The prevalence of chronic venous disease (CVD) is fairly well known, as many epidemiological studies have already been conducted around the world [1—3]. Approximately one-third of men and women aging between 18 to 64 years are suffering from varicose veins [4, 5].

According to traditional descending pathophysiological concept of varicose veins development, the onset and subsequent progression are associated with the appearance of reflux in the main trunk of GSV, which leads to varicose transformation of its tributaries. Therefore, the ablation of an incompetent GSV in patients with varicose veins has been the gold treatment standard for many years as it eliminates reflux, which is considered as a cause of the disease.

In the last decade, a new concept describing varicose veins development, has been actively discussed. It suggests that at least in many cases, a first step of the disease is not the reflux in great or small saphenous veins, but varicose transformation of its side branches. Dilatation of the tributaries leads to a reflux development in the saphenous trunk. Accordingly to this view, reflux has to be considered as a secondary phenomenon and therefore may disappear after the elimination of the causative factor. The disappearance of GSV reflux in majority of the limbs operated by isolated phlebectomy was demonstrated and confirmed in some studies [6, 7]. This approach was called ASVAL by its inventor P. Pittaluga.

The short-term and mid-term results have shown that treatment by ASVAL can lead to regression or elimination of GSV reflux with no recurrence of varicose veins in many patients [5, 8, 9]. But vascular specialists still keep skepticism about this approach due to its significant contradiction to standard approaches and the lack of supporting data, including long-term results.

The objective of our study was to assess recurrence rates of VVs and GSV reflux at 1, 2, 3, 4 and 5 years after ASVAL procedure.

We conducted a prospective study on the patients with primary VVs. Inclusion criteria were C2 or C2,3 or C2,4 disease with GSV reflux not lower than upper third of the calf. Exclusion criteria were history of deep or superficial vein thrombosis, open or healed venous ulcer (C5—C6), GSV reflux in the mid- and distal calf, concomitant small saphenous vein reflux on the limb which we were going to operate on, tortuosity of GSV, diameter of GSV of more than 1.5 cm in any segment and absence of reflux in GSV. We also excluded patients who had VVs interventions prior to the inclusion (stripping, phlebectomy, endovenous laser or radiofrequency ablation and sclerotherapy) and those who were unwilling to sign an informed consent. The study protocol was approved by local ethical committee.

We collected demographic data and medical history. During the clinical investigation, we recorded the location and extent of all VVs, presence of edema and trophic changes. We calculated so-called NZT rate (number of zones to be treated) proposed by the P. Pittaluga, et al. [6, 9]. We conducted duplex ultrasound to assess the status of the deep and superficial venous system. The presence of pathological reflux in GSV trunk and its extent were recorded. To provoke reflux, we used a distal compression maneuver. Reflux duration of more than 0.5 s was considered as pathological.

All the patients underwent ASVAL procedure under local anesthesia with 0.1% lidocaine and light sedation (benzodiazepine). The first incision was made just below the proximal connection of a dilated tributary to the GSV. The side branch was carefully ligated with a small stump, so as not to damage the GSV. The dilated tributaries have been removed by phlebectomy. After procedure we applied compression class 2 stockings. Patients were allowed to walk as soon as possible. Prophylactic doses of low-molecular-weight heparins were prescribed for five to ten days after procedure.

We assessed the rates of legs free from VVs and GSVs free from reflux. As VVs recurrence, development of new dilated tributaries on the operated leg was considered, no matter in the region where operation had been performed or in the other zone. Reflux was defined the same way as the primary phenomenon was.

Patients were examined at 12 months and then every 2, 3, 4, 5 years, both clinically and by duplex ultrasound.

Data are presented as numbers and percentages, means with a standard deviations (SD). To assess reflux absence and VVs recurrence we Kaplan-Meier analysis was performed with XLSTAT program.

We operated on 92 patients (102 limbs) with primary VVs. Among them there were 59 women (64%) and 33 men (36%). Age varied from 17 to 71 years, mean age was 46.9 (SD 13.9). Mean BMI was 26.2 (SD 5.22), min — 18.7, max — 38.5 kg/m.

Limbs were classified as C2 in 82 (80%), C2,3 in 16 (16%) and C2,4 in 4 (4%) cases according to CEAP classification. The NZT ranged from 2 to 13, mean was 9.5 (SD 7.78).

All patients were examined at all time points of the study.

GSV reflux was confirmed by duplex ultrasound before the operation in all the legs. Survival curve analysis showed 68.3% rate of GSVs free of reflux at 12 months, 52.7% — at 24 months, 46.4% — at 36 months, 44.1% — at 48 months and 32.4% — at 60 months .

89,2% legs were free from VVs at one year . The rates were 77.3%, 66.9% 53.5% and 33.7% at 2, 3, 4 and 5 years respectively.

As we revealed in our previous analysis better chances to get a good results had patients with a short refluxing segment of GSV [5]. We performed additional analysis in a sub-group of 67 operated limbs with the GSV reflux not lower than mid-thigh before surgery.

At 5 years cumulative rate of reflux free in this subgroup was slightly higher, i.e. 41% , as well as legs free of VVs rate — 37.4% .

In this study we have analyzed up to 5-year results of ASVAL procedure, which is aimed to preserve GSV trunk from ablation. We performed isolated tributaries removal by phlebectomy on 102 limbs in 92 patients with primary VVs. We followed patients annually and assessed the rates of GSVs free of reflux and legs free of varicose veins.

We have found that cumulative rates of excellent clinical (no new VVs) and hemodynamic (no reflux) results are 33.7% and 32.4% respectively.

The data on the mid- and long-term results of ASVAL procedure are scarce. There are some papers, that discussed short-term results of isolated phlebectomy, that seem to be good [5, 6, 8, 10]. But there is only one study, that assessed mid-term outcomes. P. Pittaluga, et al. confirmed no reflux in 69.2, 68.7, 68 and 66.3% cases at one, 2, 3 and 4 years after ASVAL procedure [9]. Rates of limbs free from VVs were 95.5, 94.6, 91.5, and 88.5%, respectively. The same team of researchers also assessed results up to 10 years [11]. The absence of s reflux was found in 69.7% cases at 5 years, in 68.5% at 7 years and in 64.4% at 10 years. The absence of varicose veins recurrence was observed in 84.7, 75.5 and 68.8%, respectively.

Our data significantly differ from P. Pittaluga’s, et al. Even when we conducted a sub-group calculation on the legs with GSVs refluxing not lower than to mid-thigh, we still observed the clear difference. Results were better in this subgroup. Cumulative rates of GSVs competence was 41%, rate of legs free of VVs was 37.4%. But, they remained lower than our French colleagues observed. As of now, no clear explanation to this can be given. The possible reason for the difference is that we conducted our studies in different settings. As our colleagues recruited their patients in a private center in a highly developed region, we included patients in a public health care system conditions in the less developed country.

It has to be said, that the harmful impact of reflux persistence in GSV after ASVAL procedure seems to be questionable. Reflux persistence may often be explained by presence of the pre-existed or formation of new re-entry perforators [12]. We found them in 18 limbs with persistent GSV reflux. However, in all these cases there were only 4 recurrences. We believe that persisting reflux in a preserved GSV with a re-entry perforator will have a limited impact on disease recurrence. It was confirmed that even if the reflux did not disappear after ASVAL, the volume of reflux decreased with significant clinical improvement [13], which means that we can ignore the reflux if no VVs are connected to this segment and simply follow the patient further.

The reflux remaining after an isolated miniflebectomy can be also explained by the fact that the ascending theory, underlying ASVAL principles, is not the only concept of disease progression. It may have a descending way in its basis. So, it is not surprising that the preservation of the main trunk will not lead to a regression of reflux, since the cause remains unresolved.

Despite the VVs recurrence rate seems to be rather high, re-operations were performed in only 3 cases. We ablated incompetent trunks by radiofrequency method and conducted concomitant phlebectomy. Other cases were treated by sclerotherapy.

At glance, our results may be considered as unsatisfactory, especially from traditional point of view. Reflux and VVs recurrence were frequent. On the other hand we saved every third GSV and got excellent clinical results with no new VVs in every third patient, too. These results are not significantly worse than results of approaches that are based on a saphenous trunk ablation methods. This was confirmed by L. Rasmussen, et al. who revealed reflux recurrence around 50% after stripping, laser and radiofrequency ablation and need for re-intervention in about 40% [14].

Our study has some limitations. Those are non-comparative design and small sample size. We also did not measure patient’s quality of life and did not register venous symptoms before and after procedure.

ASVAL procedure leads to reflux disappearance in incompetent GSV in more than half cases at mid-term follow up. One third of GSVs remains competent after 5 years. Every third limb after vein-sparing operation remains free from new VVs during 5 year follow up period. The results are slightly better if the GSV reflux at the baseline was not lower that mid-thigh. ASVAL method should be considered as one of the options for VVs patients.

Research conceptualisation and design — I.Z.

Collection and processing of data — I.Z., E.S., O.E., E.Z.

Statistical data processing and analysis — S.M., E.S., O.E., E.Z.

Writing — S.M., I.Z.

Editing — I.Z.