Olivier Pichot

Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: First clinical experience

BACKGROUND Radiofrequency ablation of saphenous veins has proven efficacy with an excellent side effect profile but has the disadvantage of a lengthy pullback procedure. This article reports a new endovenous catheter for radiofrequency-powered segmental thermal ablation (RSTA) of incompetent great saphenous veins (GSVs). METHODS A prospective, nonrandomized, multicenter study was conducted to evaluate the safety, feasibility, and early clinical outcomes of RSTA of the GSV. RESULTS A total of 194 patients with 252 GSVs with an average diameter of 5.7 +/- 2.2 mm (range, 2.0 to 18.0 mm) received RSTA under tumescent local anesthesia. In 58 patients (29.9%), bilateral treatment (average length treated, 36.7 +/- 10.8 cm) was done. The average total endovenous procedure time was 16.4 +/- 8.2 minutes, and the average total energy delivery time was 2.2 +/- 0.6 minutes. The corresponding endovenous fluence equivalent delivered to the proximal 7-cm vein segment was 82 +/- 25 J/cm(2) (range, 38 to 192). Follow-up at 3 days, 3 months, and 6 months was obtained from 250, 164, and 62 limbs, respectively. Occlusion rates were 99.6% for all three follow-up dates according to life-table analysis. The average Venous Clinical Severity Score was 3.4 +/- 1.2 at 3 days, 0.9 +/- 1.6 at 3 months, and 1.5 +/- 1.8 at 6 months compared with 3.9 +/- 2.0 at baseline. CONCLUSION Radiofrequency segmental thermal ablation is feasible, safe, and well tolerated.

Superficial Venous Thrombosis and Venous Thromboembolism: A Large, Prospective Epidemiologic Study

BACKGROUND Superficial venous thrombosis (SVT) is perceived to have a benign prognosis. OBJECTIVE To assess the prevalence of venous thromboembolism in patients with SVT and to determine the 3-month incidence of thromboembolic complications. DESIGN National cross-sectional and prospective epidemiologic cohort study. (ClinicalTrials.gov registration number: NCT00818688) SETTING French office- and hospital-based vascular medicine specialists. PATIENTS 844 consecutive patients with symptomatic SVT of the lower limbs that was at least 5 cm on compression ultrasonography. MEASUREMENTS Incidence of venous thromboembolism and extension or recurrence of SVT in patients with isolated SVT at presentation. RESULTS Among 844 patients with SVT at inclusion (median age, 65 years; 547 women), 210 (24.9%) also had deep venous thrombosis (DVT) or symptomatic pulmonary embolism. Among 600 patients without DVT or pulmonary embolism at inclusion who were eligible for 3-month follow-up, 58 (10.2%) developed thromboembolic complications at 3 months (pulmonary embolism, 3 [0.5%]; DVT, 15 [2.8%]; extension of SVT, 18 [3.3%]; and recurrence of SVT, 10 [1.9%]), despite 540 patients (90.5%) having received anticoagulants. Risk factors for complications at 3 months were male sex, history of DVT or pulmonary embolism, previous cancer, and absence of varicose veins. LIMITATION The findings are from a specialist referral setting, and the study was terminated before the target patient population was reached because of slow recruitment. CONCLUSION A substantial number of patients with SVT exhibit venous thromboembolism at presentation, and some that do not can develop this complication in the subsequent 3 months. PRIMARY FUNDING SOURCE GlaxoSmithKline, sanofi-aventis, and the Ministère Francais de la Santé et des Sports (Programme Hospitalier de Recherche Clinique).

Treatment of Primary Venous Insufficiency by Endovenous Saphenous Vein Obliteration

The objective of this paper is to evaluate treatment of primary venous insufficiency by endovenous saphenous vein obliteration. Three hundred one limbs were treated in 206 women and 67 men with a mean CEAP Clinical Class of 2.4 ±0.9. Endovenous obliteration was combined with high ligation in 67 limbs (22%) and with stab avulsion phlebectomies in 181 (60%). Acute occlusion was achieved in 290 limbs (96%). Obliteration failures in 11 limbs were treated by saphenous stripping or managed expectantly. Paresthesias followed 15% of treatments confined to the thigh and upper leg and affected 30% of limbs when treatment extended to the ankle (p < 0.001). Eight potentially preventable thermal skin injuries occurred, five in particularly superficial venous segments, of which four were in men. At a mean follow-up of 4.9 months, 21 (7.2%) of successfully treated veins have partially or totally (n = two) recanalized, but only 11 (3.8% of 290) have Doppler-detectable reflux. Ninety-one patients have been followed up for 6 months to 1 year, showing significant improvement in CEAP class and progressive relief from clinical symptoms. At their latest visit, 94% rated themselves as being symptom-free or substantially improved. These midterm results with endovenous obliteration in the treatment of primary varicose veins suggest that it may be as effective as surgical stripping in eliminating greater saphenous vein reflux and delaying the appearance of new varicose veins. Simple procedural modifications, such as not treating to the ankle, prophylactic infiltration about superficially placed veins, and early duplex surveillance should diminish the complications observed in this early experience.

Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities.

BACKGROUND Radiofrequency segmental thermal ablation (RSTA) has become a commonly used technology for occlusion of incompetent great saphenous veins (GSVs). Midterm results and data on clinical parameters are still lacking. METHODS A prospective multicenteral trial monitored 295 RSTA-treated GSVs for 36 months. Clinical control visits included flow and reflux analysis by duplex ultrasound imaging and assessment of clinical parameters according to the CEAP classification and Venous Clinical Severity Score (VCSS). RESULTS A total of 256 of 295 treated GSVs (86.4%) were available for 36 months of follow-up. At 36 months, Kaplan-Meier survival analysis showed the probability of occlusion was 92.6% and the probability of no reflux was 95.7%, and 96.9% of legs remained free of clinically relevant axial reflux. If complete occlusion was present at the 12-month follow-up, the risk of developing new flow by 24 and 36 months of follow-up was 3.7% and 4.1%, respectively. Diameters of the GSV measured 3 cm distal to the saphenofemoral junction reduced from 5.8 ± 2.1 mm at screening to 2.2 ± 1.1 mm at 36 months. The average VCSS score improved from 3.9 ± 2.1 before treatment to 0.9 ± 1.5 at 3 months (P < .0001) and stayed at an average <1.0 during the complete 36 months of follow-up. Only 41.1% of patients were free of pain before treatment; at 36 months, 251 (98.0%) reported no pain and 245 (95.7%) did not experience pain during the 24 months before. At 36 months, 189 of 255 legs (74.1%) showed an improvement in CEAP class compared with the clinical assessment before treatment (P < .001). Stages C(3) and C(4) combined to 46% before treatment and dropped constantly to a combined level of 8% at 36 months. However, the proportion of C(2) legs that dropped from 52.3% before treatment to <10% at 12 months showed a constant increase thereafter, reaching 33.3% at 36 months. CONCLUSION RSTA showed a high and durable success rate in vein ablation in conjunction with sustained clinical efficacy.

A clinical prediction score for upper extremity deep venous thrombosis

It was the objective of this study to design a clinical prediction score for the diagnosis of upper extremity deep venous thrombosis (UEDVT). A score was built by multivariate logistic regression in a sample of patients hospitalized for suspicion of UEDVT (derivation sample). It was validated in a second sample in the same university hospital, then in a sample from the multicenter OPTIMEV study that included both outpatients and inpatients. In these three samples, UEDVT diagnosis was objectively confirmed by ultrasound. The derivation sample included 140 patients among whom 50 had confirmed UEDVT, the validation sample included 103 patients among whom 46 had UEDVT, and the OPTIMEV sample included 214 patients among whom 65 had UEDVT. The clinical score identified a combination of four items (venous material, localized pain, unilateral pitting edema and other diagnosis as plausible). One point was attributed to each item (positive for the first 3 and negative for the other diagnosis). A score of -1 or 0 characterized low probability patients, a score of 1 identified intermediate probability patients, and a score of 2 or 3 identified patients with high probability. Low probability score identified a prevalence of UEDVT of 12, 9 and 13%, respectively, in the derivation, validation and OPTIMEV samples. High probability score identified a prevalence of UEDVT of 70, 64 and 69% respectively. In conclusion we propose a simple score to calculate clinical probability of UEDVT. This score might be a useful test in clinical trials as well as in clinical practice.

Radiofrequency-Powered Segmental Thermal Obliteration Carried out with the ClosureFast Procedure: Results at 1 Year

This prospective and multicenter study shows the results at 1 year of radiofrequency-powered segmental thermal obliteration (RSTO) carried out with the ClosureFast procedure. The RSTO clinical and duplex ultrasound imaging results were evaluated at 3 days, 3 months, 6 months, and 1 year. All procedures were carried out on outpatients under tumescent local anesthesia. Among the 295 members who were treated, 289 were reexamined at 3 days, 290 at 3 months, 289 at 6 months, and 220 at 1 year. Occlusion scores were 99.7%, 99.3%, 98.6%, and 96.9% at, respectively, 3 days, 3 months, 6 months, and 1 year. At 3 cm below the saphenofemoral junction, before the procedure, the greater saphenous vein (GSV) diameter was 5.4+/-2 mm (range 2-18). It decreased to 4.5+/-1.7 mm at 3 days, 2.4+/-1.5 mm at 6 months, and 1.3+/-0.9 mm at 1 year. In members reexamined at 1 year, the decrease in diameter of the treated vein compared with the preprocedural measurement was 79% (p<0.001, t-test). At 1 year, in 58% of the cases, duplex ultrasound imaging at mid-thigh level could not show the GSV trunk. Preprocedural pain that was present in 57.5% of the cases decreased to 10.8% of the cases at 3 days and 2% of the cases at 1 year (p<0.001, chi2 test). Among the treated limbs, 70.1% did not present with any postprocedural pain at any time of the follow-up. On the third day, the patients evaluated the mean pain intensity at 0.7+/-1.6 on a visual analog scale of 0-10. During the follow-up, no painful indurations were noticed in 67.7% of the legs. No thromboembolic complications were reported. Paresthesias were observed in 3.4% of the cases. Invalidity clinical score, evaluated at 3.9+/-2 before the procedure, decreased to 3.5+/-1.2 on the third day, 0.9+/-1.5 at 3 months, 0.7+/-1.2 at 6 months, and 0.5+/-1.1 at 1 year. This study confirms the efficacy of RSTO when using ClosureFast, which allows obliteration of the GSV trunk in 97% of cases at 1 year with few side effects and almost no postprocedural pain.

Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial

BACKGROUND The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic deep vein thrombosis (DVT) of the calf. We aimed to assess whether therapeutic anticoagulation is superior to placebo in patients with symptomatic calf DVT. METHODS In this randomised, double-blind, placebo-controlled trial, we enrolled low-risk outpatients (without active cancer or previous venous thromboembolic disease) with a first acute symptomatic DVT in the calf from 23 university medical centres or community medical clinics in Canada, France, and Switzerland. We randomly assigned (1:1) patients to receive either the low-molecular-weight heparin nadroparin (171 UI/kg, subcutaneously, once a day) or placebo (saline 0·9%, subcutaneously, once a day) for 6 weeks (42 days). Central randomisation was done using a computer-generated randomisation list, stratified by study centre. Random allocation sequences of variable block size were centrally determined by an independent research clinical centre. Study staff, patients, and outcome assessors (central adjudication committee) were masked to group assignment. Numbered boxes of active drug or placebo were provided to pharmacies in identical packaging. All patients were prescribed compression stockings and followed up for 90 days. The primary efficacy outcome was a composite measure of extension of calf DVT to proximal veins, contralateral proximal DVT, and symptomatic pulmonary embolism at day 42 in the modified intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding at day 42. The trial was registered with ClinicalTrials.gov, number NCT00421538. FINDINGS Between Feb 1, 2008, and Nov 30, 2014, we screened 746 patients, enrolling 259 patients (50% of the prespecified sample size), before the trial steering committee terminated the trial because of expiry of study drug and slow recruitment. The intention-to-treat analysis population comprised 122 patients in the nadroparin group and 130 in the placebo group. There was no significant difference between the groups in the composite primary outcome, which occurred in four patients (3%) in the nadroparin group and in seven (5%) in the placebo group (risk difference -2·1%, 95% CI -7·8 to 3·5; p=0·54). Bleeding occurred in five patients (4%) in the nadroparin group and no patients in the placebo group (risk difference 4·1, 95% CI 0·4 to 9·2; p=0·0255). In the nadroparin group one patient died from metastatic pancreatic cancer and one patient was diagnosed with heparin-induced thrombocytopenia type 2. INTERPRETATION Nadroparin was not superior to placebo in reducing the risk of proximal extension or venous thromboembolic events in low-risk outpatients with symptomatic calf DVT, but did increase the risk of bleeding. Avoidance of systematic anticoagulation for calf DVT could have a substantial impact on individual patients and from a public health perspective. FUNDING Swiss National Science Foundation, the Programme Hospitalier de Recherche Clinique in France, and the Canadian Institutes of Health Research.

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

Resume Objectif L’iatrogenie induite par les antivitamines K (AVK) represente un probleme de sante publique. L’integration, dans la strategie de prevention, d’actions d’education ciblees sur le patient pourrait contribuer a l’amelioration de l’efficacite et la securite des soins. L’objectif de ce travail etait d’evaluer un programme d’education therapeutique s’inspirant des recommandations de l’AFSSAPS et developpant une pedagogie de type « guidance individuelle ». Methode Nous avons opere une comparaison historique, a l’inclusion (avant intervention) puis 3 mois plus tard, de 2 cohortes de patients hospitalises traites par AVK pour une maladie thromboembolique (MTE), l’une experimentale (une seance d’education avant la sortie de l’hopital) et l’autre temoin (pratique courante). L’evaluation porte sur l’acquisition 1) de connaissances, 2) de comportements d’anticipation du risque et de comportements d’observance (caracterisee par la stabilite de l’INR et la survenue d’incidents hemorragiques sur la periode d’observation). Resultats Cinquante-neuf patients d’âge moyen 65 ans, ont ete inclus dans l’analyse (29 experimentaux contre 30 temoins). Un modele multivarie integrant les facteurs susceptibles d’impacter sur l’incidence des hemorragies sous AVK (socio-demographie, antecedents de MTE, stabilite de l’INR, groupe de reference du patient) met en evidence que seul le fait d’appartenir au groupe experimental induit une difference significative de frequence des incidents hemorragiques (p = 0,05 ; odds-ratio = 4,5, intervalle de confiance : [1-21]). Conclusion La probabilite d’avoir une hemorragie sous AVK est en moyenne 4 fois plus elevee chez un patient n’ayant pas suivi le programme d’education (en analyse multivariee). Un essai randomise de plus grande ampleur visant a valider ces resultats preliminaires est en cours de developpement dans la region Rhone-Alpes.

Echographic and Doppler screening of the forearm arteries in professional volleyball players

We evaluated nine professional volleyball players by clinical, echographic, and Doppler technique examina tion of the forearm and digital arteries to determine vascular damage caused by repeated trauma. The re sults of these tests showed that one-third of the sub jects had vascular lesions in the right hand; only one of these was symptomatic. This suggests that noninva sive screening should be recommended and included in the regular medical check-ups of professional ath letes in whom repeated trauma to the hand is likely, such as volleyball players.

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.