Mini-invasive foam sclerotherapy-assisted ligation versus surgical flush ligation for incompetent sapheno-popliteal junction treatment

Abstract

Objectives

Comparison of a flush sapheno-popliteal junction ligation versus a mini-invasive foam sclerotherapy-assisted ligation.

Methods

Forty-eight chronic venous disease patients underwent sapheno-popliteal junction flush ligation (group A). Forty-one patients underwent small saphenous vein ligation by means of mini-invasive incision with foam sclerotherapy of the popliteal stump (group B).

Results

At 4.1 ± 3.3 years mean follow-up, sapheno-popliteal junction recurrence was detected in four patients of group A (4/48; 8.3%) and in two cases of group B (3/41; 7.3%) (P=ns). Mean procedural time was 36 ± 11 minutes versus 21 ± 6 minutes (p<0.0001). A mild post-operative paresthesia lasting more than 24 h was reported in 6.3% (3/48) of group A versus 2.4% (1/41) (p<0.009) of group B.

At one-year check-up, Aberdeen Varicose Vein Questionnaire significantly improved in both groups with no significant difference between group A and B.

Conclusions

Foam-assisted mini-invasive sapheno-popliteal ligation represents a time and clinical-effective option, associated with a decrease in post-operative paresthesia risk.

Keywords

Small saphenous vein sapheno-popliteal junction ligation sclerotherapy nerve damage

Introduction

Lower limb chronic venous disease is one of the most frequent vascular disorders, afflicting up to 56% of men and 60% of women.^1,2

Though small saphenous vein (SSV) incompetence is involved in up to 20% of these cases, the focus on the literature related to this topic is much less than those dedicated to the great saphenous vein.^3,4

SSV incompetence can be associated with equally significant CVD signs and symptoms.^5,6

Indeed, the current guidelines present a recommendation for SSV endovenous thermal ablation in patients with CVD signs and symptoms, but the evidence is just 2B.^7,8

In a systemic revision of the literature, endovenous laser and radiofrequency ablation have demonstrated higher rates in terms of anatomical success compared to surgery, while neurologic complications remain quite significant for all these three techniques (laser: mean 4.8%; radiofrequency: mean 9.7%; surgery: mean 19.6%).⁹

Nerve damage represents the most common cause of litigation following varicose veins procedures.¹⁰

At the same time, the localization of the sapheno-popliteal junction (SPJ) can present between 4 and 10 cm above the popliteal skin crease in 13% of cases,¹¹ so making the surgical dissection potentially quite cumbersome and associated with a higher risk of sciatic,¹² fibular,¹³ and peroneal¹⁴ nerve branches damage.

The main risk is a post-procedural sensory loss, but a motor component was demonstrated even in the sural nerve with a potential deficit of the abductor digiti minimi.^15,16

The variability of the sapheno-popliteal junction (SPJ) can require a deep dissection with consequent difficult ligation flush on the popliteal stump and with a higher risk of nerve involvement.^17,18

The aim of the present investigation is to compare a traditional SPJ flush ligation with a mini-invasive foam-assisted SPJ ligation (FASL) in terms of recurrence rate, procedural time, complications, and disease-specific quality of life.

Methods

Eighty-nine patients (37 M, 52 F; age: 56 ± 6; C2-3EpAsPr) affected by SPJ incompetence were enrolled in this retrospective analysis. Forty-eight patients underwent a SPJ flush ligation (group A), the remaining 41 underwent a FASL (group B).

Incompetent tributaries along the leg were flush ligated, sparing the remaining SSV, according to the hemodynamic principle of the saphenous sparing strategy.¹⁹

In all patients, the skin incisions were sutured by a subcuticular running suture using a 4-0 monofilament absorbable thread.

Since the study was retrospective and both the procedures are used in current clinical practice a specific ethical approval was not necessary. All the patients signed an informed consent allowing the anonymous use of their data for research purpose.

All the patients have been operated on by the same surgeon and scanned by the same experienced sonographer, eliciting the flow by active foot dorsiflexion maneuver.

Groups A and B were compared for recurrence rate, procedural time, post-operative complications, disease-specific quality of life (Aberdeen Varicose Veins Questionnaire, AVVQ), skin incision aesthetic satisfaction (scored by the patient at the one year follow-up visit from 0, worst possible outcome, to 10, best possible result).

Inclusion criteria were:

Age from 18 to 75 years

BMI < 35

C2-3EpAsPr

Exclusion criteria were:

Cardiac co-morbidity

Lower limb arterial disease

Use of phlebotonic drugs

Previous varicose veins treatments

Postural defects

Previous venous thrombosis

Genetic mutations favoring thrombosis

FASL technical note

FASL is performed under local anesthesia, by a less than 2 cm incision at the popliteal skin crease. SSV is isolated and disconnected.

Keeping the lumen of the SPJ open with a small kelly, a direct injection of foam (sodium tetradecyl sulphate 3%, 1 cc) is performed.

While injecting, the stump is quickly twisted around itself so tucking the foam inside the SPJ and simultaneously also physically closing the junctional tributaries inlet (Figures 1 and 2).

Figure 1.

(a) The small saphenous vein is isolated and disconnected at the popliteal skin crease level. The distal stump is ligated. The sapheno-popliteal junction (SPJ) stump is directly incannulated by a syringe injecting foam sclerotheraphy. (b) During the injection the SPJ stump is twisted, in this case clockwise, in order to confine the foam inside the same stump, while functionally closing the inlet of the junctional tributaries.

Figure 2.

Technical drawing of the FASL procedure. (a) Anatomical presentation of the small saphenous vein (SSV) at the junction with the popliteal vein (PV). (b) Isolation and disconnection of the SSV at the popliteal crease with ligation of the distal segment of the SSV. Foam sclerotherapy injection (red arrow) inside the lumen of the saphenous-popliteal stump. During the same injection, the lumen is twisted around itself in order to confine the foam in it and to functionally close the inlet of the junctional tributaries. Once the injection is completed the stump is ligated. (c) Final anatomical presentation with the junctional tract being ligated at the popliteal skin crease level and with the remaining tract being sclerosed.

The stump is ligated at the popliteal skin crease level by using a 3-0 absorbable thread.

Statistical analysis

InStat GraphPad (GraphPad Software, Inc.La Jolla, CA 92037 USA) was used for statistical analysis. The data were expressed as mean ± st deviation, number of cases out of total or percentage. Kolmogorov–Smirnov test was used to assess the data distribution. The differences among demographic, clinical, and sonographic characteristics, procedural time, AVVQ, skin incision aesthetic satisfaction were tested by Mann–Whitney and Student’s t-tests as appropriate. The two-tailed Fisher’s exact test was used to assess recurrence rate, gender ratio, right and left limbs ratio, CEAP, and post-procedural paresthesia rate, respectively. Statistical significance was defined as p < 0.05.

Results

Groups A and B were homogeneous in hemodynamics and demographic characteristics (Table 1).

Table 1.

Patient population demographics and hemodynamics.

	All cohort	Group A	Group B	p ^a
Gender ratio (M/F)	37/52	22/26	15/26	p < 0.3976
Age (y) mean ± st.dev	56 ± 6	55 ± 5	57 ± 8	p < 0.1629
BMI mean ± st.dev	25 ± 2	25 ± 2	25 ± 2	p < 0.7727
CEAP C2	43	22	21	p < 0.6733
CEAP C3	46	36	20	p < 0.6733
R/L limbs ratio	42/47	21/27	19/22	p < 0.8336
SSV caliber mean ± st.dev	5.5 ± 0.8	5.5 ± 0.9	5.4 ± 0.8	p < 0.4620
SSV reflux time mean ± st.dev	3.2 ± 0.8	3.2 ± 0.7	3.3 ± 0.9	p < 0.7804
SPJ distance from the popliteal crease mean ± st.dev	4.9 ± 1.0	4.9 ± 1.0	4.8 ± 1.1	p < 0.5411

^aDifferences between group A and B in gender, right (R) and left (L) limbs ratio, and CEAP have been calculated by two-tailed Fisher’s exact test; whereas differences in age, BMI, SSV caliber, SSV reflux time, and SPJ distance from the popliteal crease, have been calculated by Student’s t or Mann–Whitney test.

At the popliteal skin crease, mean SSV diameter was 5.5 ± 0.8 mm and it was homogenous in all the study population. Mean reflux time was 3.2 ± 0.8 s; mean SPJ distance from the popliteal crease was 4.9 ± 1.0 mm.

At 4.1 ± 3.3 years mean follow-up, SPJ recurrence was detected in four patients of group A (4/48; 8.3%) and in three cases of group B (3/41; 7.3%) (P = ns). No recurrences were fed by newly incompetent tributaries along the leg in both groups.

Mean procedural time was 36 ± 11 min versus 21 ± 6 min (p<0.0001).

No post-procedural paresthesia was reported in 35/48 (72.9%) of group A versus 39/41 (95.1%) of group B; in the time frame between 12 and 24 h from the procedure, a mild paresthesia was reported in 10/48 (20.8%) of group A cases versus 1/41 (2.4%) of group B cases; while paresthesia lasting more than 24 h was reported in 3/48 (6.3%) of group A cases versus 1/41 of group B cases (2.4%)(p<0.009) (Figure 3).

Figure 3.

Groups A and B post-operative paresthesia occurrence at 12–24 h and after 24 h. The distribution is statistically significant different between two groups of patients (p < 0.009).

With the exception noted above describing a mild post-operative paresthesia, no other significant differences were reported in post-operative complications.

No motor function loss was reported. At the one-month follow-up, one single case of deep venous thrombosis was detected in group A in a soleal vein in the calf. No thrombosis was reported in group B. No need for analgesics was reported in both groups.

At the one-year check-up visit, AVVQ significantly improved in both groups from 17.8 ± 4.7 to 4.7 ± 3.1 in group A (p < 0.0001) and from 17.7 ± 4.9 to 4.2 ± 2.8 in group B (p < 0.0001). At the one- year follow-up visit, incision aesthetic satisfaction was scored as 7.7 ± 1.5 in group A and 8.9 ± 1.1 in group B (p<0.0001).

Discussion

SSV venous valvular incompetence treatment remains an under-evaluated topic in modern Phlebology literature.

Indeed, the current guidelines are quite contradictory reporting a grade 1B recommendation in the American document in favor of high tie at the knee crease, with selective invagination stripping of the incompetent portion of the vein.²⁰

At the same time, according to NICE guidelines, endovenous thermal ablation should be offered first, while surgery should be performed only in the instance of nonavailability of other venous therapies including foam sclerotherapy.²¹

European guidelines are recommending endovenous thermal ablation for SSV incompetence treatment, but just with a grade 2B evidence, underlining the importance of a thermal access no lower than mid-calf in order to avoid possible nerve involvement.⁷

Nerve damage remains a main concern in SSV treatment, both at the sapheno-politeal and at the distal leg region.

The present investigation demonstrates that a mini-invasive, safe, time and clinical effective approach is possible by means of the hybrid FASL surgical and sclerotherapy technique.

The sonographic finding of a flush SPJ interruption complimented with the injection of foam sclerotherapy and a twisting of the popliteal stump underlines the possibility of confining the sclerosant at the desired leaking point (Figure 4).

Figure 4.

Post-operative ultrasound image showing the sclerosed small saphenous vein (SSV) at the sapheno-popliteal junction. The arrow and the yellow dotted line indicate the sciatic nerve (N); popliteal vein (PV).

The absence of lower limb thrombosis in group B offers further confirmation on this topic.

Moreover, foam sclerotherapy safety in SSV has been already well covered in the literature.²²

The rationale for preferring the SSV isolation and disconnection together with the twisting of the sclerosed SPJ to a faster and simpler foam sclerotherapy treatment is to be found in multiple aspects.

First of all, an SSV treatment using only foam sclerotherapy is considered ineffective for a larger than 6 mm calibre.²³

Moreover, with traditional SSV sclerotherapy, foam is rapidly washed out by the deep venous system while the twisting of the SPJ performed during the injection allows the confinement of the drug inside the stump.

The same twisting brings also the benefit of closing the inlet of the SPJ tributaries, so closing a possible source of reflux recurrence.

In comparison with endovenous techniques, FASL has the advantage of treating the SPJ flush on the popliteal vein rather than leaving a potentially long popliteal stump.

When the SSV terminates within the popliteal vein high above the level of the popliteal skin crease, endovenous devices are not positioned in closed proximity of the popliteal vein mainly due to the risk of nerve damage²⁴ of endovenous heat-induced thrombosis and of anatomical limits.²⁵

On the contrary, FASL was successful in allowing an obliteration of the SPJ leaking point flush on the popliteal vein.

FASL was applied in a saphenous sparing strategy in this investigation;¹⁹ however, it could be associated also with an SSV ablative procedure.

In order to create a hemodynamically homogeneous population, all the incompetent tributaries along the SSV were flush ligated. At the same time, this also introduced the possibility that the clinical improvement following the procedure could not be associated uniquely with the SPJ treatment. Yet, the primary endpoint of this study is to analyze the recurrence rate at the SPJ, leaving the comparison of the clinical impact of the SPJ rather than the incompetent tributary ligation to further investigations.

Pressure gradient suppression by phlebectomy and/or flush ligation of incompetent tributaries of the great saphenous vein has demonstrated to lead to a potential caliber reduction.^26,27

Future investigations should address the topic of the SSV caliber variation after isolated phlebectomy/ligation.

The study population presented a homogeneous SSV caliber, thus not providing further clues regarding the possible role of the vessel diameter as risk factor for recurrences. The topic is of interest for future investigations.

In a previous publication of our group dealing with great saphenous vein, the source of recurrent reflux was found in the tributaries along the saphenous axis in up to 42.2% of cases at 5.5 years mean follow-up.²⁸

On the contrary, the reported investigation at 4.1 years follow-up did not show recurrences from newly incompetent tributaries along the SSV. Longer follow-up and larger study populations will be required to deeply assess this interesting phenomenon, potentially introducing the role of the different gravitational columns and anatomical features of the great and small saphenous system.

According to Markides data, fibular nerve is involved more frequently than the sural nerve in post-operative nerve damage.²⁹

This finding makes the SPJ management a particularly delicate issue, bringing interest toward techniques minimizing this complication rate.

At the same time, an accurate pre-operative mapping becomes fundamental in order to identify the best strategy.

A traditional 10 MHz ultrasound probe has been demonstrated to successfully identify the sciatic nerve and its branches.^25,30

According to the data presented, FASL is particularly indicated in cases of high SPJ not readily reached by endovenous devices or by surgical dissection, due to close proximity with nerve branches that could hamper the procedure.

Future investigations on SSV treatment should focus on prospective randomized trial comparing different techniques (surgery, endovenous thermal and nonthermal devices, sclerotherapy, hybrid approach) in homogeneous study population including at least equal distances of the SPJ from the popliteal crease, SSV caliber, and reflux time.

While current guidelines for SSV therapy suggest surgery as the last choice and favoring endovenous thermal ablation and foam sclerotherapy²¹ the presented data pave the way for further investigation and discussion on the topic, as a mini-invasive, hybrid approach combining foam sclerotherapy and hemodynamic surgery shows preliminary data supporting its efficacy and safety.

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.

Ethical Approval

Since the study was retrospective and both the procedures are used in current clinical practice it has not been necessary a specific ethical approval.

Guarantor

SG.

Contributorship

S Gianesini conceived and designed the study, researched literature, collected data, wrote the article, and prepared table/figures. E Menegatti contributed to article preparation, research literature, data analysis, and table/figure creations. MG Sibilla was involved in data collection and critical review of the article. D Neuhardt was involved in English language, data, and article critical review. E Maietti performed the statistical analysis. M Tessari was involved in data collection. P Zamboni was involved in patient recruitment and article critical review. All authors reviewed and edited the article and approved the final version of the article.

Acknowledgement

Preliminary data of this study were presented in the free abstracts session at the 19th European Venous Forum Annual Meeting, Athens, Greece, on 28–30 June 2018.

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