Progression of varicose veins and chronic venous insufficiency in the general population in the Edinburgh Vein Study.

OBJECTIVE: The natural history in the general population of chronic venous disease in the legs is not well understood. This has limited our ability to predict which patients will deteriorate and to assign clinical priorities. The aims of this study were to describe the progression of trunk varicose veins and chronic venous insufficiency (CVI) in the general population, to identify important lifestyle and clinical prognostic factors, and to determine the relationship between venous reflux and progression. METHODS: The Edinburgh Vein Study is a population-based cohort study in which randomly selected adults aged 18 to 64 years had an examination at baseline. This included a questionnaire on lifestyle and clinical factors, standardized assessment and classification of venous disease in the legs, and duplex scan to detect venous reflux in eight segments of each leg. A follow-up examination 13 years later included a reclassification of venous disease to ascertain progression in the development or increase in severity of varicose veins and CVI. RESULTS: Among 1566 adults seen at baseline, 880 had a follow-up examination, of whom 334 had trunk varicose veins or CVI at baseline and composed the study sample. The mean (standard deviation) duration of follow-up was 13.4 (0.4) years. Progression was found in 193 (57.8%), equivalent to 4.3% (95% confidence interval [CI], 3.7-4.9) annually. In 270 subjects with only varicose veins at baseline, 86 (31.9%) developed CVI, with the rate increasing consistently with age (P = .04). Almost all subjects (98%) with both varicose veins and CVI at baseline deteriorated. Progression of chronic venous disease did not differ by gender or leg, but a family history of varicose veins and history of deep venous thrombosis increased risk (odds ratio [OR], 1.85 [95% CI, 1.14-1.30] and 4.10 [95% CI, 1.07-15.71], respectively). Overweight was associated with increased risk of CVI in those with varicose veins (OR, 1.85; 95% CI, 1.10-3.12). Reflux in the superficial system increased the likelihood of progression, especially in combination with deep reflux (OR, 2.57; 95% CI, 1.55-4.25) and when located in the small saphenous vein (OR, 4.73; 95% CI, 1.37-16.39). CONCLUSIONS: Nearly half of the general population with chronic venous disease deteriorated during 13 years, and almost one third with varicose veins developed skin changes of CVI, increasing their risk of ulceration. Age, family history of varicose veins, history of deep venous thrombosis, overweight, and superficial reflux, especially in the small saphenous vein and with deep reflux, might influence the risk of progression.

Incidence of chronic venous disease in the Edinburgh Vein Study.

BACKGROUND: Epidemiologic research in chronic venous disease has focused on prevalence and associated risk factors. Evidence on the risks and incidence that this condition will develop is limited. The aim of this study was to measure the incidence of new varicose veins and chronic venous insufficiency (CVI) in an adult population and to investigate risk factors associated with the development of these conditions. METHODS: The Edinburgh Vein Study is a cohort study of a random sample of the general population. Invitations were sent to 1456 men and women at baseline to participate in a 13-year follow-up examination. Each participant completed a questionnaire on lifestyle and medical history and underwent an examination that included clinical classification of venous disease. RESULTS: After a mean follow-up of 13.4 (standard deviation, 0.4) years, 880 of 1456 individuals participated (60.4% response). The overall incidence (95% confidence interval [CI]) of C2 varicose veins was 18.2% (15.2%-21.6%), giving an annual incidence rate of 1.4% (1.1%-1.7%), with incidence rates similar in men and women: the 13-year age-adjusted incidence of varicose veins was 15.2% (10.4%-20.0%) in men and 17.4% (13.1%-21.7%) in women (P = .97). The 13-year incidence of varicose veins increased consistently with age from 9.8% in those aged 18 to 34 years to 25.7% in those aged 55 to 64 years (P < .001). The 13-year incidence (95% CI) of CVI was 9.2% (7.0%-11.9%), and the annual incidence rate was 0.7% (0.5%-0.9%). The incidence of CVI was similar in men and women and increased consistently with age (P < .001). Participants with a family history of venous disease were more likely to develop C2 varicose veins (odds ratio, 1.75; 95% CI, 1.12-2.71). Obesity was associated with the development of CVI: the 13-year incidence (95% CI) was 6.1% (3.7%-9.6%) in those who were of normal weight and 23.6% (14.2%-37.0%) in obese participants, with an age-adjusted odds ratio of 3.58 (1.70-7.56). CONCLUSIONS: The Edinburgh Vein Study is one of a few cohort studies to report the incidence of varicose veins and CVI in the general population. The incidence of varicose veins and CVI did not differ significantly by sex and was strongly associated with increasing age. The risk of developing varicose veins was increased in those with a family history, and the risk of CVI was increased in those with higher body mass index.

A factorial, randomized trial of pentoxifylline or placebo, four-layer or single-layer compression, and knitted viscose or hydrocolloid dressings for venous ulcers.

OBJECTIVES: We evaluated the effectiveness of pentoxifylline, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandaging for venous ulceration. METHOD: A factorial randomized controlled trial with 24-week follow-up was conducted in leg ulcer clinics in Scotland with blinded allocation to pentoxifylline (1200 mg) or placebo, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandages. The study enrolled 245 adults with venous ulcers. The main outcome measure was time to complete healing. Secondary outcomes included proportions healed, withdrawals, and adverse events. Analysis was by intention to treat. RESULTS: There was no evidence of interaction between the drug, bandages, and dressings. Pentoxifylline was associated with nonsignificant increased ulcer healing (62% vs 53%; P = .21). Four-layer bandages were associated with significantly higher healing rates (67% vs 49%; P = .009). There was no difference in healing between knitted viscose and hydrocolloid dressings (58% and 57%; P = .88). Cox regression models increased the significance of the pentoxifylline effect (relative risk of healing, 1.4; 95% confidence interval, 1.0 to 2.0). CONCLUSIONS: Pentoxifylline increased the proportion healing compared with placebo to the same extent as shown in recent systematic reviews, although this finding was only statistically significant when a secondary adjusted analysis was conducted. Four-layer bandaging produced higher healing rates than single-layer bandaging. There was no difference in time to healing between knitted viscose and hydrocolloid dressings.

Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression.

OBJECTIVE: To compare venous ulcer recurrence and compliance with two strengths of compression hosiery. METHODS: This study was a randomized controlled trial with a 5-year follow-up. The setting was the leg ulcer clinics of a teaching and a district general hospital in Scotland, United Kingdom. Patients were 300 outpatients with recently healed venous ulcers, with no significant arterial disease, rheumatoid disease, or diabetes mellitus. Interventions were fitting and supply of class 2 or class 3 compression hosiery. Four-monthly refitting by trained orthotists and surveillance by specialist nurses were performed. The main outcome measures were recurrence of leg ulceration and compliance with treatment. RESULTS: Thirty-six percent (107/300) of patients had recurrent leg ulceration by 5 years. Recurrence occurred in 59 (39%) of 151 class 2 elastic compression cases and in 48 (32%) of class 3 compression cases. One hundred six patients did not comply with their randomized compression class, 63 (42%) in class 3 and 43 (28%) in class 2. The difference in recurrence is not statistically significant, but our estimate of the effectiveness of class 3 hosiery is diluted by the lower compliance rate in this group. Restricted ankle movement and four or more previous ulcers were associated with a higher risk of recurrence. CONCLUSIONS: There was no evidence of a difference in recurrence rates at the classic level of significance (5%), but the lowest recurrence rates were seen in people who wore the highest degree of compression. Therefore, patients should wear the highest level of compression that is comfortable.

Revision of the CEAP classification for chronic venous disorders: consensus statement.

The CEAP classification for chronic venous disorders (CVD) was developed in 1994 by an international ad hoc committee of the American Venous Forum, endorsed by the Society for Vascular Surgery, and incorporated into "Reporting Standards in Venous Disease" in 1995. Today most published clinical papers on CVD use all or portions of CEAP. Rather than have it stand as a static classification system, an ad hoc committee of the American Venous Forum, working with an international liaison committee, has recommended a number of practical changes, detailed in this consensus report. These include refinement of several definitions used in describing CVD; refinement of the C classes of CEAP; addition of the descriptor n (no venous abnormality identified); elaboration of the date of classification and level of investigation; and as a simpler alternative to the full (advanced) CEAP classification, introduction of a basic CEAP version. It is important to stress that CEAP is a descriptive classification, whereas venous severity scoring and quality of life scores are instruments for longitudinal research to assess outcomes.

Lifestyle factors and the risk of varicose veins: Edinburgh Vein Study.

The objective of this study was to determine the inter-relationships between a range of lifestyle factors and risk of varicose veins to identify which factors may be implicated in the etiology. An age-stratified random sample of 1566 subjects (699 men and 867 women) aged 18 to 64 years was selected from 12 general practices throughout Edinburgh. A detailed self-administered questionnaire was completed, and a comprehensive physical examination determined the presence and severity of varicose veins. The slightly higher age-adjusted prevalence of varicose veins in men than in women (39.7% versus 32.2%) was not explained by adjustment for an extensive range of lifestyle risk factors (male odds ratio [OR] 2.11, 95% confidence interval [CI] 1.51-2.96). In both sexes, increasing height showed a significant relationship with varicose veins (male OR 1.50, 95% CI 1.18-1.93 and female OR 1.26, 95% CI 1.01-1.58). Among women, body mass index was associated with an increased risk of varicose veins (OR 1.26, 95% CI 1.02-1.54). The current study casts doubt as to whether varicose veins occur predominantly in women. In addition, no consistent relationship with any lifestyle factor was shown. Self-reported evidence suggested a familial susceptibility, thereby warranting future genetic studies.

The relationship between aortic wall distensibility and rupture of infrarenal abdominal aortic aneurysm.

OBJECTIVE: A more accurate means of prediction of abdominal aortic aneurysm (AAA) rupture would improve the clinical and cost effectiveness of prophylactic repair. The purpose of this study was to determine whether AAA wall distensibility can be used to predict time to rupture independently of other recognized risk factors. METHODS: A prospective, six-center study of 210 patients with AAA in whom blood pressure (BP), maximum AAA diameter (Dmax), and AAA distensibility (pressure strain elastic modulus [Ep] and stiffness [beta]) were measured at 6 months with an ultrasound scan-based echo-tracking technique. A stepwise, time-dependent, Cox proportional hazards model was used to determine the effect on time to rupture of age, gender, BP, Dmax, BP, Ep, beta, and change in Dmax, Ep, and beta adjusted for time between follow-up visits. RESULTS: Median (interquartile range) AAA diameter was 48 mm (41 to 54 mm), median age was 72 years (68 to 77 years), and median follow-up period was 19 months (9 to 30 months). In the Cox model, female gender (hazards ratio [HR], 2.78; 95% CI, 1.23 to 6.28; P =.014), larger Dmax (HR, 1.36 for 10% increase in Dmax; 95% CI, 1.12 to 1.66; P =.002), higher diastolic BP (HR, 1.13 for 10% increase in BP; 95% CI, 1.13 to 1.92; P =.004), and a decrease in Ep (increase in distensibility) over time (HR, 1.38 for 10% decrease in Ep over 6 months; 95% CI, 1.08 to 1.78; P =.010) significantly reduced the time to rupture (had a shorter time to rupture). CONCLUSION: Women have a shorter time to AAA rupture. The measurement of AAA distensibility, diastolic BP, and diameter may provide a more accurate assessment of rupture risk than diameter alone.

Patient, operative, and surgeon factors that influence the effect of superficial venous surgery on disease-specific quality of life.

BACKGROUND AND OBJECTIVE: Superficial venous surgery for CEAP 2 disease leads to an improvement in disease-specific quality of life (QoL) in the short term. However, which factors influence the magnitude of this improvement, how surgery affects QoL in patients with CEAP 4 to 6 disease, and whether this improvement is durable are not known. The objective of this study was to identify patient, operative, and surgeon factors that might influence the change in disease-specific QoL in the 2 years after superficial venous surgery. METHODS: This prospective study was comprised of 203 unselected, consecutive patients with CEAP 2 to 6 disease who underwent saphenous with or without subfascial endoscopic perforator surgery and who completed the Aberdeen Varicose Vein Symptoms Severity Score (AVVSSS) before surgery and at 4 weeks, 6 months, and 2 years after surgery. Univariate and multivariate analyses were performed. RESULTS: At baseline, recurrent and ulcer (CEAP 5 and 6) diseases were associated with a higher (worse) AVVSSS. Surgery was associated with a significant improvement in median (interquartile range [IQR]) AVVSSS: baseline, 17.8 (11.8 to 27.2); 4 weeks, 13.8 (7.9 to 21.3); 6 months, 9.6 (4.2 to 15.8); and 2 years, 8.1 (4.0 to 14.7). One hundred seventy-five patients (86%) at 6 months and 177 patients (87%) at 2 years reported an improvement in AVVSSS. Postoperative AVVSSS at both 6 months and 2 years was most significantly influenced by preoperative score (P <.0001). After adjustment for baseline AVVSSS, the following factors were identified in multivariate analysis as having a significant and independent positive (+) or negative (-) impact on AVVSSS: at 6 months, (-) recurrent disease (P =.009), (-) CEAP 4 disease (P =.026); and at 2 years, (+) long saphenous surgery (P =.02), (-) CEAP 5 disease (P =.030). CONCLUSION: In this unselected series, saphenous surgery with or without subfascial endoscopic perforator surgery led to an improvement in disease-specific QoL in 87% of patients out to 2 years. Although univariate analysis results suggested that many baseline factors might be associated with outcome, multivariate analysis results suggested that only surgery for recurrent disease and for CEAP 4/5 disease remained as significant negative, and only long saphenous surgery as significant positive, independent prognostic factors. These data provide evidence of the medium-term clinical effectiveness of venous surgery across the full spectrum of CEAP clinical grades, show the importance of multivariate analysis, and reemphasize the importance of minimization of recurrence.

Chronic venous insufficiency: clinical and duplex correlations. The Edinburgh Vein Study of venous disorders in the general population.

OBJECTIVE: The objective of this study was to determine the prevalence of chronic venous insufficiency (CVI) in the general population and to correlate its clinical features with sonographically proven venous reflux. DESIGN OF STUDY: The study design was a cross-sectional survey of the general population. SUBJECTS AND METHOD: Ambulatory men and women, aged 18-64 years, were selected randomly from 12 general practices. Subjects were examined for CVI. Eight segments of the deep and superficial veins were assessed for reflux by means of duplex scanning. RESULTS: A total of 1566 subjects were screened (867 women, mean age 44.8 years; 699 men, mean age 45.8 years) of whom 124 were diagnosed as having CVI: 95, grade 1; 19, grade 2; and 10, grade 3. The age-adjusted prevalence for the whole population was 9.4% in men and 6.6% in women. Prevalence of CVI correlated closely with age and sex, being 21.2% in men >50 years and 12.0% in women >50 years. Heaviness and tension, and a feeling of swelling, aching, and itching, were significantly associated with worsening grade of CVI. CVI was significantly associated with reflux in all deep and superficial segments. The frequency of reflux in both superficial and deep segments increased with the clinical severity of disease. In 30.8% of subjects with CVI in the left leg, reflux was limited to the superficial system. CONCLUSIONS: The prevalence of CVI rises steeply with age. There is a strong correlation between venous symptoms and the presence and severity of CVI. CVI is associated in approximately one third of the subjects with incompetence limited to the superficial system and in these a good therapeutic outcome could be expected from surgery to the superficial veins. The severity of clinical features, including Basle CVI grade 1, correlates significantly with prevalence of valvular reflux in the deep and superficial systems. If leg ulcers are to be prevented by timely intervention, a better understanding of the natural history of the association between presenting features and disordered hemodynamics is required.

The prevalence of thrombophilia in patients with chronic venous leg ulceration.

BACKGROUND: Thrombophilia is increasingly recognized as a risk factor for deep venous thrombosis (DVT), which in turn is a major risk factor for chronic venous ulceration (CVU). However, the relationship between thrombophilia and CVU remains unknown. The aim of this study was to define the prevalence of thrombophilia in patients with CVU and to determine whether this is associated with a history or duplex scan evidence of DVT. METHODS: Eighty-eight patients with CVU were prospectively studied. The patients underwent clinical assessment and duplex ultrasound scanning. Blood was drawn for antithrombin, proteins C and S, activated protein C resistance, factor V Leiden, prothrombin 20210A, lupus anticoagulant, and anticardiolipin antibodies. RESULTS: The study included 35 men with a median age of 61 years (interquartile range, 45 to 72 years) and 53 women with a median age of 76 years (interquartile range, 69 to 82 years). Thirty-six percent of the patients had either a history or duplex scan evidence suggestive of previous DVT. The following abnormalities were detected: four, five, and six cases of antithrombin, protein C, and protein S deficiencies, respectively; 14 cases of activated protein C resistance; 11 cases of factor V Leiden mutation; three cases of prothrombin 20210A mutation; eight cases of lupus anticoagulant; and 12 cases of anticardiolipin antibodies. Thrombophilia was not significantly related to previous DVT, deep reflux, or disease severity. CONCLUSION: Patients with CVU have a 41% prevalence rate of thrombophilia. This rate is two to 30 times higher than the rate of the general population but is similar to that reported for patients with previous DVT. However, in patients with CVU, thrombophilia does not appear to be related to a history of DVT, a pattern of reflux, or severity of disease. Many patients with CVU may have unsuspected postthrombotic disease.