Servier – Phlebolymphology

Abstract

The methods of treating varicose veins have been constantly evolving over the past 20 years, leaving a prominent place today for endovenous techniques, with conventional surgery being gradually abandoned. The modern treatment of varicose veins of the lower-limbs is performed either by tumescent endovenous thermal techniques (laser, radiofrequency, steam) or by nonthermal nontumescent techniques (ultrasound-guided foam sclerotherapy, glue cyanoacrylate, mechanochemical endovenous ablation). The introduction of minimally invasive endovenous ablation techniques (thermal and nonthermal techniques) are associated with several advantages, including minimally invasive, immediate discharge and ambulation, faster recovery, and less periprocedural morbidity. Based on the literature and recommendations, endovenous thermal ablation should be preferred to surgery and foam sclerotherapy in the treatment of small saphenous vein incompetence. The potential benefits, particularly the reduced risk of nerve damage, might be of considerable clinical importance and may lead to a preference for nonthermal techniques in the future. Extensive data about nonthermal techniques are necessary to improve outcomes and achieve robust evidence.

Introduction

Isolated saphenopopliteal reflux may occur in up to 15% of patients with primary varicose veins.¹ This reflux can be associated with equally significant chronic venous disease (CVD) signs and symptoms compared with great saphenous vein incompetence. Untreated varicose veins may sometimes lead to leg ulcerations, which are difficult to manage. Traditionally, treatment was restricted to surgery or compression therapy. Small saphenous vein surgery is considered more challenging than great saphenous vein surgery and is associated with higher recurrence and postoperative complication rates. Treating the small saphenous vein must be carried out very carefully because the ending is variable, and it is in close proximity to the nerves.

Over the past two decades, the treatment of varicose veins has been revolutionized by the introduction of minimally invasive endovenous ablation techniques (thermal and nonthermal techniques). These procedures are associated with several advantages, including a minimally invasive nature, immediate discharge and ambulation, faster recovery, and less periprocedural morbidity. They seem to have superior anatomical success rates compared with traditional surgical stripping.^2-5

Surgical anatomy

Many complications of surgical stripping of the small saphenous vein have been described, such as damage to the sural nerve, the tibial nerve, and the fibular nerve. The small saphenous vein drains blood from the external part of the foot and the posterior internal part of the leg. It is a continuation of the external marginal vein that runs along the dorsal side of the foot. At its origin, the main trunk passes below, then behind the external malleolus in the external retromalleolar groove. It then rises vertically and in a median supra-aponeurotic position along the rear of the calf, and is then attached to the sural (sensory) nerve, which must not be damaged during thermal ablation. The sural nerve is an axial nerve formed by sensory branches of the tibial and fibular nerves. The sural accessory nerve emerges from the fibular nerve. At the apex of the calf, the sural nerve and its accessory branch join in a common trunk and accompanies the small saphenous vein down to the ankle.

At the mid-leg point, the small saphenous vein enters the subaponeurotic tunnel of the sural triceps. It then bends slightly, which tends to send it deeper, and the vein continues along its path to the top of the knee joint line. At the knee joint, it bends and forms an anterior concave arch to join the popliteal vein at a level that can vary, or it may even be attached to a subordinate popliteal trunk in the great saphenous vein or the tributaries thereof, in the deep femoral vein, or it may even form a joint trunk with the gastrocnemius veins.

The sciatic nerve, which is located posterior to the thigh, is divided at variable levels, but mostly at the summit of the popliteal fossa. This division is slightly displaced from the longitudinal axis of the limb on the lateral aspect. It is divided into 2 nerves: the tibial nerve and the fibular nerve; it is advisable to stay below this area (by about 15 mm to 20 mm in general) to avoid damaging the nerve during endovenous thermal ablations.

In 15% to 20% of cases, the saphenopopliteal junction is nonexistent. The external saphenous trunk extends to the rear side of the thigh. It then bends inward to join the internal saphenous trunk, or it may run down toward the deep femoral vein.^3,6,7

Thermal techniques (laser and radiofrequency ablation) have emerged as an effective alternative to open surgery with stripping and high ligation. These methods are nevertheless accompanied by risks and side effects. Compared with open surgical therapy, the risk of damage to peripheral and motor nerves is reduced; however, it still exists as a result of heat exposure and tumescent anesthesia. Nonthermal methods that can be applied without tumescent anesthesia have been introduced as they pose a considerably lower risk of nerve lesions while proving to be effective.⁸

Recommendations for treating the small saphenous vein

International recommendations for endovenous saphenous ablation are heterogeneous, particularly for small saphenous vein treatment (Table I).^9-15 Concerning surgery, the 2011 American Venous Forum guidelines did not mention thermal treatments, but rather surgery, with level 1B evidence. For thermal treatments, the 2011 American Venous Forum guidelines recommend high ligation with invagination stripping with a grade of 1B, the 2012 International Union of Phlebology recommends thermal treatment with a grade of 1A, the 2013 NICE guidelines considered all of the saphenous axes together, without making a specific analysis of the small vs the great saphenous vein, the 2015 ESVS guidelines gave thermal treatments a grade 2B recommendation, and the 2016 AVLS and the 2016 LATAM guidelines gave grade 1B recommendations. In a recent publication, the European College of Phlebology guidelines for truncal ablation reports that, for the treatment of short saphenous reflux, endovenous laser ablation or radiofrequency ablation techniques are recommended in preference to surgery or foam sclerotherapy, assigning a 2A level of evidence.¹⁶ The 2014 Europe and LATAM 2016 guidelines gave sclerotherapy a grade 1A. The other guidelines indicated sclerotherapy treatment, but without a grade of evidence. The guidelines on nonthermal nontumescent techniques consider all of the saphenous axes together, without making a specific analysis of the small vs the great saphenous vein. Since 2016, the AVLS has recommended mechanochemical endovenous ablation with a grade 2B and the NICE accepted the procedure as standard.

Table I. Guideline recommendations.
The text in red indicated the guidelines are considering just the small saphenous vein. The rest are considering all of
the saphenous axis together, without making a specific analysis of the small vs the great saphenous vein. X, no specific
recommendation.

Literature

Before the past two decades, conventional saphenopopliteal junction ligation with or without stripping of the small saphenous vein has been the standard treatment for varicose veins associated with saphenopopliteal reflux. Small saphenous vein surgery is considered more challenging than great saphenous vein surgery and is associated with higher recurrence and postoperative complication rates. With a conventional surgical procedure, an incision is made in the popliteal fossa, and the small saphenous vein and saphenopopliteal junction are identified. The saphenopopliteal junction is then disconnected and a short segment of the small saphenous vein is either resected or stripped. Treating the small saphenous vein must be carried out very carefully because the ending is variable, and it is in close proximity to the nerves. Generally, a class II stocking is worn for a month.

In their meta-analysis, Boersma et al² reported the results of nine articles (surgical treatment of 798 small saphenous veins).^17-25 The surgical procedures were heterogeneous, included ligation and/or disconnection of the saphenopopliteal junction, with or without stripping, and there were anatomical success rates of 24% to 94% over a mean follow-up of 17.3 months. Two studies that randomized patients to either surgery or endovenous laser ablation showed inferior anatomical success rates for surgery.^17,19 Brittenden et al¹⁸ reported data from a study that randomized patients to surgery, endovenous laser ablation, or foam, showing inferior anatomical success rates compared with endovenous laser ablation, but comparable results with foam. Allegra reported long-term anatomical success in 70% of 132 small saphenous veins after 5 years of follow-up.²² Paresthesia occurred in up to 31% (mean 19.6%) and deep venous thrombosis in 0.7%. In their study, van Groenendael et al²⁶ compared the treatment of recurrences of 42 small saphenous veins (laser vs surgery) and showed that the incidence of recurrences was not statically significant between the groups. There was a faster recovery following laser ablation (1 day vs 7 days), and endovenous laser ablation reduced the incidence of sural nerve injury (9% vs 20%).

In the treatment of small saphenous veins, thermal ablation or surgery are well-established methods. Nevertheless, treatment of saphenous veins by ultrasound-guided foam sclerotherapy could also be an effective and cost-effective treatment option. Sclerotherapy is the targeted chemical ablation of varicose veins by an intravenous injection of a foamed sclerosing drug. The irritant nature of the sclerosant causes inflammation of the endothelium and sub-endothelium layers of the vein wall, resulting in fibrosis and occlusion of the vein. Traditional foam has been prepared by mixing liquid sclerosant with room air or gas, using the Tessari method or the double syringe method.²⁷

Postsclerotherapy compression is not clearly defined, but Hamel Desnos et al²⁸ found, in a randomized controlled trial, no differences between the compression group and the control group when comparing efficacy, side effects, satisfaction scores, symptoms, and QOL.

In their meta-analysis, Boersma et al² reported the results from 6 articles, including 1 randomized controlled trial (foam sclerotherapy treatment of 494 small saphenous veins).^18,29-33 The Tessari method was mostly used to produce foam (liquid-to-air ratio of 1:4 or 1:3); studies were heterogeneous and used polidocanol (1% or 3%) and sodium tetradecyl sulfate (1% or 3%), with a mean anatomical success rate that ranged from 20% to 96%. Only 2 studies described postprocedural complications and deep venous thrombosis was noted in just 1 patient. In a prospective and controlled study, Gillet et al³⁴ demonstrated a low rate of deep venous thrombosis after foam sclerotherapy of 331 small saphenous veins. Only two (0.6%) deep venous thromboses were observed, both of which were confined to the medial gastrocnemius veins and were reported in symptomatic patients.

Endothermal modalities (ie, endovenous laser ablation and radiofrequency ablation) use heat transfer to ablate incompetent venous trunks, with local infiltration of tumescent anesthesia used to protect surrounding structures from heating injury, to induce venous compression, and to limit procedural pain. The small saphenous vein is punctured at mid-calf to reduce the risk of sural nerve injury. When treating the small saphenous vein, the tip is positioned at the point where the small saphenous vein leaves the subfascial space to join the popliteal vein.¹⁶ Despite this, thermal injury may increase the rates of periprocedural pain, skin burns, and nerve injury. Postintervention compression for 1 week is often recommended, but the value and duration of compression is not clearly defined.³⁵ However, a recent meta-analysis did not reveal any advantage of compression therapy.³⁶

Endovenous laser ablation
In endovenous laser ablation, under ultrasound guidance, a bare-tipped or jacketed laser optical fiber is inserted into the vein from a distal point toward the junction, followed by laser activation. The fiber is then slowly withdrawn, and the vein becomes occluded. Boersma et al2 reported the results of 28 articles, including 4 randomized controlled trials (laser treatment of 2950 small saphenous veins).^17-19,37-61 Studies were heterogeneous regarding energy delivery, wavelengths used (810 nm, 940 nm 980 nm, and 1470 nm), and use of pulsed and continuous modes. In almost all studies, patients underwent additional therapies (phlebectomy, sclerotherapy, and stripping). Anatomical success rates were 81% to 100% and the mean follow-up was 12.5 months (range 0.5 to 48). Deep venous thrombosis was seen in 0.8% of all patients, and postprocedural paresthesia was described in 4.8%. In a randomized controlled trial, Doganci et al³⁷ showed that the puncture site affects the rate of nerve injury: the rate of paresthesia is significantly lower when the small saphenous vein is cannulated in the mild-calf. Hirokawa et al⁶² reported that the rates of pain (0% vs 25.0%) and bruising (7.0% vs 57.1%) were significantly lower in the group that used the 1470-nm laser and the radial 2-ring fiber.

Radiofrequency ablation
In radiofrequency ablation, under ultrasound guidance, a catheter electrode is inserted into the vein and the tip placed close to the junction. When activated, heat generated from the electrode results in closure of the vein. Boersma et al² reported the results of nine articles (radiofrequency ablation treatment of 386 small saphenous veins)^63-71 Studies were heterogeneous and used ClosurePlus, ClosureFast, and Celon. The anatomical success after a mean follow-up of 14.3 months ranged from 82% to 100%. Complications were poorly reported, and 5 studies described a mean deep venous thrombosis rate of 1.2% (range, 0% to 8%) and paresthesia was seen in 9.7% (mean). Park et al⁶⁵ described paresthesia in 26% of patients, but radiofrequency ablation in some patients in this cohort was performed by proximal ligation and retrograde ablation. Wo´z niak et al⁷² published a comparative analysis of 5-year outcomes of lower extremity varicose vein therapy (13 small saphenous veins) using monopolar and segmental radiofrequency ablation and reported a 100% occlusion rate and no paresthesia.

Nonthermal techniques, including mechanochemical ablation and cyanoacrylate vein ablation, have been developed with a view to remove the risk of thermal injury. The various techniques of nonthermal ablation can completely avoid the need for tumescent anesthesia, reduce the time of the intervention, per-interventional pain, bruises, and sensory nerve lesions.

Mechanochemical endovenous ablation
Mechanochemical endovenous ablation is a hybrid endovascular procedure that has two components: mechanical abrasion via a special catheter and chemical ablation by injecting foam sclerosant (sodium tetradecyl sulfate or polidocanol). The ClariVein catheter is positioned through a micros heath with the tip of the device 2 cm distal to the saphenopopliteal junction under ultrasound guidance. The mechanical damage to the endothelium is caused by the catheter’s rotating element and the chemical damage by the sclerosants.

Witte et al,⁷³ in a meta-analysis, reported the results of six articles (mechanochemical endovenous ablation of 254 small saphenous veins).^74-79 Two publications (randomized controlled trials) included the same patient population.^76,77 The primary outcome was anatomical success, defined as closure and absence of reflux on duplex ultrasound imaging. The anatomical success rate was 87% (mean) after a follow-up that ranged from 8 to 52 weeks. Studies were heterogeneous and used liquid polidocanol (1.5% or 2%) or liquid sodium tetradecyl sulfate (1.5% or 2%). There was one patient with an injury of the sural nerve after treatment resulting in transient hyperesthesia. This patient already suffered from sensory, sural neuropathy after previous saphenopopliteal junction ligation, which was aggravated by the mechanochemical endovenous ablation. Paresthesia has not been reported specifically for the small saphenous vein.

Glue cyanoacrylate ablation
n-Butyl cyanoacrylate is delivered intravascularly, and it polymerizes when it comes in contact with blood, leading to occlusion of the vessel. In animal models, the cyanoacrylate-treated veins have a granulomatous-type inflammatory response with the presence of giant cells, segmental wall thickening, and fibrosis.⁸⁰ The procedure involves using an introducer sheath, a dispensing catheter, and a syringe that is attached to a dispenser gun. The catheter is advanced into the varicose vein under ultrasound guidance. The catheter is placed in specific areas along the varicose vein and the clinician conducts a series of trigger pulls to deliver the medical adhesive. Compression is applied to the leg during the procedure. When treating the small saphenous vein, the catheter tip is positioned 3 cm to 5 cm distal to the saphenopopliteal junction.⁸¹ Compression after cyanoacrylate ablation is not mandatory. Extensive data about small saphenous vein treatment are necessary to improve outcomes and achieve robust evidence.

Eroglu et al,⁸² in a randomized controlled trial comparing cyanoacrylate, radiofrequency ablation, and endovenous laser ablation for the treatment of superficial venous incompetence, included 28 small saphenous veins (9 with cyanoacrylate, 3 with radiofrequency ablation, and 16 with endovenous laser ablation) and, at 2 years in any patient undergoing procedures, there were no reported recanalizations, deep venous thromboses, or paresthesia. In the WAVES trial, Gibson et al⁸³ showed, in 8 small saphenous veins, an anatomical success rate of 100% after a follow-up of 12 months. In their study, Yasim et al⁸⁴ treated 11 small saphenous veins and observed, after a mean follow-up of 5.5 months, no recanalizations and no adverse effects.

Safety data

Thromboprophylaxis can be prescribed for high-risk patients (previous venous thromboembolism, documented thrombophilia, obesity, immobilized patients, patients with neoplasm, and older patients). It is recommended to perform duplex ultrasound screening after thermal and nonthermal ablation within 10 days postoperatively, but this is not clearly defined.

Conclusion

In their meta-analysis, Boersma et al² reported that ablation techniques (endovenous laser ablation and radiofrequency ablation) were found to present higher pooled anatomic success rates (98.5% and 97.1%, respectively) as compared with surgery (58%) and ultrasound-guided foam sclerotherapy (63.6%). Neurologic complications were also more frequent after surgery than thermal ablation (19.6% vs 4.8% after endovenous laser ablation and 9.7% after radiofrequency ablation). Based on the literature and recommendations, endovenous thermal ablation should be preferred to surgery and foam sclerotherapy in the treatment of small saphenous vein incompetence. The potential benefits, particularly the reduced risk of nerve damage, might be of considerable clinical importance and may lead to a preference for nonthermal techniques in the future. Extensive data about nonthermal techniques are necessary to improve outcomes and acquire robust evidence. The cost analysis of varicose vein treatments should also be taken into account in future treatment recommendations.





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