Short-term results of isolated phlebectomy with preservation of incompetent great saphenous vein (ASVAL procedure) in primary varicose veins disease

Abstract

Objective

To establish an effect of isolated phlebectomy in patients with incompetent great saphenous vein (Ambulatory Selective Varices Ablation under Local anesthesia (ASVAL) procedure) on the reflux and diameter of the trunk and to assess recurrence rate of varicose veins at one year.

Material and methods

We conducted a prospective study on patients with primary varicose veins and with C2 or C2,3 or C2,3,4 or C2,4 classes of chronic venous disease and great saphenous vein incompetence. The study included 67 patients (51 women and 16 men; 75 limbs in total). Age varied from 17 to 71 years; mean age was 46.8 years (SD 13.9). We recorded the presence or absence of reflux in the great saphenous vein with duplex ultrasound before and after surgery. The recurrence of varicose veins was evaluated at 12 months. All the patients underwent isolated phlebectomy with preservation of incompetent great saphenous vein (ASVAL procedure) under local anesthesia.

Results

At one year after removing of tributaries of the incompetent trunk, 66% of them were competent. Reflux persisted in 17% of great saphenous veins with reflux above mid-thigh and in 61% of trunks with reflux extended below the mid-thigh (p = 0.0004). The diameter of all the veins decreased significantly no matter reflux disappeared or not. Varicose veins reoccurred in 13.5% cases. In 6.5% of limbs with a reflux above the mid-thigh, the recurrence was registered at one year, while in the limbs with the reflux below the mid-thigh at a baseline, the recurrence rate was 25% (p = 0.036).

Conclusion

Isolated phlebectomy with a preservation of incompetent great saphenous vein leads to disappearance of reflux in a majority of cases and to significant decrease of vein diameter in all the cases. ASVAL procedure could be considered as a less aggressive and less expensive approach in selected cases. Clear indications for isolated phlebectomy need to be established.

Keywords

Varicose veins isolated phlebectomy ASVAL

Ablation of incompetent great saphenous vein (GSV) in patients with primary varicose veins (VVs) is considered to be a mandatory part of any invasive treatment, such as stripping or more recent methods of endovenous thermal or chemical ablation.^1,2 This is a widely accepted approach which is based on a traditional view on disease development that explains the progression of VVs from the saphenous vein to the tributaries in a descending fashion.

In the past decade, other approaches known as vein sparing or hemodynamic have shown its efficacy in the treatment of VVs.³ Vein sparing techniques are based on different concepts of primary VVs origin that have been actively discussed in the literature.^4–6 The main one is the ascending theory of the VV disease evolution. It hypothesizes that at least in many cases, a first step of the disease is not the reflux in great or small saphenous veins, but varicose changes in its tributaries. 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 effect and therefore may disappear after 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.^7–9 Today, this approach is known as the ASVAL procedure (Ambulatory Selective Varices Ablation under Local anesthesia), but it faced a skeptical opinion of vascular specialists due to significant contradiction to the standard treatment base and lack of confirming data including long-term longitudinal and randomized controlled studies.

The primary aim of our study was to assess recurrence rate of VVs at one year after ASVAL procedure and the secondary aim was to establish whether the effect of the procedure on reflux and diameter of incompetent GSV plays a role in the results observed.

Materials and methods

Study group

The study protocol was approved by local ethical committee. All patients provided written informed consent. We conducted a prospective study on patients with primary VVs. We included consecutive patients with C2 or C2,3 or C2,3,4 or C2,4 classes of chronic venous disease (advanced CEAP classification),¹⁰ GSV reflux not lower than upper third of the calf (as more distal reflux has low chance to disappear as it has been shown before⁸), with unilateral or bilateral disease, willing to sign an informed consent and without exclusion criteria. Those were previous deep vein thrombosis or GSV thrombosis on the leg with VVs confirmed clinically or by duplex ultrasound, open or healed venous ulcer (C5-C6), GSV reflux in the mid- and distal calf, concomitant small saphenous vein reflux (in order to have a more homogeneous cohort) 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 had VV interventions prior to the inclusion (stripping, phlebectomy, endovenous laser or radiofrequency ablation, and sclerotherapy). Out of 142 patients being referred for VV surgery to university clinic, 67 patients with 75 eligible limbs were included between February 2014 and March 2015.

We collected data on age, sex, and duration of VVs. During the clinical investigation, we recorded location and extent of all VVs, presence of edema and trophic changes. For the estimation of the varicose reservoir extent, we used the score that was described by Pittaluga et al.^8,9 and called “number of zones to be treated.” A limb was divided into 32 zones with 8 zones on every side of the limb (anterior, posterior, medial, and lateral). Then the total number of zones in which we have found varices was calculated (Figure 1).

Figure 1.

Preoperative calculation of a number of zones to be treated. Patient has varicose veins both on anterior and medial parts of the thigh and calf. Six zones have to be treated.

Assessment of GSV was made by duplex ultrasound with patient in a standing position. The GSV was firstly visualized at glance from saphenofemoral junction (SFJ) down to a foot. If no tortuosity or aneurisms were found, we checked the reflux along the GSV. To provoke reflux, we used a distal compression maneuver. Reflux duration of more than 0.5 s was considered as pathological. The diameter of GSV was measured near SFJ right below superficial epigastric vein and at upper thigh approximately 15 cm below the inguinal fold. Duplex ultrasounds were performed by the same certified specialists from study team (IZ and EZ) before the operation and during the follow-up.

Procedure

All the patients underwent ASVAL procedure under local anesthesia with 0.1% lidocaine in a saline solution with epinephrine plus a minimal sedation with a patient kept awake (benzodiazepine). The first micro-incision had been made just below the proximal connection of a dilated tributary to the GSV which then has been ligated carefully with a small stump in order to not damage the GSV as it was suggested by the authors of ASVAL method. The dilated tributaries have been systematically and thoroughly treated by phlebectomy. At the end of the surgical procedure, we applied compression class 2 stockings. Patients were allowed to walk as soon as possible. Prophylactic doses of low-molecular-weight heparins were administered for five to seven days after the procedure according to a clinic’s protocol. The surgical procedures were performed by three surgeons (IZ, ES, and AK).

No additional procedures by thermoablation or sclerotherapy were performed during the surgical treatment. The need of any kind of additional procedures during the follow-up such as surgery, thermoablation, or sclerotherapy was considered as a failure.

Follow-up

Complications were recorded in the 30 days post-operative period. All the patients were seen six times: next day, one week, 1, 3, 6, and 12 months after procedure. Duplex ultrasound was performed at each visit. Reflux was evaluated and diameters were recorded. At one year, we looked for the clinical recurrence rate (visible VVs).

Statistical analysis

Descriptive statistics are presented as numbers and percentage for qualitative variables, with mean and standard deviation for quantitative variables. Continuous variables were compared using paired t-test. Nominal variables were tested by the two-tailed chi-square or Fisher’s exact tests. Statistical analysis was performed with VassarStats (open source online project). A p value of < 0.05 has been considered as statistically significant.

Results

Population

Sixty-seven patients with primary VVs were included and prospectively followed. There were 51 women and 16 men (3.2:1 ratio). Age varied from 17 to 71 years; mean age was 46.8 years (SD 13.9). The mean duration of VVs ranged from 1 to 55; mean was 15.2 years (SD 11.4). There were 75 limbs operated on with incompetent GSV and varicose tributaries. Only 9 (12%) limbs had competent SFJ with no reflux through the terminal valve, while in other 66 (88%) limbs SFJ was incompetent.

According to CEAP, limbs were classified as C2 in 63 (84%) cases, as C2,3 in 9 (12%) cases, and as C2,4 in 3 (4%) cases. Mean number of zones to be treated was 6.61 (SD 2.12) and ranged from 2 to 11.

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

Complications

We found GSV thrombosis on four operated limbs (5.3%) on a control duplex ultrasound next day after operation. One patient with a saphenofemoral thrombosis underwent crossectomy as it was demanded by clinic’s protocol. This patient presented with a significant dilatation of SFJ, the diameter measured at this point was 1.32 cm. She had unilateral disease and has been excluded from a further analysis.

In the three other cases, thrombus extended up to 5 to 10 cm from ligated tributary. Two of those patients had GSV trunk of more than 0.8 cm diameter, and in one patient, GSV was less than 0.8 cm. Intermediate doses (75% of treatment dose) of low-molecular-weight heparins were administered for one week. No extension of the thrombus was found at one week on duplex ultrasound. Next duplex examination at one month showed complete recanalization of all previously occluded segments of GSV in these three cases.

No deep vein thrombosis or pulmonary embolism, no infectious complications have been observed.

Reflux in GSV

On all the operated limbs, GSV reflux before the operation was confirmed by duplex ultrasound. As one patient with one operated limb and SFJ thrombosis after operation had been excluded from the study, a total of 74 limbs were followed further. We performed the first control by duplex examination the next day after phlebectomy and found 32 (43%) of GSV free of reflux. At one week, this share increased up to 74% (53 limbs) and remained more or less stable during the follow-up. At one year, 49 (66%) of GSV were competent. The percentage of GSV without reflux after ASVAL procedure during follow-up is given in Figure 2.

Figure 2.

Percentage of GSVs free of reflux during one year after ASVAL procedure (numbers under columns – limbs free of reflux out of the total number of limbs).

Among 25 refluxing GSV at one-year follow-up, the development of new varicose tributaries connected to the GSV was found in only nine cases. In the remaining 16 refluxing GSV, the reflux drained through a re-entry perforator into the deep veins.

We compared the rate of reflux persistence after one year according the extension of the preop GSV reflux above or below the mid-thigh. Only 8 out of 46 limbs (17%) with a preop GSV reflux above the mid-thigh had a persisting reflux at one year, while there were 17 out of 28 limbs (61%) for which the preop GSV reflux was extended below the mid-thigh had a persisting reflux at one year (p = 0.0004).

Diameter of GSV

The diameter of GSV at SFJ and upper thigh was compared in 72 limbs only since the GSV reflux was present only at lower thigh and upper third of a calf in two limbs and one limb was excluded from the analysis after crossectomy due to thrombosis of the SFJ. Before the ASVAL procedure, the diameter of the SFJ varied from 0.45 to 1.34 cm (mean 0.84, SD 0.20) and the diameter of the GSV at upper thigh from 0.35 to 1.12 (mean 0.61, SD 0.13). The GSV diameter decreased in all cases at postop control no matter the GSV reflux has disappeared or not (Table 1).

Table 1.

GSV diameter during follow-up (n = 72).

	Diameter at SFJ, mean (SD)	p^a	Diameter at upper thigh, mean (SD)	p^a
Before phlebectomy	0.84 (0.20)	–	0.61 (0.13)	–
Day 1	0.80 (0.19)	0.321	0.57 (0.11)	0.037
1 Week	0.80 (0.20)	0.297	0.57 (0.11)	0.018
1 Month	0.75 (0.18)	< 0.0001	0.50 (0.09)	< 0.0001
3 Month	0.73 (0.18)	< 0.0001	0.45 (0,09)	< 0.0001
6 Month	0.69 (0.18)	< 0.0001	0.44 (0,10)	< 0.0001
1 Year	0.67 (0.18)	< 0.0001	0.43 (0.11)	< 0.0001

p-level of comparison diameters at baseline and on control examinations.

Illustration of the influence of ASVAL procedure on GSV diameter is shown on Figure 3.

We compared the diameter of the veins near SFJ before and one year after the ASVAL procedure according to the persistence of the GSV reflux (Table 2).

Figure 3.

Great saphenous vein before ASVAL procedure and one year after (diameters at SFJ, upper thigh, and mid-thigh are 1.08, 0.79, and 0.80 cm before and 0.67, 0.37, and 0.36 cm after operation, respectively).

Table 2.

Changes of diameters of GSV with resolved and persisting reflux at one year (n= 72).

	Diameter at SFJ before, cm, mean (SD)	Diameter at SFJ after 1 year, cm	Reduction, %	p
GSV with absence of reflux(n= 49)	0.82 (0.18)	0.63 (0.16)	23%	< 0.0001
GSV with persisting reflux (n = 23)	0.85 (0,22)	0.73 (0.18)	14%	0.0008

VVs recurrence

VVs reoccurred on 10 lower limbs of 74 (13.5%) during the follow-up. In five of those limbs, new varicosities appeared between 3 and 6 months of follow-up, and between 6 and 12 months of follow-up in the five others.

One patient presented a VVs recurrence despite the competence of the GSV all along the follow-up. In this case, dilated tributary was not connected to GSV trunk. In five of VVs recurrence, the reflux in GSV did not disappear after operation while the GSV diameter decreased, and we found new varicose tributaries of GSV between 3 and 6 months of follow-up. In the four of VVs recurrence, the GSV reflux has completely disappeared after ASVAL procedure with a significant reduction of the GSV diameter, but new VVs connected to GSV have appeared between 6 and 12 months of follow-up with a recurrent GSVs reflux. All the patients with recurrent VVs were treated with foam sclerotherapy. No surgery required in any case.

On other 64 (86.5%) limbs, no dilated tributary was found by both clinical and duplex examination.

We compared the recurrence rate in the limbs with the extension of the GSV reflux above or below the mid-thigh. Three out of 46 limbs (6.5%) with a reflux above the mid-thigh had a newly developed veins at one year, while there were seven recurrences out of 28 limbs (25%) with the reflux below the mid-thigh at a baseline (p = 0.036).

Discussion

In the past decade, minimally invasive laser and radiofrequency techniques became a method of choice for treatment of VVs. Nevertheless, being compared with both conventional surgery and saphenous veins sparing techniques, thermoablation does not show any significant improvement in mid-term and late results. New VVs develop with the same frequency as after surgery.^3,11,12 So, ablation of the main saphenous trunk does not guarantee good clinical outcomes. Then the question may arise if it is even necessary to ablate the saphenous vein. It is possible to achieve a restoration of a normal venous flow with a vein sparing methods which are based on preserving of refluxing saphenous vein.^3,7–9,13 The biggest theoretical objection to such a strategy could be early recurrences due to persistent reflux in a preserved saphenous trunk.

The main goal of our study was to find out what happened with reflux in GSV after its dilated tributaries had being removed. We choose the one-year follow-up as the highest fear to leave a refluxing GSV is to get an early recurrence within the first months after treatment. Up to now, there are few studies reporting the results of isolated phlebectomy at one year.^8,9,13,14 We demonstrated that reflux disappeared in 66% of GSV after ASVAL procedure at one-year follow-up. These data confirm findings of both Pittaluga et al.⁹ and Biemans et al.¹⁴ who found 69.9% and 50% GSV free of reflux at one year, respectively. As in those studies, we found a significant decrease in the mean GSV diameter. Moreover, GSV shrinkage has been registered in all cases no matter reflux disappeared or not. Restoration of normal flow in a one part of superficial network after removing other part supports the ascending concept of primary VVs. However, these interesting results have been observed in a selected group of patients since only GSV reflux not lower than upper third of the calf were included in our study.

On the other hand, one third of the patients still have had refluxing GSV after phlebectomy. The first explanation of this persisting reflux might be the development of the new re-entry perforators. In 16 out of 25 limbs with persisting GSV reflux, we found re-entry perforators that drained the blood into the deep system. In all those cases, there were no recurrent VVs as all the reflux volume drained through the perforator without flowing distally through side branches. We may expect that persisting reflux in a preserved GSV will have a limited impact on disease manifestation. It was confirmed that even if the reflux had not disappeared after ASVAL, the volume of the reflux has decreased with a significant clinical improvement¹⁵ which means that we may ignore the reflux and simply follow-up the patient. Another explanation of reflux persistence after ASVAL procedure is that ascending theory not the only concept explaining the disease progression. In some patients, the varicose disease may develop downward from SFJ since the beginning. If descending mechanism is involved, the origin of the VVs is definitely the saphenous trunk. Preserving it does not lead to regression of the reflux because the base of the disease remains untouched.

Then the question arises of how to identify eligible patients for ASVAL procedure. Some possible predictions for hemodynamic success of procedure have been discussed. The best results can be achieved in C2 patients with GSV of a diameter below 0.8 cm and reflux not lower than knee, in patients with disappearing of the reflux after compression of varicose tributary at its origin.^8,14,16 In a case–control study on patients with a positive reflux elimination test by tributary compression, significantly better results with only 14% of recurrences at three years have been demonstrated in a group with a competent terminal valve. On the contrary, in cases of terminal valve incompetence, overall GSV recurrence was 88%.¹³ These findings suggest that thorough duplex ultrasound with the assessment of the flow through the SFJ and the length of the reflux before the procedure is the key point to hemodynamic success.

Our results may also indicate that better results with the ASVAL strategy can be achieved when the refluxing segment of GSV is relatively short. In our cases, only in 17% of veins with reflux not lower than a mid-thigh at a baseline remained incompetent at one year. On the other hand, in veins with more extended reflux this rate was significantly more – 61% (p = 0.0004). The same tendency has been found when we compared the recurrence rate in the limbs with different length of refluxing GSV: 6.5% vs. 25% (p = 0.036). Both hemodynamic and clinical data suggest that ASVAL could be a reasonable option for patients with GSV reflux not lower than a mid-thigh.

An overall recurrence rate at one year was 13.5%. It seems to be not in favor of isolated phlebectomy especially considering that this is a short-term result. But the recurrence rate after ASVAL procedure must be considerably less if the criteria of eligibility will be clearly established and operation will be performed in selected cases.

Removing of only tributaries has also some disadvantages. We registered 5% of GSV thrombosis after operation while Pittaluga et al.⁷ observed 1%, Zamboni et al.¹³ reported none, and Biemans et al.¹⁴ did not report on complications. The difference between the data can be explained by diameter of GSV that was higher in our series. Comparing with the Pittaluga et al. series, our patients had also a more advanced varicose reservoir since mean number of zones to be treated was 6.5 vs. 6.05. Another possible disadvantage may be a necessity to perform additional procedure some months later that might be disappointing for some patients wishing to resolve their problem with VVs in a one step.

Limitations

Our study has some evident limitations. Those are non-comparative design, small sample size, criteria of inclusion, and short follow-up. It has to be also taken into account that the results were not estimated blindly as examinations were performed by the same team members. We also did not discuss quality of life and venous symptoms scoring as the main goal of this series was to confirm the observations reported by Pittaluga et al., such as clinical success and the hemodynamic phenomenon of resolving GSV reflux after isolated phelebectomy. Further studies are needed to identify predictors of success of the ASVAL procedure more precisely and to compare it with the techniques of saphenous ablation.

Conclusion

ASVAL procedure with a preservation of incompetent GSV leads to disappearance of reflux in saphenous trunk in majority of cases. The diameter of GSV decreases significantly in all the GSVs after removing of dilated tributaries. Our findings confirm that ascending mechanism is evident in many cases of primary VVs. While it cannot be recommended for all the patients with VVs, ASVAL procedure could be considered as a less aggressive and less expensive approach in selected cases.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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