Side-effects and complications of foam sclerotherapy of the great and small saphenous veins: a controlled multicentre prospective study including 1,025 patients.

OBJECTIVES: Increasing interest in foam sclerotherapy (FS) for saphenous insufficiency has highlighted the need to study the side-effects and complications of this treatment. The aim of this study is to better assess their nature and incidence. METHODS: A multicentre, prospective and controlled study was carried out in which patients treated with FS for great (GSV) and small saphenous veins (SSV) trunk incompetence were included. Immediate untoward events were reported. Duplex ultrasound (DUS) examination was carried out to assess all patients between the eighth and 30th day. In addition, 20% of patients were called by an external auditor. RESULTS: In total, 818 GSV and 207 SSV were treated in 1025 patients in 20 phlebology clinics. Ninety-nine percent of patients were controlled with DUS and non-duplex-checked patients were all called. The saphenous trunk was occluded in 90.3% of patients. Twenty-seven (2.6%) side-effects were reported: migraine (n = 8, 4 with visual disturbance); visual disturbance alone (n = 7); chest pressure alone (n = 7); and chest pressure associated with visual disturbance (n = 5). Eleven thrombo-embolic events occurred: 10 deep vein thrombosis (DVT) but only five in symptomatic patients, and one pulmonary embolism that occurred 19 days following the FS without DVT identified by DUS. One transient ischaemic stroke, with complete clinical recovery in 30 minutes, and one septicaemia with satisfactory outcome were reported as well. CONCLUSION: This study demonstrates in a large sample of patients a low rate of adverse reactions after FS of great and small saphenous trunks. However, but the eventuality of exceptional but more serious complications has to be taken into account in the management of patients. A multicentre study like this one takes into account different practices and reports all possible complications, thus demonstrating the need for a common validated protocol.

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.

[Current status of sclerotherapy of varicose veins]. / Aktueller Stand der Sklerosierungstherapie von Varizen.

Sclerotherapy is a therapeutic technique now perfectly adapted to all types and sizes of varicose veins. Its goals are to close the lumen and reduce the diameter of the varicosity. These objectives can only be achieved by following a strict protocol. This treatment always starts with the large venous trunks such as the saphenous veins which are located deep and best treated with Duplex-guided sclerotherapy. Then the collateral and reticular veins can be directly sclerosed. Superficial starburst veins and telangiectases should only be approached after all feeder vessels have been treated. For these reasons, a detailed clinical examination should be combined with duplex sonographic investigations before any therapy is attempted. When these rules are observed, sclerotherapy is a very effective treatment.

[Echographic sclerotherapy of the great saphenous vein]. / Echo-sclérose de la grande saphène.

The writer invites us to compare the results obtained with echo-guided sclerotherapy with those obtained with "simple" sclerotherapy, the interest of which had already been shown. This study seems to be significative because an amount of 10% of positive results has been noticed. However it is only an intermediary study for the average treatment is only 18 months long. The careful supervision of the evolution of the sclerosed axis is also useful in the understanding of the importance of prescribing a complete and rigorous treatment whose aim is to increase the efficiency of the sclerosis of remaining varicose veins considerably as well as its quality and safety, on the cosmetic field.

[Sclerotherapy in children]. / La sclérothérapie chez l'enfant.

The treatment of superficial venous pathology of child is still not very developed. Yet, the frequency is certainly above the estimation of 2% made in 1969. The importance of its expansion should leads us to consider a precocious treatment. Every delay might be the source of difficulties in the future therapeutics. The preliminary non prospective study realized here, includes 43 young patients, whose mothers had varicose. The functional investigations were made after a clinical examination evocative of anomaly and they permit to evidence 6 significant reflux. The therapeutic attitude depended on the type of disease observed going from abstention till surgery. A soft sclerotherapy, generally well accepted, was a successful method without complications. The results difficult to evaluate except in case of reflux, were generally good. The main difficulty is the acceptance of this method by the medical staff, after the parents' agreement. The sclerotherapy is perfectly possible in childhood, often to be wished in case of disease, sometimes necessary, but must remain careful.

[Necessity of reconciling the objectives of the treatment of varices and arterial surgery. Practical consequences]. / Nécéssité de concilier les objectifs du traitement des varices et de la chirurgie artérielle. Conséquences pratiques.

It is unwise to treat patients with varicose veins without thinking about the possibility of atherosclerotic disease occurring later on. The various procedures of stripping, as well as cryosurgery and sclerosis injections in the saphenous veins destroy veins which are at present the best material for femoro-tibial, femoro-popliteal and coronary bypass. Every year, a great deal of limb salvages cannot be achieved because saphenous veins have been previously removed. As arterial disease occurs one or several decades after the venous complaint, every patient with varicose problems may be concerned. Further more, contrary to a frequent opinion, great saphenous veins of varicose patients are often suitable for arterial bypass. As Doppler combined to duplex scan allow to draw a precise map of the superficial venous channels with their endings, amount of flow back, and caliber of the saphenous veins, it is now possible to propose to most patients conservative procedures: ambulatory phlebectomy or sclerosis injections of peripheral veins in case of minor reflux, crossectomy or CHIVA (Ambulatory Hemodynamic Cure of Venous Insufficiency) in case of major reflux, or association of the various technics. Thus, destructing treatments of saphenous veins should be only proposed to patients whose veins are obviously unsuitable for arterial bypass.

[Ultrasonography during sclerotherapy]. / Echotomographie de la sclérose.

The authors used a prospective study of 309 great saphenous veins to analyse, by Doppler and ultrasonography, the mechanism of sclerosis following sclerosing injections. These were administered at a maximum of 50mm from the sapheno-femoral junction using a protocol based upon five sessions. It was found possible to establish a close relationship between the quality of results and small calibre. Similarly, recurrence by early repermeation was generally secondary to a sclerosing reaction having caused thrombosis. Other changes were seen during or at the end of treatment, sometimes differing greatly from clinical findings. This type of sclerosing injection therapy provided more than 90% favourable responses to treatment after a follow-up period of 15.7 months. Analysis of other parameters may possibly enable even better definition of the treatment of this condition and its natural history.

[Hyperplasia of the saphenous vein and the initial signs of varicose disease in children]. / L'hyperplasie des saphènes et les premiers signes de maladie variqueuse chez l'enfant.

The systematic examination of 237 children, aged between 2 and 17 years, and whose mothers suffer from varicosis, has revealed the absence of varicosis in 10 of these children. Some of them belonged to the same more or less affected family. The 227 others, that is 96%, had 1 to 4 saphenae which were pathological, palpable, with hyperplastic wall, more or less turgescent outside all effort. All the 4 saphenae of 129 children, that is 54%, were hyperplastic. 35 had only three (15%), 53 had only two (22%) and 9 had only one pathological saphena (4%). The saphenous hyperplasia starts on the terminal segment and progresses, with age, from top to bottom towards the distal end to finally reach the ankle. At this level, the observation of a "signal vein" reveals the presence of a pathological hyperplasia covering all the saphena. Out of these 227 children with pathological saphenae, only 88, that is 2 out of 5, complained of functional problems of veinous insufficiency of classical or infantile nature. Moreover, 16 children, that is 7%, had visible veinous or venular dilations. Neither the Doppler nor the ultrasound examination has revealed any clear signs in the 50 children examined.

[The saphenous clip]. / Le clip saphène.

The purpose of the saphenous clip is to prevent two major factors in the course of varicose vein disease: the haemodynamic factor and the parietal factor, the latter being the cause of post-surgical recurrences. Positioning of the clip is only imaginable after thorough mapping of the sapheno-femoral junction by Doppler and ultrasonography. They offer a precise and selective surgical indication, preserving healthy vessels. The first results confirm its efficacy on these two essential factors. However, the reflux is not always controlled while recurrences are not always occurring after 4 years.

[Doppler and ultrasonic diagnosis in sclerosis of the saphenous veins]. / Doppler et échotomographie dans la sclérose des veines saphènes.

Basing his report on a series of several hundreds of examinations, the author presents his experience of Doppler and echotomography in the sclerosant treatment of varicose veins. The examination procedure comprised, during the initial examination, throughout the treatment and at the end of the treatment: a dynamic study using the Doppler examination, with search for reflux and measurement of its pressure; and a morphological study, using echotomography, of the saphenofemoral junction with the measurement of different gauges and compression techniques. The examination reveals the underlying haemodynamic and morphological elements. Subsequent surveillance enables the practitioner to objectivize the velocimetric and morphological modifications induced by sclerosis, the appreciation of which has up until now been purely clinical. The modifications consist of parietal thickening with reduced gauge and the frequent presence of a transitory thrombus. The transformation of a reflux into a flux of physiological type, and indeed, its disappearance, is the main consequence of these modifications. These techniques therefore appear to be of great interest in therapeutic orientation, given their successes, failures and their causes. However, the present work has only given fragmentary and qualitative results, which a future paper will give in more detail.

[Attempt at quantification of the clinical picture of varices for epidemiologic, therapeutic and data-processing purposes]. / Essai d'une quantification clinique des varices pour l'épidémiologie, la thérapeutique et l'informatique.

The expression "presence of varices" does not mean it is possible to anticipate their importance. The use of qualifications such as large, average or small by no means solves the problems of their evaluation for they often take on a different meaning according to the interpretation of the observer. The authors suggest the use of a system of clinical evaluation whose chief characteristic is the measurement of the diameter of varices. In the field of epidemiological studies, quantification is subjected to the determination of a coefficient of maximal invasion (CMI). This is equal to the product of the maximal diameter (MD) of the varices present, by their total length (TL). CMI = MD X TL. The clinical quantification for therapeutics, that is, the quantification that can be used in daily practice, is more simple. It is achieved by the intermediary of three parameters the maximal diameter, the maximal number and height of the varices present in each area. The regular analysis of these three variables makes it possible to follow in figures, and therefore in a way which is readily transmissible, the mode of evolution of the varicose disease. Generally, this quantification completes the usual schemas, makes the teaching of sclerotherapy much easier, makes phlebology more accessible for computer data, with cartography as a basis for the anatomical reference points. The main interest in these two systems lies in the use of a simple language which can be easily understood by everyone, whatever their nationality, and this makes for a more exact appreciation of the work that has been carried out and results in much better communication.

[Importance of Doppler ultrasound tomography in medical treatment of external saphenous veins]. / Apport de l'échotomographie--Doppler dans le traitement médical des saphènes externes.

Basing his study on his experience of the Doppler and of echotomography in everyday phlebological practice, the author examines the sclerosant treatment of symptomatic short saphenous veins, by measuring the reflux and morphology of this saphenofemoral junction. It would appear that the ectasia frequently encountered in the popliteus provide an ideal injection point which greatly reduces the risks associated with this injection. The results of this study are based on 100 short saphenous veins, and confirm the effectiveness of this method of treatment (95% success rate, whatever the calibre of the saphenous vein).

[Phlebitis in a child due to a femoral exostosis. Apropos of 1 case]. / Phlébite de l'enfant sur exostose fémorale. A propos d'un cas.

The author describes the case of a child aged 11 spontaneously presenting a right surral phlebitis. The positive diagnosis was made immediately, with the aid of Functional vascular Investigation, that is venous Doppler and venous occlusion rheoplethysmography. A standard X-ray showed the existence of a right posterior femoral exostosis which looked as though it had been a causal factor in this phlebitis. However, the aetiological proof of this could not be given until seven months later, using phlebography. A survey of the existing literature does not reveal a comparable spontaneous case, without associated causal traumatism. For one thing, femoral osteogenic exostoses do not, despite their frequent occurrence, provoke more than a minimum of vascular complications, affecting the femoral or popliteal veins in particular. For another, spontaneous phlebitis in children are extremely rare and when they do occur it is as a result of haemopathies or collagenoses. Functional Vascular Investigation, now common practice in adults, made it possible to follow very precisely the development of the phlebitis in this child, and to check up on its sequelae. The great correlation between these functional investigations and clinical explorations and phlebography confirms their merit. They could be applied more systematically in infantile pathology.

[Venous ligation in ambulatory patients]. / La ligature veineuse en ambulatoire.

The author here suggests a simple treatment not of the varicose illness but of the main functional symptomatology especially affecting old people, who, too often, are negligent or neglected. By means of a simple ligation, under local anaesthetic, of a long saphenous vein below the saphenofemoral junction, it is possible to achieve the rapid treatment of trophic disorders such as ulceration or major varicose ectasia. The one thing that counts here is the idea of a short term result, and the average three-and-a-half weeks healing time for the ulcers studied attests to this. The indications involve about 2% of the population and apply especially to old people who either refuse to be operated on or wouldn't benefit by surgery. However, this method is still an exceptional therapeutic solution.

[Varices of the lower limbs and pregnancy]. / Varices des membres inférieurs et grossesses.

Pregnancy, a causal factor and very often a revealing element of varicose veins, is still viewed by many as an obstacle to their treatment. The inclusion of its role in the development of the varicose vein should be based on different theories--dynamic, histochemical and biochemical--which, far from being in confrontation are complementary and which the authors attempt to summarize. Clinical treatment of pregnancy varices does not differ from that of ordinary venous deficiency varices, but the speed with which the varices appear and the speed of their development necessitates an effective treatment. The best treatment of pregnancy varices is still their prevention, essentially by sclerosis, resort to surgery being advisable only after the last pregnancy. Venotropes and elastic support should preferably be used during pregnancy if necessary. Sclerotherapy, which is remarkably effective, will only be reserved for the cure of a painful or ulcerous problem, or if there is risk of varicose rupture.