II. Primary chronic venous disease

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Prevalence and incidence of chronic venous disease and lymphedema
Felizitas Pannier, Germany

The Bonn Vein Study I was conducted in 2000 on 3072 participants who were selected using a simple random sampling from the registries of residents of Bonn, Germany plus two rural townships. The study aim was to determine the prevalence of venous disorders in urban and rural populations, the frequency of its signs and symptoms, and the risk factors. Participants, at that time, were aged 18 to 79 years (1350 men, 1722 women).

The Bonn Vein Study II was a follow-up study, which occurred 6.6 years later on the same population. The aim was to identify the incidence of newly developed chronic venous disorders and progression of preexisting chronic venous disease. From May 2007 to September 2008, all participants of the Bonn Vein Study I were invited for a reinvestigation. The participants answered a standardized questionnaire and had a clinical examination and duplex ultrasound as was done in the Bonn Vein Study I. In addition to the questionnaire and the phlebological investigations, a skin fold test at the dorsum of the second toe was performed. The so-called Stemmer’s sign was slightly positive (Stemmer’s I) when the skin fold was between 0.5 and 1 cm. Stemmer’s II and Stemmer’s III occurred when the skin fold was >1 cm and when the skin fold was extremely enlarged, respectively.

The Bonn Vein Study I results showed the following clinical, etiological, anatomical, pathophysiological (CEAP) classification distribution: C0 (9.6%), C1 (59.0%), C2 (14.3%), C3 (13.4%), C4 (2.9%), C5 (0.6%), and C6 (0.1). The response rate after 6.6 years was 84.6% (1978 participants). The prevalence of varicose veins rose from 22.7% to 25.1% and for chronic venous insufficiency from 14.5% to 16%. The incidence for new varicose veins was 13.7% and for new chronic venous insufficiency 13.0%, which increased with age. Participants with a C2 classification during the Bonn Vein Study I increased to higher C classes in 19.8% and 31.8% for nonsaphenous and saphenous varicose veins, respectively. A total of 1.5% of the men and 2% of the women had clinical lymphedema represented by Stemmer’s sign II and III. The prevalence of a positive Stemmer’s sign II and III was markedly higher in the urban population (2.4%) compared with the rural population (0.7%) and increased with the clinical stages of chronic venous diseases according to the CEAP-classification.

The prevalence of lymphedema increased significantly with age (odds ratio, 5.4), obesity (odds ratio, 4.9), female sex (odds ratio, 2.1), urban living (odds ratio, 2.8), and sitting professions (odds ratio, 1.6). The incidence reached 0.8% per year for a slightly positive Stemmer’s sign and 0.3% per year for an increased positive Stemmer’s sign.

Prevalence and incidence of venous leg ulcer and lymphedema in the general population
Eberhard Rabe, Germany

The Bonn Vein Study I was a population-based cross-sectional study with participants chosen using simple random sampling from population registers (18 to 79 years of age). A total of 3072 patients were included (43.9% were male and 56.1% were female). Edema, leg ulcer, and lymphedema at any time in the past were observed in 30.7% (16.2% men and 42.1% women), 1.1% (1.2% men and 1.0% women), and 1.8% (1.1% men and 2.4% women) of patients, respectively. The clinical, etiological, anatomical, pathophysiological classification distribution was as follows: C0s (20%), C1 (21.6%), C2 (16%), C3 (14.6%), C4 (7.1%), C5 (1.4%), and C6 (0.5%).

The Bonn Vein Study II was conducted using the same population and procedure as in the Bonn Vein Study I. Follow-up was started in August 2007 (6.6 years after the end of the Bonn Vein Study I, with an 84.6% response rate [n=1978]) and the investigations finished in October 2008. The incidence of varicose veins was 13.7% overall, 7.1% in patients <39 years, 13.2% in patients between 40 and 59 years, and 18.5% in patients >59 years. The incidence of a C3 to C6 classification was 3.9% in patients <39 years, 10% in patients between 40 and 59 years, and 22% in patients >59 years.

The increased risks for ulcerations include the severity of the clinical venous disease (especially with the presence of skin changes), history of deep vein thrombosis, higher body mass index, smoking, reflux in the deep veins, low pumping function in photoplethysmography, and limited range of ankle movement (not wholly due to the effects of an active ulcer). The other increased risks of venous ulceration include lipodermatosclerosis, corona phlebectatica, and eczema.

Regarding the lymphedema incidence (looking for Stemmer’s sign [enlargement of skin fold between the first and second toe]), the Bonn Vein Study I found that 15.8% of the total population had a positive Stemmer’s sign, with 25.2% in the patients between the ages of 60 and 69 and 35.75% in the patients between the ages of 70 and 79. A positive Stemmer’s sign was found in 65.4% and 73.7% of the patients in the C6 and C5 class, respectively. The Bonn Vein Study II found a positive Stemmer’s sign in 2.4% of the patients <39 years, 4.8% in the patients between 40 and 59 years, and 6.2% in patients >59 years.

According to this study, lymphedema has a prevalence of 1.8% for the total population and an incidence of 0.3% per year, with an increased risk due to age, obesity, sitting professions, urban population, and female sex.

Varicose veins

In the introduction, two keynote seminars were presented. Albert Granados (El Salvador) focused on his results with endovenous laser ablation in 285 patients and Imre Bihari (Hungary) highlighted the risk factors for recurrences after endovenous laser surgery in 43 cases. Double saphenous veins, extremely dilated veins, high body mass index, and redo surgery were the most frequently mentioned risk factors. Imre Bihari showed a lower recurrence rate in his series and postulated that it was due to the distance of the ablated vein from the saphenofemoral junction: 0.5 cm compared with the 2 cm that is accepted by other surgeons.

Alexander Kantarovsky (Israel) presented his work with endovenous laser ablation and showed a positive financial aspect of this procedure in public hospitals. Using low power and a slow pull back rate, Svatopluk Kaspar (Czech Republic) showed that the limits of the endovenous laser procedure extend down to extremely dilated truncal varicose veins. Hong Hwang (Korea) investigated the safety and efficacy of total endovenous laser ablation without any phlebectomy or sclerotherapy in 554 symptomatic legs with saphenous vein incompetence. Recanalization occurred in 21 legs during the follow-up period. There were few side effects and the patients’ level of satisfaction was either good or very good. Philippe Desnos (France) presented the results of the EVTA study (EndoVenous Thermal Ablation), which explored the feasibility and tolerability of the thermal ablation of incompetent saphenous veins in patients older than 75 years. This was a prospective observational multicenter study conducted under the aegis of the French and Swiss Societies of Phlebology. Occlusion was achieved in 100% of the saphenous veins after 3 months, and paresthesia occurred with a lower proportion when local tumescent anesthesia was performed vs general anesthesia. Endovenous thermal ablation can be considered safe and effective in an elderly population under local tumescent anesthesia. Daniele Camilli (Italy) presented the results of a procedure that restores the competency of the great saphenous vein by external valvuloplasty. This procedure can save the saphenous vein from further grafts. André Cornu-Thenard (France) proposed improving the clinical, etiological, anatomical, pathophysiological (CEAP) classification by adding an “a” or a “b” to each C class, as has already done for the C4 class (C4a, pigmentation or eczema; C4b, lipodermatosclerosis or white atrophy).

Kasuo Miyake (Brazil) evaluated the viscosity and flow hydrodynamics of the most commonly used sclerosing agents in a rabbit model (dextrose, ethanolamine oleate, sodium tetradecyl sulfate). Vessel size and the viscosity and strength of the sclerosant are responsible for ulceration during sclerotherapy, not extravasation.

Adel Kamhavy (Egypt) presented his work using combined surgical and foam sclerotherapy approaches for the management of acute bleeding from reticular varicose veins in 125 patients. Until now, there were no reports on the use of foam sclerotherapy during surgery in such cases, and yet, this technique is simple, safe, and effective.

Interim results of the multicenter, randomized controlled trial comparing mechanochemical ablation with radiofrequency ablation were presented by Roshan Bootun (UK). A total of 170 patients undergoing truncal ablation were randomized to either group. The end point was an assessment of pain using a visual analogue scale and quality of life using the Aberdeen Varicose Veins Questionnaire. The previously reported results showed that mechanochemical ablation is less painful than radiofrequency ablation. However, after 6 months of follow-up, the clinical scores and quality of life scores were similarly improved in both treatment groups.

A new gluing method for treating varicose veins was presented by Johan Ragg (Germany). The method combines point-wise gluing for vein wall adhesion and catheter sclerotherapy for rapid endothelium denaturation (“scleroglue technology”). The objective of this new method is to bridge some disadvantages of the gluing method alone. Preliminary results on 21 patients are promising as this method provides reliable denaturation and economical gluing.

Makoto Mo (Japan) presented the rate of venous thromboembolic complications after endovenous thermal ablation in Japan. Data on 43 203 cases were obtained from 143 institutions. The total reported Endovenous Heat Induced Thrombosis (EHIT) included: EHIT class 2 (318 cases; 1%); EHIT class 3 (51 cases; 0.1%); EHIT class 4 (7 cases; 0.013%); pulmonary embolism (2 cases; 0.0067%); and any other venous thrombosis event (24 cases; 0.06%). Venous thrombosis complications after endovenous laser ablation were rare.

Retrospective analysis of an ultrasound study done on female patients for varicose veins
Devendra Dekiwadia, India

The primary goal of the presented study was to investigate concomitant associated pelvic vein refluxes in patients with chronic venous disease. From September 2013 to September 2014, 126 female patients with varicose veins were studied using linear ultrasound while standing and a transvaginal probe for ovarian vein reflux. The author observed that 28.57% (n=36) of the patients with varicose veins had associated pelvic vein refluxes. An increased suspicion of refluxing pelvic veins, mainly the ovarian and hypogastric veins, were observed where varicosities were noted in the medial and posterior thigh, gluteal region, and vulvar varicosities. Only 30% of these patients complained of pelvic pain, while the rest had typical symptoms of edema in the lower calf, ankle, and foot, night cramps, eczema, and visible varicose veins.

Patients with a refluxing great saphenous vein at the saphenofemoral junction or any level toward the ankle with ovarian reflux were primarily treated with thermal ablation and bunch phlebectomy ±sclerotherapy of the great saphenous vein and then kept for follow-up. A second group of patients with no great saphenous vein varicosity, but multiple varicosities in the lower limbs with a normal saphenofemoral junction, underwent coil deployment and were kept for follow-up.

Venous leg ulcer

AVF–SVS guidelines for the management of venous ulcer
Fedor Lurie, USA

Venous leg ulcers have a major socioeconomic effect that is related to several factors: (i) the prevalence, which ranges between 0.06% and 2%; (ii) the common occurrence, representing up to 80% of all leg ulcers; and (iii) the predilection for recurrence of 50% to 70% within 6 months. As a result, the current direct cost of treatment for venous leg ulcers in the US is between $10 000 and $12 000 per year per patient, which is comparable with Germany. Thus, the direct expenditures for the treatment of venous leg ulcers may amount to 1% of the health-care budgets for some European countries. The indirect costs are also significant due to the lost productivity from work for the patient and the family members, out-of-pocket expenses (copays), transportation, and premature disability.

Guidelines should develop “best practices” to achieve the best health outcomes for the most reasonable health care dollar. As the treatment of venous leg ulcers uniquely involves all health care providers, the American Venous Forum and Society for Vascular Surgery (AVF–SVS) guidelines should address primary care physicians, surgeons, dermatologists, wound care specialists, and nurse- and physical therapist– dependent care.

During the presentation, the following recommendations were stressed:
1. Guideline 1.1: Venous leg ulcer definition We suggest using a standard definition of venous ulcer as an open skin lesion of the leg or foot that occurs in an area affected by venous hypertension. (Best practice)
2. Guideline 2.1: Venous anatomy nomenclature We recommend using the International Consensus Committee on Venous Anatomical Terminology for standardized venous anatomy nomenclature. (Best practice)
3. Guideline 2.2: Venous leg ulcer pathophysiology We recommend having a basic practical knowledge of venous physiology and venous leg ulcer pathophysiology for all practitioners caring for venous leg ulcers. (Best practice)

Clinical Evaluation:
4. Guideline 3.1: Clinical evaluation We recommend that a clinical evaluation for evidence of chronic venous disease be performed for all patients with suspected leg ulcers fitting the definition of a venous leg ulcer. (Best practice)
5. Guideline 3.2: Nonvenous causes of leg ulcers We recommend identifying the medical conditions that affect ulcer healing and other nonvenous causes of ulcers. (Best practice)
6. Guideline 3.3: Wound documentation We recommend measuring and documenting serial venous leg ulcer wounds. (Best practice)
7. Guideline 3.4: Wound culture We suggest against taking routine cultures from venous leg ulcers and recommend only obtaining wound cultures when clinical evidence of an infection is present. (Grade 2; Level of evidence, C)
8. Guideline 3.5: Wound biopsy We recommend conducting a wound biopsy for venous leg ulcers that do not improve with standard wound and compression therapy after 4 to 6 weeks of treatment and for all ulcers with atypical features. (Grade 1; Level of evidence, C)
9. Guideline 3.7: Arterial testing We recommend conducting an arterial pulse examination and measuring the ankle brachial index on all patients with venous leg ulcers. (Grade 1; Level of evidence, B)
10. Guideline 5.4: Compression – arterial insufficiency In a patient with a venous leg ulcer and underlying arterial disease, if the ankle brachial index is ≤0.5 or if the absolute ankle pressure is <60 mm Hg, we do not suggest compression bandages or stockings. Investigation: 11. Guideline 3.9: Venous duplex ultrasound We recommend comprehensive venous duplex ultrasound examination of the lower extremity in all patients with suspected venous leg ulcers. (Grade 1; Level of evidence, B) 12. Guideline 3.10: Venous plethysmography We suggest selectively using venous plethysmography to evaluate patients with suspected venous leg ulcers, if the venous duplex ultrasound does not provided definitive diagnostic information. (Grade 2; Level of evidence, B) Compression: 13. Guideline 5.1: Compression – ulcer healing In a patient with a venous leg ulcer, we recommend compression therapy to increase the healing rate of venous leg ulcers. (Grade 1; Level of evidence, A) 14. Guideline 5.2: Compression – ulcer recurrence In a patient with a healed venous leg ulcer, we suggest compression therapy to decrease the risk of ulcer recurrence. (Grade 2; Level of evidence, B) Intervention: 15. Guideline 6.1: Superficial venous reflux and active venous leg ulcer – ulcer healing In a patient with a venous leg ulcer (C6) and incompetent superficial veins that have an axial reflux directed to the bed of the ulcer, we suggest ablation of the incompetent veins in addition to standard compressive therapy to improve ulcer healing. (Grade 2; Level of evidence, C) 16. Guideline 6.2: Superficial venous reflux and active venous leg ulcer – prevent recurrence In a patient with a venous leg ulcer (C6) and incompetent superficial veins that have an axial reflux directed to the bed of the ulcer, we recommend ablation of the incompetent veins in addition to standard compressive 17. Guideline 6.3: Superficial venous reflux and healed venous leg ulcers In a patient with a healed venous leg ulcer (C5) and incompetent superficial veins that have an axial reflux directed to the bed of the ulcer, we recommend ablation of the incompetent veins in addition to standard compressive therapy to prevent recurrence. (Grade 1; Level of evidence, C) 18. Guideline 6.4: Superficial venous reflux with skin changes at risk of venous leg ulcers (C4b)
In a patient with skin changes at risk of venous leg ulcers (C4b) and incompetent superficial veins that have an axial reflux directed to the bed of the affected skin, we suggest ablation of the incompetent superficial veins in addition to standard compressive therapy to prevent ulceration. (Grade 2; Level of evidence, C)

Considering the most recent AVF–SVS guidelines, the treatment of venous ulcers requires a multispecialty approach, involving compression, local wound care, sclerotherapy, stenting, reconstruction, ablation, phlebectomy, or drug therapy.

For the complete AVF–SVS guidelines, please refer to the original publication by O’Donnell Jr.1

1. O’Donnell TF Jr, Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery_ and the American Venous Forum. J Vasc Surg. 2014; 60:3S-59S.

Surgical management of venous ulcers
Mark Malouf, Australia

Treating the cause of venous hypertension and addressing the ulcer or wound are two considerations that require surgical management in patients with venous ulcers. In the local vicinity of venous ulcers, there are often obvious varicosities that can be associated with nearby incompetent perforating veins (>40% of C6) or saphenous trunk reflux. Deep vein reflux and obstruction at different levels may also be present and should be considered, especially for a nonresponding ulcer.

When treating a venous ulcer, the role played by the calf muscle pump and the possibility of coincidental arterial disease in the affected limb must not be ignored. Comorbid illnesses, such as diabetes, anemia, vasculitis, obesity, cardiac failure, or immobility, may be just as important as the diseased veins themselves. Detailed venous duplex mapping is essential to develop a tailored treatment plan to reduce the venous hypertension. Depending on the mapping results, several surgical and minimally invasive treatment options are available to treat the venous pathology, similar to the options available for C2 patients.

Meanwhile, treatment strategies for C6 patients may need to be modified because of the severity and tortuous or recurrent nature of the superficial varicosities and the increased incidence of coexisting perforator or deep vein reflux/obstruction. The availability of thermal ablation is increasing and the cost is going down; therefore, worldwide use is growing. Meanwhile, sclerotherapy is cheap, repeatable, and a very good option, especially in developing countries. The worldwide frequency of open surgery on superficial veins is going down, but this option may still be preferable in some countries. Ambulatory phlebectomy under local anesthesia is very effective in reducing local venous hypertension around a venous ulcer, often combined with sclerotherapy. We must never lose sight of the fact that there may also be proximal venous obstruction, especially for ulcers that are difficult to manage, which can be treated with endovascular techniques.

Deep vein surgery is being performed in selected centers around the world for certain patients who have had both the superficial venous disease and perforators corrected and still suffer from ulcers. Deep vein surgical procedures include endovenectomy, creation of new vein valves, or if valve cusps do exist, restoration of deep vein competence using external or open valvuloplasty. Adequate treatment of superficial venous reflux is expected by many practitioners to speed the healing rate of the venous ulcers, to reduce its recurrence, and to extend the ulcer-free intervals, which is also supported by some data.

In terms of the venous ulcer itself, surgical debridement is commonly required to remove necrotic and/or infected tissue and to stimulate regeneration from the base and epithelialization from the ulcer edge. Skin grafting for large or recalcitrant ulcers is commonly performed, but only after treating the underlying venous hypertension and excluding the malignancy or vasculitis on biopsy. Methods of skin grafting include a split thickness graft, which may or may not require meshing, or pinch grafting under local anesthesia to stimulate healing.

The management of venous leg ulcers is still a challenge. Nevertheless, areas of venous reflux or obstruction should be treated with whatever methods are available in the office, clinic, or operating room; the functional factors and lifestyle should be improved; the wounds should also be treated, with surgery, if necessary; and the recommended guidelines should be observed.

Therapeutic alternatives for venous ulcers
Fernando Vega Rasgado, Mexico

Venous ulcers are estimated to affect 10% to 35% of the entire US population, and ≈4% of people >65 years old have active ulcers. Many ulcers can have a multifactorial etiology. In 354 leg ulcers, Koerber et al showed that 5.3% were venous leg ulcers, 3.7% were arterial leg ulcers, 14.7% were ulcers of mixed venous and arterial origin, and 13.5% were vasculitic ulcers, ie, diabetic leg ulcer.1 The ulcers with an inflammatory border and skin necrosis are often associated with chronic inflammatory diseases, such as ulcerative colitis or rheumatoid arthritis. Leg ulcers may also occur in patients with Klinefelter’s syndrome. Malignant conditions must be excluded to make a differential diagnosis.

Compression improves the healing of ulcers, multicomponent compression systems are more effective than single-component compression systems, high compression is more effective than lower compression, and medical compression stockings are more effective than short-stretch bandages. So far, the Unna boot is considered the “goldstandard bandage” in compression therapy of venous ulcers.

Additionally, the author discussed a paper showing that the 24-week healing rate was significantly reduced in patients with poor ankle motility: 13% in legs with an ankle motility <35 degrees compared with 60% in legs with an ankle motility >35 degrees; ankle motility was an independent risk factor for the healing rate of chronic venous ulcers when adjusted for age, ulcer chronicity, and popliteal vein reflux (P=0.001).2

Several adjunctive therapies may help heal venous ulcers. As such, negative wound pressure treatment that creates a negative pressure on the ulcer bed favors granulation tissue and shortens healing time. Leg elevation for 10 minutes every 24 hours produces significant fluid drainage from the legs, promoting tissue dryness and blood flow to the skin around the ulcer. Nadroparin may play an adjuvant role in treating venous ulcers because it favors pain relief and improves quality of life, even if it does not improve healing. The application of an autologous platelet-rich gel in nonhealing vascular ulcers can be helpful. Connexin 43 (α-connexin carboxylterminal peptide) appears to accelerate both fibroblast migration/proliferation and wound re-epithelialization.

Compression remains the most useful and effective method of treating venous ulcers and a multilayer technique is the most effective. The Unna boot remains the gold-standard treatment, and differential diagnoses and new methods should be considered, especially for poorly healing ulcers.

1. Koerber A, Schadendorf D, Dissemond J. Genese des ulcus cruris. Hautarzt. 2009;60:488.
2. Barwell R, Taylor M, Deacon J, Davies C, Whyman MR, Poskitt KR. Ankle motility is a risk factor for healing of chronic venous leg ulcer. Phlebology. 2001;16:38-40.

Laser ablation of perforating veins in C5 patients with postthrombotic syndrome does not prevent ulcer

Igor Zolotukhin, Russia

A randomized controlled trial to establish whether laser ablation of perforators decreases the recurrence rate of postthrombotic ulcers at a 1-year follow-up was presented. For the study, 63 patients were randomly assigned to either endovenous laser ablation of incompetent calf perforating veins with subsequent compression treatment using class 3 stockings or to compression alone.

There were 91 incompetent calf perforating veins on 31 limbs with diameters ranging from 0.2 to 0.85 cm (mean, 0.4) in the study group and 87 incompetent calf perforating veins with diameters ranging from 0.2 to 0.86 cm (mean, 0.41) in the control group. Laser ablation was performed with a 940 nm device and the amount of energy delivered depended on the perforator caliber (from at least 75 J for 0.2 to 0.3 cm veins to 325 to 600 J for veins >0.6 cm). Number of ablated veins ranged from 1 to 7 per leg.

Duplex ultrasound showed that 77% of perforators had been successfully occluded 3 to 5 days postprocedure. Ulcer recurrence during 12 months occurred in 32% of patients in the study group and 34% of patients in the control group (P=0.859). Mean venous clinical severity score after follow-up was 12 in both groups. Only 24% of the perforators remained occluded after 1 year.

Laser ablation of incompetent calf perforating veins performed with the usual amount of energy does not prevent either the incompetent perforating veins from recanalizing or the ulcer from reoccurring in patients with a clinical, etiological, anatomical, physiological (CEAP) class of C5 and a postthrombotic syndrome.

Free paper session on venous ulcers: new concepts in venous ulcer treatment

The keynote address titled “Abolishing most distal reflux: does it count?” was presented by Wassila Taha Elkashishi (Egypt), where the term “ulcer veins” was mentioned. The results show that 88% of ulcers were healed within 1 year after foam sclerotherapy.

Ernesto Nieves (Colombia) discussed the results of a prospective, randomized clinical trial comparing conventional treatment of venous ulcers with conventional treatment plus ultrasound-guided foam sclerotherapy. The healing rate within the group receiving sclerotherapy was 83.3% at 6 months and 12.5% within the group receiving conventional local therapy only. Ernesto Nieves also presented “Prospective clinical trial on the rapid healing of venous ulcers with thermal, axial, and perforator interruption of the reflux source (TAPIRS) plus multilayer bandage,” where it was shown that such techniques lead to a faster healing. Istvan Rozsos (Hungary) focused on measuring transcutaneous oxygen tension before and after treating ulcers with ultrasound-guided foam sclerotherapy.

Atsushi Tabuchi (Japan) discussed the traditional surgical approach of using subfascial endoscopic perforator vein surgery for treating venous stasis ulcers. Contrary to general belief and guideline recommendations, subfascial endoscopic perforator vein surgery was combined with stripping or endovenous laser ablation in almost 80% of incompetent saphenous trunks in 51 limbs with venous ulcers. The healing rate for the ulcers was 90.4% after 6 months and the cumulative recurrence-free rate was 97.5%. No side effects were reported. Venous filling index, venous volume, and residual volume fraction were assessed pre- and postoperatively and improvements were observed 24-months postprocedure.

Francine Heatley (UK) introduced the trial design of the EVRA ulcer trial (Early Venous Reflux Ablation), a randomized clinical trial comparing early with delayed endovenous treatment of superficial venous reflux in patients with chronic venous ulcers. The objective of the trial is to clarify the controversy surrounding the timing of superficial venous intervention. This study will be the first large, randomized, multicenter trial to report on the clinical efficacy, quality of life changes, and cost-effectiveness of treating ≈2500 patients with venous ulcers by early superficial venous intervention.

Conservative treatment of primary chronic venous disease: compression therapy

The in vivo performance of compression stockings using air plethysmography
Christopher Lattimer, UK

Manufacturers extensively test compression stockings to quantify compression strength, pressure graduation, surface contour, and knit. Despite this testing, compression stockings are not tolerated by some people and they could even cause harm. Furthermore, he stressed that compliance is a major issue. These factors may be related to how stockings augment venous return. This study compared the in vivo performance of elastic compression stockings between healthy controls and patients with varicose veins, postthrombotic syndrome, and lymphedema using air plethysmography.

Stocking ejection force was tested by measuring the reduction in calf volume of a congested calf after sudden deflation of a thigh cuff (outflow fraction). The ability of a stocking to resist increases in calf volume after incremental thigh-cuff inflations was tested by measuring incremental thigh-cuff pressure causing maximal increase in calf volume (IPMIV). Reflux and gravitational drainage were tested in mL/s using dependency (venous filling index) and elevation (venous drainage index) maneuvers, respectively.

A total of 12 legs were tested in each group using no compression, knee-length class 1 (18 to 21 mm Hg) compression, and then class 2 (23 to 32 mm Hg) compression. Stocking interface pressures (mm Hg) were measured in the supine position at two points using the PicoPress® (this device measures the pressure exerted by elastic compression in both static and dynamic conditions). The values of the outflow fraction, IPMIV, venous filling index, and venous drainage index were quantified in each of the four groups. Stockings significantly improved the outflow fraction and IPMIV both in controls and patients with varicose veins. The venous filling index improved significantly in patients with varicose veins. There was a 6-fold improvement in the venous drainage index in the only postthrombotic syndrome patient with an iliac occlusion from 2.3 (none) to 14.3 and 13.3 with a class 1 and 2 stockings, respectively.

Results of stocking performance tests that measure acute volume changes in vivo in response to provocation maneuvers may explain why the legs of some patients improve with a stocking and why other legs may not benefit to the same extent. The hemodynamic performance of stockings could be quantified in vivo, and as such, the overall results show that patients with postthrombotic syndrome gained the least benefit from using stockings, but others showed significant hemodynamic improvements. For patients with postthrombotic syndrome, stockings should perhaps be prescribed after air plethysmography has been performed to identify which patients will definitively benefit.

Pressure and stiffness: the two sides of the compression coin
Eberhard Rabe, Germany

Compression therapy of the lower limbs is a fundamental component in the management of acute and chronic venous disease and lymphatic diseases. The treatment can be performed using compression bandages, compression stockings, and intermittent pneumatic compression devices. Medical compression stockings are made of elastic textiles. According to the exerted pressure, different compression classes are available. The pressure profile of each compression class responds to the resting pressure in the ankle region. The pressure exerted on the leg should compress the veins and improve the function of the muscle pumps. This can be demonstrated in the supine position; however, in the upright position, even 30 to 40 mm Hg elastic compression stockings may not be able to sufficiently compress the veins.

A second mode of action is the pressure changes during muscle contraction or walking. The ability to withstand the circumference enhancement of the leg during muscle activity or simply after changing from the supine to the upright position depends on the stiffness of the material. Stiffness is defined as pressure increases with an increase in leg circumference. The static stiffness index (SSI) is measured as the in vivo pressure while standing upright minus the pressure in the supine position. A high SSI means that the pressure under the stocking will rise significantly in the upright position and it will be able to improve the venous function better than material with a low SSI. Some indications, such as chronic venous insufficiency with skin changes or venous ulcers, benefit more from a high SSI than other indications, such as symptomatic varicose veins without chronic venous insufficiency.

For these reasons, it is recommended to consider both the compression class and the stiffness of the material used. Stiffness is probably a more relevant parameter of practical interest than compression when prescribing compression stockings. Consequently, for clinical, etiological, anatomical, physiological (CEAP) classes C1s to mild C3, leg swelling after prolonged standing, thromboprophylaxis, and diabetic edema, an SSI <5 is recommended; for CEAP classes C3 (severe) to C4a, deep vein thrombosis, and arm lymphedema, a medium stiffness stocking (SSI =5-7) is recommended; and for CEAP classes C4b to C6 and lymphedema, a high stiffness stocking (SSI >7) is recommended.

Elastic compression elicited beneficial cardiovascular effects: a complex clinical study in healthy,
lymphedematous, and lipedematous individuals

Győző Szolnoky, Hungary

Research on compression therapy is mostly focused on venous and lymph flow; however, the effect of medical compression stockings on cardiovascular responses have been poorly studied, which means that the systemic effect of compression still needs further clarification. Medical stockings with mild compression improve pulse wave velocity, which is the gold-standard measurement of aortic elastic properties. Sports stockings are considered efficient at improving running capacity, but their mode of action remains to be elucidated. Nongraduated stockings exert remarkable venous hemodynamic effects, but their systemic cardiovascular effect has never been measured. Recent studies showed that secondary lymphedema and lipedema patients present with a high aortic stiffness. Sustained compression with elastic material is the cornerstone of controlling limb volume, despite the fact that its cardiovascular impact has been poorly investigated.

The goal of this research was to determine whether measurable beneficial effects on aortic function could be attributed to knee-high leg sport stockings or nongraduated stockings in healthy individuals or medical compression stockings in patients with lymphedema and lipedema. Aortic elastic properties were determined before and after using compression garments in eligible subjects, and included blood pressure assessment, two-dimensional echocardiography, and pulse wave velocity measurements. The whole study was conducted under static circumstances, except for the group who were performing sports with nongraduated stockings for which dynamic measurements with treadmill exercises were obtained.

According to the working hypothesis, sports and nongraduated knee-high stockings for healthy individuals and stockings for patients with lymphedema and lipedema should positively influence cardiovascular outcomes.

Free paper session on venolymphatic disorders and compression therapy

Jaroslav Strejcek (Czech Republic) gave the keynote seminar titled “Comparison of the hemodynamic effects of different compression systems for the treatment of venous leg ulcers.” He presented an historical overview on using external compression for leg ulcers, from the beginning until the latest advancement, in compression therapy. The impact of certain types of compression tools on venous hemodynamics, as measured by calibrated photo plethysmography (D-PPG), was demonstrated.

Christopher Lattimer (UK) presented the study “Performance of compression stockings in venous insufficiency using air plethysmography.” The effect of compression therapy was assessed using the venous filling index, incremental thigh-cuff pressure causing the maximal increase in calf volume (IPMIV), outflow fraction, and ejection fraction. The control group was compared with both a group of patients with varicose veins and a group of patients with postthrombotic syndrome. Stockings significantly resisted calf volume increases and enhanced the venous return in controls and patients with varicose veins. They had a positive hemodynamic effect only in selected postthrombotic patients.

Johann Ragg (Germany) presented new eccentric compression tools in his presentation “Cartridge-applied silicone pads for eccentric compression of varicosities after sclerotherapy: saphenous, popliteal, and spider vein application.” Results of the study comparing eccentric and concentric compression showed a high satisfaction and a low rate of local complications, but the product is not on the market yet.

Lymphedema problems were covered by Shashi Gogia (India) and Young Ki Shim (Korea). The first presentation focused on the treatment possibilities from a tropical point of view. Lymphedema treatment can have satisfactory outcomes, but it has to be managed as a chronic disease and patient compliance is the key. Young Ki Shim discussed a microsurgery technique using free vascularized normal lymph node transfer, which was based on his experience in 14 cases. This technique can be applied under very specific indications and complete normalization of lymphedema may not be possible with this technique due to the number of transferred normal lymph nodes that may not sufficiently drain all of the lymphatic fluid from the affected limb.

Chang Shu (China) presented the results of a retrospective analysis of the treatment of congenital vascular malformations using a multidisciplinary approach. He presented his 12-year work on 2926 patients in a single center, where the efficacy and safety of their imaging protocol and therapeutic strategy were evaluated. Management included conservative care, sclerotherapy, embolization, surgical resection, and/or combinations of these therapies. A multidisciplinary approach can result in favorable outcomes with an acceptable complication rate. Another two presentations were dedicated to the same topic. During the discussion, Byung Boong Lee (USA) stressed the importance of using the webpages of the International Society for the Study of Vascular Anomalies (www.issva.org), where up-to-date classifications are available.

Compression therapy in venolymphatic disorders

Jean-François Uhl (France) discussed the effect of compression therapy on the anatomy of leg veins and provided several beautiful images to support the discussion. When a 22 mm Hg compression is applied in a standing position, this narrows the deep veins, but not the superficial system–the action of compression on the varicose veins is done mainly by effects on the muscles and deep veins. Compression enhances the intramuscular pressure; therefore, it has a direct effect on the muscular compartments and veins (calf pump). This finding reinforces the idea that compression must be applied mainly at the calf.

Fedor Lurie (USA) presented “Hemodynamic aspects of intermittent pneumatic compression.” Intermittent pneumatic compression affects systemic hemodynamics and increases venous flow velocity and flow rate during compression. Hemodynamic effects depend on the device, the patient’s position, and other factors. The relationship between clinical benefits and the hemodynamic effects of intermittent pneumatic compression remains to be defined.

In the presentation “Application of compression bandages: do types and skills matter?” by Ji Hye Hwang (Korea), the differences between stockings and bandages were discussed, and an overview of the science behind compression bandaging for chronic venous edema, ulcers, and lymphedema was introduced.

The role of compressive dressing of the elastic leg stocking and bandage
Soo-Kyung Bok, Korea

Compression therapy has been an effective treatment for the management of venous and lymphatic diseases for “thousands” of years. There are three types of compression therapy: compression bandages, compression stockings, and intermittent pneumatic compression. When pressure is applied to the human body, the liquid is not compressed. When the tissue pressure increases, liquid flows into the blood vessels or other regions. The mechanism of action proposed in compression therapy is to reduce the ultrafiltration pressure of the capillary by increasing interstitial pressure and improving venous and lymphatic circulation by decreasing the diameter of vessels.

The indications for compression therapy include the following: (i) prevention and therapy of edema; (ii) after active treatment of varicose veins; (iii) lipodermatosclerosis; (iv) maintenance treatment after leg ulcers; (v) after deep vein thrombosis to prevent a postthrombotic syndrome; and (vi) management of lymphedema.

The difference between resting pressure and working pressure was clarified. Resting pressure is the pressure measured under static conditions and it is increased with strong stockings and bandages. Working pressure is the pressure measured during muscle contraction and it promotes muscular pumping. Material with a lower elasticity promotes a larger working pressure. Inelastic bandages maintain their hemodynamic effectiveness over time despite a significant loss of pressure, which is important for the management of leg ulcers.

The indications according to medical compression stocking pressure include:
1. Light compression stockings (<20 mm Hg) a. Improvement in venous symptoms b. Prevention of leg swelling related to prolonged sitting and standing c. Prevention of deep vein thrombosis in bedridden patients 2. Medical compression stockings (30 to 40 mm Hg) a. Improved healing of venous leg ulcers b. Prevention of ulcer recurrence c. Prevention of postthrombotic syndrome after a proximal deep vein thrombosis d. Maintenance therapy in lymphedema Venous compression plays a major role reducing the incidence of ostthrombotic syndrome, especially in severe cases.

Adjustable Velcro compression devices are more effective than inelastic bandages to reduce venous
edema: a randomized, controlled pilot study.

Giovanni Mosti, Italy

The aim of this study was to assess if the treatment phase with readjustable Velcro® devices could be as effective as or more effective than inelastic bandages and easier to handle compared with both bandages and elastic stockings. A total of 40 legs from 36 patients (17 males and 19 females) aged 71.4±10.2 years (range, 52 to 85 years) were included. All of the patients had been affected for more than 3 months with chronic leg edema due to primary and/or secondary chronic venous disease. The patients were randomized into one of two different compression systems– inelastic bandages or Circaid Juxtafit®–and compression was applied for 1 week. The exclusion criteria were patients with skin changes due to venous insufficiency (clinical, etiological, anatomical, physiological classification of C4 to C6), clinical signs of lymphedema (positive Stemmer’s sign), cardiac and renal failure, conditions requiring diuretics, corticoids, and/or Ca2+ antagonists, compression therapy in the last 3 weeks, and an ankle brachial pressure index <0.8. The treatment with Velcro® devices was performed with inelastic bandages for 1 week, which were changed after 1 day; subsequently the patients were moved to a knee-length stocking adjusted to the reduced leg size. Circaid Juxtafit® was used chronically and patients were allowed to readjust the device depending on their perception of looseness. The patients reported no worsening of symptoms in any case, that application and reapplication was quite easy, that there was an improvement in cosmetic appearance, that it was easier to put on shoes with the adjustable Velcro® devices, and, in some cases, a desire to move from Velcro® devices to elastic stockings after the edema disappeared. Circaid Juxtafit® is more effective than inelastic bandages for the treatment of edema. The maintenance of pressure over time may be the deciding advantage for a better effect, good tolerability, and an absence of unwanted effects for both devices, but some problems were found with the long-term use of CircAid Juxtafit® after the edema disappeared.

Compression treatment in lymphedema
Attilio Cavezzi, Italy

Lymph transport, not venous capillary reabsorption, is the main process responsible for interstitial fluid balance. Lymphedema is a clinical manifestation of lymphatic system insufficiency and deranged lymph transport. The central disturbance is a low output failure of the lymphatic system, meaning that there is an overall reduction in lymphatic transport. According to the author, lymphatic decongestive therapy consists of a daily inelastic bandage (subbandage pressure >45 mm Hg), exercise and movement, skin care with questionable use of drugs, and pneumatic therapy. The effects of compression therapy in lymphedema include an increase in the interstitial pressure, a reduction in capillary filtration, a shift of fluid into noncompressed parts of the body, an increase in lymphatic reabsorption, stimulation of lymphatic transport, improvement in the vascular-muscle pump, breakdown of fibrosclerotic tissue, and protection of the skin. In compression therapy, bandages achieve a result in the intensive phase and elastic garments (stockings and sleeves) maintain the results in the chronic phase.

The pressure exerted by the bandage decreases over time, which is mainly caused by a reduction in volume in the extremities resulting in an immediate effect (even in healthy legs) that is more pronounced in patients with massive edema. In the lymphedema “maintenance phase,” it is important to achieve clinical improvement by using custom-made flat-knitted compression stockings, self-compression elastic bandages, and adjustable Velcro devices and pumps (at home), if possible. The proper pressure of the elastic garments (eg, gloves, sleeves, and stockings) is 30 to 50 mm Hg. Optimal lower limb compression is about 40 mm Hg and optimal upper limb compression around 20 to 30 mg Hg. The limits and side effects of compression treatment in lymphedema include low patient compliance, abnormally shaped limbs, and the necessity to redo the nonadhesive bandage on a daily basis. Contraindications include local infections, arterial diseases, and side effects or complications, such as pain, tissue ischemia, allergy, paresthesia, and skin lesions.

Multilayer, multicomponent, inelastic, and low-stretch bandages that provide high pressure in the lower limbs and lower pressure in the upper limbs during the therapy phase may be more effective and tolerable than adjustable Velcro devices. Custommade elastic stockings, self-applied elastic bandages, and adjustable Velcro devices are indicated in the maintenance phase.

Compression after invasive treatment of varicose veins
Thomas Noppeney, Germany

A previous publication by Melrose et al highlighted the importance of compression therapy after stripping surgery for varicose veins.1 This was a randomized trial comparing patients with or without compression treatment in the postoperative period. Compression therapy was shown to result in a significant reduction in postoperative pain, length of hospital stay, and an improvement in wound healing. A French study, published by Rastel et al, reported results from a survey questionnaire sent to 675 surgeons regarding their practice of using compression therapy after surgery.2 Results were as follows: (i) a 41.5% return rate; (ii) 97.1% used compression after varicose vein surgery; (iii) 38.8% used compression bandages <8 days and 24.5% used compression bandages for 8 to 15 days; (iv) 12.7% and 84.6% used compression stockings after the compression bandages for an additional 8 to 15 days or 15 to 30 days, respectively; (v) and the total time for compression was 2 to 6 weeks. Huang et al recently published a meta-analysis on four randomized controlled trials from 1999 to 2009 involving 686 patients. The study evaluated different durations of compression therapy after varicose vein surgery and their outcomes on postsurgery pain and leg volume and the complications of short-term compression (3 to 10 days) vs long-term compression (3 to 6 weeks).3 The results indicated that there were no benefits of long-term compression therapy after varicose vein surgery regarding postoperative pain, leg volume, incidence of complications, and duration of absenteeism from work.

Compression therapy is able to reduce postoperative hematomas (Grade 1B), pain (Grade 1B), and leg volume (Grade 1B), but the ideal length and pressure of compression is unclear.

1. Melrose DG, Knight MT, Simandl E. The stripping of varicose veins: a clinical trial of intermittent compression dressings. Br J Surg. 1979;66:53-55.
2. Rastel D, Perrin M, Guidicelli H. Compressive therapy after varicose vein surgery: results of a French national inquiry [in French]. J Mal Vasc. 2004;29:27-34.
3. Huang TW, Chen SL, Bai CH, Wu CH, Tam KW. The optimal duration of compression therapy following varicose vein surgery: a meta-analysis of randomized controlled trials. Eur J Vasc Endovasc Surg. 2013;45:397-402.

Surgical treatment of primary chronic venous disease

World’s first interventional technique to restore venous valve function
Johann C. Ragg, Germany

Building on the data obtained from more than 1000 venous punctures after ultrasound-guided tumescent anesthesia in the great saphenous junction, Johann Ragg proposed injecting a hyaluronic gel, which is used by dermatologists as a filler for the saphenous proximal fascia junction, to provide effective compression that reduces the caliber and the reflux. A special needle was developed to avoid intraluminal injections. In a pilot study, 23 patients with proximal incompetence of the great saphenous vein (diameter, 7.0 to 11.5 mm; mean, 8.6 mm) were selected to receive a diameter reduction by circumferential injection of a 2% solution of hyaluronic gel (crosslink degree, 2%). The injections were performed with a safety system consisting of a relocatable sharp cannula and a flexible blunt outer metal catheter using continuous ultrasound monitoring until there was an absence of reflux. The follow-up was performed by ultrasound after 12, 26, and 52 weeks. An orthograde flow could be established in 15 of 22 cases after 52 weeks (68.2%). In conclusion, valvuloplasty by ultrasound-monitored hyaluronic gel injection is feasible, safe, and effective, and clinical applications with low rates of supplementary injections seem to be achievable.

Isolated phlebotomy leads to the disappearance of great saphenous vein reflux. Experience with ASVAL
principles in Russia

Igor Zolotokhin, Russia

The ascending theory of developing primary varicose veins claims that pathological processes start in the tributaries and then reflux develops in the saphenous trunk. The ambulatory selective varices ablation under local anesthesia (ASVAL) method consists of isolated phlebectomies without any intervention on an incompetent saphenous trunk. A study was conducted to estimate the impact an isolated phlebectomy may have on the great saphenous vein diameter and reflux. A total of 51 limbs from 43 patients (35 women and 8 men) with great saphenous vein incompetence and varicosities underwent operations. A total of 82%, 4%, and 4% of the patients in this study had a clinical, etiological, anatomical, physiological classification of C2, C3, and C4, respectively. The C5 and C6 patients, where the great saphenous vein diameter was >15 mm and the reflux was below the upper one-third of the calf, were excluded from the study. The follow-up occurred at 7 days and at 1, 3, 6, and 12 months postsurgery. Disappearance of the reflux was observed in 61% of the patients 1-year posttreatment and a great saphenous vein thrombosis was observed in 5.6% of the patients. In conclusion, the ASVAL method could be applied safely, but there is a need to establish the patients that could be selected for this technique.

Endovenous treatment of primary chronic venous disease: cyanoacrylate adhesive

Use of cyanoacrylate adhesive for treatment of an incompetent great saphenous vein: 12-month results of
the VeClose trial

Nick Morrison, USA

Endovenous laser ablation has been used successfully to treat incompetent saphenous veins. One disadvantage is the need for tumescent anesthesia, which involves multiple punctures along the length of the target vein. In the present study, the use of cyanoacrylate adhesive was tested for its ability to occlude the saphenous vein. Ideal venous adhesives should have a high viscosity, prevent embolization, provide adequate contact with the intimal surface, undergo rapid polymerization, remain soft and imperceptible after implantation, prevent recanalization, and require a low dose. A total of 222 patients with symptomatic great saphenous vein reflux were divided into two groups–cyanoacrylate adhesive (108 patients) and radiofrequency ablation (114 patients). The follow-up was performed at 3 days, and at 1, 3, 6, and 12 months postprocedure using duplex ultrasound. Complete vein occlusion was observed after 12 months in 96.8% of the patients administered radiofrequency ablation and in 96.8% of the patients administered cyanoacrylate adhesive. A significantly lower rate of ecchymosis was observed in the cyanoacrylate adhesive group. In conclusion, there is a noninferiority for closure rates using cyanoacrylate adhesive when compared with radiofrequency ablation at 12 months, making cyanoacrylate adhesive a safe and effective method for treating incompetent saphenous veins.

Endovenous treatment of primary chronic venous disease: sclerotherapy

Detergent sclerosants are consumed and deactivated by circulating blood cells and proteins
David Connor, Australia

Initially, a study was presented showing that deep vein thrombosis and systemic side effects are quite low, even if sclerosants enter in the deep veins. Then, a study from David Connor’s center investigating the deactivating effects of circulating blood cells and lymphatic fluid on the lytic activity of detergent sclerosants was discussed. Samples of whole blood, platelet-rich plasma, and isolated leukocytes were incubated with various concentrations of sodium tetradecyl sulphate or polidocanol, and after, they were added to human umbilical vein endothelial cells, which were then counted using a fluorescent plate reader. Full blood counting was performed using a hematology analyzer. Platelet lysis and microparticle formation was assessed using lactadherin binding in flow cytometry.

Detergent sclerosant activity was decreased in whole blood when compared with plasma and saline controls. There was a 23- and 59-fold increase in sclerosant lytic activity on endothelial cells for sodium tetradecyl sulphate and polidocanol, respectively, in saline compared with whole blood. At high concentrations, sclerosants lysed erythrocytes, leukocytes, and platelets. Platelets were more sensitive to the lytic activity of sclerosants than other cell types, but neutrophils were the most susceptible. The presence of erythrocytes and leukocytes decreased the lytic activity of sclerosants. Sclerosants, at all concentrations, induced erythrocyte-derived microparticle formation.

In conclusion, detergent sclerosants are consumed and deactivated by circulating blood cells. This deactivating effect is beyond the neutralizing effects of plasma proteins and contributes to the overall neutralizing effect of blood. Different types of blood cells exhibit varying levels of vulnerability to the lytic activity of sclerosants, with platelets being the most vulnerable and erythrocytes the least vulnerable (platelets > leukocytes > erythrocytes).

Complications of foam sclerotherapy: is it safe?
Kurosh Parsi, Australia

Foam sclerotherapy may result in drug- and/or gas-related complications of a generalized or localized nature. Anaphylaxis and anaphylactoid reactions are serious complications following foam sclerotherapy and may even result in life-threatening anaphylaxis. Anaphylaxis is usually an IgE-mediated type I hypersensivity reaction occurring after reexposure to an antigen, but it can also occur through type II and III hypersensivity reactions. Anaphylaxis is an immune-mediated, dose-independent reaction, whereas anaphylactoid reactions are nonimmune-mediated, dosedependent reactions that result from direct activation of mast cells and complement.

In anaphylaxis, symptoms can be continuous for 5 to 32 hours or they can be biphasic in 20% of patients (symptoms return after resolution of the initial presentation, usually within 1 to 8 hours). Manifestations can be cutaneous (flushing, pruritus, urticaria, angioedema), respiratory (laryngeal edema, dyspnea, wheezing, respiratory arrest), gastrointestinal (nausea, vomiting, abdominal cramping, diarrhea), cardiovascular (tachycardia, hypotension, cardiac arrhythmias, cardiovascular collapse), renal (acute tubular necrosis), and hematological (diffuse intravascular coagulation). Differential diagnosis should be performed with the most common manifestations, such as vasovagal reaction, acute anxiety, hypoglycemia, asthma, and transient ischemic attacks/stroke. Determining the serum tryptase levels in mast cells should be performed 1 to 4 hours after the onset of anaphylaxis to confirm the diagnosis. Additionally, skin testing should be done 4 to 6 weeks after the reaction to confirm the agent because other substances, such as latex, local anesthetic agents, or antiseptic can be involved in the reaction. The initial treatment is an intramuscular injection of 0.5 mg adrenaline (1 mg/mL), which can be repeated every 5 minutes as clinically needed, ventilator support, and IV fluids as needed.

Another possible local complication of foam sclerotherapy is the venoarteriolar reflex (VAR) vasospasm, which can result in skin stellate necrosis. In a VAR vasospasm, a vein is rapidly dilated, resulting in a reflex vasospasm of the associated arteries and arterioles. Vasoconstriction occurs due to an increase in transmural pressure and distension of the veins. VAR vasospasms have three immediate stages: white, red, and blue (where the pathophysiology is similar to the Raynaud phenomenon). It is more likely to occur after rapid injections or if a lumen or dead space within a previously treated vein is being injected. Treatment may include: (i) topical vasodilators, such as topical nitrates; (ii) antiplatelet agents or nonsteroidal anti-inflammatory drugs; (iii) systemic anticoagulants; and (iv) systemic steroids.

Intra-arterial injection is a rare, but potentially destructive, complication of foam sclerotherapy that is less likely to occur when the procedure is performed under ultrasound guidance. The danger areas include the small saphenous artery adjacent to the small saphenous vein, the septocutaneous arteries in the medial thigh and knees, recent case of superficial varicosities that are collateral for an occluded popliteal artery, and true arteriovenous malformations (rare). An immediate intramuscular or intravascular injection of hydrocortisone 100 mg or a subcutaneous injection of enoxaparin 1.5 mg/kg is necessary.

Further information can be found in the following publication: Cavezzi A, Parsi K. Complications of foam sclerotherapy. Phlebology. 2012;27(1 suppl):46-51.

New data supporting safety of foam sclerotherapy
Lorenzo Tessari, Italy

Considering that sclerosing agents are blood inactivated, the interaction between sclerosing agents and blood was investigated to identify blood ligands. First, an electrophoretic assessment of plasma proteins was done to identify the proteins involved in binding sclerosing agents. Blood samples (n=31) were collected from patients with chronic venous disease and tested by capillary and agarose gel electrophoresis. The electrophoretic runs were performed with the addition of polidocanol or sodium tetradecyl sulphate. A second investigation was then performed to identify the binding strength between the plasma proteins and sodium tetradecyl sulphate after sclerotherapy. Free sodium tetradecyl sulphate and total protein-bound sodium tetradecyl sulphate were measured. Patients undergoing saphenous vein sclerotherapy (n=6) were divided into two groups. In group A (4 patients), a blood sample was obtained from the brachial vein before injecting a 3% sodium tetradecyl sulphate solution into the great saphenous vein (T0). Blood samples were obtained at 1, 3, 5, and 10 minutes postinjection. In group B (2 patients), the procedure was performed with the same method, but on the ipsilateral femoral vein.

Polidocanol mainly binds to β-globulins, while sodium tetradecyl sulphate binds to albumin and α-globulins. In the brachial vein, the average protein-bound sodium tetradecyl sulphate concentrations were 0, 0.568, 5.98, 6.91, and 7.2 μg/mL at T0, 1, 3, 5, and 10 minutes, respectively, and the free sodium tetradecyl sulphate concentration was 0 μg/mL. In the femoral vein, the average protein-bound sodium tetradecyl sulphate concentrations were 0, 1.62, 13, 24.6, and 8.67 μg/mL at T0, 1, 3, 5, and 10 minutes, respectively, and the free sodium tetradecyl sulphate concentration was 0 μ g/mL.

The origin of the sclerotherapy complications could not be linked only to the direct drug effect along the systemic circulation. High productions of endothelin-1, histamine, and serotonin after foam sclerotherapy could be responsible, at least in part, for the neurovascular, respiratory, and visual disturbance complications.

Balloon control of the saphenofemoral junction during foam sclerotherapy
Nick Morrison, USA

The following questions were addressed during the talk: (i) what happens to foam when it is injected into a leg vein?; (ii) is it necessary to occlude the saphenofemoral and saphenopopliteal junctions during foam sclerotherapy of calf tributaries?; and (iii) are we trying to prevent active sclerosant, foam, or vasoactive compound dispersal with an occlusive balloon?

Some have advocated balloon occlusion of the saphenofemoral junction during foam sclerotherapy to prevent foam from entering the deep vein system. The idea that such a maneuver might be successful is simply not justifiable in the author’s point-of-view. In fact, his group performed intraoperative duplex examination of the deep vein system, simultaneous transthoracic echocardiography, and transcranial Doppler monitoring during injection, demonstrating that foam progresses not only into the deep vein system, but into the central circulation and indeed into the cerebral circulation in some patients with right-to-left shunts (estimated to be >25% of the normal population).

Further, occlusion of the proximal saphenous vein, rather than preventing progression of foam into the deep vein system, actually encourages flow into the deep vein system, because it is prevented from gradually progressing through the saphenofemoral junction and is forced into perforator veins. Additionally, after releasing the balloon, there will be an immediate bolus of foam entering the deep vein system, which progresses to the heart. It is more likely that a bolus of foam will be degraded less quickly than smaller amounts, and it will more likely progress through a right-to-left shunt, such as a patent foramen ovale, than smaller amounts that will gradually migrate to the heart following foam injection of a nonoccluded great saphenous vein. It is precisely for this reason that an occlusion balloon–tipped catheter is rarely used. Finally, using simultaneous transthoracic echocardiography and/or transcranial Doppler monitoring of the middle cerebral artery during ultrasound-guided foam sclerotherapy, it has been shown that using any of the suggested methods to prevent migration of some foam bubbles from the injected superficial vein into the deep vein system and beyond (eg, leg elevation, small volume of foam, postinjection rest) is simply ineffective. Complications, such as deep vein thrombosis and systemic symptoms, will continue to occur at a certain rate, even if the values are low. Meanwhile, there are still insufficient data to determine the role of differing methods of foam production, different gases, volume restriction, type of veins being treated, and possible measures to eventually avoid complications.

Prevention of visual and neurologic disturbances after sclerotherapy
Alessandro Frullini, Italy

Neurological disturbances occur at an average rate of 1.4% (0% to 14%).1 A possible cause of sclerotherapy complications may be due to the release of vasoactive molecules from the damaged endothelium, such as endothelin-1.2 Endothelin-1 is associated with retinal vasospasms, migraines, and cerebral ischemia. Neurological complications may be more frequent with foam sclerotherapy due to a longer and more efficient induction of endothelium injury.3 Consequently, the anti–endothelin-1 action of aminaftone in an animal model was investigated. Three groups of rats were treated with polidocanol sclerotherapy alone (group 1) or with 30 mg/kg/day and 150 mg/kg/day of aminaftone 15 days before sclerotherapy with polidocanol (group 2 and group 3, respectively). Rats showed an early mortality rate of 40%, 13.3%, and 20% in group 1, group 2, and group 3, respectively. After pretreatment with aminaftone, the cellular release of endothelin-1 was significantly lower after 6 (P<0.01) and 12 hours (P<0.05) compared with controls. As a result of this experimental study, the PROCOMET study (PRevention of neurOlogiCal and visual disturbances after sclerOtherapy with aMinaphtonE prophylacTic measures), to evaluate the potential influence of aminaftone on reducing neurological disturbances after sclerotherapy of telangiectasias in humans, was started. The preliminary results confirm that aminaftone may reduce neurological disturbances and support further inclusion of patients.

1. Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C. Systematic review of foam sclerotherapy for varicose veins. Br J Surg. 2007;94:925-936.
2. Frullini A, Felice F, Burchielli S, Di Stefano R. High production of endothelin after foam sclerotherapy: a new pathogenetic hypothesis for neurological and visual disturbances after sclerotherapy. Phlebology. 2011;26:203-208.
3. Frullini A, Barsotti MC, Santoni T, Duranti E, Burchielli S, Di Stefano R. Significant endothelin release in patients treated with foam sclerotherapy. Dermatol Surg. 2012;38:741-747.

Endovenous treatment of primary chronic venous disease: thermal ablation

Endovenous thermal ablation technique

Today, endovenous laser ablation and radiofrequency ablation are the standard treatments for varicose veins. In many countries, surgical methods have been completely replaced by these techniques; however, many controversies on their clinical effects remain. Published studies have reported very different technical (ie, occlusion rates) and clinical (eg, frequency of varicose vein recurrence) results. The possible reasons for this discrepancy could be related to using slightly different methodologies and/or to the skill level of the operator. The goal of this symposium was to learn some tips and tricks from colleagues who have extensive experience in this field.

Imre Bihary (Hungary) presented a technique that was introduced and developed by a group of colleagues from Hungary, Slovakia, Serbia, and the Czech Republic. Their endovascular method involves placing the laser tip no further than 0.5 cm from the femoral vein, using a high linear endovenous energy density (LEED) of 100 J/cm, thoroughly compressing the saphenofemoral junction with a cooled anesthesia (40°C), and treating insufficient perforators at the same time. With this method, the reported recurrence rate was 2.3% over 5 years.

Uldis Maurins (Latvia), a well-known supporter of endovenous laser ablation, recommended conducting ablation procedures with a 1470 nm laser and a 10W power LEED (=vein diameter x 7 for a radial two-ring fiber), placing the tip as close to the saphenofemoral junction as possible, and performing cooled tumescent anesthesia. He does not use compression after the procedure and advises waiting 3 months before treating tributaries of the ablated trunk because they may almost disappear. A 96% occlusion rate has been reported at 1 year.

Kürşat Bozkurt (Turkey) discussed the good results that can be achieved by both laser ablation and radiofrequency ablation and a possible role for a new method of glue ablation that has generated promising early results which look quite promising. Juan Antonio Orrego (Chile) discussed how to obtain excellent results with ablation techniques and stated that precise mapping with duplex ultrasound before thermal ablation and a good awareness of the different variants of the superficial venous network are necessary.

The patient’s opinion of outcomes 1 year after endovenous laser ablation of the great saphenous vein
or small saphenous vein

Anders Lundell, Sweden

In this study, the patients’ opinion on the outcomes after undergoing endovenous laser ablation at the Venous Centre in Malmo, Sweden were registered anonymously and separately on a touch screen by the patient using a web-based program. From January 1, 2013 through December 31, 2013, 1086 patients were treated with endovenous laser ablation, and in most cases, simultaneous phlebotomies were made under light sedation and tumescent anesthesia. The follow-up appointment was attended by 87% of the treated patients (749 women and 337 men). A total of 42.7% of patients were classified as C2 according to the clinical, etiological, anatomical, pathological classification, 8.9% were C3, 34% were C4, 3.5% were C5, and 3% were C6. At 1 -year posttreatment, 92% of patients described a significant reduction in their symptoms, 7.5% felt the same, and 5% felt worse. The discrepancy between ultrasound data and patient survey data could indicate that patients’ expectations regarding the treatment result were not met in 8% of patients 1 year after the endovenous laser ablation, which highlights the need to perform a thorough preoperative examination and gather the patient’s information.

Cryolaser and cryosclerotherapy (CLaCS) guided by augmented reality to treat telangiectasias, feeder
veins, and small varicosities: a 10-year experience

Kasuo Miyake, Brazil

A new technique to treat the combination of telangiectasia and the associated causative reticular veins (“feeder veins”) of the leg (CLaCS – Cryo Laser Cryo Sclerotherapy) was presented. The CLaCS technique employs the following features: (i) augmented reality viewing of the feeder veins; (ii) application of transdermal laser energy to the feeder veins and overlying telangiectasias; (iii) injection of the feeder veins and surface telangiectasias with a sclerosant; and (iv) skin temperature protection and numbing of the skin with application of cold-air flow throughout the procedure. Photodocumentation was performed before and after the procedure in all patients.

A 1064 nm Nd:YAG transdermal laser was set to a 6 mm spot size, an average fluency of 70 J/cm2, and a 15 ms pulse width. The laser was then directed at the feeder veins, which were identified through augmented reality (VeinViewer), and the overlying and nearby telangiectatic vessels. Feeder-vein sclerotherapy was then performed, with telangiectatic vessels being injected with a sclerosing solution containing 75% dextrose.

This method does not result in anaphylaxis or skin ulcers due to the high viscosity of the dextrose solution. During the 10 years of using this procedure, hyperpigmentation was as low as 0.48% due to the synergy between the thermal lesion and the osmotic lesion, and burning was rare (0.24%) due to the low-energy fluency. The laser damages the endothelium and causes edema and internal diameter reduction. The edema generates a trapping effect for the dextrose solution, which leads to a longer contact time between the sclerosant and the vein; thereby, resulting in an increase in the effectiveness of sclerotherapy and a reduction in the rates of pigmentation. There was a 75% average clearance after two sessions.

There is a synergy between the CLaCS technique and augmented reality because the dextrose effect is increased by the laser thermal damage. This synergistic effect leads to less clot formation and less hyperpigmentation. Thus, the CLaCS technique for treating telangiectasias of the legs appears to be superior to both sclerotherapy and laser ablation. Visualization and treatment of feeder veins are important for producing optimal resolution and preventing recurrences.

Effect of topical lidocaine and prilocaine cream on pain scores for endovenous laser ablation (EVLA) as
an outpatient procedure

Ranjish Vijayan, India

An innovative anesthetic technique in patients undergoing endovenous laser ablation under tumescent anesthesia was presented. The effect of topical Toplap® cream (eutectic mixture of 2.5% lidocaine and 2.5% prilocaine) was tested using pain scores. A total of 100 consecutive varicose vein patients requiring laser ablation for truncal veins were included in the study. Topical Toplap® cream was applied 60 to 90 minutes prior to the procedure over the whole length of the vein to be ablated and over the superficial varicosities planned for hook phlebectomy. Endovenous laser ablation and hook phlebectomy were performed under tumescent anesthesia. A total of 78% of the patients underwent both hook phlebectomy and endovenous laser ablation. The pain score was analyzed using the visual analogue scale immediately postprocedure, with an average pain score of 2.72. During a postprocedural questionnaire, all patients indicated that they would opt for endovenous laser ablation under the same type of anesthesia if they needed the procedure for the other limb. The use of a topical anesthetic cream during endovenous laser ablation under tumescent anesthesia appears to reduce the pain score and improve patient’s acceptance of the procedure.

Steps to avoid nerve damage during endovenous laser ablation for the small saphenous vein
Jean-Luc Gerard, France

Detailed anatomic data on avoiding nerve damage during endovenous laser ablation for the small saphenous vein were presented. In fifteen studies on the treatment of small saphenous vein reflux using endovenous laser ablation, paresthesia rates between 1.6% and 11% (mean, 4%) were observed, which were exclusively related to lesions in the sensory fiber, but were not related to lesions in the nerve motor. Mapping the nerves along the path of the small saphenous vein is very important to avoid nerve damage, and it is also highly recommended to mark the saphenous popliteal junction using duplex scanning prior to surgery. It is recommended to use only local tumescent anesthesia with or without light sedation, as the patient should be conscious, but never general anesthesia or spinal anesthesia. Finally, the lower one-third of the leg should be avoided.