Introduction

Varicose veins (VVs) are the most frequent pathology of peripheral vessels which affects 20—40% of adult population in the western country [1, 2]. If not managed the disease can lead to chronic venous insufficiency (edema, hyperpigmentation, venous eczema, lipodermatosclerosis, ulcer). Endovenous ablative methods are now accepted as the gold standard of VVs invasive treatment worldwide [3]. Despite this, some phlebologists are actively using the CHIVA (Conservatrice et Hémodynamique de l’Insuffisance Veineuse en Ambulatoire) method of hemodynamic correction, which was developed by the French angiologist C. Franceschi [4]. The aim of the CHIVA strategy is to restore physiological blood flow without saphenous trunks removing. One of the main CHIVA principles is to interrupt reflux from deep to saphenous veins. The trunks of great and/or small saphenous veins remains preserved to keep superficial tissues drainage. A Cochrane systematic review confirmed that the CHIVA is as effective method as stripping and may reduce nerve injury and bruising rates [5, 6]. In its original form CHIVA is performed by open ligation of the GSV at the saphenofemoral junction (SFJ) [4]. This became a serious disadvantage after the widespread endovenous techniques. To avoid open surgery approach S. Gianesini et al. suggested joint use of endovenous ablation and CHIVA principles [7]. This new combination was first called the hot-CHIVA method by Erika Mendoza at the conference in Dresden 2016. It includes ablation of the only one segment of GSV trunk near SFJ. Thus, the GSV trunk remains preserved while reflux from the deep vein is eliminated. The results of further researches were promising [8–10].

Aim — to compare GSV radiofrequency ablation of the only segment close to SFJ and preservation of the rest of the GSV trunk (hot-CHIVA) and conventional GSV ablation of the whole refluxing GSV in VVs patients.

Material and methods

Study design

This was a single-center, prospective, non-randomized, non-inferiority comparative study conducted on patients with primary VVs. Patients were enrolled from November, 2019 to February, 2021.

Inclusion criteria were disease described as C2EpAsPrGSVa, C2,3EpAsPrGSVa according to CEAP [11], with reflux not lower than upper part of the calf, age ≥18 years, SFJ diameter ≤ 15 mm, incompetence of terminal valve, GSV reflux ≥ 0,5 sec, re-entry perforator on the thigh or upper part of the calf for patients in the hot-CHIVA group. Exclusion criteria were C4—C6 classes CEAP, pregnancy, deep vein reflux ≥ 1 sec, SSV reflux ≥ 0,5 sec, interventions for VVs prior to the inclusion. Those unwilling to sign an informed consent were also excluded. The study protocol was approved by Local ethical committee of our university (December 2019, Protocol ID 192). The protocol was registered at clinicaltrials.gov (NCT05372146).

All patients were examined clinically. Age, height, weight, body mass index, gender, side of disease, personal history of VVs were recorded. Medical history was taken. Disease description was made using advanced CEAP classification. QoL was measured by CIVIQ-20 which is a disease-specific questionnaire for patients with chronic venous disease [12] and postprocedural pain on the operated leg was measured with a 10-cm visual analogue scale (VAS).

Duplex ultrasound was performed in a standing position to access deep veins and GSV. We recorded reflux extension and presence of re-entry perforators on a thigh or upper calf. Diameter of GSV near SFJ, at the middle, and lower part of the thigh was measured at inclusion in the both groups.

Procedure

In the study group (hot-CHIVA group) GSV was punctured 20—25 cm below SFJ. Radiofrequency catheter (ClosureFast) was inserted and positioned at SFJ distally to the superficial iliac circumflex vein. Four cycles were used for the one segment below SFJ. Catheter was retrieved after its temperature cooled down to 40 °C (Fig. 1). In controls GSV was punctured at a distal part of a refluxing segment. The catheter was positioned at SFJ and conventional radiofrequency procedure was performed with four cycles below SFJ and two cycles for every next segment (Fig. 2).

Fig. 1. Hot-CHIVA procedure scheme.

Fig. 2. Conventional RFA procedure scheme.

After thermal ablation phlebectomy was performed using Varady hooks in both groups. All procedures were performed under tumescent anesthesia.

End-points

The primary end-point was QoL measured by CIVIQ-20 one year after the procedure.

Secondary end-points were VVs recurrence at 12 months, postprocedural pain measured with 10-cm visual analogue scale (VAS) at 3 months. In the study group remained GSV trunk diameter at mid- and lower thigh was measured at 1, 3, 6, 12 months after procedure.

Sample size

The sample size was calculated considering the non-inferiority limit of 5 QoL score of CIVIQ-20 between groups at 12 months after procedure, with a pooled standard deviation (SD) of 6.95 which was obtained by reviewing the literature [13]. The type 1 error was set at 0.025, the power of the study at 0.90. Drop-out rate in both groups was set at 5%. Thus, we needed to involve 43 patients for each group.

Statistical analysis

Data are presented using descriptive statistics. Normally distributed data are presented as mean with SD. Not normally distributed data are presented as median (Me) and interquartile range (Q₁—Q₃). Because the data of the primary end points were not normally distributed, nonparametric Mann—Whitney U tests were used for analysis. For the primary outcome we used one-tailed Mann—Whitney U tests with the null hypothesis: the control group — the study group ≥ 5; thus, values of p<0.025 were considered significant (I error, 2.5%). For group comparisons of all other metric variables, the Mann—Whitney U test was used for independent groups and the Wilcoxon signed rank test for related groups. Categoric variables were compared by Pearson's chi-squared test or Fisher exact test. Values of p ─ 0.05 were considered significant for all tests.

Results

We recruited 43 patients into each group. Characteristics of both groups’ patients are presented in Table 1. There was no difference registered in age, gender, family history of VVs, disease duration, BMI, CEAP class, QoL score, leg discomfort, diameter of GSV at SFJ.

Table 1. Characteristic of the groups before procedure (n=86)

Four patients were lost for one year follow-up. Thus, data on primary end-point were analyzed in 41 patients in each group. QoL significantly improved at 1 month after treatment already in both groups (Fig. 3). QoL significantly improved after 12 months in both groups with no difference between groups — 96.25 (92.5—100.00) and 95.00 (91.25—98.75) (p=0.001).

Fig. 3. QoL before and after procedure.

Two patients (4.9%) in each group presented with recurrent varices after 12 months (p=1.0). Postprocedural pain did not differ in groups (Table 2).

Table 2. Postprocedural pain measured by VAS

Note. * — p-value for two-sided Mann—Whitney U test.

Significant reduction in GSV diameter at mid-thigh from 0.55 (0.48—0.64) to 0.31 (0.25—0.38) and distal thigh from 0.5 (0.43—0.6) to 0.31 (0.26—0.41) was recorded at 12 months (p=0.001). Significant decreasing of GSV diameter was observed at 1 month follow up already (Table 3).

Table 3. GSV diameter in hot-CHIVA group during follow up

Discussion

In this prospective study we compared outcomes of conventional RFA of GSV with thermal ablation of only one segment of GSV close to SFJ. We confirmed that the hot-CHIVA is not inferior to conventional thermal ablation in improving QoL at 12 months after procedure. No differences in QoL, VVs recurrence rate and postprocedural pain between both groups patients were registered.

Data on the combination of hemodynamic correction principles with endovenous ablation are scarce. S. Gianesini et al. presented one-year results of a small study on 14 patients operated by hot-CHIVA technique. GSV reflux suppression and a GSV caliber reduction at 15 cm below SFJ (from 9.4±0.5 to 3.1±0.2 cm; p<0.001) was observed. Moreover, VCSS improved from 7±2 to 2±1 (p<0.05) [8]

The same researchers have later reported data on radiofrequency and laser ablation of the 6 cm segment of GSV close to the saphenofemoral junction [10]. The primary end-point was technical success at 1 year follow up. Obliterated segment recanalized in 5/85 (5.8%) cases, two after radiofrequency and three after laser ablation. Reflux recurrence was observed in two cases, one after each thermal technique. A significant decrease in the GSV diameter was observed in the RFA group (from 5.8±1.1 to 3.5±0.5 mm; p<0.0001) and in the EVLA group (from 5.6±0.9 up to 3.4±0.6 mm; p<0.00001). There were no significant differences between ablation methods in clinical severity on the VCSS scale, periprocedural pain, or aesthetic satisfaction [10].

E. Mendoza and F. Amsler reported data on 104 patients who underwent thermal ablation of the first segment of GSV [9]. Decrease in the diameter of GSV at upper thigh was registered. No differences in the results depending on the method of thermal ablation were observed [9]. Results of the hot-CHIVA were comparable to those of classical CHIVA [14—16].

We confirmed previously published data on GSV shrinkage after the hot-CHIVA. We observed decreasing of GSV diameter after 1 month follow-up with the lowest diameters registered at one year after the procedure. We have also confirmed Gianesini et al. data regarding clinical improvement after the hot-CHIVA [10]. They used a VCSS score, while we measured QoL by CIVIQ-20. The CIVIQ-20 score increased significantly which confirmed the clinical effect of procedure. Besides, not only that we obtained similar results as in published papers, but we have also compared such important outcomes as postprocedural pain measured by VAS and VVs recurrence rates to what happened in patients who underwent conventional thermal ablation. We found no difference between groups. Thus, less invasive vein-sparing technique was proved to be as effective as standard procedure at one year follow up [10].

Nowadays, the endovenous ablative methods including RFA are accepted as the gold standard for VVs invasive treatment worldwide [3]. RFA leads to low number of recurrences, has a high reflux free rate at five years, and a good improvement in the QoL, compared to high ligation and stripping, as well as sclerotherapy. Patients after thermal ablation have less pain and swelling than after surgery which leads to quicker recovery and faster return to normal activities [3, 17, 18]. At the same time, there could be some adverse events that are related to the thermal injury of the saphenous trunks. Among them are hyperpigmentation, skin burns, and skin retraction above the ablated vein [19, 20]. On the other hand, vein-sparing procedures have recently become more and more popular in practice of phlebologists around the world [21, 22]. To date, all studies of the open CHIVA method have shown good early and long-term results, with the same recurrence rate, and improvement of QoL as the thermal ablation [6]. Thermal ablation of only short segment of refluxing GSV close to SFJ looks attractive as it allows to avoid open access to SFJ to interrupt reflux from the deep venous system. Besides that, hot-CHIVA has less risk of a thermal damage of due to limiting procedure to a short vein segment. Thus, the hot-CHIVA retains the benefits of thermal obliteration but at the same time according to CHIVA approach saves the GSV trunk distally to SFJ and reduce risks of adverse events. Combination of hemodynamic principles with thermal ablative techniques makes CHIVA more appealing for physicians as it allows to skip open ligation of saphenous trunk.

Limitations

The main limitations of our study are a non-randomized design and relatively short follow up period. It is worth to mention also that hot-CHIVA can be used only in selective patients who have re-entry perforators.

Conclusions

Segmental thermal ablation of GSV close to saphenofemoral junction (hot-CHIVA) is as effective as conventional whole refluxing GSV trunk thermal ablation at one year follow up in selected patients.

Author’s contributions:

Research conceptualisation and design — I.A. Zolotukhin, V.I. Golovina

Collection and processing of data — I.A. Zolotukhin, E.I. Seliverstov, O.I. Efremova, V.I. Golovina

Statistical data processing and analysis — V.I. Golovina, V.A. Panfilov

Writing — V.I. Golovina

Editing — I.A. Zolotukhin

Conflicts of Interest: The authors declare that there is no conflict of interests.

Funding information: This research received no funding.

Ethics approval: Study protocol was approved by the ethical committee of Pirogov Russian National Research Medical University (No. 192, 21.12.2019) and was registered at clinicaltrials.gov as NCT05372146.

Consent to participate: All participants have agreed to be included in this clinical study and provided a written informed consent.

Data Availability statement: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.