Treating great and small saphenous vein insufficiency with histoacryl in patients with symptomatic varicose veins and increased risk of surgery

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 (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.


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.


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.


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 />


VASA ◽  
2019 ◽  
Vol 48 (5) ◽  
pp. 405-412
Author(s):  
Eyüp Serhat Çalık ◽  
Ümit Arslan ◽  
Bilgehan Erkut

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.


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 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 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.


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.


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.


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