In vivo biological effects of foam sclerotherapy.

OBJECTIVES: This study aims to assess by biological markers the in vivo consequences of foam sclerotherapy (FS) of saphenous veins. The secondary objective of this randomised controlled trial (RCT) is to compare results of two randomised groups: with or without post-treatment compression. PATIENTS AND METHODS: Forty patients with incompetent great or small saphenous veins underwent ultrasound-guided FS. Randomisation was conducted immediately after sclerotherapy to two parallel groups, one (CG) with compression stockings and the other (WCG) without compression. A laboratory work-up was done on days 0 (before sclerotherapy), 1, 7, 14 and 28. The studied markers were: fibrinogen, factor VIII, thrombomodulin, thrombin-antithrombin complex, D-dimers, platelet factor 4 and troponin. RESULTS: General data repartition was homogenous for CG and WCG. Twenty patients were included in each group (females 90%; mean age 58 years). On day 28 (D28), the occlusion rate of the veins was 100% in both groups. In all the samples (D0-D28), apart from a moderate D-dimers' increase at D1-D14, no significant biological change was observed in either the WCG or the CG groups. CONCLUSION: In terms of inflammation and coagulation, FS seems to have a minimal effect on peripheral blood, either with or without post-treatment compression and does not appear to have an effect on the myocardial risk.

Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression.

OBJECTIVES: This study aims to compare the efficacy and side effects of foam sclerotherapy of the saphenous veins with or without post-treatment compression using graduated elastic stockings. DESIGN: This is a prospective open randomised controlled trial conducted in two centres. PATIENTS AND METHODS: Sixty patients with incompetent great (GSV) or small saphenous veins (SSV) underwent ultrasound-guided foam sclerotherapy. Randomisation was conducted immediately after sclerotherapy to two parallel groups, one (CG) with compression stockings (15-20 mmHg worn during the day, for 3 weeks) and the other (WCG) without compression. Efficacy of sclerotherapy and all of the side effects were assessed, including side effects in the treated region. On days 14 and 28, clinical and duplex ultrasound (DUS) assessments were performed by independent experts. Patients also completed quality of life (QOL), symptom questionnaires and provided satisfaction scores. RESULTS: Five men and 55 women ranging in age from 32 to 78 (mean 57 years) years were included: 29 in the WCG and 31 in the CG group. On day 28, abolition of venous reflux and occlusion of the vein was obtained in 100% of the cases in both groups. The length of the occluded vein was the same in both groups (mean 36 cm for the GSV and 30 cm for the SSV) as was the mean diameter of the occluded vein (5 mm). Symptoms and QOL questionnaires showed equivalent improvement in both groups on day 28 compared to pre-treatment assessments. Side effects were few with no statistical difference between the two groups. Patient satisfaction scores were high in both groups for the outcome of sclerotherapy results, and good or very good for compression in 50% of the CG cases. CONCLUSION: We found no difference between compression and control groups when comparing efficacy, side effects, satisfaction scores, symptoms and QOL. Further studies are required to establish the role of compression in sclerotherapy and to evaluate other compression strategies.

Efficacy of polidocanol foam versus liquid in sclerotherapy of the great saphenous vein: a multicentre randomised controlled trial with a 2-year follow-up.

OBJECTIVE: To compare the relative efficacy of polidocanol (Aetoxisclerol, Kreussler, Germany) when used as a foam or liquid in the treatment of saphenous incompetence. MATERIALS AND METHODS: Multicentre, prospective, randomised controlled trial conducted in patients with incompetence of the great saphenous vein (GSV) with a truncal diameter of 4-8 mm. The great saphenous vein was injected using a single injection 2-2.5 ml of either 3% polidocanol or sclerosant foam containing one-fifth 3% polidocanol to four-fifths air (DSS technique). Clinical assessments and duplex ultrasound scanning were performed after 3 weeks and then every 6 months for 2 years. No re-injection was performed irrespective of the immediate result. The main outcome measure was elimination of GSV reflux. RESULTS: Ninety-five patients participated in the study, 47 were randomised to the foam sclerosant group and 48 to the liquid group. No significant difference between the 2 groups was found regarding sex, age, height, weight and saphenous vein diameter. At 3 weeks, complete elimination of reflux was obtained in 17 of the 48 patients (35%) who received liquid sclerotherapy, versus 40 of the 47 subjects (85%) in the foam group (p<0.001, Chi squared). The incidence of immediate venous spasm and the length of the sclerotic reaction, occlusion measured by echography, were significantly greater in the foam group. There was no difference in the incidence of ecchymosis, inflammatory reactions or other side effects. Follow-up of 6, 12, 18 and 24 months confirms our early results published in 2003. In total only 5 patients were lost to follow-up at 2 years (all of them were in foam group). These patients were included in the final outcome analysis as treatment failures (success rates at 2 years: 53% in foam group and 12% in liquid group). CONCLUSION: The sclerosant foam used in this study was more than twice as effective as the liquid from which the foam was prepared.

Comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-blind trial with 2 year-follow-up. "The 3/1 Study".

OBJECTIVES: To compare 1% and 3% POL foam in treating the great saphenous vein (GSV) by ultrasound guided sclerotherapy. DESIGN: Multicentre, prospective, randomised, double-blind trial with 2 year-follow-up. PATIENTS AND METHODS: 148 patients with GSV reflux (saphenous trunk diameter 4-8 mm) were randomised to undergo ultrasound guided foam sclerotherapy using either 1% or 3% POL foam in a single session. Foam production was standardised using a sterile disposable syringe kit including sterile air and the Turbofoam machine. Duplex ultrasonography was used to assess the outcome at 3 weeks, 6 months, 1 year, 18 months and 2 years. The main criterion of success was the disappearance of the venous reflux. The length of occlusion of the vein (only measured at 3 week-echography assessment) was a secondary criterion. Side effects were assessed. RESULTS: 74 patients were included in each group. The mean volume of foam injected was 4.4 ml for the 3% group and 4.6 ml for the 1% group. After 3 weeks, reflux was abolished in 96% (71 patients) of the 3% group and 88% (68 patients) of the 1% group (NS). The mean occlusion length of the vein was 38 cm for the 3% group and 34 for the 1% group (NS). After 2-years, reflux was absent in 69% of the 3% group and 68% of the 1% group (NS). 14 patients were lost to follow-up at 2 years. CONCLUSION: This study demonstrates equivalent efficacy for 1% POL and 3% POL foam in sclerotherapy of the GSV where the trunk is less than 8 mm in diameter. These data obtained two years of follow-up confirm our previously reported 6 month-follow-up data published in 2005.

[Foam echosclerotherapy by puncture-direct injection: technique and quantities]. / Echosclérothérapie à la mousse par ponction-injection directe à l'aiguille: technique et doses.

Foam echosclerotherapy by puncture - direct injection (EMPID) is a technique approved by the French Health Authorities for the management of varicose veins. It combines two principles: the injection of a sclerosing agent by echomonitored direct puncture and the use of this sclerosing agent as a foam. The procedure consists of four stages: targeting of the vein to sclerose and selection of the puncture site, venous puncture under echographic guiding, injection of the sclerosing product under complete echographic monitoring, and post-injection control, checking for the impact of the action and the distribution of the foam in the treated vein. First intention indications concern essentially isolated troncular reflux in lesser and great saphena veins and varicose recurrences. In second intention, EMPID is also an alternative to conventional varicose resection surgery. Emphasizing the principle of precaution, we underline the usefulness of a fine, extemporaneous, standardized and reproducible microfoam - high doses, in particular large volumes of foam, are unwarranted since it has been proven that small volumes are as effective. The recommended concentrations are directly linked to the maximal diameter of the saphena trunks targeted. The volume of foam to be injected must be determined on an individual basis and depends on the presence or not of post-injection spasm, the degree of venous filling and the endothelial impregnation of the treated varicosity (which can be easily monitored because of the spontaneous visualization of the foam producing a tracing effect on the ultrasound); it should not exceed 7.5 ml per session. Apart from the classical side effects due to the liquid form, the foam presents its own, very rare, side effects consisting of minor, constantly and spontaneously reversible, eye disorders. The foam is contraindicated for patients suffering from migraine due to higher incidence of such visual disorders. EMPID is an outpatient procedure for the treatment of varicosities which requires considerable operator skill. This technique cannot be proposed on a large scale without proper and specific training.

Thermal ablation of saphenous veins is feasible and safe in patients older than 75 years: A prospective study (EVTA study).

OBJECTIVES: To investigate the tolerance and safety of thermal ablation (TA), consisting of radiofrequency or endovenous laser (EVLA) of saphenous veins (SV) in elderly (group 1 ≥75 years), compared with a control group (group 2 <75 years). METHOD: An Observational multicenter-prospective study was conducted, under the aegis of the French and Swiss Societies of Phlebology (18 centers). Ninety patients were included in group 1, 617 in group 2 (mean age 80 years and 53 years; 69% women in both groups), representing 863 SV. Mean trunk diameters were similar in both groups (small SV: 6 mm; great SV: 7 mm). In group 1, comorbidities were more frequent, particularly cardiac insufficiency, diabetes, history of thrombosis, and CEAP clinical class was significantly higher. RESULTS: EVLA was used in 86% of cases. Settings used were similar in both groups for each technique. Only 6% of TA was performed in an operating room for group 1 (14% group 2). Tumescent local anaesthesia (TLA) alone was used in 91% of cases in group 1 (85% group 2). The mean pain score was only 1.6 for the procedure itself (VASP 0-10; 10 max.) and 1.4 for the 10 days following the procedure. Side effects were few, but rate of paraesthesia was higher when general anaesthesia was used (11.8%) compared with TLA alone (2.2%). At three months, 100% of SV was occluded in group 1 (99.5% group 2), with high satisfaction score (9.3/10). CONCLUSION: TA is safe and effective in elderly; it should be performed strictly under TLA to minimize side effects.

[A misunderstood treatment for hyperhidrosis: ionization. Principles, material, methodology, early results]. / Un traitement méconnu de l'hyperhidrose: l'ionisation. Principes, matériel, méthodologie, résultats précoces.

Based on a new and specific apparatus developed by one of the authors, an original method of treatment of palmoplantar hyperhidrosis, either essential or associated with acrocyanosis, is described in detail. The extremities to be treated are placed in tanks containing tap water ensuring conduction fo current between epidermis and electrode. The recommended current of 20 milli-amperes is obtained by adjustment of a potentiometer. Treatment sessions (20 minutes for hands or feet, 40 for all four extremities) take place with a well defined frequency: 3 the first week, 2 the second, I the following two weeks. Maintenance sessions are necessary when sweating recurs. In a longitudinal series of 29 patients, 28 (96.5%) were significantly improved. From the 5th session onwards, the decrease in hyperhidrosis was evaluated by patients as very pronounced in 5 cases (17.2%) and as complete in 21 cases (72.5%). In 5 of the 6 patients with hyperhidrosis associated with acrocyanosis, the patients reported attenuation of cyanotic coloration of skin and relative warming up of extremities treated. Tolerance was excellent in 28 cases, incidents being rare and minor. Patients with pacemakers cannot be treated by this method.

[Value of the velocimetry study of the uterine arteries in retro-placental hematoma. Report of 3 cases]. / Intérêt de l'étude vélocimétrique des artères utérines dans l'hématome rétro-placentaire. A propos de 3 observations.

Retroplacental hematoma is a sudden accident with unfavorable prognosis, especially since predictive signs (clinical, biological or ultrasonographic) are very frequently absent. The purpose of this study was to determine whether velocimetric study of the uterine arteries is of predictive value in this pathology. The equipment used was Doppler ultrasound with spectral analysis (4-MHz probe) without echography. Each examination consisted in systematic study of both uterine arteries and of umbilical flow. The recording technique for the uterine arteries is described, and 3 cases of retroplacental hematoma are reported. In all 3 cases, the resistance index for one of the uterine arteries (right twice, left once) was high, with the presence of a (proto-diastolic notch on the curve, whereas the umbilical index was normal and there were no other signs predictive of the placental accident. The value of Doppler exploration has already been demonstrated for numerous obstetric indications, and it should be possible to include others, particularly if this preliminary study is confirmed on a larger scale.

Endovenous laser procedure in a clinic room: feasibility and side effects study of 1,700 cases.

OBJECTIVES: To assess the feasibility of saphenous veins ablation by laser in a clinic room. To study immediate and short term (1 to 6 months) complications and to pinpoint those that could be directly linked to this environment. Efficacy of the technique should also be documented. METHODS: Retrospective study (22 centres) carried out in France and Switzerland. Patients with insufficiency of great saphenous vein (GSV) or small saphenous vein (SSV). Clinical stages of clinical, [corrected] aetiological, anatomical and pathophysiological classification (CEAP) C2 to C6. Endovenous laser procedures were performed outside an operating theatre, under local anaesthesia and without high ligation. Efficacy criteria: occlusion of the vein and disappearance of the pathological reflux (duplex scan assessment). The side effects and complications were studied. RESULTS: A total of 1703 procedures (1422 patients) were performed; 74% of the patients were women. [corrected] The mean age of the patients was 57. A total of 1394 GSV and 309 SSV were treated (mean diameters 7.2 mm and 6.4 mm, respectively). Overall success level was 97% and mean length of veins treated was 40 cm for GSV and 21 cm for SSV. Energy applied in joules per centimeter was homogenous (mean and median 64 for GSV and 65 for SSV). Complications were rare and 'simple' apart from one pulmonary embolism which occurred 10 days after a GSV procedure, although no deep vein thrombus was found. A total of two infections were observed: one was an infection localized at the site of access and the other was erysipelas. [corrected] CONCLUSION: Except 2 limited infections (0.1%), this large retrospective study of laser procedures performed outside the operating theatre did not reveal any significant specific complications as regards the environment required. The efficacy results were equivalent to those found in the literature. Regarding cost and constraints induced by operating theatre environment, the clinic room should be able to offer an easier and economic alternative option for saphenous veins ablation with laser [corrected]

Sclerotherapy of varicose veins in patients with documented thrombophilia: a prospective controlled randomized study of 105 cases.

OBJECTIVES: The aim of this study was to assess thrombotic complications following sclerotherapy in thrombophilic patients in combination with thromboprophylaxis, in two randomized arms using low molecular weight heparin (LMWH) or warfarin. Patients and methods This study received approval from the Ethics Committee. A total of 105 patients (81 females, 24 males) ranging in age from 20 to 82 years (mean 50) were selected: 75 with Factor V Leiden mutation, 18 with prothrombin 20210A mutation, 7 with high level of Factor VIII, 5 combinations of these. After randomization, 51 and 54 patients received warfarin and LMWH, respectively. A total of 199 sclerotherapy sessions were performed. Foam was used in 160 treatments. RESULTS: No episodes of symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) occurred; no instances of DVT were revealed by ultrasound-monitoring. CONCLUSIONS: This study suggests that in the three most common forms of thrombophilia, sclerotherapy, in combination with thromboprophylaxis, can be performed safely. Prophylaxis with LMWH is easier to use than warfarin.

[Ionophoresis: effective and misunderstood treatment in hyperhidrosis. Principles, material, methodology and results]. / L'ionophorèse: traitement efficace et méconnu de l'hyperhidrose. Principe, matériel, méthodologie, résultats.

The development of a modern and specific device, using the principle of ionophoresis, enables now to treat a symptom, sometimes severely disabling, before which physicians felt helpless until now: hyperhidrosis. The methodology is simple, and the treatment well tolerated. The efficacy, demonstrated by our study, is particularly impressive, if a strict protocol is followed.

[The value of velocimetric investigation of the uterine arteries in retro-placental hematoma. 3 cases]. / Intérêt de l'étude vélocimétrique des artères utérines dans l'hématome rétro-placentaire. A propos de 3 observations.

Retro-placental hematoma is a sudden event with a serious prognosis which is aggravated by the very frequent absence of premonitory clinical, biological or ultrasonic signs. Does a velocimetric investigation of the uterine arteries have any predictive value in this disorder? The apparatus used was a continuous Doppler with spectral analysis and a 4 MHz probe no ultrasonic location. Each examination involved the exploration of 2 uterine arteries and of the umbilical flow. The method of recording the uterine arteries is described. Three cases of retro-placental hematoma are reported. In these three cases, an increase in the resistance index of one of the uterine arteries (the right artery in 2 cases and the left in 1 case) was detected with the presence of a protodiastolic notch on the trace, whereas the umbilical index itself was normal and no other sign was present which could predict the placental event. The value of the Doppler recording is already established in many obstetric indications, and these should be extended yet further, particularly if this preliminary study is confirmed on a larger scale.

[Value of a velocimetric study of the uterine arteries in retroplacental hematoma. 3 case reports]. / Intérêt de l'étude vélocimétrique des artères utérines dans l'hématome rétro-placentaire. A propos de 3 observations.

Retroplacental hematoma is a sudden event with a poor prognosis, the latter being aggravated by the very frequent lack of predictive clinical, laboratory or echographic signs. Does studying the velocity of blood flow in uterine arteries have a predictive value in this disease? The equipment used was a continuous Döppler with spectral analysis and probe of 4 MHz, without echographic identification. Each examination systematically included the study of the 2 uterine arteries and the umbilical flow. The technique for recording flow in the uterine arteries is described. A report is given of three cases of retroplacental haematoma. An increase in the resistance index in one of the uterine arteries was found in the three cases (twice on the right, and once on the left), with a protodiastolic notch on the curve, whereas the umbilical index itself was normal and there were no other sign that indicated the placental event. The Döppler is already known to be of value in numerous indications in obstetrics: it should be possible to extend these indications even further, particularly if this preliminary study is confirmed on a broader scale.