Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins.

BACKGROUND: This was a prospective study of radiofrequency segmental thermal ablation (RFA) for the treatment of incompetent varicose great saphenous veins (GSVs). The present report describes long-term follow-up at 5 years. METHODS: The 5-year follow-up of this multicentre European study included assessment of the Venous Clinical Severity Score (VCSS), and GSV occlusion and reflux on duplex imaging. RESULTS: A total of 225 patients had 295 GSVs treated by RFA, achieving an initial vein occlusion rate of 100 per cent. With 80·0 per cent compliance, Kaplan-Meier analyses showed a GSV occlusion rate of 91·9 per cent and a reflux-free rate of 94·9 per cent at 5 years. Among the 15 GSVs noted with reflux during follow-up, only three showed full recanalization of the GSV at 1 week, 6 months and 3 years. Of the 12 legs with partial recanalization, reflux originated at the saphenofemoral junction in ten, with a mean length of the patent segment of 5·8 (range 3·2-10) cm; only six patients were symptomatic. Mean(s.d.) VCSS scores improved from 3·9(2·1) at baseline to 0·6(1·2), 0·9(1·3) and 1·3(1·7) at 1, 3 and 5 years. CONCLUSION: At 5 years RFA proved to be an efficient endovenous treatment for incompetent GSVs in terms of sustained clinical and anatomical success for the vast majority of treated patients.

Great saphenous vein ablation with steam injection: results of a multicentre study.

OBJECTIVE: To assess the safety and efficiency of steam vein sclerosis (SVS) of the great saphenous vein (GSV) in a multicentre open prospective cohort study. DESIGN: 75 consecutive adult patients with GSV reflux, CEAP C2-C5 and vein diameter 4-13 mm. METHODS: Patients treated using an SVS™ generator delivering homogenous pulses of superheated steam were followed up at 8 days and 1, 3, 6 and 12 months (clinical, duplex ultrasound, quality of life [QoL] with SF12). RESULTS: 88 veins were treated in 75 patients. At 6 months, 72/75 (96%) veins were obliterated (95% CI: 89-99) and Kaplan-Meier analysis found an obliteration rate of 96.1% at 12 months. QoL increased at 6 months for both the physical and mental components (p = 0.049 and p < 0.001 respectively). SVS was well tolerated: no major complications were reported. Adverse events occurred mainly at day 8 and incidents amounted to ecchymosis (n = 60) and pain (n = 7). CONCLUSIONS: SVS achieved an obliteration rate similar to that of other thermal ablation techniques. It was well tolerated with minimal post-operative pain.

Reprinted article "Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up".

PURPOSE: To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial. METHODS: Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire. RESULTS: The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment. CONCLUSION: The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.

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).

Effect of novel environmental stimuli on rat behaviour and central noradrenaline function measured by in vivo microdialysis.

RATIONALE: Although physically aversive stimuli induce functional changes in central noradrenergic neurones, little is known about the noradrenergic response to environmentally aversive stimuli. OBJECTIVES: The first aim was to characterise environmental features that are perceived as stressful by rats. The second was to investigate whether changes in the concentration of extracellular noradrenaline are induced by these environmental features. METHODS: A light/dark shuttle-box was used to test rats' behavioural response to a range of stimuli (novelty, bright light, and the presence of an unfamiliar rat), either before or after microdialysis probe implantation. Changes in the concentration of extracellular noradrenaline in the frontal cortex and hypothalamus in vivo were then evaluated on exposure to these same test conditions. RESULTS: Naive rats spent less time in a brightly-lit test arena than a dark one. However, the behavioural response to the light arena was attenuated by the presence of an unfamiliar rat. Probe implantation intensified the response to the light arena but did not affect behaviour in the dark arena. In the microdialysis studies, there was no change in the concentration of extracellular noradrenaline on transfer of rats to the dark arena but there was an increase in both the frontal cortex (+45%) and hypothalamus (+75%) on exposure to the light arena. A similar increase was induced in both brain regions when the light arena contained an unfamiliar rat. CONCLUSIONS: Implantation of a microdialysis probe modifies the behavioural responses to certain environmental stimuli. Regardless of this, the extent to which rats perceive a novel environment as aversive is not the only determinant of the noradrenergic response to such stimuli. However, differences in stimulus controllability in the microdialysis and the behavioural experiments could influence the apparent intensity of the stress.

[125 reinterventions for recurrent popliteal varicose veins after excision of the short saphenous vein. Anatomical and physiological hypotheses of the mechanism of recurrence]. / 125 réinterventions pour récidives variqueuses poplitées après exérèse de la petite saphène. Hypothèses anatomiques et physiologiques du mécanisme de la récidive.

Recurrence of popliteal varicose veins has long been attributed to insufficient excision of an incompetent short saphenous vein. Indeed, recurrence is still frequent after surgery of the short saphenous. In order to assess the risk of insufficient excision and study the mechanism of recurrence, we reviewed 125 popliteal procedures for recurrence after excision of an incompetent short saphenous vein. Among this series, 48 were personal procedures and among these, 43 had been performed without preoperative ultrasound explorations prior to 1991. Recurrences were classified into five categories (table I) according to the anatomic presentation at reoperation. Type 1) 17 patients had an intact short saphenous (13.6%) with either an inadequate incision or a simple recanalized suture. Type 2) 53 patients had a long stump (42.4%) with new superficial varicose communications. Type 3) 4 patients had a small residual and incompetent short saphenous trunk (3.2%), 20 patients had both a long stump and an incompetent residual trunk (16%). Type 4) 29 patients had incompetent popliteal perforating veins (23.2%). Type 5) 2 patients developed recurrence on a new varicose communication which followed the posterior nerves of the thigh. Among our personal series, 43 reoperations for recurrence were performed without preoperative duplex Doppler exploration. Among them, excision was insufficient in 38 (table II). The 5 patients reoperated after preoperative ultrasound exploration had a popliteal perforating vein. Recurrence with a popliteal perforator was significantly more frequent in men than in women (table III). The delay to reoperation for popliteal recurrence after surgery of the short saphenous (50% at 6 years) was significantly shorter than the delay to reoperation for inguinal recurrence after surgery of the greater saphenous (50% at 12 years) (table V). Insufficient excision was observed in 75.2% of the cases, but 23.2% of the recurrences were due to the development of an incompetent popliteal perforating veins. These perforating veins were residual stumps of the short saphenous with complex pathways, unrecognized perforating veins associated with the short saphenous at the first operation, or a new popliteal incompetence. Ces perforantes de la fosse poplitée pourraient être des moignons résiduels de petites saphènes à trajet complexe, des perforantes méconnues associées à la petite saphène developing in several perforating vessels described in the popliteal fossa. The lack of preoperative ultrasound data made it difficult to interpret these recurrences. The development of perforating veins in the popliteal fossa is a type of recurrence which is probably the expression of particular hemodynamic phenomena in the popliteal venous circulation. These phenomena probably involve the flexion of the popliteal vein, the contraction of the calf muscles, and also popliteal valvular incompetence frequently demonstrated in patients who develop short saphenous vein insufficiency.

Evaluation of the pain in varicose vein surgery under tumescent local anaesthesia using sodium bicarbonate as excipient without any intravenous sedation.

OBJECTIVE: In order to simplify varicose vein surgery, we studied the possibility of tumescent local anaesthesia (TLA) using sodium bicarbonate 1.4% as excipient without any intravenous sedation. METHODS: For three months, 215 patients were included in two centres for ambulatory varicose vein surgery performed without any intravenous sedation. Clinical results and pain were evaluated according to the type and duration of surgery. RESULTS: Mean perioperative pain was evaluated at 2.7 on a visual scale (0-10). In 91% of the cases, surgery was deemed to be slightly painful. Preoperative pain was not linked to the technical means of surgery but to the psychological and organizational environment of the centre. CONCLUSIONS: In many of the cases, varicose vein surgery could be performed under TLA without any intravenous sedation. Ambulatory varicose vein surgery without any intravenous sedation could be highly cost-effective.

Foam sclerotherapy combined with surgical treatment for recurrent varicose veins: short term results.

OBJECTIVE: To study the short term results of combined peroperative foam sclerotherapy (PFS) and surgical treatment for recurrent varicose veins. METHODS: PFS was used to treat 129 limbs with recurrent varices: 100 great saphenous (GSV), 29 small saphenous veins (SSV). Foam was prepared with 1% polidocanol mixed with 4 times its volume of air. The 100 GSVs comprised 28 trunks directly connected with the femoral vein, 28 connected to a lymph node venous network, 11 associated with perforators and 33 isolated trunks. The 29 SSVs comprised 4 trunks directly connected to the popliteal vein, 7 isolated trunks, 15 popliteal perforators and 3 recanalisations after SSV stripping. All operations included phlebectomies. In twenty limbs re-ligation of the SFJ and 4 SPJs was carried out. All were performed under local anaesthesia in an ambulatory setting. Patients were assessed clinically and by colour duplex ultrasound after 3 and 40 days follow-up. RESULTS: 120 patients (93%) showed complete obliteration of saphenous trunks, junctions and varices. The 9 incomplete obliterations were 3 venous recanalisations in the SSV compartment and 6 perforators (4 popliteal and 2 femoral). Two asymptomatic deep venous thromboses were detected by colour duplex 3 days after operation. CONCLUSION: PFS facilitates surgical treatment of recurrent varicose veins. There is a small risk of post-operative deep vein thrombosis.

Embolisation of symptomatic pelvic veins in women presenting with non-saphenous varicose veins of pelvic origin - three-year follow-up.

AIM: To evaluate the clinical results of embolisation of symptomatic, incompetent pelvic veins in women presenting with perineal veins. PATIENTS AND METHODS: Twenty-four women presenting with non-saphenous perineal varicose veins and who experienced pelvic vein syndrome were treated. Symptoms was scored on a visual analogue scale assessing dyspareunia, pelvic and lower limb pain. Lower limb varices were investigated by duplex ultrasonography. Pelvic veins were studied by pelvic vein angiography with simultaneous embolisation of incompetent veins. Ovarian and internal iliac veins were systematically embolised when incompetent. Follow-up assessment of symptoms and varices was carried out at 1, 2 and 3 years. RESULTS: All patients presented with perineal veins, 2 with sciatic vein incompetence and 2 with a perforator of the thigh or buttock. Pelvic venous angiography was performed via right femoral access in 87% of the cases and confirmed the presence of incompetent ovarian and internal iliac veins. The mean number of coils used per vein was 6 and all were successfully embolised. No serious complications were encountered. The mean clinical improvement score was 80%, 77%, 80% and 76% at respectively 45 days, 1, 2 and 3-year follow-up. CONCLUSION: In women of reproductive age, non-saphenous varicose veins associated with pelvic venous incompetence (PVI) should undergo pelvic vein investigation. In this clinical series we achieved a satisfactory improvement in symptoms after 3 years following treatment of incompetent pelvic veins.

Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up.

PURPOSE: To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial. METHODS: Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire. RESULTS: The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment. CONCLUSION: The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.

[The results of internal saphenous vein stripping under local anesthesia in outpatient care (700 cases)]. / Résultat des strippings saphène interne sous anesthésie locale en ambulatoire (700 cas).

700 operations involving complete removal of varicose veins in a single stage by invaginated long stripping and phlebectomies under local anesthesia on an out-patient basis were reviewed. Anesthesia consisted of local injections and a femoral block using Mepivacaine or Lidocaine. The out-patient approach adopted did not cause any complications. 95% of patients were satisfied with the method of anesthesia. Three types of neurological sequelae were studied: local numbness due to tearing of a strip of nerve by Muller's hook (7%) was transitory: sub-malleolar numbness was avoided when the lower incision for the stripping was low and sub-malleolar; damage to the saphenous nerve occurs in 1.2 per cent of cases following general anesthesia because of recognition of the particular pain associated with stretching of the nerve during stripping and passage through this junctional area by the Müller technique.

[Comparative results of stripping under general anesthesia and under locoregional anesthesia (200 cases)]. / Résultats comparés des strippings sous anesthésie générale et sous anesthésie loco-régionale (200 cas).

A study showing the improved results of operations on varices performed under local anaesthetic was based on 100 complete files of operations on varicose veins including crossectomy, long invaginated stripping and superficial phlebectomies (type Muller) carried out in one operation under general anaesthetic, and 100 identical files of operations performed under local anaesthetic. The fact that the result is more comfortable under local anaesthetic is especially to lengths of hospitalization, which mean that day surgery is preferable in 80% of cases, and also to the length of time off work which, statistically, can be reduced by local anaesthetic. Finally, the study of anatomic sequelae (varicosities and post-operative neurological disorders) shows particularly that the development of varicosities during the operative period probably depends on oestroprogestative impregnation, and shows much more clearly that local anaesthetic facilitates the avoidance of lesion to the short saphenal nerve during the stripping, because of the pain signal triggered.

Diameter reduction of the proximal long saphenous vein after ablation of a distal incompetent tributary.

In this study, we measured the diameter of the competent long saphenous vein proximally and distally to the anastomosis of an isolated incompetent tributary in 12 patients. Measurements were made both before and 30-45 days after surgical removal of the tributary. The preoperative diameter of the saphenous vein proximal to the anastomosis was greater than distally. The difference between proximal and distal to the tributary veins sections diminished from 1.59 mm to 0.39 mm (p = 0.0033) after surgical removal of the tributary alone. This phenomenon may be compared with other hemodynamic occurrences between the superficial and deep system. The incompetence of a tributary induces a proximal dilatation of the long saphenous vein. The isolated ablation of an insufficient tributary appears to be a useful measure to prevent degeneration of greater saphenous vein function as this procedure reduces the saphenous diameter.

Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study).

PURPOSE: This study was designed as a prospective multicenter randomized comparison of procedure-related complications, patient recuperation, and quality-of-life outcomes between patients undergoing vein stripping with high ligation and patients undergoing great saphenous vein (GSV) obliteration with temperature-controlled radiofrequency ablation without adjunctive high ligation (Closure procedure). METHODS: Eighty-five patients (86 limbs) from five sites (France, 2; Austria, 1; United States, 2) were randomly allocated to undergo radiofrequency obliteration (RFO) or stripping and high ligation (S&L). Final analysis included data for 44 limbs in the RFO group and 36 limbs in the S&L group. Follow-up examinations were performed at 72 hours, 1 week, 3 weeks, and 4 months. All patients completed the CIVIQ2 quality-of-life (QOL) questionnaire and underwent clinical and ultrasound examinations at each follow-up visit. RESULTS: Immediate success on the day of treatment was reported for 95% (42 of 44) of limbs in the RFO group and 100% (36 of 36) of limbs in the S&L group. In seven RFO limbs (16.3%) a scan obtained 72 hours after the procedure showed flow in the proximal GSV. Five of these segments had reflux in the open segment. At 1 week two of these closed, and an additional segment closed at 3 weeks. In no cases did flow reappear after complete occlusion of the GSV. Time to return to normal activities was significantly less in the RFO group (mean, 1.15 days; 95% confidence interval [CI], 0.05-2.34) compared with the S&L group (mean, 3.89 days; CI, 2.67-5.12; P =.02). In the RFO group, 80.5% of patients returned to routine activities of daily living within 1 day, compared with 46.9% of patients in the S&L group (P <.01). Patients in the RFO group were able to return to work in 4.7 days (CI, 1.16-8.17), compared with 12.4 days (CI, 8.66-16.23) for the S&L group (P <.05). Analysis of the QOL surveys showed statistically significant differences in favor of the RFO group for global score and pain score during follow-up. The magnitude of the difference, however, progressively decreased between 1 week and 4 months. CONCLUSIONS: In the absence of significant complications, such as deep vein thrombosis and pulmonary embolism, severe neuritic sequelae, and skin burns, there are significant early advantages to endovascular obliteration of the GSV compared with conventional vein stripping.