Clinical characterization of consecutive patients treated with endovenous radiofrequency ablation of the great saphenous vein in Northwest China

Yongfeng Zhao; Qian Yang; Xiaoyu Zhao; Zilong Dong; Xi Chen; Zhen Liu; Peng Tang; Hui Xu; Yung-Wei Chi; Liwen Liu

doi:10.4103/2589-9686.376921

ORIGINAL ARTICLE

Year : 2022 | Volume : 5 | Issue : 4 | Page : 94-99

Clinical characterization of consecutive patients treated with endovenous radiofrequency ablation of the great saphenous vein in Northwest China

Yongfeng Zhao¹, Qian Yang², Xiaoyu Zhao¹, Zilong Dong¹, Xi Chen¹, Zhen Liu¹, Peng Tang³, Hui Xu¹, Yung-Wei Chi⁴, Liwen Liu¹
¹ Department of Ultrasound, Xijing Hospital of the Air Force Medical University, Xi'an, China
² Department of Ultrasound, The First Medical Center of Chinese PLA General Hospital, Beijing, China
³ Department of Orthopedics and Rehabilitation, China Rehabilitation Research Center, Beijing Charity Hospital, Beijing, China
⁴ University of California, Davis, Vascular Center, Sacramento, CA, USA

Date of Submission	04-Oct-2022
Date of Decision	19-Dec-2022
Date of Acceptance	20-Dec-2022
Date of Web Publication	15-May-2023

Correspondence Address:
Dr. Liwen Liu
Department of Ultrasound, Xijing Hospital, Air Force Medical University, Xi'an
China

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2589-9686.376921

Abstract

INTRODUCTION: The goal of this study was to characterize consecutive patients in Northwest China treated with endovenous radiofrequency ablation (RFA) and foam sclerotherapy over a 10-month period in 2020.
METHODS: A total of 55 (31 men) patients were analyzed. An ultrasound examination was performed preprocedure and at set intervals up to 6 months postprocedure. The clinical-etiological-anatomical-pathophysiological classification, Venous Clinical Severity Score (VCSS), and heaviness, achiness, swelling, throbbing, and itching (HASTI) score were used.
RESULTS: Ultrasound confirmed 23 (41.8%) patients had unilateral disease and 32 (58.2%) had bilateral disease. Of the total 87 limbs, C2 predominated (42;48.3%). At 6 months postprocedure, VCSS improved in the C2, C4, C5, and C6 classes (P < 0.001); HASTI improved in the C2, C3, C4, and C5 classes (P < 0.001).
CONCLUSION: This is one of the few clinical characterizations of patients who had RFA and foam sclerotherapy in Northwest China. Overall, both the VCSS and the HASTI score demonstrated improvement postintervention.

Keywords: Color Doppler ultrasound, foam sclerotherapy, radiofrequency ablation, varicose veins of the lower extremities

How to cite this article:
Zhao Y, Yang Q, Zhao X, Dong Z, Chen X, Liu Z, Tang P, Xu H, Chi YW, Liu L. Clinical characterization of consecutive patients treated with endovenous radiofrequency ablation of the great saphenous vein in Northwest China. Vasc Invest Ther 2022;5:94-9

How to cite this URL:
Zhao Y, Yang Q, Zhao X, Dong Z, Chen X, Liu Z, Tang P, Xu H, Chi YW, Liu L. Clinical characterization of consecutive patients treated with endovenous radiofrequency ablation of the great saphenous vein in Northwest China. Vasc Invest Ther [serial online] 2022 [cited 2023 Jun 4];5:94-9. Available from: https://www.vitonline.org/text.asp?2022/5/4/94/376921

Introduction

Chronic venous insufficiency (CVI) is a common medical condition^[1] affecting approximately 26% of adults and a frequent cause of discomfort, loss of productivity, and poor quality of life.^[1],[2] Varicose veins of the lower extremities are typically due to venous hypertension caused by venous reflux and/or obstruction of venous flow and are characterized by venous tortuosity, dilation, skin changes, and/or ulceration in the lower extremities.^[3]

The incompetent great saphenous vein (GSV) and small saphenous vein (SSV) in patients with CVI have been managed with a variety of invasive and noninvasive interventions. Invasive procedures include high ligation and stripping, phlebectomy, foam sclerotherapy, and endovenous ablation. Noninvasive therapies primarily involve medication, compression therapy, leg elevation, weight control, and exercise.^[4] Over the past two decades, minimally invasive endoluminal treatment modalities have become viable alternatives to traditional surgery to address superficial venous reflux including ultrasound-guided foam sclerotherapy, radiofrequency ablation (RFA), endovenous laser therapy, endovenous microwave therapy, and nontumescent nonthermal mechanochemical methods such as ClariVein (Merit Medical, South Jordan, UT, USA) and VenaSeal Closure System (Medtronic, Minneapolis, MN, USA) with the goal of achieving equal or better efficacy than conventional surgery and reduced postoperative morbidity.^[1]

In China, despite the high prevalence of CVI, epidemiological data are scarce. The prevalence of CVI in China in 1998 was 8.9%.^[5] This number represented a lower estimation than that of the Bonn Vein Study,^[6] which showed an overall prevalence above 20%. Moreover, patient characteristics before and after endovenous intervention are largely overlooked. Therefore, the authors felt the need to better characterize Chinese patients with CVI using clinical criteria that included theclinical-etiological-anatomical-pathophysiological (CEAP) classification, the Venous Clinical Severity Score (VCSS), and the heaviness, achiness, swelling, throbbing, and itching (HASTI) score and duplex ultrasound findings to address the knowledge gap.

Methods

This study was approved by the Xijing Hospital institutional review board, and written informed consent was obtained from all patients.

A total of 55 consecutive patients who underwent RFA and foam sclerotherapy of the GSV were analyzed between July 2019 and April 2020 in Xijing Hospital (Xian, Shaanxi, China). The CEAP classification, the VCSS, and the HASTI score were used to clinically characterize the patients pre- and postprocedure. Preoperative examinations included a physical examination, ultrasound studies, and routine laboratory tests.

The distribution and extent of venous reflux and the vein diameter and closure rate were evaluated by color Doppler ultrasound (HITACHI Ascendus, Tokyo, Japan; probe L75, 5–18 MHz). Duplex ultrasound of the venous system was performed on the patients in a standing position. A GSV reflux ≥0.5 s from the saphenofemoral junction (SFJ) to the distal thigh with a vein diameter ≥3 mm in addition to clinical CVI symptoms were the indicators for intervention. Patients with deep-vein thrombosis, deep-vein reflux, or acute superficial vein thrombosis were excluded from the analysis. The diameter of the GSV was measured at points 2 cm below the SFJ, mid-thigh, and distal thigh; the largest diameter of the assessed segment was recorded. Patients were categorized as having unilateral or bilateral disease. All the procedures were done in an outpatient office.

One of the three experienced physicians performed the procedures. The GSV and associated varicose veins were marked preoperatively. The patient's leg was prepared with an antiseptic solution and draped in a sterile fashion. The procedure was performed with the patient under local anesthesia (lidocaine hydrochloride 1%). Under ultrasound guidance through a micropuncture access, a 7 Fr sheath was cannulated over a guide wire and a radiofrequency catheter was placed through the sheath just above the knee. Its tip was positioned 3 cm distal to the SFJ. Tumescent anesthesia was prepared as a 1:1000 lidocaine-to-normal saline mixture and infused along the GSV segment intended for ablation. RFA was performed using ClosureFast catheters (Medtronic®, Minneapolis, MN, USA). Radiofrequency energy was delivered at 120°C. Each 7-cm venous segment was treated in a 20-s cycle with segmental pullback.

Associated varicosities were treated by foam sclerotherapy in the same sitting. To perform ultrasound-guided foam sclerotherapy, foam was prepared by connecting two 10 ml syringes using a three-way stopcock. The sclerosant, 0.5% aethoxysklerol (Kreussler Pharma, Wiesbaden, Germany) was mixed with room air at a 1:4 liquid-to-air ratio. No more than 10 cc of foam was injected in any given session. Under real-time ultrasound guidance, the varicosities were injected with foam sclerotherapy at multiple points.

External compression was applied manually over the treated segment. A crepe bandage was applied from the foot to the groin along with a compression stocking. The patient was advised to walk for 30 min after the procedure. The compression stocking was routinely worn on average for 1 month.

Study visits took place at baseline, the time of the procedure, then 3 days, 1, 3 weeks, 1, 3, and 6 months following the procedure. Ultrasound assessment was performed to evaluate the occlusion rate of the GSV, which was defined as no blood flow in the treated segment of the GSV, and the distance of the GSV thrombosis to the SFJ was recorded. The CEAP score was used to categorize the patients; the VCSS and the HASTI score were used for clinical assessment. Side effects and complications were reported.

Statistical analyses

All statistical analyses were performed using the Statistical Package Prism 8 (GraphPad Software, San Diego, CA, USA). For normal distribution data, the results were expressed as the mean ± standard deviation (SD). The two-way analysis of variance test was used to analyze the quantitative data. To test for the probability of significant differences among the samples from the various groups, the Student's t-test was used for paired or unpaired data (two-tailed). Continuous variables were expressed as median ± SD and P < 0.05 was considered statistically significant.

Results

Fifty-five consecutive patients (31 men and 24 women) with a total of 87 limbs were analyzed. The average age was 54.6 ± 10.3 years (range, 31–89 years). The mean body mass index was 24.4 ± 3.0 kg/m² (range 18.7–30.4 kg/m²). The mean diameter of the GSV was 8.7 ± 2.9 mm. The mean length of GSV treated was 25 ± 6.3 cm. Patient characteristics are summarized in [Table 1].

Table 1: Patient demographics

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Of the 87 limbs, C2 predominated in 42 (48.3%) limbs [Table 2]. Duplex ultrasound confirmed that 23 (41.8%) patients had unilateral disease and that 32 (58.2%) had bilateral disease. The primary etiology was present in 82 (94.3%) limbs, and all 87 (100%) limbs had GSV incompetence [Table 2].

Table 2: Characteristics of clinical-etiological- anatomical-pathophysiological clinical scores

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The mean diameters of the GSV at baseline, on posttreatment day 3 and at 1, 3 weeks, 1, 3, and 6 months were 8.7 ± 2.9 mm, 7.5 ± 3.9 mm, 7.1 ± 2.8 mm, 6.8 ± 2.4 mm, 6.6 ± 3.2 mm, 6.0 ± 2.7 mm, and 2.6 ± 0.4 mm, respectively. The overall trend indicated that the GSV diameter incrementally diminished from baseline to 6-month follow-up [F = 39.45; P < 0.001, [Figure 1]a]. The distance from the tip of the GSV thrombosis to the SFJ at 1 week and at 3 weeks, 1, 3, and 6 months was 2.3 ± 1.7 mm, 2.0 ± 1.9 mm, 1.9 ± 0.6 mm, 1.4 ± 1.0 mm, and 1.3 ± 1.0 mm, respectively. This distance was incrementally less at the 6 months than at the 1-week postprocedure follow-up [F = 29.59; P < 0.001, [Figure 1]b].

Figure 1: (a) Changes in the mean diameter of GSV over time. (b) The distances from the tip of GSV thrombosis to SFJ over time, *P < 0.001. GSV: Great saphenous vein, SFJ: Saphenofemoral junction

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In comparison to baseline, at the 6-month follow-up, all C classes indicated a trend of improvement according to the VCSS and the HASTI score. C2, C4, C5, and C6 demonstrated the strongest improvement in VCSS compared to baseline (P < 0.001) [Figure 2]a. The HASTI score followed the same trend: Significant improvement was evident in C2, C3, C4, and C5 at the 6-month follow-up [P < 0.001, [Figure 2]b].

Figure 2: Relationship between VCSS (a) and HASTI (b) according to CEAP class *P < 0.001. CEAP: Clinical-etiological-anatomical-pathophysiological, VCSS: Venous Clinical Severity Score, HASTI: Heaviness-achiness-swelling-throbbing-itching

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The ulcer healing rate for C6 patients at the 6-month follow-up was 100% (6/6). The 6-month assessment showed a GSV occlusion rate of 100% (87/87 limbs). Technical success was achieved in all patients. There were no procedural-related complications. One (1.1%) limb developed superficial thrombophlebitis and was managed using nonsteroidal anti-inflammatory medication. Pigmentation occurred in the majority of patients but dissipated gradually within weeks to months in most cases. No deep venous thrombosis, pulmonary embolism, or transient blindness were reported.

Discussion

CVI is the most prevalent vascular disorder worldwide; it affects at least 25% of the adult population.^[7] In the Vein Consult Program,^[2] more than 91,000 participants in various geographic regions were evaluated. The authors concluded that the worldwide prevalence of CVI was around 60% and that the incidence was even higher in developed countries.^[8] In the United States, approximately 23% of adults have varicose veins; more commonly they are women and older adults (40–80 years).^[9] Based on a study published in 2006, the prevalence of CVI in China was close to 10%, slightly higher in women.^[10] This number represented a lower estimation compared to that of the Edinburgh Vein Study,^[3] which indicated a much higher prevalence rate of 18%.^[11]

A recent study based on a survey of the practice patterns of 681 vascular specialists in China demonstrated that traditional surgery was the mainstay of treatment for varicose veins at 64% versus 30% for endovenous thermal ablative methods.^[12] Related issues, such as clinical class of disease, deep-vein reflux and obstruction, medical insurance, and local economy and customs may have influenced the physician's choice of treatment.^[12] However, qualitative and quantitative clinical assessments were not routinely used in practice.^[13]

In our study, the mean age of presentation was 54.6 years, with more men (56.4%) than women. This finding contradicted the findings of other population-based epidemiological analyses, which suggested a female predominance in CVI. This finding could be due to geographic bias, because in the Northwestern region of China strenuous labor such as farming and mining are common occupations and are typically held by men.^[13]

Many studies have demonstrated high saphenous vein occlusion rates of RFA in the short and medium term. In Japan, Tamura and Maruyama reported 99.4% occlusion of the treated veins, and partial recanalization was observed in one limb.^[14] In Germany, Proebstle et al. reported 295 GSVs treated by RFA, achieving an initial vein occlusion rate of 100%.^[15] Moreover, Perrin and Rasmussen et al. both showed the high occlusion rates of RFA in the short and medium term.^[16],[17] Kayssi et al. reported an occlusion rate of 99% during the follow-up period.^[18] In our study, the GSV occlusion rate was 100% at 6 months, which is consistent with results in published reports.

Endovenous ablative methods for venous ulcer healing have become one of the main management modalities due to their high efficacy. Zhu et al. retrospectively studied 35 patients from Eastern China who underwent ultrasound- and fluoroscopy-guided foam sclerotherapy that resulted in an ulcer-healing rate of 100% and a 1-year recurrence rate of 2.9%.^[19] Kulkarni et al. reported an ulcer healing rate of 91.2% and a recurrence rate of 4.7% at 1 year after ultrasound-guided foam sclerotherapy.^[20] Grover et al. managed 54 venous ulcers with foam sclerotherapy and achieved a healing rate of 88% at 5.3 months and a recurrence rate of 9.2% at 1 year.^[21] We achieved 100% ulcer healing at 6 months.

The VCSS and the HASTI score are internationally recognized assessment tools to evaluate the severity of CVI. In our study, both scores demonstrated overall improvement in clinical status after the procedure. The VCSS showed a significant improvement in the C2, C4, C5, and C6 classes at 6 months, and the HASTI score showed a similar finding in the C2, C3, C4, and C5 classes during the same period. The reason why such improvement was not statistically significant across all C classes may be due to the small sample size. For example, C6 had the lowest number of patients yet both the VCSS and HASTI score demonstrated quantitative and qualitative improvement 6 months postprocedure compared to baseline; only VCSS reached statistical significance. Moreover, these improvements were based on addressing only GSV and associated varicose veins, whereas 38%–57% also had concomitant SSV and/or perforator vein reflux, which was not addressed in this study. In other words, addressing only the GSV in the setting of concomitant SSV and/or perforator vein reflux enabled us to achieve satisfactory outcomes in this patient population.

Limitations

The study must be interpreted with caution due to several limitations. First, the interrelation between the VCSS and the HASTI score was not studied because of the small sample size. Second, 38%–57% of the patients had either SSV and/or perforator vein reflux, which may affect the final outcome because only GSV was addressed. Nevertheless, the trend toward improvement was obvious across the CEAP classes: some were statistically significant, whereas others were not. Third, as previously mentioned, the improvement based on the VCSS and the HASTI score was not statistically significant across all C classes and was likely related to the small sample size, which could be overcome with an increase in the number of participants. Finally, the effect of the deep system on treatment outcome was not addressed because those with deep venous reflux were excluded from the analysis.

Conclusion

This study represents one of the few clinical descriptions of patients with CVI who underwent treatment in Northwest China. Although this study was limited by the small sample size, the results of endovenous RFA appear very encouraging. Overall, the clinical outcomes and duplex ultrasound features were consistent with those found in the literature.

Acknowledgments

The authors would like to thank the participants of the study.

Financial support and sponsorship

The project was supported by grants from the National Natural Science Foundation of China (No. 8181708) and China Postdoctoral Science Foundation (No. 2021T140795) to QY and from the Xi'an Science and Technology Plan Project (No. 21YXYJ0134) to QY.

Conflicts of interest

There are no conflicts of interest.

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