Servier – Phlebolymphology

VARICOSE VEINS
Surgery
Chronic venous insufficiency – surgery

Chairpersons: H. A. Maffei (Brazil), J. P. Albino (Portugal)

Transilluminated miniphlebectomy
A. J. C. FLOR (Austria)

Reduction in:
– unnecessary manipulation
– bleeding
– lesion of lymphatic vessels
– sensitive skin nerves
– operation time
can be achieved by means of transilluminated miniphlebectomy.
The veins were visualized by insertion of the light rod into the subcutaneous tissue, and removed by means of Varady’s hook. The light rod, with an oblique tip, was equipped with an exit for light fibers and a canular opening for the saline flow solution. Miniphlebectomy following hydrodissection was performed by incision at the marked perforating veins and crossing. The author emphasized the importance of quicker recovery time and better cosmetic results.

Segmentary ambulatory saphenectomy
G. CHAVEZ REYES, S. J. CHIRINOS CARAZA (Peru)

New surgical approach to varicose veins: color duplex evidence base
C. PEREIRA ALVES, J. NEVES, L. MONIZ (Portugal)

Color duplex ultrasonography is the “gold standard” in varicose vein diagnostics. According to this method, modern surgery should remove the incompetent vein segment and junctions, preserving the competent ones. C. Pereira presented early results of the surgical approach of the great saphenous vein (GSV) primary varicose veins. He suggested classic surgery only in saphenofemoral junction (SFJ) reflux plus truncal GSV reflux. In the segmental trunk, GSV reflux without SFJ reflux suggested no ligation of SFJ and tributaries. Segmental varicose branch avulsion in vein reflexive branches were performed. The authors presented promising results, but they emphasized the need for longer follow-up.

Alternative treatment of reflux of the long saphenous vein by crossectomy and microfoam injection through a multipurpose catheter
M. D. ANDRÉS, W. VERBERCK (Argentina)

Crossectomy with a 3-cm extirpation of the great saphenous vein (to reduce the possibility of neoangiogenesis) and introduction of a hydrophilic catheter with a Terumo quide into the distal trunk were performed. According to the Tessari method, microfoam was injected through the catheter so that the microfoam was distributed regularly. In the ultrasound control performed between 30 and 90 days, a total obliteration was observed in 90% of patients. In the clinical follow-up and Doppler ultrasound of 23 patients, no recurrences were seen for a year. The most dangerous complications were: varicophlebitis in two cases and hematoma in one case. The authors emphasized the possibility of controlling a frequent and progressing disease with this method, which is easy and economical.

Outcome of internal valvuloplasty with additional procedures for chronic venous insufficiency
N. HAYASHIDA, N. YAJIMA, H. MURAYAMA, K. MATSUO, H. KITO, S. ASANO, M. YANAI, M. YAMAMOTO (Japan)

The purpose of this study was the evaluation of the outcome of internal valvuloplasty with additional procedures for chronic venous disease. Valvuloplasty with additional procedures (high ligation and stripping of large saphenous vein, etc) were performed in 30 limbs of 28 patients with CVI. The indication for the valvuloplasty was reflux of the femoral vein valve above grade III assessed by means of descending venography. Deep vein thrombosis occurred in two limbs on the 14th day after the operation. All patients received oral warfarin preventatively for one month.
Internal valvuloplasty with additional procedures is an effective treatment option for primary chronic venous insufficiency. However, postoperative deep vein thrombosis should be prevented by antithrombotic therapy.

The crochet needle: three decades as a surgical instrument in varicose vein surgery
T. TAKAYANAGI (Brazil)

Although the crochet needle has been used as a surgical instrument in varicose vein surgery for three decades, it still provides excellent benefits for vascular surgeons in terms of surgical dynamics, as well as aesthetics, obtained in the surgical treatment of varicose veins. The crochet needle is such a valuable tool that it has not been replaced by any other instrument.

Curettage of subcutaneous tissue in the treatment of spider-web telangiectasias
T. TAKAYANAGI (Brazil)

The etiologies of spider-web telangiectasias are: vascular dilatation secondary to estrogen and progesterone hormonal alterations, cellulites, phlebitis, trauma, and pregnancy, as well as shunt opening of micro arteriolar-venous fistulae. The author suggested removal of the feeding vein located by Doppler ultrasound or by decompression of the point where the feeding vein is located and rapid recanalization of the telangiectatic network. Through the same incision, the crochet needle was inserted to perform the curettage of the adjacent subcutaneous tissue or breaking any eventual residual branches. The author concluded that this procedure is incomparably more efficient that any other method.

Endoluminal treatment

LECTURE

1320 nm endoluminal laser treatment of the great saphenous vein: 2-year follow-up
M. GOLDMAN (USA)

The author described his experience with 810 nm endovenous laser closure devices, observing that there was a high incidence of pain and perforation of the vein walls, which caused ecchymosis. For this reason he experimented with the new 1320 nm endoluminal laser which is not absorbed by blood and permits little perivascular heat transmission, preventing perforation of the vein. He presented his experience with 95% venous closure after 1-year follow-up, and good cosmetic results.

Endovascular techniques for treatment of varicose veins

In the framework of the Joint Symposium UIP/Italian College of Phlebology (ICP).
Chairpersons: G. Genovese (Italy), S. Mancini (Italy)

This session consisted of a number of presentations from several countries, dealing with the value of endovascular techniques in the treatment of varicose veins. The experience and results from the last 5 years suggest that these minimally invasive procedures have the same efficacy as conventional surgery with less complications. At the end of the session there was general agreement that randomized controlled studies are needed.
G. Magi from Italy presented data from a personal experience of 120 procedures (111 great saphenous vein, 6 anterior saphenous veins, and 3 short saphenous veins) of venous obliterations using laser; 90% of veins remained occluded at 24 months.
G. Botta presented the data from the Italian endovenous laser register that was created in 2004 with 1076 procedures (77% female and 23% male; mean age 55 years; CEAP class 2-59%, class 3-19%, class 4-17%, class 5-1% and class 6-4%; GSV diameter <10 mm 67% by duplex assessment; surgical (61%) and percutaneous (39%) access to GSV) using laser 980 nm (power 12 watts, pulse 1 sec and interval 1 sec). The most frequent adverse effect was ecchymosis (40%) with no reports of DVT or hematoma. The conclusion was that this new technique has the same benefits of the surgery, with a lower rate of complications.
Based on the experience of using different levels of energy with ELVeS 980 nm, J. L. Gerard from France was able to give the following advice: a high rate of recanalization can be caused by inadequate energy, and so we must use a minimum energy of 40 joules/cm, calculate the energy before beginning, increase time rather than power, and use continuous mode instead of pulse mode. However, if more than 75 joules/cm are used there is an increased risk of paresthesias or pain. He also concluded that anticoagulation treatment is not a contraindication and does not affect the results, and duplex scan examination must be done before and during all the procedure.
E. Rabe from Germany presented the preliminary data (89 patients; 62 female; 67 GSV and 22 SSV; mean age 55.5 years) from the Bonn study (to evaluate endovenous laser in the treatment of the saphenous veins) and a review of the literature. He concluded that the advantages of this technique are: puncture of the vein with no groin incision, short recovery time, good short-term results, few side effects, minimally invasive with local anesthesia, improvement of QoL, high patient satisfaction, less time-consuming, and done on an outpatient basis. The disadvantages can be: cannulation not always possible in pretreated or tortuous veins, local pain in the first week, ecchymosis in the majority of patients, DVT rate 1%, additional treatment of branches is necessary, costs (comparable with surgery, cheaper than RF, but more expensive than foam schlerotherapy), poor standardization with results of occlusion rate depending on the energy applied (J/cm), sufficient publications only on GSV, no multicenter prospective randomized and comparative studies available.
The purpose of the presentation by L. S. Kabnick from the USA was to look at data using minimally invasive devices which were approved as early as 1999 for the ablation of the saphenous vein.
Analysis of 4-year radiofrequency (RF) data revealed a cohort of 916 patients (1120 limbs) treated. Clinical results revealed reflux free GSV at 1 year 89%, 2 years 88%, 3 years 86%, and 4 years 86%. Complications from RF treatment were: pulmonary embolism 0.1%, deep vein thrombosis 1%, skin burns 0.8%, infection 0.2%, paresthesia at 1 week 12.3%, and 2 years 4.9%.
Single center reports regarding laser reveal GSV closure rates from 93% to 99% with cumulative spawning 1 to 4 years. In the personal experience (275 cases) of the author there was no pulmonary embolism, skin burns, or infections and in most patients bruising disappeared within 2 weeks.
The author concluded that, presently, although not widely used, laser appears to be more efficacious in controlling venous reflux. RF causes less discomfort and bruising than laser. Laser, when used in the continuous mode, causes less bruising and discomfort than previously reported by pulse mode. In contrast, RF is more complex to use in terms of setup, catheter-char accumulation, catheter cost, catheter pullback time, and total procedural time. Finally J. FERREIRA from Brazil presented the results of a multicenter, open, retrospective, nonrandomized review, using two wavelength lasers for procedures (810/980 nm) in continuous and pulsed mode. These data, from Argentina, Brazil, Chile, Ecuador, and Peru, are based on a total of 4755 GSV treated in 3169 patients, with no reports of serious complications, and a high index of functional and cosmetic success, minimal discomfort and high satisfaction scores. There were no differences when using 980 or 810 nm lasers, and there was no consensus on whether to do a concomitant crossectomy or not.

Prospective randomized study of endovenous radiofrequency obliteration (Closure®) versus ligation and vein stripping (EVOLVeS study): 2-year follow-up
In the framework of the Symposium of the German speaking phlebological societies of Austria, Germany, and Switzerland.
S. SCHULLER-PETROVIC (Austria)

This prospective multicenter study included 85 patients (86 limbs) with great saphenous vein (GVS) incompetency. They were randomily allocated to undergo radiofrequency obliteration of the GSV without adjunctive high ligation or stripping and high ligation, of the GSV. Sixty patients were re-examined at 2 years. At 2 years, the number of patients without any reflux in the GSV was not significantly different between the 2 groups (91.2% in the radiofrequency group versus 91.7 % in the surgery group). In two patients, recanalization of the GSV occured after initial occlusion. Prevalence of neovascularization was 2.9% in the radiofrequency group and 16.7% in the surgery group (NS). No significant difference was noted for presence of varcicose veins between the two groups (14% in the radiofrequency group versus 21% in the surgery group). Analysis of the quality of life surveys showed statistically significant differences in favor of radiofrequency (global score and pain score) at 1 week and 4 months that persisted at 2 years.

References:
– Lurie F, Creton D, Eklof B, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up. Eur J Vasc Endovasc Surg. 2005;29:67-73.
– Lurie F, Creton D, Eklof B, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and vein stripping in a selected patient population (EVOLVeS study). J Vasc Surg. 2003; 38: 207- 214.

State of the art on endo- laser vein treatment: “the light and the end of the tunnel”

Chairpersons: J. Ferreira (Brazil), L. Kabnick (USA)
Moderators: A. Scuderi (Brazil), E. Rabe (Germany)

With the participation of:
G. SPREAFICO (Italy), D. KONTOTHANASSIS (Greece), D. GREENSTEIN (UK), J. GERARD (France), F. PANNIER-FISCHER; E. RABE (Germany), M. DURAN (Ecuador), W. LAHL (Germany), S. GOCKERITZ (Germany), L. KABNICK (USA)

Laser light is absorbed by two chromophores, hemoglobin in the blood and water in the venous wall. The spectrum of water absorption is not the same for all laser lights. Using 980 nm laser light, 99.4% of water is absorbed in a volume of 1 mL of blood. Laser light absorbed by blood is transformed into heat. High temperature at the optic fiber tip carbonizes the blood, and water changes into steam and absorbs the heat that keeps the temperature at the tip stable around 100°. This is called “steambubble formation.” Laser light results in contact damage (coagulation and vaporization of the vein wall, perforations) and no-contact damage caused by the diffusion of heat throughout the vein. Different wavelengths from 810 nm to 1320 nm create this effect, and are used in endolaser treatment.
This session presents the ELVeS procedure which uses a 980 nm laser light (Biolitec).
The ELVeS kit consists of a 600 micron optic fiber, a 5 Fr introducer sheath, 0.035” J guide wire and a 18-19 Gauge needle. The step-by-step instructions were as follows:
– Preoperative duplex echography study
– Percutaneous entry into the vein
– Introduction of the J guide wire
– Withdrawal of the entry needle and insertion of the dilatator and introducer sheet
– Removal of dilatator and guide wire introduction of the laser fiber
– Positioning of the end of the fiber 1 cm below the inferior epigastric vein
– Perivenous anesthesia inside the “Egyptian Eye”
– Laser energy delivery in a pulsed withdrawal of 2 to 3 mm or continuous withdrawal of the fiber (the importance of fine tuning in real time with Computer-Assisted Control of the pullback speed was demonstrated by S. Gockeritz (Germany). Energy delivery of 60 to 80 Joule/cm is necessary to have a persistent occlusion of the treated venous segment. Vein occlusion by bandage or local compression is not necessary, because vein occlusion is preferentially caused by hemoglobin- mediated absorption and to a lesser degree by vein wall shrinkage.
Perivenous anesthesia or tumescence was believed to prevent skin burns and paresthesiae from nerve lesions, W. Lahl (Germany) demonstrated, in his study, no difference in thermic skin damage between patients treated with or without tumescence by placing a temperature probe at the outer venous wall.
The endovascular laser can be successfully used in the treatment of insufficient greater and smaller saphenous veins, Giacomini veins, recurrent varicose veins, and perforating veins. Positioning of the fiber tip in the insufficient vein at the level of venous ulcers stimulates wound healing. ELVeS treatment gives the best results in combination with completion phlebectomies. The success rate for the vein ablation ranges from 90% to 95%.
We have to accentuate the importance of a good knowledge of Duplex echography as a preoperative tool (hemodynamic diagnosis, vein diameter, defining where the reflux begins and where it disappears), operative tool (positioning of the fibertip below the epigastric vein) and postoperative tool (follow-up).
A large number of complications can be avoided by a good technique (venous puncture, duplex knowledge). Most frequent complications are ecchymosis (75%), paresthesia (3%), superficial phlebitis (1.87%), burns (0.46%), inflammatory pain during the first week, and induration of the treated vein. Rather rare complications are deep venous thrombosis, pulmonary embolism, infection, major bleeding, and arteriovenous fistula formation.
The endolaser technique has been found to be easy, efficacious, and safe. The outpatient setting and the very short period of convalescence open new prospects in terms of health care and social costs. The further organization of International Endovascular Working Groups is important to obtaint answers to many phlebological questions (long-term results, final standardization of the endolaser procedure, antiocoagulation strategy) and for the results to be collected in a homogeneous and comparable manner.

Sclerotherapy

LECTURE

Foam sclerotherapy in the treatment of varicose veins: state of the art

S. SADOUN (France)

The use of sclerosing foams (SF) for the treatment of varicose veins has become widespread and is becoming more popular, since more and more colleagues are becoming familiar with this treatment. Most of the recent publications and personal experiences indicate that foam sclerotherapy (FS) gives better results in comparison with classical liquid sclerotherapy (CLS) in larger veins. Some literature tends to indicate an increased rate of undesired side effects if foam is used, such as phlebitis, visual disturbances, and others. Some of these side effects are likely to have been caused by high volumes of foam, whereas for other side effects, the reasons are not known. Interestingly, very little attention is paid to the foam used itself. One hypothesis for the development of side effects is that eventually some of them are caused by the type of foam, which implies a closer look at the foam with regard to its standardization. A useful characterization of SF is provided by the European Consensus Conference on Foam Sclero-Therapy (ECCFS), where SF has been defined by (at least):
1. type and concentration of the sclerosing agent
2. type of gas
3. ratio of liquid to gas
4.the method of preparation
5.the time between processing and use
6. bubble sizes.
With the choice of using one of two major sclerosing agents, one of 6 possible concentrations (0.25%, 0.5%, 1%, 2%, 3%, 4%), and one of 3 commonly used ratios of liquid and gas (1 plus 3, 1 plus 4, or 1 plus 5), already as many as 36 different foams may be generated. The choice of materials and the technique used for foam preparation increases this number to approximately 6000. In addition, the time between processing and use, the method of foam administration (cannula/ needle/ catheter), and injection speed rises the number of different possibilities to the enormous number of >100 000, not to mention differences in puncture sites and foam volumes administered to individual patients. It is the author’s opinion that standardization of foam preparation and administration would greatly help to make clinical results (more) comparable, and may eventually help to increase efficacy, while eventually lowering the rate of side effects at the same time. Different parameters were systematically checked, and the parameters for obtaining the “best” foam (eg, the best stability) were identified, leading to a proposal for a standardization of sclerosing foam and for its use, which will be presented.

Sclerotherapy

In the framework of the joint round table UIP/Panamerican Society of Phlebology and Lymphology.
Chairpersons: N. Rosli (Argentina), S. Gomez (Brazil), D. Otrante
(Cuba), M. Musich (Argentina)

This session consisted of a number of presentations, mainly from Argentina, dealing with the value of different techniques of sclerotherapy (ST) in the treatment of varicose veins (VV).

U. P. Tropper, from Fundación Flebológica Argentina, reported the experience from nine centers with over 300 000 patients treated with ST and combined approaches (high ligature, post-sclerotherapy phlebo-exeresis, safety angle of 45º, physical sclerosis by a foreign body) over the last 5 years. He mentioned that the action of a sclerosing substance depends on the type and concentration of the agent, the exposure time, and the vessel size. He also gave his personal point of view on the treatment of large VV with minimum doses of sclerosant by means of the microfoam technique. More than 300 cases were treated using hydroxypolietoxi- dodecane 0.5%, injected via catheter at the safety angle, and the results were satisfactory in 59% with one application. It was necessary to perform two applications in 32% of the cases, 3 in 6% and 4 in 3%. He concluded that the optimal results obtained with the microfoam technique, coupled with the fact that the usual complications of liquid sclerosing agents are minimized, suggest this technique may be more advantageous than surgical approaches in the future.
E. Tkach related his personal experience with the use of ST with turbulence (injection of 15 to 20 cm3 of foam and immediate suction, procedure repeated 4-5X with echo-color Doppler visualization).
J. Sas focused his presentation on the more frequent sclerotherapy complications and possible forms of their treatment: pigmentation, cutaneous necrosis, temporary edema, pain, thrombophlebitis, allergic rections.
A. Avramovic reported the results of a retrospective study in 1032 patients between 68 and 90 years. The used solutions for ST were: hydroxypoliethoxidodecane from 0.5% to 3%, tetradecyl sodium sulphate from 0.5% to 3%, and glucose solution at 25%. It was practised in both GSV and SSV, isolated VV, reticulate and telangiectasias, with 80% of cases treated with a positive evolution. He concluded that ST is a very important weapon in the therapeutical arsenal for elderly people.
Finally, J. Chunga-Chunga, from Peru, gave his personal point of view about the importance of immediate elastic compression after ST.

Chronic venous insufficiency Conventional sclerotherapy

Chairpersons: J. Strejcek (Czech Republic), M. E. R. Castro (Brazil), H. Guedes (Brazil)

Antithrombotic potential of sclerosants: in vitro effects on coagulation, red cells, and platelets
K. PARSI, T. EXNER, D. D. F. MA, E. JOSEPH (Australia)

In this excellent presentation the authors tried to answer the question of whether the most commonly used detergent sclerosants: sodium tetradecyl sulphate (STS) and polidocanol (POL) cause haemolysis, platelet lysis, or prolonged clotting time when added to whole blood, platelet-rich plasma, and platelet-poor plasmas.
They stated that low concentrations of sclerosants have procoagulant activity because:
– they shorten phospholipid-dependent clotting tests such as NAPTT (non-activated clothing time), XACT (factor Xa- activated clotting time)
– they damage platelet membrane expressing procoagulant phospholipids
– they release procoagulant platelet-derived microparticles.
Very low concentrations of sclerosants achieve procoagulant activity with increased exposure time, and this may justify immediate walking after sclerotherapy to minimize exposure of deep veins to low concentrations of sclerosants.
High concentrations of STS dissolve and inactivate the procoagulant phospholipids and additional lysis of microparticles. STS has potent anticoagulant activity when compared with POL, and this may justify modification of the technique to use multiple injections of low volume and high concentration of sclerosants, rather than infusion of large volumes which, via dilution and neutralization may achieve procoagulant acivity.

Is there a need to standardize the preparation and the use of sclerosing foam?
J. C. WOLLMANN (Germany)

The use of sclerosing foam was standardized in 2003 by Breu and Guggenbichler. The type and concentration of the sclerosing agent, type of gas, ratio of liquid to gas, and the method of preparation were described. Nevertheless, sclerosing foam preparation is still subject to multiple choices. The author suggested defining very accurately:
1. The syringe sizes
2. Needle sizes
3. Sterile gas volume
4. Number of movements
5. Power of movements
6. Speed and duration of movements.

Risks and complications of sclerotherapy
M. VANDENDRIESSCHE (Belgium)

Leg vein polidocanol foam sclerotherapy in patients over 75 years
G. BROCHNER, M. HERRERA (Argentina)

Sclerotherapy is an effective and safe method of treating veins. Complications are rare, but can be severe. There can be the following most dangerous complications: allergic (urticaria, bronchospasm, anaphylactic shock) and thromboembolic (intravenous clot, superficial thrombophlebitis, deep vein thrombosis, pulmonary embolism).
Even persons over 75 years with chronic venous insufficiency can benefit from foam sclerotherapy. Brochner obtained good results with high selection criteria without patient immobilization. He considered this method especially useful in patients with bleeding varicose veins.

Evidence of arterial venous malformation theory on telangiectases development
I. BIHARI, E. MAGYAR, A. MURANY (Hungary)

The aim of the study was to characterize the differences between the circulation of the spider veins and the surrounding skin, as well as to assess what has a greater influence on their circulation, perforator vein insufficiency or arterial venous (AV) fistula. Biopsy and histological examination was performed from Doppler pulse-positive sites in 19 cases. Laser Doppler flowmetry was used to detect the flow in normal skin and spider veins in 22 limbs of 19 patients. At places where Doppler instrument could detect arterial pulse, AV malformations were found in 16 out of 19 cases. The flow in spider veins was 1.8 times faster on average than in the surrounding skin. The authors concluded that:
1. Higher flow in some spider veins suggests anopen AV shunt
2. Histologically found shunts were open
3. Not every spider vein is connected to an open AV shunt
4. Higher flow is more frequent than congestion
5. It is supposed that these are normal skin AV shunts, which are diseased because of trauma, estrogen therapy, hereditary disposition, or high venous blood pressure.

Advances in sclerotherapy and postsclerotherapy compression: “my way and my practice”

Chairperson: M. Goldman (USA)

Echosclerotherapy using Tessari foam: the Australian Experience
P. THIBAULT (Australia)

The author demonstrated an Australian method of echosclerotherapy of the incompetent trunk of the greater saphenous vein, using Tessari foam. A total of 1019 patients treated with foam echosclerotherapy over a 4-year period from 2000 to 2004 were analyzed for occurrence of adverse effects. The results were compared with those of 820 patients treated with liquid echosclerotherapy. The author concluded that foam sclerotherapy is safe and effective method for the treatment of incompetence of the greater saphenous vein with a low rate of complications compared with liquid sclerotherapy.

Efficacy of lauromacrogol foam vs liquid in sclerotherapy of the greater saphenous vein: a 2-year follow-up
P. OUVRY (France)

Patients with great saphenous vein (GSV) reflux with a diameter ranging from 4 to 8 mm were randomized to 3% aetoxisclerol solution (n=48) and the same volume of foam containing one fifth 3% aetoxisclerol and four-fifths air (n=47). Patient characteristics and vein diameter were similar in both groups. At 3 weeks foam sclerotherapy was superior to liquid in the complete elimination of reflux: 40/47 vs 17/48, P<0.001. There was no difference in the incidence of complications. At 6, 12, 18, and 24 months foam was superior to liquid. It was concluded that foam was twice as effective as the liquid.

Advances in sclerotherapy and postsclerotherapy compression: “my way and my practice”
P. COLERIDGE-SMITH (UK)

The author presented his technique of foam sclerothrapy. Tessari foam was used. The greater saphenous veins were cannulated under local anaesthesia with the patient in a supine position. The spread of the foam were controlled with ultrasound imaging. It is very important to prevent wicking of the sclerosant into the deep venous system by elevation of the limb and intensive exercises of the ankle joint. Just after sclerotherapy, a strong compression bandage was applied.

Post-foam sclerotherapy and post-varicose vein surgery compression
A. CAVEZZI (Italy)

Eighty patients were included in this study. Medical compression stockings (Struva 23 or Struva 35) were applied just after surgical operation or foam sclerotherapy. A good result was achieved in all cases. Compression stockings have demonstrated a high resting pressure in comparison with bandages, which had a higher working pressure. The author concluded that compression stockings (Struva 23 or Struva 35) after operation or sclerotherapy can be widely used, but with some limitations, such as obese patients or very large varicose veins.

The use of a microbubble contrast agent in the early assessment of foam sclerotherapy
P. RAYMOND-MARTIMBEAU (USA)

Three weeks post-treatment, 172 patients with 202 apparently sclerosed greater saphenous veins treated with intravenous injection of foam (ratio 4:1) sodium tetradecyl sulfate (1%, 4 mL) were evaluated with contrast-enhanced imaging after intravenous injection of microspheres of human albumin perflutren microbubble contrast agent. The lumen was evaluated 30 seconds after initiation of contrast agent injection. To evaluate the perfusion of the lumen, intermittent compression of the vein with the probe was performed. The results of contrast-enhanced imaging were compared with those of non-contrast imaging in terms of the presence or absence of visible residual flow within the lumen. Images were assessed qualitatively by two independent observers to determine the contrast enhancement effect. As a result, in 124 (61.4%) of the 202 treated incompetent greater saphenous veins, contrast-enhanced imaging showed multiple enhancing channel within the sclerosed zones. In conclusion the author underlined that contrast-enhanced venous imaging is a new reliable and useful tool in the early assessment of the therapeutic response to foam sclerotherapy for greater saphenous vein incompetence.

Sclerotherapy treatment of varicose and telangiectatic leg veins: “my way and my practice”
M. GOLDMAN (USA)

While it appears simple to inject a solution into a vein with a needle and syringe, proper technique can increase efficacy and minimize complications. Over the last 20 years, my technique of performing sclerotherapy concentrated on four important concepts:
1.The logical progression of sclerotherapy treatment;
a. Treat refluxing points first
b. Treat largest veins first
c. Treat proximal to distal.
2. Use the minimum effective sclerosing concentration appropriate for the specific vein treated;
a. Endolumnal 1320 nm laser closure of the GSV or SSV
b. Ambulatory phlebectomy for vessels >6 mm in diameter.
c. STS Foam for vessels >1mm in diameter:
I. 0.25% for 1-3 mm diameter
II. 0.5% for 3-5 mm diameter
III. 1% for 5-7 mm diameter
IV. 3% for >7 mm diameter.
d. 72% glycerin for vessels < 1 mm in diameter
e. 1064 nm long pulsed Nd:YAG laser for res tant vessels.
3. Treat the entire venous network of a single leg in a single session.
Post-treatment compression 24 hours a day for 7 days with 30- to 40-mm Hg graduated compression stocking.

Sclerotherapy – ask the experts

Chairpersons: E. Rabe (Germany), A. Scuderi (Brazil)

Sclerotherapy and surgery
B. PARTSCH (Austria)

Surgery has been the main form of treatment for large varicose veins for many years. Due to the development of foam and the combined use of duplex ultrasound, there has been a renaissance of sclerotherapy in the last 10 years. Not every patient is suited to a stripping operation of large varicosities. An alternative treatment is attractive in older patients or patients with concomitant diseases like diabetes, adiposity, history of deep vein thrombosis, or even the presence of a venous ulcer. Recurrent varicose veins after a primary stripping operation are more found more frequently than has been suspected for many years. Due to a higher complication rate, redo surgery is unpopular. In these patients, ultrasound-guided foam sclerotherapy offers a safe, comparatively simple, and inexpensive alternative to conventional surgery. Although foam sclerotherapy has many advantages, there will always be patients who are better treated by surgery. Varicose veins of large diameter are less successfully treated by sclerotherapy. Varicose convolutes located subcutaneously often leave unsightly patches of indurated and hyperpigmented skin after sclerotherapy, and are easily treated by stab-avulsion phlebectomy. Ultrasound-guided foam sclerotherapy is another useful tool in the treatment of large varicose veins.

Echoguided sclerotherapy and foam
A. CAVEZZI (Italy)

Sclerosing foams (SF) are mixtures of gas and liquid solution with surfactant properties, affording full control of drug concentration inside the vein and contact time with the endothelium. Cabrera proposed the use of a microfoam of sodium tetradecyl sulfate and polidocanol for sclerotherapy in 1993. Many authors subsequently reported different methods for foam production. Sclerosing foam is characterized in part by the following parameters:
• Type and concentration of sclerosant
• Type of gas, ratio of liquid to gas
• Additional nonactive substances
• The method of preparation
• The time after processing
• Bubble size distribution
The microfoam has a number of unique physical properties. Bubble size, fluid-to-gas ratio, and foam breakdown rate are all highly important. New measurement techniques were developed to define the essential differences between microfoams, foams, and froths, depending on the diameter of bubbles:
• Froth >500 μ
• Foam >300-500 μ
• Microfoam <250 μ
Microfoams are characterized by:
• Density
• Stability
• Bubble size distribution
Density is controlled by the ratio of fluid to gas. Stability is dependent on viscosity, dissolved gas, temperature, and bubble homogeneity. Bubble size distribution measurement is complex, and must also be performed quickly. Use of sclerosing foam is an appropriate procedure in the therapy of varicose veins. Sclerosing foam is a powerful tool in expert hands, and in general more effective than the liquid form of sclerosants. It is necessary to have good skills in conventional liquid sclerotherapy before starting with foam sclerotherapy.

The differences between polidocanol and STS
M. MALOUF (Australia)

Venous sclerotherapists worldwide use polidocanol (POL) and sodium teradecil sulfate (STS). These are two highly effective and trusted detergent sclerosants for treating varicose and spider veins. In liquid form STS is two to three times more potent than POL, but their clinical effect is approximated when made into a foam. Chemically POL is a synthetic long-chain fatty alcohol related to lignocaine. It contains ethyl alcohol and phosphate buffers. STS is a synthetic long-chain fatty acid salt stabilized in benzyl alcohol and sodium phosphate, and preserved with a variable level of carbitol. The two sclerosants contain different ionic/non-ionic properties, behave differently in micelle formation, and there is a difference in the stability of their respective sclerosing foams. There are major clinical differences in the use of these two sclerosants. Pain on injection with STS is commonly noted, and sometimes severe. POL is almost painless on injection, related to its local anesthetic property. The likelihood of developing anaphylaxis or allergy is quoted as being over 20 times higher with STS than with POL. A higher concentration of POL liquid is needed to achieve the same potency and perhaps efficacy of sclerosis compared with STS liquid. Foaming augments the potency of both solutions to reach equivalent clinical efficacy. Recent clinical trials were performed comparing these two sclerosants, for the treatment of esophageal varices and later for the treatment of varicose veins and spider veins of the legs (including the Australian Polidocanol Study 1991-94 and Goldman’s presentations 1998 and 2002). These studies found the efficacy of both sclerosants to be equal. Concerning the frequency and severity of complications, such as allergy, pigmentation, and injection ulceration, the Australian trial showed that POL produces much fewer and less severe complications compared with STS. Many sclerotherapists who have used both sclerosants have favored POL for the above reasons. Others prefer using the sclerosant that they are used to and accept a higher rate of pain, potential complications, and possible anaphylaxis.

Side effects induced by incorrect techniques (of sclerotherapy)
J. J. GUEX (France)

Thrombotic complications of sclerotherapy are usually not related to an incorrect technique, but sometimes to the wrong indication or lack of respect of contraindications. The importance of compression after sclerotherapy to prevent deep venous thrombosis is likely, but evidence is scarce. Extensive superficial reactions, sometimes considered to be superficial thrombophlebitis, can be observed after injection of too-strong sclerosing agents. The incidence of necrotic complications has dramatically decreased due to the evolution of the technique. They are attributed either to intraarterial or at least to extravascular injections. Severe necroses were mostly observed after injection of junctions without duplex guidance. The latest reports from insurance companies in France indicate no severe necrosis. The safety of ultrasound-guided sclerotherapy has been sufficiently demonstrated. Obviously, the open needle allows one to keep access to the vein and to double-check reflux of blood in the line and position of the needle in the vein. Small necroses are due to extravascular injections in fragile areas such as the ankle or the anteromedial aspect of the lower leg. Visual troubles are worrisome complications, even if no case of lasting visual impairment has been reported so far. We have observed that these were mostly observed after foam or air block injections, and mostly after treatment of reticular or spider veins. The responsibility of air bubbles and not foam seems likely. In all cases, attention must be paid to prepare foam at the last minute in order to use it during its stability period. Poor results of sclerotherapy can be attributed to either tactical or strategic mistakes. In the latter group we find a lack of preliminary assessment of the whole venous system, while in the first group the main cause is poor technique. Poor results which can be considered as side effects are matting and pigmentation. Good understanding of the disease and good training should limit their frequency to almost zero.

Chronic venous insufficiency-foam sclerotherapy

Chairpersons: L. R. Villalonga (Cuba), M. Sato (Japan)

Foam of polidocanol 3% versus 1% in greater saphenous vein sclerotherapy: preliminary results
C. HAMEL-DESNOS, F. A. ALLAERT, J. P. BENIGNI, G. BOITELLE, F. CHLEIR, P. OUVRY, M. SCHADECK, P. R. DESNOS (France)

Aprevious study showed that foam of 3% polidocanol (POL) provides better results than liquid form for sclerotherapy of the great saphenous vein (respectively 85% versus 35% reflux free). This randomized double-blind study investigates whether a lower concentration of POL (1%) may provide the same result with a better tolerance. One hundred and fifty-eight patients with great saphenous vein (GSV) reflux were included (diameter between 4 and 8 mm) and randomly allocated to the two treatment groups. A first injection of 2.5 mL was performed 10 cm below the saphenofemoral junction by direct puncture under duplex assistance. In case of unsuccessful spasm, injections may be repeated up to three times (maximal injected volume: 7.5 mL). Only one treatment was performed. Two or three injections were required for two thirds of the patients. The success rate was 80% at 6 months (18 recanalizations/144 patients) and 75% at 1 year. One deep venous thrombosis was observed. The study is still blinded until the end of the trial (February 2006) but the results are in favor of an equivalence between the two concentrations of foam.

Reference:
Hamel-Desnos C, Desnos P. R. Wollmann JC, Ouvry P, Mako S, Allaert FA. Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results. Dermatol Surg. 2003; 29:1170-1175.

Clinical and hemodynamical outcomes of duplex-guided foam sclerotherapy: a 24-month follow-up study
R. GONZALES ZEH, S. BARAHONA-CRUZ (Chile)

In this prospective open study, 143 patients were included and 175 procedures were performed : 106 on the GSV and 69 on the SSV. All patients were treated by duplex-guided injection using polidocanol 3% with Tessari’s technique. The volume of the injection was calculated for each patient depending on the diameter of the vein (mean: 7 mm for GSV and 5 mm for SSV) and the length of the reflux. At 1 year, reflux was observed in 9.4% of the GSVtreated and in 4.3 % of the SSV-treated patients. At 2 years, reflux was observed in 14% of the GSVtreated and in 10% of the SSV-treated patients. One case of DVT was observed at 1 week by systematic duplex.

Indications and outcome of greater saphenous vein foam sclerotherapy
F. VIN (France)

Foam sclerotherapy of the great saphenous vein is indicated in cases of a venous diameter less than 7 mm. Previous studies have shown that recanalization occured in 50% of the treated veins if the initial diameter is above 8 mm. Two hundred eighty limbs were treated. A first injection of 3 cc of polidocanol 3% (1/4 air) was performed, and if needed, a second procedure was performed 2 weeks later (3 cc at the upper third of the thigh and 2 cc at the lower third). Occlusion was obtained at the first session of treatment in 85% of the cases and at the second session in 92.8% of the cases. At 1 year, 79.9% of the patients had a GSV occluded, 12.7% did not and, 7.4% were lost of follow-up. Few complications were observed: one case of DVT and 3.3% of venous inflammation.

Chronic venous insufficiency – echo guided sclerotherapy

Chairpersons: A. Frullini (Italy), P. M. Canongia (Brazil)

With the participation of:
A. I. SHIMANKO, M. L. DIBIROV, A. J. VASILIEV, S. A. SOLOMATIN, N. A. POSTNOVA, S. V. TSURANOV (Russia), A. CORNU-THENARD (France), N. CROCETTI, D. PAOLICELLI, C. MINGARELLI (Italy), T. ALBERTI, M. VASSALLO, J. MEJIAS, L. RODRIGUEZ (Venezuela), N. MORISSON, D. NEUHARDT (USA), J. BRODERSEN, J. RICHTER (Germany)

Duplex-guided sclerotherapy with a sclerosant agent or foam is used for the treatment of great or small saphenous vein insufficiency, and incompetent perforating veins with open trophic ulcerations. Rare superficial venous aneurysms are normally treated surgically; however, a series of nine cases of venous aneurysms treated with echosclerotherapy represents a promising alternative procedure.
Catheter-directed echo-guided sclerotherapy by percutaneously inserting an angiography catheter under echographic guidance with positioning distal to the ostial valve and slowly injecting foam while removing the catheter seems even more effective and controlable. The primary success rate is 89%; 3-months follow-up shows a closing rate of 93% (Alberti et al). The KAVS catheter was designed to reduce the side effects of the slerosing agent (pigmentation, superficial phlebitis, skin necrosis, visual disturbances, deep venous trombosis). By inflating a distal balloon at the saphenofemoral junction, foam can be injected under duplex ultrasound without entering the deep venous system. The amount of foam is reduced by aspiration at the end and only the foam which is interacting with the venous wall is left. It has been mentioned that sclerotherapy is never completely controllable; there is always a loss of the agent to the deep system by collaterals and perforating veins.
In order to prevent side effects, it is important to have an idea of the maximal volume of foam that can be injected. A table with two parameters (vein diameter and vein length to be sclerosed) helps to define the needed volume. Several influencing factors such as position of the patient and spasm of the vein during injection have to be taken into account.
The introduction of foam and technical improvements are turning duplex guided sclerotherapy into a valuable method comparable to other surgical and non-surgical techniques (endovascular radiofrequency and laser venous closure).

Miscellaneous

Chairpersons: J. Sas (Argentina), F. R. Bastos (Brazil)

Sclerotherapy and thrombophilia
C. HAMEL-DESNOS, J. L. GILLET, F. A. ALLAERT, P. R. DESNOS (France)

The authors of this large multicenter prospective randomized study in ninety-four patients with thrombophilia treated different types of varicous vein disorders with sclerotherapy under anticoagulant treatment. The patients were randomized to two groups, one treated with low-molecularweight heparin and the other with oral anticoagulation with warfarin. There was no occurrence of clinical deep or superficial thrombosis during and after the procedures. Protection with low-molecularweight heparins or warfarin appears a useful tool to use in this kind of patient.
It will be necessary to perform randomized studies under ultrasonic control to demonstrate the efficacy of anticoagulation therapy in patients with thrombophilia treated for varicous veins disorders.

The use of foam sclerotherapy during varicose vein surgery
J. F. UHL, M. LEFEBVRE-VILARDEBO, D. CRETON (France)

The combination of venous surgery and foam sclerotherapy in the same surgical session can help us to treat complex cases of venous insufficiency like inaccessible veins, lymph and venous dystrophies, popliteal cavernomas, venous recurrences with good results.

LYMPHEDEMA

Compression Therapy in Lymphoedema,
In the framework of the SIGVARIS symposium.
J. L. CATALDO (Brazil)

According to conservative estimates, several million people in Brazil suffer more or less from some form of lymphedema. Most patients have inadvertently learnt details about the disease and the appropriate modes of treatment from therapists. Throughout the entire course of medical studies, little attention is devoted to diseases of the lymphatic system, and consequently doctors in Brazil have little acquaintance with the problems of lymphedema. Because of the increasing numbers of surgical operations, the incidence of lymphedema has certainly increased, but improvements in treatment and refined therapeutic techniques have done much to lessen the burden of the disease. The treatment of lymphedema must include a range of the therapeutic options such as:
• Hygiene/skin treatment
• Manual whole-body and segmental lymphatidrainage
• Compression therapy with bandages and then with custom-made compression stockings
• Special physical exercises
• Diet
• Psychological motivation

ULCERS
Venous ulcers – clinical and compression management of venous ulcers

Chairpersons: J. Hafner (Switzerland), M. Avramovic (Argentina)

Biotechnologies in the treatment of venous leg ulcers: fibroblast and keratinocyte autograft
L. CORCOS, D. DE ANNA, L. DONEGA, F. PELLEGRINI, P. COLAMUSSI, P. KUWORNU, C. POGGI, D. ZAGNI (Italy)

The autologous skin graft represents the basis for the modern surgical treatment of vascular leg ulcers. At the present time biotechnologies make it possible to take a small skin fragment with a 2-to 3-cm2 biopsy, which is divided into the two essential components: dermatocytes and keratinocytes. Extensive tissue layers (100 to 200 cm2) are then developed in vitro and are separately implanted on the ulcer surface. The authors performed a clinical trial, using biotechnologies on 210 ulcerated legs over the last 3 years. Half of the ulcers had typical venous origin and were related to CVI. The procedure was divided into two steps: in the first, typical surgical procedures for CVI were performed. The second step was much longer and more difficult: a small skin graft was taken from the anterior region of the patient’s elbow. Next, it was divided in the biology laboratory into the two main components – dermatocytes and keratinocytes. Separated keratinocytes were allowed to multiply in a hyaluronic acid bed, and were then implanted in the debrided ulcer surface after 4 weeks. A clinical follow-up of all cases was performed at a mean of 14 months (range: 3 months to 3 years).
Reduction in ulcer size of more than 25% was observed in 80.6% of treated ulcers. Reduction of more then 50% of initial size was observed in 66% of treated. Only in 6 cases was total wound healing observed. Perhaps in the future this method may replace the traditional Tiersch method.

Laser treatment in chronic leg ulcers
P. CASONI (Italy)

A wide variety of methods have been tried, but few have been assessed in randomized trials. The aim of this study was to test whether the topical use of a laser source such as Diode 810 nm can improve healing time. Of 180 leg ulcers, over 3 years a group of 44 homogeneouscases with non-healing vascular leg ulcers were randomized 2 weeks after conventional treatment (multilayer bandage, elastic stockings, and non ad pancement). Patients continued treatment with the bandage changed twice a week and randomized to receive laser Diode 810 nm treatment 60/100 J/cm2 (n=22 Group A) or a simple nonadherent dressing (n=22 Group B) The main end point for this trial was the time to complete healing. A comparison of images and of life tables up to 3 months of treatment was made.
At the end of the study 60% of group A (treated with laser plus occlusive dressing) and 35% of group B (without laser source) had completely healed. Life table analysis showed a significant difference (P=0.032).
Thus, it is now possible to consider a new method of treating leg ulcers.

Surgical treatment of non-healing venous ulcers-crural fasciectomy versus shave therapy
C. SCHWAHN-SCHREIBER (Germany)

Long-term results after shave therapy of venous leg ulcers resistant to other treatment
In the framework of the Symposium of the German speaking phlebological societies of Austria, Germany and Switzerland.
H. J. HERMANNS (Germany)

Surgical treatment by shave therapy by crural fasciectomy are indicated in venous ulcers that are still nonhealed after 1 year of optimal treatment. In fact, in these two retrospective studies, the mean duration of operated venous ulcers was around 15 years before surgery. Shave therapy is the removal of the ulcer and of the surrounding epifascial fibrotic tissue by a dermatome (dermatolipectomy). Crural fasciectomy is the removal of the ulcer and of the surrounding fibrotic tissue together with the underlying fascia (dermatolipo-fasciectomy) with a scalpel. In both procedures, the defect is immediately covered by a mesh split skin graft. The results in term of complete healing are equivalent with the two procedures. At 1 year, complete healing rates are between 61% and 64%, and around 75% to 80% at several years of follow-up. Postoperative treatment included compression therapy for life, intermittent pneumatic compression therapy at home, manual decongestive massages, and education of the patient. Currently, shave therapy is the method of choice. Crural fasciectomy is indicated in cases of important tendon necrosis.

Short-stretch or multilayer elastic bandaging in venous ulceration? Results of a randomized clinical trial
P. J. FRANKS, C. J. MOFFATT, The Wound Healing Nursing Research Group (United Kingdom)

The purpose of this trial was to compare the use of a Cohesive Short Stretch System-CSSB (Actico- Activa Healthcare, Flexiban-Activa Healthcare) with a generic 4-layer bandage system-4LB (Flexiban-Activa Healthcare, Setocrepe-SSL, Elset- SSL, Coban-3M) in the management of chronic venous ulceration. In all, 156 patients met the entry criteria and were randomized from the 12 clinical centers with median (range) ulcer size of 4.33 (0.33 to 123.10) cm2. Analysis revealed that after 24 weeks a total of 111 (71%) of patients had complete ulcer closure, 32 (21%) had withdrawn from the trial, 12 (8%) remained with open ulceration and one patient had died. Of the 74 patients randomized to 4LB, 51(69%) had ulcer closure on treatment compared with 60/82 (73%) on CSSB. Intention-to-treat analysis reduced a hazard ratio for healing of 1.08 (95% CI 0.63 to 1.85, P=0.79). Withdrawal rates were similar between groups (15, 20% 4LB, 17, 21% CSSB). Ulcer closure rates for patients treated with CSSB were similar to those for patients managed by the 4LB system in this trial. Both systems appear to be equally effective in healing chronic venous ulcers.

LECTURE
Efficacy of a compression stocking for therapy of chronic venous ulcer compared with bandages
M. JÜNGER (Germany)

One hundred and thirty-four patients with venous leg ulcers were included in this study (prospective, multicenter, open-labeled, randomized, active controlled study with blinded assessment of the primary end point). Exclusion criteria were infected ulcer or obesity. U-Stocking (Venotrain® ulcertec) or bandages applied for at least 8 hours per day over 12 weeks. The primary end point was the healing rate after 12 weeks as assessed by planimetric measures. The secondary outcome variables were duration until healing, extent of ulcer healing, experience of use, and patient compliance. As a result, therapy with the U-Stocking produced a significantly higher rate of complete healing of 47.5% (29/61) versus 31.7% (19/60) with bandages, one-sided P=0.0129 (95%-CI for differences: 4.3% to 28.5%). Mean duration until healing was 46 days in both groups. Time required for application of the U-Stocking was a mean of 5.4 min (SD 5.4) versus 8.5 min (SD 6.5) for bandages, P=0.0001. So, the U-Stocking was superior to bandages in compression therapy for venous ulcer.

LECTURE
New technical method (mixtures of gas) in the production of Tessari’s sclerotherapy-foam and postsclerotherapy compression
L. TESSARI (Italy)

The author has reported new technical procedure for the production of the sclerosing foam. New foam is consists of a mixture of the sclerosant solution and soluble/biocompatible gas (CO2). This foam allows greater safety and favors the transendothelial release of these self maintaining and facilitating the homogeneous contact of the sclerosant with the endothelium for a longer time. For postsclerotherapy compression, the author used the Struva® stockings by Medi (Struva® 23 or Struva® 35).

Venous ulcers

Chairpersons: L. Norgren (Sweden), P. Mendonça (Brazil)

Ultrasonic treatment of infected leg ulcers: preliminary results
A. L. LA ROSA, R. M. MOIA, M. R. BUFFONI, M. Y. YUSUF, C. B. BLUS, L. P. PERVERSI, P. M. MARONE (Italy)

Ultrasound is known to have two properties of dissection on biological tissues and can damage bacterial cells through two mechanisms, cavitation and heating. The authors developed a Debridement Ultrasonic System to treat leg ulcers and simultaneously obtain a local bactericidal effect. The purpose of this study was to evaluate the efficacy and time consumption of radical ultrasonic debridement in the treatment of leg ulcers, the degree of the bactericidal effect in vivo, and the effective killing action of cavitation alone in an experimental model.
Fifteen patients (3 males, 12 females) presenting with infected leg ulcers underwent ultrasonic debridement: 7 ulcers were treated with a steel probe (group I), and 8 ulcers with a titanium probe (group II). A gross examination of intraoperative results of ultrasonic debridement of ulcers, with respect to surface appearance after fibrin and necrotic tissue removal was performed between groups I and II. The ultrasonic local bactericidal effect was investigated between group I and II, with culture immediately after ultrasonic procedure and after 24 and 36 hours. The killing action of cavitation alone, using a titanium tip in pulsed mode, was studied with sonication of a suspension of S. Aureus at 30 s, 45 s, 1 min, 1.30 min, with external refrigeration of samples, maintained at a temperature of 37° C.
At gross observation, all 15 ultrasonically treated patients showed a radical debridement of ulcers after only one procedure, with no significant difference between group I and II. Ultrasonic debridement was rapid with a medium time duration of 9 s per cm2 and minimally painful. A complete bactericidal effect in group I resulted in 6 out of 7 ulcers after only one procedure, and maintained after 24 and 36 hours. In group II only 1 ulcer experienced complete bacterial killing. The sonication of S. Aureus in vitro at 30 s and 45 s revealed insignificant bacterial killing; at 1 min there was 48.80% killing due to cavitation. Ultrasonic exposure of the sample at 1.30 min increased bacterial killing to 56.96%.
Ultrasound seems very promising in the debridement of the leg ulcers, with favorable results for rapidity and treatment with minimal pain. The study suggests that the higher bactericidal power of the steel probe tested in vivo depends on its greater aptitude to develop heat as opposed to the titanium probe.

The debridement of hard-to-heal leg ulcers by means of Versajet
G. MOSTI, M. L. IABICHELLA, P. PICERNI, A. MAGLIARO, V. MATTALIANO (Italy)

Debridement is a mandatory step for promotion of healing in necrotic and sloughy ulcers. The authors’ experience with the Versajet Hydrosurgery System (Smith & Nephew), a new tool for mechanical debridement of exudating ulcers, based on a Fluidjet technology that, using the Venturi effect, excises and aspirates the unwanted tissue, were presented.
Observation was performed in a group of 104 patients with nonhealing venous leg ulcers. In the majority of the cases (n=75) the debridement was achieved in 1 step; 2 and 3 treatments were required in 24 and 7, respectively. The Versajet procedure is quick (mean time per treatment: 5 min); it considerably shortens the in-hospital time by roughly 5 days as it shortens the debriding time from 6.1 to 1.4 days and promotes a quicker healing process. The debridement is selective, removing only the tissue centered in the working end and sparing the healthy tissue. Debriding with Versajet is highly effective in reducing the bacterial burden of the ulcer bed from 1 860 260 to 7 816 CFU cm2. The pain caused by Versajet is well tolerated, especially when set for gentle debridement; the pain level valued with a visual analog scale was 4.3. Compared with usual debridement with gauze and saline solution, the pain is the same or less. If multiple treatments are required, the combined use with moist dressings is synergistic, as the dressings soften the necrotic tissue, thus facilitating the following Versajet debridement. The results show that Versajet may be considered a new, very effective tool for ulcer debridement, allowing a quick, selective, with minimal pain and bleeding debridement; it considerably decreases the bacterial burden and leaves a flat surface ready for the skin graft.

Compliance and measurable results of applying compression
In the framework of the JOBST Symposium.
M. JÜNGER (Germany)

The author presented the results of hemodynamic examination of patients with different stages of CVI. He showed that improvement of venous outflow directly correlates with maximal walking pressure and resting pressure of the compression bandages. The author presented a new compression system: Ulcercare® (Jobst, BSN) for treatment of patients with CVI CEAP 6 class. Ulcercare® consists of two below-knee stockings which provide 40 mm Hg ankle pressure. This combination is very effective and comfortable for use in patients with active venous ulcers. Also, the author presented new compression leggings. In spite of absence of foot compression, these leggings significantly improve venous return.

LECTURE
Study of the effect of five different methods of compression in the treatment of venous leg ulcers
In the framework of the SIGVARIS Symposium.
E. O. BRIZZIO (Argentina)

Thirty-five patients with active venous leg ulcer were included. The five different types of compression were used over 6 months:
A) Sigvaris Stocking AD (Delilah) with minimum compression (15-20 mm Hg)
B) Sigvaris Stocking AD (862) with medium compression (20-30 mm Hg)
C) Sigvaris Stocking AD (863) with high compression (30-40 mm Hg)
D) Four-layer short stretch bandage
E) Inextensible CircAid Boot.
At the end of treatment 27 ulcers were closed and 8 ulcers were active. There was no significant difference between types of compression. Editor’s comment: This study was underpowered.

THROMBOSIS

LECTURE
Vascular endothelial growth factor gene therapy accelerates venous thrombus resolution and recanalization
K. G. BURNAND (UK)

After observing the rise in the expression of the vascular endothelial growth factor (VEGF) during venous thrombus resolution, this group from the UK designed this study in mice, creating a thrombus in the interior of vena cava which was injected with adenovirus VEGF (adVEGF) in different concentrations. They observed that treatment with adVEGF reduced thrombus size and increased recanalization. This could form the basis of a novel treatment of deep vein thrombosis in humans.

Thrombo-embolic pathologysurgical management

Chairpersons: F. A. Allaert (France), M. Portiho (Brazil)

Combined open and endovascular recanalization of symptomatic chronic iliofemoral venous thrombosis
G. S. ODERICH, A. A. NOEL, H. BJARNASON, P. GLOVICZKI (USA)

Six consecutive patients who underwent combined open and endovascular recanalization of chronically occluded (n=5) or stenosed (n=1) iliofemoral veins were retrospectively reviewed.
There were 4 males and 2 females with a mean age of 41 years (range, 30 to 49 years). Five patients had thrombophilia and all were treated with oral anticoagulants and compression stockings. CEAP classification was class 4 in three patients, class 5 in one, and class 6 in two. Two patients had associated inferior vena cava (IVC) occlusion and two patients had bilateral iliofemoral vein occlusions. All patients underwent open common femoral vein exposure, femoral vein endophlebectomy, bovine pericardial patch venoplasty, and stenting of the occluded/stenosed venous segments. There was one early iliofemoral vein occlusion due to poor inflow, which was successfully treated with thrombectomy, arteriovenous fistula, and femoral vein stent. Mean follow-up was 25 months (range, 1 to 63 months). All patients showed clinical improvement and both class 6 patients had healed ulcers at 2 and 3 months, respectively. At the last follow-up, CEAP classification was class 3 in 3 patients and class 5 in 3 patients. Two patients had late unilateral iliofemoral occlusions and one had femoral vein restenosis, yet only one of these 3 had mild recurrent symptoms. One patient who had IVC and bilateral iliofemoral recanalization developed unilateral iliofemoral vein occlusion and failed attempted recanalization. Another patient with femoral vein restenosis was successfully treated with a stent, and the third patient with asymptomatic iliofemoral vein occlusion was treated conservatively. Early results of combined open and endovascular recanalization of chronically occluded or stenosed iliofemoral veins demonstrate significant symptom improvement, despite recurrent thrombosis or restenosis in three of eight recanalized iliofemoral segments in 6 patients. Open endophlebectomy and patch venoplasty may provide adequate venous inflow and allow endovascular treatment of patients previously considered unsuitable for iliofemoral vein stenting.

Thrombolytic therapy and thrombectomy of acute venous thrombosis
G. R. ASKERKHANOV, M. A. KAZAKMURZAEV, I. S. ISMAILOV (Russia)

One hundred and five patients with acute iliofemoral venous thrombosis were treated with thrombolytic therapy with subsequent thrombectomy in 44 cases. Different methods of thrombolytic therapy with streptokinase were used. In conclusion the author underlined that the combination of the thrombolytic therapy with early thrombectomy radically removes thrombus, preserves competence of valves, and decreases the rate of rethrombosis.

Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low dose urokinase in patients with acute proximal venous thrombosis of the leg
S. HOSHINO, T. OGAWA, H. MIDORIKAWA, K. SATO (Japan)

Twenty-five patients with proximal DVT were divided into two groups: 10 patients underwent catheter-directed thrombolysis (CDT) and 15 patients had a combination of CDT with intermittent pneumatic compression (IPC). In this group a temporary vena cava filter was implanted for 3 to 7 days. The pulmonary embolization was assessed by pre- and postoperative angiography. There was no symptomatic pulmonary embolization in either group. In the CDT+IPC group, new asymptomatic pulmonary emboli and small thrombi in the vena cava were found. In spite of the initial thrombolysis, results in the CDT+IPC group were best. The author concluded that combination of the CDT and IPC gave the best results compared with CDT alone, and was not associated with increased risk of symptomatic pulmonary embolization.

Acute pulmonary thromboembolism. Emergent treatment with rt-PA
A. LIMURIS, N. FISTAS, C. H. EFTIMIADES (Greece)

Twenty patients with pulmonary thromboembolism were treated with rt-PA infusion.The thrombolytic therapy with rt-PA was started with a 10-mg bolus intravenous injection for 4 min and slow infusion of 40 mg for 60 min. Pulmonary angiography was performed in all cases. After full thrombolysis all patients received low-molecularweight heparin for 7 days and then oral anticoagulants. Three patients died as a consequence of right heart fealure. In the other cases good results were achieved.

Mini-invasive treatment of chronic venous insufficiency
N. SALIMZHANOV (Russia)

A total of 1110 patients with chronic venous insufficiency were treated. Complex examinations including X-ray phlebography, phlebotonometry, duplex scanning, and radionuclide phlebography were performed. The author used a combination of the different mini-invasive methods such as microphlebectomy, SEPS, and sclerotherapy. For rehabilitation the author used medical compression, stockings, intermittent pneumatic compression, and venotonics. In all cases good functional and cosmetic results were achieved.

Surgical considerations for acute and chronic pulmonary thromboembolism
M. ANDO, T. NISHIBE, M. YAMASHITA, M. SATO, R. HOSHINO, Y. KONDO (Japan)

Eighteen patients with acute pulmonary thromboembolism and 93 patients with chronic postembolic pulmonary hypertension were operated on. In 18 cases pulmonary embolectomy was performed, and in 93 cases thromboendarterectomy using deep hypothermia and circulatory arrest. All patients had pulmonary hypertension with pressure ranging from 30 to 70 mm Hg (mean 45 mm Hg). The author concluded that emergency thrombectomy with cardiopulmonary bypass was an effective operation for restoration of the pulmonary artery (1 patient died). Surgical treatment of patients with chronic occlusion of the pulmonary artery is more dramatic. Twelve patients died of heart and respiratory failure, but 77 showed good clinical results.

System inflammatory response syndrome in patients with deep venous thrombosis
V. SOROKA, P. CHECHULOV (Russia)

System inflammatory response syndrome (SIRS) is a well-known medical problem. SIRS can predict outcomes in patients with vascular inflammatory diseases. We investigated the score of SIRS criteria (WBC, temperature reaction, tachypnea, and tachycardia) in patients with acute deep thrombosis (DVT) and evaluated the rate of the complications, such as recurrent thrombosis, pulmonary embolism, and chronic venous insufficiency. In addition to the SIRS score we assessed the level of procalcitonin. In the majority of the cases SIRS was identified. Patients who had two or more positive SIRS criteria had recurrent thrombosis and pulmonary embolism (P<0.01). The risk of this complication was well-correlated with a high level of procalcitonin (mean 2±0.4). The author concluded that levels of procalcitonin are a good predictor of SIRS and early thromboembolic complications.

Purulent deep vein thrombophlebitis of the leg: surgery or not?
C. RANDON (Belgium)

The author presented a clinical case, and 12 cases from the literature, of the treatment of purulent DVT. Different therapeutic modalities were discussed. Most cases of purulent DVT can be managed by conservative treatment. Broad-spectrum antibiotics are added based on cultures; if negative and other sources of infection are excluded, they are started on an empirical basis and given for at least 6 weeks (amoxiclav with an aminoglycoside). Surgical therapy for purulent DVT consists of a thrombectomy or thrombolysis in patients with cerulea alba dolens, and in young patients with thrombosis of the common femoral or iliac vein to avoid CVI. The incomplete removal of the thrombus (remnants of the thrombus due to adherence at the vein wall) more then 2 weeks after onset of the DVT is a disadvantage in both procedures. Deep phlebectomy is the only operation where every septic focus is removed, but has a high risk of morbidity and mortality due to the extent of the operation. If septicemia persists after 4 weeks of broad-spectrum antibiotics, a surgical thrombectomy or thrombolysis is performed. If the clot can not be removed, a full excision of the affected vein is indicated.

Endovascular treatment of venous disorders

In the framework of the joint meeting UIP/Brazilian Society of Angiology and Vascular Surgery.
Chairpersons: L. Moura, A. Frankini, G. Pitta, F. Miranda Jr (Brazil)

This was a didactic session about current practice in Brazil.

F. Miranda Jr made a review of the history of iliac vein compression (May-Thurner/CockettSyndrome), revision of symptoms and signs, and his personal diagnostic experience in the field of echocolor Doppler (sensitivity 73% and positive predictive value 91%). He also presented some data from the literature in endovascular treatment of compression of the iliac vein with PTA and stenting: primary and secondary permeability with deep vein thrombosis (DVT; 52% and 90%) and without DVT (60% and 100%).
A. Von Ristow recounted his personal experience in the treatment of proximal venous thrombosis with thrombectomy. He mentioned the goals (prophylaxis of potentially lethal DVT or pulmonary embolism, prophylaxis of post-thrombotic syndrome, and treatment of severe DVT), indications (impeding venous gangrene, phlegmasia cerulea alba and dolens) and the specific importance of duplex scan and angio CT in diagnostic investigation. He also presented the results of his personal technique (insertion of temporary vena cava filter; surgical exposure of ipsilateral vessels; proximal thrombectomy; angioplasty/stenting if indicated; distal thrombectomy; creation of an A-V fistula; closure of the fistula 30 to 45 days later by endovascular methods) in 52 cases (9 isolated lower cava, 17 lower cava + distal veins, 18 iliofemoral + distal veins, 8 femoral + distal veins). In this series the frequency of this procedure in patients with DVT was 7.1% and the early results were: good in 41, partial rethrombosis in 9, 1 amputation, and 1 death. The late results in 43 of the patients were: good in 33 and light post-thrombotic syndrome in 10. He concluded that venous thrombectomy is a safe and effective procedure.
Finally, C. Peixoto gave his personal point of view on the treatment of proximal vein thrombosis by catheter thrombolysis with rt-PA (2 mg/h over 18- 24 hours). He reported 85% of clinical success (patency > 90% with concomitant iliac stent) and emphasized the importance of the experience with this technique to achieve good results.

ASSESSMENT OF TREATMENT EFFICACY
Quality of Life
SERVIER Session on the Quality of Life

Chairpersons: G. Jantet (France), S. Park (Korea)

– Epidemiological results of the RELIEF study across different continents. G. Jantet (France)
– Multilingual validation of a CVD-specific questionnaire of QoL: the example of the CIVIQ in Spain. F. S. Lozano (Spain)
– QoL changes in patients with chronic venous disease: comparison of the CIVIQ and the SF12. J. J. Guex (France)
– Relationship between signs, symptoms and quality of life in patients with chronic venous disease. M. Perrin (France)
– Change in the quality of life in patients with chronic venous disease: results of a 6-month study using MPFF*. P. L. Antignani (Italy)
The objective of this new analysis on the cross-sectional RELIEF Study was to compare demographic, clinical, and quality of life characteristics of patients with chronic venous disease in different continents. RELIEF was held in general practices from 18 countries in Europe, Asia, and Latin America. Patients diagnosed with clinical class C0s to C4 according to the clinical, etiological, anatomical, pathophysiological (CEAP) classification, over 18 years of age, male or female, of any race, whether wearing compression stockings or not, were enrolled in the study. Venous reflux was detected by means of a pocket Doppler. Symptoms (sensation of swelling, cramps, leg heaviness) were assessed on a 4-point scale, pain was rated on a visual analogue scale (VAS), edema was estimated by measuring leg circumference, and quality of life (QoL) by using the Global Index Score (GIS) of the CIVIQ. Comparison between continents used Chi2 tests or the Fischer exact test for discrete variables, and the Kruskal-Wallis test for continuous variables.
A total of 3948 patients were enrolled in this analysis. Patients were mainly Caucasian (77.9%), and female, (81.1%), with a mean age 45.5 years, and mean duration of CVD of 12.4 years. Differences were seen in Asia (A) where patients’ mean age (41.6 years) was significantly lower than in Europe (E) and Latin America (LA) (P<0.0001). The proportion of men in Asia (40.1%) was far higher than in Europe (15%) and in Latin America (13.5%), (P=0.001). Moreover, Asian patients waited less than their European or Latin American counterparts before seeing a doctor (5.1 years in A versus 13.6 years in E and 11.7 years in LA, P<0.001). Asian patients in the great majority declared having no family history of venous disease (84%), versus only about 26% in Europe and in Latin America (P<0.001) where declarations were similar (P=0.6).
Although Asian and Latin American patients were classified in less severe CEAP categories (% in C0s- C2: 70.8 in A and 66.3 in LA, P=0.768) than European patients (% in C0s-C2: 61.2, P<0001), they were suffering more from symptoms and had a worse quality of life (P<0.001 versus Europe). Sensation of swelling was the most reported symptom in LA, while in Asia it was cramps. It seems through this analysis that the behavior towards CVD was different depending on the continent considered. Men in Asia consulted more frequently and earlier than patients (mostly women) from Europe and Latin America. Symptom perception is continent-dependent, and so is the impact of the condition on the QoL.
The validation program of the Spanish version of CIVIQ, presented by F. S. Lozano, was performed in two steps: 1) qualitative validation which assesses conceptual equivalence between the French source version and the Spanish CIVIQ. 2) psychometric validation regarding validity, reliability, and responsiveness of the instrument.
Four hundred and seventy-six patients completed the CIVIQ. The patients’ mean age was 46 years (+ 12) with 11.3% men and 87.6% women. Distribution of patients into the CEAP clinical classes was as follows: 2.3% in CoS, 25.9% in C1, 43.6% in C2, 19.8% in C3, and 8.4% in C4. The 4-dimension structure of the CIVIQ was retrieved in the Spanish version, with a restriction for the social dimension. This is most probably due to cultural bias. The cross-sectional validity was ensued. The Spanish CIVIQ has demonstrated its capacity to discriminate among the different severity groups of illness at baseline (Spearman’s correlation coefficients >0.30). So was the clinical longitudinal validity, with good correlations between variation in the CIVIQ scores and clinical score changes across a 6-month treatment with an oral micronized phlebotropic drug (MPFF*, Laboratoires Servier, France). Reproducibility was excellent, with all intraclass correlation coefficients >0.70, and so was responsiveness with mean changes for all dimensions statistically significant in clinically improved patients (P<0.000 for all the CIVIQ dimensions). The CIVIQ can be used independently in Spain for assessment of treatment outcomes in chronic venous disorders or for measurement of the impact on QoL of the condition. Psychometric properties of the Spanish CIVIQ have met the cross-cultural validation criteria. As for the four other languages validated the same way (English for Singapore and India, German for Austria, Polish, and Portuguese) the Spanish CIVIQ might be used either as a global index or a multidimensional profile.
J. J. Guex demonstrated that the generic SF-12 is a useful tool for the assessment of QoL changes in patients with CVD, while the CVD-specific instrument CIVIQ seems to be more responsive to the physical repercussions of the disease. Comprehensive assessment of QoL should include both generic and disease-specific measures using fully validated tools. Translation and cultural adaptation of QoL questionnaires into different languages and countries must follow internationally established criteria.
On the other hand, the management of chronic venous disorders with phlebotropic drugs should greatly improve the QoL of patients, particularly at the early stages of the disease.
In a multivariate analysis performed to assess the impact of demographic data, reflux, signs, and symptoms on the quality of life of patients with chronic venous disorders, M. Perrin showed that age, female gender, BMI, ankle circumference, presence of reflux, and assignment to C3 and C4 CEAP clinical classes had a significant impact on QoL, with a variation of less than 3 GIS points on the CIVIQ. On the other hand, symptoms of chronic venous disorders, especially heaviness in the legs and pain, were found to significantly (P<0.0001) alter patients’ QoL, with a decrease of 7 to 14 points on the GIS for each symptom.
In conclusion, in as much as MPFF* improves venous symptoms, as evidenced through the RELIEF study in patients C0s to C4, such prescription may be recommended to improve QoL.
According to P. L. Antignani, the relationship between symptoms, signs, and the quality of life of patients with CVD has never been analyzed in a single study. This triangular relationship remains to be better evaluated. This could be the aim of further trials using the revised CEAP classification for the description of signs, validated scales for the assessment of symptoms, and generic and specific QoL scales for the evaluation of disease impact on patients’ health.
*Registered as Ardium®, Alvenor®, Arvenum® 500 mg, Capiven®, MPFF at a dose of 500 mg, Detralex®, Elatec®, Flebotropin®, Variton®, Venitol®.

Health-related quality of life in patients suffering from lower limb lymphedema
In the framework of the thematic session: epidemiology and socioeconomics.
P. J. FRANKS, C. J. MOFFATT, D. C. DOHERTY, A. F. WILLIAMS, P. S. MORTIMER (UK)

Health-related quality of life (QoL) has already been examined in patients suffering from arm lymphedema, but rarely in patients with lower-limb lymphedema. The aim of this study was to determine the validity and the accuracy of MOS-SF36 quality of life scale, and other scales measuring the pain (McGill short form) and the functional ability (Barthel index) in patients with lower-limb lymphedema. Patients included were 164, 70.7% of whom were female and mean age was 76.9 years. The SF 36 questionnaire appeared to be the most appropriated scale in this patient group. The SF 36 measured a deficit in all quality of life scores, especially the physical domain, the social domain, and the emotional field. The QoL was lower in females than in males, but this difference was not statistically significant. After 24 weeks of follow-up, treatment led to a significant improvement in 6 of 8 scores of the SF 36. Patients treated by bandages exhibited the greatest benefit in all different scores of the SF 36, compared with patients treated with hosiery or with patients not treated.
SF 36 appeared to be appropriate in evaluation of QOL in patient with lower-limb lymphedema, especially for testing the impact of different treatments in this population.

Scoring symptoms and signs

Ascribing leg symptoms to chronic venous disorders. The construction of a simple scoring system
In the framework of the thematic session: epidemiology and socioeconomics.
P. H. CARPENTIER, C. POULAIN, A. CORNU-THENARD, R. FABRY, F. CHLEIR, B. GUIAS, C. BETTAREL BINON, G. MISEREY (France)

The aim of this work was to develop a simple venous symptom scoring system. The scoring system has to discriminate between different etiologies of symtoms and to be applicable in clinical practice. Two groups of patients were selected from different institutional or private vascular centers. One group (n=123) had documented chronic venous disorders without any arterial, neurologic, or rheumatologic comorbidity. The second group (n=94) had arterial, rheumatologic, or neurologic diseases but no venous disorders. They filled out a 54-item questionnaire characterizing leg symptoms. Six out of 54 symptoms were associated with the highest likehood ratio of having venous disorders in the first group of patients: type of symptoms (heaviness or sensation of swollen legs); associated symptoms (itching, restless legs or phlebalgia); worsened by warmth or improved by exposure to cold environment; absence of worsening by walking; site of the symptoms (whole leg); increasing throughout the day. These 6 items were combined and analyzed on ROC curves to test their specificity and sensibility. The most efficient score was obtained by combining four items: type of symptoms; associated symtoms; worsened by warmth or improved by exposure to cold environment and absence of worsenning by walking. If the score was >3 (3 or 4 criteria/4), the specificity was 95% and the sensibility 76% for having chronic venous disorders. If the score was <1 (0 criteria/4), the specifity was 94% and the sensitivity 67% for not having chronic venous disorders. This venous symptom scoring system was subsequently validated in two new series of patients.
The 4-criteria scoring system is able to efficiently discriminate patients with chronic venous disorders. Reproducibility in real clinical conditions and applicability in other countries are therefore needed.

Compression

LECTURE
Determinants of pressure exerted by medical compression stockings
W. BLÄTTLER (Switzerland)

The force exerted by Medical Compression Stockings (MCS) was measured with the Zwick dynamometer, the pressure exerted on the leg with the Sigat instrument. Leg circumference was determined with the Perometer and local radius calculated from computer tomographic slices. Three types of stockings were tested: Sigvaris Glamour (23-32 mm Hg), Sigvaris 503 (23-32 mm Hg) and Neo Durelna (30-40 mm Hg). Twentyeight healthy volunteers took part in various experiments, both under static and dynamic conditions. The pressure measured at the leg/MCS-interface corresponded to that determined on the dynamometer, provided it was assessed at an area where the local radius was close to that of the ideal round leg. Tissue characteristics and type of MCS had no influence. Leg circumference showed no appreciable variation with movements (average change at b=+0.08cm, b1=-0.56cm, c=0.01cm, d=+0.49cm). Consequently, only small effects on global interface pressures were observed. However, significant variations of local radii and interface pressures were found along the leg circumference, eg, at the c-site the local radius varied between 50 and 250 mm. Stockings reduced the variation of radius to 80 to 140 mm. With a Sigvaris 503 stocking on the leg the interface pressure along the circumference varied between 20 and 40 mm Hg. So, the MCS tested exerted the predefined pressures on the leg. Muscle activity was not associated with appreciable changes of leg circumference, but with significant variations of local radii. Therefore, the global interface pressures showed only minimal changes while the local pressures varied importantly. Thus, interface pressure measurements obtained at one single site only may lead to erroneous. The presented data obtained with MCS do not support the existence of a substantially different working and resting pressure.