Clarivein mechanochemical ablation of the great and small saphenous vein: Early treatment outcomes of two hospitals

2015 ◽  
Vol 31 (3) ◽  
pp. 192-197 ◽  
Author(s):  
Charlotte L Deijen ◽  
Michiel A Schreve ◽  
Jan Bosma ◽  
A Jorianne de Nie ◽  
Vanessa J Leijdekkers ◽  
...  

Objectives Mechanochemical endovenous ablation is a novel technique for the treatment of great saphenous vein and small saphenous vein incompetence which combines mechanical injury of the endothelium with simultaneous infusion of liquid sclerosant. The main objective of this study was to evaluate early occlusion. Methods All consecutive patients who were eligible for the treatment with mechanochemical endovenous ablation were included. Inclusion period was from the introduction of the device in the hospitals (September 2011 and December 2011) until December 2012. Results A total of 449 patients were included representing 570 incompetent veins. In 506 treated veins, duplex ultrasonography was performed at follow-up: 457 veins (90%) were occluded at a follow-up of 6 to 12 weeks. In univariate and multivariate analysis, failure of treated great saphenous vein was associated with saphenofemoral junction incompetence (OR 4; 95% CI 1.0–17.1, P = 0.049). Conclusions The Clarivein device proves to be safe and had a high short-term technical effectiveness.

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.


Vascular ◽  
2020 ◽  
pp. 170853812094725
Author(s):  
Maurizio Pagano ◽  
Giovanna Passaro ◽  
Roberto Flore ◽  
Paolo Tondi

Objective To describe the mid-term outcome after inferior selective crossectomy in a subset of patients with symptomatic chronic venous disease and both great saphenous vein and suprasaphenic valve incompetence. Methodsː Retrospective analysis of prospectively collected data was conducted. During an eight-year period, 1095 ligations of all saphenofemoral junction inferior tributaries and great saphenous vein stripping were performed in 814 Clinical, Etiology, Anatomy, Pathophysiology C2–C6 patients. Duplex ultrasound follow-up examinations were performed after 30 days, 6 months, and 2 years, and saphenofemoral junction hemodynamic patterns and varicose veins recurrence rates were evaluated. Results Two hundred and twenty patients completed the two-year follow-up period. At the 30-day Duplex ultrasound evaluations, two different hemodynamic patterns were described. Type 1, with physiological drainage of saphenofemoral junction superior tributaries, was observed in 214 patients. Type 2, without flow in saphenofemoral junction superior tributaries, was observed in six patients. Overall varicose vein recurrence rates were 0, 2.3, and 2.7% at the 30-day, 6-month, and 2-year follow-up examinations, respectively. At the two-year follow-up, Type 1 patients showed 0% varicose vein recurrence, while Type 2 patients showed 100%. Conclusionsː Inferior selective crossectomy seems to be a valid and safe option in case of both suprasaphenic valve and great saphenous vein incompetence. Duplex ultrasound evaluation, according to our protocol, allows us to identify two different saphenofemoral junction hemodynamic patterns that could predict varicose vein recurrence at mid-term. An optimal stump washing after inferior selective crossectomy, warranted by patency and large caliber saphenofemoral junction superior tributaries, seems to be the key point in preventing varicose vein recurrence in this context. However, large prospective studies regarding saphenofemoral junction modifications and varicose vein recurrence are needed to confirm these preliminary observations.


2016 ◽  
Vol 32 (1) ◽  
pp. 6-12 ◽  
Author(s):  
TY Tang ◽  
JW Kam ◽  
ME Gaunt

Objectives This study assessed the effectiveness and patient experience of the ClariVein® endovenous occlusion catheter for varicose veins from a large single-centre series in the UK. Methods A total of 300 patients (371 legs) underwent ClariVein® treatment for their varicose veins; 184 for great saphenous vein (GSV) incompetence, 62 bilateral GSV, 23 short saphenous vein (SSV), 6 bilateral SSV and 25 combined unilateral great saphenous vein and SSV. Patients were reviewed at an interval of two months post procedure and underwent Duplex ultrasound assessment. Postoperative complications were recorded along with patient satisfaction. Results All 393 procedures were completed successfully under local anaesthetic. Complete occlusion of the treated vein was initially achieved in all the patients, but at eight weeks’ follow-up, there was only partial obliteration in 13/393 (3.3%) veins. These were all successfully treated with ultrasound-guided foam sclerotherapy. Procedures were well tolerated with a mean pain score of 0.8 (0–10). No significant complications were reported. Conclusions ClariVein® can be used to ablate long and short saphenous varicose veins on a walk-in–walk-out basis. Bilateral procedures can be successfully performed, and these are well tolerated as can multiple veins in the same leg. Early results are promising but further evaluation and longer term follow-up are required.


2017 ◽  
Vol 33 (8) ◽  
pp. 534-539 ◽  
Author(s):  
Emma B Dabbs ◽  
Laurensius E Mainsiouw ◽  
Judith M Holdstock ◽  
Barrie A Price ◽  
Mark S Whiteley

Aims To report on great saphenous vein diameter distribution of patients undergoing endovenous laser ablation for lower limb varicose veins and the ablation technique for large diameter veins. Methods We collected retrospective data of 1929 (943 left leg and 986 right leg) clinically incompetent great saphenous vein diameters treated with endovenous laser ablation over five years and six months. The technical success of procedure, complications and occlusion rate at short-term follow-up are reported. Upon compression, larger diameter veins may constrict asymmetrically rather than concentrically around the laser fibre (the ‘smile sign’), requiring multiple passes of the laser into each dilated segment to achieve complete ablation. Results Of 1929 great saphenous veins, 334 (17.31%) had a diameter equal to or over 15 mm, which has been recommended as the upper limit for endovenous laser ablation by some clinicians. All were successfully treated and occluded upon short-term follow-up. Conclusion We suggest that incompetent great saphenous veins that need treatment can always be treated with endovenous laser ablation, and open surgery should never be recommended on vein diameter alone.


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.


2003 ◽  
Vol 10 (2) ◽  
pp. 350-355 ◽  
Author(s):  
Gudmundur Danielsson ◽  
Christel Jungbeck ◽  
Karin Peterson ◽  
Lars Norgren

Purpose: To measure changes in venous function after elimination of great saphenous vein reflux using endovenously-applied heat with a specially designed catheter. Methods: In a prospective clinical study, 13 patients (8 women; mean age 39 years, range 25–59) with symptomatic chronic venous insufficiency were treated for reflux at the saphenofemoral junction. A radiofrequency catheter (Restore) with expandable electrodes that shrinks the vein by controlled constriction of subendothelial collagen was used to restore valve competence. Extirpation of local varicosities was performed simultaneously. Main outcome was change in venous function as measured by plethysmography (foot volumetry) and change in diameter and reflux time at the saphenofemoral junction after 6 and 12 months. Results: Reflux in the greater saphenous vein was eliminated or reduced to below 0.5 seconds in all patients. The venous function was significantly improved after 6 months' follow-up, with decreased refilling rate/expelled volume related to foot volume (p=0.019). The patients were clinically improved, although only 7 (54%) were entirely free from reflux. Three (21%) patients had thrombus in the vein the day after the treatment, 2 at the treatment site and 1 at the entry site of the introducer. After 1 year, the patients are still satisfied with the results, although venous function is no longer significantly improved compared to baseline. Conclusions: It is possible to safely restore valvular competence by means of internally shrinking the vein diameter. The venous function is improved, although the vein has a tendency to increase in width with time; limited reflux reappears, with deterioration of venous function.


2017 ◽  
Vol 13 (3) ◽  
pp. 234-237
Author(s):  
R.M. Karmacharya ◽  
M Devbhandari ◽  
Y.R. Shakya

Background Radiofrequency ablation of varicose vein have gained popularity compared to conventional surgery due to comparable long term results in addition to definite immediate superiorities. This modality has been started in Nepal since August 2003 and the study on short term fate of ablated vein segment confirms the anatomical benefit in addition to the clinical benefit.Objective To analyze short term fate of segment of great saphenous vein that has been treated by Radiofrequency ablation in terms of occlusion of saphenofemoral junction and absence of recanalisation on Doppler ultrasonography finding done at 3-6 months postoperative period.Method Total 81 cases subjected for radiofrequency ablation of great saphenous vein in thigh segment during August 2013 – September 2014 were followed up in between 3 to 6 months by Doppler ultrasonography. The findings were classified into type 1 to 4 results based on the anatomic closure of saphenofemoral junction and absence of recanalisation on treated segments.Result There were total 81 cases with 54.3% female and 45.7% male patients. Mean short term follow up duration was 4.9 months (S.D. 1.1 months). Great Saphenous Vein was cannulated most frequently in between 5 cm above knee to 5 cm below knee. Mean number of Radio Frequency Ablation (RFA) segments were 6.6 (SD=3.1). There was complete occlusion (Type 1 results) in 51 cases (63.0%). In 24 cases (29.6%) there was competent saphenofemoral junction with partial recanalisation in distal part of Great Saphenous Vein (GSV) (Type 2 results). In six cases (7.4%) there was incompetent saphenofemoral junction with partial recanalisation in distal part of Great Saphenous Vein (Type 3 results). There were no cases with incompetent saphenofemoral junction with complete recanalisation in distal part of Great Saphenous Vein (Type 4 results).Conclusion Radio Frequency Ablation for varicose vein, besides making clinical improvements, is also associated with good anatomical results.


2011 ◽  
Vol 27 (2) ◽  
pp. 67-72 ◽  
Author(s):  
S Elias ◽  
J K Raines

Objective The purpose of this study was to assess the safety and efficacy of the ClariVein® system that employs mechanochemical ablation of the great saphenous vein (GSV). Method Patients eligible for ablation of the GSV underwent micropuncture access with only local anaesthesia to insert a 4 or 5 Fr sheath. The ClariVein® catheter was placed through the sheath, the wire was extruded, and the distal tip of the wire positioned 2 cm from the saphenofemoral junction under ultrasound guidance. Catheter wire rotation was then activated for 2–3 seconds at approximately 3500 rpm. With the wire rotating, infusion of the sclerosant was started simultaneously with catheter pullback. The sclerosant used was 1.5% liquid sodium tetradecyl sulphate (Sotradecol©, Bioniche Pharma Group, Geneva, Switzerland). Results Thirty GSVs in 29 patients were treated. All patients have reached six-month follow-up; the average number of postoperative days is 260. No adverse events have been reported. The Primary Closure Rate is 96.7%. Conclusion Mechanochemical ablation appears to be safe and efficacious. The ClariVein® technique eliminates the need for tumescent anaesthesia. The great majority of incompetent GSVs can be treated with this technique.


2014 ◽  
Vol 31 (1) ◽  
pp. 23-33 ◽  
Author(s):  
I Flessenkämper ◽  
M Hartmann ◽  
K Hartmann ◽  
D Stenger ◽  
S Roll

Objectives High ligation and stripping was compared to endovenous laser ablation for the therapy of great saphenous vein varicosity. Long-term efficacy was assessed in terms of avoidance of inguinal reflux and mechanisms of recurrence were investigated. Design Multicentre, randomised, three-arm, parallel trial. Materials and methods A total of 449 patients were randomised into three different treatment groups: high ligation and stripping group ( n = 159), endovenous laser ablation group ( n = 142; 980 nm, 30 W continuous mode, bare fibre) or a combination of laser ablation with high ligation (endovenous laser ablation group/ high ligation group, n = 148). Patients were examined clinically and by duplex ultrasound once a year. The primary end point of this study is inguinal reflux at the saphenofemoral junction after 2 years. This paper presents secondary data on sonographically determined inguinal reflux and clinical recurrences in the treated area after up to 6 years of follow-up. Results Median time to follow-up was 4.0 years; the mean time follow-up 3.6 years. Follow-up rates were: 2 years 74%, 3 years 47%, 4 years 39%, 5 years 36% and 6 years 31%. Most reflux into the great saphenous vein appeared in the endovenous laser ablation group (after 6 years: high ligation/stripping versus endovenous laser ablation p = 0.0102; high ligation/endovenous laser ablation vs. endovenous laser ablation p < 0.0002). Furthermore, more refluxive side branches were also observed in the endovenous laser ablation group (after 6 years high ligation/stripping vs. endovenous laser ablation p = 0.0569; high ligation/endovenous laser ablation vs. endovenous laser ablation p = 0.0111). In terms of clinical recurrence during the 6 years post therapy, no significant differences between the three treatment groups were observed ( p values from log-rank test: high ligation/stripping vs. endovenous laser ablation p = 0.5479; high ligation/stripping vs. high ligation/endovenous laser ablation p = 0.2324; high ligation/endovenous laser ablation vs. endovenous laser ablation p = 0.0848). The postoperative decline and later development in Class C (clinical etiological anatomical pathological) went parallel in all groups. Conclusions Clinical recurrence appears with the same frequency in all three treatment groups, but the responsible pathological mechanisms seem to differ. Most reflux into the great saphenous vein and side branches appears after endovenous laser ablation, whereas more saphenofemoral junction-independent recurrences are seen after high ligation/stripping.


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