Chronic Venous Disease Patients Research Articles

Use of Compression Stockings in Chronic Venous Disease: Patient Compliance and Efficacy

Compressive stockings are considered the centerpiece of treatment in chronic venous disease (CVD). It is known that stockings fail in some patients for varied reasons: they are ineffective despite wear in some, but more commonly patients are unable or unwilling to use them as prescribed. Detailed statistics regarding stocking compliance have not been available except in a few selected series focused on leg ulcers. This study focuses on use, compliance, and efficacy of compression stockings among a large cohort of patients referred to a tertiary venous practice. A total of 3,144 new CVD patients were seen from 1998 to 2006. As a referral practice, patients had been under the care of primary-care physicians or specialists for variable times before. A detailed history of past and present compressive regimens was part of our initial evaluation of CVD patients. These data were entered into a time-stamped electronic medical record and later analyzed. Only 21% of patients reported using the stockings on a daily basis, 12% used them most days, and 4% used them less often. The remaining 63% did not use the stockings at all or abandoned them after a trial period in the past. The primary reasons given for nonusage were as follows: unable to specify a reason, 30%; not prescribed by the primary physician, 25%; did not help, 14%; binding/"cutting off" of circulation, 13%; "too hot" to wear, 8%; limb soreness, 2%; poor cosmetic appearance, 2%; unable to apply without help, 2%; contact dermatitis or itching, 2%; and other (cost, work situation, etc), 2%. Multiple factors were cited by 8%. Surprisingly, there was no difference in compliance between men and women (39% vs. 38%) or among different decile age groups. Compliance was relatively better at 50% in patients who gave a prior history of deep vein thrombosis (n = 675) compared to 35% in those without such a prior history (n = 2,437) (p < 0.0001). Compliance was poor in CEAP lower (0-2) as well as higher (3-6) clinical classes (p = nonsignificant). Overall compliance with stockings was low and statistically not different in several subsets with significant symptoms: compliance in pain, 39%; swelling, 37%; stasis dermatitis, 46%; and stasis ulceration, 37%. Compliance was relatively better with longer duration of symptoms: <1 year, 25%; 1-5 years, 34%; 6-10 years, 40%; >10 years, 44% (p < 0.003). Symptoms were still persistent in about a third (37%) of the patients despite apparent compliance with prescribed stockings. Compressive stockings are inapplicable in about a quarter of patients due to the condition of the limb or the general health of the patient. They are ineffective despite wear in about a third of patients seen. In the remainder, noncompliance with prescribed compressive stockings is an apparent major cause of treatment failure. Noncompliance is very high in patients with CVD regardless of age, sex, etiology of CVD, duration of symptoms, or disease severity. The reasons for noncompliance can be grouped into two interdependent major categories: (1) wear-comfort factors and (2) intangible sense of restriction imposed by the stockings.

A Randomized, Double-Blind Multicentre Clinical Trial Comparing the Efficacy of Calcium Dobesilate with Placebo in the Treatment of Chronic Venous Disease

To assess the efficacy of calcium dobesilate on the quality-of-life (QoL) of patients with chronic venous disease (CVD). Randomised, parallel, double blind, placebo-controlled clinical trial. Patients were recruited from vascular surgery clinics and randomised to 500mg capsules of calcium dobesilate twice a day for 3 months or placebo. The primary outcome measure was 'QoL after 3 months' treatment measured by the specific Chronic Insufficiency Venous International Questionnaire (CIVIQ). Secondary outcomes were QoL at 12 months and assessment of the CVD signs and symptoms. The principal analysis was undertaken on the intention-to-treat (ITT) data. Five hundred and nine patients were recruited (246 to calcium dobesilate and 263 to placebo). The analysis of the 'QoL after 3 months' showed no significant differences between groups (p=0.07). For secondary outcomes, oedema and symptoms of CVD, there were no significant differences between groups. In a multi-factorial analysis, the 'QoL at 12 months' was better in the calcium dobesilate group than in placebo group (p=0.02). Treatment with calcium dobesilate was not found to be superior to placebo on the QoL of CVD patients. The sustained effect of calcium dobesilate observed after treatment should be confirmed in future studies.

Hemochromatosis C282Y gene mutation increases the risk of venous leg ulceration

Chronic venous disease (CVD) is the most common vascular disorder, progressing in approximately 10% of cases toward chronic venous leg ulceration, whereas the hemochromatosis gene (HFE) C282Y mutation is the most common recognized genetic defect in iron metabolism. Because CVD leads to local iron overload in the affected legs, we investigated whether two common HFE mutations could increase the risk of chronic venous leg ulceration. This was a case-control study at the Vascular Diseases Center, University of Ferrara, Italy. From a cohort of 980 consecutive patients affected by severe CVD (CEAP clinical classes C4 to C6) we selected 238 cases with the exclusion of any other comorbidity factor potentially involved in wound etiology (group A). They were subdivided into group B, including 137 patients with ulcer (classes C5 and C6: 98 primary and 39 postthrombotic cases), and group C, including 101 cases with no skin lesions (class C4). They were completely matched for sex, age, and geographic origin with 280 healthy controls (group D). A total of 518 subjects were polymerase chain reaction genotyped for HFE mutations (C282Y and H63D). We assessed the risk of ulceration by comparing the prevalence of ulcer in homogenous cases with and without the HFE variants. Other main outcome measures were the sensitivity, specificity, and predictive values of the genetic test in CVD cases. C282Y mutation significantly increases the risk of ulcer in primary CVD by almost seven times (odds ratio, 6.69; 95% confidence interval, 1.45-30.8; P = .01). Application of the HFE test in primary CVD demonstrated increased specificity and positive predictive values (98% and 86%, respectively), with negligible sensitivity and negative predictive values. The overlap of primary CVD and the C282Y mutation consistently increases the risk of developing venous leg ulceration. These data, which have been confirmed in other clinical settings, suggest new strategies for preventing and treating primary CVD. The number of patients affected by primary CVD is so great that the vast majority of ulcers are also related to this common problem. On the other hand, there is not a reliable way for identifying in advance, from the broad base of primary CVD patients (20-40% of the general population), the high risk minority (10% of primary CVD cases) who will develop a venous ulcer. In such cases, a simple C282Y blood genetic test demonstrated an elevated specificity in predicting ulcer development (98%, CI 95%, 92.8-99.7). The genetic test could be applied starting from the C2 class, varicose veins, the most common situation observed in clinical practice. In perspective, the presence of the C282Y mutation would strengthen the indications and priorities for surgical correction of superficial venous insufficiency.

The influence of venous thromboembolism on quality of life and severity of chronic venous disease

It is not known whether burden-of-illness differs in chronic venous disease patients with prior venous thromboembolism compared with patients with other forms of chronic venous disease. To compare severity of disease and quality of life in chronic venous disease patients with and without prior venous thromboembolism. The VEINES Study population is an international cohort of 1531 outpatients with chronic venous disease in Belgium, France, Italy and Canada. Clinical severity of chronic venous disease graded using the seven-category 'CEAP' scale, and quality of life using standardized generic (SF-36) and venous disease-specific (VEINES-QOL/Sym) questionnaires were compared in patients with and without venous thromboembolism. Multivariable analyses with adjustment for known confounders were used to examine associations between venous thromboembolism and quality of life. One hundred and fifty-one (10%) patients had prior venous thromboembolism. These patients had more severe chronic venous disease than those without venous thromboembolism (P <0.0001), including a higher frequency of healed or active ulcers (29% vs. 7%, respectively). Multivariable analyses controlling for age, sex, country, education, body mass index, years of chronic venous disease and comorbid conditions demonstrated that prior venous thromboembolism was an independent predictor of poorer generic quality of life (SF-36 Mental Component Summary score, P=0.047; SF-36 Physical Component Summary score, P=0.012) and venous disease-specific quality of life (VEINES-QOL, P = 0.0002; VEINES-Sym, P=0.009). Disease severity is worse and quality of life poorer in chronic venous disease patients with prior venous thromboembolism compared with patients with other forms of chronic venous disease. Our findings support the need for further research of interventions to prevent and treat the long-term complications of venous thromboembolism.

Sapheno-femoral Junction Reflux in Patients with a Normal Saphenous Trunk

Objective To determine the patterns and clinical importance of saphenofemoral junction (SFJ) reflux in patients with chronic venous disease (CVD) and a normal great saphenous vein (GSV) trunk. Methods Fifteen hundred consecutive patients were examined using duplex ultrasound (DU) in three centres. Patients with reflux involving the SFJ and/or its tributaries only were included and its prevalence and patterns were studied. Patients with GSV trunk reflux or in any other veins were excluded. The SFJ diameter was categorised as normal, dilated or varicose. The results of surgery were evaluated by DU in 42 patients 1 year after the procedure. Results SFJ area incompetence with a competent GSV trunk occurred in 8.8% of limbs. It was significantly more common in CEAP class 2, 13.6% compared to class 3, 8.2% ( p=0.03), class 1, 2.7%, class 4, 4.4% and classes 5 and 6 together, 1.5% ( p<0.001 for all). The SFJ had a normal diameter in 21%, dilated in 62% and varicose in 17%. Reflux was seen in 39% of limbs with a normal SFJ diameter, in 85% of those with a dilated SFJ and in all varicose SFJs. Of the 42 operated limbs, 27 had ligation and division of the SFJ and tributary phlebectomies. Fifteen had tributary phlebectomies only, leaving the SFJ intact. At one-year follow-up, SFJ area reflux was found in six limbs (14.3%), involving the SFJ alone in 1, a main tributary in 1 and 4 small tributaries. No reflux was found in the GSV trunk. All but two of the 42 patients were satisfied with the results. Conclusions SFJ reflux with tributary involvement and sparing of the GSV trunk occurs in 8.8% of CVD patients. Such reflux is found in the entire spectrum of CVD, but it is more common in class 2. Local surgery with or without SFJ ligation has very good results at 1 year. DU scanning prior to treatment is important in all patients so that the intact GSV can be spared.

Heart sounds

The Villalta scale (VS) is a recommended and widely used clinical severity score for diagnosis and grading of post-thrombotic syndrome (PTS). However, patients with primary chronic venous disease (CVD) who have a history of deep venous thrombosis (DVT) may be classified as having PTS even though post-thrombotic disease is not actually present. The purpose of this study was to investigate the biases of the VS with use in patients with pre-existing CVD.This single-center, prospective, observational study included patients who were diagnosed with CVD during a 12-month period from 2016 to 2017. The VS and the Venous Clinical Severity Score (VCSS) were completed, and bilateral lower extremity venous duplex ultrasound studies were performed. The correlation of the VS with the VCSS was analyzed. Sensitivity, specificity, positive bias, and negative bias of the VS combined with a history of DVT were calculated. For patients in whom DVT developed during the study, the VS score was taken 12 months after the onset of DVT and compared with the score before DVT.A total of 288 patients were included. The VS score correlated well with the VCSS, with a correlation coefficient of 0.86 (P < .001). The two scores changed similarly over time. The accuracy of the VS combined with a history of DVT was 94.1%, with a sensitivity of 71.4% and a specificity of 95.9%. The positive bias was as high as 42.3%, although the negative bias was 2.3%. The VS score decreased to a normal level during follow-up in 41.7% of the CVD patients in whom a new DVT developed (n = 12).The use of the VS for defining PTS appeared to misclassify those with primary CVD and a history of DVT as having PTS by 42.3%. Using the VS at follow-up in patients with PTS and pre-existing CVD may be misleading. Re-evaluation of the results of previous studies that used the VS may be needed.