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).

[Quality standards for ultrasonographic assessment of peripheral vascular malformations and vascular tumors. Report of the french society for vascular medicine. 2018 Update]. / Standards de qualité pour la pratique de l'examen écho-Doppler dans l'étude des malformations et tumeurs vasculaires. Rapport de la Société française de médecine vasculaire (SFMV) : actualisation 2018.

The quality standards of the French Society of Vascular Medicine for the ultrasonographic assessment of vascular malformations are based on the two following requirements: (1) technical know-how: mastering the use of ultrasound devices and the method of examination; (2) medical know-how: ability to adapt the methods and scope of the examination to its clinical indication and purpose, and to rationally analyze and interpret its results. AIMS OF THE QUALITY STANDARDS: To describe an optimal method of examination in relation to the clinical question and hypothesis. To homogenize practice, methods, glossary, and reporting. To provide good practice reference points, and promote a quality process. ITEMS OF THE QUALITY STANDARDS: The 3 levels of examination; their clinical indications and goals. The reference standard examination (level 2), its variants according to clinical needs. The minimal content of the examination report; the letter to the referring physician (synthesis, conclusion and proposal for further investigation and/or therapeutic management). Commented glossary (anatomy, hemodynamics, semiology). Technical bases. Setting and use of ultrasound devices. Here, we discuss ultrasonography methods of using of ultrasonography for the assessment of peripheral vascular malformations and tumors (limbs, face, trunk).

Towards an individualized management strategy for patients with chronic venous disease: Results of a Delphi consensus.

Objective To obtain consensus on management criteria for symptomatic patients with chronic venous disease (CVD; C2-C6) and superficial venous reflux. Method We used a Delphi method by means of 36 statements sent by email to experts in the field of phlebology across the world over the course of three rounds. The statements addressed criteria for different venous treatments in patients with different characteristics (e.g. extensive comorbidities, morbid obesity and peripheral arterial disease). If at least 70% of the ratings for a specific statement were between 6 and 9 (agreement) or between 1 and 3 (disagreement), experts' consensus was reached. Results Twenty-five experts were invited to participate, of whom 24 accepted and completed all three rounds. Consensus was reached in 25/32 statements (78%). However, several statements addressing UGFS, single phlebectomies, patients with extensive comorbidities and morbid obesity remained equivocal. Conclusion Considerable consensus was reached within a group of experts but also some gaps in available research were highlighted.

[Quality standards for duplex ultrasonographic assessment (duplex us) of abdominal aortic stent grafts]. / Standards de qualité pour la pratique de l'écho-Doppler dans la surveillance des endoprothèses aortiques abdominales.

The quality standards of the French Society of Vascular Medicine for the ultrasound assessment of lower limb arteries in vascular medicine practice are based on the principle that these examinations have to meet two requirements: technical know-how (knowledge of devices and methodologies); medical know-how (level of examination matching the indication and purpose of the examination, interpretation and critical analysis of results). OBJECTIVES OF THE QUALITY STANDARDS: To describe an optimal level of examination adjusted to the indication or clinical hypothesis; to establish harmonious practices, methodologies, terminologies, results description and report; to provide good practice reference points and to promote a high quality process. THEMES OF THE QUALITY STANDARDS: The three levels of examination, indications and objectives for each level; the reference standard examination (level 2) and its variants according to indications; the minimal content of the exam report, the medical conclusion letter to the corresponding physician (synthesis, conclusion and management suggestions); commented glossary (anatomy, hemodynamics, signs and symptoms); technical basis; device settings. Here, we discuss duplex ultrasound for the supervision of the aortic stent grafts.

Postural Diameter Change of the Saphenous Trunk in Chronic Venous Disease.

OBJECTIVE: The aim of this study was to analyze the correlation between the extent of diameter change from standing to supine position ("postural diameter change," PDC), and patient or duplex ultrasound (DUS) characteristics in lower limbs with and without saphenous trunk (ST) reflux. METHODS: Measurements were carried out in 193 limbs with primary great saphenous vein, anterior accessory saphenous vein, or small saphenous vein reflux, and 48 control limbs without ST reflux. The inner diameter of the ST was measured with DUS in the standing and lying positions. The PDC, calculated as a percentage, followed the formula: (standing diameter - lying diameter)/standing diameter × 100. Clinical findings (according to the highest "C" - of the CEAP classification), venous clinical severity score, body mass index (BMI), time of visit, and inside and outside temperature were documented. Limbs were divided into two groups using the median value of PDC as a cut off to increase interpretability of the analysis. RESULTS: The median PDC of the ST was 19% in limbs with ST reflux compared with 24% in control limbs (p = .16). In limbs with and without ST reflux, only older age and increased BMI were independently associated with a low PDC of the ST (R(2) 0.13). In limbs with ST reflux, median PDC was significantly lower in C4-C6 (16%, interquartile [IQR] 8-21) than in C0-C1 (23%, IQR 12-35) or C2-C3 limbs (21%, IQR 11-33; p = .016). In addition, PDC was significantly lower in veins with a large diameter (>7 mm) than in those with a small diameter (p = .003). CONCLUSION: Low PDC of the ST correlates with older age and increased BMI. Whether PDC might become a useful additional DUS tool to classify the severity of chronic venous disease and thereby influence the management strategy should be further investigated.

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.

Management strategies for patients with varicose veins (C2-C6): results of a worldwide survey.

OBJECTIVES: This study evaluated how patient characteristics and duplex ultrasound findings influence management decisions of physicians with specific expertise in the field of chronic venous disease. METHODS: Worldwide, 346 physicians with a known interest and experience in phlebology were invited to participate in an online survey about management strategies in patients with great saphenous vein (GSV) reflux and refluxing tributaries. The survey included two basic vignettes representing a 47 year old healthy male with GSV reflux above the knee and a 27 year old healthy female with a short segment refluxing GSV (CEAP classification C2sEpAs2,5Pr in both cases). Participants could choose one or more treatment options. Subsequently, the basic vignettes were modified according to different patient characteristics (e.g. older age, morbid obesity, anticoagulant treatment, peripheral arterial disease), clinical class (C4, C6), and duplex ultrasound findings (e.g. competent terminal valve, larger or smaller GSV diameter, presence of focal dilatation). The authors recorded the distribution of chosen management strategies; adjustment of strategies according to characteristics; and follow up strategies. RESULTS: A total of 211 physicians (68% surgeons, 12% dermatologists, 12% angiologists, and 8% phlebologists) from 36 different countries completed the survey. In the basic case vignettes 1 and 2, respectively, 55% and 40% of participants proposed to perform endovenous thermal ablation, either with or without concomitant phlebectomies (p < .001). Looking at the modified case vignettes, between 20% and 64% of participants proposed to adapt their management strategy, opting for either a more or a less invasive treatment, depending on the modification introduced. The distribution of chosen management strategies changed significantly for all modified vignettes (p < .05). CONCLUSIONS: This study illustrates the worldwide variety in management preferences for treating patients with varicose veins (C2-C6). In clinical practice, patient related and duplex ultrasound related factors clearly influence therapeutic options.

Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer.

After a proximal deep-vein thrombosis (P-DVT), the risk of diagnosis of a previously unsuspected cancer is high. Isolated distal DVT (iD-DVT; i.e. infra-popliteal DVT without pulmonary embolism [PE]) and isolated superficial-vein thrombosis (iSVT; i.e. without concomitant DVT and PE) are at least as frequent as P-DVT but their association with subsequent cancer is uncertain. We exploited data from the OPTIMEV prospective, observational, multicentre study to i) compare the risk of subsequent cancer three years after a first objectively confirmed iSVT, iD-DVT and iP-DVT in patients without a prior history of cancer or of venous thromboembolism, ii) assess predictors of subsequent cancer in cases of iD-DVT. The overall cumulative rates of cancer among the 304 patients with iSVT, 536 patients with iD-DVT, and 327 patients with iP-DVT were similar (3.4% 95% confidence interval [1.8-6.2], 3.9% [2.5-5.9] and 3.9% [2.3-6.8], respectively), regardless of whether the index venous thromboembolic event was unprovoked or associated with a major transient risk factor. Neither anatomical (muscular vs deep-calf DVT) nor ultrasound scan characteristics (number of thrombosed veins, clot diameter under compression) seemed strongly associated with the risk of cancer in cases of iD-DVT. In patients managed in routine practice, all the different clinical expressions of lower limb venous thromboembolism are associated with a similar risk of subsequent cancer. From a clinical practice point of view, this suggests that cancer screening, without discussing the necessity, or not, of such screening, should not differ between a deep-proximal, deep-distal or superficial location of thrombosis.

[Quality standards for ultrasound assessment of the superficial venous system of the lower limbs. Report of the French Society for Vascular Medicine]. / Standards de qualité pour la pratique des examens écho-Doppler dans l'exploration du réseau veineux superficiel des membres inférieurs. Rapport de la Société française de médecine vasculaire (SFMV).

The quality standards of the French Society for Vascular Medicine for the ultrasound assessment of the superficial venous system of the lower limbs are based on the two following requirements: technical know-how (mastering the use of ultrasound devices and the method of examination); medical know-how (ability to adapt the methods and scope of the examination to its clinical indications and purpose and to rationally analyze and interpret its results). AIMS OF THE QUALITY STANDARDS: To describe an optimal method of examination in relation to the clinical question and hypothesis; to achieve consistent practice, methods, glossary terminologies and reporting; to provide good practice reference points and to promote a high quality process. THEMES OF THE QUALITY STANDARD: The three levels of examination. Their clinical indications and goals. The reference standard examination (level 2) and its variants according to clinical needs. The minimal content of the examination report, the letter to the referring physician (synthesis, conclusion and management suggestions) and iconography. Commented glossary (anatomy, hemodynamics, semiology). Technical basis. Ultrasound devices settings. We discuss of use of Duplex ultrasound for the assessment of the superficial veins of the lower limbs in vascular medicine practice.

[Detection of micro-embolic signals: a review of the literature]. / Détection de signaux micro-emboliques: revue de la littérature.

BACKGROUND: The detection of micro-embolic signals (MES), by transcranial Doppler sonography might be useful for risk stratification in patients with symptomatic and asymptomatic carotid or cerebral artery stenosis, dissections, aortic atheroma, interventional procedures, and right to left cardiac shunts. AIM: Review of the technique and clinical situations of MES detection. METHODS: PubMed search from 1990 to 2012. RESULTS: MES were found in 0,19, 48% versus 0,3, and 12% of patients with symptomatic and asymptomatic inferior than 30, 30 to 69, and 70 to 99% carotid stenosis, respectively. MES were related to the risk of recurrent stroke or transient ischemic attack (TIA). In the ACES study, the absolute annual risk of stroke or TIA after 2 years was 7% with vs 3% without MES. In patients with intracranial stenosis, the risk of stroke recurrence was 48% with vs 7% without MES at 13.6 months follow-up. MES were reported in 25% of the symptomatic versus none of the asymptomatic patients with intracranial stenosis. CONCLUSION: Detection of MES is feasible and reproducible for multicenter studies, using rigourous methodology and long lasting recordings. It may contribute to risk stratification, especially in patients with extra- or intracranial stenosis.

[Quality standards for ultrasound assessment (CW-Doppler, Duplex US) of the lower limb arteries in vascular medicine. Report of the French Society for Vascular Medicine]. / Standards de qualité pour la pratique des examens Doppler et écho-Doppler artériel des membres inférieurs en médecine vasculaire. Rapport de la Société française de médecine vasculaire (SFMV).

The quality standards of the French Society of Vascular Medicine for the ultrasound assessment of lower limb arteries in vascular medicine practice are based on the principle that these examinations have to meet two requirements: technical know-how (knowledge of devices and methodologies); medical know-how (level of examination matching the indication and purpose of the examination, interpretation and critical analysis of results). OBJECTIVES OF THE QUALITY STANDARDS: To describe an optimal level of examination adjusted to the indication or clinical hypothesis; to homogenize practices, methodologies, terminologies, results description and report; to provide good practice reference points and to promote a high quality process. THEMES OF THE QUALITY STANDARDS: The three levels of examination, indications and objectives for each level; the reference standard examination (level 2) and its variants according to indications; the minimal content of the exam report, the medical conclusion letter to the corresponding physician (synthesis, conclusion and management suggestions); commented glossary (anatomy, hemodynamics, signs and symptoms); technical basis. Device settings. Here, we discuss CW-Doppler and Duplex ultrasound in various indications for lower limbs arteries assessment.

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.

Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins - UIP consensus document.

OBJECTIVES: Duplex ultrasound has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this article was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology and terminology to be used for assessment after treatment of incompetent superficial and perforating veins in the lower limb by ultrasound imaging. DESIGN: The study design was consensus meetings leading to a consensus document. METHODS: The UIP invited group submitted relevant literature references and written contributions concerning the methodology, terminology and value of duplex imaging after treatment. The authors prepared a draft document that was circulated to a larger group of experts and revised according to the comments received. Eventually, all participants agreed upon the final version of the article. RESULTS: Formal analysis of the results of interventions for varicose veins relies on adequate preoperative assessment and a careful description of the procedure employed. The timing of investigations of outcome should be classified as immediate (1-4 weeks), short-term (1 year), midterm (2-3 years) and long-term (5 years or more). The examination should employ standard methodology and formally described variables, which can be tailored to the intervention that was undertaken. The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination and reporting after various treatments for varicose veins, including novel treatments under scientific study. CONCLUSIONS: Duplex ultrasonography is a fundamental component of the investigation of the lower limb venous system after treatment for varicose veins.

[Sub acute ischemia of a lower limb in a patient with juvenile peripheral arterial disease and arterial cocaine toxicity]. / Ischémie subaiguë d'un membre inférieur et toxicité artérielle périphérique de la cocaïne chez une patiente présentant une artériopathie juvénile.

A 35-year-old woman was hospitalized for subacute ischemia of the left leg following an intermittent claudication for some weeks. She also presented paleness and coldness of both hands. The radial pulses could not be palpated. Smoking was the only cardiovascular risk factor. Duplex ultrasonography and angiography revealed a left popliteal thrombus combined with low diameter leg arteries and in the upper limbs stenosis of the left radial artery and thrombosis of the right radial artery. Search for a metabolic, embolic or thrombophilic etiology was negative. More minute history taking revealed use of cannabis and recent nasal administration of cocaine. Her condition improved with heparin therapy except for the upper limbs with ischemia of the hands and disabling Raynaud's phenomenon. This report highlights the combined arterial toxicity of drugs often used together by drug addicts. The association of cannabis use and tobacco smoking is not rare in patients with Buerger-like juvenile arteriopathy and cocaine may provoke peripheral vascular disease by embolism or in situ thrombosis. Interrogation of a patient presenting with Buerger-like peripheral arterial disease should insist on detecting use of drugs in association with tobacco smoking.

[Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. / Optimisation de l'interrogatoire dans l'évaluation du risque de maladie thromboembolique veineuse: l'étude OPTIMEV.

UNLABELLED: Venous thromboembolism (VTE) is a frequent disease and remains a major cause of mortality and morbidity among our patients. During the 20 past years, clinical description, diagnostic tools, and treatment have changed dramatically. Most published data describing risk factors for VTE no longer apply to the patients seen in daily practice. We present here the rationale, aims, and methodology of the OPTIMEV Study (OPTimisation de l'Interrogatoire pour la Maladie thromboEmbolique Veineuse). RATIONALE: Risk factors for VTE are numerous, complex and interactions between them and their clinical importance is difficult to measure (table I). For example, odds ratios for VTE recurrence vary greatly across longitudinal studies. We searched the National Library of Medecine (PubMed) and the Amedeo website using the following keywords: "venous thromboembolism", "pulmonary embolism", "deep vein thrombosis", "risk factors". We selected 84 relevant articles published between 1972 and 2005. Based on this literature analysis, we identified the following major risk factors: VTE recurrence, surgery, cancer, immobilization, age, biological factors. For these factors, data are lacking and some questions are proposed. OBJECTIVES: The broad objective of the study is to better evaluate clinical risk factors that fit today's practice against VTE. Specific aims are: 1) to determine whether risk factors are different between proximal and distal deep vein thrombosis (DVT); 2) to develop and prospectively validate a new prediction rule for outpatients. The primary hypothesis is that careful assessment of VTE recurrence, adequate surgical thromboprophylaxis, cancer staging, and varicose vein stratification according to the CEAP classification, is mandatory for accurate evaluation of thromboembolic disease risk. METHODS: We conducted a multicenter, prospective, cohort study of 10000 patients. Enrollees are inpatients and outpatients presenting with a clinical suspicion of VTE in Emergency Departments and outpatient clinics in France. 4173 patients have been enrolled at this time (Figure 2). All eligible patients are enrolled during a selected period of time through different seasons. Data are collected by physicians in charge of the patients using an electronic case recording form. Collected data include baseline characteristics, risk factors, results of diagnostic investigations. Outcome measures obtained through telephone interview at 3 and 12 months include cancer diagnosis, VTE recurrence, haemorrhagic events, treatments, death. Univariate and multivariate analysis will be performed using multilevel logistic regression. The study organization is performed by the Centre d'Investigation Clinique de Grenoble and is sponsored by the French Society of Vascular Medicine. First results, to be published in 2006, will allow development of new prediction rules for VTE diagnosis.

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.

[Impact of an education program on patient behaviour favoring prevention of drug-related adverse events: a pilot study in patients receiving oral anticoagulants for thromboembolic venous disease]. / Impact d'un programme d'éducation thérapeutique sur les attitudes de prévention vis-à-vis du risque iatrogène: étude pilote contrôlée visant les patients sous anticoagulants oraux pour maladie thromboembolique veineuse.

OBJECTIVE: Adverse events related to oral anticoagulants represent a major public health problem. Including patient education as part of the prevention strategy could contribute to improved effectiveness and safer use of drugs. The present study aimed at evaluating the outcomes of a patient education program inspired by recommendations from French Health Authorities (AFSSAPS) and based on an "individual guidance" approach. METHOD: The study was conducted in two groups of hospitalized patients treated with oral anticoagulants for thromboembolic disease. Each patient in the first (intervention) group attended an individual teaching session conducted at discharge by a trained pharmacist. Patients in the second (control) group were given usual care. These two groups were compared at inclusion (before intervention) and three months later. The outcomes considered were the acquisition of: 1) knowledge, 2) risk anticipation and compliance behaviours characterized by the stability of INR and the incidence of hemorrhagic episodes during the period of observation. RESULTS: Fifty-nine patients (average age 65 years) were included (29 in the intervention group and 30 in the control group). Three months after the intervention, the intervention group exhibited 1) better knowledge (higher rate of restitution of treatment-related information--name of the drug, administration plan, targeted range for INR (...), interpretation of INR results (p<0.05), management of a specific scenario where INR declines concomitant to elevation of anticoagulant dose (p<0.05)); 2) higher rates of relevant behaviours (p<0.05)--in the event of a missed dose, anticipating an event with a high risk of bleeding, dealing with signs of overdose--and higher compliance profile (ns) (stability of INR, and number of hemorragic episodes). A multivariate model integrating the potential explanatory variables for frequency of hemorrhagic episodes at 3 months (demographic data, history of thrombotic disease, INR stability, reference group (intervention/control)), showed that the only variable significantly associated with frequency of bleeding events was the reference group of the patient (p=0.05; odds-ratio=4.5, interval of confidence: [1-21]). CONCLUSION: Multivariate analysis demonstrated that the probability of developing a hemorrhagic event when taking an oral anticoagulant is on average 4-fold greater in patients given usual care than in patients given individual guidance a pharmacist. A larger randomized trial is currently under way in the Rhône-Alpes region, France, to validate these exploratory results.

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.

Duplex imaging analysis of the long saphenous vein reflux: basis for strategy of endovenous obliteration treatment.

BACKGROUND: The purpose of this study was to characterize greater saphenous vein (GSV) reflux in order to better define indications for appropriate endovascular obliteration treatment. METHODS: Color-flow duplex imaging was used prospectively to categorize 133 lower limbs of 102 consecutive outpatients, presenting with chronic superficial vein disease associated with GSV incompetence. Sapheno-femoral junction (SFJ) and tributaries morphology and hemodynamics, and GSV main trunk reflux extent were assessed. RESULTS: GSV reflux was related to terminal valve incompetence in 70 (52.3%) limbs, to sub-terminal valve incompetence in 37 (27.8%), and to segmental incompetence of the GSV trunk in 26 (19.6%). Reflux originated from common femoral vein (CFV) and/or SFJ tributaries and/or GSV collaterals, including multiple origins combinations. CFV was the reflux origin in 77 (57.9%). GSV reflux arose from SFJ or trunk tributaries in 69 (51.9%) and 32 (24%), limbs respectively. Circumflex and superficial epigastric veins were involved in 65.2% and 50.7% respectively of the SFJ tributaries. GSV reflux extended down to the mid-third of the calf or below in only 45 cases (33.7%). The age of the patients was not correlated with reflux origin. CONCLUSIONS: Preliminary analysis suggests that in 2/3 of the cases, endovenous obliteration treatment should extent from the thigh to just below the knee. Furthermore, in order to preserve GSV competent valves and collateral veins drainage, treatment should start just below the main SFJ tributary when the terminal valve is still competent, and just below the main branches connection when only the GSV trunk is incompetent.