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 ◽  
...  

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.

2020 ◽  
pp. 026835552093974
Author(s):  
Boutros Karam ◽  
Moustafa Moussally ◽  
Hussein Nassar ◽  
Karim Ataya ◽  
Rola Jaafar ◽  
...  

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.


2021 ◽  
Vol 49 (5) ◽  
pp. 030006052110143
Author(s):  
Dominic Mühlberger ◽  
Erich Brenner ◽  
Norbert Frings ◽  
Bruno Geier ◽  
Achim Mumme ◽  
...  

Objectives External valvuloplasty (eVP) is a reconstructive surgical method to repair the function of the terminal and preterminal valves. We evaluated the 6-month outcomes of eVP regarding the diameter of the great saphenous vein (GSV). Methods Patients from five vein centres were included in this observational study. Follow-up involved detailed duplex sonography of the GSV. The venous clinical severity score (VCSS) and the C class of the clinical, aetiologic, anatomic and pathophysiologic (CEAP) classification were recorded. Results We enrolled 210 patients, with a follow-up rate of 58%; eVP was sufficient in 95.24% of the patients. The GSV diameters decreased significantly from 4.4 mm (standard deviation (SD): 1.39) to 3.9 (SD: 1.12), 4 cm distal to the saphenofemoral junction (SFJ); from 3.7 mm (SD: 1.10) to 3.5 mm (SD: 1.02) at the mid-thigh; from 3.6 mm (SD: 1.14) to 3.3 mm (SD: 0.94) at the knee and from 3.1 mm (SD: 0.99) to 2.9 mm (SD: 0.78) at the mid-calf. VCSS decreased significantly from 4.76 (SD: 2.13) preoperatively to 1.77 (SD: 1.57) 6 months postoperatively. Conclusions GSV function can be restored by eVP; diameters over the total length of the GSV decreased significantly.


2016 ◽  
Vol 32 (1) ◽  
pp. 43-48 ◽  
Author(s):  
Pamela S Kim ◽  
Muath Bishawi ◽  
David Draughn ◽  
Marab Boter ◽  
Charles Gould ◽  
...  

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.


2018 ◽  
Vol 33 (9) ◽  
pp. 646-652 ◽  
Author(s):  
Orsini Camillo

Objective This retrospective study presents the long-term results of catheter-directed foam sclerotherapy of the great saphenous vein. Method From January 2003 to June 2017, 277 patients with varices and great saphenous vein incompetence were treated with echo-guided foam sclerotherapy. Forty-six patients were treated with long-catheters guided by foam sclerotherapy. Foaming was carried out with sodium-tetra-decyl-sulphate. Results Results were examined in the two groups: A (long-catheters) and B (other procedures). The median overall follow-up was 52.1 months. In the A-group, the complete occlusion rate was 34/46 pts (73.9%) and partial occlusion was 10/46 (21.7%). In the B-group, respectively, 130/231 (56.2%) and 90/231 (38.9%). Comparisons between groups were statistically significant (p = 0.023; p = 0.021). Failures involved, respectively, 2/46 (4.3%) and 11/231 (4.7%) with no statistical significance. The complication rates were similar in the two groups. Conclusions In this long-term experience (median follow-up exceeding four years), foam-guided sclerotherapy of the great saphenous vein with a long-catheter turned out to be more effective than the usual foam-guided sclerotherapy.


2017 ◽  
Vol 33 (8) ◽  
pp. 547-557 ◽  
Author(s):  
Krishna Prasad Bellam Premnath ◽  
Binu Joy ◽  
Vijayakumar Akondi Raghavendra ◽  
Ajith Toms ◽  
Teena Sleeba

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.


Phlebologie ◽  
2014 ◽  
Vol 43 (04) ◽  
pp. 197-200
Author(s):  
A. Brunner ◽  
J. Noppeney ◽  
T. Noppeney

Summary Introduction: In 1998, radiofrequency ablation (VNUS Closure Plus™) was authorised in Germany and Europe for the treatment of superficial reflux. We participated in a clinical registry set up by the manufacturing company in 1998. The aim of this retrospective paper was to analyse the long-term results after radiofrequency ablation. Materials, methods and patients: In 1998, we operated on twelve patients (8 women, 4 men). In accordance with the concept of standard vein stripping surgery, all endovenous ablations were combined with crossectomy or ligature of the saphenopopliteal junction. Each vein was thermally ablated over its entire length and no tumescent anaesthesia was performed. The mean age of the twelve patients was 44.9 years. On ten occasions, the entire length of the great saphenous vein was treated, on one occasion the great saphenous vein at the level of the lower leg and on one occasion the entire length of the small saphenous vein. The mean duration of surgery was 80 minutes. Results: The follow-up period was 3 to 168 months, with a mean duration of 80 months. Six patients were followed up for longer than 120 months. In eight cases, the follow-up examination was performed using duplex ultrasound, in two cases using clinical examination and non-invasive testing, in one case using clinical examination and in one case via a telephone interview.The most frequent perioperative complication, occurring in six cases, was hypaesthesia at the medial malleolus or lower leg. There was one case of perioperative thrombophlebitis of a lateral branch in the lower leg and one case of a third-degree thigh burn with subsequent infection of the great saphenous vein canal. No deep vein thrombosis or pulmonary embolism occurred in any of the operated patients.Of the eleven great saphenous veins treated, one recanalised after 14 months, the others had closed or were no longer detectable on ultrasound. The small saphenous vein treated was also no longer detectable.In one patient, a major recurrence at the saphenofemoral junction with recurrent lateral branches in the thigh and lower leg were determined 168 months after surgery. No recurrent varicosis was determined in the other patients.


2016 ◽  
Vol 32 (6) ◽  
pp. 415-424 ◽  
Author(s):  
Malcolm Sydnor ◽  
John Mavropoulos ◽  
Natalia Slobodnik ◽  
Luke Wolfe ◽  
Brian Strife ◽  
...  

Purpose To compare the short- and long-term (>1 year) efficacy and safety of radiofrequency ablation (ClosureFAST™) versus endovenous laser ablation (980 nm diode laser) for the treatment of superficial venous insufficiency of the great saphenous vein. Materials and methods Two hundred patients with superficial venous insufficiency of the great saphenous vein were randomized to receive either radiofrequency ablation or endovenous laser ablation (and simultaneous adjunctive therapies for surface varicosities when appropriate). Post-treatment sonographic and clinical assessment was conducted at one week, six weeks, and six months for closure, complications, and patient satisfaction. Clinical assessment of each patient was conducted at one year and then at yearly intervals for patient satisfaction. Results Post-procedure pain ( p < 0.0001) and objective post-procedure bruising ( p = 0.0114) were significantly lower in the radiofrequency ablation group. Improvements in venous clinical severity score were noted through six months in both groups (endovenous laser ablation 6.6 to 1; radiofrequency ablation 6.2 to 1) with no significant difference in venous clinical severity score ( p = 0.4066) or measured adverse effects; 89 endovenous laser ablation and 87 radiofrequency patients were interviewed at least 12 months out with a mean long-term follow-up of 44 and 42 months ( p = 0.1096), respectively. There were four treatment failures in each group, and every case was correctable with further treatment. Overall, there were no significant differences with regard to patient satisfaction between radiofrequency ablation and endovenous laser ablation ( p = 0.3009). There were no cases of deep venous thrombosis in either group at any time during this study. Conclusions Radiofrequency ablation and endovenous laser ablation are highly effective and safe from both anatomic and clinical standpoints over a multi-year period and neither modality achieved superiority over the other.


2016 ◽  
Vol 19 (3) ◽  
pp. 118 ◽  
Author(s):  
Mustafa Tok ◽  
Oktay Tüydeş ◽  
Ahmet Yüksel ◽  
Sefa Şenol ◽  
Serkan Akarsu

<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 />


2016 ◽  
Vol 32 (3) ◽  
pp. 194-199 ◽  
Author(s):  
Alptekin Yasim ◽  
Erdinc Eroglu ◽  
Orhan Bozoglan ◽  
Bulent Mese ◽  
Mehmet Acipayam ◽  
...  

Objective This report aims to present the early results of a retrospective study of the use of N-butyl cyanoacrylate (VariClose®)-based non-tumescent endovenous ablation for the treatment of patients with varicose veins. Method One hundred and eighty patients with varicose veins due to incompetent saphenous veins were treated with the VariClose® endovenous ablation method between May 2014 and November 2014. The patient sample consisted of 86 men and 94 women, with a mean age of 47.7 ± 11.7 years. The patients had a great saphenous vein diameter greater than 5.5 mm and a small saphenous vein diameter greater than 4 mm in conjunction with reflux for more than 0.5 s. Patients with varicose veins were evaluated with venous duplex examination, Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP), and their Venous Clinical Severity Scores were recorded. Results The median CEAP score of patients was three, and the saphenous vein diameters were between 5.5 and 14 mm (mean of 7.7 ± 2.1 mm). A percutaneous entry was made under local anesthesia to the great saphenous vein in 169 patients and to the small saphenous vein in 11 patients. Duplex examination immediately after the procedure showed closure of the treated vein in 100% of the treated segment. No complications were observed. The mean follow-up time was 5.5 months (ranging from three to seven months). Recanalization was not observed in any of the patients during follow-up. The average Venous Clinical Severity Scores was 10.2 before the procedure and decreased to 3.9 after three months (p < 0.001). Conclusion The application of N-butyl cyanoacrylate (VariClose®) is an effective method for treating varicose veins; it yielded a high endovenous closure rate, with no need for tumescent anesthesia. However, long-term results are currently unknown.


2014 ◽  
Vol 30 (3) ◽  
pp. 194-199 ◽  
Author(s):  
N Shadid ◽  
P Nelemans ◽  
J Lawson ◽  
A Sommer

Objective To investigate which clinical characteristics at baseline are predictive for great saphenous vein recurrence following ultrasound-guided foamsclerotherapy. Material and methods Data of patients treated for great saphenous vein incompetence with ultrasound-guided foamsclerotherapy were derived from a multicentre prospective randomized controlled trial comparing surgery versus ultrasound-guided foamsclerotherapy with a follow-up of two years. Recurrence of reflux was determined on colour duplex scans at three months, one year and two years. Univariate and multivariate Cox regression analysis was used to evaluate the effect of gender, age, C of CEAP classification, diameter of great saphenous vein, injected foam volume, presence of distal great saphenous vein reflux, presence of reflux in the anterior accessory saphenous vein and Venous Clinical Severity Score on risk of recurrent reflux. Results Two hundred twenty-five patients were available for analysis. Treatment after one single session was successful in 120 patients and recurrence of saphenous reflux was observed in 105 patients within two years during follow-up. Significant associations with risk of recurrence were observed for mid thigh great saphenous vein diameter (HR = 1.012 with 95% CI: 1.002–1.022, p = 0.022) and presence of distal great saphenous vein reflux (HR = 1.882 with 95% CI: 1.029–3.443, p = 0.040). Conclusion In conclusion, this prospective study suggests that ultrasound-guided foamsclerotherapy treatment for the proximal great saphenous vein is less effective for patients with a large vein and a refluxing distal great saphenous vein at baseline.


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