Persistent incompetent truncal veins should not be treated immediately

Abstract

Background

The traditional attitude for the treatment of chronic venous disorder is to systematically treat incompetent truncal veins. We wanted to evaluate the outcomes of not treating all incompetent truncal veins with regard to our experience of focusing the treatment to the varicose tributaries.

Methods

Retrospective study on all procedures of surgical treatment consecutively performed for varicose veins by single phlebectomy with preservation of a refluxing great saphenous vein (GSV), according to the principles of the ambulatory selective varices ablation under local anesthesia (ASVAL) during four years of practice. The clinical and hemodynamic outcomes have been evaluated at eight days, one year, and once a year.

Results

We have included 1212 lower limbs (LLs) that underwent consecutive ASVAL procedures in 816 patients (611 women and 205 men) aged between 19 and 93 years (mean age 53.7 years). The CEAP Class C classification was C0–C1 = 0%; C2 = 85.6%; C3 = 5.4%; C4 = 7.8%; C5 = 0.7%; C6 = 0.7%. Symptoms were present in 854 cases (70.5%). A thrombosis of the GSV was diagnosed at eight days postoperative in 13 cases (1.1%). A total of 1010 LLs were followed after the first postoperative year (mean follow-up of 44.5 months). A secondary major procedure was done in 30 cases during the follow-up: a striping of the GSV in nine cases and a redo phlebectomy in 21 cases. The cumulative incidence of a persistent or recurrent GSV reflux, of a varicose recurrence, and of secondary major procedure at five years after life table analysis was 33.8%, 13%, and 4.5%, respectively. A GSV reflux extended above plus below the knee and multiple connections of the varicose tributaries to the GSV at the calf were associated with a varicose recurrence (respectively 66.7% versus 55.3% p < 0.05 and 46.7% versus 12.8% p < 0.05).

Conclusion

A treatment limited to the varicose tributaries by phlebectomy is safe and efficient at midterm with preservation of the main veins of the superficial venous system. It can be performed in a large group of patients thanks to a proper exclusion of cases with advanced chronic venous disorder. Therefore, the systematic treatment of an incompetent truncal vein is not relevant in the majority of the cases.

Keywords

Varicose veins Truncal reflux ASVAL

Introduction

The traditional attitude for the treatment of chronic venous disorder (CVD) is to systematically suppress incompetent truncal veins.^1–4 This attitude is applied either in primary treatment or in case of residual or recurrent reflux after a first procedure, in accordance to the theory that the signs and symptoms of chronic venous insufficiency (CVI) are related to the truncal reflux.^5–7

However, another concepts have emerged this late decade considering that a truncal reflux can be consecutive to the development of a varicose reservoir on the tributaries and not at its origin,^8–15 with the possibility of a reversibility of the truncal reflux by the treatment of the tributaries only. In addition, some publications have reported that all truncal refluxes have not the same characteristics and therefore not the same clinical consequences,^16,17 calling into question the systematic treatment of all truncal refluxes without considering the clinical relevance of the treatment.

Since we have adopted the attitude of focusing the treatment of CVI on the varicose reservoir with the preservation of the truncal veins as often as possible according to the principles of the ambulatory selective varices ablation under local anesthesia (ASVAL),^13,14 we have a large experience of untreated truncal reflux. We wanted to report in this paper our experience in order to evaluate the choice of not treating all incompetent truncal veins for the primary treatment, and also for the persistent incompetent truncal veins after the treatment.

Method

We have conducted a retrospective study for which we reviewed all procedures of surgical treatment consecutively performed for varicose veins (VVs) by single phlebectomy with preservation of a refluxing great saphenous vein (GSV), according to the principles of the ASVAL, during four years of practice in the two surgery facilities of our Institute (Monaco and Nice).

We chose to include in the retrospective study only the lower limbs (LLs) that had a reflux on the GSV in order to have a more homogeneous population. Therefore, the LLs presenting a reflux on the short saphenous vein were not included.

Preoperative data

The preoperative data were reviewed, in terms of age, sex, CEAP class C, the presence of symptoms (pain, heaviness, a swelling sensation, pruritus, night cramps, restlessness, tingling, heat).

The hemodynamic and anatomical data were recorded via duplex ultrasound (DUS) examination performed with the patient standing upright. The reflux was evaluated by duplex scanning using the manual venous flushing maneuver in the calf region, and the diameter of the GSV was measured ultrasonically at the sapheno-femoral junction (SFJ). The reflux in the GSV was recorded at the moment of the sudden release of manual compression of the calf. Under these conditions, a reflux was considered to be pathological if the reflux duration (RD) exceeded 0.5 s for the superficial veins and 1 s for the deep veins. A mapping (cartography) was systematically realized through a drawing representing the extension of the reflux along the GSV and the location of the connection of the varicose tributaries to the GSV.

The volume of the varicose reservoir has been evaluated regarding the number of zones to be treated (NZT) as reported in a previous publication.^13,14 The presence of a varicose recurrence was determined according to the recurrent varices after surgery (REVAS) definition.¹⁸

Surgical procedure

The decision to preserve the saphenous vein was made subjectively by the surgeon for patients who appeared to be at a less advanced stage of the CVD, both hemodynamically (e.g., with a continent ostial valve and partial saphenous-vein reflux) as well as clinically (e.g., with an absence of symptoms and/or trophic disorders).

All patients were operated on by two surgeons (PP and SC) in both surgery facilities, the surgeons having the same activity in terms of volume and techniques.

Follow-up

According to the protocol of follow-up usually used in our institute, the patients were seen again by the surgeon who had operated on them (PP or SC) at eight days and one year after the operation, and then once a year. The presence of a varicose recurrence according to the REVAS criteria,¹⁸ i.e., the presence of visible or palpable varices greater than 3 mm in a limb that had previously undergone an operation, was sought during the follow-up as well as the redo procedure performed to treat the varicose recurrence. Our aim was to compare the clinical and hemodynamic preoperative data of the patients with and without varicose recurrence during the follow-up, in order to find the criteria that could predict a failure of the strategy to not treat a refluxing GSV.

Statistics

The averages of continuous variables were calculated with a standard deviation at the alpha threshold of 0.05. The qualitative bivariate comparisons used the chi-square test and the Student’s t-test comparisons of average values. Midterm survival was determined using Kaplan–Meier and cumulative incidence life table analysis. Statistical analysis was performed using XLSTAT software (Addinsoft France, Paris, France). The significance level for all of the comparisons was set at p = 0.05

Results

Population

From October 2003 to December 2007, 1212 LLs underwent consecutive ASVAL procedures in 816 patients (611 women and 205 men) aged between 19 and 93 years (mean age 53.7 years). The LLs were classified on the CEAP Class C classification as following: C0–C1 = 0%; C2 = 85.6%; C3 = 5.4%; C4 = 7.8%; C5 = 0.7%; C6 = 0.7%. Symptoms were present in 854 cases (70.5%).

A reflux was preoperatively present on the GSV in all cases. The mean diameter of the GSV at the SFJ was at 7.2 mm (median 7.0 ranged 3–14 mm). No deep venous reflux was observed.

During the same period of activity, 275 GSV stripping procedures were carried out in 249 patients and 305 LLs. The comparison of the data of the population operated by ASVAL and stripping showed that the patients treated by ASVAL were younger, more frequently female and had a less advanced stage of CVD in terms of CEAP Class C, frequency of symptoms and hemodynamics (Table 1).

Table 1.

Characteristics of patients treated by ASVAL and stripping.

	ASVAL	Stripping	p
Age (average)	53.7	61.2	<0.01
Female gender	74.9%	64.3%	<0.01
CEAP Class C
C0–C1	0%	3.3%	<0.01
C2	85.6%	66.9%	<0.01
C3	5.4%	8.7%	<0.01
C4	7.8%	15.3%	<0.01
C5	0.7%	2.9%	<0.01
C6	0.7%	2.9%	<0.01
Competence of the SFJ	46.7%	16.4%	<0.01
Diameter of the SFJ (average)	7.2 mm	8.4 mm	<0.01

SFJ: sapheno-femoral junction; ASVAL: ambulatory selective varices ablation under local anesthesia.

Operation performed

The ASVAL procedures were done by phlebectomy technique through staged micro-incisions with a Muller hook (n°0 or n°1). All surgical procedures were performed under tumescent local anesthesia. No additional combined liquid or foam sclerotherapy was associated for the treatment of VVs. All of the operations were carried out in an ambulatory fashion.

Immediate follow-up

All patients were reviewed at the first postoperative control eight days after the surgery. A thrombosis of the GSV was diagnosed in 13 cases (1.1%): in four cases, the GSV presented a preoperative segmental dilatation of more than 10 mm (9–18 mm), in four cases, the GSV presented a preoperative major difference in diameter of the GSV (more than 10 mm) on both sides of the resected varicose tributary, and in five cases, the GSV was not present within the saphenous fascia at the thigh below the resected varicose tributary. All patients were treated medically with heparin therapy.

No other postoperative complication was seen.

Follow-up after the first year

Among the 816 patients operated on, 680 were reviewed beyond the first year with a mean follow-up of 44.5 months (median 60 ranged 12–72 months).

A varicose recurrence was observed in 90 out of the 1010 LLs not lost for follow-up after the first postoperative year.

Freedom of presence of a persistent or recurrent GSV reflux >0.5 s in the treated LL at one, two, three, four, and five years after life table analysis was 69.6%, 69%, 68.6%, 67.8%, and 66.2%, respectively (Figure 1). The cumulative incidence of a persistent or recurrent GSV reflux at one, two, three, four, and five years after life table analysis was 30.4%, 31%, 31.4%, 32.2%, and 33.8%.

Figure 1.

Kaplan–Meier analysis shows for freedom of persistent or recurrent GSV reflux >0.5 s. Red dotted lines represent 95% confidence intervals.

Freedom of varicose recurrence in the treated LL at one, two, three, four, and five years after life table analysis was 99.5%, 98%, 95.2%, 91.1%, and 87%, respectively (Figure 2). The cumulative incidence of a varicose recurrence at one, two, three, four, and five years after life table analysis was 0.5%, 2%, 4.8%, 8.9%, and 13%.

Figure 2.

Kaplan–Meier analysis shows for freedom of varicose recurrence. Red dotted lines represent 95% confidence intervals.

A secondary major procedure was performed in 30 cases during the six years of follow-up: it consisted in a secondary stripping of the GSV in nine cases and in a redo phlebectomy with preservation of the GSV again in 21 cases. No secondary echo-guided foam echosclerotherapy has been done. Freedom of secondary major procedure in the treated LLs at one, two, three, four, and five years after life table analysis was 99.8%, 99.3%, 98.4%, 97.1%, and 95.5%, respectively (Figure 3). The cumulative incidence of major secondary procedure at one, two, three, four, and five years after life table analysis was 0.2%, 0.7%, 1.6%, 2.9%, and 4.5%.

Figure 3.

Kaplan–Meier analysis shows for secondary major intervention (surgical procedure or foam echo-guided sclerotherapy). Red dotted lines represent 95% confidence intervals.

All of the nine patients who had a secondary stripping of the GSV had a symptomatic recurrence with a major recurrent saphenous reflux, while the patients who had redo surgical procedure limited to phlebectomy were asymptomatic and without recurrent GSV reflux in 18 and 13 out of 21 cases, respectively.

At last, the limbs having presented a varicose recurrence during the follow-up remained untreated because of the absence of cosmetic and/or functional concern.

Comparison of the cohorts with and without emergence of a varicose recurrence

The comparison of the preoperative demographics, the CEAP class C classification and the frequency of symptoms according to the emergence or not of a varicose recurrence during the follow-up did not show any significant difference (Table 2). The study of the preoperative hemodynamics and diameter of the SFJ did not show as well a significant difference for the preoperative frequency of the competence of the SFJ and for the diameter of the GSV at the SFJ (Table 2). We observed that the LLs with a varicose recurrence during the follow-up had significantly a more frequent GSV reflux located above plus below the knee or extended at the whole GSV compared to the patients free of recurrence (66.7% versus 55.3% p < .05 and 13.3% versus 7.6% p < .05, respectively). At the opposite the LLs free of recurrence had a more frequent preoperative GSV reflux limited above the knee (32.1% versus 16.7% p < 0.05) (Table 3).

Table 2.

Comparison of the preoperative data for demographics, CEAP class C classification, frequency of symptoms, frequency of the competence and the diameter of the sapheno-femoral junction according to the emergence or not of a varicose recurrence during the follow-up.

	Absence of varicose recurrence during follow-up	Presence of varicose recurrence during follow-up	p
Number of lower limbs	90	920
Preoperative mean age (years)	53.7	54.6	NS
Female gender	74.4%	74.9%	NS
CEAP Class C
C0–C1	0%	0%	NS
C2	85.9%	83.3%	NS
C3	5.3%	6.7%	NS
C4	7.2%	7.8%	NS
C5	0.9%	1.1%	NS
C6	0.9%	1.1%	NS
Competence of the SFJ	46.7%	45.6%	NS
Diameter of the SFJ (average)	7.2 mm	7.5 mm	NS

SFJ: sapheno-femoral junction.

Table 3.

Comparison of the preoperative hemodynamic assessment of the GSV according to the emergence or not of a varicose recurrence during the follow-up.

Preoperative GSV reflux location	Presence of varicose recurrence during follow-up	Absence of varicose recurrence during follow-up	p
Above knee	16.7%	32.1%	<0.05
Above + below knee	66.7%	55.3%	<0.05
Below calf (isolated)	4.4%	5%	NS
Whole GSV	13.3%	7.6%	<0.05

GSV: great saphenous vein.

The LLs in which a varicose recurrence was seen during the follow-up had more frequently a preoperative multiple connections of the varicose tributaries to the GSV at the calf, with a higher NZT in comparison to the patients without recurrence (46.7% versus 12.8% p < 0.05 and 9.5 versus 7.5 p < 0.01), while in LLs free of recurrence the connections of the varicose tributaries were more frequently located at the thigh or the upper calf (respectively 19.9% versus 2.2% p < 0.05; and 34.5% versus 20.0% p < 0.05) (Table 4).

Table 4.

Comparison of the preoperative location of the connection of the varicose tributaries to the GSV and comparison of the NZT according to the emergence or not of a varicose recurrence during the follow-up.

	Presence of varicose recurrence during follow-up	Absence of varicose recurrence during follow-up	p
Number of lower limbs	90	920
Thigh	2.2%	19.9%	<0.05
Tigh + calf	27.8%	26.1%	NS
Upper calf	20.0%	34.5%	<0.05
Lower calf	3.3%	6.7%	NS
Multiple at the calf	46.7%	12.8%	<0.05
Preoperative varicose vein volume
NZT	9.5	7.5	<0.05

GSV: great saphenous vein; NZT: number of zones to be treated.

At last, the patents who had a secondary stripping of the GSV during the follow-up have had a preoperative GSV reflux extended above plus below the knee in all cases.

Discussion

The patients for whom we have chosen to leave untreated a refluxing GSV were selected in the group with a more limited CVI comparing to the patients treated by stripping of the GSV during the same period (less frequent chronic venous disease C4–C6, less frequent JSF incompetence, lower diameter of the JSF). We have previously reported these criteria of selection for performing a treatment limited to the varicose tributaries leaving an incompetent truncal vein.^13,14 The guidelines of the American Venous Forum has suggested the “preservation of the saphenous vein using the ambulatory selective varicose vein ablation under local anesthesia (ASVAL) procedure only selectively in patients with varicose veins.”¹⁹ However, we can ask ourselves if the selection was not carried out for the stripping rather than for the ASVAL since during the period of the study 1212 ASVAL procedures were performed for only 275 stripping. It clearly appears that in our experience the option of not treat the incompetent truncal vein was the first choice while the stripping was the choice by default. It could also suggest that the patents that we usually treat are mostly C2 patients with a limited CVD. The cases of postoperative thrombosis of the GSV were observed with a frequency similar to the one that we have previously reported (around 1%).¹⁴ The presence of an important segmental dilatation, a major difference in diameter of the GSV (more than 10 mm) on both sides of the resected varicose tributary were already identified as risk factors for the thrombosis of the saphenous vein after single phlebectomy.¹⁴ We have also observed in the present study that the absence of the GSV within the saphenous fascia at the thigh below the resected varicose tributary could lead to a postoperative thrombosis of the saphenous vein. All of these particular anatomical situations may lead to not leave untreated the incompetent truncal vein. The freedom of a persistent or recurrent reflux on the GSV after the ASVAL procedure was similar in this large retrospective study to the ones that we have previously reported,^13,14 with the same aspect of Kaplan–Meier analysis showing a flat survival curve with a frequency of 30% of persistent GSV reflux assessed since the first postoperative control with a very slight evolution during the follow-up (from 30.4% at one year to 34.6% at five years.). Biemans et al.,²⁰ showed a lower frequency of abolition of the GSV reflux after single phlebectomy at one year (50%), but this study included unselected patients. More interestingly, in the present study, the freedom of varicose recurrence was higher than the freedom of GSV reflux (from 99.8% at one year to 87% at five years versus 69.6% to 66.6%), meaning that a significant proportion of patients had a GSV reflux without any clinical significance. It probably explains the limited frequency of major secondary procedures observed in this study during the follow-up (from 0.2% at one year to 4.5% at five years). A secondary stripping of the GSV was carried out in nine LLs for which a varicose recurrence was associated to symptoms and to a major GSV reflux. Meanwhile, 2/3 of the LLs having presenting a varicose recurrence did not undergo any secondary major procedure in absence of patient’s concern. Biemans et al.,²⁰ showed that despite a 50% frequency of persistent GSV reflux at one year, no patients deteriorated its CEAP Class C, 2/3 of the patients had a complete resolution of symptoms and the VCSS and AVVQ were improved in all cases. We have previously published a prospective study showing that even in cases in which the GSV was not abolished after single phlebectomy, the reduction of the peak velocity combined with the decrease of the GSV diameter led to a reduction of the volume of the reflux.¹⁷ We concluded that beyond the threshold of 0.5 s defining a pathological reflux, the volume of the reflux could explain the clinical consequences. The effect of single phlebotomy on the volume of GSV reflux might explain the absence of clinical consequences in the majority of the persistent or recurrent GSV refluxes after ASVAL. Several authors have reported the good clinical results of isolated phlebectomy since a long time.^21–23 Biemans et al., have stated that the abolition of the reflux may not be the only end-point to take in account in order to evaluate the success of the treatment, because a large number of patients had a significant improvement of symptoms and VCSS-AVVQ scores and did not need and additional treatment after single phlebectomy, even if the GSV reflux was persisting.²⁰

However, we wanted to analyze of the cohort of patients who have presented a varicose recurrence after phlebectomy in order to identify criteria for a better selection of patients eligible to an ASVAL procedure. We found that a preoperative reflux extended above plus below the knee or at the whole GSV was significantly more frequent in LLs that had a varicose recurrence during the follow-up. Biemans et al.,²⁰ observed in their study that results were better after single phlebectomy when the reflux was present preoperatively in only one segment of the GSV. In addition, we found in the present study that the LLs with a varicose recurrence during the follow-up had a higher preoperative extension of the varicose reservoir with a significant higher NZT and multiple connections with the GSV especially at the calf. This observation supports our previous report on the linear trend that exists between the extension of the varicose reservoir and the risk of varicose recurrence after treatment.¹⁴

These observations highlight the fact that the treatment of the varicose reservoir is essential for the treatment of the varicose disease rather than the treatment of the truncal vein. At least the treatment of an incompetent truncal vein should not be systematic nowadays. At the opposite a modern concept should lead to an individualized “à la carte treatment” since every patient has a different clinical and hemodynamic situation of the disease at the time of treatment, which cannot match to a “one size fits all” that represents the traditional strategy of systematic treatment of an incompetent truncal vein. As Biemans et al.²⁰ say, sparing the GSV regains its role as one of the main veins of the superficial venous system, leads to fewer and less expensive operations, which is safer for the patient and costs less, and preserves a material that can be used as a natural bypass. We have previously reported the benefit of a mini-invasive surgical treatment of VVs in term of cost.¹⁴

However, the criteria for the indication of ASVAL are difficult to determine in absence of an adequate validation in the literature, especially by randomized control trials, that leads to give a low grade of recommendation for this approach in the international guidelines.¹⁹

A phlebectomy reflux elimination success test (PREST) prediction model has been reported including C class C classification, number of refluxing segments, GSV diameter (above the tributary), and reflux elimination test result, in order to give a score that correlates with a probability of restoring GSV competence.²⁰ But the most promising criterion for a proper and simple selection of patients for ASVAL is a preoperative reflux elimination test which is defined positive if the reflux of the saphenous vein is completely abolished by compression of a varicose tributary at the moment of the sudden release of manual compression on the calf, during a DUS examination. This test has been reported as an independent and strong predictor for the treatment success²⁰ with a positive predictive value of abolition of the GSV reflux at 95%.²⁵

Conclusion

A treatment limited to the varicose tributaries by phlebectomy is safe and efficient at midterm with preservation of the main veins of the superficial venous system. It can be performed in a large group of patients thanks to a proper exclusion of cases with advanced CVD with the use of appropriate hemodynamic and clinical preoperative criteria. Therefore, the systematic treatment of an incompetent truncal vein is not relevant in the majority of the cases.

Footnotes

Conflict of interest

None declared.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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