Tournay (French) technique

The Tournay procedure encompasses the basic principle of ‘French phlebology’ developed by Tournay et al:⁶ treating varicose veins ‘from high to low’ (‘de haut en bas’). The rationale for this technique is in first eliminating high-pressure reflux blood flow at the point of occurrence. Treating from proximal to distal sites also eliminates the weight of the column of blood on the sclerosed point. This has the advantage of minimizing thrombosis and the extravasation of red blood cells (RBCs) from a sclerosed vein segment. The French school advocates placement of very few injections at this ‘high (proximal)’ point before treating more distal veins or sections of the same vein at a later date. This same philosophy toward treatment was also reported from the Mayo Clinic in 1941 by Heyerdale and Stalker.⁷ The principle of eliminating reflux from the saphenofemoral junction (SFJ) was espoused even earlier by Moszkowicz⁸ in Germany in 1927 and by de Takats and Quint⁹ in the United States in 1930. Thus the ‘French technique’ is multicultural in its origin.

In addition to developing a treatment regimen with the tenet just mentioned in mind, it is critical to obliterate the SFJ accurately because its location and anatomy are so variable (see Chapter 1). To determine the origin of high pressure in the varicose vein, a noninvasive diagnostic evaluation of the patient should be performed first (see Chapter 5). The handheld Doppler device helps detect points of reflux from the deep to the superficial veins, through either incompetent saphenofemoral or saphenopopliteal junctions or perforating veins. In certain circumstances, additional testing is required. If any points of reflux are detected, they should be treated first. After the high-pressure flow has been eliminated, treatment should proceed first with injection of the largest varicose veins, then injection of the reticular feeding veins, and finally treatment of the remaining ‘spider’ veins.

In defense of the logic of the French technique, de Groot⁴ pointed out that any vein in the leg belongs to either the greater saphenous system or the lesser saphenous system (Fig. 9.1). This concept implies that a vein within the defined area of the great saphenous vein (GSV) eventually drains into the GSV. Therefore, reflux in that vein is derived from reflux at the SFJ. This concept directs treatment toward the reflux point. Unfortunately, clinical examination of the location of a vein does not always correctly determine the point of reflux. Therefore the clinical examination must be correlated with a noninvasive examination to establish the optimal order of therapy.

Figure 9.1 Diagram of the great saphenous vein (GSV) and small saphenous vein (SSV) ‘systems’.

(Redrawn from de Groot WP: J Dermatol Surg Oncol 15:191, 1989.)

Sigg (Swiss) technique

In contrast to the French technique, the Swiss technique of Sigg¹⁰ and the modification by Dodd and Cockett¹¹ advocate total sclerosation of the entire varicose vein, including incompetent perforator veins (IPVs) and the SFJ. This technique has also been adopted by some physicians who modify Fegan’s technique of sclerotherapy of the IPVs (described in the following section). Included in this school are Reid and Rothnie,¹² who treated 1358 legs of 974 patients and found that selective injection of perforator veins was ineffective, requiring multiple additional treatments of the entire vein. They evolved a technique of placing multiple injections at intervals along the varicose veins to produce diffuse sclerosis and have reported very favorable results. This latter technique is called the total-vein sclerotherapy technique.

Fegan technique

Fegan et al¹³ proposed a view opposite to the previously mentioned one, namely that saphenofemoral incompetence could occur as a result of perforator incompetence alone. They reached this conclusion by demonstrating that the calf muscle pump is more powerful than the abdominal or femoral muscles regarding venous flow in the leg. They proposed that sclerotherapy of the IPVs should be performed first, to restore normal function. Fegan’s examination of the SFJ and GSV with phlebography after sclerotherapy of IPVs showed narrowing of the vessel lumen in 9 of 11 patients.¹⁴ However, surgical exploration of clinically diagnosed areas of perforator vein incompetence has found at best a 60% incidence of perforator veins being correctly identified clinically.¹⁵ In addition, phlebographic examination performed on 112 patients with clinically suspected incompetent perforators showed that the clinical examination correctly identified only 38% of perforator veins below the knee and only 17% of thigh perforators.¹⁶ An additional study of 180 limbs with primary varicose veins studied with clinical examination, ascending deep-to-superficial venography, Doppler ultrasound, and ambulatory venous pressure measurements showed that only 40% of these patients had evidence of perforator incompetence. Of them, 30% had no hemodynamic significance to the perforator veins.¹⁷ Thus, the rationale for Fegan’s technique is open to dispute.

Despite the lack of accuracy of clinical diagnosis of IPVs, many authors have found Fegan’s technique gives excellent results. Tolins¹⁸ reported favorable results using Fegan’s technique; he injected varicose veins in areas of fascial defects with 0.5 mL of sodium tetradecyl sulfate (STS) solution at up to 23 sites per leg. Although this many injections may seem similar to the number with total vein sclerotherapy, three-quarters of the patients had two to five injections. Doran and White¹⁹ concluded after 2 years of follow-up that there was no difference between the results from Fegan’s technique and ligation and stripping procedures for varicose veins. Hobbs²⁰ concluded from his comparative study of sclerotherapy with Fegan’s technique versus traditional surgery that sclerotherapy is the best treatment of nontruncal varicose veins and IPVs of the lower leg. Tretbar and Pattisson²¹ have found in their follow-up examinations of 264 patients treated with Fegan’s technique that treatment failures usually occurred in patients with very large or fat legs with varicosities originating above the knee. They believed this failure was caused by the difficulty of placing injections accurately within the veins of these patients and maintaining adequate compression. Sladen²² analyzed 263 limbs with up to 7 years of follow-up and found that more than 95% of his patients were satisfied with the treatment and said they would have it repeated. He estimated a retreatment rate of approximately 5% per year. His patients averaged 3.6 to 5.25 injections per treatment session, and 46% to 74% required one treatment session only. Sladen, in agreement with Hobbs, found that all patients with saphenofemoral reflux eventually required surgery. Therefore, although varicose veins treated with Fegan’s technique respond well to treatment, the supposition of Fegan’s technique – that sclerosis of the IPVs is of primary importance and may reverse the remaining pathology in the GSV system – may not be correct universally.

Hobbs²³ provided evidence that when saphenofemoral and perforator incompetence occur together, both abnormalities should be corrected. Kerner and Schultz-Ehrenburg^24,25 studied the functional effects of sclerotherapy with photoplethysmography (PPG) and concluded that the greatest functional improvement occurred with obliteration of the SFJ. Obliteration of the IPVs of the lower legs was of variable importance. Treatment of perforator veins of the upper leg had no functional significance that could be ascertained with PPG.

Treatment of reflux from the saphenofemoral junction

There are at least three schools of thought regarding which type of therapy is appropriate for initial treatment of the junctional points of reflux: surgical ligation (with or without limited stripping) of the SFJ versus sclerotherapy of the SFJ versus sclerotherapy of IPVs alone. Bergan (see Chapter 10), Goldman,²⁶ Hobbs,^20,27 and others argue that surgical treatment of the junctions is the most appropriate and successful mode of treatment, but this was before the use of endovenous ablation techniques. Neglen,²⁸ in a comprehensive review, determined that with proper follow-up, including functional testing at 5 years, surgical therapy of the GSV in a patient with incompetence of the SFJ, is significantly better than sclerotherapy.²⁸ Color-flow duplex evaluation, from 3 to 55 months after treatment (mean of 27.5 months) of 89 limbs in 55 patients with an incompetent SFJ treated with the Sigg technique, found that only 6% of veins remained sclerosed despite improvement in symptoms in 50%.²⁹ Butie³⁰ has shown that sclerotherapy of the SFJ is difficult and unreliable with the use of liquid STS 3%, which is the strongest sclerosing agent approved for use by the US Food and Drug Administration (FDA). This has been confirmed even when sclerotherapy was performed at the SFJ under angioscopic guidance (see ‘Endoscopic injection’ section).³¹ In this case, 12 GSVs were occluded at the SFJ through angioscopically guided sclerotherapy with STS 3% liquid (prior to the use of foamed detergent sclerosants). A total of 2 to 5 mL was injected into the GSV just below the junction, which was occluded by manual pressure. Nine veins were evaluated at follow-up, and all were reopened and incompetent between 1 and 12 months. Although these carefully performed, unbiased studies have been carried out only recently, this opinion is not new. As far back as 1934, Cooper,³² in a series of more than 85,000 injections in more than 3000 patients, documented that the number of sclerosing injections required to produce obliteration of the varicose vein was markedly decreased after ligation of the SFJ.

In addition to its lack of consistent success, sclerotherapy of the SFJ has the inherent risk of damaging the deep venous system and the femoral vein when sclerosing solution is injected in the upper thigh region. This has been demonstrated by radiologic examination showing the rapid flow of contrast media from a varicose GSV into the femoral vein when injections are performed in the upper thigh.³³ With incompetence of the SFJ, it is recommended that sclerotherapy be used for treating residual varicosities after surgery.

Despite the information in the preceding paragraph, multiple phlebologists have demonstrated that the junctions can be successfully closed with sclerotherapy alone in 50% to 91% of patients.^34–40 A comprehensive illustrated discussion of the technique is presented in other sources.⁴¹ The difficulty in properly evaluating these conclusions is due to the natural evolution of varicose veins, which obscures the results of both surgical and sclerotherapy treatment. It is sometimes difficult to distinguish between a recanalized vein and a new vein. Results also depend on the type of follow-up examinations (i.e. clinical or objective with duplex or Doppler ultrasound) of patients. One study with clinical 6-year follow-up demonstrated a nearly 90% success rate with sclerotherapy.³⁴ By whatever method, closure of the SFJ has been shown in pressure studies to prevent retrograde flow in the saphenous and perforator systems.⁴² This suggests that incompetence of the perforator veins occurs as a result of a primary development of saphenofemoral reflux. Therefore, when the GSV or its tributaries are involved, the SFJ, when incompetent, should be the first area to be treated.

Treating incompetence of the SFJ may differ from treating an incompetent saphenopopliteal junction (SPJ). The small saphenous vein (SSV) has a variable termination (see Chapter 1) that is often difficult to approach surgically, but can be approached with modern endovenous ablation techniques. Ligation alone at the SPJ has a 95% failure rate at 1 year.⁴³ Sclerotherapy is much more effective, perhaps because of the larger extent of destruction of abnormal feeding veins into this region.⁴³

In summary, long-term comparative studies with objective methods for evaluating outcome of the various techniques are lacking. The literature consists mainly of anecdotal reports and clinical studies with short follow-up periods.

A comparison of three independent observers regarding treatment outcome of varicose vein surgery shows 60% agreement in assessing visual improvement, with 30% agreement between observers when symptomatic response and visual impression are compared.⁴⁴ It is my opinion that no one ‘school’ is absolute but that the correct order of treatment should be individualized for each patient. Some patients have only perforator incompetence and a normal SFJ; thus, Fegan’s technique would be adequate. Patients with saphenofemoral incompetence require treatment of that junction before treatment is initiated elsewhere. Still other patients have no obvious hemodynamic cause for the origin of their varicose veins, thus directing treatment toward the entire varicosity, as described by Sigg.⁴⁵ A careful workup of all patients is necessary before therapy is begun. In addition to deciding on the sequence of treatment, the physician must consider the various modifications of the injection procedure that some physicians profess have various benefits. As before, comparative and objective studies of these treatment modifications have not been reported. This chapter discusses sclerotherapy treatment of varicose veins, perforator veins, and the SFJ and reviews the available literature. Variations in treatment are addressed, and illustrative cases are presented. A summary of the three schools of sclerotherapy is found in Table 9.1.

Foam sclerotherapy (whether ultrasound guided or not) changes the outcome of the above-mentioned techniques. This ‘new’ or at least ‘newly appreciated’ sclerotherapy technique has such advantages that it allows treating long segments in a single injection. This aspect is close to the total-vein sclerotherapy technique. Foam sclerotherapy is likely to replace all other techniques for sclerotherapy of veins greater than 2 mm in diameter. With the reservations indicated above about the probable role of the venous reservoir, ultrasound-guided sclerotherapy can be used for treating most varicose veins, including trunks of all diameters. The fate of junctions has been completely revised after evaluation of patients treated by endovenous ablation (radiofrequency and laser) and it is obvious that a revolution in varicose veins management is in progress.

Patient position

Standing

Although the previous description of the treatment of varicose veins seems simplistic, the actual treatment methods for achieving effective sclerotherapy are numerous. Until the 1950s, sclerotherapy was performed with the patient standing throughout the procedure. The purpose was both to distend the varicose vein, allowing easier needle insertion, and to produce firm thrombosis of the treated vein.⁴⁶ Multiple disadvantages of varicose thrombosis were realized (see Chapter 8), and various methods were devised to limit postsclerotherapy thrombosis. Additionally, injecting sclerosing solution while the patient is standing forces the injection to occur against the hydrostatic pressure of a large column of blood. This may cause the solution to seep along the needle into the perivenous tissues, possibly leading to a chemical phlebitis or tissue necrosis.⁴⁷

Another disadvantage of the total standing technique is the sclerosing solution may escape through a perforator vein and damage the deep veins, especially if more than 1.5 mL of sclerosing solution is injected in a single site.⁴⁸ Another radiographic study has shown that an injection of 0.5 mL of contrast media travels rapidly (in 5 seconds) 8 cm distal to the injection site.⁴⁹ Also, this amount of contrast does not completely fill the vein. An additional radiographic study of the standing position, using metrizamide (Amipaque) 150 as the contrast media (diluted to an isomolarity and specific gravity similar to that of polidocanol (POL)), showed that the injection of 1.5 mL remained in contact with a convoluted varicosity for approximately 10 seconds before flowing rapidly into the deep venous system through a presumed perforator vein (Fig. 9.2, A and B).⁵⁰ In contrast, when the patient was supine, the contrast media extended proximally along the varicosity and remained relatively undiluted for more than 18 seconds (Fig. 9.2, C and D).⁵⁰ However, injections in some patients, when using the latter technique, also resulted in the contrast media’s remaining in contact with the varicosity for a longer period with the patient in the standing position (Fig. 9.3). Therefore, multiple variables, including the type of varicosity, its location, the location of associated perforator veins, and the movements of the patient (with associated calf and foot muscle contraction) while standing, may all affect the distribution of the sclerosing solution. For these reasons, the standing technique is not recommended.

Figure 9.2 Injected contrast media, 1.5 mL, shown, A, seconds and, B, seconds after injection into a varicose vein while the patient was standing. Injected contrast media, 1.5 mL, shown, C, seconds and, D, 18 seconds after injection into a varicose vein while the patient was supine.

(Courtesy of George Heyn, MD, Department of Vascular Surgery, Berlin, Germany.)

Figure 9.3 A, Contrast media, 1.5 mL, shown 10 seconds after injection into a varicose vein while the patient was supine. Note the distribution of the contrast media proximally within the varicose vein. B, Contrast media, 1.5 mL, shown 10 seconds after injection into a varicose vein while the patient was standing. Note the contrast media remains for a relatively long time within the venous convolution.

(Courtesy of George Heyn, M.D., Department of Vascular Surgery, DDR-Berlin.)

Leg elevation (Fegan)

Another obvious disadvantage of the standing technique is the vasovagal reaction (see Chapter 8). To prevent the sequelae of a vasovagal reaction, Fegan⁵⁶ recommended that patients sit at the end of the examining table with their legs hanging down while the physician, sitting in front on a low stool, inserts the needle. The leg is then raised while the patient fully reclines for 1 to 2 minutes to empty it of blood. The physician stands to support the raised leg, which is rested on the shoulder or against the chest, and the varicose veins are injected. With this or any technique that moves the patient after the needle is inserted, it is important to ensure that the needle is not displaced from the vein, either by fixing it to the skin with tape (if butterfly catheters or needles attached to syringes are used) or by holding the needle while the leg is raised. Since the varicose veins will collapse when the leg is raised, blood withdrawal must be checked as soon as possible after the leg is raised to ensure that the needle has not slipped out of the vein. The lack of spontaneous pulsatile flow from the needle without an attached syringe is proof of nonarterial placement of the needle.

To ensure that the sclerosing solution acts on the intended vein segment during injection, Fegan⁵⁶ recommended applying pressure with fingers a few centimeters proximal and distal to the injection point. Finger pressure is maintained for 30 to 60 seconds, and the leg is then bandaged from the toes to the injection site. With this method, injections are made only at the points of fascial defects (which are thought to represent sites of IPVs). Injections proceed from distal to proximal sites, with each vein segment or fascial defect treated.

After injection of varicose veins in the elevated leg, compression should be applied immediately to prevent the vein’s filling with blood. This can be performed easily with the use of the following method. Before insertion of the needle, a compression stocking is placed over the foot and heel and allowed to bunch up at the ankle. After the needle is inserted into the varicosity, the leg is raised. Proper placement is then confirmed through blood withdrawal, and the sclerosing solution is injected. A foam pad is placed over the injection site and secured in place with foam or elastic tape. The compression bandage then can be advanced over the injection site and foam pad in a distal to proximal manner (Fig. 9.4). With this technique, radiographic studies after injection of 0.5 mL of contrast medium show that when the leg is raised above the horizontal plane, the contrast medium travels rapidly for 30 cm before reaching the deep venous system.⁴⁹ The sclerosing solution is diluted and probably inactivated by the time it reaches the deep venous system (see Chapter 7). With this technique it may not be necessary to repeat injections every few centimeters in the varicose vein.

Figure 9.4 A, Localization of an incompetent perforator vein (IPV) through the use of a handheld Doppler device. B, Cannulation of the IPV with a 26-gauge butterfly needle. C, The leg is elevated 45 degrees, and 0.5–1.0 mL of sclerosing solution is placed into the now empty perforator vein under minimal pressure. Note placement of a finger distal to the injection site to feel for extravasation of solution (which would indicate improper placement of the needle and necessitate immediate discontinuance of treatment and infiltration of the injection site with lidocaine 1%). D, Immediate compression of the treated vessel with an STD foam pad and tape dressing.

With the leg-raising technique the varicose vein would be presumed empty of blood, but this is not the case. Duplex examination demonstrates that the GSV is not totally emptied of blood, even with an 80-degree incline, although tributaries to the GSV are emptied at 45 degrees.⁵⁷ In ‘huge’ varicosities, as much as 18 mL of blood can be withdrawn when the leg is raised 45 degrees above the horizontal.⁵⁸ Therefore, Perchuk⁵⁸ developed a method for ensuring an ‘empty’ vein. His method consists of inserting the needle into the varicose vein, elevating the leg 45 degrees, and then withdrawing blood through that needle into a syringe until further blood withdrawal is impossible. Then, a syringe with sclerosing solution is attached to the needle and the injection is made, followed by application of local pressure for 5 minutes. The use of compression bandages or stockings after treatment was not mentioned. A two-way stopcock may also be used for this technique. Perchuk, in an evaluation of 84 patients, found that this technique produced excellent results and limited all complications.⁵⁸ Pigmentation, thrombophlebitis, and recurrence were very rare. Fegan,⁵⁹ however, disagreed with Perchuk’s conclusions and stated that the vein would empty of blood if raised for a longer time and at a more acute angle.

Foam sclerotherapy

Since the earlier editions of this textbook, the use of foam sclerosants has increased dramatically. Far from the primitive techniques described by so many authors and well detailed in Wollmann’s history of sclerosing foams,⁶¹ it is now considered as a completely new treatment for varicose veins.^62,63 Shaking the syringe⁶⁰ or aspirating in a closed glass syringe,⁶⁴ to quote only two of the well-known historic methods, are now obsolete. Three main options remain: high-speed beating in a carbon dioxide-rich atmosphere (Cabrera’s technique⁶⁵), specific gas mixture combined with POL and passed through a patented sieve in an aerosol canister (Varisolve, Provensis Ltd., UK), and Tessari’s method, using the transfer between two syringes of sclerosant and room air. The latter technique offers different variations: a three-way stopcock as initially described⁶⁶ (Fig. 9.5), a two-way female connector like in the DSS technique⁶⁷ (Fig. 9.6), or an automated foaming device, Turbofoam (KreusslerPharma, France), described in Chapter 7, which has the ability to mix the sclerosant with different types of gases through the use of a three-way connector. The Tessari technique is the most common means for foam creation.⁶⁸

Figure 9.5 Generation of a foam sclerosing solution using a three-way connector: 1 mL of sclerosing solution was mixed with 4 mL of room air.

Figure 9.6 Generation of foam using a two-way female-to-female connector. A, 1 mL of detergent sclerosing solution is in one syringe and 4 mL of room air is in the other syringe. B, when the air and detergent sclerosing solution is mixed, a foam is generated.

Immediately following the injection of foam sclerosant, the bubbles displace blood and contact with the sclerosant and endothelium begins. Clinically, this is apparent as vasospasm within seconds or minutes, erythema of the feeding telangiectasias, or no immediate visible change (Table 9.2a Pt1). After several days, venous inflammation is present with thickening of the venous wall and presence of a sclerus. This is evidenced clinically by induration, erythema, and tenderness. Weeks to months later, fibrosis results in a progressive decrease in the diameter of the treated vein and clinically by the absence of the varicosity. Occasionally, a fibrous cord may be palpated (Table 9.2b Pt2). At times, complete clearance of the varicose veins does not take place, owing to either partial or total recanalization of the treated vein (Table 9.2c Pt3).

Table 9.2 A-C Pathophysiologic and clinical effects from foam sclerotherapy

Foam stability

Foam stability is affected by foam composition, foam volume, and injection technique.⁷⁵ Composition variables, including the homogeneity of bubble size, viscosity, and temperature, all influence the ‘quality’ and longevity of foam (Table 9.3).⁷⁶ Heat increases the stability of foam.⁷⁷

Bubble size is inversely related to the difference in density between a liquid and gas, as represented in the equation below.⁷⁶

9.1

where

Carbon dioxide is 1.5 times denser than room air; therefore, foam bubbles prepared from carbon dioxide are smaller than those of air. Foam bubbles produced via turbulent flow in the Tessari technique and the double syringe system are smaller (less than 100 µm) in size as compared to the larger bubbles produced in the Monfreux technique. This smaller bubble size is associated with an increased surface area of sclerosant, increased displacement of blood inside the vessel, and decreased likelihood of mixing with blood following the initial injection. Therefore, an increased amount of sclerosant can be delivered to the endothelial cells.^78,79 Interestingly, the Monfreux method of foam creation has been associated with an increased incidence of side effects. It is speculated that the larger bubbles produced in this method advance more readily in the venous system.⁷⁸

The majority of phlebologists utilize readily available room air for foam creation in sclerotherapy; however, carbon dioxide is becoming increasingly popular.⁸⁰ Carbon dioxide foam bubbles quickly disintegrate; this effect is more pronounced as the sclerosant to gas ratio is increased.⁶¹ The following equation describes foam stability in vivo:

9.2

where

Carbon dioxide has a much greater diffusibility into blood as compared to nitrogen (the dominant gas in room air), and as a result, the foam-half life is reduced for carbon dioxide. When carbon dioxide is mixed with oxygen for foam creation, the foam-half life is increased due to the decreased diffusibility of this mixture.⁸¹

Room air foam half-life varies according to the percent of sclerosant solution. In the study by Rao and Goldman,⁸² they found a 1% concentration of STS or POL had the maximal foam half-life (90 and 120 seconds, respectively) (Tables 9.4 and 9.5). We recently discovered carbon dioxide foam half-life did not vary according to the concentration of sclerosant solution; however, a mixture of 77% carbon dioxide/23% oxygen did. We also found that foam half-life for room air is over three times longer than carbon dioxide half-life and 1.5 times longer than a combination of 70% carbon dioxide/30% oxygen (see Table 9.3).⁸³

Silicone coating is present in syringes and syringe connectors to provide lubrication, but silicone is also an anti-foaming agent. Prior studies by Rao et al and Lai et al, have shown the amount of silicone in syringe connectors does not affect foam stability; however, foam stability varies between syringe manufacturers due to variances in the silicone content of their syringes.^82,84 Hill⁸⁵ investigated the effect of a 5 µm syringe filter on carbon dioxide foam half-life. In the absence of the filter, foam half-life was 22.7 and 30.1 seconds for STS 2% and POL 2%, respectively. Half-life was prolonged to 35.9 and 48.9 seconds, respectively, with the addition of a 5 µm filter. Of note, carbon dioxide foam stability was greater in POL versus STS throughout the study.

Foam has a spontaneous evolution before and after being injected in varicose veins. Before injection, small bubbles tend to group as bigger units (known as LaPlace’s law) and after some time foam is replaced by large bubbles whose effect will be what was observed with Orbach’s air-block. Stability of the foam can be evaluated by several techniques,⁸² and one should not talk about foam when prepared more than 90 seconds in advance. The preparation of foam does not change the concentration of sclerosing agent. This is completely different from what happens to the foam when injected. If injected into an isolated segment, a plug of foam is created and behaves as in a syringe, remaining in contact with the endothelium long enough to destroy it and induce venospasm. As the foam is forced from the contracting segment of vein, it mixes at the expanding interface with blood. This is responsible for dilution of foam and the scattering of bubbles, and surface sclerosing agent is rapidly deactivated by attachment to plasma protein and cell membranes. This explains why bubbles, when found far from the injection site for example, in the lung, heart, or brain consist of air and do not carry detectable amounts of sclerosing agent or have any sclerosing properties.⁸⁶

Regarding the use of foam, the trend in Europe is to develop a consensus for volumes and concentrations.^80,87 At the 2nd European Consensus Meeting on Foam Sclerotherapy, experts agreed than no more than 10 mL of foam per injection should be injected into a GSV. The range of volume injected into the GSV varied between less than 2 mL up to 10 mL per injection. The maximum recommended volume of foam per leg and per session was felt to be 10 mL. The Monfreux technique of foam creation was no longer recommended for any subtype of vein.⁸⁰ In France, there appears to be a reduction in concentrations,⁸⁸ with vessel spasm used as an indicator for the correct amount of foam injected. However, this option is true only for a proximal and direct injection of terminal parts of the saphenous veins. We have previously advocated for a more distal approach⁶² with placement of an open vein access (‘butterfly’ needle or catheter; Figs 9.7 and 9.8), filling the vein with relatively low volume concentrations, and massaging to the desired area under duplex control (Fig. 9.9). With several years of experience this is no longer deemed necessary. The necessary volume can be estimated from the diameter and the length of vein, as indicated in Table 9.6. In our practice, however, we do not currently use volumes above 10–12 mL in a single vein. It should not be forgotten that although foam is not air and usually occupies the entire vessel lumen, foam floats, so that in large-diameter veins it will principally be in contact with the upper part of the vein, where gravity leads it (Fig. 9.10). The only solution to this problem is a reduction in the diameter, which can be obtained by compression, leg elevation, or induction of venous spasm. Ten to thirty milliliters of normal saline can be injected perivenously, in a technique similar to tumescent anesthesia for endovenous laser or RF ablation, to cause venous compression and decrease recurrence rates.⁸⁹

Figure 9.7 Great saphenous vein (GSV) butterfly injection. Injection of the GSV trunk is often facilitated by an access through a more superficial, incompetent, and varicose extrafascial tributary. An initial concentration of foam around 1% is usually sufficient, provided the injected volume allows filling up of the tributary and the GSV up to the upper level of valvular incompetence.

Figure 9.8 Venous access with catheter and injection. Use of catheters and connectors is a little more complicated than the use of simple butterfly needles but is necessary to access the trunks when remote injection through extrafascial tributaries is not feasible. Use of a three-way stopcock allows to fill up with saline and to rinse the connector.

Figure 9.9 Massage foam to desired areas. Hyperechogenicity of foam makes it the perfect contrast medium for remote sclerotherapy. With little practice it becomes really easy to place foam in any vein from a distant open vein access (butterfly or catheter). Use of low or medium concentrations avoids adverse reactions, and the massage stimulates the appearance of a spasm, ensuring the efficacy of the method. In this case, the long-time feared sclerotherapy of the anterior saphenous vein becomes a simple and reliable procedure.

Figure 9.10 Effects of Archimedes’ law on foam contact with venous wall in veins of various diameters.

The most common technique for foam sclerotherapy is via ultrasound guidance⁸¹ and using the direct puncture technique.⁸⁰ While many authors employ short catheters, long catheters with balloon tips have become more prevalent due to a possible increased efficacy. However, long catheters may cause an increased incidence of deep venous thrombosis⁸¹ due to a passage through perforators, even if foam is re-aspirated at the end of the procedure. The recommendations from the 2nd European Consensus Meeting on Foam Sclerotherapy is to inject the GSV at the proximal thigh if using the direct puncture technique and distal to the knee if using long catheters. For the SSV, injection should be at the level of the mid calf in order to minimize adverse events including canulization of the popliteal artery.⁸⁰

Even if every phlebologist using foam sclerotherapy has been impressed by results (see Case Study 13 later in this chapter), evidence-based medicine applies to phlebology too and controlled trials are needed to demonstrate the validity of the technique. Efficacy of foam sclerosants is more substantially documented today than it was when writing the previous editions of this textbook and evidence is now available.^{67,70,90–92} Cabrera et al⁹³ have followed 500 lower limbs treated with their unique carbon dioxide-foam mixture, with no greater than 81% of the GSV and 96.5% of the superficial branches remaining closed at over 3 years. Results have not been as impressive when room-air-generated foam is used. Fruillini and Cavezzi⁷⁸ found an 88% success rate when the foam was generated with the glass syringe/Monfreux technique versus 93% when generated with the Tessari technique. Although their follow-up was 20 to 180 days, it is clear that the method for generating foam is important regarding treatment efficacy. Even Tessari reports a 74% efficacy of complete obliteration in a 2-year evaluation of 38 GSVs and SSVs and 194 collateral branches treated.⁹⁴ In a randomized controlled trial, proprietary pharmaceutical polidocanol microfoam (PPPM; Varisolve) was compared with superficial vein surgery or sclerotherapy in 654 patients with moderate to severe saphenous vein (GSV or SSV) incompetence. The overall success rates were 83.4% for PPPM and 88.1% for control at 3 months, and 78.9% and 80.4%, respectively, at 12 months; at neither time point was the difference significant.⁹⁵

A 3-year follow-up study in UGFS using either STS or POL for the GSVs, SSVs, and their tributaries revealed a 52.4% success rate. Veins that failed the primary treatment session were re-treated. The 3-year success rate for this group was increased to 76.8%.⁹⁶ A 5-year 56% efficacy rate was found in a prospective study investigating UGFS prepared from STS of the GSVs. This protocol consisted of weekly foam sclerotherapy treatments until reflux was no longer detected by ultrasound. Additional treatments were performed if recanalization was detected. Currently, this study contains the longest follow-up duration of all published studies on foam sclerotherapy.⁹⁷ In a recent meta-analysis that included 9000 patients, the median efficacy of foam sclerotherapy was 87% with a median recurrence rate of 8%.⁶⁸

Darke and Baker⁹⁸ investigated the number of UGFS treatment sessions required for clinical evidence of complete occlusion of varicose veins. Clinical complete occlusion rates at 6 weeks following the last treatment were as follows: 74.1% with a single treatment, 89.1% with two treatments, and 89.5% with three treatments. O’Hare et al⁹⁹ found no difference in efficacy rates at 6 month in veins of less than or greater than 7 mm in diameter that were treated with UGFS. However, Myers et al⁹⁶ found that treatment success was decreased in veins greater than 6 mm as compared to veins of less than 5 mm. This report also concluded success rates were higher in GSVs versus SSVs.

Multiple studies have investigated the influence of various sclerosant concentrations in relation to the efficacy rate of foam sclerotherapy. Efficacy rates were highest for POL 1.5% or STS as compared to 3% or more dilute concentrations in a study investigating saphenous veins and their tributaries.⁹⁶ A similar study investigating POL for UGFS of GSVs less then 8 mm found short term (3 week) success rates of 96% and 88% in subjects receiving POL 3% foam and POL 1% foam, respectively (difference was not statistically different). After 2 years, the success rates were 69% in patients treated with POL 3% foam and 68% in those treated with POL 1% foam.⁸⁸ Ceulen et al¹⁰⁰ initially found a significant difference in efficacy rates of UGFS between 1% and 3% POL foam at 1-year follow-up (69.5% and 80.1%, respectively). However, when these subjects were followed for 2.5 years, there was no difference in efficacy between the two concentrations of POL (66.7% and 66.8%, respectively).¹⁰¹ No exclusion criteria were made in this study with regards to the diameter of the GSV.^100,101

Side effects

A foam bolus can even occur when a small quantity of foam is injected. Hill et al⁷⁵ showed that leg elevation, but not manual pressure of the SFJ, decreased the migration of foam in sclerotherapy in UGFS of the great saphenous vein. At least this could ensure that bubbles will be washed of their sclerosing molecules, but will release much bigger bubbles. Other methods to decrease foam migration include multiple, sequential injections of foam sclerosant volumes less than 0.5 mL.¹⁰² A meta-analysis investigating side effects in over 9000 patients by Jia et al⁶⁸ found the median rates of deep venous thrombosis and pulmonary embolus were less than 1% each. The median values of visual changes and headache were 1.4% and 4.2%, respectively. Chest tightness and coughing occurred in less than 1%. In a large, prospective, multicenter study of foam sclerotherapy in 1025 patients the incidence of migraine was 0.78% (with aura 0.59%;.19% without aura), visual disturbance 0.68%, chest tightness 0.68%, chest tightness with visual disturbance 0.49%, deep venous thrombosis 0.98%, pulmonary embolism 0.1%, and transient ischemic attack 0.1%.¹⁰³

A recent study of patients with incompetent GSVs treated with UGFS created from either carbon dioxide or room air, in a 1 : 4 sclerosant to gas dilution ratio, demonstrated decreased incidences of foam-bubble-related side effects including chest tightness (3.1% to 18%), cough (1.6% to 16%), and dizziness (3.1% to 12 %). There was a trend towards decreased visual disturbances in the carbon dioxide versus room air group (3.1% to 8.2%), though this difference was not found to be statistically significant. There were no differences in vital signs or echocardiogram (ECG) changes between the two cohorts. An overall 71.79% decrease in bubble-related side effects (as compared to room air) was attributed to the carbon dioxide foam.¹⁰⁴ When cerebral emboli were monitored via transcranial Doppler ultrasound in patients treated with foam created from either room air or a 70% carbon dioxide/30% oxygen mixture, no statistical differences were found between these two cohorts with regard to the rate of high intensity transient signals in the middle cerebral artery.¹⁰⁵

One can speculate that the decreased upstream foam-related side effects are attributable to the short carbon dioxide foam half-life⁸³ and the increased diffusibility of this gas into blood in comparison to nitrogen and oxygen.^81,83 In a study of 116 patients with stasis ulcers, the incidence of visual changes and cough occurred in less than 2% of patients treated with carbon dioxide created UGFS.¹⁰⁶ In a large multicenter prospective study by Guex et al, visual disturbances occurred in 0.28% of patients treated with foam sclerotherapy created using room air.¹⁰⁷

Intravenously injected bubbles of less than 10 µm do not produce symptoms in patients, regardless of the presence of a patent foramen ovale.¹⁰⁸ Ceulen et al¹⁰⁹ noted foam microbubbles created from room air appeared in the right atrium and ventricle 0.75 to 15 minutes following injection. In the small study by Morrison et al,¹¹⁰ foam bubbles were identified in the deep venous system and the right atrium within 10 seconds of the initial injection of foam sclerotherapy into a 1-mm telangiectatic vein. This finding was reproducible in all 15 subjects. In a related study, these bubble emboli ‘showers’ could last minutes and were present in the left side of the heart in 33% of subjects, indicating a shunt. Of interest, 57% of this group of patients showed transcranial Doppler evidence of bubble emboli.¹¹¹

Four cases of transient ischemic attacks and cerebrovascular events have been reported in the literature. All patients had examples of right to left cardiac shunting, such as patent foramen ovale and atrial septal defects, discovered on further workup.^103,112,113 These bubbles can appear in the middle cerebral artery in under 35 seconds.¹¹⁴ Treatment for foam-induced neurological events includes administration of 100% oxygen followed by immediate transfer to an emergency department and the initiation of hyperbaric oxygen therapy.¹¹³ As the dominant gas in room-air bubbles is nitrogen, foam bubble half-life is decreased as the concentration of oxygen increases and the nitrogen decreases.¹¹⁵ Theoretically, in the event of cerebral emboli, the osmotic diffusion of oxygen and nutrients should be able to compensate for small bubbles but not larger bubbles.¹¹⁶

Deep venous thrombosis is a rare occurrence in foam sclerotherapy with an incidence of 0.015%.¹⁰⁷ Shadid et al¹¹⁷ recommends maintaining a high index of suspicion for the development of deep venous thrombosis when superficial thrombophlebitis occurs distant from the treatment area. Pulmonary embolus have been reported following UGFS.^103,118 Infection is a rare event following foam sclerotherapy, but cases of cellulitis and Klebsiella sepsis have been reported.¹¹⁹

Our technique for the treatment of reticular and telangiectatic leg veins

Our classification for veins are as follows: varicose veins are torturous and larger than 4 mm, reticular veins range from 1 to 4 mm, and telangiectactic veins are less than 1 mm. For the most successful outcome of foam sclerotherapy of telangiectatic leg veins, the feeding incompetent reticular veins must be treated simultaneously. At our clinic, we initiate with treatment of refluxing veins, the largest veins, and proceed in a proximal to distal fashion. The double syringe system with room air in a 1 : 5 dilution (1 part sclerosant solution: 4 parts gas) is our preferred method for foam creation. For reticular veins between 1 and 3 mm, we prefer STS 0.25% or, alternatively, POL 0.25% to 0.5%. We increase the concentration of STS to 0.5%, and POL up to 1%, for veins 3 to 5 mm in diameter. Telangiectatic leg veins are treated with liquid STS 0.25%, liquid POL 0.5%, or glycerin 72% with lidocaine 1% or without epinephrine (adrenaline). Our patients remain in the supine position without leg elevation for the duration of the treatment. Following treatment, the patient remains supine as nursing staff apply 30 to 40 mmHg compression stockings. Immediate ambulation for 15 to 30 minutes is required. For the next week, 24 hours a day (for one author RAW, only during waking hours), the patient remains in their compression stockings.^120,121

Other applications of foam sclerotherapy

Combination therapy

Foam sclerotherapy with saphenofemoral ligation versus high ligation, stripping, and multiple phlebectomies was evaluated by Kalodiki et al.¹²³ With 3-year follow-up, there was no statistical difference in the recurrence rates between these two treatment regimens on Doppler ultrasound evaluation.

Foam sclerotherapy can be combined with endovenous laser ablation at the time of surgery or can be performed at follow-up visits. In a study by King, UGFS was combined with either the 980 nm or 1320 nm endovenous laser for the treatment of incompetent saphenous veins. At 1-month follow-up, treatment success was seen in 97% of patients.¹²⁴ Further long-term data and controlled clinical trials will be necessary to evaluate whether combined endovenous laser ablation combined with foam sclerotherapy is superior to endovenous laser ablation alone. Any varicosities remaining at 6 weeks post procedure and distal to the site of endovenous ablation should, in our experience, be treated by foam sclerotherapy.

Contraindications

Air bolus

The air-bolus technique was first advocated by Orbach⁶⁰ to ensure that sclerotherapy treatment of varicose veins occurred with minimal thrombosis. The rationale for instilling air before injecting the sclerosing solution is that clearing the vessel of blood allows undiluted contact to occur between the solution and the vessel wall. This procedure was thought to minimize the concentration and quantity of solution required to produce endothelial injury. A comparative evaluation of this technique demonstrated enhanced efficacy of treatment regardless of the type of sclerosing agent used.¹³² In reality, the potential complications of air embolism, as addressed in Chapter 8, are nil. A disadvantage of this technique is that air proximal to the sclerosing solution in the syringe causes compression of the solution, producing leakage of solution from the needle after depression of the plunger has stopped. This may cause extravasation of solution on needle withdrawal.

Radiologic studies have shown air-bolus injections into large varicose veins in the area of the GSV are ineffective in clearing the vessel of blood, even when 0.5 mL of air is injected immediately before the injection of contrast medium.⁴⁹ In addition, the air inhibits complete and even filling of the varix both proximal and distal to the injection site. In smaller varicosities, injected air forms several bubbles and does not act as a bolus. It also moves independently of the position of the patient and is not totally under the influence of gravity. Therefore, the air-bolus technique may not be advantageous for use in treating varicose veins.

Use of a tourniquet

The use of a tourniquet is not recommended as an aid to injection. Although it may distend the vein for easier cannulation, the increased pressure in the varicose vein may force sclerosing solution into normal veins. In addition, the tourniquet impedes flow in the normal vein, thus limiting the normal dilution of sclerosing solution. However, the tourniquet may be used to facilitate placement of the needle into the vein. It is then removed, ensuring that the intended vein has been cannulated, and the solution is then injected.

Ultrasound-guided injection

Ultrasound is a useful tool to help visualize injection of a varicose vein in patients who have deeply situated perforator veins, in the obese patient in whom the varicose vein is not easily palpable, in patients with recurrent varicose veins, and in patients with an unusual or complex anatomy that makes finding the point of maximum reflux difficult. Ultrasonic guidance alone does not compensate for lack of dexterity or experience. In fact, injection may be riskier, because of the complex reasons that necessitate its use. Earlier experience with less detailed ultrasound imaging demonstrated multiple complications, with the most severe being arterial injection with loss of significant amounts of tissue (see Chapter 8).¹³³ The use of foamed sclerosant has also decreased the risks.

Ultrasound-guided injection was first described in 1989 and is a natural extension of the use of ultrasound in patient evaluation.^134–138 The technique for injection is similar to that for standard sclerotherapy except that the needle used is usually longer and of larger a diameter. The author generally uses a 1.5-inch, 22-gauge needle, which is sufficiently large to be echogenic. Smaller needles (25-gauge) could not be easily seen with earlier Duplex ultrasound devices, but with newer high resolution devices even needles of 30-gauge diameter can be visualized.

The needle is introduced into the vein open (not attached to a syringe) to ensure venous placement, because arterial injection must be avoided (Fig. 9.11A) (see Chapter 8). Injection of the foamed sclerosing solution is seen as echogenic flow (Fig. 9.11C). The injection continues until the vein goes into spasm, thrombosis occurs or foam is seen filling the vein (see Fig 9.11D, Figs 9.12 and 9.13).

Figure 9.11 A, Needle is inserted close to the transducer tip and along the sagittal plane of the transducer. Depth of target incompetent perforator vein (IPV) is measured on the B-mode image from skin surface to segment of IPV. B, B-mode ultrasound image showing needle approaching IPV. C, B-mode ultrasound image of needle located in vein with sclerosant flowing in the vein. D, Postinjection B-mode image of IPV showing vessel spasm.

(From Thibault PK, Lewis WA: J Dermatol Surg Oncol 18:895, 1992.)

Figure 9.12 Keep needle bevel down. A, When using butterfly needles (and syringe-attached needles too), attention must be paid not to damage the opposite venous wall; thus it is suggested to turn the bevel down. B, Turning the bevel down has another advantage: it limits the obstruction of needle lumen when in contact with the venous wall. This is especially important when attaching the butterfly needle to the skin with adhesive tape.

Figure 9.13 A, Cross section of needle pre-injection into 5 mm diameter vein; B, GSV before treatment 5 mm in diameter; C, Immediate post perivenous tumescent anesthesia, the vein has decreased in diameter to 1.8 mm.

(Courtesy of Paul Thiabault, MD)

To provide an even safer method for injection, Grondin and Soriano¹³⁹ advocate the use of a 20-gauge, 44-mm Teflon or radiopaque catheter to cannulize the vein under ultrasound guidance to further enhance accurate visualization of proper needle placement. Their reported rate of complications in 500 patients is 19.4% postinjection pain, 6.4% superficial phlebitis, and no cases of intra-arterial injection, pulmonary emboli (PE), deep vein thrombosis (DVT), or extravasation necrosis. Parsi and Lim¹⁴⁰ also advocate this ‘long line’ echosclerotherapy and comment on the lack of any arterial injection using this technique in their 3-year experience.

Kanter and Thibault¹⁴¹ reported their 2-year experience in treating 202 limbs with ultrasound-guided sclerotherapy. Of these limbs, 23.7% had recanalized at 1 year with no additional veins recurring at 2 years. No complications were reported in their patients. They injected 3% STS in 1-ml increments beginning 3 to 4 cm distal to the SFJ and continued with distal injections every 30 to 90 seconds until persistent vessel spasm occurred or a maximum of 15 mL was injected. This is not possible with foam as the vein will spasm too quickly. Compression with a class II stocking was maintained for 1 week. Two weeks after treatment, any additional nonsclerosed veins were again treated in this manner. For liquid sclerotherapy, the best results were seen in patients treated with larger volumes of STS. Thibault¹⁴² followed 35 of his patients for 5 years and noted 25.7% with recurrent veins and 40% with persistent reflux. Thus, duplex-guided GSV sclerotherapy with liquid sclerosing solution is only moderately effective.

Finally, a Doppler ultrasound-guided 18- or 20-gauge (2.75-inch or 1.5-inch, respectively) introducer needle (SmartNeedle, Advanced Cardiovascular Systems, Temecula, Calif.) is commercially available. This device has the proposed benefit of allowing distinction of arterial from venous flow before treatment and has been used to prevent erroneous arterial puncture during placement of a central venous catheter.¹⁴³

Foam is the best contrast medium for ultrasound-guided injections. Microbubbles are perfect reflectors and when injected into a vein, foam appears as a white cloud responsible for a subjacent black shadow cone (see Fig. 9.9). Being completely opaque to ultrasound it does not allow control on the deeper part of the injection, and in large veins, where foam floats along the more superficial venous wall, some doubt remains regarding appropriate contact of the whole venous wall.

Duplex ultrasound is also useful in assessing the response to initial treatment. When patients return for follow-up examination, duplex evaluation can guide subsequent injections to sections of the vein that have not sclerosed fully or to a previously unrecognized area of reflux. When sclerotherapy is successful, the venous wall appears thickened, particularly at the intimal layer, with ultrasound (Fig. 9.14). The vein is noncompressible. When endofibrosis is subtherapeutic, the lumen is open with partial intravascular thrombosis. These findings indicate the need for a further sclerotherapy injection. Incomplete sclerosis appears as a series of multiple echoes represented as intraluminal white dots.¹³⁴ Superficial thrombophlebitis appears as an enlarged luminal diameter with minimal parietal changes, partial compressibility, echogenic blood flow, and a lumen partially filled with echogenic material.¹⁴⁴

Figure 9.14 Duplex ultrasound transverse image of the great saphenous vein after sclerotherapy. Note presence of adherent heterogeneous material within the lumen and thickening of the endothelium.

(From Raymond-Martimbeau P: Semin Dermatol 12:123, 1993.)

Thibault and Lewis¹⁴⁵ found that IPVs are the most common site of reflux from deep to superficial veins in patients with recurrent postsurgical varicose veins. In their series of 122 limbs in 76 patients, after ligation and stripping of the SFJ or SPJ, 71.3% of patients had recurrent incompetent superficial thigh veins in the distribution of the GSV. Thirty-two percent of patients had incompetent veins in the distribution of the SSV. These veins can then be injected with sclerosing solution.¹³⁸ In this setting, ultrasound-guided injection is particularly helpful, since an obvious varicosity does not always occur over an incompetent perforator.¹⁴⁶ In addition, surgical exploration for the perforator in this setting is often difficult.¹⁴⁷ Thirty-six patients (38 limbs) with IPVs after surgical stripping were injected with 0.5 to 1 mL of STS 3% under ultrasound guidance.¹³⁸ Repeat injections were required at 6 to 8 weeks in six patients. Thirty-six of 38 limbs were successfully closed at 6- and 12-month follow-up without notable complications.

Rapid healing of persistent venous leg ulcers with an underlying perforating vein treated with duplex UGFS appears to be effective in producing rapid healing of the ulcers.¹⁴⁸ Cabrera et al¹⁰⁶ reported that, at 6-month follow-up, 83% of their patients’ ulcers healed after a single ultrasound-guided sclerotherapy treatment with their proprietary foam (Variglobin).

Treatment of a proximal perforating vein with UGFS has also been shown to cause resolution of the associated varicose vein.¹⁴⁹

Ultrasound-guided sclerotherapy may also be particularly effective in treating the incompetent SSV. Schadeck¹⁵⁰ injected the SSV an average of 3.17 times over 5 years in 74 patients to maintain closure of the vein. Bullens-Goessens et al¹⁵¹ found an enhancement in functional improvement after ultrasound-guided sclerotherapy of the SSV in 11 patients evaluated with air plethysmography.

Doppler-guided injection

This technique is of historical significance only and is not recommended since portable high resolution ultrasound devices are readily available. The concept of this abandoned technique is that a handheld Doppler probe may guide accurate cannulation and injection of sclerosing solution into poorly visible varicose veins. The Doppler probe is used to determine the point of maximum reflux and is positioned approximately 1 cm distal or proximal to that point. While an assistant holds the Doppler probe in place, the needle or syringe is advanced toward the vein with slight negative pressure on the plunger. Puncture of the vessel is heard as a tinkling sound, and the syringe fills with venous blood. Injection is heard as a flushing sound, almost like flushing a toilet.

Cornu-Thenard¹⁵² found that approximately 20% of varicose veins change their position by 1 cm or more when patients move from a standing to a supine position. Therefore, preinjection markings of varicose veins with the patient standing to localize veins that may disappear when the patient lies down are not reliable. Doppler evaluation is important when the patient is supine to ensure accurate needle placement. A multicenter study of this technique in 220 patients with approximately 1400 injections demonstrated successful cannulation in all but 18 injections.¹⁵³

The advantage of Doppler-guided injection is its simplicity. A single operator with practice may perform this technique with one hand holding the needle and the other hand holding the Doppler probe (Fig. 9.15). The ideal vein to treat with this method is palpable standing, measuring 4 to 5 mm in diameter, and impalpable supine.

Figure 9.15 Schematic representation of the relationship between the Doppler transducer and syringe. Continuous-wave Doppler localizes the inflow at the needle tip. The continuous wave beam and the long axis of the needle are virtually perpendicular as the needle passes under the Doppler transducer. The needle and Doppler transducer must be separated by several centimeters at the skin surface for proper alignment and transmission of suction and injection sounds.

(Redrawn from Cornu-Thenard A, De Cottreau H, Weiss RA: Dermatol Surg 21:867, 1995.)

Endoscopic injection

Venous endoscopy has been reported as being useful when injecting the SFJ or perforator veins but, given the availability of superior duplex ultrasound technology, it is rarely performed.^31,154 Van Cleef¹⁵⁵ first presented this technique in 1989 for treatment of the GSV at the SFJ. This technique uses an angioscope inserted through an 11-French Seldinger introducing set (USCI-Bard, Billerica, Mass.) while the patient is either standing or in a reverse Trendelenburg position. Endoscopes should have a diameter of 0.85 mm. Irreversible spasm may occur if the introduction occurs with the patient supine.³¹

The saphenous vein is cannulated with a 16-gauge needle, with the dilator and 11-French sheath inserted over a guidewire after the needle is removed. The angioscope is advanced with visualization, helped by 5% dextrose solution infusion at 37°C and manual compression of the refluxing SFJ, while the patient is supine. The endoscope is brought to within 2 to 3 cm of the ostial valves, and the sclerosing solution is injected through the infusion channel.

Manual compression of both the injection site and the angioscope insertion site is maintained until vessel spasm is complete. After 5 minutes, the venous lumen is irrigated and observed for endothelial destruction, which is noted as a change from the normal pearly-white color to a reddish gray. A compression dressing is then applied. At present, visualized endovenous changes have not been correlated with outcome. Sclerotherapy under endoscopic control is considered an experimental procedure.

Intravascular ultrasound-controlled injection

Intravascular ultrasound (IVUS) provides a unique perspective for evaluating vessel walls before, during, and after therapeutic interventions. Echographic data processing and computerized image manipulation can produce accurate luminal and transmural images of blood vessels. Electronically switched array devices use frequencies of 12 to 25 MHz in 4- to 12-French catheters to produce cross-sectional images of vascular segments. However, with present probes, a bright circumferential artifact known as a ‘ring down’ surrounds the catheter and prevents imaging of structures in the area immediately surrounding the catheter.¹⁵⁶

Determining the luminal and vessel wall morphology of normal and minimally diseased vessels, using IVUS produces a dimensional accuracy of 0.05 mm.^157–159 This device can visualize calcified and noncalcified arterial lesions and intimal tears or flaps and can distinguish between the media, intima, and adventitial layers of the vessel wall. This technology has primarily been used in evaluating arterial lesions. Future devices may one day combine the benefits of angiography, angioscopy, and IVUS in a single compact unit.

Raymond-Martimbeau^160,161 have reported injection through an IVUS probe. This technique allows injection to continue while the vein wall is resonated by the ultrasound probe until sclerosis is visualized by whitening of the entire vein wall (Fig. 9.16). The advantage of this technique is the assurance of complete destruction of the vein wall. The concentration or quantity of solution can be varied until effective endosclerosis is seen. This is rendered unnecessary by foam sclerotherapy.

Figure 9.16 Intravascular ultrasound cross-sectional image from a segment of the great saphenous vein after injection of iodine sodium iodide. Note presence of intimal thickening and intimal destruction at the 2 o’clock position.

(From Raymond-Martimbeau P: Role of sclerotherapy in greater saphenous vein incompetence. In Bergan JJ, Goldman MP, editors: Varicose veins and telangiectasias: diagnosis and treatment, St Louis, 1993, Quality Medical Publishing.)

Raymond-Martimbeau¹⁶⁰ performed a study of 25 incompetent sites diagnosed with IVUS and treated with sclerotherapy using liquid iodine sodium iodide in concentrations of 1% to 3% and volumes of 0.25 to 1 ml. In 21 cases (84%), partial echogenic intimal thickening was observed within 1 to 6 minutes (mean, 2.7 minutes). Circumferential intimal thickening became evident within 3 to 26 minutes (mean, 6.2 minutes). The lumen then filled with echogenic material and decreased in diameter. Within 1 week, the treated segment was transformed into a fibrous cord that disappeared completely between 2 and 12 weeks. In four cases (16%), weak or no intimal thickening occurred and the vein recanalized within 2 to 12 weeks. These patients were then treated successfully in a second session. With the use of foam sclerotherapy the advantages of IVUS are diminished, although in the age of liquid sclerosants it was only useful in defining the success of treatment and in ensuring accurate placement of sclerosing solution.

Transcatheter duplex ultrasound-guided sclerotherapy

When liquid sclerosant ultrasound-guided sclerotherapy was challenging for treating GSV reflux at the SFJ junction, a technique of transcatheter duplex ultrasound-guided sclerotherapy was developed by Min and Navarro, who used endovenous transcatheter techniques of vessel occlusion under image guidance (Fig. 9.17).¹⁶² Fifty-one GSVs in 50 patients were treated with this technique. With the use of ultrasound guidance and local anesthesia, the GSV was entered 15 to 45 cm (mean, 35 cm) below the SFJ. A 5-French infusion catheter was placed over a 0.035-inch diameter guidewire and positioned under ultrasound guidance 2 to 3 cm below the SFJ. An injection of 2 mL of STS 3% was made in this location, with additional 0.3-mL injections given at 3- to 5-cm intervals as the catheter was withdrawn. The treated leg was then compressed with a class II (30- to 40-mmHg) graduated compression stocking that was worn for a minimum of 7 days, and the patient was instructed to walk immediately. A mean of 4.5 mL (2 to 5 mL) of STS 3% was given in each vein. All veins remained closed at 3- to 12-month (mean, 8 months) follow-up.

Figure 9.17 The infusion catheter enters the great saphenous vein at the knee level, and its tip is positioned 2 to 3 cm below the saphenofemoral junction using ultrasound guidance.

(Redrawn from Min RJ, Navarro L: Dermatol Surg 26:410, 2000.)

Transcatheter duplex ultrasound-guided sclerotherapy represents the use of Seldinger principles in cannulating the GSV for the safe delivery of concentrated sclerosant. This important step helped minimze inadvertent arterial injection with liquid sclerosant. The insertion of a catheter to deliver sclerosing solution is not a new procedure and was described by Rose in 1941.¹⁶³ Here, the catheter was introduced into the GSV intraoperatively to sclerose the distal GSV after ligation at the SFJ. Use of the ureteric catheter was discontinued in 1945, and the practice of simultaneous sclerotherapy was ended in 1946 with the introduction of a simplified method for ligation of the GSV proximally and distally.

To summarize the preceding discussion, sclerotherapy of the GSV may be accomplished best by the use of a foam sclerosant placed accurately with duplex-guided endoluminal catheters or high resolution with easily visualized needles monitored with continuous duplex ultrasound monitoring.

VeinRx infusion catheter

Of historical interest, a proprietary industry-designed catheter received FDA 510k clearance in 2005 for infusion of physician-specified fluids, including thrombolytics. The catheter combines a distal occlusion balloon and a series of unique, sealable infusion ports that enable even and simultaneous distribution of sclerosant along the entire treatment length of the target vessel. Either liquid or foam sclerosant may be used with this catheter.

The VeinRx infusion catheter (VeinRx Inc, Miami, Fla.) was designed to temporarily occlude a proximal vessel segment with a distal expandable balloon and then deliver a predetermined dose of a physician-specified fluid along the lumen of the vessel.

As illustrated in Figure 9.18, the infusion catheter comprises a distal occlusion balloon, fixed infusion length catheter body with infusion holes, and trifurcated hub. Figure 9.19 is a line drawing that further illustrates the catheter design. The FloLock trifurcated hub is designed to connect the following three main systems of the device (Fig. 9.20). A tubing extension incorporating a stopcock on one side of the hub is the port used to inflate and deflate the occlusion balloon. The Luer connection in the center of the hub is used to mount the syringe loaded with the desired sclerosant. Opposite the balloon port and nearest the blue button is a port for controlling the FloLock channel. The FloLock channel allows the physician to determine accurately whether the infusion ports are open or closed (Fig. 9.21), a feature previously unavailable in standard infusion catheters. This channel uses an inflatable elastomeric bladder to either close or open the infusion ports.

Figure 9.18 Photograph of foam extruding through multiple holes in the distal portion of the VeinRx catheter with inflation of the balloon.

(Courtesy VeinRx, Inc., Miami, Fla.)

Figure 9.19 Diagrammatic representation of the VeinRx catheter.

(Courtesy VeinRx, Inc., Miami, Fla.)

Figure 9.20 Photograph of the proximal end of the VeinRx catheter showing the infusion ports.

(Courtesy VeinRx, Inc., Miami, Fla.)

Figure 9.21 Diagram illustrating the effusion of solution from the distal ports on the VeinRx catheter.

(Courtesy VeinRx, Inc., Miami, Fla.)

This feature is used to eliminate port obstruction before and during catheter placement, support pre-purging and holding the purge in the catheter before and during placement, and precise control of sclerosant during infusion. The device is provided in sterile packaging for single-patient use. The infusion catheter is manufactured with well-known and commonly used medical-grade materials.

The distal end of the catheter incorporates a compliant latex occlusion balloon. The balloon eliminates communication between the GSV and the SFJ and enables the sclerosant to produce maximal therapeutic action in the target vein. With the balloon inflated, the physician can deliver a predetermined amount of sclerosant through the catheter and into the GSV, with subsequent flow of sclerosant into incompetent perforators and tributaries. The sclerosant chemically ablates the targeted segment of the vein and has the potential for providing a complete treatment within a single procedure.

There is also the possibility of a small amount of the sclerosant entering the deep venous system through communicating perforator veins. However, this potential is relatively insignificant when compared to femoral vein intrusion of sclerosants in the setting of direct-injection/ultrasound-guided sclerotherapy.

The importance of having a series of infusion ports along the lumen length is to optimize the treatment of the GSV by localized delivery of the sclerosant. Sclerosant is uniformly delivered when all infusion ports are patent. This design also reduces the possibility of having excess sclerosant flow into large communicating veins near the target vein.

Treatment of large-diameter great saphenous veins

The treatment of the GSV with foam sclerotherapy has been discussed and found to be effective depending on the method of foam injection and the concentration and volume of solution. However, almost all of the previously cited studies set an upper limit for the diameter of the GSV to be no more than 8 mm.¹⁶⁴ One study used Variglobin 8%–12% (non-foamed since non-detergent) to inject 500 GSVs with diameters of between 6 and 12 mm measured 3 cm distal to the SFJ.¹⁶⁵ The authors reported a 22% failure rate irrespective of vein diameter. Barrett et al⁹⁰ reported outstanding efficacy in GSV with diameters greater than 10 mm injected with foamed STS. This was also found by Valsamis.¹⁶⁶ Therefore, proper technique and the use of an appropriate concentration and/or type of sclerosing solution can allow successful treatment of large-diameter GSVs, although length of follow-up must be a critical factors in all of these studies.

Thibault ⁸⁹ has described a technique for compressing the cannulated GSV with tumescent anesthesia placed in the surrounding facial sheath which may also lead to improved efficacy and reduce recurrences (Fig. 13).

Treatment of vulvar varicosities

Vulvar varicosities can be treated effectively with sclerotherapy. Two problems in their treatment are sclerosis of the proximal point of reflux and compression of the treated vein. Since vulvar veins may arise from the internal iliac (hypogastric), pudendal, obturator, uterine, or ovarian veins deep within the pelvis, treatment directed at the most proximal point of reflux cannot be attempted directly. Instead, the most proximal visible varicosity is cannulated and sclerosing solution injected in a proximal manner. With this technique, 1 to 2 mL of liquid 0.5% to 1.0% STS is injected slowly. Distal varicosities are then treated. Alternatively, foamed 0.25 to 0.5% STS may be injected.

A pelvic support device has been developed to compress the vulvar veins (V2-supporter, Prenatal Cradle Inc, Hamburg, Mich.). This device is worn until veins have resolved. Five patients treated in this manner showed no evidence of recurrence in a 1-year follow-up.¹⁶⁷ Adverse sequelae have not been noted. A 2-year follow-up of these five patients (and two others) also demonstrated no adverse sequelae and resolution of the varicose veins.¹⁶⁸

Treatment of venous malformations (liquid sclerosant)

Venous malformations (VM), as described in Chapter 4, consist of variably sized vessels. Sclerotherapy has proven to be very useful in their treatment. In a study by Yamaki et al,¹⁶⁹ 28 patients with a variety of VM on the face, neck, extremity, and elsewhere were treated with duplex-guided sclerotherapy with POL 3%. Eighty-two percent of the patients had effective resolution. Pain on injection in 82%, marked swelling in 75%, hemoglobinuria in 14%, and superficial epidermal necrosis in 10.7% were the reported adverse sequelae.

Lee et al¹⁷⁰ reported a 92% efficacy in treating 30 patients with a variety of VM with absolute ethanol. Multiple sessions were required and 24 total adverse effects occurred in the 92 sessions given. Adverse effects consisted of nerve palsy in five, ischemic bullae in nine, tissue necrosis in two, tissue fibrosis in two, and DVT in one. The authors proposed that this treatment helps to debulk and stabilize the VM, permitting simpler surgical correction. An additional report on 399 sessions in 87 patients by Lee and colleagues¹⁷¹ showed similar results with long-term efficacy.

Foam sclerotherapy using the Cabrera foam on 50 patients with VM was beneficial in 92% after an average of 12 sessions with a mean of 30 months’ follow-up.¹⁷² Of the 46 responders, 18 showed complete disappearance of the VM and 15 showed a reduction of over 50% in size of the VM. Of the 39 patients who reported pain, it disappeared in 25 and was reduced in 14. Three cases of skin ulceration occurred. For more information on foam sclerotherapy in venous malformations, please see the above foam sclerotherapy section.

Treatment of other venous conditions

A variety of other venous conditions have been reported to resolve with sclerotherapy. A report of complete resolution of a venous lake of the lip after two treatments with POL 1%, without adverse effects, has been reported.¹⁷³

Hemangioma showing late involution was successfully shrunk with an injection of 5% ethanolamine oleate, allowing surgical excision.¹⁷⁴

Multiple hereditary glomangiomas were treated with 0.2% to 3% STS, depending on the size of the lesion.¹⁷⁵ An average of two treatments where the lesions were injected with 0.5 to 1 mL of solution was required for lesion improvement.

Treatment of pyogenic granuloma with 5% monoethanolamine oleate in nine patients, who were all injected once, resulted in complete resolution of the lesion within 2 weeks.¹⁷⁶ An additional study on 15 lesions in 14 patients treated with 0.5% STS (0.15–2 mL) one to five times (mean, 2.2) showed complete resolution in 12 lesions.¹⁷⁷ No adverse effects were seen in any patient.

Treatment of recurrences

When unsuccessful or in case of recurrence, sclerotherapy does not modify the initial, pretherapeutic varicose pattern, which reappears as it was before or smaller. This is not the case with surgery, and, very often, recurrent varices after surgery (REVAS) are extremely difficult to manage.¹⁷⁸ Therefore, if surgery can be, in certain selected cases, considered as an alternative treatment after sclerotherapy failure, sclerotherapy is the usual and most appropriate recourse for recurrence after surgery of varicose veins. The progress in ultrasound guidance and, most of all, the use of foam sclerosing agents have revolutionized the approach to this difficult problem.

As stated in the REVAS consensus document,¹⁷⁸ all recurrences must be completely assessed by duplex in order to map all leaks and refluxes. After surgery of junctions, two types of recurrence can be observed:

Before onset of UGFS, both types were issues. Since, in the first case, direct injection was rendered difficult by the small diameters, and, in the second case, appropriate long-term control of reflux was doubtful. Now, both types of recurrence can be easily treated either by direct echo-guided puncture and foam injection or by remote access through more superficial tributaries. REVAS veins are usually prone to sclerose since the venous wall remodeling has been severe and since dysplasia allows easier sclerosis. Anyway, in all these cases, attention must be paid to an annual check-up of veins in order to take care of new recurrences as soon as possible.

For most patients, the difference between ‘new veins’ and ‘recurrent veins’ is not obvious at all and this misunderstanding is likely to create some difficulties in doctor–patient relationships. A simple diagram explaining evolution of varicose veins with or without treatment can be extremely useful (Fig. 9.22; also see Case Study 13 later in this chapter).

Figure 9.22 Evolution of varicose veins. Although we do not have a simple and accurate criterion of evaluation of varicose veins’ severity and extent, the concept is simple enough and patients can understand it easily. This diagram represents the evolution of the varicose status and the influence of active management. If it is true that there is some spontaneous trend toward worsening, the status is always better when patients are appropriately treated by sclerotherapy, especially with maintenance treatments (theoretical approach).

Pregnancy

Besides the risk of absorption of the sclerosing solution by the fetus, pregnancy is associated with dilation of the entire venous system through multiple mechanisms that do not normalize until 3 months postpartum (see Chapter 3).^192,193 Therefore, although sclerotherapy can be and has been performed successfully by many physicians on pregnant women,^194–198 the increase in venous distensibility counteracts the desired contraction of the treated varicose vein (see Chapters 3, 4, and 8). Finally, varicose veins may decrease in size and disappear after delivery (see Chapters 3 and 4).¹⁹⁹ Thus, waiting may eliminate the need for the procedure.

One situation that may justify sclerotherapy during pregnancy is the presence of significant and painful vulvar varicosities, which develop in approximately 2% of pregnant women.²⁰⁰ They usually occur by the second trimester and are more likely in multiparous women. Although they rarely thrombose, they are painful, especially with walking. Bed rest, leg elevation, and localized compression are usually effective in alleviating symptoms, but sclerotherapy may be necessary in severe cases.

Venography has shown that vulvar varices arise from any combination of the following: obturator vein; internal pudendal vein; inferior gluteal vein; external iliac, uterine, and ovarian veins; obturator vein; presacral veins; common femoral vein; and the GSV.^201,202 Because of this variable and extensive system of reflux and the thin-walled, fragile nature of these veins, sclerotherapy is preferred over surgical excision or avulsion (see Case Study 7 later in this chapter).

Inability to ambulate

Walking after treatment is very important because it ensures rapid dilution of the sclerosing solution, which may enter normal deep veins. In addition, stagnation of blood flow is avoided, and the possibility of excessive thrombosis lessened, by the liberation of thrombolytic factors during muscle contraction when walking. Walking also decreases physical distention of the vein caused by reflux.

A corollary to the contraindication just mentioned is the performance of sclerotherapy during surgical ligation. Although this procedure has been performed by many surgeons and was advocated by de Takats in 1930,²⁰³ it was usually limited to a point distal to the SFJ on the GSV and therefore was performed on an ambulatory basis. In 1934, Faxon²⁰⁴ modified this technique to include ligation at the SFJ with retrograde injection of the GSV. He achieved good results (although follow-up was poor) in his series of 117 cases except for one case of fatal PE, which was attributed to faulty technique by a resident surgeon. In more recent times, Conrad²⁰⁵ reports great success with this technique when used in conjunction with ligation at the SFJ. Hubner²⁰⁶ reported similar success without mention of complications in 413 patients followed for more than 1 year. Patients treated with POL 4% had an 83% success rate, whereas patients treated with Variglobin 4% had a 94% success rate. However, Hubner separates the two procedures by a few hours to a day because his patients had the ligation performed by a surgeon in a separate office and return to him for sclerotherapy. This latter scenario ensures that the patient is ambulatory for both procedures.

In spite of the above-mentioned successful results, there are potential complications that call for separating the two procedures. First, many varicose veins will resolve after surgical treatment of the high-pressure reflux points, so subsequent sclerotherapy is minimized or not necessary.²⁰⁷ Secondly, the surgical period is often one of minimal ambulation because of postoperative pain and the use of general or regional anesthesia. The delay in adequate ambulation may allow the sclerosing solution to migrate to the deep venous system where unwanted damage could occur (see Chapter 8).²⁰⁰ The authors recommend postoperative sclerotherapy be delayed for 2 to 3 weeks.

History of thrombophlebitis and deep vein thrombosis

Patients with a history of certain venous diseases may be predisposed to the development of excessive thrombosis with injection of a sclerosing agent (that is, development of an excessive phlebitic reaction; see Chapter 8).

Patients with low-risk thrombophilia (activated protein C resistance, hyperhomocysteinemia especially, factor II, factor V Leiden) can be treated with sclerotherapy. A prospective study in progress will determine the best prophylaxis (see Chapter 8).

Regarding patients already treated with oral anticoagulation, the contraindication is more dependent on the disease treated by anticoagulation than on anticoagulation itself. Patients treated for atrial fibrillation can be sclerosed without inconvenience; most of the time, the course of their treatment is simpler than for normal patients.

Also, in rare patients, the dilated superficial system may serve as a conduit for carrying blood to the heart. Interruption of the superficial system may then increase venous insufficiency. Therefore, PPG, both with and without application of a superficial tourniquet or a trial of 30- to 40-mmHg graduated compression stockings, helps determine which patients will benefit and which may be harmed by sclerotherapy treatment.

Another simple test to determine if the varicosity resulting from DVT is a necessary conduit is a modification of the Perthes’ test (see Chapter 5). A tensiometer cuff is inflated to 110 mmHg, and the patient is asked to walk quickly for 5 minutes. If the patient complains of heavy pain, or if the leg becomes livid, or both, the varicosity is necessary as a collateral channel. This test has allowed, without complication, surgery on 53 limbs with varicose veins in 52 patients with prior DVT.²⁰⁸

Allergic reaction

Patients are rarely allergic to a sclerosing solution, but a different solution can usually be substituted. If the allergic reaction consists of generalized urticaria, with or without an erythematous papulosquamous appearance, French authors advocate continuing treatment with the offending sclerosing solution with the addition of antihistamines before and after treatment (see Chapter 8).²⁰⁹

Infrequently, patients develop periorbital edema and a maculopapular cutaneous eruption even with the use of unadulterated hypertonic saline solutions. In this case, ‘allergic reaction’ may be the result of histamine release by intravascular basophils or perivascular mast cells that are directly damaged by the sclerosing solution (see Chapter 7).²¹⁰ Under this circumstance, administration of antihistamines before and after the procedure appears safe while therapy is continued.

Patients taking disulfiram

Patients taking disulfiram (Antabuse) should not be treated with POL or Sclerodex, since these sclerosing solutions contain ethyl alcohol.

Patients taking tamoxifen

As described in Chapter 8, tamoxifen is often responsible for extensive superficial phlebitis in patients treated by sclerotherapy, even of reticular or spider veins. We consider it to be a relative contraindication.

Patients taking hormones

Hormonal replacement as discussed previously is not considered a contraindication to sclerotherapy. If a patient is at risk for venous thrombosis they should not be on hormonal replacement in the first place.

Other contraindications

Schematic principal types of varicose networks, schematic treatments

Appendix 9.1

Appendix 9.2

Appendix 9.3

Appendix 9.4

Appendix 9.5

Appendix 9.6