

Registry to investigate the efficacy and safety of the VenaBlock© VeIn SEaling system for VaRicose veins in SingApore – Six months results of the RIVIERA trial

2021 ◽  
pp. 026835552110251
Author(s):  
YL Linn ◽  
CJQ Yap ◽  
SXY Soon ◽  
SL Chan ◽  
VBX Khoo ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Varicose Veins ◽  
Duplex Ultrasound ◽  
Venous Occlusion ◽  
Clinical Severity ◽  
Puncture Site ◽  
Venous Clinical Severity Score

Background The Venablock© Venous Closure System (Invamed, Ankara, Turkey) is a novel cyanoacrylate-based non-thermal non-tumescent embolization device to block refluxing truncal veins for chronic venous insufficiency and varicose veins. The aim was to prospectively evaluate the safety and 6 months efficacy of Venablock© for the treatment of primary great saphenous vein (GSV) and small saphenous vein (SSV) incompetency in a multi-ethnic cohort from Singapore. Methods This was a single arm, single investigator prospective study of 29 patients (39 limbs, 39 truncal veins) recruited over a 5-month period (August 2019 to February 2020), who were treated with the Venablock© device at a tertiary vascular unit in Singapore. Patients with symptomatic varicose veins (C2–6) and had truncal reflux > 0.5 second on venous Duplex ultrasound were included. Follow-up occurred at 2 weeks, 3 and 6 months with dedicated quality of life questionnaires and a targeted Duplex ultrasound performed to check for continued venous occlusion. Result Mean age was 61.4 (±11.0) years and mean BMI was 26.2 (±5.7) kg/m2. 11/29 (37.9%) were males. Most common CEAP class treated was 2 (12/29, 41.3%). Mean diameter of treated GSV was 5.7 (±2.0) mm, 4.8 (±1.7) mm and 4.2 (±1.3) mm for the proximal, mid and distal above knee segments respectively. Mean time from access puncture to sheath removal was 23.4 (±10.0) mins. Vein occlusion at 2 weeks, 3 and 6 months was 39/39 (100%), 39/39 (100%) and 36/37 (97.2%) respectively. 5/29 (17.2%) developed puncture site infections, of which 3/29 (7.7%) required formal surgical drainage. 3/29 (7.7%) developed phlebitis. At 6 months, revised Venous Clinical Severity Score improved from 5.2 (±3.5) to 2.1 (±2.9; p < .001); EuroQol-5 Dimension score, from 7.4 (±2.1) to 5.7 (±1.4; p < .001); Aberdeen Varicose Vein Questionnaire score, from 18.1 (±15.5) to 7.9 (±8.9; p = .007); and Chronic Venous Insufficiency Questionnaire, from 18.6 (±16.2) to 4.5 (±6.3; p < .001). Conclusion Venablock© is a safe and efficacious option of treating truncal venous insufficiency in a multi-ethnic Asian cohort from Singapore in the short term. There is a significant improvement in QoL. Longer follow-up is required to assess the durability of this technique, in particular the higher puncture site infection rates observed compared to other glue-based therapies.

Ablation therapy with cyanoacrylate glue and laser for refluxing great saphenous veins – a prospective randomised study

VASA ◽  
2019 ◽  
Vol 48 (5) ◽  
pp. 405-412
Author(s):  
Eyüp Serhat Çalık ◽  
Ümit Arslan ◽  
Bilgehan Erkut
Keyword(s):  
Laser Ablation ◽  
Venous Insufficiency ◽  
Clinical Severity ◽  
Life Questionnaire ◽  
Compression Stockings ◽  
Cyanoacrylate Glue ◽  
Endovenous Laser Ablation ◽  
Saphenous Veins ◽  
Venous Clinical Severity Score

Summary: Background: Endovenous cyanoacrylate ablation is a new technique for the treatment of clinically symptomatic venous insufficiency. The results of a prospective comparative study of cyanoacrylate glue versus endovenous laser ablation for the management of incompetent great saphenous veins are presented. Patients and methods: A total of 400 subjects were treated with cyanoacrylate ablation or endovenous laser ablation between April 2014 and April 2016. The preprocedural, procedural, postprocedural, and follow-up data were recorded and compared. Results: There were 208 procedures in cyanoacrylate ablation group (CAA) and 204 in endovenous laser ablation group (EVLA). Operative time was 13 ± 3.4 minutes in the CAA and 31.7 ± 8.8 minutes in the EVLA (< 0.001). All procedures in both groups were successful, and the target vein segments were fully occluded at the end of the procedure. Periprocedural pain was less in the CAA (< 0.001). Enduration, ecchymosis, and paresthesia rates were significantly higher in the EVLA (< 0.001). The mean length of follow-up was 14 months (range 10–16). The 3, 6 and 12 months closure rates were 97.4%, 95.6%, and 94.1% for EVLA and 98.6%, 97.1% and 96.6% for CAA respectively. In both groups, the Venous Clinical Severity Score and Chronic Venous Insufficiency Quality of Life Questionnaire with declined significantly with no difference between groups. Conclusions: Management of incompetent great saphenous veins both endovenous cyanoacrylate ablation and laser ablation results in high occlusion rates. Endovenous cyanoacrylate ablation technique is fast and simple with low periprocedural pain that does not require tumescent anesthesia and compression stockings.

Mechanochemical ablation for symptomatic great saphenous vein reflux: A two-year follow-up

2016 ◽  
Vol 32 (1) ◽  
pp. 43-48 ◽  
Author(s):  
Pamela S Kim ◽  
Muath Bishawi ◽  
David Draughn ◽  
Marab Boter ◽  
Charles Gould ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Saphenous Vein ◽  
Severity Score ◽  
Great Saphenous Vein ◽  
Clinical Severity ◽  
Mechanochemical Ablation ◽  
Venous Clinical Severity Score ◽  
Occlusion Rate ◽  
The Mean

Background Several studies have shown comparable early efficacy of mechanochemical ablation to endothermal techniques. The goal of this report was to show if early efficacy is maintained at 24 months. Methods This was a two-year analysis on the efficacy of mechanochemical ablation in patients with symptomatic C2 or more advanced chronic venous disease. Patients with reflux in the great saphenous vein involving the sapheno-femoral junction and no previous venous interventions were included. Demographic information, clinical, and procedural data were collected. The occlusion rate of treated veins was assessed with duplex ultrasound. Patient clinical improvement was assessed by Clinical-Etiology-Anatomy-Pathophysiology (CEAP) class and venous clinical severity score. Results Of the initial 126 patients, there were 65 patients with 24 month follow-up. Of these 65 patients, 70% were female, with a mean age of 70 ± 14 years and an average body mass index (BMI) of BMI of 30.5 ± 6. The mean great saphenous vein diameter in the upper thigh was 7.6 mm and the mean treatment length was 39 cm. Adjunctive treatment of the varicosities was performed in 14% of patients during the procedure. Closure rates were 100% at one week, 98% at three months, 95% at 12 months, and 92% at 24 months. There was one patient with complete and four with partial recanalization ranging from 7 to 12 cm (mean length 9 cm). There was significant improvement in CEAP and venous clinical severity score (P < .001) for all time intervals. Conclusion Early high occlusion rate with mechanochemical ablation is associated with significant clinical improvement which is maintained at 24 months, making it a very good option for the treatment of great saphenous vein incompetence.

Five-year outcomes of mechano-chemical ablation of primary great saphenous vein incompetence

2019 ◽  
Vol 35 (4) ◽  
pp. 255-261
Author(s):  
Naomi DE Thierens ◽  
Suzanne Holewijn ◽  
Wynand HPM Vissers ◽  
Debbie AB Werson ◽  
Jean Paul PM de Vries ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Clinical Severity ◽  
Long Term Results ◽  
Venous Clinical Severity Score ◽  
Ceap Classification ◽  
Chemical Ablation ◽  
Anatomical Success

Objective The aim of the study is to report long-term results after mechano-chemical ablation for the treatment of great saphenous vein incompetence. Methods Mechano-chemical ablation was performed using the ClariVein device with polidocanol as the sclerosant. Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification, Venous-Clinical-Severity-Score (VCSS), anatomical-success, RAND-SF36 and the Aberdeen-Varicose-Vein-Questionnaire (AVVQ) were obtained by clinical examination, questionnaires and duplex ultrasonography through five years’ follow-up (Clinicaltrials.gov, NCT01459263). Results Ninety-four patients (113 great saphenous veins) were included in the study. Five-year follow-up data were available for 75 limbs (66.4%). Freedom from anatomical failure was 78.7% (N = 45) with 64.6% (N = 42) having an improvement in the VCSS ≥1. A total of five reinterventions were performed through five years with a median time to reintervention of 38 months. The VCSS at five years was 2 (IQR 1; 4) and was still significantly improved compared to baseline (p < 0.001). A deterioration of the VCSS was observed in 21.5%. Conclusion Through five-year follow-up, there are a significant number of anatomical and clinical failures in this series, mainly driven by partial recanalizations.

Cyanoacrylate adhesive embolization and sclerotherapy for primary varicose veins

2017 ◽  
Vol 33 (8) ◽  
pp. 547-557 ◽  
Author(s):  
Krishna Prasad Bellam Premnath ◽  
Binu Joy ◽  
Vijayakumar Akondi Raghavendra ◽  
Ajith Toms ◽  
Teena Sleeba
Keyword(s):  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Varicose Veins ◽  
Clinical Severity ◽  
Cyanoacrylate Glue ◽  
Cyanoacrylate Adhesive ◽  
Venous Clinical Severity Score ◽  
Primary Varicose Veins ◽  
Vein Reflux

Various treatment methods are available for the treatment of varicose veins, and there has been a recent surge in the usage of cyanoacrylate glue for treating varicose veins. Purpose To investigate the technical possibility, efficiency and safety of cyanoacrylate adhesive embolization and sclerotherapy using commonly available n-butyl cyanoacrylate glue for the treatment of primary varicose veins due to great saphenous vein reflux with or without incompetent perforators. Materials and Methods One hundred forty-five limbs of 124 patients with varicose veins due to great saphenous vein reflux were subjected to cyanoacrylate adhesive embolization and sclerotherapy – adhesive embolization of great saphenous vein in the thigh and perforators using cyanoacrylate followed by sclerotherapy of any residual varicose veins in the leg. Procedural success, venous closure rates and clinical improvement were assessed. Follow-up for 1, 3, 6, 9 and 12 months was obtained. Results Technical success rate was 100%. Saphenous vein closure rate was 96.5% at one year. There was no femoral venous extension of cyanoacrylate in any of the patients. Posterior tibial vein extension of cyanoacrylate was seen in three patients (2.6%) without untoward clinical effect.Significant improvement was found in venous clinical severity score (VCSS) from a baseline mean of 7.98 ± 4.42 to 4.74 ± 3, 1.36 ± 1.65 and 0.79 ± 1.19 at 1, 6 and 12 months’ follow-up. Ulcer healing rate was 100%. Conclusion Cyanoacrylate adhesive embolization and sclerotherapy for the treatment of primary varicose veins is efficacious and can be performed as an outpatient procedure, but has a guarded safety profile due to its propensity to cause deep venous occlusion if not handled carefully.

Improvement of dynamic venous function after thermal ablation with steam vein occlusion – 6-weeks and 1-year follow-up after 167 treatments

2021 ◽  
pp. 1-15
Author(s):  
W. Konschake ◽  
M. Tembulatov ◽  
S. Lutze ◽  
A. Arnold ◽  
M. Jünger ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Clinical Severity ◽  
Leg Pain ◽  
Venous Reflux ◽  
Local Pressure ◽  
Vein Occlusion ◽  
Venous Clinical Severity Score ◽  
Venous Function ◽  
One Year

BACKGROUND: In this paper, the method of steam vein occlusion for the treatment of the great/small saphenous vein (GSV/SSV) was analyzed in terms of a therapeutic influence on the dynamic parameters of global vein function, its effects on subjective symptoms based on chronic venous insufficiency (CVI) and the side effects of the steam vein sclerosis (SVS). It has been questioned whether the effects of this method lead to a recommendation for routine clinical practice. METHODS: The venous drainage and the venous refilling time (T0) of the leg treated were determined by photoplethysmography (Elcat, Wolfratshausen, Germany) before, six weeks and one year after the intervention to examine the effects on global venous function. Further changes of clinical symptoms and findings were assessed by the Venous Clinical Severity Score (VCSS), preoperatively and after one year, and the complication rate at 6-week follow-up was monitored. RESULTS: The SVS was performed on 167 veins (GSV: 124; SSV: 43) in a total of 156 patients. Eight patients (5.1%) did not attend the 6-week follow-up, while 29 patients (18.6%) were lost in the 1-year follow-up. Patients were suffering from symptoms such as leg pain and leg edema, which resulted in a VCSS of 9.4 (cumulated mean score of all patients) preoperatively. The T0 was reduced to mean values of 20.6 s (GSV cohort) and 21 s (SSV cohort). The VCSS improved to 6.0 after one year. This correlated with the hemodynamic parameters. The T0 increased in the GSV cohort after six weeks to 31.8 s, p <  0.001, and showed a nonsignificant improvement to 32.2 s, p = 0.509, in the 1-year check. The T0 also increased in the SSV cohort significantly after 6 weeks to 30.1 s, p <  0.001, and showed a nonsignificant reduction after one year, p = 0.289. A total of 71%of the GSV and 69.8%of the SSV of the patients involved no complications following the treatment. Light complications (grade 1) occurred (reddening, hematoma, hyperpigmentation) in the majority: 24.2%of the GSV and 18.6%of the SSV. We noticed one grade 3 complication with thrombosis in the SSV cohort, which led to a pulmonary embolism. Forty-seven complete questionnaires were analyzed (responder rate: 28.1%); 40.4%of the patients had light complaints after the treatment, such as pain, warmth or local pressure sensations (Fig. 7); 63%of those patients noticed only slight pain at a maximum of 3 out of 10. The majority (91%) would recommend this procedure. CONCLUSION: The SVS revealed endoluminal catheter-based intervention to abolish venous reflux of the G/SSV as safe. As one therapeutic target is to eliminate venous reflux, effectiveness of a method cannot be based on sonographic data alone; one must further assess patients’ symptoms and dynamic venous function. This data shows an improvement of patients’ symptoms which correlated well with the improvement of the venous function in digital photoplethysmography. The SVS can be recommended as a catheter-based treatment in the future.

Early-Term Outcomes for Treatment of Saphenous Vein Insufficiency with N-Butyl Cyanoacrylate: A Novel, Non-Thermal, and Non-Tumescent Percutaneous Embolization Technique

2016 ◽  
Vol 19 (3) ◽  
pp. 118 ◽  
Author(s):  
Mustafa Tok ◽  
Oktay Tüydeş ◽  
Ahmet Yüksel ◽  
Sefa Şenol ◽  
Serkan Akarsu
Keyword(s):  
Saphenous Vein ◽  
Clinical Severity ◽  
Percutaneous Embolization ◽  
Early Term ◽  
Technical Success Rate ◽  
Venous Clinical Severity Score ◽  
Occlusion Rate ◽  
Vein Insufficiency

<strong>Background:</strong> The purpose of this study was to present early-term outcomes of VariClose® Vein Sealing System, which is a novel, non-thermal, and non-tumescent percutaneous embolization technique for treatment of saphenous vein insufficiency.<br /><strong>Methods:</strong> Between March 2014 and July 2015, 189 saphenous veins in 141 patients were treated with Variclose Vein Sealing System containing n-butyl cyanoacrylate. Pre-, intra-, post-procedural, and follow-up data of patients were collected and retrospectively reviewed.<br /><strong>Results:</strong> Mean age of patients was 42.5 ± 14.0 years, of which 53% were female. Technical success rate of intervention was 98.9%. Mean procedure time was 14.3 ± 7.5 minutes. Eighty-nine percent of patients (n = 126/141) were available at mean follow-up time of 6.7 months. Mean Venous Clinical Severity Score was significantly improved from 8.3 ± 2.2 at pre-procedure period to 3.3 ± 1.8 at follow-up. No complete recanalization was observed, but 2 patients were presented with partial recanalization during follow-up. The complete occlusion rate was 98.4%. No serious adverse event related to procedure was observed.<br /><strong>Conclusion:</strong> Variclose Vein Sealing System appears to be safe and effective in treatment of saphenous vein insufficiency. Further randomized studies with long-term outcomes are required for determining optimal treatment modality in patients with saphenous vein insufficiency.<br /><br />

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