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 ◽  
...  

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.

VASA ◽  
2018 ◽  
Vol 47 (5) ◽  
pp. 416-424 ◽  
Author(s):  
Karel Novotný ◽  
Míla Roček ◽  
Radek Pádr ◽  
Radim Pavlík ◽  
Michal Polovinčák ◽  
...  

Abstract. Background: Treating great and small saphenous vein trunk insufficiency with cyanoacrylate glue is the least taxing treatment method of all available techniques. Due to long-term unavailability of commercial kits with n-butyl-2-cyanoacrylate (histoacryl) in the Czech Republic, we used a modified technique. Patients and methods: Fifty-six limbs in 49 patients suffering from great saphenous vein or small saphenous vein insufficiency in combination with symptomatic chronic venous insufficiency and complicating comorbidities were treated with a modified endovascular cyanoacrylate glue application technique. Results: The immediate success rate of the treatment was 98 %. In follow-up intervals of six weeks, six months, one year, and two years, the anatomical success rates of embolization (recanalization of no more than 5 cm of the junction) were 98, 96, 94, and 94 %, respectively. At identical intervals the venous insufficiency was scored according to the Aberdeen Varicose Vein Questionnaire and the American Venous Clinical Severity Score. In both cases, improvement was demonstrated over the two-year follow-up, with a 0.5 % significance level. Specific clinical signs of venous insufficiency were also evaluated, such as pain, oedema, clearance of varicose veins, and healing of venous ulceration. One severe complication – a pulmonary embolism – was reported, without consequences. Conclusions: We demonstrated that treating insufficient saphenous veins with modified histoacryl application brought a relief from symptoms of venous insufficiency and that the efficiency of this technique is comparable to commonly used methods.


2017 ◽  
Vol 33 (4) ◽  
pp. 242-250 ◽  
Author(s):  
Krishna Prasad BP ◽  
Binu Joy ◽  
Ajith Toms ◽  
Teena Sleeba

Recurrent lower limb venous insufficiency is often a challenge in clinical practice and is most commonly due to incompetent perforators. Many of these patients do not have adequate symptom relief with compression and require some form of treatment for incompetent perforator interruption. Various treatment methods have been tried with different efficiencies. Objective To evaluate the feasibility, efficiency and safety of an outpatient combined cyanoacrylate adhesion–sodium tetradecyl sulphate sclerotherapy for treatment of patients with symptoms of persistent or recurrent lower limb venous insufficiency secondary to incompetent perforators. Methods Eighty-three limbs of 69 patients with symptoms of persistent or recurrent lower limb venous insufficiency secondary to incompetent perforators were treated with cyanoacrylate embolization of incompetent perforators and sclerotherapy of dilated collateral veins (surface branch varicose veins). Technical success, procedural pain, perforator occlusion, venous occlusion, clinical improvement and ulcer healing were assessed. Follow-up was done three- and six-month post-procedure. Results Procedure could be successfully performed in all patients. One hundred and ninety-one perforators were treated in total. Perforator and varicose veins occlusion rate was 100%. Deep venous extension of cyanoacrylate occurred in four (4.8%) patients, with no adverse clinical outcome. Venous clinical severity score improved from a baseline of 8.18 ± 3.60 to 4.30 ± 2.48 on three-month follow-up and 2.42 ± 1.52 on six-month follow-up (p < 0.0001). All ulcers showed complete healing within three months. Significant prolonged thrombophlebitis occurred in 38.5% of limbs. Conclusion Combined cyanoacrylate adhesion and setrol sclerotherapy is technically easy, has a lot of advantages including being an outpatient procedure and highly efficacious but with a guarded safety profile.


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.


2019 ◽  
Vol 34 (8) ◽  
pp. 543-551 ◽  
Author(s):  
Tjun Y Tang ◽  
Harsha P Rathnaweera ◽  
Jia W Kam ◽  
Tze T Chong ◽  
Edward C Choke ◽  
...  

Objectives The aim of this prospective single-centre study is to assess the effectiveness and patient experience of the VenaSeal™ Closure System, a novel non-thermal, non-tumescent catheter technique, which uses cyanoacrylate glue to occlude the refluxing truncal superficial veins to treat varicose veins and chronic venous insufficiency, in a multi-ethnic Asian population from Singapore. Methods Seventy-seven patients (93 legs; 103 procedures) underwent VenaSeal™ Closure System ablation. Forty-nine (63.6%) for great saphenous vein incompetence, 16 (20.8%) bilateral great saphenous vein, 2 (2.6%) small saphenous vein and 10 (13.0%) combined unilateral great saphenous vein and small saphenous vein/anterior thigh vein reflux. In addition, 65/93 legs (69.9%) had C4–C6 disease. Patients were reviewed at 2 weeks, 3, 6 and 12 months post-procedure. Results There was 100% technical success. 28/77 (36.4%) underwent concomitant phlebectomies. All procedures were well tolerated with a mean post-operative pain score of 3.0 (range: 0–5). After three months, median patient satisfaction was 9.0 (interquartile range: 7.0–10.0). At two-week follow-up, the great saphenous vein was completely occluded in 88/88 (100%) veins and small saphenous vein completely closed in 11/11 (100%) veins. At three-month follow-up, the great saphenous vein was occluded in 51/53 (96.2%) veins and small saphenous vein completely closed in 5/5 (100%) veins. At six-month follow-up, the great saphenous vein was completely occluded in 42/45 (93.3%) veins and small saphenous vein completely closed in 5/7 (71.4%) veins. At one year, great saphenous vein and small saphenous vein occlusion rates were 54/59 (91.5%) and 5/8 (62.5%), respectively. There was one deep vein thrombosis. Transient superficial phlebitis was reported in 10/93 (10.8%) legs, which were all self-limiting. There were 9/103 (8.7%) anatomical recurrences, but no patients required re-intervention as they were asymptomatic. Conclusions Cyanoacrylate glue is a safe and efficacious modality to ablate refluxing saphenous veins in Asian patients in the short term. There is a high satisfaction rate and peri-procedural pain is low. Early results are promising but further evaluation and longer term follow-up are required.


2018 ◽  
Vol 64 (8) ◽  
pp. 729-735
Author(s):  
Moacir de Mello Porciunculla ◽  
Dafne Braga Diamante Leiderman ◽  
Rodrigo Altenfeder ◽  
Celina Siqueira Barbosa Pereira ◽  
Alexandre Fioranelli ◽  
...  

SUMMARY OBJECTIVE This study aims to correlate the demographic data, different clinical degrees of chronic venous insufficiency (CEAP), ultrasound findings of saphenofemoral junction (SFJ) reflux, and anatomopathological findings of the proximal segment of the great saphenous vein (GSV) extracted from patients with primary chronic venous insufficiency (CVI) submitted to stripping of the great saphenous vein for the treatment of lower limb varicose. METHOD This is a prospective study of 84 patients (110 limbs) who were submitted to the stripping of the great saphenous vein for the treatment of varicose veins of the lower limbs, who were evaluated for CEAP clinical classification, the presence of reflux at the SFJ with Doppler ultrasonography, and histopathological changes. We study the relationship between the histopathological findings of the proximal GSV withdrawal of patients with CVI with a normal GSV control group from cadavers. RESULTS The mean age of the patients was higher in the advanced CEAPS categories when comparing C2 (46,1 years) with C4 (55,7 years) and C5-6(66 years), as well as C3 patients (50,6 years) with C5-6 patients. The normal GSV wall thickness (mean 839,7 micrometers) was significantly lower than in the saphenous varicose vein (mean 1609,7 micrometers). The correlational analysis of reflux in SFJ with clinical classification or histopathological finding did not show statistically significant findings. CONCLUSIONS The greater the age, the greater the clinical severity of the patients. The GSV wall is thicker in patients with lower limb varicose veins, but those histopathological changes are not correlated with the disease’s clinical severity or reflux in the SFJ on a Doppler ultrasound.


2014 ◽  
Vol 30 (6) ◽  
pp. 397-404 ◽  
Author(s):  
Jose I Almeida ◽  
Julian J Javier ◽  
Edward G Mackay ◽  
Claudia Bautista ◽  
Daniel J Cher ◽  
...  

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.


2020 ◽  
Vol 93 (1) ◽  
pp. 34-39
Author(s):  
Ashikesh Kundal ◽  
Navin Kumar ◽  
Deepak Rajput ◽  
Udit Chauhan

<b>Objective:</b> The purpose of this study was to compare the outcome of the great saphenous vein (GSV) sparing versus stripping during Trendelenburg operation for varicose veins. <br><b>Methods:</b> This was a prospective randomized study of primary varicose vein patients who underwent Trendelenburg operation. Data of patients operated on over a period of 16 months was collected, including: below knee GSV diameter by Duplex Ultrasound and revised venous clinical severity score (rVCSS), calculated preoperatively and postoperatively at 2<sup>nd</sup>, 4<sup>th</sup>, and 8<sup>th</sup> week. <br><b>Results:</b> A total of 36 patients undergoing Trendelenburg operation were included in the study. Nineteen patients underwent GSV sparing while 17 underwent stripping of GSV till just below the knee after juxtafemoral flush ligation of the great saphenous vein. There was a significant decrease in the below-knee GSV diameter (19% after 2 months) and rVCSS (60.8%) in the sparing group. The stripping group also showed an almost similar decrease in below-knee GSV diameter (19.6% after 2 months) and rVCSS (66.3%). However, no significant difference was found between the two groups in terms of change in GSV diameter (P = 0.467) and rVCSS (P = 0.781). <br><b>Conclusion:</b> Trendelenburg procedure with sparing of GSV can be done routinely for operative management of varicose veins, where surgery is needed.


2021 ◽  
Vol 11 (4) ◽  
pp. 102-107
Author(s):  
Melissa Andreia De Moraes Silva ◽  
Luiz Henrique Silva de Sordi ◽  
Lara Camargo Rezende Grillo ◽  
Elisa de Paula Garcia ◽  
Luisa Resende Silva ◽  
...  

Objectives: to evaluate the association of the greater saphenous vein (GSV) diameter in the treatment of patients with severe chronic venous insufficiency (C6 CEAP classification) with ultrasound-guided polidocanol foam sclerotherapy (UGFS).  Methods: A prospective, descriptive and analytical study of 28 patients (30 limbs) that underwent UGFS. Patients were divided into 2 subgroups by GSV diameter (< 8 mm and ≥ 8 mm). Variables analyzed were ulcer healing, clinical intercurrences, clinical CEAP classification, Venous Clinical Severity Score (VCSS), diameter of the treated vein and presence of occlusion or recanalization by Doppler ultrasound. Patients were analyzed at the 1st, 3rd, and 6th months post-treatment. Results: The average age was 68.7 ± 10.5 years, 23 (82,1%) were women, and the average body mass index was 29.2 kg/m2. Although an improvement in VCSS score was observed during follow-up, no significant intergroup difference was noted. Seventeen (56%) limbs presented occlusion of the treated vein at the 1st month, 11 (36%) at the 3rd month, and 9 (30%) at the 6th month of follow-up. The ulcer healing rate was 56,6%. The average ulcer healing time was 90 days. Three (10%) patients presented with ulcer recurrence at the 6th month.  Survival analysis showed no significant difference in ulcer healing rate between subgroups after one year of follow-up (log-rank, p = 0,178). Conclusion: There was no difference between the subgroups of large and small VSM diameter in terms of symptom severity. However, significant reduction of VCSS and pain relief was observed after foam sclerotherapy.


Vascular ◽  
2019 ◽  
Vol 27 (4) ◽  
pp. 352-358
Author(s):  
Atilla Sarac

Objectives This study aims to present the early results of a prospective study of the use of novel n-butyl-2 cyanoacrylate (VenaBlock)-based nontumescent endovenous ablation with a guiding light for the treatment of patients with varicose veins. Methods Five hundred and seventy-three patients with lower-limb venous insufficiency were treated within in the previous four years. The study enrolled adults aged 21–70 years with symptomatic moderate to severe varicosities (C2–C6 patients clinical, etiological, anatomical, and pathophysiological classification) and great saphenous vein reflux lasting longer than 0.5 s with great saphenous vein diameter ≥ 5.5 mm assessed in the standing position. Duplex ultrasound imaging and clinical follow-up were performed on the third day, first month, and sixth month. Clinical, etiological, anatomical, pathophysiological classification; venous clinical severity score; and completed Aberdeen varicose vein questionnaire were recorded. Results Five hundred and seventy-three patients aged 21–70 years with lower-extremity venous insufficiency treated with n-butyl-2. The mean treatment length was 30.6 ± 5.3 cm and the average n-butyl-2 delivered was 1.2 ± 0.3 ml. The mean procedure time was 10.8 ± 4.7 min. There was no deep venous thrombosis, pulmonary embolism, or paresthesia. We observed ecchymosis in eight patients (1.4%) at the entry site at the third day follow-up. Phlebitis was encountered with 10 (1.8%) patients. No skin pigmentation, hematoma, paresthesia, deep-vein thrombosis, or pulmonary embolism was observed. Procedural success was 100%, and complete occlusion was observed after treatment, at the third day follow-up and at first month. Kaplan–Meier analysis yielded with overall clinical recurrence-free rate after a mean follow-up of 23.96 months was 99.38%. All patients had significant improvement in venous clinical severity score and quality-of-life scores postoperatively ( p < 0.0001). Venous clinical severity score scores at preintervention and 24th month were 5.8 ± 1.0 (range 4–8) and 0.6 ± 0.6 (range 0–4), respectively ( p < 0.0001). Aberdeen varicose vein questionnaire scores at preintervention and 24th month were 19.7 ± 6.4 (range 9–30) and 4.4 ± 1.1 (range 1–9), respectively ( p < 0.0001). Conclusions The procedure appears to be feasible, safe, and efficient in treating the great majority of incompetent great saphenous veins with this technique.


2017 ◽  
Vol 32 (10) ◽  
pp. 665-669 ◽  
Author(s):  
Erdinc Eroglu ◽  
Alptekin Yasim ◽  
Murat Ari ◽  
Hasan Ekerbicer ◽  
Aydemir Kocarslan ◽  
...  

Aim To present mid-term results of patients with varicose veins treated with N-butyl cyanoacrylate (VariClose®), a nontumescent endovenous ablation technique. Patients and method Endovenous ablation was performed on 180 patients with saphenous vein incompetence between May and October 2014. One hundred sixty-eight subjects capable of being followed-up for 30 months were included. Patients’ pre- and postoperative data were recorded. Results Procedures were performed on the great saphenous vein in 159 patients and on the small saphenous vein in nine patients. Saphenous vein diameters ranged between 5.5 mm and 14 mm. Full ablation was achieved in all patients following the procedure. No complications were encountered. Patients were monitored for 30 months. Ablation rates were 100% at the 3rd month, 98.3% at the 6th month, 96.6% at 1 year, and 94.1% at 30 months. Mean venous clinical severity score was 10.2 before procedures, decreasing to 3.9 at 3 months, 4.2 at 6 months, 2.9 at 12 months, and 2.7 at 30 months ( p = 0.000). Conclusion Due to its high success rate, absence of complications, no tumescent anesthesia requirement and high patient satisfaction, endovenous ablation with N-butyl cyanoacrylate is a good method. However, long-term follow-up results are now needed.


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