V – TREATMENT
Chairperson: C Allegra
C. Allegra (Italy)
The term superficial thrombophlebitis (ST) refers to an inflammatory and thrombotic process in a superficial vein. Its incidence has never been properly investigated, but is probably higher than that of deep vein thrombosis (DVT). ST may extend to the deep vein system through the saphenofemoral or saphenopopliteal junction or by perforators. The risk of thrombus extension is especially high if it is close to the saphenofemoral junction (£ 2 cm). The reported prevalence of complicating DVT or pulmonary embolism (PE) varies widely. According to a Cochrane systematic review (published in 2008), it was 6-44% for DVT (concomitant or subsequent), 20-33% for asymptomatic PE, and 2-13% for symptomatic PE. These discrepancies are probably caused by the differences in methodology used in respective studies. However, the evidence of optimal ST therapy is scarce. So far only one randomized controlled trial (RCT) has been performed – CALISTO which proved the efficacy and safety of fondaparinux at prophylactic dose in ST. The management of ST patients may present a problem from a medicolegal point of view.
V. Stvrtinova (Slovakia)
Superficial thrombophlebitis (ST) is not as benign as has long been thought and is included by some authors as a part of venous thromboembolism (VTE). It may quite often be complicated by deep vein thrombosis (DVT), sometimes even in the contralateral leg, or pulmonary embolism (PE). The real incidence of ST is not exactly known. The extent of ST may be underestimated by clinical examination and should be assessed by ultrasound.
New data of ST epidemiology were provided by POST, the French observational multicenter study. Of 844 patients with ST, 24.9% had DVT at the time of ST presentation. In the rest of the group, 10% of thromboembolic complications occurred during follow-up, in spite of anticoagulation therapy, which was given to the vast majority of them.
Moreover, the CALISTO trial has recently shown significant reduction of thromboembolic complications in ST patients treated with fondaparinux at prophylactic dose for 45 days (compared with placebo). In the light of the new data, the CEVF has reached a consensus on how to manage ST patients:
• to look properly for risk factors in all cases of ST on nonvaricose veins and in recurrent ST on varicose veins (potential cancer, thrombophilia, systemic disease)
• to examine the superficial and deep vein system in both legs by duplex ultrasound immediately after ST clinical diagnosis if ST is close (£10 cm) to the saphenofemoral or saphenopopliteal junction
• to use compression in all patients
• immediate mobilization in all patients
• to use fondaparinux 2.5 mg daily subcutaneously for 45 days for ST that is at least 5 cm long on ultrasound
J. Hirmerova (Czech Republic)
CALISTO is the first and the only randomized, placebo-controlled trial of anticoagulation in superficial thrombophlebitis (ST). Patients (n = 3002) with isolated ST (length at least 5 cm on ultrasound) were included; those with ST close to saphenofemoral junction (£ 3 cm) or with recent cancer or venous thromboembolism (VTE) were excluded. The trial has proven the efficacy and safety of fondaparinux (2.5 mg daily for 45 days), namely85% reduction of the relative risk of thromboembolic complications (deep vein thrombosis, pulmonary embolism, ST extension or ST recurrence). This is a great contribution to the hitherto poor evidence for optimal ST treatment, but many questions and doubts remain. Some authors suggest changing the guidelines for ST treatment with recommendation of fondaparinux. Others do not consider this approach costeffective, arguing that the rate of VTE in the placebo group in CALISTO is also relatively low and that ST has however an extremely low mortality. Further studies are needed to document the cost of the suggested therapy and the impact on quality of life. Defining the high-risk group of ST patients will probably be a crucial issue.
PH. Carpentier (France)
The first evidence about the life-saving effect of anticoagulation in patients with venous thromboembolism (VTE) was provided by the historic trial by Barritt and Jordan (published in 1960 in The Lancet). The other milestone in the history of VTE treatment came in the last decade of the last century with the introduction of low-molecular-weight heparin (LMWH) and the published evidence about its noninferiority in comparison with unfractionated heparin (UFH) as well as about the efficacy and safety of outpatient treatment of VTE. The last ACCP guidelines (published in 2008) recommend LMWH subcutaneously (sc), UFH intravenously (iv) or sc or fondaparinux sc for the initial VTE treatment, followed by warfarin.
Recently published evidence about new anticoagulants may cause revolutionary changes in the treatment (dabigatran and rivaroxaban as effective and safe as warfarin). Moreover, unprovoked VTE is associated with increased risk of recurrence and ACCP guidelines recommend treatment duration of at least 3 months with possible therapy prolongation according to the benefit/risk evaluation. Quite recently, long-term rivaroxaban has been proven to have beneficial effects in the patients with unprovoked VTE.
Another promising new anticoagulant, idraparinux (applied sc only once weekly), was noninferior to standard care in the patients with deep vein thrombosis (DVT) but worse in those with pulmonary embolism (PE). It is highly probably that the first days of VTE treatment are crucial and PE is probably a sign of a more active thrombotic process. This fact is reflected in ACCP recommendation to start anticoagulation even in the presence of suspected VTE pending the results of diagnostic studies as well as in the recommendation to start warfarin with adequate overlap with LMWH or UFH.
There is also slowly growing evidence about the benefit of the strategy of thrombus removal (catheter-directed thrombolysis) in the sense of achieving better venous patency and less postthrombotic syndrome than standard treatment. ACCP guidelines suggest this method in selected patients with ileofemoral thrombosis.
Finally, elastic compression stockings have proved effective in preventing postthrombotic syndrome in proximal thrombosis and their use is recommended by ACCP guidelines in symptomatic DVT as soon as possible. The problem may be the known poor compliance of the patients.
R. Kreidy (Lebanon)
The incidence of venous thromboembolism (VTE) increases exponentially with age. Therefore, in younger VTE patients a proper examination of the cause seems prudent. The study presented was a retrospective evaluation of 75 under-50s (mean age 40.7 years) with deep vein thrombosis (DVT), compared with a control group of older VTE patients (283 patients, mean age 64 years).
In the younger group, DVT in the left leg prevailed (60%; right leg 30.7%, both legs 9.3%). The risk factors for DVT in the younger group were: inherited thrombophilia, pregnancy, estrogen therapy, family history of VTE, long-haul air travel, and inferior vena cava congenital malformations.
H. Jawad (UK)
ONPULSETM is a new device, constructed for mechanical thromboprophylaxis. It is based on the activation of the foot and calf venous muscle pump. Transcutaneous electrical stimulation of the peroneal nerve provokes controlled isometriccontraction of the muscle. The effects of this technique were studied in 10 healthy volunteers. Several parameters were measured in the stimulated and nonstimulated leg and the control study without stimulation was performed later. Duplex ultrasound, laser Doppler and pulse oxymetry were used to assess the following parameters: blood flow volume, velocity, oxygen saturation. Safety and acceptability of the technique were evaluated as well.
ONPULSETM had a positive effect on the microcirculation and increased mean venous velocity without having any significant effects on vital signs. The results seem promising and research with this new technique is still going on.
J. Spáčil (Czech Republic)
Thromboprophylaxis in medical patients was incorporated in practice two decades later than in surgical patients and is still quite underused in many facilities. Two large studies have proven the efficacy of pharmacological thromboprophylaxis in medical patients – MEDENOX (with enoxaparine), PREVENT (with dalteparine) and ARTEMIS (with fondaparinux). The author analyzed the use of thromboprophylaxis in his own medical department. The first analysis was performed between 2004 and 2005 and the second in 2009-2010. The situation has improved – in the first period thromboprophylaxis was given to 51% of patients and in the second period it was given to 64% of patients at risk of venous thromboembolism (VTE). The results were compared with those of international studies – in the ENDORSE cross-sectional study only 39.5% of medical patients at risk received thromboprophylaxis (the Czech Republic also participated in the study and 44% of patients received prophylaxis). The last ACCP guidelines recommend using thromboprophylaxis with anticoagulation for all acutely ill medical patients with congestive heart failure, severe respiratory disease, confined to bed, and having one of the additional risk factors: cancer, previous VTE, sepsis, acute neurologic disease, inflammatory bowel disease. Several issues need to be resolved in the future – thromboprophylaxis for outpatients, thromboprophylaxis of extended duration, and the use of emerging new anticoagulants in prophylaxis in medical patients.
M. Malouf (Australia)
M. Malouf provided an overview about how to choose the best treatment for varicose veins worldwide with the integration of modern technologies. He considered good quality duplex ultrasound to be the key to improving outcomes. This essential investigation of venous incompetence by ultrasonography must be performed preferably by the treating physician with the aim of revealing the exact hemodynamic pathophysiology in superficial, deep, and perforating veins. One important issue is that good quality venous duplex sonography in not available in many areas of the world, thus limiting diagnosis and excluding certain treatment options. Again, it was emphasized that there is a need for a new UIP consensus on this, to standardize the technique around the world.
The speaker reminded the audience of the importance of venoactive drugs and compression stockings in this overall strategy, and of the interventional treatments, including chemical ablation (liquid, foam), thermal ablation (laser, radiofrequency and steam) and varicose vein surgery, that need to be duplex ultrasound-guided. He pointed out that different geographic regions contain bias in which treatments are reimbursed and by whom and to whom. Patients are biased by perceptions and advertising, and by the availability of treatments. He concluded that it is essential to integrate the above techniques if we wish to arrive at the same end point of absence of symptoms, improved clinical appearance and quality of life, no further duplex ultrasound evidence of venous reflux, with little or no recurrence over time. The speaker considered that the treatment options are all effective if employed appropriately on the basis of accurate duplex mapping. On the other hand we must avoid over-treatment based on just duplex results. One should treat patients and their symptoms rather than incompetent veins.
AA. Ramelet (Switzerland)
A. Ramelet reminded the audience that venoactive drugs (VADs) form a heterogeneous group of plant-derived (flavonoids, saponins, among others) or synthetic (mainly calcium dobesilate) medicinal products that have effects on certain signs (edema) and symptoms associated with chronic venous disease (CVD). Their principal mode of action includes an anti-edema effect (reduction of capillary permeability, improvement of lymphatic drainage, reduction of orthostatic edema), increase of venous tone, inhibition of leukocyte adhesion to the venous and valvular wall, inhibition of the release of inflammation mediators, of leukocyte adhesion molecules, and of prostaglandin synthesis, and reduction of the inflammatory reaction in venous valves.
He emphasized the role of inflammation as a key point in the pathogenesis of CVD and the specific effect of VADs in reducing venous pain, which is not achieved by nonsteroidal anti-inflammatory drugs. This specific painkilling mechanism effect needs further elucidation.
Besides some concerns in the past, it is now possible to differentiate the efficacy of several VADs that have been evaluated through basic research, randomized controlled trials, meta-analyses, and consensus conferences. They are useful if their indications are respected, if they increase the effect of compression, and if their side effects are rare.
He concluded his lecture with a SWOT analysis of these VADs: Strengths (painkilling effect, effectiveness from C0s to C6, low toxicity and long experience, increasing research, new drugs), Weaknesses (bad reputation in the past, old studies of low quality whence difficulty of establishing effectiveness, unproven awareness of toxicity), Opportunities (increase of prevalence of CVD, new interest in CVD, research about polyphenols, interest for nutraceuticals) and Threats (academics’ ignorance, social insurance, new low-level studies)
FA. Allaert (France)
Venoactive drugs are recommended and widely used in patients with venous edema. However, very few studies have documented their effect on ankle edema of venous origin. The author searched Medline for the articles published from 1975 to 2009. Only double-blind studies comparing venoactive drugs against placebo or against other comparators and providing A, B or C levels of evidence were included in the meta-analysis. Finally, 10 studies with 1010 patients were identified, documenting the effect of micronized purified flavonoid fraction (MPFF), hydroxyethylrutoside, ruscus extract, and diosmin. All the drugs were associated with a significant reduction of ankle edema compared with placebo, except for diosmin. MPFF was significantly more effective than ruscus extract and hydroxyethylrutoside. The meta-analysis confirms the validity of the grade A recommendation for use of MPFF in venous edema in recent international guidelines.
The author himself pointed out the heterogeneity among the studies as a possible limitation of the meta-analysis.
Chairpersons: M. Malouf, JC. Ragg
J. Uhl (France)
The author presented a study designed to shed light on the mechanism of action of external compression on superficial and deep veins. MRI of the calf was performed before and after compression by different stockings and bandages in 13 patients (5 with varicose veins, 8 healthy subjects). The results were really exciting. Low compression (20 mm Hg) believed to be indicated in superficial venous insufficiency did not lead to significant changes in extrafascial veins but it led to 60-80% reduction of volume of the deep veins. Only if a pressure of at least 60 mm Hg was applied was there flattening of the superficial veins. This can explain, of course, the effectiveness of 20 mm Hg compression stockings alone in prevention of venous thromboembolism. This study clearly demonstrated that compression needs to be investigated further, because our perceptions may be mistaken.
F. Vega (Mexico)
F. Vega pointed out some discrepancies in using Laplace’s law that mislead investigators and practitioners when they are dealing with compression. In his opinion Laplace’s law talks about blood pressure which is transmitted from the inside, whereas compression acts from the outside. So, this law applies to pressure exerted from the inside and it is wrong to talk about compression forces exerted in the opposite direction. Because of this we can’t say that we get real measurements of pressure of stockings, since they depend on the structure under the measuring chamber.
A. Cornu-Thenard (France)
The author presented his method of reducing edema by means of compression stockings prescribed initially, instead of the usual way of using bandages first and then compression stockings. If a reduction of edema is judged sufficient after three to four days of day-and-night wearing of a stocking, the same one is used daily. If not, a second or even third stocking is superimposed. This is an interesting approach because it is believed that to achieve good results in venous or lymphatic edema we need to use the bandages because they have a high stiffness index. As for stockings, there are not many studies published about their stiffness. So it is generally accepted that they have low stiffness not quite suitable for initial treatment of edema. The next presentation was just devoted to this point.
JP. Benigni (France)
JP. Benigni pointed out that increasing of the stocking’s stiffness can be achieved by superimposition of them. A good example of such an effective superimposing could be sets of two stockings for patients with venous ulcers. These are actively used now by many specialists.
Some papers were rather far from fundamental problems. J. Ragg (First experience with a new compression modality (Phlebopress) and J.P. Benigni (Efficiency on pain reduction of a thigh pad under elastic compression after stripping of the great saphenous vein: results of a case control study) conducted studies of compression devices which were applied under the bandage after stripping or foam sclerotherapy for eccentric compression. In a group of 64 patients undergoing microfoam treatment, J Ragg showed that a new pad with a lentiform cross-section reduced vein diameter by 68.8% (95% CI 32.2-82.1%) compared with 48.2% (95% CI 24.1-62.7%) in the control group (no pads). There were no adverse events. Minor skin irritation not limiting the patient’s comfort or application time occurred in 9.4% of cases. JP Benigni (France) and colleagues included 53 patients in a study to evaluate pain reduction if a pad was added at thigh level under the elastic stockings. 36 patients were included in the pad group and 17 in the control group. The level of pain was measured on a visual analogue scale from day 1 to day 7. On day 1 pain was 40.8 ± 20.8 in the control group and 27.4 ± 24.2 in the pad group (P=0.05). On Day 7, pain was 15.3 ± 13 in the control group and 3.7 ± 5.5 in the pad group (P<0.0001). J. Uhl (Evaluation of symptoms in CVD patients with foot static disorders: a prospective study) described the role of orthopedic soles in addition to medical compression stockings (MCSs) in patients with foot static disorders. 30 symptomatic CVD patients were divided into four groups (control: no treatment; compression: MCS alone; sole: sole alone; MCS + sole) and evaluated over four consecutive weeks. The efficacy of stockings in relieving the venous symptoms was confirmed and also, in cases of associated foot static disease, the quality of life of the patients was further improved by adding an orthopedic sole.
Chairpersons: JP. Benigni, A. Pospisilova
JP. Benigni (France)
He presented the results of a prospective study in 19 patients (mean age 76) with C6 and without diabetes or peripheral artery disease. Oxide zinc bandages were applied directly on the ulcer without dressings and were changed every 5 days. After 45 days, 5 ulcers had healed and 14 had improved. The author concluded that this kind of bandage, which is similar to Unna’s boot, achieved good healing rates at low cost. He also stated that randomized controlled studies comparing the above method with a multi-layer bandage need to be performed before drawing a definite conclusion.
The same author conducted a study (Compression stockings for treating venous leg ulcers) comparing the in vitro pressures given by the manufacturers of three anti-ulcer kits with the in vivo interface pressures measured in 18 healthy subjects. Two stiffness indices were calculated (static stiffness index – SSI and dorsiflexion stiffness index – DFSI). Two anti-ulcer kits (Hartmann’s Saphenamed UCV and Medi Mediven Ulcer kit) provided the recommended compression, but one of them (Jobst’s Ulcer care) did not. All three kits were rigid enough only when strong muscular compression occurs (SSI less than 10, DFSI more than 10).
D. Peric (Serbia)
A study by the Serbian team showed better healing results with two- or multilayer compression systems than with single-component compression systems. They performed the open randomized prospective study in 131 patients with an ulcer surface area of more than 3 cm2 and ulcer duration more than 3 months. In a single-layer group (tubular-form compression device Tubulcus, III class) healing rate during 26 weeks of treatment was 25% (13/42 patients), in a twolayer group (Tubulcus plus one 15 cm wide elastic bandage with 200% stretch) – 67.4% (31/46) and in a multi-layer group (Tubulcus plus two elastic bandages) – 74.4% (32/43).
V. Stojiljkovic from the same team presented a study entitled “Risk factors related to the failure of venous leg ulcers to heal with compression treatment”. 189 patients were treated within 52 weeks by the multi-layer bandaging system mentioned above. 24 (12.7%) of ulcers failed to heal. A small ulcer surface area (<20 cm2), duration of venous ulcer <12 months, a decrease in calf circumference of more than 2 cm during the first 50 days of treatment, and emergence of new skin islets on the wound surface were favorable prognostic indicators of ulcer healing. BMI >35 kg/m2, short walking distance during the day (<200 m), history of wound debridement, and deep ulcers (>2 cm) were indicators of slow healing. Calf-ankle circumference ratio <1.3, fixed ankle joint, and reduced ankle range of motion (<20 degrees) were the only independent parameters associated with non-healing (P< 0.01). The results suggest that non-healing ulcers are related to impairment of the calf muscle pump.
Two papers pointed out a role of sclerotherapy in accelerating venous ulcer healing and preventing recurrence. L. Hnatek, Czech Rep, (Foam sclerotherapy – a safe and fast intervention for acceleration of venous ulcer healing) included in his study 85 patients with C6 who were treated previously by compression alone (22 of them for more than a year). After foam sclerotherapy with polidocanol (0.5- 2%), the ulcer did not close in only 9 patients. F. Zernovicki, Slovakia (Recurrent leg ulcers) presented his experience of using compression and compression plus chemical obliteration of perforating veins in 270 patients. The recurrence rate after closure of perforators was much lower (0.7% vs 5.2% with compression only).
M. Jünger (Germany)
A new type of compression stocking, enriched with chitosan (a derivative of chitin, with reported antibacterial, antifungal, anti-inflammatory effects) has been studied. Stockings with chitosan in low or high concentrations were compared with cotton stockings. The study was performed in 10 healthy volunteers. Healthy volunteers were compared with patients with chronic venous insufficiency. A study was done in healthy volunteers after a standardized exercise (treadmill test). Several parameters were monitored: skin humidity, transepidermal water loss, skin roughness, microbial burden of the skin, skin temperature, patient comfort. Cutaneous moisture and barrier function were slightly better after stockings with chitosan and smoothing of the skin was observed in comparison with cotton stockings. This new type of compression may have positive effect on skin microclimate.
MH. Meissner (USA)
Compression therapy is supposed to have beneficial effects on hemodynamics as well as on the microcirculation. However, research in healthy volunteers and in patients with leg ulcers has proven only some of these putative effects – in the light of available studies the effect of compression on venous flow velocity is doubtful, vein diameter is reduced only in the supine position, improvement in muscle pump function is probable, and there is a positive effect on the microcirculation (maintaining of the anti-inflammatory and anticoagulant properties of the endothelium).
In clinical practice, compression is used to prevent deep vein thrombosis (DVT). In surgical patients, the meta-analysis of randomized controlled trials (RCTs) provides evidence about significant reduction of DVT risk. However, in medical patients the benefit is only marginal or even nonexistent (in stroke patients). This paradox may be explained by the role of intra-operative venodilation, endothelial tears with exposure of subendothelial collagen followed by initiation of thrombosis.
Compression has a beneficial effect on healing of venous ulcers – this is also proven in the meta-analysis of RCTs.
According to the ACCP (American College of Chest Physicians) guidelines, compression stockings should be used in high-risk surgical patients as an adjunct to pharmacologic thromboprophylaxis and should also be applied in patients with acute DVT. Randomized controlled studies have demonstrated their efficacy, when worn for 2 years, in preventing postthrombotic syndrome.
Chairpersons: AA. Ramelet, L. Veverkova
L. Veverkova (Czech Republic)
This Czech team reported a retrospective study comparing two different endovenous treatments for varicose veins: 62 patients underwent RF on the GSV and 68 underwent endovenous laser on the GSV and SSV. There were no statistical differences between the 2 groups in the occlusion rate (more than 90%) at 36- 46 months. Failures in both groups were due to technical faults or unsuitable GSV diameter. RF has the advantages of shorter operating time, shorter time of work disability, and lower postoperative pain. Unfortunately, the lack of precise statistical analyses and precise data related to the tools used to evaluate quality of life and disability prevent any conclusion regarding the best method to choose.
R. Vellettaz (Argentina)
The author wanted to establish and evaluate a perioperative anesthetic protocol in order to decrease complications and patient discomfort when using local anesthesia during endovenous laser treatment (EVLT). In this retrospective nonrandomized study, 699 great saphenous veins (GSVs) were treated with a diode 980 laser with intravenous sedation associated with local tumescent anesthesia according to the Klein protocol. All the procedures were well tolerated. Postoperative pain was mild in 67.55% of patients and recovery was fast.
Tumescent local anesthesia is widely used with endovenous techniques (1): it reduces peri- and post- operative pain to a very low level, reduces or even eliminates ecchymosis, and preserves postoperative quality of life, as reported in several studies. The high dilution of local anesthetic allows injection of a large volume without adverse effects (2). The combination of intravenous sedation with local tumescent anesthesia improved surgical conditions by decreasing perioperative pain due to local anesthetic injection, with no incidence on the discharge criteria. This anesthetic management should be used for almost all kinds of varicose vein ambulatory treatment.
Proebstle TM, Paepcke U, et al. High ligation and stripping of the long saphenous vein using the tumescent technique for local anesthesia. Dermatol Surg. 1998 Jan; 24(1): 149-53.
Chastanet S, Pittaluga P, et al. Surgical treatment of varices with tumescent local anaesthesia heavily diluted in bicarbonate : the gentle surgery. Monaco World Congress of the UIP, e-abstract book Monaco, 2009; 111-112
V. Ciubotaru (Romania)
VANST (ambulatory nonstripping surgical therapy of varicose veins) consists in disconnecting the varicose veins from the venous circuit by ligation without removing them. It is done under local anesthesia and in an ambulatory setting. No ecchymosis or hematomas have been reported. No compression was needed. The rate of recurrence at 5 years was 4.3% with good aesthetic results. The author considers that all kinds of varicose veins can be treated by this noninvasive technique. Only one center and one surgeon tried this new method. We need much more data concerning the design of this study as well as for the evaluation criteria used and the analysis of the results.
I. Bihari (Hungary)
The saw knife invented by a Czech surgeon many years ago is used to destroy and remove big varicose veins, perforators, or veins within lipodermatosclerotic tissues. The knife is anchored into the vein wall and twisted to remove the vein. We have no data concerning post-op bruising or hematomas, but dysesthesia occurred after the procedure in 7% of cases, and disappeared within 6 months. This method is of little interest because this knife is much more damaging than the hook and we don’t have any data on post-procedure cosmetic results or quality of life.
K. Sritharan (UK)
The aim of this study was to evaluate the perceived risks and benefits of varicose vein surgery. Patients have to complete a questionnaire. The results showed that most of the patients relied on information from their doctor alone and that 44% thought treating their varicose vein would yield other health benefits, as preventing diabetes or aiding weight loss. Developing deep venous thrombosis was the main risk after the surgery for 52% of the patients even if 67% thought that varicose vein surgery is a low-risk procedure. This very well designed study by A Davies’s group showed that despite the many available sources of scientific information, patients are still unaware of the benefit- risk ratio of varicose vein surgery, and that doctors should be much more involved in spreading medical information.
D. Radu (Romania)
The Babcock technique was used to remove the GSV, and the tributaries were treated with the phlebotome and Wolmark rings to improve the aesthetic results. Unfortunately, no details concerning the cosmetic results were provided. These two old methods were abandoned some years ago in many countries because of their poor cosmetic results: ecchymosis, hematomas, bruising, and scars. Many improvements have been made in stripping, by using, for example, a pin stripper, which is much less traumatic. Moreover, using a small hook through skin puncture avoids skin damage and nerve injuries.
R. Haruta (Japan)
Subfascial endoscopic perforator surgery (SEPS) can be difficult to learn and some technical difficulties and complications have been reported. To simplify the technique, this team changed the access port using a two-port system to avoid inflation at the thigh, a dissecting balloon catheter, and CO2 gas injection at high pressure. No complications have been reported and the operating time was short. This simplified method would probably help many surgeons who are uncomfortable with the original technique, even if the routine treatment of incompetent perforators is still under discussion. Multicenter studies are required to confirm the reproducibility of the technique.
V. Ciubotaru (Romania)
The author considers that thrombophlebitis is an emergency and should be operated on at the same time as varicose vein disease. The surgical method used was VANST combined with thrombectomy. The only restriction is that the time between the onset of the thrombosis and surgery should not exceed 14 days. No complications have been reported in 574 procedures. No DVT or PE mentioned and the postoperative course was uneventful.
No firm conclusion can be drawn because of the lack of data and the use of this specific surgical method. Nevertheless, removing the clot as soon as possible would probably decrease pigmentation and skin damage. Cosmetic results are still expected.
V. Ciubotaru (Romania)
The author noted a frequent association between saphenopopliteal valve insufficiency and GVS dilatation. This saphenopopliteal reflux transmitted through an oblique communicating vein of the calf could influence the surgical strategy. This anatomical situation was observed in 10.8% patients and led to treatment of both saphenous trunks at the same time in order to limit recurrences. No varicose vein recurrence has been reported. We don’t have any data concerning the duration of follow-up or the type of the surgical procedure performed on the saphenous trunks. We can only suggest that a precise duplex scan as well as a good mapping prior to the intervention could avoid any misunderstanding and prevent any surgical failure.
Chairpersons: Breu F.X.-Cavezzi A.
This was a session about the mechanisms, efficacy, side effects, and possible innovations in foam sclerotherapy.
K. Parsi (Australia) shared with us his experimental findings regarding in vitro effects of two detergent sclerosants, namely sodium tetradecyl sulfate (STS) and polidocanol (POL), on coagulation, platelet activation, aggregation, antithrombotic pathways, and fibrinolysis. Since POL is a nonionic and STS is an ionic detergent they have different effects on proteins, which are denatured by SDS. It was found that at higher concentration (>0.3%) STS prolongs all clotting times, and has anticoagulant properties, significantly destroying FV and FVII, enhancing the effect of activated protein C, and mimicking the effect of antithrombin. STS at high concentration has both an anticoagulant and a pro-thrombotic activity. It destroys protein C, protein S and antithrombin, but this effect is neutralized by its complex anti-thrombotic activity and the final net effect will be anti-thrombotic. At high concentration STS destroys plasminogen, but at the same time destroys inhibitors of fibrinolysis also and the effect will be antifibrinolytic and non-prothrombotic. At lower concentration both detergents have procoagulant properties, POL stronger than STS. Both STS and POL at low concentration stimulate platelet lysis, the release of platelet microparticles, and the release of intracellular calcium from platelets, but inhibit platelet aggregation. At low concentration clots are formed, coagulation time is reduced, clot formation rate is increased, and antifibrinolytic effect is present. Although in vivo confirmation of these effects is lacking, the data presented might have some clinical implications. Since high concentration sclerosants have anticoagulant activity it would be desirable to apply high concentration and low volume and to prevent the dilution and neutralization of sclerosant due to excessive mixing with blood. We should keep in mind that sclerotherapy acts not only on the vein wall but also on circulating blood. Further investigations are needed.
P. Coleridge Smith (UK) posed several questions regarding the efficacy of foam sclerotherapy. How well does it work? How safe is? What do we do to optimize the treatment? He concluded that current trials and meta-analyses do not entirely reflect the clinical outcomes that are achieved in practice. Clinical series published by experts show 80-85% efficacy in curing varicose veins at 5 years, which is a very good result compared with surgery. Foam sclerotherapy has excellent efficacy in treating recurrent varicose veins after surgery. But good technique in skilled hands is everything, emphasized the speaker at the end of his presentation. Unfortunately, we do not have a single standardized and validated technique at the present time.
A. Cavezzi (Italy) started his talk about possible innovations in foam sclerotherapy with two very important physical principles: the smaller the bubbles the higher the active area of foam, the smaller the residual empty space among bubbles and the longer the half-life of bubbles the longer the time of contact with the venous wall. His team did experimental studies to assess the influence of a few variables in the formation and injection of the sclerosant foam and to assess possible innovative procedures in foam sclerotherapy. He concluded that smaller syringes (2.5 mL) generally produce smaller bubbles when using air, not when using CO2/O2. Smaller syringes (2.5 mL) generally produce longer-lasting foam. Low silicon or no-silicon BD Discardit syringes (5 mL) produce smaller bubbles and longer-lasting foam. Conventional syringes (eg, BD, ICO, Braun, etc) produce larger bubbles and much shorter half-life foam. 21G or 23G needles do not denature foam. CO2 produces the smallest bubbles and most homogenous foam, albeit short-lasting. CO2/O2 prolongs half-life compared with CO2. Counter resistance and three-way valve 30 rotation significantly reduce bubble size and increase foam duration. Further studies will investigate how these experimental findings can be implemented in daily practice.
N. Morrison (USA) demonstrated ultrasonographically that foam was present in the peripheral veins, perforators, deep venous system, and right heart within 10- 30 seconds after every injection, no matter the size of the vein injected, how peripheral it was, or the volume of injected foam. If transcranial Doppler is additionally employed, in the presence of the right-to-left shunt, emboli can then be identified in the cerebral circulation. Since 25-30% of the population has a rightto- left shunt, it is not just of theoretical importance that emboli or endothelial breakdown products can be transmitted to the systemic circulation. Methods such as leg elevation, patient immobility, limitation of volume of injected foam, avoidance of movement involving the Valsalva maneuver, all of which are intended to prevent the migration and distribution of these emboli, have been shown to be largely ineffective. Neurosensory side effects have been reported to be rare to uncommon (0-2.6%) in different clinical series and may include visual disturbances, headache, dizziness, hemiparesis, and syncope, all of which are nearly always transient. The question remains open whether the symptoms are related to cardiac and cerebral emboli or not. More recently it has been suggested that circulating emboli following foam sclerotherapy may not be related to neurosensory symptoms, but rather may be a result of endothelial damage releasing a powerful vasoconstrictor such as endothelin. “Biocompatible” gas (CO2/O2) may produce fewer untoward effects than air. The fact is that foam sclerotherapy is generally a very safe and effective method of venous ablation, associated with few side effects and rare to uncommon adverse effects, but caution and training is advised and more information on the physiologic effects of foam is needed.
FX. Breu (Germany) presented the first experience in Germany with CO2/O2 gases in foam sclerotherapy. Based on a post-treatment observational German study on sclerotherapy he concluded that there is no advantage of CO2/O2 versus room air in the case of small volumes of foam. There is, however, a trend towards fewer side effects with CO2/O2 (especially visual disturbances and hyperpigmentation) in the case of high volumes. That’s why CO2/O2 foam may be more effective because larger volumes can be administered and it is probably particularly suitable for large-caliber vessels. However, in a very recent publication (Sarvananthan T, et al, J Vasc Surg 2011, in press) in which a total of 10 819 patients were reviewed (1023 articles searched) no association between the volumes of foam used and the reporting of neurological side effects was identified and no association between the gas used or the ratio of gas and sclerosant and the number or type of neurological side effects was observed. In conclusion, the question of which gas is the best remains open.
Chairpersons: Raymond-Martimbeau P, Frullini A.
This session consisted of a number of presentations dealing with sclerotherapy in the treatment of varicose veins.
F. Vega (Mexico) presented his personal experience using oxygen + polidocanol to make the foam in sclerotherapy in order to prevent serious neurological effects and improving microbubble quality and solubility in blood.
53 legs were sclerosed in 40 patients, foam prepared with 1 mL polidocanol (concentration from 0.5% to 3%) and 4 mL of O2 with a maximum volume injected of 60 mL (average 26.6 mL). No patient had minor or major adverse effects, three required a retreatment, all patients had thrombectomy after 7 days. Sclerosis with foam prepared with O2 and polidocanol is a good option to prevent or reduce neurological effects; foam sclerotherapy performed with O2 allows safer high volume injection.
A. Sommer (The Netherlands) presented a prospective, randomized, controlled study to establish the effectiveness and reduction in health care costs of ultrasoundguided foam sclerotherapy (UGFS) versus surgery. 227 patients underwent high ligation/stripping, 233 UGFS. Follow-up was at 3 months, 1 year, 2 year. Primary outcome: recurrence with a reflux > 0.5 s, 1 or more venous complaints. Secondary outcome: direct hospital costs. At clinical presentation,patients (83% CEAP class C2) were randomized and treated either by UGFS or by high ligation/stripping. GSV diameter in the upper thigh ranged 6.1 mm to 6.8 mm. At 3 months, foam sclerotherapy was performed again in 18 patients and surgery in 3, and at 1 year UGFS was done in 18 patients, and surgery in 7. At 2 years, 35% of the UGFS group showed reflux > 0.5 s, compared with 21% in the surgery group. Tired feeling and cramps improved by more than 50% and pain or restless legs by 50% in both groups. The treatment cost per patient was 1812 euros in the surgery group, and 731 euros in the UGFS group. Complications included thrombophlebitis (7.50%) and hyperpigmentation (12.3%) in the foam group. In conclusion, UGFS is as effective as surgery and costs less.
P. Raymond-Martimbeau (USA) reviewed 11 case studies related to neurological events and disturbance after liquid or foam sclerotherapy and established potential risks and prevention methods. Neurological effects were seen in 61% of women and 38.5% of men (mean age 45 years), 72.7% in large veins and 9% in small veins. The sclerosing agents used were mainly polidocanol and STS. Most patients developed symptoms within 5-20 min after the first treatment. 141 cases of migraine and visual disturbance have been described and among these 15 reported the presence of patent foramen ovale, but its presence was not checked in all cases. TIA and stroke cases typically resulted from paradoxical arterial embolism of the median cerebral artery or vertebral artery, but the underlying mechanism is poorly explained. Air embolism was reported in 6 case studies. Risk factors involved: volume of sclerosant and rate and number of injections, gas used, patient position (no sitting or head elevated), cytokines such as endothelin a strong vasoconstrictor released from the vessel during foam sclerotherapy, microbubbles can precipitate platelet aggregation. Finally the author suggested using the smallest bubbles possible, hydration to avoid constipation, and the Valsalva maneuver during the procedure and prescreening in patients with a history of cryptogenic stroke, severe migraines with aura, sleep apnea, platypnea orthodoxia, stroke with chronic obstructive pulmonary disease, severe co-morbidities.
A. Frullini (Italy) summarized the role of endothelin in visual and neurological disturbances during foam sclerotherapy. The vasoconstrictor endothelin is ten times more most powerful than angiotensin, and induces vasoconstriction and platelet aggregation. The production of endothelin was tested in two groups of rats, Group 1 at 0,1, and 5 min after injection of liquid POL or STS, and Group 2 at 0,1, and 5 min after foam POL or STS. After 5 min the highest production of endothelin was observed in Group 2 with POL (22 pg/mL). Significant endothelin release is present after sclerotherapy and this could be the clue to a new pathogenesis of visual and neurological complications.
A. Cavezzi (Italy) presented his experimental data on the influence of a few variables in the formation and injection/dynamics of the sclerosant foam and to indicate a few possible procedures in foam sclerotherapy. Through an optical microscope an independent blinded observer examined videos and pictures at different time intervals. Several syringes, catheters, needles, gases, and techniques were tested as to bubble size and duration of the foam. 3% sodium tetradecylsulfate (STS) + air or other gases to form foam with a counter-resistance applied at one of the two syringes and 30° rotation in the three-way valve.
BD Discardit 5 mL and Terumo 2.5 mL syringes resulted in the smallest bubble diameter; higher silicone content syringes produced larger bubbles. 23G and 25G needles produced smaller bubbles, 27G and cannula 18 needles larger bubbles.
Gases: CO2 alone produced smaller bubbles than CO2 + O2, and the smallest bubbles and consistent bubbles were produced with CO2+O2 and STS in a 3:1 ratio. An 4-F catheter resulted in 54 micron and 64 micron diameter bubbles at 10” and 30”. When no resistance or no narrowing of the three-way valves was applied, the resulting bubbles showed a 10-20 micron larger diameter, mainly at 10”. Half liquid time (HLT) figures were 190” for 5 mL + 10 mL BD Discardit combination, 163” for 5 mL BD Discardit + 2.5/5 mL Terumo combination, 148” for 2.5 mL Terumo + 5 mL Terumo combination. A 63% decrease in HLT was evident when using conventional, higher silicone content syringes. When no resistance or no three-way valve rotation was included , HLT was 30” shorter. Using CO2 instead of air gave 51” shorter HLT, CO2 + O2 25% shorter HLT. SF with a 4F catheter showed 14” HLT than needle based HLT.
Conclusions: smaller syringes (2.5 mL) produce longer-lasting foam. The BD Discardit syringe (5 mL) produces smaller bubbles and long-lasting foam. Conventional syringes produce larger bubbles and much shorter half-life foam.
BD Discardit 5 mL + Terumo 2.5 mL (or 5 mL) is the best combination in daily practice.
23G or 25G needles do not denature foam. CO2 produces the smallest bubbles and more homogeneous foam, but short-lasting foam; CO2 + O2 prolongs halflife compared with CO2 alone. Resistance and three-way valve 30° rotation reduces bubble size and increases foam duration.
Chairpersons: T. Proebstle, J. Marusiak
C. Stuckey (USA)
The author related his experience of radiofrequency (RF) in private practice over 4 years. He treated a total of 1403 vessels using 1062 catheters through 1361 accesses. The originality of this report is that the author was able to treat more than one vessel from a given access site.
MS. Delbridge (UK)
The recommended energy setting used for the Olympus Celon system is 1.5-2 sec/cm at 18 W and led to a 73% occlusion rate. To increase the occlusion rate without increasing the degree of injury and complications, the author decreased the pull-back speeds to 3-4 s/cm in order to deliver higher energy levels. In this nonrandomized single-center retrospective study, when using lower pull-back speeds the occlusion rate at 6 weeks significantly increased to 97% with an average applied energy of 68 J/cm compared with 36 J/cm with faster pull-back speeds. There were no significant differences between the two groups concerning complications, even if a DVT occurred in the slower pull-back speeds group.
Since the present study is retrospective and single-center, further studies with longer follow-up are required to confirm these interesting results.
S. Belentsov (Russia)
This prospective randomized study investigated the early results after RF ablation of the saphenous trunks. 146 patients with GSV diameters of 4-26 mm and SSV diameters 3-14 mm were treated. Only one minor complication occurred and the occlusion rate was 100% after 6 months.
Good results of RF ablation at 4-year follow-up have been already reported by Pichot and Proebstle. But it is interesting to note that even great saphenous trunks (diameter 26 mm) can be treated by RF with an excellent occlusion rate.
J. Marusiak (Czech Republic)
The author reported the results of a retrospective study of stripping and RF ablation in 180 varicose vein patients. Both groups were treated under general or spinal anesthesia associated with local tumescent anesthesia only for the RF group.
Hematoma, paresthesia, infection, cosmetic results, and recurrence were analyzed. There were no statistical differences between the two groups concerning the number of complications and the rate of clinical or hemodynamic recurrence, but the authors concluded that RF is less painful and results in a better quality of life.
It would have been interesting to compare cosmetic and quality of life results of two different surgical techniques, but because of the use of tumescent local anesthesia in RF group no conclusion can be drawn from this study.
TM. Proebstle (Germany)
The author described a new GSV ablative technique using N-butyl cyanoacrylate glue injected through a catheter. The author considers that the main interest of this technique is that no anesthesia is required and no compression needed. This preliminary study was designed to demonstrate the safety and early efficacy of the method. Eight patients from the Dominican Republic, with a mean GSV diameter of 6.2 mm, were treated using a mean volume of 1.6 mL. No pain was reported during or after the procedure and the complete occlusion rate was 97% at 180- month follow-up. No complications were observed.
Many techniques are used to ablate the GSV and glue is a new one. It seems to be a nonaggressive technique and does not require anesthetic drugs like sclerotherapy. But one would prefer local anesthesia before the puncture of the catheter.
No compression was applied in this study, but some teams have used one-day compression after stripping using a pin-stripper or an endovenous procedure under local tumescent anesthesia in an outpatient setting.
Cyanoacrylate has already been used in surgery to close the skin, to seal and reinforce suture lines, to treat digestive fistula, to control bleeding, and to anchor mesh for hernia repair. But strong inflammation has been reported in some cases leading to deterioration of the tissues, pain, or skin damage, but this was not the case in this study. The author considers cyanoacrylate glue to be quite different from others in that it causes chronic “cold” inflammation rather than acute inflammation. If there is no acute inflammation, there is a lower risk of neurologic side effects as observed with foam sclerotherapy and the immediate occlusion of the vein is probably due to the obliteration of the lumen by the glue itself. So, there could be a risk of embolism as described in one study (1). No embolism was reported in this study thanks to the high viscosity of the glue reported by the author.
These preliminary results have demonstrated the feasibility of the procedure even if the number of patients is very low. No immediate side effects were reported, there was no pain, and the early occlusion rate is excellent, but longer follow-up is required. This could be an interesting technique when ablation of the saphenous vein is required, but should not be used routinely. If the procedure is cost effective and very easy to do, it could be very useful, particularly in poor countries.
Kirti Gupta: Embolization of Cyanoacrylate glue in systemic circulation in a case of hepatocellular carcinoma: an autopsy report Diagnostic Pathology 4:45 , 2009
JF. Uhl (France)
The aim of this study was to evaluate the effectiveness of Celon RF by assessing occlusion rate and clinical results. 100 GSVs were treated using recommended settings for the Celon Catheter (power 19W; pull back 0.6 cm/s, energy 40 J/cm). Few complications and little pain were noted at one week, but 11% of GSVs were recanalized at 2 years. Moreover, the author pointed out that a technical problem occurred during the procedure: the charcoalization of the electrode related to delivery of higher power. To avoid charcoalization and to improve the occlusion rate, the author suggested decreasing the power to 5 W and increasing the application time (pull back 0.1 cm/s). The results of a new study using these new parameters will be given soon.
Some studies have already reported a poor occlusion rate when using recommended settings. We agree with the author that decreasing the power will reduce side effects and that increasing the application time will increase the energy delivered, so a better rate of occlusion is expected. Meanwhile, a strict protocol should be established in a randomized controlled trial.
Chairpersons: T Proebstle, J Strejcek
S. Kaspar (Czech Republic)
The aim of this study was to compare 980 diode (hemoglobin-specific) / 1320 nm Nd Yag (water-specific) / 1470 nm diode (water-specific) lasers and to analyze sides effects and occlusion rate on day 5 using a VAS, quality of life questionnaire, CIVIQ2, and duplex scan. Continuous fiber pull-back and local tumescent anesthesia were used in all cases. Results showed better results in terms of pain, return to daily activity, bruising, and induration with water lasers and better results in terms of bruising and induration with the 1470 nm diode compared with the 1320 nm Nd Yag diode. The occlusion rates were similar. Patients preferred the 1470 nm diode to the 1320 nm and 980 nm diodes.
This prospective study confirms what we know: radial fiber and higher wavelengths give better results in terms of side effects. A radial fiber tip was used with the 1470 nm diode only, but the author considers that this had no impact on the global results because the same quantity of energy was delivered with all 3 lasers.
R. Van den Bos (The Netherlands)
The author described a new GSV ablation technique using steam, produced by a generator and delivered at 120°C into the vein through a catheter. The experimental study was done on sheep and showed good reduction of the vein lumen due to thrombotic occlusion. The human study was done on 24 patients to assess quality of life and GSV occlusion rate at 1 year. One pulse/cm of steam was delivered. Occlusion of the GVS was complete in 13/20 GSVs and partial in 11. No important side effects were noted and post-op quality of life was good. In order to increase the occlusion rate by increasing the heat on the vein wall, the author now uses 2-3 pulses/cm, and the new results will be reported soon.
This new technique seems to be effective in GSV ablation. It is safe and uses a natural product—water. We hope this will decrease the cost of the endovenous treatment of the GSV. With future development of very small and flexible catheters, we could probably use this technique to treat collateral veins. We are also waiting for randomized controlled trials comparing RF, laser, and steam.
S. Elias (USA)
The author described another new technique for ablation of the saphenous trunk. A wire was introduced through a catheter into the vein and guide by Doppler ultrasound. Rotation of the wire at the top of the catheter damages the vein intima. Starting 1 cm from the saphenofemoral junction, the catheter was pulled back at 1-1.5 mm/s and a 1.5% STS solution was injected slowly during the pullback. No anesthesia was required and compression was applied for 2 weeks. The author reported a study where 30 GSVs were treated using 8-10 cc of STS for the GSV. No deep venous thrombosis and no complications were reported, and the occlusion rate was 100% at 6 months of follow-up. This is an interesting albeit single-center study with very short follow-up.
A. Frullini (Italy)
The author described a combination of laser and foam therapy in order to treat large veins (> 1.5 cm). An endovenous water-laser (Holmium 3100) was used to reduce vein diameter to facilitate the action of the foam. In a pilot study, a 50% reduction in vein diameter was obtained at 3 months, which is uncommon with foam alone. No anesthesia was required and no pain or complications were noticed.
T. Proebstle (Germany)
Until 2004 the endovenous failure rate was 5-15% due the low energy doses delivered. After 2004 new concepts were discovered: the energy applied has to be proportional to the vein diameter.
Some details could improve the results: vein compression with the ultrasound probe during the laser procedure making more vein contact with the laser fiber and the slow pull-back of the fiber delivering enough energy (80 to 100 Joules).
Nowadays literature reports indicate 95% to 100% occlusion after five years of follow-up. The focus in recent years has been on reducing side effects by means of new laser wavelengths and new fibers (ceramic, radial). It seems that wavelength matters: the 1470 nm diode is better than the 810 nm diode. Comparative trials during the last 3 years show no relevant difference between endothermal treatments and surgery.
1 – Perrin M. et al. J Vasc Surg (2006)43:327
2 – Ceulen RP. et al. Dermatol Surg 2007;33:276-8.
3 – Proebstle TM. et al. J Vasc Surg (2006)44:834-9.
4 – van den Bos R. et al. J Vasc Surg (2009);49:230-9.
S. Kaspar (Czech Rep.)
Crossectomy was first performed by Trendelenburg in 1890 and is still considered as an option in endovenous ablation. Papers analyzing the distribution of GSV reflux demonstrated: 54% in the terminal valve, 16% in the preterminal valve, 11% in the terminal vein, 6% in mid-thigh perforators, 8% in association with lymphatic and venous reflux, and 5% of other causes.
Observing these results we note that crossectomy is not necessary in 50% of cases.
The important endovenous laser treatment (EVLT) recommendations are: correct positioning (ultrasound-guided) of the catheter or fiber just below the superficial epigastric vein, during the procedure. Advantages of EVLT technique are esthetic results (no incisions), absence or very low incidence of neovascularization, less hematoma compared with surgery, and earlier recovery.
The main goals of EVLT are obliteration of the vessel and maintenance of venous drainage.
Marsh et al 2010 reported 0.15% DVT in 2195 cases of EVLT.
1- Disselhoff BC et al, Eur J Vasc Endovasc Surg 2011 May;41(5):685-90.
2- Marsh P et al, Eur J Vasc Endovasc Surg 2010 Oct;40(4):521-7.
3- Puggioni A et al, J Vasc Surg 2005 Sept.42(3):488-93
4- Proebstle TM etl al, J Vasc Surg 2011 Jul ;54(1) :146-52
Chairpersons: S. Kaspar, H. Partsch
R. Vellettaz (Argentina)
The author did a retrospective analysis of complications of laser ablation. He did 1008 procedures with a 980 nm device. No EVLT turned into conventional surgery. Postoperatively there was pain in 67.55% of cases, ecchymosis in 100%, hematoma in 7.04%, superficial thrombophlebitis in 6.25%, paresthesia in 3.67%, and pigmentation in 3.27%. There were no serious complications either intra- or postoperatively.
J. Ragg (Germany)
The author presented the long-term results of laser ablation. Of 11 900 endovenous laser procedures on great, small, or accessory anterior saphenous veins performed from 2002 till 2010, 614 cases were available for 8-year follow-up. 34 of them (5.5%) had recurrent reflux. Neovascularization in the junction area or residual stumps were not observed. This paper led to some debate about what should be assessed as an outcome of any kind of ablation procedure – technical or clinical parameters.
profiles
R. Van den Bos (The Netherlands)
This Dutch team compared in vitro the impact of wavelength, pull-back speed, and power level on the endovenous temperature profile. They measured temperature in an experimental setting using thermocouples. Different laser parameters and 2 different pull-back speeds (2 and 5 cm/s) with 2 lasers – 940 nm and 1470 nm – were used. The experiments showed that low pull-back speed and increasing of power (up to 14 W) both cause higher maximal temperatures. The use of different wavelengths did not influence the temperature profile so the heat induction is independent of laser wavelength. This study is interesting in view of current opinion regarding the clinical advantages of lasers of higher wavelength.
R. Van den Bos (The Netherlands)
In spite of the large number of studies concerning varicose veins published in recent years, the literature providing evidence of the efficacy of endovenous treatment is relatively scarce. One reason may be the lack of interest shown by manufacturers of medical devices in research (unlike drug companies). In fact, endovenous techniques were implemented in clinical practice before good randomized controlled trials were published.
As to the comparison of endovenous techniques, some randomized controlled trials came to the conclusion that the efficacy is similar: in one trial EVLA was better than RFA and in the other trial EVLA, RFA, or stripping was better than foam sclerotherapy. Secondary outcomes were not routinely monitored. The problem is the lack of methodological consensus (defining what to monitor, how and at when). The parameters suggested to be worth evaluating may be pain, bruising, number of days before to return to normal activities, and patient satisfaction.
Chairperson: S. Michelini.
S. Michelini (Italy) shared with us his clinical experience on lipedema/ lymphedema. Lipedema affects only women and consists of symmetrical, sticky edema of different sizes, pain, tenderness, and with poor response to diet and physical exercise. At the advanced stages it causes marked impairment of individual functions, with serious psychological repercussions, and can be associated with lymphedema. It is important to distinguish lipedema/lymphedema from pure lymphedema. 49 patients were studied at three clinical stages. The authors found an impairment of the ability of patients proportional to clinical disease stage and in the third stage higher-than-average values were noted in the qualifiers of the four domains related to lower limbs (structure, function, performance, and need for facilitators). The patients were treated with complex physical decongestive treatment and in 16 cases with liposuction. At the end of treatment the final garment with elastic compression of 25-40 mm Hg was prescribed depending on the tolerance shown by the patient during the intensive treatment. This disease is little known to the medical community and its effect on quality of life is underestimated as it is considered mainly a cosmetic and dietary problem. That’s why more awareness and knowledge is needed in this issue.
A. Materankova (Czech Rep.) presented her team’s experience with hyaluronidase enzyme injection in the treatment of secondary lymphedema, recurrent erysipelas, and lymphorrhea. The enzyme hyaluronidase degrades hyaluronic acid of subcutaneous proteoglycans, removes scarred tissue, and efficiently helps reconstruct lymphatic drainage of the affected area. Particular steps of the method were mentioned, especially the main rule of performing injections deliberately from the central collecting lymph nodes gradually towards peripheral parts of the body affected by secondary lymphedema, recurring erysipelas, or lymphorrhea. Through two case presentations the authors demonstrated how effective the method is. However, this has yet to be proved in larger studies.
F. Passariello (Italy) described the usefulness in the assessment of lymphedema of the ultrasound volumetry he has developed. The well-known indirect tape volumetry is an easy procedure, which isn’t however able to evaluate the involvement of tissue layers in lymphedema. Ultrasound volumetry measures the volumes of the cutaneous, subcutaneous, and musculoskeletal compartments. Standard anatomical limb reference points are used to achieve more stable measurements. The computation uses the cone trunk formula, modified and extended to the computation of internal volumes. In addition, lengths can be related to the height and standardized according to the weight and to the body mass index or the standard length of limb segments. Measured data are managed by special software, which provide computation and data storage facilities. The method, though still in the observational phase and requiring validation, allows the clinician to detect even localized and subclinical dysfunction in upper andlower limb lymphedema. It is rather time-consuming but is a low-cost lymphedema monitoring method and should be used by experts after validation.
Finally, S. Michelini, shared with us the results of a very impressive study of the genetics and clinical characteristics of Italian families with primary lymphedema. Primary lymphedema usually arises at puberty and may be associated with distichiae (double row of eyelashes). Transmission is autosomal dominant with variable penetrance. The genes involved are mainly those coding for the transcription factor FOXC2 and for receptor 3 of vascular endothelial growth factor VEGFR3. The authors conducted a clinical study in 47 patients from selected Italian families in order to analyze the genotype-phenotype correlation and shed light on prevalence of hereditary lymphedema associated with FOXC2 and VEGFR3 mutations. Patients were selected by a network of medical specialists in lymphology located in 11 Italian regions. The inclusion criteria was the assessment of lymphedema by lymphoscintigraphy, exclusion of secondary causes, enrollment of patients whose family had at least 2 cases of lymphedema and disease onset less than 25 years. Genetic tests involved the extraction of DNA by salting-out from 100 blood samples (1 mL each), which was followed by PCR amplification of the entire coding region and thus sequencing. The work is ongoing, but five new mutations, a mutation already described in literature and several as yet unpublished changes in intronic sequences, were detected. This is the first Italian study in which FOX2 and VEGFR3 mutations were sought among a wide range of clinically selected patients with primary lymphedema. Compared with American series this study shows a significantly lower rate of mutation, suggesting the existence of a new gene playing a major role in the etiology of primary lymphedema in Italian patients.
L. Grozdinski (Bulgaria)
Multiple sclerosis is an inflammatory and neurodegenerative disease of the central nervous system, but its etiology and pathogenic mechanism are unclear. This study compares the ultrasound findings in 50 control patients with 500 patients with multiple sclerosis (from 20 different countries). In the control group the presence of CCSVI was 8% (4 patients) in contrast to 92.25% (461 patients) in those with multiple sclerosis. In all of them, venography confirmed the presence of stenosis, not only in the jugular (100%) but also in the azygos veins (73%). Ultrasound sensitivity was 98%, specificity 66%, and concurrence 91%.
Balloon angioplasty was performed in 1114 (91%) stenosed veins and stent implantation in 98 (9%). Stent thrombosis was high (20 of them, 20%) and low in angioplasty (1, 0.8%). There weren t any major events.
The clinical improvement after treatment was 81% in early follow-up and 60% at 12 months. 21% of patients returned to the previous situation without relapse and the score on the Expanded Disability Status Scale changed from 6.1 pretreatment to 5.2.
The authors concluded that in patients with multiple sclerosis a high frequency of CCSVI is present, and after dilatation of venous stenoses multiple sclerosis symptoms improve. Randomized controlled studies are needed.
