Primary chronic venous disorders

Early epidemiologic studies 

Several epidemiological studies of chronic venous disease in various countries have been performed over the last several decades. Most of these have focused on varicose veins.10, 11, 12, 13, 14, 15, 16, 17 Earlier studies reported varicose veins to be present in 1% to 73% of females and 2% to 56% of males. The prevalence of CVI in these studies ranges from 1% to 40% in females and 1% to 17% in males.10 However, the results have varied with geography and study methods. Varicose veins have a prevalence of 25% to 33% and 10% to 20% in Western females and males, respectively.10, 11, 15, 17 The annual incidence of varicose veins in the Framingham study was 2.6% in women and 1.9% in men.18 The prevalence of skin changes varied between 3% and 13% in the population. The prevalence of active and healed ulcers varied between 1% and 2.7%. Established risk factors for chronic venous disease include older age, family history, female gender, multiple pregnancies, standing occupation, and obesity in females.10, 11, 14, 18

However, the early data has several limitations including the use of different definitions for varicose veins and CVI, inclusion of different age groups, and frequently a failure to include a random sample of the general population. As the prevalence of chronic venous disease increases with age and is higher in females, the data has to be adjusted for age and gender. Furthermore, many studies have relied on amnestic data from questionnaires rather than clinical and duplex evaluation. Only a few recent studies have used the CEAP classification.19, 20, 21

Epidemiologic studies based on the CEAP classification 

In recent years, three studies have been published based on the CEAP classification.22 They differ with respect to mode of recruitment of the study population, age, and methods of investigation19, 20, 22(Table III).

Table III. Prevalence of C0-C6 (CEAP) in the Bonn21, Polish20 and French19 Studies

		Bonn Vein Study			Polish Study	French Study
	Design	Random sample			Cross-sectional	Cross-sectional
	Survey	General population			Consecutive primary Care patients	Telephone lists
	Investigators	Phlebologists			Primary care physicians	Vascular physicians
	CVI definition	C3 – C6			C1 – C6	Trophic skin changes
	Participants	3072			40,095	409
	Males	1350			6404	277
	Females	1722			33691	132
	Classification	All (%)	Male (%)	Female (%)	All (%)	Male (%)	Female (%)
	C0	9.6	13.6	6.4	51.5
	C1	59.1	58.4	59.5	16.5
	C2	14.3	12.4	15.8	21.8	23.7	46.3
	C3	13.4	11.6	14.9	4.5	1.1	2.2
	C4	2.9	3.1	2.7	4.6	4.0	2.1
	C5	0.6	0.6	0.6	1.0	1.4	0.7
	C6	0.1	0.1	0.1	0.5	0.0	0.0

The Bonn Vein Study enrolled 3072 (1722 women, 1350 men) participants, 18 to 79 years of age, from a random sample of the population registers of Bonn and two rural townships.21 All participants completed a standardized questionnaire and underwent a clinical and duplex examination by four trained phlebologists. The complete CEAP was used for classification.

Leg complaints consistent with venous disease (leg heaviness, subjective swelling) were present in 49.1% and 62.1% of German males and females, respectively. With respect to CEAP-classification, only 9.6% of the population (13.6% men, 6.4% women) showed no signs of venous disorders (CO); 59.1% (58.4 men, 59.5% women) showed only telangiectasias or reticular veins (C1). Varicose veins without edema or skin changes (C2) where present in 14.3% (12.4% men, 15.8% women); pretibial pitting edema (C3) in 13.4% (11.6% men, 14.9% women); skin changes (C4) including eczema, pigmentation, or lipodermatosclerosis in 2.9% (3.1% men, 2.7% women); and healed (C5) or active (C6) ulceration in 0.6% and 0.1%, respectively (Table III). The prevalence of stages C2 to C6 disease increased with age. Only in stages C2 and C3 was the prevalence significantly higher in females. The urban population showed a higher frequency of CVI (C3 to C6). In a multivariate analysis adjusted for age and region of living, risk factors for varicose veins included older age, female gender, pregnancy and obesity in women. Risk factors for CVI were older age, obesity, and urban residence.

In a cross-sectional, multicenter Polish study,20 40,095 adults were interviewed and clinically evaluated by 803 participating primary care physicians. Patients were classified by highest CEAP clinical severity and CVI was defined as stages C1 to C6. Leg complaints were present in 81% in patients with varicose veins and 35% of the varicose-free participants. C0 was found in 51.1% of the population, C1 in 16.5%, C2 in 21.8%, C3 in 4.5%, C4 in 4.6%, C5 in 1.0%, and C6 in 0.5%. Risk factors for CVI and varicose veins were similar.

A French cross-sectional survey evaluated a subpopulation of patients enrolled in a study of Raynaud’s phenomenon.19 All patients were evaluated using a standardized questionnaire and examination by a vascular specialist. C0 or C1 disease was present in 48.7% of patients; C2 was present in 23.7% and 46.3% of males and females, respectively; C3 was found in 1.1% and 2.2%, respectively; and C4 in 4.0% of the men and 2.1% of the women. Healed ulcers were found in 1.4% of the males and 0.7% of the females. No active ulcers were identified in this study. The main risk factors for varicose veins included family history, advanced age, pregnancy, and height in women and exercise less than once a week in men.

Varicose veins 

Despite advances in our understanding of varicose veins, the underlying etiology remains uncertain. Early theories presumed that varicose veins arose from the effects of valvular incompetence and venous hypertension and arose in a descending fashion from valvular incompetence at the saphenofemoral or saphenopopliteal junction. Unfortunately, there is little evidence of a constitutive valvular abnormality in primary venous disease and these theories cannot explain why truncal varicosities are often found below competent valves, why normal valves are often seen between those exhibiting varices, or why dilation often precedes valvular incompetence.23, 24 Rather than being initiated at the saphenofemoral junction, both detailed studies of surgical specimens and ultrasound observation suggest that primary valvular incompetence is a multicentric process that develops simultaneously in discontinuous venous segments.25

Recent theories have focused on intrinsic structural and biochemical abnormalities of the vein wall, hypothesizing that varicose veins develop because of underlying connective tissue defects and altered venous tone.26, 27, 28 Varicose veins demonstrate diverse histologic abnormalities, including irregular thickening of the intima, fibrosis between the intima and adventitia, atrophy and disruption of elastic fibers, thickening of individual collagen fibers, and disorganization of the muscular layers that are heterogeneously distributed throughout the great saphenous vein and its tributaries.29, 30, 31, 32, 33, 34

The histological changes suggest that varicose veins have reduced contractility and compliance. Varicose saphenous veins show an increased collagen and reduced elastin content.35 Saphenous smooth muscle content, as well as total protein content, is reduced and effective contraction may be further compromised by fragmentation of the muscle layers.33, 36 Similar findings in limbs without varices but at risk for their development and in the forearm veins of varicose vein patients suggest that abnormalities in vein wall architecture precede the development of both overt varicosities and valvular incompetence.26, 28

It remains unclear whether these structural changes are primary or result from other pathologic processes. Proposed mechanisms have included hypoxia induced endothelial changes; downregulated apoptosis; changes in enzyme activity associated with decreased energy metabolism and increased lysosomal activity; and underlying defects in venous tone associated with a loss of vascular reactivity.29, 33, 37, 38, 39

Chronic venous insufficiency 

Clinical evaluation 

The clinical evaluation determines the nature and the severity of the underlying venous problem and its impact on the patient’s quality of life. In this phase, the presenting symptoms and signs are assessed and assigned to a hierarchy of categories including telangiectasias, varicose veins, venous edema, skin changes, and ulceration. The disease classification,8, 50 severity, and effect on the patient’s quality of life determine the degree of investigation required to guide treatment.

Laboratory evaluation 

The laboratory evaluation of chronic venous disease defines the cause of the problem as congenital, primary, or secondary; the anatomic location of the problem in the superficial, perforator, or deep systems; and the pathophysiologic mechanism as pure reflux, reflux with obstruction, or dominant obstruction. The pathophysiologic mechanisms are localized to 18 defined segments from the calf to the inferior vena cava (IVC).

Saphenous ablation 

Surgical methods of removing the great saphenous vein from the circulation have included proximal ligation alone, proximal ligation with ankle to groin stripping, and proximal ligation with knee to groin stripping. It is generally agreed that ligation alone, without removal of the saphenous vein, is inadequate62 as the patent vein in the thigh continues to reflux. The stripping operation has durable results because the saphenous vein is permanently removed. The groin dissection itself may have favorable long-term consequences but its immediate effect is prolonged soreness and tenderness.

Despite the acknowledged limitations of surgery and the negative patient perception of vein stripping, there are advantages to operative treatment of varicose veins. The operation can be performed as a single procedure and when done in a well-equipped operating room with effective anesthesia, all of the pathologic veins can be dealt at one time. Both saphenous extirpation and phlebectomy can be done at one sitting with no need for immediate retreatment. There are several modern ways to diminish morbidity,5 but there is always some downtime. Because of this, attempts have been made to minimize postoperative discomfort and yet maintain the benefits of saphenous vein extirpation.

Great saphenous vein stripping 

Groin-to-knee stripping of the saphenous vein is generally considered in every patient requiring surgical intervention. Although the decision may be against saphenous stripping, removal of the varicose clusters via stab avulsion or some form of sclerotherapy is an absolute requirement in nearly all patients.

Properly performed preoperative marking serves to document the extent of varicose vein clusters and identify the clinical points where control of varices is required. As a rule, incisions in the groin and at the ankle should be transverse and placed within skin lines. The groin incision should be high enough to permit identification of the saphenofemoral junction. The best cosmetic results in the thigh and leg are generally obtained with vertical incisions. Transverse incisions are used in the region of the knee, and oblique incisions are appropriate over the patella when the incisions are placed in skin lines.

The practice of identifying and carefully dividing each of the tributaries to the saphenofemoral junction has been dominant for over 90 years. The rationale for this has been the perceived inadvisability of leaving behind a network of anastomosing inguinal tributaries. The importance of these efforts has been underscored by descriptions of residual inguinal networks as an important cause of varicose vein recurrence.63 However, this central principle of varicose vein surgery is currently under challenge, on the grounds that groin dissection can lead to neovascularization and subsequent recurrence of varicosities.

After exposure of the saphenofemoral junction, a disposable plastic Codman stripper can be introduced from above downward. Although plastic disposable vein strippers and their metallic equivalents were designed to be used with various-sized olives to remove the saphenous vein, an inversion technique in which the vein is tied to the stripper below its tip, inverted into itself, and removed distally is more efficient and reduces tissue trauma in the thigh. Alternatively, an Oesch stripper can be employed.

Passage of the stripper from above downward to the ankle serves to confirm the absence of functioning valves, and stripping of the vein from above downward is unlikely to cause nerve damage. In exposing the saphenous vein at knee level, the superficial fascia must be incised because the vein lies between this structure and the deep fascia of the thigh. If the stripper passes unimpeded to the ankle, it can be exposed with an exceedingly small skin incision placed in a carefully chosen skin line. At the ankle, the vein should be carefully dissected to free it from surrounding nerve fibers. If this is not done, saphenous nerve injury will result, and the patient will experience numbness of the foot.

Subcutaneous extravasation of blood during and after saphenous vein stripping is a major cause of discomfort and occasional permanent skin pigmentation. Use of high volume, dilute tumescent local anesthesia will minimize extravasation. Applying a hemostatic tourniquet after Esmark exsanguination of the limb can also minimize such extravasation. If a tourniquet is not used, the entire operation can be performed with the limb elevated 30 degrees. To decrease oozing into the venectomy tract, a 5 cm roller gauze soaked in a 1% lidocaine-epinephrine solution can be attached to the stripper using the ligature fastening the saphenous vein to the stripping device. The hemostatic pack, which lies within the saphenous vein, can be pulled into the tract with minimum tissue trauma; when it is not inverted into the vein itself, it can act as an obturator to facilitate removal of the saphenous vein without tearing. As the vein is removed by inversion, the gauze is left in place for hemostasis.

Incisions to remove varicose clusters vary according to the size of the vein, the thickness of the vein wall, and the degree of adherence to perivenous tissues. Except in areas where skin lines are obviously horizontal, vertical incisions 1 to 3 mm in length are appropriate and successive incisions are spaced as widely as possible. Varicosities are exteriorized by means of hooks or forceps. Dissection of each perforating vein at the fascial level is not required and may in fact be cosmetically undesirable. There is no need to ligate or clip the ends of each varix. The combination of leg elevation, trauma-induced venospasm, and direct pressure ensures adequate hemostasis.

Neovascularization after saphenous vein stripping 

The advent of minimally invasive techniques, such as radio-frequency and laser ablation of the great saphenous vein, has focused attention on neovascularization in the groin as a potential cause of recurrent varicose veins after saphenous stripping. Neovascularization is commonly seen following the traditional stripping procedure64 and is thought secondary to “frustrated” venous drainage from the abdominal wall and perineum.65 Regardless of the mechanism, the result is recurrent reflux in thigh or lower leg veins.

Although the phenomenon had been previously described,66 neovascularization was only a clinical curiosity until venous ultrasound became widely available for postoperative surveillance of patients.67 It must now be accepted that this condition is more common than previously realized.68 Neovascularization has been demonstrated by a variety of imaging techniques including phlebography corrosion casts. Histologic study has confirmed that the vessels seen as regrowth of veins at the saphenofemoral junction are truly new vessels.69 Many now believe that neovascularization is a major cause of recurrent groin reflux after varicose vein surgery.70

Endovascular Management of Varicose Veins 

Lower extremity varicose vein disease is most often associated with truncal venous insufficiency involving the saphenous system; the great saphenous vein, the small saphenous vein, and/or incompetent major tributaries or perforator veins. As discussed above, varicose vein disease has historically been treated with stripping of the saphenous vein, and interruption and removal of the major tributary and perforator veins.71 However, endovenous ablation procedures have more recently been reported to be safe and effective methods of eliminating the proximal portion of the great saphenous vein, the small saphenous vein, and even tributary and perforator veins from the venous circulation, with faster recovery and better cosmetic results than stripping.60, 72, 73, 74 The three currently available methods to achieve ablation of diseased veins are: the Closure procedure using a radio-frequency (RF) catheter and generator (VNUS Medical Technologies, Inc, Sunnyvale, Calif); the endovenous laser ablation procedure using a laser fiber and generator (various manufacturers); and endovenous chemical ablation with ultrasound guided foam sclerotherapy (either injected or catheter-directed). The first two methods use electromagnetic energy to destroy the vein in situ; the latter utilizes a foamed chemical detergent (Polidocanol or sodium tetradecylsulfate). As with stripping, portions of the great and/or small saphenous vein, perforator veins, and varicose tributaries remaining after these endovenous procedures must be treated with either injection sclerotherapy or phlebectomy.

Endovenous thermal ablation 

Prolonged exposure of tissues to high frequency energy results in total loss of architecture with disintegration and carbonization. Clinical observation suggests that these minimally invasive procedures do destroy the saphenous vein and ultimate results are quite acceptable and comparable to stripping of the saphenous vein. However, patients experience minimal discomfort and time lost from work.

Clinical trials evaluating RF ablation of the great saphenous vein have demonstrated success rates equivalent to or better than historical results for stripping.73, 75 These findings were confirmed in a prospective, randomized study comparing RF ablation with stripping.76 Several reports, some with follow-up as long as 5 years, have confirmed the safety and efficacy of RF saphenous vein ablation65,77 (Table IV). Ablation rates of 90% or more have been routinely demonstrated.78

Table IV. Efficacy of VNUS closure of the saphenous vein

		1-year	2-year	3-year	4-year	5-year
	Number	458	240	119	107	37
	Reflux free	90%	88%	87%	87%	84%
	Varicose vein recurrence	14%	16%	14%	21%	22%

Adapted from Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg 2002;35:1190-6.77 VNUS Medical Technologies, Inc, San Jose, Calif.

Following the introduction of RF ablation, reports appeared demonstrating an unprecedented rate of successful great saphenous vein ablation using laser energy.79 The original clinical trials, and 3-year follow-up data, confirm the high success rate reported earlier.80, 81 Other centers have similarly reported high rates of successful ablation.74

The details of heat ablation of the truncal veins have been described elsewhere.65 In brief, after ultrasound localization of the truncal vein, it is accessed either directly through a micro incision or percutaneously under ultrasound guidance, at a suitable site near the knee or higher. A sheath followed by the RF catheter or laser fiber are inserted into the truncal vein and advanced to the most superior point of treatment. Following injection of ultrasound guided, dilute local anesthetic into the saphenous sheath, the generator is activated and the vein is ablated during withdrawal of the catheter/fiber.

Patient selection 

Inclusion criteria should include: symptoms and physical signs of venous insufficiency; duplex ultrasonography, performed by a fully qualified sonographer, documenting a patent vein with reflux greater than 0.5 seconds; patent deep venous system; vein conducive to catheterization; and full patient mobility. Exclusion criteria include arteriovenous malformations; restricted ambulation; and deep venous obstruction. As a practitioner’s experience with endovenous ablation expands, relative exclusion criteria may be relaxed, and patients with deep venous reflux, previous venous treatment, large diameter veins, or those on chronic anticoagulant therapy or hormone replacement therapy may be safely and successfully treated.

Complications 

Intraoperative and postoperative complications occur infrequently, and are generally well tolerated and short-lived. Intraoperative complications include: difficult device access or advancement and treatment interruption (RF only). Postoperatively, patients may encounter bruising and pain (more often with laser);82 paresthesia; thermal skin damage; superficial thrombophlebitis; lymphedema; and DVT. The risk of the most clinically significant of these, DVT, is generally reported to be less than 1%,78 usually in calf veins. Paresthesias have been reported in 2% to 16% of patients following RF ablation and are usually transitory.83 In a report of patients followed carefully in one center, the incidence of DVT and paresthesia was essentially equivalent with laser and RF ablation.84

Notably, as discussed above, there is a relative absence of neovascularization after thermal ablation of the great saphenous vein.77 Endovenous ablation of the great saphenous vein deliberately leaves the superficial epigastric vein intact, which, it is believed, has resulted in few reports of neovascularization at the 5-year interval.

Follow-up 

The risk of incomplete ablation and recanalization of the treated vein as well as the need for adjunctive treatment of the distal great saphenous vein, refluxing tributaries, and small saphenous vein mandate careful follow-up after vein ablation. Color-flow Doppler ultrasound, interviews, and physical examinations at appropriate intervals are needed to achieve successful treatment. It is not appropriate to merely ablate the proximal vein and expect the patient’s symptoms and varicosities to resolve. Unless one is committed to careful follow-up and adjunctive treatment, the practitioner and the patient will be left with unsatisfactory results.

There is considerable confusion in the literature regarding the definition of successful treatment, the means used to detect treatment failures, and the reporting of results. Recent advancements in ultrasound technology have allowed more critical evaluation of clinical results than were possible in the past. Duplex examination after vein ablation should include grey-scale, compression, and color flow Doppler modalities. Identification of treatment failure is dependent on the sensitivity of the ultrasound equipment used, the expertise of the sonographer, and the vigor with which the examination is conducted.

The development of foam sclerotherapy has further called into question even the most critical examination techniques. Because foam is an excellent ultrasound contrast medium, injection into distal vein segments, tributaries, and incompetent perforators will sometimes reveal an incompletely treated vein that is occluded by all other duplex criteria. Whether these minimally patent segments will become clinically significant is currently unknown. However, patients complaining of localized pain in the area of a previously ablated vein deserve very careful examination to identify incompletely ablated segments.

It has been reported that most incompletely ablated veins will be seen in the first few months after treatment.80 However, patients with recurrent symptoms and partially patent segments have been identified more than 3 years following apparently successful ablation. Thus, it is necessary to perform careful follow-up of these patients for 1 year, and then yearly, or certainly when recurrent symptoms occur.

Sclerotherapy of Varicose Veins 

Sclerotherapy is a well-accepted treatment modality not only for varicose veins of the lower or upper extremities, but also for vascular malformations such as small hemangiomas and varicose veins associated with the Klippel-Trenaunay syndrome, where surgery may not be indicated. Sclerotherapy is considered the treatment of choice for cosmetic nuisances such as spider veins or telangiectasias and venous lakes. Advances in imaging technology have also extended the use of sclerotherapy to treatment of reflux in areas such as the saphenofemoral and saphenopopliteal junctions. Some of the “new” techniques are being evaluated and more representative results should become available within a few years.

Clinical evaluation 

After the initial interview, physical examination determines the type of varicose veins and the most appropriate type of treatment. An extensive noninvasive evaluation is not required in patients with mild telangiectasias. However, the durability of sclerotherapy in the presence of severe reflux is often limited and patients with more extensive disease require an assessment of deep and superficial reflux with Doppler and duplex ultrasound examinations.

Indications for sclerotherapy 

Sclerotherapy is clearly indicated in the following situations: Telangiectasias and venous lakes, usually 1 mm or less in diameter; varicosities between 1 to 3 mm in diameter without connection to refluxing main trunks; residual or recurrent varicosities without obvious connection to incompetent main venous trunks; congenital malformations of venous predominance such as small hemangiomas; and some diffuse congenital malformations where surgery is contraindicated. Hemorrhage due to variceal rupture can also be effectively treated with sclerotherapy. Sclerotherapy may also enhance the venous ulcer healing in some situations. This is a temporary measure while definitive treatment is planned. Finally, the introduction of foam sclerotherapy has widened the indications for sclerotherapy to include the main great and small saphenous trunks, varicose tributaries, and perforating veins.

Sclerotherapy is not indicated in elderly and sedentary patients afflicted by arthritis or medical conditions that prevent active mobilization. Relative contraindications may include the presence of severe systemic diseases such as diabetes, cardiac or renal insufficiency, emphysema, collagen diseases, and malignancies; arterial insufficiency documented by an ankle brachial index below 0.7; a history of asthma or strong allergic conditions that may predispose to anaphylaxis; a body surface index >26 where compression is difficult to apply; and the use of anticoagulants, which may be associated with a risk of large hematomas or ecchymosis.

Sclerosants 

Sclerosants are classified according to their mode of action as osmotic agents, detergents and chemical or corrosive agents. Osmotic agents include hypertonic sodium chloride (23.4%), 65% glucose and sodium salicylate; the detergent agents are sodium tetradecyl sulfate, polidocanol and sodium morrhuate; and corrosive or chemical sclerosants include sodium and potassium iodide, chromglycerine, and absolute alcohol. Only the detergent agents, sodium tetradecyl sulfate, sodium morrhuate, and ethanolamine oleate are approved by the United States Food and Drug Administration. The most commonly utilized agents in this country are sodium tetradecyl sulfate and hypertonic sodium chloride (the latter not FDA approved as a sclerosant).

All currently available sclerosants cause irreversible molecular damage to the venous wall, permanently deactivating the vein and producing a destructive endosclerosis. They specifically affect lipids on the endothelial cell surface, softening the endothelium and causing the endothelial cells to detach and fall apart in plaques. Deeper layers, including the media, are affected and spasm is regularly seen with ultrasound during treatment. Few severe side effects have been reported with foam sclerotherapy, but local side effects, including hyperpigmentation and mild superficial thrombophlebitis may occur.

Sclerosant concentration depends on the size of vein to be treated. In general, dilute sclerosants are used for small veins and higher concentrations for larger veins. Telangiectasias (1 mm or less) are usually treated by injecting 0.125% to 0.25% sodium tetradecyl sulfate or 0.5% polidocanol. Veins 3 to 6 mm respond well to 0.5% to 0.75% sodium tetradecyl sulfate or 0.75% to 1.0% polidocanol. Veins larger than 6 mm diameter require 3.0% sodium tetradecyl sulfate or 2.0% to 3.0% polidocanol.85

Foam sclerotherapy 

The liquid form of sclerotherapy was universally used in the past. The “air-block” technique86 has been used in small venules, where displacement of the blood column by microbubbles can be observed. This method was modified by Cabrera87 to produce a thicker, larger mass of sclerofoam. The action of foam sclerosant differs from that of the liquid; foam forming a coherent mass that displaces the blood column and allowing controlled, prolonged contact with the venous endothelium. The development of foam sclerotherapy has extended its utility to include the ultrasound-guided treatment of large venous trunks and bulky, deeply seated congenital vascular malformations of venous predominance.

Only detergent based sclerosants, such as polidocanol and sodium tetradecyl sulfate, can be used as a foam. Sclerofoam is produced by mixture of a well-tolerated, physiologic gas and a relatively small amount of the detergent sclerosant. Oxygen, CO2, and room air have all been successfully utilized. Although many methods of producing foam have been described, the easiest may be that reported by Tessari, using two syringes connected by a three-way stopcock.69 Two syringes are connected by a three-way stopcock, creating foam by alternatively moving the syringe pistons up and down. Such foam persists for a few minutes and can be injected into tributary varicosities and the saphenous veins. Depending on the vein size, Frullini88 recommends total volumes of 3 to 5 mL of 1% to 1.5% sodium tetradecyl sulfate or 2% to 3% polidocanol. Telangiectasias are successfully treated with 0.10% to 0.25% polidocanol foam. The higher concentrations are used for large truncal veins less than 9 mm in diameter. In treating the saphenous trunks, sclerosing foam may be directly injected or delivered by means of an indwelling catheter, sometimes with an occlusive balloon just below the saphenofemoral junction. Others have described duplex controlled catheter injection of sclerosing foam in a bloodless field using controlled-ischemia.89

Ultrasound guided foam sclerotherapy for saphenous trunks with patent deep venous junctions remains investigational in the U.S., although clinical trials are either in progress or planned for the near future. However, numerous reports from Europe have demonstrated excellent results using foam sclerosants for ablation of the saphenous veins.72 Successful ablation has been reported in greater than 90% of patients.90 Others have shown long-term (5 years) fibrosis in up to 81% of treated veins. A 98% rate of great saphenous occlusion was reported in 65 extremities followed for up to 31 months using the bloodless field technique described by Trinidad.89

Despite the promise of foam sclerotherapy, previous experience with liquid sclerosants must be kept in mind when treating the junctions. Waugh91 reported recurrence rates of nearly 60% at 5 years using sclerotherapy either alone or in combination with high ligation for the treatment of primary varicose veins. In the modern era, randomized studies performed from England, Sweden, and North America have documented that “liquid sclerotherapy”, used as a single form of treatment, for all types of varicose veins has a very high incidence of recurrence.92, 93 The introduction of these new techniques has opened new avenues of investigation. Careful evaluation and large randomized trials comparing liquid vs foam sclerotherapy with and without saphenous ablation will provide new insights into the true value of sclerotherapy as a method of treatment for varicose veins.

Consensus recommendations 

Consensus recommendations regarding foam sclerotherapy were generated during the Second International European Symposium on Sclerotherapy.94 The following is a summary of the consensus conclusions.

Reflux and venous stasis 

Venous skin changes in general and venous ulceration in particular are traditionally attributed to reflux rather than obstruction. However, the experience with venous stents clearly demonstrates that the pathogenesis involves a poorly understood, complex interaction between reflux and obstruction.101 Although the vast majority of post-thrombotic cases involve both obstruction and reflux, the frequent presence of May-Thurner type obstructive lesions in “primary” disease has only recently been recognized. In such cases, symptoms may improve following stent placement alone without correction of the reflux component. Raju and Neglen have hypothesized that the obstructive lesion is an often silent, permissive condition predisposing to symptoms once additional pathology such as reflux develops.101 In common with other well known permissive conditions such as hyperacidity and peptic ulcer, obesity and diabetes, correction of the permissive condition alone is often curative.

Measurement of reflux 

Venous filling time (VFT) determined by ambulatory venous pressure measurement and the venous filling index (VFI90) measured by air plethysmography are reliable quantitative global indices of venous function of which reflux is a dominant and reversible component.96 Improvements in VFT and VFI90 have been documented after valve reconstruction. VFT improves by at least 4 seconds, often more, but seldom normalizes following valve reconstruction. This is partly due to the multiple factors that determine ambulatory venous pressure and the outstation nature of valve reflux. Ulcers will fail to heal if VFT persists below 5 seconds following valve repair.

Duplex has replaced descending venography as the preferred technique to identify reflux at specific sites and has the potential to be used quantitatively. As of now, it is only qualitative.100 Initial enthusiasm for valve closure time to quantify reflux has proved disappointing. A related parameter, calculation of reflux volume has proved unreliable as well. Peak reflux velocity has been shown to be of value statistically, but the variance is such that it is not clinically useful.

Unfortunately, there is still no reliable quantitative measure to guide the optimal site for valve repair; to prioritize the relative importance of superficial, perforator and deep interventions; or to assess outcome. For this reason, controversy regarding the optimal valve site for repair (femoral vs popliteal “gatekeeper”) still persists. Raju prefers the femoral site only because it is technically easier. Fortunately, venous reflux, as most venous pathologies, responds clinically to partial correction at least in the short term.

Techniques of valve reconstruction 

The oldest and most durable repair in ultrasound terms, is internal valvuloplasty.98, 99, 102 External and transmural techniques are faster, allowing multiple single stage valve reconstructions, and can be used even in smaller caliber veins.103 The latter techniques deteriorate faster in duplex terms but this is not reflected in clinical outcome. All techniques, including the internal valvuloplasty, show alarming degrees of deterioration by ultrasound.106 The cause of such deterioration remains unknown. There is no clinical evidence that multiple valve reconstructions are better than single repairs in “primary” disease.