Radiofrequency Ablation in Our Approach to the Treatment of Varicose Veins of the Lower Extremities

Introduction, Objectives, and/or Purpose: Lower extremity varicose vein disease (LEVVD) are one of the most common clinical problems affecting millions of people worldwide. The introduction of endovenous methods started a real revolution in the treatment of this problem and significantly improved the results of patient’s treatment. Thermal ablation techniques are considered the treatment of first choice in patients with chronic venous disease according to international clinical guidelines. Since its approval in 1999 the several randomized trials have been conducted comparing endovenous RFA with surgical stripping or endovenous saphenous vein laser therapy, sclerotherapy or nonthermal techniques. All of them demonstrated that RFA has equal or better results. However, the use of a standard RF protocol according to a number of studies does not always allow to achieve anatomical success in long-term observation which causes the recanalization of the main trunk vein in 10-15% of patients and recurrence in 11-12% of patients in the basin of the anterior accessory saphenous vein and worsening clinical manifestations disease, and quality of life of patients. That is why the goal of our study was to improve the radiofrequency ablation protocol for the treatment of varicose veins of the lower extremities.

Methods: The open prospective study conducted from 2018 to 2022 included 210 consecutive patients with LEVVD of clinical class C2-C6 with lesions of the basin of the GSV. Operative interventions were performed using the Closure RFG and ClosureFast TM Catheter (Medtronic, San Jose, CA, USA) with a working part of the catheter of 7 cm. The suggested changes in the RFA technique consisted in positioning the end of the radiofrequency catheter at a distance of 0.5 cm from the SFJ and performing the RFA procedure based on tissue impedance: the ablation was considered successful when the impedance was 12 W, only after proceeding to the next segment of treatment. The effectiveness of the procedure was evaluated by the anatomical success of vein obliteration determined by ultrasound scanning in the first 48 hours after the procedure and after 1, 6, 12 and 24 months. Simultaneously evaluating the clinical performance according to the VCSS scale, and quality of life parameters using AVVQ questionnaires. The development of postoperative complications was recorded. Statistical analysis was processed in the StatPlus software package (AnalystSoft, USA, 2021).

Results: The clinical characteristics of patients included in the study are shown in Table 1.
The implementation of the offered radiofrequency ablation protocol requires an additional approach to tumescent anesthesia. Special attention should be paid to the infiltration solution in the area of ​​the saphenous-femoral junction: to the end of the ClosureFast working part, the catheters brought the end of the infiltration needle, thereby achieving the sonographic effect of a "kiss", after which the infiltrated area under the main trunk of the vein is assigned to achieve full compression of the distal part veins Figure 1.
The results of the performed preoperative ultrasound examination determined the following sonographic parameters some of which affect the RF ablation procedure: the length of the pathologically changed segment of the large saphenous vein was 38.4 ± 2.64 cm, the average diameter of the vein was determined at the saphenous-femoral junction of glass 12 ± 1.2 mm, the diameter of the GSV at the level of 3 cm distal to the SFJ was 8.9±1.34 mm, and the diameter of the vein in the middle third of the thigh was 9.1 ± 1.41 mm. The importance of determining the diameter of the great saphenous vein at the level of the saphenous-femoral junction is manifested in a statistically significant difference from the average level of correlation of the diameter between the great saphenous vein (r=0.398, p=0.0016), determined in the area of ​​the saphenous-femoral junction, and in the survey areas provided for by the consensus documents Taking into account the proven statistical differences in GSV diameter at different levels emphasizes the need for differentiated application of radiofrequency energy during GSV radiofrequency ablation. The average time during which the radiofrequency ablation procedure was carried out was 5.3 ± 0.51 min. The performers at the same time had 16.1 ± 0.89 RF cycles.
The results of duplex monitoring in the first 48 hours, 7 days and 1 month after the surgical treatment showed 100% occlusion of the treated segments of the great saphenous vein obtaining the effect of "radiofrequency crossectomy" in the jugular area Figure 2.
After 6 months in 208 (99.1%) patients was the complete occlusion of the vein and in 2 (0.9%) - partial occlusion of the vein in a 1 cm segment from the SFJ without pathological reflux. This tendency continues and is currently observed after 1 year. 2 years after the procedure 4 (1.9%) had a stump of the proximal segment up to 1 cm from the SFJ but without pathological reflux.
64 (30.5%) patients had one or more adverse events during the first 2 weeks after treatment. The most specific weight was attributed to minor complications in the form of ecchymoses along the course of the main trunk of the vein, which were observed in 40 (19.1%) patients, although this complication is more likely related to the performance of tumescent anesthesia. Induration and hyperpigmentation occurred in 12 (5.7%) and 8 (3.8%) patients respectively and did not require special treatment. In one patient (0.5%) paresthesia was observed in the projection of the medial surface of the lower leg, which also disappeared within a month after the procedure. Among the formidable complications in 2 (0.9%) cases during ultrasound monitoring asymptomatic distal deep vein thrombosis was diagnosed and in 1 (0.5%) EHIT II was appeared, which can obviously be related to the large diameter of the vein in the SFJ area - 2,4 cm. All patients with manifestations of VTE were prescribed rivaroxaban at a dose of 10 mg per day for 30 days with a positive sonographic picture. Clinical manifestations of pulmonary embolism were not observed in any patient.
The use of VCSS to evaluate the effectiveness of regression of clinical symptoms showed the following results: already 1 month after the ablation the positive dynamics changed the VCSS indicator from 7.8 ± 1.4 before the treatment to 6.1 ± 2.7. After 6 months this tendency was maintained and reaching a statistically significant difference of 4.4 ± 1.9 (p < 0.001) and 4.1 ± 1.6 at 12 months increasing statistically slightly (4.3 ± 1.4) to 24 months of follow-up.
Quality of life is increasingly recognized as a critical measure in health care because it takes into account patients' own perspective on their health. That is why special attention in the research process is focused on the analysis of quality of life indicators obtained with the help of the AVVQ specialized phlebological questionnaire. The average AVVQ score at the initial stage was 9.36 ± 0.98 and statistically significantly improved after 1 month of observation 3.36 ± 0.81 (p < 0.001) continuing positive dynamics up to 24 months of observation 2.18 ± 0.82.

Conclusion(s): The use of the offered features of the radiofrequency ablation protocol (location of the end of the radiofrequency catheter at a distance of 0.5 cm from the sapheno-femoral joint and the use of a differentiated number of RF ablation cycles depending on the tissue impedance) in patients with varicose veins of the lower extremities, allows minimizing the recurrence of the disease by performing the effect "radiofrequency crossectomy". The offered features of the method have a positive effect on the regression of clinical symptoms, since already 6 months after the treatment a statistically significant (p < 0.001) decrease in the severity of the clinical manifestations of the disease is observed. The positive dynamics of the quality of life indicators confirms the effectiveness of the implementation of the offered changes in the methodology because already 1 month after the treatment it is contributes to a three-fold improvement in the quality of life of patients with varicose veins of the lower extremities according to the results of the AVVQ questionnaire (p < 0.001). It has a good safety profile but requires careful tumescent anesthesia of the jugular area.