Abstract Objectives Ischemic digital ulcers (DU) represent a major complication of systemic sclerosis (SSc). We investigated the impact of controlling the ulcerative disease on disability, pain, and ...quality of life in SSc patients receiving bosentan. Methods ECLIPSE (Study AC-052-517) is a 2-year prospective, multicenter, and observational study. Patients with SSc who experienced at least 1 DU in the previous year and received bosentan were included between October 2009 and March 2011. Disability scores Cochin Hand Function Scale (CHFS) and Health Assessment Questionnaire Disability Index (HAQ-DI), pain scores (visual analog scale), and quality-of-life scores (SF-36) were collected at inclusion and 1 year later (primary endpoint). A controlled ulcerative disease was defined by the absence of ongoing/new DU episode between inclusion and 1-year follow-up. Results Data were available at 1 year for 120 patients out of 190 included. During follow-up, 46 (38.3%) patients experienced a new DU episode. The number of DU per patient decreased from 1.4 ± 1.8 at inclusion to 0.6 ± 1.6 ( p < 0.0001) at 1 year. Disability scores decreased from 1.0 ± 0.7 to 0.9 ± 0.7 ( p = 0.04) for the HAQ-DI and from 29 ± 20 to 25 ± 20 ( p = 0.005) for the CHFS; the pain score decreased from 4.3 ± 3.1 to 2.9 ± 2.8 ( p < 0.0001). This improvement was attributed to patients with a controlled ulcerative disease (48.3%), who significantly improved HAQ-DI ( p = 0.04), CHFS ( p = 0.04), and pain score ( p = 0.046). Conclusions In patients with SSc, control of the ulcerative disease for 1 year was associated with significant attenuation of hand disability.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Background Apart from compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVDs). Spa treatment is a popular way to administer physical ...therapy for CVDs in France, but its efficacy has not yet been assessed in a large trial. The objective was to assess the efficacy of spa therapy for patients with advanced CVD (CEAP clinical classes C4-C5). Methods This was a single-blind (treatment concealed to the investigators) randomized, multicenter, controlled trial (French spa resorts). Inclusion criteria were primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5). The treated group had the usual 3-week spa treatment course soon after randomization; the control group had spa treatment after the 1-year comparison period. All patients continued their usual medical care including wearing compression stockings. Treatment consisted of four balneotherapy sessions per day for 6 days a week. Follow-up was performed at 6, 12 and 18 months by independent blinded investigators. The main outcome criterion was the incidence of leg ulcers at 12 months. Secondary criteria were a modified version of the Venous Clinical Severity Score, a visual analog scale for leg symptoms, and the Chronic Venous Insufficiency Questionnaire 2 and EuroQol 5D quality-of-life autoquestionnaires. Results Four hundred twenty-five subjects were enrolled: 214 in the treatment group (Spa) and 211 in the control group (Ctr); they were similar at baseline regarding their demographic characteristics, the severity of the CVD, and the outcome variables. At 1 year, the incidence of leg ulcers was not statistically different (Spa: +9.3%; 95% confidence interval CI, +5.6 - +14.3; Ctr: +6.1%; 95% CI, +3.2 - +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa: −1.2; 95% CI, −1.6 - −0.8; Ctr: −0.6; 95% CI, −1.0 - −0.2; P = .04). A significant difference favoring spa treatment was found regarding symptoms after 1 year (Spa: −0.03; 95% CI, −0.57 - +0.51; Ctr: +0.87; 95% CI,+0.46 - +1.26; P = .009). EuroQol 5D improved in the treatment group (Spa: +0.01; 95% CI, −0.02 - +0.04) while it worsened (Ctr: −0.07; 95% CI, −0.10 - −0.04) in the control group ( P < .001). A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2 scale (Spa: −2.0; 95% CI, −4.4 - +0.4; Ctr: +2.4; 95% CI, +0.2 - +4.7; P = .008). The control patients showed similar improvements in clinical severity, symptoms, and quality of life after their own spa treatment (day 547). Conclusions In this study, the incidence of leg ulcers was not reduced after a 3-week spa therapy course. Nevertheless, our study demonstrates that spa therapy provides a significant and substantial improvement in clinical status, symptoms, and quality of life of patients with advanced venous insufficiency for at least 1 year.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Clinical analysis of the corona phlebectatica Uhl, Jean-François, MD; Cornu-Thenard, André, MD; Satger, Bernadette, MD ...
Journal of vascular surgery,
2012, 2012-Jan, 2012-01-00, 20120101, Volume:
55, Issue:
1
Journal Article
Peer reviewed
Open access
Background The corona phlebectatica (CP) is classically described as the presence of abnormally visible cutaneous blood vessels at the ankle with four components: “venous cups,” blue and red ...telangiectases, and capillary “stasis spots.” Previous studies showed that the presence of CP is strongly related to the clinical severity of chronic venous disorders (CVD) and the presence of incompetent leg perforators. The aim of this study was to select the most informative components of the CP in the assessment of the clinical severity of CVD patients. Methods A multicentric series of 262 unselected patients (524 limbs) consulted for CVD were clinically evaluated using a standardized form to record the CEAP “C” items and the presence of the four CP components. Standard categorical and ordinal statistics were used to describe the external validity of the CP components as severity indexes, taking the “C” classes as reference. Results “Stasis spots” ( P < .001; r = .44) and blue telangiectases ( P < .01; r = .32) were linearly associated with the ascending order of “C” classes, whereas the relationship is less clear for the red telangiectases and the “venous cups.” The association pattern of the four components showed that only the blue telangiectases and the “stasis spots” were consistent with each other. Blue telangiectases were found more sensitive (0.91 vs 0.75) but less specific (0.52 vs 0.80) than “stasis spots” for advanced venous insufficiency (CEAP “C4-6”). Conclusion This study shows that only blue telangiectases and “stasis spots” provide valuable information in patients with CVD and deserve to be taken into account in the evaluation of such patients. Further studies are needed to show the reproducibility of this data, which we regard as essential for clinical use.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives Except for compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVD). Spa treatment is a popular way to administer physical ...therapy for CVD in France, but its efficacy has not been evaluated yet. This study aimed to assess the efficacy of balneotherapy associated with patient education, as performed in the spa resort of La Léchère, in patients with advanced chronic venous insufficiency (CEAP clinical classes C4/C5). Methods The study was a randomized controlled trial, spa therapy being administered on top of the usual medical care. Evaluation was by a blinded independent investigator. Subjects were patients with primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5), living in Grenoble area, and willing to undergo a spa treatment course in La Léchère. The treated group had the three week spa treatment course in La Léchère, soon after randomization; the control group also had a spa treatment, but starting at day 365. The treatment consisted of four balneology sessions per day, six days a week during three weeks, and three educational workshops. An independent follow-up was performed in Grenoble hospital every three months for 15 months. The main outcome criterion was the severity of the skin changes, as evaluated by means of malleolar chromametry. Quality of life, as measured by the Chronic Venous Insufficiency Questionnaire 2 scale, a visual analog scale (VAS) for leg symptoms, and the occurrence of leg ulcers were used as secondary criteria. The year after spa treatment in the treated group was compared with the year before spa treatment in the control group. Results Fifty-nine subjects were enrolled (29 in the treatment group and 30 in the control group). No statistically significant difference between groups was found at study onset regarding age, sex, etiology, CEAP “C” class, and the outcome variables. After treatment, chromametry showed significantly decreased pigmentation and erythema in the treatment group compared with the controls ( P < .01). Quality of life ( P < .01) and symptoms ( P < .001) also improved significantly. These differences remained significant after one year follow-up. The control patients improved similarly after their own spa treatment (day 450). Conclusion This study shows that spa therapy, associating balneotherapy and patient education, is able to improve significantly the skin trophic changes of the CVD patients and their CVD related quality of life and symptoms. This effect is of large magnitude and remains significant one year after the treatment course.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Occlusion of the ulnar artery is found in a substantial proportion of elderly patients. The aim of this study was to estimate the prevalence of ulnar artery occlusion in a sample of the ...general population of France, look for its risk factors, and evaluate its clinical correlates. Methods This study was an offshoot of a cross-sectional epidemiologic study in the general population of four locations in France (Tarentaise, Grenoble, Nyons, and Toulon). In phase I, random samples of 2000 individuals per location aged ≥18 years old were interviewed by phone for screening of Raynaud phenomenon. In phase II, subsamples of individuals were invited to a medical interview and physical examination where the presence of Raynaud phenomenon and occupational risk factors were recorded and a bilateral clinical Allen test was performed for the detection of ulnar artery occlusion. Phase II comprised 688 women and 335 men. Results In 36 men and seven women, at least one occluded ulnar artery was found. The estimated prevalence was 9.6% in men and 1.0% in women ( P < .001). The occluded artery was more often in the dominant hand of both men (8.1% vs 2.4%; P < .001) and women (0.9% vs 0.4%; P = .34). Ulnar artery occlusion was found more often in men aged >50 years (16.4%) than in younger men (1.4%; P < .001). Besides age, male sex, and dominant side, the only independent risk factor was an occupational exposure in men to repeated palmar trauma, with a significant quantitative relationship in the frequency of the impacts ( P < .001) and the duration of the exposure ( P < .001). Exposures to hand-held vibrating tools and cigarette smoking did not show a significant relationship in the multivariate analysis. Most individuals with ulnar artery occlusion did not have associated complaints; however, the diagnostic criteria for Raynaud phenomenon was validated in 13 of the 36 affected men. The association remained significant after adjusting for occupational exposure to vibrating tools. One individual reported a previous episode consistent with an attack of permanent digital ischemia. Conclusion This study confirms a substantial prevalence of ulnar artery occlusions in the general population, mostly in middle-aged and elderly men, which appears to be principally related to an occupational exposure to repeated occupational palmar trauma. Although there is a significant association with Raynaud phenomenon, most often the consequences of this occlusion remain subclinical.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives The goal was to create a simple diagnostic scoring system able to differentiate leg symptoms related to chronic venous disorders (CVD) from those produced by other causes. Methods A ...prospective observational study was done of ambulatory or hospitalized patients from 13 private and five institutional vascular centers. Two groups of patients with leg symptoms were investigated. The CVD-positive (CVD+) patients had clinically documented CVD and significant venous reflux at duplex ultrasound examination, but no arterial, rheumatologic, or neurologic disorders. The CVD-negative (CVD−) patients had disorders of an arterial, rheumatic, or neurologic origin but no clinical or duplex ultrasound signs of CVD. Patients completed a 54-item questionnaire characterizing their symptoms. Items of the diagnostic score were selected as those associated with the highest likelihood ratio (LR) for CVD in a first series of patients. They were combined into a few criteria, the number of which, when validated in a patient, would produce the value of the score for this patient. Selection of the most relevant score was performed through the comparison of the surface area under receiver operating characteristic curves. The construct validity of this score was evaluated through a factor analysis. The diagnostic performance of the scoring system was evaluated in a second series of patients similar to the first series. Results In the construction phase, 123 CVD+ patients and 94 CVD− patients were enrolled. The validation series consisted of 92 patients (67 venous and 25 nonvenous). The most efficient scoring system was composed of four combined criteria: sensation of heavy or swollen legs (sensitivity, 0.82; specificity, 0.55; LR, 1.84); associated with itching, impatient legs, or phlebalgia (sensitivity, 0.55; specificity, 0.92; LR, 6.41); worsened by a hot environment or improved by a cold environment (sensitivity, 0.78; specificity, 0.71; LR, 2.72); not worsened by walking (sensitivity, 0.89; specificity, 0.62; LR, 2.33). The score was calculated as the number (0 to 4) of the above criteria validated by the patient, with a threshold level of >3, it was shown to have a high specificity (0.95) and a fair sensitivity (0.75) for CVD. Factor analysis showed the construct validity of the score, and consistent results were found in the validation series. Conclusion The clinical relevance of this scoring system remains to be evaluated prospectively in standard clinical conditions. However, these results already document that venous symptoms can be differentiated from leg symptoms of other origins.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Ischaemic digital ulcers (DUs) are common in patients with systemic sclerosis (SSc) and are a cause of disease-related morbidity. In an earlier trial, treatment with bosentan, an oral endothelin ...receptor antagonist, reduced the occurrence of new DUs by 48%. The present study (RAPIDS-2, for 'RAndomized, double-blind, Placebo-controlled study with bosentan on healing and prevention of Ischemic Digital ulcers in patients with systemic Sclerosis') was conducted to more fully evaluate the effects of bosentan treatment on DUs associated with SSc.
This double-blind, placebo-controlled trial conducted at 41 centres in Europe and North America randomised 188 patients with SSc with at least 1 active DU ('cardinal ulcer') to bosentan 62.5 mg twice daily for 4 weeks and 125 mg twice daily thereafter for 20 weeks (n=98) or matching placebo (n=90; total 24 weeks). The two primary end points were the number of new DUs and the time to healing of the cardinal ulcer. Secondary end points included pain, disability and safety.
Over 24 weeks, bosentan treatment was associated with a 30% reduction in the number of new DUs compared with placebo (mean ± standard error: 1.9±0.2 vs 2.7±0.3 new ulcers; p=0.04). This effect was greater in patients who entered the trial with more DUs. There was no difference between treatments in healing rate of the cardinal ulcer or secondary end points of pain and disability. Peripheral oedema and elevated aminotransferases were associated with bosentan treatment.
Bosentan treatment reduced the occurrence of new DUs in patients with SSc but had no effect on DU healing. Bosentan was well tolerated and may be a useful adjunct in the management of patients with SSc with recurrent DUs.
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