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)

2018 ◽  
Vol 34 (4) ◽  
pp. 231-237 ◽  
Author(s):  
Kathleen Gibson ◽  
Renee Minjarez ◽  
Krissa Gunderson ◽  
Brian Ferris

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.

Vascular ◽  
2018 ◽  
Vol 26 (5) ◽  
pp. 547-555 ◽  
Author(s):  
Turhan Yavuz ◽  
Altay Nihat Acar ◽  
Huseyin Aydın ◽  
Evren Ekingen

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.


Vascular ◽  
2017 ◽  
Vol 26 (2) ◽  
pp. 194-197 ◽  
Author(s):  
Mehmet Senel Bademci ◽  
Kaptanıderya Tayfur ◽  
Gökhan Ocakoglu ◽  
Serkan Yazman ◽  
Muhammet Akyüz ◽  
...  

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.


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.


Vascular ◽  
2021 ◽  
pp. 170853812110113
Author(s):  
Yusuf Kuserli ◽  
Ali Aycan Kavala ◽  
Saygin Turkyilmaz

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.


Vascular ◽  
2016 ◽  
Vol 25 (2) ◽  
pp. 149-156 ◽  
Author(s):  
Kathleen Gibson ◽  
Brian Ferris

Purpose Cyanoacrylate closure of the great saphenous vein with the VenaSeal™ Closure System is a relatively new modality. Studies have been limited to moderate-sized great saphenous veins and some have mandated postoperative compression stockings. We report the results of a prospective study of cyanoacrylate closure for the treatment of great saphenous vein, small saphenous veins, and/or accessory saphenous veins up to 20 mm in diameter. Methods Fifty subjects with symptomatic great saphenous vein, small saphenous veins, and/or accessory saphenous veins incompetence were each treated at a single session. Compression stockings were not used post-procedure. Subjects returned to clinic at week 1 and again at one month. Post-procedure evaluations were performed at seven days and one month and included numerical pain rating score, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire score, and time to return to work and normal activities. Duplex ultrasound was performed at each visit. Findings Procedural pain was mild (numerical pain rating scale 2.2 ± 1.8). All treated veins (48 great saphenous vein, 14 accessory saphenous veins, and 8 small saphenous veins) had complete closure by duplex ultrasound at seven days and one month. Mean time to return to work and normal activities was 0.2 ± 1.1 and 2.4 ± 4.1 days, respectively. The revised venous clinical severity score was improved to 1.8 ± 1.4 ( p < .001) and Aberdeen Varicose Vein Questionnaire score to 8.9 ± 6.6 ( p < .001) at one month. Phlebitis in the treatment area or side branches occurred in 10 subjects (20%) and completely resolved in all but one subject (2%) by one month; 98% of subjects were “completely” or “somewhat” satisfied, and 2% “unsatisfied” with the procedure at one month, despite the protocol disallowance of concomitant side branch treatment. Conclusions Cyanoacrylate closure is safe and effective for the treatment of one or more incompetent saphenous or accessory saphenous veins. Closure rates were high even in the absence of the use of compression stockings or side branch treatment. Time back to work or normal activities was short and improvements in venous severity scores and QOL were significant, comparing favorably with alternative treatment methods.


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.


2014 ◽  
Vol 30 (8) ◽  
pp. 541-548 ◽  
Author(s):  
Arjun Jayaraj ◽  
Mark Meissner

Objective Post-thrombotic syndrome is a chronic complication of acute deep venous thrombosis in the lower extremity. The role of graduated compression stockings in the prevention of post-thrombotic syndrome has been studied with opinion being divided on the beneficial effects. We aim to answer this question with a randomized controlled study that uses multiple scoring instruments to assess post-thrombotic syndrome. Methods Sixty-nine consecutive patients with acute deep venous thrombosis diagnosed by duplex ultrasonography were randomized to treatment with graduated compression stockings or no graduated compression stockings. Venous Clinical Severity Score and Villalta-Prandoni Score, commonly used scoring systems, were used to appraise post-thrombotic syndrome at 3, 6, 12, 18, and 24 months following diagnosis of deep venous thrombosis. In both scoring systems, the individual either had post-thrombotic syndrome or no post-thrombotic syndrome. Cumulative incidence was computed using Kaplan–Meier analysis. Relative risk was assessed for age, obesity, varicose veins, and iliofemoral deep venous thrombosis. Results As measured by both Villalta-Prandoni Score and Venous Clinical Severity Score instruments, the graduated compression stockings group had a lower incidence of post-thrombotic syndrome compared to the control group, but only when one month was used as cut off time for the first diagnosis of post-thrombotic syndrome. When 6 or 12 months were used, there was no difference in the incidence of post-thrombotic syndrome between the two groups. The burden of post-thrombotic syndrome was significantly more when the Villalta-Prandoni Score instrument (∼75%) was used as compared to the Venous Clinical Severity Score instrument (∼30%) at 24 months’ follow-up. Obesity was the only statistically significant predictor for the development of post-thrombotic syndrome. Conclusion As assessed by both Villalta-Prandoni Score and Venous Clinical Severity Score instruments, use of graduated compression stockings does not reduce the incidence of post-thrombotic syndrome. There is a significant difference in the incidence post-thrombotic syndrome as detected by Villalta-Prandoni Score and Venous Clinical Severity Score instruments with incidence of post-thrombotic syndrome dependent on instrument and cut off time interval used to assess post-thrombotic syndrome. However, larger prospective studies are required to confirm these differences.


2007 ◽  
Vol 45 (5) ◽  
pp. 1008-1015.e2 ◽  
Author(s):  
Michael A. Vasquez ◽  
Jiping Wang ◽  
Marchyan Mahathanaruk ◽  
Glenn Buczkowski ◽  
Esther Sprehe ◽  
...  

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.


2016 ◽  
Vol 31 (1_suppl) ◽  
pp. 106-113 ◽  
Author(s):  
Ahmet Kürşat Bozkurt ◽  
Muhammet Fatih Yılmaz

Introduction Cyanoacrylate ablation is the newest nonthermal vein ablation technique. The one-year results of a prospective comparative study of a new cyanoacrylate glue versus endovenous laser ablation for the treatment of venous insufficiency is presented. Material and methods A total of 310 adult subjects were treated with cyanoacrylate ablation or endovenous laser ablation. The primary endpoint of this study was complete occlusion of the great saphenous vein. Secondary endpoints were procedure time, procedural pain, ecchymosis at day 3, adverse events, changes from baseline in Venous Clinical Severity Score, and Aberdeen Varicose Vein Questionnaire. Results Operative time was shorter (15 ± 2.5 versus 33.2 ± 5.7, <0.001), and periprocedural pain was less (3.1 ± 1.6 versus 6.5 ± 2.3, <0.001) in cyanoacrylate ablation group compared to the endovenous laser ablation group. Ecchymosis at the third day was also significantly less in cyanoacrylate ablation group (<0.001). Temporary or permanent paresthesia developed in seven patients in endovenous laser ablation group and none in cyanoacrylate ablation group (p = 0.015). One, three, and 12 months closure rates were 87.1, 91.7, and 92.2% for endovenous laser ablation and 96.7, 96.6, and 95.8% for cyanoacrylate ablation groups. Closure rate at first month was significantly better in cyanoacrylate ablation group (<0.001). Although there is a trend of better closure rates in cyanoacrylate ablation patients, this difference did not reach to the statistical difference at sixth and 12th month (p = 0.127 and 0.138, respectively). Both groups had significant improvement in Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire postoperatively (<0.001), but there was no significant difference in Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire scores between the groups at first, sixth, and 12 months. Only a slightly better well-being trend was noted in cyanoacrylate ablation group in terms of Aberdeen Varicose Vein Questionnaire scores (p = 0.062). Conclusions The efficacy and safety analysis shows that cyanoacrylate ablation is a safe, simple method which can be recommended as an effective endovenous ablation technique. The follow-up data more than one year will clarify the future role of cyanoacrylate ablation for the treatment incompetent great saphenous veins.


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