XI. Endovenous ablation session
XI. Endovenous ablation session
Results of randomized control clinical trial of energy settings in endovenous laser ablation
Denis Borsuk (Russia)
In a previous study, it was demonstrated that, in endovenous laser ablation for chronic venous disease treatment, using the same linear endovenous energy density with a different power setting is associated with significantly different effects on vein wall damage and tissue depth penetration. The aim of this investigation was to analyze three energy settings for clinical effects in terms of vessel recanalization and procedural pain. Patients with chronic venous disease (C2EpAsPr) were randomized for endovenous laser ablation (n=154) at 5 W (50 patients), 7 W (57 patients), and 10 W (47 patients). All the procedures were performed at 70 J/cm. Pain was evaluated by using a visual analog scale at 1 day, 1 week, and 2 months after endovenous laser ablation. Recanalization was assessed at 6 months. Pain at day 1 was rated as 0 (1 quartile 0; 3 quartile 1) in the 5 W group, 0 (1 quartile 0; 3 quartile 1) in the 7 W group, and 0.5 (1 quartile 0; 3 quartile 2) (P=0.355) in the 10 W group. Administration of painkillers showed no difference between the three groups (X2=0.236; P=0.889). No difference was reported in pain at 1 week and 2 months (1 week, P=0.317; 2 months; P=0.569). No great saphenous vein recanalization was reported at 6 months in all patients. Endovenous laser ablation at different power settings with the same linear endovenous energy density does not present significant differences in terms of pain and recanalization, despite the previously demonstrated difference in vein wall damage.
A randomized clinical study of radiofrequency ablation versus 1470nm laser for great saphenous vein reflux
Christos Karathanos (Greece)
Most studies have compared radiofrequency ablation with a previous generation of laser technology. Our aim was to compare the outcome of radiofrequency ablation and endovenous laser ablation with the new-generation 1470-nm laser for the treatment of great saphenous vein reflux. Consecutive patients with great saphenous vein reflux were randomized to radiofrequency ablation (VNUS ClosureFAST TM) or endovenous laser ablation with a 1470-nm fiber (radial [ELVes®] or linear [VenaCure]) at a single academic center. Data on clinical classification (CEAP), 10-cm visual analog scale (VAS) for pain, venous clinical severity score (VCSS), and chronic venous insufficiency quality-of-life questionnaire (CIVIQ) were recorded. Assessment visits were performed at 7 days, 30 days, and 1 year postablation, including clinical examination and duplex scan. The primary outcome was anatomic success, defined as the absence of reflux or recanalization of the great saphenous vein. The secondary outcomes were procedure related complications (thrombotic complications, ecchymosis, tenderness), postoperative pain using the VAS scale, and improvement in VCSS and CIVIQ scores.
The study randomized 135 patients to radiofrequency ablation (group I; n=45), endovenous laser ablation with a 1470-nm radial fiber (group II; n=45), and endovenous laser ablation with a 1479-nm linear fiber (group III; n=45). Patient demographics, CEAP classification, mean linear endovenous energy density, average vein diameter, and length of ablated vein were comparable between the three groups. No major complications were observed postoperatively. Endothermal heat-induced thrombosis was observed in 2 patients in group I, 1 patient in group II, and 2 patients in group III (4.4% vs 2.2% vs 4.4%, respectively; P>0.5). Minor complications, such as ecchymosis and tenderness, were similar in all groups at all visits. The great saphenous vein occlusion rate at 12 months was 93% in group I, 93% in group II, and 95% in group III (P>0.5). During follow-up, all patients showed a significant improvement in all domains compared with the postoperative assessment (P<0.05). The VCSS improved more in group II at 1 week (P=0.02). The CIVIQ pain score improved more at 7 and 30 days after treatment. Endothermal venous ablation using the radiofrequency ablation and 1470-nm radial or linear fiber laser are equally effective and safe modalities for the treatment of great saphenous vein reflux. Endovenous laser ablation with the 1470-nm radial fiber showed better outcomes in terms of early postoperative VCSS and pain CIVIQ scores. However, clinical and quality of life improvements were similar after 30 days in all groups during the first postoperative year.
Endovenous laser ablation in patients with venous aneurysms and large diameter of great saphenous vein
Barys Maslianski (Belarus)
Endovenous laser ablation is a commonly used technique to treat patients with varicose veins. The majority of scientific research evaluating the clinical effect of endovenous laser ablation concerns the diameter of the great saphenous vein ≤13 mm. There are controversial opinions about the efficacy of endovenous laser ablation in large-diameter great saphenous veins. There are limited data about attempts of endovenous treatment for venous aneurysms in the literature. An aneurysm can be defined as an isolated dilatation of any vessel. Aneurysms may occur in any part of the vascular system. The definition of venous aneurysm remains controversial because there is no precise size criterion. According to different authors, venous aneurysm can be defined as an isolated segment of venous dilatation 1.5- to 2-times the normal size of a contiguous vein or 3-times the size of a normal vein. Venous aneurysms can be isolated or be contained within a segment of varicose vein. Venous aneurysms typically occur in the extremities, either in the superficial or deep venous systems. The incidence of superficial venous system aneurysms is around 0.1%. Types of venous aneurysms include saccular and prejunctional. The most common complications in great saphenous vein aneurysms are deep venous thrombosis, thrombophlebitis, pulmonary embolism, rupture, and focal peripheral neuropathy. This presentation described the experience with using endovenous laser treatment for patients with uncomplicated venous aneurysms and large-diameter great saphenous veins. Great saphenous veins with diameters >14 mm were defined as large. A local 2-fold increase in the diameter of the vein was considered a venous aneurysm. A retrospective review of patients who underwent endovenous laser ablation between January 2016 and December 2018 was conducted. A total of 685 protocols were reviewed.
There were 207 (30%) cases with large great saphenous veins: 64 men (31%) and 143 women (69%), mean age 52.8 years (range, 36.2-72.8 years). Venous aneurysms were diagnosed in 34 (4.9%) patients. Three patients had the saccular type and 31 patients had the prejunctional type. The procedure was performed using a radial laser fiber and a 1470-nm laser under tumescent anesthesia. The follow-up period was 3 to 6 months. The mean great saphenous vein diameter was 16.5 mm before ablation. The largest diameter was found in patients with saccular aneurysms (28, 31, and 34 mm). The closure rate was 100% in this group. Complications occurred in 8 patients (3.9%). The most common complication was paresthesia, which occurred in 6 (2.9%) cases. In another 2 (1%) cases, thrombophlebitis was diagnosed. There were no major complications. Failure of closure was only seen in 1 (0.48%) case.
Great saphenous vein aneurysms can be associated with a thrombophlebitic process and the risk of a pulmonary embolism. Patients presenting with a great saphenous vein aneurysm containing a thrombus warrant surgical intervention. Endovenous laser ablation should be used as an alternative to surgery in cases of nonthrombosed venous aneurysms to avoid thrombus formation. It is an effective and safe procedure for treating patients with venous aneurysms and large-diameter great saphenous veins. This method has a low risk of serious complications.
Endovenous laser ablation with 1940 nm laser and radial fibers in varicose vein surgery, 2 years follow-up
Uldis Maurins (Latvia)
The study aided to demonstrate the outcome and side effects after endovenous laser ablation with a 1940-nm diode laser (biolitec) and a 2-ring radial fiber (ELVeS radial 2-ring, biolitec) on refluxing great saphenous veins. Between February 2016 and March 2017, 100 great saphenous veins from 100 consecutive patients were treated by endovenous laser ablation for great saphenous vein incompetence with a 1940-nm laser by using a 2-ring radial fiber, 8 W power, and continuous fiber pullback without using compression therapy after treatment. Mean linear endovenous energy density was 69 J/cm and the endovenous fluence equivalent was 38 J/cm2. Endovenous laser ablation was performed under tumescent anesthesia; additional miniphlebectomies were not applied. All patients were examined clinically and with duplex ultrasound prior to intervention and at the follow-up visits at day 10 (D10), day 180 (D180), and after 2 years (D720) for complications, occlusion, flow, and reflux in the treated vein segment. The clinical evaluation included clinical CEAP, venous clinical severity score (VCSS), presence of recurrent varicose veins, and patient satisfaction. After an average follow-up period of 10 days, 96 treated patients (96 great saphenous veins) were reinvestigated. After 6 months (SD, 5), 96 treated patients (96 great saphenous veins) were reinvestigated, and after 25 months (SD, 5), 92 treated patients (92 great saphenous veins) were reinvestigated. Four patients were lost to follow-up after 6 months and an additional 2 patients after 2 years. At up to 2 years of follow-up, all treated veins remained occluded. After 2 years, 79 patients were very satisfied with the method, 12 were satisfied, and 1 was fairly satisfied. In 1 case, endothermal heat-induced thrombosis II was observed at 10 days of follow-up, but no severe complications, such as deep vein thrombosis, occurred. The average pain score during intervention was 1.8, on the day of the intervention, it was a 1.5, and, during the first 10 days, it was reduced to 0.9. Intake of painkillers during the first 10 days was on average 1 tablet (SD, 2.8).
In this prospective follow-up study with 100 consecutive patients and 100 treated great saphenous veins, a high occlusion rate of 100% could be demonstrated 2 years after treatment. In comparison with other studies using lower wavelengths, postoperative pain was reduced. Taking the very low pain levels and complication rate into account, posttreatment compression is not necessary if modern treatment devices are used. In conclusion, endovenous laser ablation of great saphenous veins with a 1940-nm diode laser and radial fibers is a minimally invasive, safe, and efficient therapy option with a very high success rate and a very low level of periprocedural pain.
Laser crossectomy versus infra-epigastric closure – randomized study
Johann Christof Ragg (Germany)
With today’s endovenous approaches, the great saphenous vein is ablated with a “safety distance” from the junction, sparing all other branches and thus leading to a considerable number of recurrences, in particular consecutive anterior accessory great saphenous vein (AAGSV) insufficiencies. Consequently, additional treatments are required, potentially more frequently than after a surgical crossectomy. Should ablation of nonrefluxive AAGSVs be routinely included or are technical modifications required? A prospective, randomized trial was performed to clarify the conditions for distinguished AAGSV strategies. The trial randomized 240 consecutive patients with great saphenous vein insufficiency (C2-C6; d=6.5-17.8), reflux origin from the saphenofemoral junction (destroyed or malfunctioning terminal valve), nonrefluxive AAGSV, and no other refluxive branch of the saphenofemoral junction to endovenous laser ablation (EVLA, 1470 nm, radial, 50-80 J/cm) starting at the femoral vein level (“laser crossectomy” [group A]) or to endovenous laser ablation starting below the epigastric vein junction (group B). Both procedures were combined with ultrasound-guided coaxial perivenous local anesthesia (CPLA). Ultrasound follow-up was performed after 1 day and after 1, 6, 12, and 24 months.
Great saphenous vein occlusion was obtained in all cases, but with different morphologies. Laser crossectomy (group A) showed no stumps (88/120 [73.3%]), minor stumps <5 mm (14/120 [11.7%]), or moderate stumps 5 to 17 mm (mean, 11.5 mm; 18/120 [15%] at the 1-month exam); 118/120 (98.3%) entries of AAGSV were covered. In group B, great saphenous vein stumps of 8-31 mm length (mean, 23 mm) were present in 12/l20 cases. AAGSV entry was covered in 13/120 cases (10.8%). Within the 2-year follow-up, AAGSV insufficiency was detected in 5/120 cases (4.2%) in group A and 26/120 (21.7%) in group B (P>0.01). Just 1/120 (group A) and 6/120 (group B) cases were clinically relevant. Therefore, consideration of AAGSV anatomy is crucial for the right choice of strategy. “Laser crossectomy,” even if attacking just the great saphenous vein, is more effective in preventing secondary AAGSV reflux than techniques leaving stumps. Further studies will have to detect factors of AAGSV vulnerability, such as the diameter or previous phlebitis, to consider primary ablation in selected cases.
Endovenous laser therapy of the GSV: 3-years results of a randomised prospective study comparing 0 and 2 cm ablations distance from the deep vein
Juris Rits (Latvia)
In the last 20 years, endovenous thermal ablation has developed as a gold-standard treatment for insufficient saphenous varicose veins. Nevertheless, the influence of an untreated proximal segment of the target vein on the development of reflux and recurrence after thermal ablation of a refluxing great saphenous vein remains unclear. Between April 2013 and January 2016, 146 legs in 146 consecutive patients were treated by endovenous ablation with a 1470-nm diode laser for great saphenous vein incompetence by using a 2-ring radial fiber. All patients were randomized into two groups. In group 1, ablation was started from the level of the deep vein and, in group 2, ablation was started 2 cm below the deep vein. Investigations where performed clinically and by duplex ultrasound prior to intervention (screening visit), on the day of intervention (DO), and at follow-up visits on day 14 (D14), 90 (D90), and 900 (D900) after the procedure for side effects, complications, occlusions, reflux, and recurrences. The primary end point of this study was reflux in the saphenofemoral junction (stump left and anterior accessory vein [AASV]) after 3 years. The secondary end points were venous clinical severity score (VCSS), CEAP improvement, pain, and complication rates between the two groups.
At day 900, 35 patients were lost to follow-up: 19 in group 1 and 16 in group 2. There were no statistically significant differences in VCSS and CEAP in improvement between the two groups at any time point of follow-up. Characteristics of pain and necessity to use painkillers did not differ between the groups: 76% of patients did not take any painkillers at any time after the procedure (no between-group differences). There was no difference in the diameter reduction 3 cm below the saphenofemoral junction, but a statistically significant difference was noted according to the greatest diameter of the stump: 0.41 cm in group 1 and 0.60 cm group 2 (P<0.001). Reflux in the AASV was observed in 8% in group 1 and 14% in group 2. Reflux in the stump was detected in 4% in group 1 and 19% in group 2 (P<0.05). There were no between-group differences according to satisfaction with treatment at any time point. Proximal clinical recurrent varicose veins were observed in 9.6% in group 1 and 15.25% in group 2 (P<0.05), which was related to reflux in the stump and/or AASV. There were no between-group differences according to satisfaction with treatment. The improvement in VCSS and CEAP was equal in both groups. In addition, the complication risk was low in both groups. Pain level and usage of painkillers were the same. However, the long stump of the great saphenous vein was associated with higher risk of developing proximal reflux and recurrences in more longterm follow-up.
