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.

[A programme to support clinical evaluation of medical devices: pilot experiment in the Rhône-Alpes region]. / Structure de soutien à l'évaluation clinique des dispositifs médicaux : expérience pilote en région Rhône-Alpes.

INTRODUCTION: The drug and medical devices Committee of the University Hospital of Lyon faces the weakness of clinical data available to justify medical devices purchase. The Hospital of Lyon has worked with several organisms of the Rhône-Alpes region to set up a pilot programme aimed at encouraging small and medium enterprises (SMEs) to realise clinical studies for the evaluation of their medical device. We report the results of this experiment which took place from 2007 to 2010. METHODS: Eligible projects were selected on the basis of their scientific interest. A specific structure for regulatory and methodological support was set up. RESULTS: Twenty companies applied, seventeen were selected. Eight research protocols were written; four clinical studies were implemented. These studies were performed by micro-companies for medical devices that could be considered as innovative device or substantial novelty. Two draft protocols were started but deferred by choice of the company. For projects that did not lead to a research protocol or study, the main causes were: a longer than expected development phase (n = 3); a problem linked to methodological feasibility (n = 1); the unsuccessful search for a principal investigator (n = 2); or the company's choice (n = 5). DISCUSSION AND CONCLUSION: This pilot experience in France has supported and trained regional SMEs in clinical research. Its continuation could encourage manufacturers to conduct clinical trials of good quality.

[Risk factors for early bronchiolitis at asthma during childhood: case-control study of asthmatics aged 4 to 12 years]. / Antécédent de bronchiolite précoce et asthme du grand enfant: étude cas-témoins chez des asthmatiques de 4 à 12 ans.

UNLABELLED: The group of general paediatrics of the French Paediatrics Society conducted a case-control study in order to verify the link between the occurrence of an acute bronchiolitis early during the first year of life, more specifically during the first trimester, and asthma during later childhood. METHODS: Parents of 4-to-12-year-old children answered a questionnaire during a general paediatrics visit. Exposition was attested by a diagnosis of bronchiolitis mentioned on the personal health record of the child. Environmental factors and medical history, obtained from the parents and by checking the health record of the child, were studied using multivariate analysis. RESULTS: Nineteen paediatricians included 80 children with asthma and 160 controls. Fifty-four per cent of asthmatic children had a medical history of bronchiolitis during the first year of life versus 17% of control children (P < 0.001). Mean age of bronchiolitis occurrence was 6.6 months in both groups (P = 0.98). Multivariate analysis showed that occurrence of bronchiolitis during the first year of life was significantly more frequent in asthmatic children (P < 0.001, OR = 5.6, IC95 = [2.6-11.6]) but this effect was not observed during the first trimester of life. CONCLUSION: Bronchiolitis during the first year of life was significantly related to later asthma in 4-to-12-year-old children treated by general paediatricians. On the other hand, a very early bronchiolitis during the first trimester of life did not appear, in our set of data, as a contributive factor to explain asthma in later childhood.

High-dose albuterol by metered-dose inhaler plus a spacer device versus nebulization in preschool children with recurrent wheezing: A double-blind, randomized equivalence trial.

UNLABELLED: Inhaled albuterol is the most frequently used bronchodilator for acute wheezing, and nebulization is the standard mode of delivery in hospital setting. However, recent guidelines consider spacer devices as an easier to use, and cost-saving alternative and recommend the high-dose metered-dose inhaler bronchodilator. OBJECTIVE: To demonstrate clinical equivalence between a spacer device and a nebulizer for albuterol administration. DESIGN: Randomized, double-blind, parallel group equivalence trial. SETTING: Pediatric emergency wards at 2 tertiary teaching hospitals. PATIENTS: Sixty-four 12- to 60-month-old children with acute recurrent wheezing (32 per group). INTERVENTIONS: Albuterol was administered through the spacer device (50 microg/kg) or through the nebulizer (150 microg/kg) and repeated 3 times at 20-minute intervals. Parents completed a questionnaire. OUTCOME MEASURES: Pulmonary index, hospitalization, ease of use, acceptability, and pulse oximetry saturation. RESULTS: The 90% confidence interval of the difference between treatment groups for the median absolute changes in pulmonary index values between T0 and T60 was [-1; +1] and was included in the equivalence interval [-1.5; +1.5]. Clinical improvement increased with time. Less than 10% of the children (3 in each group) required hospitalization (2 in each group attributable to treatment failure). Parents considered administration of albuterol using the spacer device easier (94%) and better accepted by their children (62%). CONCLUSIONS: The efficacy of albuterol administered using the spacer device was equivalent to that of the nebulizer. Given its high tolerance, repeated 50-microg/kg doses of albuterol administered through the spacer device should be considered in hospital emergency departments as first-line therapy for wheezing.

Low molecular weight heparin in prevention of perioperative thrombosis.

OBJECTIVE: To determine whether prophylactic treatment with low molecular weight heparin reduces the incidence of thrombosis in patients who have had general or orthopaedic surgery. DESIGN: Meta-analysis of results from 52 randomised, controlled clinical studies (29 in general surgery and 23 in orthopaedic surgery) in which low molecular weight heparin was compared with placebo, dextran, or unfractionated heparin. SUBJECTS: Patients who had had general or orthopaedic surgery. INTERVENTION: Once daily injection of a low molecular weight heparin compared with placebo, dextran, or unfractionated heparin. MAIN OUTCOME MEASURES: Incidence of deep venous thrombosis, pulmonary embolism, major haemorrhages, and death. RESULTS: The results confirm that low molecular weight heparins are more efficacious for the prophylactic treatment of deep venous thrombosis than placebo (common odds ratio 0.31, 95% confidence interval 0.22 to 0.43; p < 0.001) and dextran (0.44, 0.30 to 0.65; p < 0.001). The results suggest that low molecular weight heparins are also more efficacious than unfractionated heparin (0.85, 0.74 to 0.97; p = 0.02), with no significant difference in the incidence of major haemorrhages (1.06, 0.93 to 1.20; p = 0.62). CONCLUSIONS: Low molecular weight heparins seem to have a higher benefit to risk ratio than unfractionated heparin in preventing perioperative thrombosis. However, it remains to be shown in a suitably powered clinical trial whether low molecular weight heparin reduces the risk of fatal pulmonary embolism compared with heparin.