Update of the SFMV (French society of vascular medicine) guidelines on the conditions and safety measures necessary for thermal ablation of the saphenous veins and proposals for unresolved issues.

Venous insufficiency is a very common disease affecting about 25% of the French population (if we combine all stages of its progression). It is a complex disease and its aetiology has not yet been fully elucidated. Some of its causes are well known, such as valvular dysfunction, vein wall defect, and the suctioning effect common to all varicose veins. These factors are generally associated and together lead to dysfunction of one or more of the saphenous veins. Saphenous vein dysfunction is revealed by ultrasound scan, a reflux lasting more than 0.5 seconds indicating venous incompetence. The potential consequences of saphenous vein dysfunction over time include: symptoms (heaviness, swellings, restlessness, cramps, itching of the lower limbs), acute complications (superficial venous thrombosis, varicose bleeding), chronic complications (changes in skin texture and colour, stasis dermatitis, eczema, vein atresia, leg ulcer), and appearance of unaesthetic varicose veins. It is not possible to repair an incompetent saphenous vein. The only therapeutic options at present are ultrasound-guided foam sclerotherapy, physical removal of the vein (saphenous stripping), or its thermal ablation (by laser or radiofrequency treatment), the latter strategy having now become the gold standard as recommended by international guidelines. Recommendations concerning thermal ablation of saphenous veins were published in 2014 by the Société française de médecine vasculaire. Our society has now decided to update these recommendations, taking this opportunity to discuss unresolved issues and issues not addressed in the original guidelines. Thermal ablation of an incompetent saphenous vein consists in destroying this by means of a heating element introduced via ultrasound-guided venous puncture. The heating element comprises either a laser fibre or a radiofrequency catheter. The practitioner must provide the patient with full information about the procedure and obtain his/her consent prior to its implementation. The checklist concerning the interventional procedure issued by the HAS should be validated for each patient (see the appended document).

[Questions--answers on the use of rivaroxaban for the treatment of venous thromboembolic disease]. / Questions - réponses sur l'utilisation du rivaroxaban pour le traitement de la maladie thromboembolique veineuse.

Rivaroxaban is a direct oral anticoagulant targeting factor Xa. Efficacy and safety of rivaroxaban were evaluated through the phase 3 EINSTEIN program, consisting in three clinical trials regarding the treatment of deep vein thrombosis (EINSTEIN DVT), pulmonary embolism (EINSTEIN PE), and in secondary prevention after a first episode of venous thromboembolic disease (EISNTEIN EXT). Rivaroxaban was recently approved both by the European and the French Health agencies for the treatment of DVT and prevention of deep vein thrombosis recurrence. This report addresses the use of rivaroxaban in clinical practice in such indications.

[Compression therapy and deep-vein thrombosis: a clinical practice survey]. / Compression veineuse et thrombose veineuse profonde. Enquête de pratique en médecine vasculaire.

BACKGROUND: Compression therapy constitutes the cornerstone of prevention of post-thrombotic syndrome in patients with deep-vein thrombosis (DVT). However, no consensus has been reached regarding the optimal timing for initiation, duration, and strength of compression therapy. OBJECTIVE: To document prescribing practices of compression therapy in case of DVT by French Vascular Medicine physicians. METHODS: E-mail survey sent in 2009 to all physicians members of the French Society of Vascular Medicine. RESULTS: Seven hundred and sixty-one vascular medicine physicians (56.6% private practice, 19.8% hospital-based and 23.6% both private practice and hospital-based physicians) responded. At diagnosis, 94.3% (n=707) systematically prescribed compression therapy. The initial compression consisted in elastic compression stockings (ECS) for 57.3% of patients (n=426) and in bandages for 42.7% (n=317). When physicians initially prescribed bandages, in 92.3% of cases they later switched to elastic compression stockings (ECS). Finally, 95.8% (n=712) of vascular medicine physicians reported prescribing ECS during DVT follow-up. The ECS ankle pressure gradient was 15-20 mmHg in 64.3% of cases and 20-36 mmHg in 35.5%. Most physicians (85.9%, n=631) modulated the duration of compression therapy according to the results of follow-up compression ultrasonographic explorations. Only a limited proportion of physicians took into account thrombus localization or its initial extention. CONCLUSION: In case of DVT, French vascular medicine physicians systematically prescribed compression therapy. However, the strength of compression was lower than recommended by international guidelines. Efficacy and benefits (potential better compliance) of this common practice should be assessed with a randomized controlled trial.

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.

Efficacy of Daflon 500 mg in venous leg ulcer healing: a double-blind, randomized, controlled versus placebo trial in 107 patients.

The objective of this study was to evaluate the efficacy of Daflon 500 mg (Dios)* in venous ulcers. A multicenter, double-blind, randomized, controlled versus placebo (Plac) trial was conducted, with stratification according to the size of ulcer (< or = 10 cm and > 10 cm). The protocol called for a two-month treatment with Dios (one tablet = 450 mg micronized purified Diosmin) or a placebo, two tablets/day, in addition to compression therapy. Evaluations were performed every fifteen days, from D0 to D60. The primary endpoint, in accordance with Alexander House group requirements were: percentage of patients with complete ulcer healing, ie, comparison between Dios and Plac group at D60, and comparison of survival curves in each group between D0 and D60 (log rank test). Secondary endpoints included ulcer surface area assessed by computerized planimetric measurements, qualitative evaluation of ulcers, and symptoms. The patients were 105 men and women ranging in age from eighteen to eighty-five years, with standard compression stocking, who were undergoing standardized local care of ulcer and had no significant arterial disease (ankle/arm systolic pressure index > 0.8). Fifty-three patients received Dios, and 52 received Plac. The 2 groups were well matched for age (m +/- 1 SD = seventy-one +/- eleven years), gender, ulcer size, and associated disorders. Among patients with ulcer size < or = 10 cm (Dios = 44, Plac = 47) a significantly larger number of patients had a complete ulcer healing at two months in the Dios group (n = 14) in comparison with the Plac group (n = 6) (32% vs 13%, P = 0.028) with a significantly shorter time duration of healing (P = 0.037). No difference was shown for the secondary criteria, except for sensation of heavy legs (P = 0.039) and a less atonic aspect of ulcer (P = 0.030) in favor of Dios. Among the 14 patients with ulcer size > 10 cm (Dios = 9, Plac = 5), subjected to a descriptive analysis only, no ulcer healed. This study showed that a two-month course of Daflon 500 mg at a daily dose of two tablets, in addition to conventional treatment, is of benefit in patients with venous ulcer < or = 10 cm by accelerating complete healing.

Benefit of a 2-month treatment with a micronized, purified flavonoidic fraction on venous ulcer healing. A randomized, double-blind, controlled versus placebo trial.

OBJECTIVE: To assess the efficacy of a micronized purified flavonoid fraction (Daflon 500 mg = Dios) in venous leg ulcer healing, in addition to compression therapy and standardized local care. DESIGN: Double-blind, multicentre, randomized, parallel groups, controlled versus placebo trial; stratification according to ulcer size. SUBJECTS: 107 patients, with venous ulcer of the leg for at least 3 months, and accepting bandaging therapy. RESULTS: 105 patients (Dios = 53, placebo = 52) were available for an intention to treat (ITT) analysis. Age (mean +/- SD, 71+/-11 years), gender (M = 33, F = 74) and ulcer size were evenly distributed among both groups. 99 patients completed the protocol (Dios = 51, placebo = 48). Among the 91 patients with ulcer size < or = 100 cm (Dios = 44, placebo = 47), a significantly higher number of patients had complete ulcer healing at 2 months in the Dios group (n = 14) in comparison to the placebo group (n = 6) after ITT analysis (32 vs. 13%, p = 0.028) and after per protocol analysis (32 vs. 14%, p = 0.048), and a shorter time duration of healing (p = 0.037). Among the 14 patients with ulcer size > 10 cm (Dios = 9, placebo = 5), no ulcer healed. CONCLUSION: This study showed that a 2-month course of purified micronized flavonoid fraction (2 tablets/day), in addition to conventional treatment, is of benefit in patients by accelerating complete healing of venous leg ulcers which are < or = 10 cm in diameter.

[Lymphatic complications from variceal surgery]. / Complications lymphatiques de la chirurgie des varices.

INTRODUCTION: Lymphatic injuries are unavoidable during varicose vein surgery. However these injuries seldom lead to complications. This study was held to try to find an explanation to this contradiction which seems to be only noticeable. MATERIAL AND METHOD: If anatomy shows that it is impossible to operate on varicose veins without injuring lymphatic vessels, the regeneration power of these latters, known for a long time, is such that complications due to these injuries are all the more exceptional that surgeries are less traumatizing than it used to be. Nowadays, each surgeon is only faced to a small number of such complications during their career. This rareness makes a methodical personal study quasi-impossible. That is why we sent a questionnaire to about thirty surgeons specialized in this field. This questionnaire, about their experience, dealt with lymphatic complications they had met during varicose veins surgery. RESULTS: Twenty three answers were sent in time and deal with more than 184,000 surgeries. The lymphatic complication rate is about 8.7%, 5.4% of which are lymphorrhea, 2.6% of lymphocele, 1.09% of lymphangitis and 0.5% of lymphoedema. Of course, these figures are approximate. Lymphoedema is the only long-lasting lymphatic complication of the varicose veins surgery. CONCLUSIONS: According to us, sclerotherapy seems to be more effective than surgery, in case of signs, even benign, of lymphatic insufficiency.

[Echography and sclerotherapy]. / Echo-sclérose.

Duplex-scanning represents major progress in diagnosis of venous insufficiency. It now permits also amelioration of sclerotherapy, by direct visual reference to the Doppler screen by which means we guide puncture of the vein and control the injection, whether the vein is deep or the location difficult. It permits us also to follow up the results rigorously. The video shows the injection technique by Doppler guidance. The authors report the initial results of a study of 72 consecutive cases.

[Distal obliterating arteriopathy of the lower limbs in a systemic disease. Treatment with normovolemic hemodilution. [Report of one case]]. / Artériopathie oblitérante distale des membres inférieurs dans le cadre d'une maladie de système. Traitement par hémodilution normovolémique [à propos d'un cas].

The authors report on a 31 year old man with a generalised illness consisting of: buccal aphthous ulcers, distal arteriopathy, multiform cutaneous lesions (necrotising vasculitis, folliculitis, nodules), hypersensitivity at the site of puncture, Raynaud's syndrome and superficial venous thromboses. After the failure of various therapies (calcium heparin, ticlopidine, colchicine, corticoids, immunostimulants), the patient was successfully treated by normovolemic haemodilution on 20 occasions, obtaining each time healing of the skin lesions within 2 to 4 weeks.

[Ultrasonography of the popliteal fossa. Survey of a small saphenous arteriole before sclerotherapy]. / Echographie du creux poplité. Recherche d'une artériole petite saphène avant sclérothérapie.

Routine investigation by ultrasonography with pulsed Doppler was carried out in 125 patients, candidates for sclerosing injections of the short saphenous. Study of the contents of the popliteal fossa, of the short saphenous, of the position of its junction in relation to the joint line of the knee, as well as detection of a possible satellite arteriole of the short saphenous was undertaken from a hemodynamic and topographic standpoint. A small calibre satellite arteriole of the short saphenous was a virtually constant finding, situated deep to the junction of the short saphenous, parallel to the latter at its origin, and interposed between the popliteal and short saphenous veins. Variations in the size and/or position of this vessel in relation to the saphenous could be considered as being partially responsible for complications of sclerosing injections in this area. Study involved the junction of the short saphenous, its size, continence and position in relation to the joint line of the knee, as well as the presence, size and position in relation to the saphenous of a satellite arteriole.

[Stripping using invagination over a calibrated stent]. / Les strippings par invagination sur mèches calibrées.

After crossectomy which remains the most important stage, a short stripping is performed in an upward direction, substituting a packing for the olive shaped knob normally used. The width of this gauze packing depends on the diameter of the saphenous vein. Traction of the lower end of the stripper, at the ankle, pulls down the packing within the saphenous vein, causing its invagination. The saphenous vein is thus turned outside in over the packing as it comes out through the lower incision. Besides, this packing ensures haemostasis and is only removed at the end of the procedure. Advantages of this method: absence of haematomas and nerve lesions. Smaller lower incision.

[A trial of silver sulfadiazine in the local treatment of venous ulcer]. / Essai de la sulfadiazine argentique dans le traitement local de l'ulcère veineux.

Silver sulfadiazine, in cream form, has been mostly used in the treatment of burns. Its trial in the treatment of leg ulcers has been satisfactory. This preparation is well tolerated, and effective on wound cleansing and granulation tissue formation. It is particularly indicated in cases of superinfected ulcers, effective on most Gram + and Gram - bacteria.