Our mid-and long-term results of endovenous radiofrequency ablation in great saphenous vein insufficiency

Authors

Abstract

AimVenous insufficiency may occur due to problems in the return of blood to the heart and reverse flows. Endovascular procedures have emerged as an alternative to classical open surgery in treatment. In this study, we aimed to examine the mid- and long-term results of our radiofrequency ablation (RF) applications, which is an endovascular method.
MethodsIn our study, we included 193 patients who underwent RF in our clinic between June 2017 and March 2022. All patients underwent ablation with an RF catheter by entering the great saphenous vein (GSV) at the appropriate level under local tumescent anesthesia and under Dopplerultrasound guidance. Postoperative follow-up of the patients and Dopplerultrasound controls at the 1st, 6th, 12th and 24th months were performed, and GSV patency and reflux conditions were recorded.
Results133 patients were female (68.9%) and 60 patients were male (31.1%). The age range was 22-82 (mean: 52). It was determined that GSV recanalisation and reflux developed in 6 patients (3.1%) at the 1-month follow-up, in 9 patients (4.6%) at the 6th month, and in 11 patients (5.6%) at the 12th and 24th months.
ConclusionRF method is a feasible method with low complications, high patient comfort and success in suitable patients. However, recanalization and recurrence still occur. To achieve higher success rates, the reasons underlying recanalization and recurrence should be examined.

Keywords

Introduction

The condition in which superficial veins gain elongation and tortuosity is defined as varicose veins.¹ In the pathogenesis of venous disease, venous insufficiency occurs especially with the formation of reflux flows. Deterioration of the valves, which allow flow in one direction, is held responsible for this situation. The vessel that loses its function creates venous hypertension in the distal part, threatening other vessels and increasing the symptoms of the disease at the tissue level. These may impair the quality of life with leg pain, swelling, restlessness, night cramps, and skin changes that may lead to ulceration.²
It is known that telectasias (C1), known as capillary varicose veins, are seen in 80% of the population, varicose veins (C2) in 20-64%, venous insufficiency (C3-6) in 5% and ulcers (C5-6) in 1-2%.³ As the disease progresses, it reduces the person’s quality of life and work capacity with increasing symptoms and loss of function and creates an additional burden on the country’s economy with treatment costs.⁴ Therefore, it is of particular importance to treat the disease early, before it reaches advanced stages.
The radiofrequency ablation method is one of the methods popularly known as closed surgery performed without surgical incisions, stitches, or general anesthesia. It is a method that is easy to apply, has fewer side effects, faster recovery and even allows patients to continue working on the same day. Thanks to these advantages, it can be a method that is easily accepted and preferred by patients.
Another important part of the treatment is educating patients and informing them about the things they must follow throughout their life regarding the disease. The main point in this regard is focused on reducing venous pressure. These are a combination of lifestyle, appropriate elastic compression, physical activity regulation, weight regulation and venotonic agents. However, the most important point of the entire treatment is the early correction of the basic damaged vascular pathology. In this regard, the importance of a method that is acceptable to the patient becomes evident.
In this study, we aimed to evaluate the mid- and long-term results of the radiofrequency ablation method we applied in great saphenous vein insufficiency.

Materials and Methods

We included 193 patients who underwent RF with the diagnosis of venous insufficiency in our clinic between June 2017 and March 2022. In our study, 133 patients were female (68.9%) and 60 patients were male (31.1%). While the age range was 22-82, the average age was 52 ± 30 (Table 1). All of our patients were diagnosed with Doppler ultrasonography (USG), which was the indication for surgery. In USG, the procedure was performed on patients with GSV reflux lasting more than 2 seconds and BSV diameter over 5.5 mm in the knee area. The average diameter of the BSV in all cases was 6.9 mm (5.5-15 mm). The procedure was performed on both legs of 13 patients, but in separate sessions.
Since the procedure would be performed under local anesthesia, patients did not need preoperative anesthesia evaluation. Before the procedure, the GSV course, diameter, sapheno-femoral junction relationship, aneurysm status, location of the anterior accessory branch, diameter, distal feeding power, and collateral vessels were examined with ultrasound while the patient was standing. Other accompanying venous pathologies (perforating reflux, small saphenous vein diameter and course) and most importantly the packages contained in the venous system were marked by determining what should be intervened and what should be removed. No patient required spinal or general anesthesia or sedation. After the patient was monitored, betadine was applied to the leg and sterile conditions were provided with a surgical drape. The USG vascular probe was taken to the operating table through the camera cover. Under USG guidance, a sheath (7F) was placed in the GSV at an appropriate level, mostly below the knee, using the Seldinger technique. Radiofrequency catheter (Veineo®, Fcare system NV, Belgium) was placed through the sheath under USG control, approximately 1 cm distal to the saphenofemoral junction, leaving the epigastric superior vein open. Then, tumescent anesthesia (2 pieces of 8.4% sodium bicarbonate, 20 mL 2% prilocaine, 0.5 mg adrenaline in 500 mL isotonic at +4°C) was infiltrated around the great saphenous vein under USG guidance. RF was applied by reaching 120°C for 4 seconds in each 1 cm segment. After the procedure, USG control showed that GSV was closed. Additional pouch excision and perforating ligation were performed on patients when necessary.
After all procedures were completed, the leg was put under elastic compression and the patient was taken to the service for lower extremity elevation. The patient was mobilized postoperatively and was discharged. After the elastic bandage was applied for 24 hours, the patient was allowed to wear medium pressure (20-30 mmHg) compression stockings. Additionally, calcium dobesilate 2 × 500 mg was added to the patients’ treatment. The first 10th day and 1st, 6th, 12th and 24th month follow-ups were performed, and any developing complications, Doppler USG and GSV clearances, and reflux status were recorded.
Ethical Approval
This study was approved by the Ethics Committee of Çanakkale Onsekiz Mart University (Date: 20.09.2023, Decision No: 2023/12-12).

Results

According to the preoperative CEAP classification of the patients, 130 patients (67%) were determined as C2, 155 patients (80%) were determined as C3, and 49 patients (25%) were determined as C4. In preoperative Doppler USG, the diameter of the GSV in the knee region was found to be an average of 6.7 mm in men, 7.1 mm in women, and 6.9 mm in all cases. All procedures were completed within 20-60 minutes. The procedure was performed on one leg of the patients, and 13 patients needed the procedure on the other leg and another session was performed. While the procedure was performed on the left leg in 105 (54.4%) patients, the procedure was performed on the right leg in 88 (45.6%) patients. All patients were mobilized and discharged on the same day (Table 1).
On the 10th postoperative day, there was tenderness along the GSV line in 17 patients (8.8%), erythema in 15 patients (7.7%), phlebitis in 9 patients (4.6%), ecchymosis in 6 patients (3.2%), and cellulite in 2 patients (2.1%). Skin-epidermal abrasion due to elastic bandage was detected in 2 patients (1%). All complaints resolved with local treatment.
At the 1-month follow-up, hardness along the GSV trace and hyperpigmentation at the same level occurred in 24 patients (12.4%). In the 1st month Doppler USG controls, it was determined that the GSV was open and reflux occurred in 6 (3.1%) patients.
At the 1-year follow-up, Doppler USG revealed that 11 (5.6%) patients developed open recanalization and reflux in the GSV. The same patency rate was observed at the 2-year follow-up (Table 2).

Discussion

Venous insufficiency and varicose veins continue to be a common disease today. Although stripping and other additional procedures performed with open surgery, which is a traditional method, are still applied, they have disadvantages such as postoperative pain, bleeding, ecchymosis, nerve damage, cosmetic problems and the need for general or spinal anesthesia.⁵ It is aimed to reduce these undesirable situations that occur in open surgery with the new endovenous developing methods. Radiofrequency ablation method is one of these systems. The aim is to close the vein by ablation method by sending radiofrequency energy from outside to the catheter placed in the malfunction of the vein segment through percutaneous access.
The lower complication rate and better recovery time of RF compared to open surgery have led to the increasing popularity of minimally invasive interventions in the treatment of venous diseases.^6,7 The number of thermal ablation methods, including RF, for the treatment of venous disease has surpassed the number of open surgeries in many countries in recent years.^8,9 Some scientific and medical authorities have begun to recommend RF ablation as the first step in varicose veins and venous insufficiency.^10,11
In the EVOLVeS study, it was shown that patients who underwent RF ablation compared with open surgery were able to return to their daily routines and business lives earlier and experienced less pain and better cosmetic results.¹²
As with open surgery, deep vein thrombosis (DVT) may develop after endovenous interventions. Akça et al. reported in their study that they observed DVT at a rate of 0.7% after RF,¹³ and in 2 of our patients, DVT developed in the early post-procedure period. One of these patients had Down syndrome, and hematological disorders can also be seen in these syndromic cases. In the subsequent genetic examination of the patient, Factor XIII and MTHFR (A1298C) heterozygous mutations were detected, which may predispose to thrombus. This is a condition that may be related to developed thrombus. The presence of additional accessory saphenous veins in both patients and their wide base connection with the saphenofemoral junction (SFJ) may have triggered the formation of stasis currents and the development of thrombus. However, studies with a larger patient group are needed to support this.
Avacedo et al. in their study found the recanalization rate in GSV to be 8.7% in the 3rd year after RF. Current meta-analysis studies found RF ablation recanalization rates less than 5 years to be 11.6% and more than 5 years to be 12.9%.¹⁴ In our study, we found the 2-year rate to be 5.6%. Although the advantages and short-term results of RF ablation are widely known, Whiteley et al.¹⁵ also demonstrated its long-term benefit by reporting a 15-year RF ablation success rate of 88% with a good result. Studies have found the surgical stripping recurrence rates to be 17.9% before 5 years and 32.8% after 5 years.¹⁴ This rate shows that the recurrence rate in classical surgical practices is significantly higher over time. This situation once again shows the importance of prioritizing endovascular applications.

Conclusion

Endovenous applications are the generally preferred and prioritized methods. RF method is also an option that should be considered in suitable cases with low complications, high patient comfort and success. However, recanalization and recurrence still occur. To achieve higher success rates, the reasons underlying recanalization and recurrence should be examined.

Declarations

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About This Article

Received:

April 11, 2024

Accepted:

May 20, 2024

Published Online:

June 4, 2024

Printed:

July 1, 2024