A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results

Objective This study aims to present the early results of a retrospective 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 Patients with lower limb venous insufficiency were treated with n-butyl-2-cyanoacrylate (VenaBlock Venous Closure System) between April 2016 and July 2016. The study enrolled adults aged 21–70 years with symptomatic moderate to severe varicosities (C2–C4b) and great saphenous vein reflux lasting longer than 0.5 s with great saphenous vein diameter between 5.5 and 15 mm assessed in the standing position. No compression stockings were used after the procedure. Duplex ultrasound imaging and clinical follow-up were performed on the third day, first month, sixth month, and 12th month. Clinical, etiological, anatomical, pathophysiological classification; venous clinical severity score; and completed Aberdeen varicose vein questionnaire were recorded. Results Five hundred thirty-eight patients with great saphenous vein incompetency underwent n-butyl-2-cyanoacrylate ablation. The mean ablation length was 25.69 ± 4.8 cm, and the average amount of n-butyl-2-cyanoacrylate delivered was 0.87 ± 0.15 ml. The mean procedure time was 11.7 ± 4.9 min. Procedural success was 100%, and complete occlusion was observed after treatment and at the third-day follow-up. We observed ecchymosis in five patients (1.00%) at the entry site at the third-day follow-up. Phlebitis was encountered with six (1.20%) patients. No skin pigmentation, hematoma, paresthesia, deep vein thrombosis, or pulmonary embolism was observed. Kaplan–Meier analysis yielded an occlusion rate of 99.4% at the 12-month follow-up. All patients had significant improvement in venous clinical severity score and Aberdeen varicose vein questionnaire scores postoperatively ( p <0.0001). Venous clinical severity score scores decreased from 5.43 ± 0.87 to 0.6 ± 0.75. Aberdeen varicose vein questionnaire scores decreased from 18.32 ± 5.24 to 4.61 ± 1.42. Conclusions The procedure appears to be feasible, safe, and efficient in treating the great majority of incompetent great saphenous veins with this technique.

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Two-year follow-up of a n-butyl-2-cyanoacrylate glue ablation for the treatment of saphenous vein insufficiency with a novel application catheter with guiding light

Vascular ◽

10.1177/1708538118823838 ◽

2019 ◽

Vol 27 (4) ◽

pp. 352-358

Author(s):

Atilla Sarac

Keyword(s):

Saphenous Vein ◽

Severity Score ◽

Venous Insufficiency ◽

Great Saphenous Vein ◽

Clinical Severity ◽

The Third ◽

Clinical Severity Score ◽

Venous Clinical Severity Score ◽

The Mean

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.

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Mechanochemical ablation for symptomatic great saphenous vein reflux: A two-year follow-up

Phlebology The Journal of Venous Disease ◽

10.1177/0268355515627260 ◽

2016 ◽

Vol 32 (1) ◽

pp. 43-48 ◽

Cited By ~ 17

Author(s):

Pamela S Kim ◽

Muath Bishawi ◽

David Draughn ◽

Marab Boter ◽

Charles Gould ◽

...

Keyword(s):

Clinical Improvement ◽

Saphenous Vein ◽

Severity Score ◽

Great Saphenous Vein ◽

Clinical Severity ◽

Mechanochemical Ablation ◽

Venous Clinical Severity Score ◽

Occlusion Rate ◽

The Mean

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.

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Need for adjunctive procedures following cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of postprocedure compression: Three-month data from a postmarket evaluation of the VenaSeal System (the WAVES Study)

Phlebology The Journal of Venous Disease ◽

10.1177/0268355518801641 ◽

2018 ◽

Vol 34 (4) ◽

pp. 231-237 ◽

Cited By ~ 8

Author(s):

Kathleen Gibson ◽

Renee Minjarez ◽

Krissa Gunderson ◽

Brian Ferris

Keyword(s):

Saphenous Vein ◽

Varicose Vein ◽

Severity Score ◽

Rating Scale ◽

Great Saphenous Vein ◽

Clinical Severity ◽

Compression Stockings ◽

Saphenous Veins ◽

Clinical Severity Score ◽

Venous Clinical Severity Score

Purpose Studies examining cyanoacrylate closure of saphenous veins with the VenaSeal™ System have not allowed concomitant procedures for tributaries at the time of the index procedure. Outside of clinical trials, however, concomitant procedures are frequently performed in conjunction with endovenous ablation. We report on the frequency of need for saphenous tributary treatment three months after cyanoacrylate closure of the treatment of great saphenous vein, small saphenous vein, and/or accessory saphenous vein. Methods Fifty subjects with symptomatic great saphenous vein, small saphenous vein, and/or accessory saphenous vein incompetence were treated with no postprocedure compression stockings. Concomitant procedures were not allowed. Treating physicians predicted the type and nature of any concomitant procedures that they would usually perform at the time of ablation, if not limited by the constraints of the study. Evaluations were performed at one week, one and three months and included duplex ultrasound, numeric pain rating scale, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire, and time to return to work and normal activities. At the three-month visit, the need for and type of adjunctive procedures were recorded. Results Complete closure at three months was achieved in 70 (99%) of the treated veins (48 great saphenous veins, 14 accessory saphenous veins, eight small saphenous veins). Revised venous clinical severity score improved from 6.4 ± 2.2 to 1.8 ± 1.5 (P < .001) and Aberdeen Varicose Vein Questionnaire from 17.3 ± 7.9 to 6.5 ± 7.2 (P < .0001). Sixty-six percent of patients underwent tributary treatment at three months. The percentage of patients who required adjunctive treatments at three months was lower than had been predicted by the treating physicians (65% versus 96%, p=.0002). Conclusions Closure rates were high in the absence of the use of compression stockings or side branch treatment. Improvement in quality of life was significant, and the need for and extent of concomitant procedures was significantly less than had been predicted by the treating physicians.

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A new percutaneous technique: N-butyl cyanoacrylate adhesive for the treatment of giant saphenous vein insufficiency

Vascular ◽

10.1177/1708538117724647 ◽

2017 ◽

Vol 26 (2) ◽

pp. 194-197 ◽

Cited By ~ 4

Author(s):

Mehmet Senel Bademci ◽

Kaptanıderya Tayfur ◽

Gökhan Ocakoglu ◽

Serkan Yazman ◽

Muhammet Akyüz ◽

...

Keyword(s):

Saphenous Vein ◽

Varicose Vein ◽

Severity Score ◽

Early Period ◽

Duplex Ultrasound ◽

Clinical Severity ◽

Tumescent Anesthesia ◽

Clinical Severity Score ◽

Venous Clinical Severity Score ◽

Vein Insufficiency

Background We have made a retrospective evaluation of the results of the cyanoacrylate ablation technique which has recently started to be used in the treatment of giant saphenous vein insufficiency today and in which tumescent anesthesia is not required. Methods Giant saphenous vein was treated in 50 patients between September 2015 and September 2016 by using endovenous cyanoacrylate ablation. In the procedure, tumescent anesthesia and varsity socks were not used. Control duplex ultrasound evaluation was performed in the post-procedural 1st, 6th and 12th months. Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire scores were evaluated. Results In the 50 patients who were treated, full closure was observed in giant saphenous vein in 47 (94%) patients in the 12th month control duplex ultrasound. The mean age of the patients was 46.4 (20–70) and 30 (60%) of them were female. The median Venous Clinical Severity Score scores in the 1st, 6th and 12th months were 3, 2 and 1, respectively ( p < 0.001); the median Aberdeen Varicose Vein Questionnaire scores in the 1st, 6th and 12th months were 7, 5 and 4, respectively ( p < 0.001). In the access site, two (4%) patients developed phlebitis and one (2%) developed ecchymosis. However, deep venous thrombosis, pulmonary embolism and paresthesia were not observed. Conclusion Considering the early period results in the treatment of giant saphenous vein insufficiency, cyanoacrylate ablation makes a more reliable alternative than endovenous thermal ablation methods in that it does not require tumescent anesthesia and it has a low incidence of adverse effects.

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Comparison of high saphenous ligation and stripping, radiofrequency ablation, and subfascial endoscopic perforator surgery for the treatment of active venous ulcers: Retrospective cohort with five-year follow-up

Vascular ◽

10.1177/17085381211011356 ◽

2021 ◽

pp. 170853812110113

Author(s):

Yusuf Kuserli ◽

Ali Aycan Kavala ◽

Saygin Turkyilmaz

Keyword(s):

Radiofrequency Ablation ◽

Saphenous Vein ◽

Severity Score ◽

Great Saphenous Vein ◽

Clinical Severity ◽

Venous Ulcers ◽

Vein Occlusion ◽

Clinical Severity Score ◽

Venous Clinical Severity Score ◽

Subfascial Endoscopic Perforator Surgery

Objective To compare the use of high saphenous ligation and stripping, radiofrequency ablation, and subfascial endoscopic perforator surgery for the treatment of active venous ulcers. Methods One hundred ninety-five ( n = 195) subjects who were treated for venous leg ulcers were enrolled between 2009 and 2014. Three groups were formed (Group A: high saphenous ligation and total stripping, Group B: radiofrequency ablation of the great saphenous vein + perforators, and Group C: radiofrequency ablation of the great saphenous vein + subfascial endoscopic perforator surgery) ( n = 65 for each group). The venous clinical severity score for baseline, 1st, 6th, and 12th months, great saphenous vein occlusion at the 1st, 6th, and 12th months, and ulcer rates for the 1st, 2nd, 3rd, 4th, and 5th years were recorded. Results For venous clinical severity score, only the first month decrease was significant for the subfascial endoscopic perforator surgery group ( p = 0.001). Great saphenous vein occlusion was higher at the 6th and 12th months for the high saphenous ligation and stripping and subfascial endoscopic perforator surgery groups than for the radiofrequency ablation group ( p = 0.036 and p = 0.037). The rate of ulcers for the subfascial endoscopic perforator surgery group was lower at the second, third, fourth, and fifth years ( p = 0.011). No significant difference was found between groups for the five-year recovery rates ( p > 0.05). Conclusion Subfascial endoscopic perforator surgery technique in conjunction with radiofrequency ablation of axial vein was superior to both high saphenous ligation and stripping and radiofrequency ablation of axial and perforators for ulcer healing.

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Evaluation of liquid or foam sclerotherapy in small varicose veins (ceap c1) with venous clinical severity score

Revista da Associação Médica Brasileira ◽

10.1590/1806-9282.64.12.1117 ◽

2018 ◽

Vol 64 (12) ◽

pp. 1117-1121 ◽

Cited By ~ 2

Author(s):

Mehmet Ali Kaygin ◽

Umit Halici

Keyword(s):

Severity Score ◽

Skin Necrosis ◽

Varicose Veins ◽

Clinical Severity ◽

Foam Sclerotherapy ◽

Clinical Severity Score ◽

Severity Scores ◽

Study Results ◽

Venous Clinical Severity Score ◽

The Mean

SUMMARY OBJECTIVE: We aimed to evaluate the efficacy of liquid or foam sclerotherapy of varicose veins using venous clinical severity scores and possible complications. METHODS: A total of 318 patients (268 females, 50 males) who were treated with liquid or foam sclerotherapy between January 2012 and December 2012 were included in this study. RESULTS: Skin necrosis was observed in only 6 patients (1. 8%), thrombophlebitis in 10 patients (3. 1%), and hyperpigmentation in 18 patients (5. 6%) in this study group. The mean venous clinical severity score was calculated as: pain score, 1. 23 ± 0.88; varicose vein score,1.85 ± 0. 8; edema score, 0.64 ± 0.77). Pain and edema decreased at the control examination, 1 month after completion of sclerotherapy sessions. Varicose veins completely disappeared after sclerotherapy. While the decrease in edema in the foam sclerotherapy group was significantly less (P<0.001), the decline in pain showed an increasing trend (P=0.069). While skin necrosis did not develop after foam sclerotherapy, rates of pigmentation and local thrombophlebitis were similar (P>0.05). CONCLUSION: In conclusion, we observed that both sclerotherapy methods are effective with a low rate of complications, alleviating the complaints of patients with small varicose veins, and providing considerable improvement in venous clinical severity scores.

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Five-year outcomes of mechano-chemical ablation of primary great saphenous vein incompetence

Phlebology The Journal of Venous Disease ◽

10.1177/0268355519861464 ◽

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 ◽

...

Keyword(s):

Saphenous Vein ◽

Great Saphenous Vein ◽

Clinical Severity ◽

Long Term Results ◽

Venous Clinical Severity Score ◽

Ceap Classification ◽

Chemical Ablation ◽

Anatomical Success

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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Cyanoacrylate adhesive embolization and sclerotherapy for primary varicose veins

Phlebology The Journal of Venous Disease ◽

10.1177/0268355517733339 ◽

2017 ◽

Vol 33 (8) ◽

pp. 547-557 ◽

Cited By ~ 2

Author(s):

Krishna Prasad Bellam Premnath ◽

Binu Joy ◽

Vijayakumar Akondi Raghavendra ◽

Ajith Toms ◽

Teena Sleeba

Keyword(s):

Saphenous Vein ◽

Great Saphenous Vein ◽

Varicose Veins ◽

Clinical Severity ◽

Cyanoacrylate Glue ◽

Cyanoacrylate Adhesive ◽

Venous Clinical Severity Score ◽

Primary Varicose Veins ◽

Vein Reflux

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.

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Endovenöse Laserablation bei Stammvarikosis der Vena saphena magna (VSM) und Vena saphena parva (VSP) sowie bei VSM-Krossenrezidiven (KR) mit neuer radiär abstrahlender Laserfaser – 3 Monatsergebnisse einer prospektiven single-centre-Studie

Phlebologie ◽

10.1055/a-0853-3256 ◽

2019 ◽

Vol 48 (03) ◽

pp. 177-181

Author(s):

Martin Kiderlen ◽

Nina Schäffer ◽

Lisa Schuler ◽

Athanasios Theodoridis ◽

Iris Weingard ◽

...

Keyword(s):

Severity Score ◽

Clinical Severity ◽

Beam Angle ◽

Single Centre ◽

Clinical Severity Score ◽

Venous Clinical Severity Score ◽

Vena Saphena Magna

Zusammenfassung Einleitung Die thermische Venenablation varikös veränderter Stammvenen der unteren Extremität ist in Deutschland aufgrund der guten Wirksamkeit, Anwendungssicherheit und hoher Patientenzufriedenheit eine anerkannte und häufig durchgeführte Behandlungsmöglichkeit. Zielsetzung der prospektiven Anwendungsbeobachtung (AWB) war die Untersuchung des Operationserfolges, der Patientenzufriedenheit und des Auftretens von Nebenwirkungen bei endovenöser Behandlung der varikös veränderten Vena saphena magna (VSM), Vena saphena parva (VSP) sowie bei Krossenrezidiven (KR) unter Verwendung der ETQ 360° FUSED Fiber™. Material und Methoden Insgesamt wurden 162 varikös veränderte Venen (VSM n = 76, VSP n = 65, KR n = 25) bei 144 Patienten behandelt und in die AWB eingeschlossen. Ein duplexsonographisches Follow-up erfolgte nach 10–14 Tagen sowie 3 Monaten. Die ETQ 360° FUSED Fiber™ hat eine Wellenlänge von 1470 nm bei einem beam angle von 60°. Für die endovenöse Therapie der VSM und von KR wurde eine Faser mit einem Faserkerndurchmesser von 600 µm bei einem Spitzendurchmesser von 1,8 mm und 8 Watt Behandlungsenergie eingesetzt. Zur Behandlung der VSP wurde ein Faserkerndurchmesser von 400 µm bei einem Spitzendurchmesser von 1,3 mm und 6 Watt Behandlungsenergie gewählt. Ergebnisse Alle thermisch behandelten VSM (n = 6) und VSP (n = 65) waren bei Visite 2 und Visite 3 vollständig verschlossen. In der KR Gruppe (n = 25) zeigten sich bei Visite 2 Verschlussraten von 96 % und Teilverschlussraten von 4 %. Bei Visite 3 konnten noch Verschlussraten von 80 % und Teilverschlussraten von 16 % nachgewiesen werden. In 4 % der Fälle kam es zu einer vollständigen Rekanalisierung. Tiefe Beinvenenthrombosen (TVT) oder Lungenembolien (LE) wurde in keiner der Kohorten diagnostiziert. 1,4 % der an der VSM behandelten Patienten gaben bei Visite 3 Sensibilitätsstörungen im Behandlungsareal an, in der VSP Gruppe waren es 6,15 %. Patienten der KR Kohorte gaben keinerlei Einschränkungen bezüglich der Sensibilität an. Die Patientenzufriedenheit war in allen Gruppen sehr hoch, in allen 3 Gruppen verbesserte sich der Venous Clinical Severity Score (VSCC) signifikant. Zusammenfassung Die Behandlung der VSM, VSP und von KR mit der ETQ 360° FUSED Fiber™ ist effizient, komplikationsarm und mit einer hohen Patientenzufriedenheit assoziiert.

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