The evaluation of a novel technique to treat saphenous vein incompetence: preclinical animal study to examine safety and efficacy of a new vein occlusion device

2012 ◽  
Vol 29 (1) ◽  
pp. 16-24 ◽  
Author(s):  
A Farber ◽  
A Belenky ◽  
M Malikova ◽  
O Brenner ◽  
Z Brandeis ◽  
...  
Keyword(s):  
Animal Study ◽  
Saphenous Vein ◽  
Fibrous Tissue ◽  
Duplex Ultrasound ◽  
Histopathological Analysis ◽  
Novel Technique ◽  
Vein Occlusion ◽  
Occlusion Device ◽  
Preclinical Animal Study

Objectives We tested a novel technique to treat great saphenous vein (GSV) incompetence in an animal model. Methods V-block (VVT Medical Ltd, Kfar Saba, Israel), an occlusion device composed of a nitinol frame and anchoring hooks, was percutaneously deployed at the saphenofemoral junction in 12 sheep. Four of the 12 sheep were treated with adjunctive liquid sclerotherapy. Animals underwent duplex ultrasound, venography and histopathological evaluation immediately postimplantation at 30, 60 and 90 days. Results V-block was successfully deployed in all animals without adverse events. There was no device migration at follow-up. Histopathological analysis demonstrated V-block to be lodged within the GSV and surrounded by fibrous tissue in all samples. Obliteration of the GSV lumen, widespread intimal loss and multifocal medial smooth muscle loss was noted. Conclusions In this animal study V-block was deployed without complications, remained in stable position and led to GSV occlusion. This device has promise for future use in humans.

Endovenous laser ablation of the great saphenous vein – Varying energy may not affect outcome

2016 ◽  
Vol 32 (1) ◽  
pp. 13-18 ◽  
Author(s):  
Carlos S Nejm ◽  
Jorge RR Timi ◽  
Walter Boim de Araújo ◽  
Filipe C Caron
Keyword(s):  
Laser Ablation ◽  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Varicose Veins ◽  
Duplex Ultrasound ◽  
Endovenous Laser Ablation ◽  
Vein Occlusion ◽  
Saphenous Veins ◽  
Occlusion Rate

Objectives To determine great saphenous vein occlusion rate after endovenous laser ablation using the 1470-nm bare-fiber diode laser to supply either 7 W or 15 W and evaluate procedure-related complications. Method Patients with varicose veins of the lower extremities (CEAP class C2–C6) were randomly assigned to undergo either 7-W (18 patients, 30 limbs) or 15-W (18 patients, 30 limbs) endovenous laser ablation. Duplex ultrasound follow-up was at 3–5 days, 1, 6, and 12 months postoperatively. Results Occlusion rate was 100% in both groups at 3–5 days and 1 month and 86.7% in 7-W and 100% in 15-W patients at both 6 and 12 months, with no difference between groups ( p > 0.05). Four (13.3%) 15-W and 3 (10%) 7-W patients had paresthesia at 3–5 days, with no difference between groups ( p > 0.05). Conclusions These preliminary data suggest that both techniques are similarly effective in the treatment of varicose great saphenous veins.

Inferior selective crossectomy for great saphenous vein incompetence: Our experience

Vascular ◽  
2020 ◽  
pp. 170853812094725
Author(s):  
Maurizio Pagano ◽  
Giovanna Passaro ◽  
Roberto Flore ◽  
Paolo Tondi
Keyword(s):  
Saphenous Vein ◽  
Varicose Vein ◽  
Great Saphenous Vein ◽  
Duplex Ultrasound ◽  
Venous Disease ◽  
Recurrence Rates ◽  
Saphenofemoral Junction

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.

scholarly journals Endovenous Ablation of Varicose Veins Experience at Tertiary Neurological Center

2018 ◽  
Vol 1 (2) ◽  
pp. 94-96
Author(s):  
Sandeep Raj Pandey ◽  
George Bush Jung Katwal ◽  
Sharad Hari Gajuryal
Keyword(s):  
Saphenous Vein ◽  
Thermal Ablation ◽  
Great Saphenous Vein ◽  
Varicose Veins ◽  
Duplex Ultrasound ◽  
Normal Activity ◽  
Vein Thrombosis ◽  
Long Term Follow Up ◽  
Endovenous Thermal Ablation

Introduction: Endovascular ablation of varicose vein either by radiofrequency ablationor laser delivers sufficient thermal energy to incompetent vein segments to produce irreversible occlusion, fibrosis and ultimately disappearance of the vein.Materials and Methods: Three hundred patients with varicosities due to primary or recurrent sapheno-femoral or sapheno-popliteal junction and great or small saphenous veinreflux underwent out-patient and in-patient endovenous thermal ablation between January 2015 to December 2017.The great saphenous vein was ablated from 2-2.5 cm below sapheno-femoral junction to knee and the small saphenous vein was ablated from mid-calf to the sapheno-popliteal junction.Results: Patient returning time to normal activity was 0–1 days returning to normal daily activity were immediately after 4 hours. Duplex ultrasound follow-up (median 3-months) confirmed abolition of sapheno-femoral junction/great saphenous vein and sapheno-popliteal junction/small saphenous vein reflux in all limbs. There were no instances of skin burns or deep vein thrombosis, but, 7 patients developed transient cutaneous numbness involving sural nerve and 1 developed endovenous heat induced thrombosis 3.Conclusions: This is likely to be more effective than conventional surgery, although long-term follow up is required.  Despite being expensive in comparison to open surgery, endovenous thermal ablation is superior in terms of: minimizing pain, avoiding incision, early mobilisation and discharge. Changing the treatment distance from 2 cm to 2.5 cm peripheral to the Deep veins junction may result in a diminished incidence of endovenous heat induced thrombosis 3.

scholarly journals ClariVein® – Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins

2016 ◽  
Vol 32 (1) ◽  
pp. 6-12 ◽  
Author(s):  
TY Tang ◽  
JW Kam ◽  
ME Gaunt
Keyword(s):  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Varicose Veins ◽  
Duplex Ultrasound ◽  
Single Centre ◽  
Foam Sclerotherapy ◽  
Early Results ◽  
Endovenous Ablation ◽  
The Uk

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.

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.

ClariVein™ – One year results of mechano-chemical ablation for varicose veins in a multi-ethnic Asian population from Singapore

2018 ◽  
Vol 33 (10) ◽  
pp. 687-694 ◽  
Author(s):  
Shao N Khor ◽  
Jiang Lei ◽  
Jia W Kam ◽  
Steven Kum ◽  
Yih K Tan ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Great Saphenous Vein ◽  
Varicose Veins ◽  
Asian Population ◽  
Vein Occlusion ◽  
Early Results ◽  
Short Saphenous Vein ◽  
Chemical Ablation ◽  
One Year

Objectives This study assessed the effectiveness and patient experience of ClariVein for varicose veins and chronic venous insufficiency (CVI) in a multi-ethnic Asian population from Singapore. Methods A total of 121 patients underwent mechano-chemical ablation. Patients were reviewed at an interval of one week, and at 3, 6 and 12 months post procedure and underwent Duplex ultrasound with patient satisfaction assessment. Results At three months of follow-up, the great saphenous vein and short saphenous vein occlusion rates were 90.8% and 96.0%, respectively. At six months of follow–up, the GSV and short saphenous vein occlusion rates were 86.9% and 90.9%, respectively. At one year, great saphenous vein and short saphenous vein occlusion rates were 84.8% and 94.3%, respectively. Conclusions Early results are similar to what is described so far in the mechano-chemical ablation literature but recurrences are more than expected at one year. This is disappointing but is tempered by the fact that the majority of patients were asymptomatic and required no reintervention.

Endovenous Laser Ablation for Incompetent Saphenous Vein Combined With Fluoroscopy-Guided Endovenous Foam Sclerotherapy in Varicose Tributaries: Long-Term Follow-up Results

2016 ◽  
Vol 101 (11-12) ◽  
pp. 590-597
Author(s):  
Song Am Lee ◽  
Sang Woo Park ◽  
Ik Jin Yun ◽  
Jae Joon Hwang ◽  
Jun Seok Kim ◽  
...  
Keyword(s):  
Laser Ablation ◽  
Saphenous Vein ◽  
Duplex Ultrasound ◽  
Long Term Results ◽  
Foam Sclerotherapy ◽  
Endovenous Laser Ablation ◽  
Percutaneous Sclerotherapy ◽  
Long Term Follow Up

The aim of this study is to describe the long-term results of 980-nm endovenous laser ablation (EVLA) combined with fluoroscopy-guided endovenous foam sclerotherapy using a microcatheter into varicose tributaries. This report reviewed experiences with fluoroscopy-guided endovenous foam sclerotherapy using a microcatheter followed by EVLA, from July 2005 to November 2007. The sclerosing foam was injected through the microcatheter using 1% polidocanol or sodium tetradecyl sulfate. Patients were evaluated clinically and with duplex ultrasound from 1 week to 3 years to assess treatment efficacy and adverse reactions. Technical success was seen in 460 of 461 limbs (99.8%). Continued closure of the saphenous veins and complete sclerosis of varicose tributaries were noted in 351 of 408 limbs (86%) at 1-month follow-up, all 328 limbs at 3-month follow-up, all 299 limbs at 6-month follow-up, all 146 limbs at 1-year follow-up, all 94 limbs at 2-year follow-up, and all 32 limbs at 3-year follow-up. No serious complications were noted. Bruising was noted in 79.0%, and pain or tightness was noted in 68.4%. Hyperpigmentation was noted in 54.2%. EVLA for incompetent saphenous vein combined with endovenous foam sclerotherapy appears to offer the obvious benefits of less additional percutaneous sclerotherapy. However, many problems, like long-lasting pain and hyperpigmentation, can lessen the value of this procedure.

Mechanochemical ablation for great and small saphenous veins insufficiency in patients with type III shunt

2020 ◽  
pp. 026835552095169
Author(s):  
Vicente Mosquera-Rey ◽  
José A Del Castro Madrazo ◽  
María Ángeles M Herrero ◽  
Rubén A Cordeu ◽  
Ernesto A Azofra ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Clinical Success ◽  
Duplex Ultrasound ◽  
Additional Treatment ◽  
Success Rates ◽  
Type Iii ◽  
Saphenous Veins ◽  
Venous Shunt ◽  
Anatomical Success

Objective the aim of this study was to assess the results of mechanochemical endovenous ablation either in the primary or recurrent saphenous vein insufficiency, including only patients with veno-venous shunt type III. Methods retrospective analysis of a prospective study of patients with symptomatic chronic venous insufficiency who underwent ClariVein® technique. A total of 134 saphenous veins were included between August 2017 and August 2018. Follow-up was performed by Duplex ultrasound at 1, 6 and 12 months. Primary endpoints were technical and anatomical success. Secondary endpoints were the need for further treatment of varicose collateral veins by sclerotherapy, outcomes regarding recurrent insufficiency and clinical success. Results A total of 111 great saphenous veins and 23 small saphenous veins were treated with a technical success of 95.6%. The overall anatomical success rates at 1, 6 and 12 month were 96.2%, 88.8% and 84.4%, respectively, without differences between primary and recurrent insufficiency. Deferred sclerotherapy over varicose collaterals was carried out in 28% of the patients with anatomical success. Clinical improvement was achieved in 87.3%. Conclusions MOCA technique has proven to be an effective technique, although additional treatment over varicose collaterals could be necessary in up to one-third. Atrophy of the saphenous vein and the lack of persistent varicose collateral veins during follow-up seem to be indicators of successful therapy.

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.

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