scholarly journals A randomized prospective long-term (>1 year) clinical trial comparing the efficacy and safety of radiofrequency ablation to 980 nm laser ablation of the great saphenous vein

2016 ◽  
Vol 32 (6) ◽  
pp. 415-424 ◽  
Author(s):  
Malcolm Sydnor ◽  
John Mavropoulos ◽  
Natalia Slobodnik ◽  
Luke Wolfe ◽  
Brian Strife ◽  
...  

Purpose To compare the short- and long-term (>1 year) efficacy and safety of radiofrequency ablation (ClosureFAST™) versus endovenous laser ablation (980 nm diode laser) for the treatment of superficial venous insufficiency of the great saphenous vein. Materials and methods Two hundred patients with superficial venous insufficiency of the great saphenous vein were randomized to receive either radiofrequency ablation or endovenous laser ablation (and simultaneous adjunctive therapies for surface varicosities when appropriate). Post-treatment sonographic and clinical assessment was conducted at one week, six weeks, and six months for closure, complications, and patient satisfaction. Clinical assessment of each patient was conducted at one year and then at yearly intervals for patient satisfaction. Results Post-procedure pain ( p < 0.0001) and objective post-procedure bruising ( p = 0.0114) were significantly lower in the radiofrequency ablation group. Improvements in venous clinical severity score were noted through six months in both groups (endovenous laser ablation 6.6 to 1; radiofrequency ablation 6.2 to 1) with no significant difference in venous clinical severity score ( p = 0.4066) or measured adverse effects; 89 endovenous laser ablation and 87 radiofrequency patients were interviewed at least 12 months out with a mean long-term follow-up of 44 and 42 months ( p = 0.1096), respectively. There were four treatment failures in each group, and every case was correctable with further treatment. Overall, there were no significant differences with regard to patient satisfaction between radiofrequency ablation and endovenous laser ablation ( p = 0.3009). There were no cases of deep venous thrombosis in either group at any time during this study. Conclusions Radiofrequency ablation and endovenous laser ablation are highly effective and safe from both anatomic and clinical standpoints over a multi-year period and neither modality achieved superiority over the other.

2020 ◽  
pp. 026835552093974
Author(s):  
Boutros Karam ◽  
Moustafa Moussally ◽  
Hussein Nassar ◽  
Karim Ataya ◽  
Rola Jaafar ◽  
...  

Introduction Endovenous laser ablation (EVLA) has become the gold standard for the treatment of saphenous vein reflux. We report the long-term clinical and ultrasound results of EVLA. Methods This study is a retrospective review of patients who underwent EVLA of saphenous vein over four years. Clinical results were assessed using venous clinical severity score (VCSS), and ultrasound results were classified according to Bush classification. Results Over a median follow-up time of 4.4 years, 168 EVLA-treated patients showed a drop in VCSS from 4.38 to 1.39. Ultrasound results of 140 treated great saphenous veins showed that 64% had one or more cause of recurrence. The presence of neovascularization correlated well with the lack of improvement of VCSS. Conclusion EVLA resulted in drop in VCSS from 4.38 to 1.39. Among 140 treated great saphenous veins, reflux in the anterior accessory saphenous vein was the primary cause (23.5%) of recurrence.


2016 ◽  
Vol 15 (2) ◽  
pp. 113-119
Author(s):  
Walter Junior Boim de Araujo ◽  
Jorge Rufino Ribas Timi ◽  
Carlos Seme Nejm Junior ◽  
Fabiano Luiz Erzinger ◽  
Filipe Carlos Caron

Abstract Background In endovenous laser ablation (EVLA), the great saphenous vein (GSV) is usually ablated from the knee to the groin, with no treatment of the below-knee segment regardless of its reflux status. However, persistent below-knee GSV reflux appears to be responsible for residual varicosities and symptoms of venous disease. Objectives To evaluate clinical and duplex ultrasound (DUS) outcomes of the below-knee segment of the GSV after above-knee EVLA associated with conventional surgical treatment of varicosities and incompetent perforating veins. Methods Thirty-six patients (59 GSVs) were distributed into 2 groups, a control group (26 GSVs with normal below-knee flow on DUS) and a test group (33 GSVs with below-knee reflux). Above-knee EVLA was performed with a 1470-nm bare-fiber diode laser and supplemented with phlebectomies of varicose tributaries and insufficient perforating-communicating veins through mini-incisions. Follow-up DUS, clinical evaluation using the venous clinical severity score (VCSS), and evaluation of complications were performed at 3-5 days after the procedure and at 1, 6, and 12 months. Results Mean patient age was 45 years, and 31 patients were women (86.12%). VCSS improved in both groups. Most patients in the test group exhibited normalization of reflux, with normal flow at the beginning of follow-up (88.33% of GSVs at 3-5 days and 70% at 1 month). However, in many of these patients reflux eventually returned (56.67% of GSVs at 6 months and 70% at 1 year). Conclusions These data suggest that reflux in the below-knee segment of the GSV was not influenced by the treatment performed.


Vascular ◽  
2016 ◽  
Vol 24 (6) ◽  
pp. 649-657 ◽  
Author(s):  
Renata Balint ◽  
Akos Farics ◽  
Krisztina Parti ◽  
Laszlo Vizsy ◽  
Jozsef Batorfi ◽  
...  

Objective The aim of this review article was to evaluate the long-term technical success rates of the known endovenous ablation procedures in the treatment of the incompetence of the great saphenous vein. Methods A literature search was conducted in the PubMed-database until the 5 January 2016. All publications with four to five years follow-up were eligible. Meta-analysis was performed by the IVhet-model. Results Eight hundred and sixty-two unique publications were found; 17 of them were appropriate for meta-analysis. Overall, 1420 limbs were included in the trial, 939 for endovenous laser ablation, 353 for radiofrequency ablation and 128 for ultrasound guided foam sclerotherapy. Overall, technical success rates were 84.8% for endovenous laser ablation, 88.7% for radiofrequency ablation and 32.8% for ultrasound guided foam sclerotherapy. There were no significant differences between endovenous laser ablation, radiofrequency ablation and ultrasound guided foam sclerotherapy regarding the great saphenous vein reopening ( p = 0.66; OR: 0.22; 95% of CI: 0.08–0.62 for radiofrequency ablation vs. endovenous laser ablation; p = 0.96; OR: 0.11; 95% of CI: 0.06–0.20 for endovenous laser ablation vs. ultrasound guided foam sclerotherapy; p = 0.93; OR: 3.20; 95% of CI: 0.54–18.90 for ultrasound guided foam sclerotherapy vs. radiofrequency ablation). Conclusion Both endovenous laser ablation and radiofrequency ablation are efficient in great saphenous vein occlusion on the long term. Lacking long-conducted large trials, the efficacy and reliability of ultrasound guided foam sclerotherapy to treat great saphenous vein-reflux is not affirmed.


Vascular ◽  
2014 ◽  
Vol 23 (1) ◽  
pp. 3-8 ◽  
Author(s):  
Firat H Altin ◽  
Selim Aydin ◽  
Kamuran Erkoc ◽  
Tevfik Gunes ◽  
Bortecin Eygi ◽  
...  

Objective The present study aimed to evaluate the efficacy of endovenous laser ablation with a 1470-nm laser and to analyze the short- to mid-term results of endovenous laser ablation procedures to treat great saphenous vein insufficiency. Method In this retrospective study, 200 patients (230 limbs) with symptomatic varicose veins secondary to great saphenous vein insufficiency treated with 1470-nm endovenous laser ablation were studied. Patients were evaluated clinically on the first day, first week, first month, and sixth month after the operation. Treated limbs were evaluated as separate treatment events. Results The short-term occlusion rate was 99% and mid-term occlusion rate was 100%. Induration or swelling was the most common minor complication (13%). No major complication such as deep venous thrombosis and pulmonary embolus occurred. Preoperatively documented mean venous clinical severity score significantly reduced from 4.9 ± 2.3 to 2.5 ± 1.1 ( p < 0.05). Conclusion Endovenous laser ablation procedure of great saphenous vein with a 1470-nm diode laser is a minimally invasive, safe, and efficient treatment option in all-suitable patients with high short- and mid-term success rate.


2011 ◽  
Vol 27 (3) ◽  
pp. 128-134 ◽  
Author(s):  
D Carradice ◽  
N Samuel ◽  
T Wallace ◽  
F A K Mazari ◽  
J Hatfield ◽  
...  

Objective Many venous trials mix patients with great saphenous vein (GSV) and small saphenous vein (SSV) diseases. There is no evidence that both respond similarly to treatment and our aim was to test this assumption. Method This cohort study compares patients with isolated GSV and SSV incompetence following treatment with open surgical ligation or endovenous laser ablation (EVLA). Outcomes included: quality of life (QoL; Aberdeen Varicose Vein Questionnaire [AVVQ]; Short Form 36 [SF36]; Euroqol [EQ5D]; and Venous Clinical Severity Score [VCSS]). Results A total of 370 patients with no differences in baseline QoL, underwent treatment. Despite equivalent morbidity, SSV sufferers had a lower VCSS ( P < 0.001). Following surgery, SSV patients scored higher (worse) on AVVQ ( P = 0.045) than GSV sufferers, but lower (better) following EVLA ( P = 0.042). Conclusion The morbidity associated with SSV incompetence is greater than suggested by its clinical severity and responds differently following treatment to that of the GSV. Trials should consider patients with GSV and SSV reflux separately. EVLA may offer additional benefits to SSV sufferers.


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.


2013 ◽  
Vol 29 (2) ◽  
pp. 765-771 ◽  
Author(s):  
Mohammad Mozafar ◽  
Khashayar Atqiaee ◽  
Hamidreza Haghighatkhah ◽  
Morteza Sanei Taheri ◽  
Ali Tabatabaey ◽  
...  

2014 ◽  
Vol 30 (5) ◽  
pp. 325-330 ◽  
Author(s):  
S Sufian ◽  
A Arnez ◽  
N Labropoulos ◽  
S Lakhanpal

Objectives To evaluate the incidence of heat-induced thrombosis, its progression and risk factors that may contribute to its formation after endovenous laser ablation. Methods This was a prospective evaluation of all patients who had endovenous laser ablation of the great saphenous vein, accessory saphenous vein, and small saphenous vein using 1470 nm wavelength laser, from March 2010 to September 2011. All patients who developed endovenous heat-induced thrombosis at the saphenofemoral junction or at the saphenopopliteal junction were included. Demographic data, history of venous thrombosis, body mass index, vein diameter, reflux time, catheter tip position, endovenous heat-induced thrombosis progression, number of phlebectomies, and venous clinical severity scores were analyzed. Duplex ultrasound was done in all patients preoperatively, and 2–3 days postoperatively. Results Endovenous laser ablation was performed in 2168 limbs. Fifty-seven percent had great saphenous vein, 13% accessory saphenous vein, and 30% small saphenous vein ablation. Endovenous heat-induced thrombosis was developed in 18 limbs (12 at saphenofemoral junction and six at saphenopopliteal junction) for an incidence of 0.9%. Eight were class 1 and 10 were > class 2. No pulmonary embolism was reported. The percentage of men with endovenous heat-induced thrombosis was higher compared to those without (39% vs. 24%, p = .14). The median age for endovenous heat-induced thrombosis patients was 59.6 compared to non-endovenous heat-induced thrombosis ( p = .021). Great saphenous vein/accessory saphenous vein diameter for endovenous heat-induced thrombosis patients was 8.0 mm versus 6.3 mm for non-endovenous heat-induced thrombosis patients ( p = .014), and for small saphenous vein it was 5.7 mm versus 4.5 mm ( p = .16). Multiple concomitant phlebectomies were performed in 55.6% of the endovenous heat-induced thrombosis patients compared to 37% in non-endovenous heat-induced thrombosis ( p = .001). All other parameters were similar between endovenous heat-induced thrombosis and non-endovenous heat-induced thrombosis group. Endovenous heat-induced thrombosis resolution occurred in 16 cases at 2–4 but two cases progressing from class 1 to 2, before resolution. The mean VCSS score for endovenous heat-induced thrombosis patients preoperatively was 5.6 and improved to 2.8 ( p = .003) at one month. Conclusion Risk factors associated with endovenous heat-induced thrombosis formation after endovenous laser ablation include: vein size, age, and multiple phlebectomies. Endovenous heat-induced thrombosis resolves in 2–4 weeks in most patients but it may worsen in few.


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