Determinants of health-related quality of life during the 2 years following deep vein thrombosis

Summary. Background/objectives: We prospectively measured change in quality of life (QOL) during the 2 years after a diagnosis of deep vein thrombosis (DVT) and evaluated determinants of QOL, including development of the post‐thrombotic syndrome (PTS). Patients/methods: Consecutive patients with acute DVT were recruited from 2001 to 2004 at eight hospitals in Canada. At study visits at baseline, and 1, 4, 8, 12 and 24 months, clinical data were collected, standardized PTS assessments were performed, and QOL questionnaires were self‐completed. Generic QOL was measured using the Short‐Form Health Survey‐36 (SF‐36) questionnaire. Venous disease‐specific QOL was measured using the Venous Insufficiency Epidemiological and Economic Study (VEINES)‐QOL/Sym questionnaire. The change in QOL scores over a 2‐year follow‐up was assessed. The influence of PTS and other characteristics on QOL at 2 years was evaluated using multivariable regression analyses. Results: Among the 387 patients recruited, the average age was 56 years, two‐thirds were outpatients, and 60% had proximal DVT. The cumulative incidence of PTS was 47%. On average, QOL scores improved during follow‐up. However, patients who developed PTS had lower scores at all visits and significantly less improvement in QOL over time (P‐values for PTS*time interaction were 0.001, 0.012, 0.014 and 0.006 for PCS, MCS, VEINES‐QOL and VEINES‐Sym). Multivariable regression analyses showed that PTS (P < 0.0001), age (P = 0.0009), proximal DVT (P = 0.01) and inpatient status (P = 0.04) independently predicted 2‐year SF‐36 PCS scores. PTS alone independently predicted 2‐year VEINES‐QOL (P < 0.0001) and VEINES‐Sym (P < 0.0001) scores. Conclusions: Development of PTS is the principal determinant of health‐related QOL 2 years after DVT. Our study provides prognostic information on patient‐reported outcomes after DVT and emphasizes the need for effective prevention and treatment of the PTS.     

Prevalence and predictors for post‐thrombotic syndrome 3 to 16 years after pregnancy‐related venous thrombosis: a population‐based,cross‐sectional,case‐control study

Background:  The long‐term outcome of pregnancy‐related venous thrombosis (VT) is not known. Objectives:  To assess predictors and long‐term frequency of post‐thrombotic syndrome (PTS) after pregnancy‐related VT. Patients/Methods:  In 2006, 313 women with pregnancy‐related VT during 1990–2003 and 353 controls answered a comprehensive questionnaire that included self‐reported Villalta score as a measure of PTS. Cases were identified from 18 Norwegian hospitals using the Norwegian Patient Registry and the Medical Birth Registry of Norway. The latter was used to select as possible controls women who gave birth at the same time as a case. Thirty‐nine patients and four controls were excluded because of VT outside the lower limbs/lungs or missing Villalta scores. Two hundred and four patients had DVT in the lower limb and 70 had pulmonary embolism (PE). The control group comprised 349 women naive for VT at the time of the index pregnancy. Results:  Forty‐two per cent of cases with DVT in the lower limb, compared with 24% of cases with PE and 10% of controls, reported a Villalta score of ≥ 5. Severe PTS (Villalta score of ≥ 15) was reported among 7%, 4% and 1%. Proximal postnatal, but not antenatal, thrombosis was a strong predictor of PTS with an adjusted odds ratio of 6.3 (95% confidence interval, 2.0–19.8; P = 0.002). Daily smoking before the index pregnancy and age above 33 years at event were independent predictors for post‐thrombotic syndrome. Conclusions:  PTS is a common long‐term complication after pregnancy‐related DVT. Proximal postnatal thrombosis, smoking and higher age were independent predictors of the development of PTS.     

Deep venous thrombosis after surgery for Achilles tendon rupture: a provoked transient event with minor long‐term sequelae

Summary. Background: Deep venous thrombosis (DVT) occurs frequently in patients undergoing orthopedic surgery, but there is a lack of knowledge regarding long‐term sequelae of DVT after different types of surgical procedures. Objective: To describe the long‐term effect of symptomatic (SDVT) and asymptomatic (ADVT) deep venous thrombosis on venous function and subsequent incidence of post‐thrombotic syndrome (PTS) in patients who have undergone surgery for Achilles tendon rupture. Patients/methods: This observational follow‐up study includes 83 patients with postoperative DVT, examined after a mean of 7 years. There were two series of patients: 45 with SDVT and 38 with ADVT. In both series, more than 90% of the DVTs were limited to calf veins. Follow‐up examinations comprised color duplex ultrasonography (CDU), strain‐gauge plethysmography (SGP), clinical examination including scoring for venous disease and questionnaires for quality of life (QOL). Results: A mild degree of PTS was found in 11% of the patients: 13% in SDVT and 8% in ADVT patients. The rate of recurrent ipsilateral DVT was 2%. Deep venous reflux was more common in patients with SDVT than in ADVT patients (84% vs. 55%, P < 0.01). Only a few patients had plethysmograpically abnormal findings without difference between the two groups. Conclusion: DVT after surgery for Achilles tendon rupture consists mainly of distal DVTs and are associated with a low risk for PTS. Deep venous reflux was more common in SDVT than in ADVT patients, probably as an effect of larger DVTs in the former group.     

Clinical and economic impact of compression in the acute phase of deep vein thrombosis

Essentials

• The value of compression therapy in acute phase of deep vein thrombosis is still unclear.
• Patients with deep vein thrombosis received acute compression hosiery, bandaging, or none.
• Acute compression reduces irreversible skin signs related to post thrombotic syndrome.
• Compression hosiery may be the preferred choice for the acute phase

Summary

Background

The effectiveness of compression therapy in the acute phase of deep vein thrombosis (DVT) is not yet determined.

Objectives

To investigate the impact of compression therapy in the acute phase of DVT on determinants of the Villalta score, health‐related quality of life (HRQOL), and costs.

Patients/Methods

Eight hundred and sixty‐five patients with proximal DVT (substudy of the IDEAL DVT study) received, immediately after DVT diagnosis, either no compression, multilayer bandaging, or hosiery. In the acute phase and 3 months after diagnosis, HRQOL was determined by use of the EQ‐5D, SF6D, and VEINES‐QoL intrinsic method (VEINES‐QoL^int). At 3 months, signs and symptoms were assessed for the total and separate items of the Villalta score, and healthcare costs were calculated.

Results

The compression groups had lower overall objective Villalta scores than the no‐compression group (1.47 [standard deviation (SD) 1.570] and 1.59 [SD 1.64] versus 2.21 [SD 2.15]). The differences were mainly attributable to irreversible skin signs (induration, hyperpigmentation, and venectasia) and pain on calf compression. Subjective and total Villalta scores were similar across groups. Differences in HRQOL were only observed at 1 month; HRQOL was better for hosiery (EQ‐5D 0.86 [SD 0.18]; VEINES‐QoL^int 0.66 [SD 0.18]) than for multilayer compression bandaging (EQ‐5D 0.81 [SD 0.23; VEINES‐QoL^int 0.62 [SD 0.19]). Mean healthcare costs per patient were €417.08 (€354.10 to €489.30) for bandaging, €114.25 (€92.50 to €198.43) for hosiery, and €105.86 (€34.63 to €199.30) for no compression.

Conclusions

Initial compression reduces irreversible skin signs, edema, and pain on calf compression. Multilayer bandaging is slightly more effective than hosiery, but has substantially higher costs, without a gain in HRQOL. From a patient and economic perspective, compression hosiery would be preferred when initial compression is applied. Trial registration: IDEAL DVT study ClinicalTrials.gov number, NCT01429714.     

Comparison of the clinical history of symptomatic isolated distal deep‐vein thrombosis vs. proximal deep vein thrombosis in 11 086 patients

Background: The clinical significance of symptomatic isolated distal deep vein thrombosis (DVT) is uncertain. Consequently, this leads to important disparities in its management. Objective: To examine the clinical history of isolated distal DVT and to compare it with that of proximal DVT. Methods: Using data from the international, prospective, RIETE registry on patients with confirmed symptomatic venous thromboembolism (VTE), we compared the risk factors and 3‐month outcome in patients with isolated distal DVT vs. proximal DVT. Results: Eleven thousand and eighty‐six patients with symptomatic DVT, but without pulmonary embolism, were included between 2001 and 2008; 1921 (17.3%) exhibited isolated distal DVT. Anticoagulant treatment was received by 89.1% (1680/1885) of isolated distal DVT and 91.8% (7911/8613) of proximal DVT patients for the entire follow‐up period. Isolated distal DVTs were more associated with transient risk factors (i.e. recent travel, hospitalization, recent surgery), whereas proximal DVTs were more associated with chronic states (i.e. ≥75 years or with active cancer). At 3 months, major bleeding rate was lower in patients with isolated distal DVT (1.0% vs. 2.2%, P < 0.01), whereas VTE recurrence rate was equivalent (2.0% vs. 2.7%, P = 0.07). The mortality rate was lower in patients with isolated distal DVT (2.7% vs. 7.5%; P < 0.001); this was mainly due to a lower rate of non‐VTE‐related deaths (2.2% vs. 6.3%; P < 0.001). Active cancer was the main predictive factor of death in patients with isolated distal DVT. Conclusions: Proximal and isolated distal DVT patients differ in terms of risk factors and clinical outcomes, suggesting different populations. In the short term, the life expectancy of patients with isolated distal DVT depended chiefly on their cancer status.     

D‐dimer testing in pregnant patients: towards determining the next ‘level’ in the diagnosis of deep vein thrombosis

Summary. Background: The role of D‐dimer in excluding deep vein thrombosis (DVT) in pregnancy is currently uncertain. We hypothesized that the specificity of sensitive D‐dimer assays could be improved without compromising sensitivity by using higher D‐dimer cut‐off values. Objective: To determine the test characteristics of two rapid enzyme‐linked immunosorbent assays and three latex agglutination assays in pregnancy. Method: We recruited consecutive pregnant women who presented to participating centers with suspected DVT for the study. Symptomatic women were investigated with compression ultrasonography, and received 3 months of clinical follow‐up to assess for the presence of venous thrombosis. Plasma samples for D‐dimer were collected and frozen at the time of presentation. The median and mean D‐dimer values for respective trimesters of pregnancy in patients with and without DVT were calculated. Receiver operating curves (ROCs) were plotted for respective assays to establish the best cut‐points. The test characteristics corresponding to standard cut‐points and these ‘pregnancy’ cut‐points are presented. Results: The prevalence of DVT in our cohort was 6.6% (95% confidence interval 4.0–10.6%). The mean and median D‐dimer values were significantly increased throughout pregnancy. Overall, women with confirmed DVT had higher D‐dimer levels than women without DVT (P < 0.0001). Improved specificities (62–79%) were observed with the use of higher cut‐points obtained from ROCs for all five assays, and high sensitivities were manintained (80–100%) for DVT diagnosis. Conclusion: Using higher cut‐points than those used in non‐pregnant patients, the specificity of D‐dimer assays for the diagnosis of DVT in pregnancy can be improved without compromising sensitivity. Validation in prospective management studies is needed.     

ADHD Symptoms Related to Profiles of Self‐Esteem in a Longitudinal Study of Twins A person‐oriented approach

PROBLEM: There are conflicting research data regarding the relationship between attention deficit hyperactivity disorder (ADHD) and low self‐esteem. METHODS: A person‐oriented approach was used to study the relationships between ADHD symptoms and self‐esteem in a longitudinal study of twins starting when they were 8 years old. A cluster analysis was performed at age 13 using five subscales from a self‐esteem questionnaire. FINDINGS: High scores of ADHD symptoms were linked to profiles characterized by lower scores in the domains “skills and talents” and “psychological well‐being”. CONCLUSION: Children with high scores of ADHD symptoms often have specific problem profiles of self‐esteem.     

Validation of the Korean language version of the incontinence‐quality of life scale

The purpose of this study is to determine the reliability and validity of the translated Korean version of the incontinence‐quality of life (I‐QOL) in a sample of community‐dwelling Korean American women with urinary incontinence in the USA. A survey design was used and a convenience sampling method of 176 Korean American women who reported having urinary incontinence symptoms was used. Translation–back translation procedures were used to translate the English version of the I‐QOL into Korean version. Reliability of the Korean I‐QOL questionnaire was demonstrated by Cronbach's α coefficients. Pearson's correlations of an item with its own scale and other scales were calculated to evaluate item‐convergent and item‐discriminant validity. Confirmatory factor analysis was performed to examine the underlying factor structure of the Korean version of the I‐QOL. Cronbach's α coefficient for all three subscales was greater than 0·70. The results of item‐convergent validity indicated that each item was strongly correlated with the originally belonged subscale. Item‐discriminant validity was evidenced by all lower correlations of an item to the other subscales than that of own subscale. Three factors were extracted from I‐QOL, accounting for 67·37% of the variance. The findings supported the reliability and validity of Korean version of I‐QOL questionnaire. It would be considered as a valuable instrument to assess the different aspects of health‐related quality of life in incontinence patients and recommended for use in clinical research.     

Assessing burden of illness following acute deep vein thrombosis: data quality, reliability and validity of the Norwegian version of VEINES-QOL/Sym, a disease-specific questionnaire

The data quality, reliability and validity of the Norwegian version of VEINES-QOL/Sym were assessed in 74 patients with deep vein thrombosis (DVT). This patient-reported questionnaire produces two scale scores of venous disease-specific quality of life and venous symptoms. Items had low levels of missing data. Item-total correlations ranged from 0.41 to 0.78 with the exception of 0.29 for the symptom item 'night cramps'. Internal consistency was supported by Cronbach's alpha of 0.88 and 0.94 for VEINES-Sym and VEINES-QOL, respectively. Test–retest reliability assessed for 40 patients gave intraclass correlation coefficients of 0.83 and 0.88 for VEINES-Sym and VEINES-QOL, respectively. Assessment of correlation between the two scales and other clinical measures supports the construct validity of the scales. The results indicate acceptable internal consistency, test–retest reliability and validity of the Norwegian version of the VEINES-QOL/Sym questionnaire in patients with DVT. The results follow those of previous studies, and support the use of VEINES-QOL/Sym in the evaluation of patient outcomes and burden of illness in clinical studies of venous thrombosis.     

The Wells rule and D‐dimer for the diagnosis of isolated distal deep vein thrombosis

Summary. Background: Pretest clinical probability with the Wells rule and D‐dimer have been widely investigated for the diagnosis of symptomatic proximal deep vein thrombosis (DVT) of the lower limbs, but they have not been formally tested for symptomatic isolated distal DVT diagnosis. Objective: To evaluate the diagnostic accuracy of the Wells rule and D‐dimer for isolated distal DVT. Design, Setting, and Patients: This was a single‐center, cross‐sectional study including 873 consecutive outpatients with suspected DVT, in whom pretest clinical probability determination, D‐dimer determination (STA Liatest; cut‐off of < 500 ng mL^?1) and complete compression ultrasonography of both lower limbs were performed. Results: The isolated distal DVT prevalence was 12.4% (90/725). The sensitivity of the Wells rule for isolated distal DVT was 47% (95% confidence interval [CI] 36–57%), the specificity was 74% (95% CI 70–77%), and the negative and positive predictive values were 91% (95% CI 88–93%) and 20% (95% CI 15–26%), respectively. Patients with isolated distal DVT had higher D‐dimer levels than patients without DVT (1759 ± 1576 vs. 862 ± 1079 ng mL^?1, P = 0.0001). D‐dimer was negative in 13 patients with isolated distal DVT. D‐dimer sensitivity and specificity for isolated distal DVT were 84% (95% CI 75–91%) and 50% (95% CI 46–54%), respectively, with a negative predictive value of 96% (95% CI 93–98%). In patients with low pretest clinical probability, the D‐dimer negative predictive value was 99% (95% CI 95–100%). Conclusion: In clinically suspected DVT with negative proximal compression ultrasonography, pretest clinical probability with the Wells rule has a low diagnostic accuracy for isolated distal DVT. D‐dimer has a better negative predictive value, but alone it does not exclude isolated distal DVT. In patients with low pretest clinical probability, D‐dimer had a negative predictive value of > 95% for isolated distal DVT.     

Impact of von Willebrand disease on health‐related quality of life in a pediatric population

Summary. Background: Von Willebrand disease (VWD) is the most frequent inherited bleeding disorder. Whether VWD is associated with health‐related quality of life (HR‐QoL) in children is unknown. Objectives: This nationwide cross‐sectional study measured HR‐QoL in children with moderate or severe VWD. Our primary aim was to compare HR‐QoL of VWD patients with that of reference populations. Additionally, we studied the impact of bleeding phenotype and VWD type on HR‐QoL. Methods: HR‐QoL was assessed with the Infant/Toddler QoL Questionnaire (0–5 years) and Child Health Questionnaire (6–15 years), and compared with reference population scores. Multivariate analysis was used to evaluate the influence of type of VWD and bleeding phenotype on HR‐QoL scores. Results: Preschool children (0–5 years, n = 46) with VWD had lower HR‐QoL scores for general health perceptions and parental time than reference populations. School children (6–15 years, n = 87) with VWD had lower scores for physical functioning, role functioning – emotional/behavioral, general health perceptions, and physical summary. Type of VWD was associated with HR‐QoL in school children for bodily pain, general health perceptions, parental emotion, family activities, and physical summary. Scores of children with type 3 VWD were, on average, 15 points lower than those of the reference population on the above‐mentioned scales. A more severe bleeding phenotype was associated with a lower score on 11/15 physical, emotional and social scales. Conclusion: HR‐QoL is lower in VWD children than in reference populations, in particular in school children. The negative impact of VWD is sensitive to type of VWD and bleeding phenotype; as well as physical scales, emotional and social scales are affected.     

A prospective,longitudinal study of central venous catheter‐related deep venous thrombosis in boys with hemophilia

Summary. Background: Central venous catheters (CVCs) are often inserted into boys with hemophilia to secure venous access for factor prophylaxis and immune tolerance induction therapy. Complications associated with CVCs include catheter‐related infections, local hemorrhage, and mechanical failure. Less frequently reported is CVC‐related deep venous thrombosis (DVT). We conducted a prospective study to determine the frequency and outcome of this complication. Methods: All boys (n = 16) with congenital hemophilia A or B with a CVC in place who were registered in the pediatric comprehensive care program at the Hospital for Sick Children, Toronto, were included in the study. They were prospectively assessed by imaging studies and clinical examinations for CVC‐related DVT at two time‐points, 2 years apart. Each boy was evaluated for inherited hypercoagulability. Results: Eleven (69%) of the 16 boys had radiological evidence of DVT at the first evaluation and 13/16 (81%) at the second evaluation. In two boys there was improvement in the venogram findings at the second evaluation. None of the CVC‐related DVTs completely resolved. Median age at the time of initial insertion of a CVC was 1.0 years (range 0.02–6.7 years). Median duration of CVC placement was 6.4 years (range 3.3–15.5 years). Only 4/13 boys with DVTs had clinical evidence of upper venous system obstruction. Only one boy, who did not develop a DVT, had a low protein C level. Conclusions: CVC‐related DVTs occur in the majority of boys with hemophilia who have CVCs inserted for a prolonged period of time. Annual screening with imaging is recommended for boys with CVCs in place for ≥ 3 years. Consideration should be given to removing CVCs as soon as peripheral venous access is feasible.     

Absence of long‐term analgesic effect from a short‐term S‐ketamine infusion on fibromyalgia pain: A randomized,prospective, double blind,active placebo‐controlled trial

To assess the analgesic efficacy of the N‐methyl‐D‐aspartate receptor antagonist S(+)‐ketamine on fibromyalgia pain, the authors performed a randomized double blind, active placebo‐controlled trial. Twenty‐four fibromyalgia patients were randomized to receive a 30‐min intravenous infusion with S(+)‐ketamine (total dose 0.5 mg/kg, n=12) or the active placebo, midazolam (5 mg, n =12). Visual Analogue Pain Scores (VAS) and ketamine plasma samples were obtained for 2.5‐h following termination of treatment; pain scores derived from the fibromyalgia impact questionnaire (FIQ) were collected weekly during an 8‐week follow‐up. Fifteen min after termination of infusion the number of patients showing a reduction in pain scores >50% was 8 vs. 3 (P<0.05), at t=180 min 6 vs. 2 (ns), at the end of week‐1 2 vs. 0 (ns) and at end of week‐8 2 vs. 2 in the ketamine and midazolam groups, respectively. Ketamine effect on VAS closely followed ketamine plasma concentrations. For VAS and FIQ scores no significant differences in treatment effects were observed in the 2.5‐h following infusion or during the 8‐week follow‐up. Side effects as measured by the Bowdle questionnaire (which scores for 13 separate psychedelic symptoms) were mild to moderate in both study groups and declined rapidly, indicating adequate blinding of treatments. Efficacy of ketamine was limited and restricted in duration to its pharmacokinetics. The authors argue that a short‐term infusion of ketamine is insufficient to induce long‐term analgesic effects in fibromyalgia patients.     

Treatment of upper‐extremity deep vein thrombosis

Summary. Background: Upper extremity deep vein thrombosis (DVT) can result in fatal pulmonary embolism if not treated. Patients with malignancy may be at particularly high risk. Heparin or low‐molecular‐weight heparin followed by warfarin has been used as standard treatment for lower extremity DVT. However, a paucity of studies exist reporting the efficacy and safety of these regimens in patients with upper extremity DVT. We studied the effectiveness and safety of treatment with dalteparin sodium followed by warfarin and also dalteparin sodium monotherapy for 3 months in patients with confirmed upper extremity DVT. Methods: Consecutive patients with confirmed upper extremity DVT received daily dalteparin sodium for 5–7 days followed by warfarin therapy for 3 months (phase I) or dalteparin sodium monotherapy for 3 months (phase II). The primary outcome measure was the incidence of new symptomatic venous thromboembolism during the 3‐month follow‐up period. The outcome measure of safety was the incidence of major and minor bleeding. Results: Of 631 consecutive patients screened, 74 were eligible and 67 enrolled. No patients receiving either phase I (0%; 95% CI, 0–12%) or phase II (0%; 95% CI, 0–9%) therapy had venous thromboembolism on 3‐month follow‐up. One patient (4%; 95% CI, 0–18%) receiving phase I therapy experienced major bleeding. Five patients died during the follow‐up period; none were attributed to pulmonary embolism. Conclusions: Patients with upper extremity DVT may be treated safely with either dalteparin sodium followed by warfarin or dalteparin sodium monotherapy for 3 months with a good prognosis.     

Economic burden and cost determinants of deep vein thrombosis during 2 years following diagnosis: a prospective evaluation

Summary. Background: Few studies have evaluated the long‐term economic consequences of deep vein thrombosis (DVT). None of them have incorporated prospectively collected clinical data to ensure accurate identification of incident cases of DVT and DVT‐related health outcomes of interest, such as post‐thrombotic syndrome (PTS). Objectives: To prospectively quantify medical and non‐medical resource use and costs related to DVT during 2 years following diagnosis, and to identify clinical determinants of costs. Methods: Three hundred and fifty‐five consecutive patients with acute DVT were recruited at seven Canadian hospital centers. Resource use and cost information were retrieved from three sources: weekly patient‐completed cost diaries, nurse‐completed case report forms, and the Quebec provincial administrative healthcare database (RAMQ). Results: The rate of DVT‐related hospitalization was 3.5 per 100 patient‐years (95% confidence interval [CI] 2.2–4.9). Patients reported a mean (standard deviation) of 15.0 (14.5) physician visits and 0.7 (1.2) other healthcare professional visits. The average cost of DVT was $5180 (95% CI $4344–6017) in Canadian dollars, with 51.6% of costs being attributable to non‐medical resource use. Multivariate analysis identified four independent predictors of costs: concomitant pulmonary embolism (relative increase in cost [RIC] 3.16; 95% CI 2.18–4.58), unprovoked DVT (RIC 1.65; 95% CI 1.28–2.13), development of PTS during follow‐up (RIC 1.35; 95% CI 1.05–1.74), and management of DVT in the inpatient setting (RIC 1.79; 95% CI 1.33–2.40). Conclusions: The economic burden of DVT is substantial. The use of measures to prevent the occurrence of PTS and favoring outpatient care of DVT has the potential to diminish costs.     

Risk factors for post‐thrombotic syndrome in patients with a first deep venous thrombosis

Summary. Background: Post‐thrombotic syndrome (PTS) is a chronic complication of deep venous thrombosis (DVT). Objectives: To determine the risk of PTS after DVT and to assess risk factors for PTS. Methods: Patients were recruited from the Multiple Environmental and Genetic Assessment (MEGA) study of risk factors for venous thrombosis. Consecutive patients who suffered a first DVT of the leg were included in a follow‐up study. All patients completed a questionnaire and DNA was obtained. PTS was ascertained in a structured interview using a clinical classification score. Results: The 1‐year cumulative incidence of PTS was 25% and 7% for severe PTS. Elastic compression stockings were prescribed in 1412 (85%) patients. The majority used their stockings every day. Women were at an increased risk compared with men [risk ratio (RR) 1.5, 95% confidence interval (CI) 1.3–1.8]. Similarly, obese patients had a 1.5‐fold increased risk of PTS compared with normal weight patients (RR 1.5, 95% CI 1.2–1.9), with a 1‐year cumulative incidence of 34% compared with 22%. Patients who already had varicose veins had an increased risk (RR 1.5, 95% CI 1.2–1.8) of PTS. DVT in the femoral and iliac vein was associated with a 1.3‐fold increased risk of PTS compared with popliteal vein thrombosis (RR 1.3, 95% CI 1.1–1.6). Patients over 60 years were less likely to develop PTS than patients below the age of 30 (RR 0.6, 95% CI 0.4–0.9). Malignancy, surgery, minor injury, plaster cast, pregnancy or hormone use did not influence the risk of PTS neither did factor (F)V Leiden nor the prothrombin 20210A mutation. Conclusions: PTS is a frequent complication of DVT, despite the widespread use of elastic compression stockings. Women, obese patients, patients with proximal DVT and those with varicose veins have an increased risk of PTS, whereas the elderly appeared to have a decreased risk.     

Association of Crown‐Rump Length at 11 to 14 Weeks' Gestation and Risk of a Large‐for‐Gestational‐Age Neonate

Objective. The purpose of this study was to evaluate the association between crown‐rump length (CRL) and the risk of a large‐for‐gestational‐age (LGA) neonate. Methods. Data were retrospectively collected on consecutive women with a healthy singleton pregnancy followed to delivery at our center from 2003 to 2006 who underwent nuchal translucency, pregnancy‐associated plasma protein‐A, and free β‐human chorionic gonadotropin screening at 11 to 14 weeks' gestation. Pregnancies were dated by the last menstrual period (LMP) confirmed by CRL at 6 to 10 weeks or the known time of fertilization. The fetal CRL at 11 to 14 weeks was obtained from frozen sonographic images. The measured CRL was converted to gestational weeks using the method of Hadlock et al (Radiology 1992; 182:501–505). The expected gestational age (GA) by the LMP was subtracted from the measured GA to yield the ΔCRL. The association between the ΔCRL and birth weight was statistically analyzed. Results. The sample included 521 women. Fifty neonates (9.6%) were LGA (≥90th percentile), 38 (7.3%) small for gestational age, and 433 (83.1%) appropriate for gestational age. The LGA group was characterized by significantly larger‐than‐expected CRL measurements (P = .033). The birth weight percentile and rate of LGA neonates were significantly higher in pregnancies in which the ΔCRL was ½ week or greater (P = .007 and .033, respectively). There was a significant linear correlation between the ΔCRL and birth weight percentile (P = .001). On multivariate logistic regression analysis, the ΔCRL was the only significant predictor of an LGA neonate (odds ratio, 1.6; 95% confidence interval, 1.07–2.4; P = .023). Conclusions. Pregnancies with LGA neonates are characterized by larger‐than‐expected CRL measurements at 11 to 14 weeks' gestation.     

Influence of different IgG anticardiolipin antibody cut‐off values on antiphospholipid syndrome classification

Summary. Background: While medium to high titers of anticardiolipin (aCL) antibodies, defined as >40 GPL units or >99th percentile, is a laboratory criteria for the ‘definite’ diagnosis of antiphospholipid syndrome (APS), agreement between the two cut‐offs has not been validated. Objective: To validate the current aCL laboratory criterion by verifying the effect of the two cut‐offs on APS classification. Patients/methods: Ninety aCL positive APS patients were selected on the basis of their GPL values above the 99th percentile (17.4 GPL), which was calculated by testing 100 age‐ and sex‐matched healthy subjects. Results: A significant difference in the IgG positivity (P < 0.0001) was found between the APS laboratory profiles as 20 out of the 24 (83.3%) patients with single positivity (aCL alone), six out of the 23 (26.1%) with double positivity (aCL plus lupus anticoagulant or anti‐β₂glycoprotein I), and none out of the 43 with triple positivity (aCL plus lupus anticoagulant and anti‐β₂glycoprotein I) had titers between the 99th percentile and 40 GPL units. Moreover, the rate of aCL values between the 99th percentile and 40 GPL units was significantly higher (P < 0.0001) in patients with pregnancy morbidity (73.7%) as compared to those with vascular thrombosis (16.9%) and those with both conditions (16.7%). Conclusion: The 99th percentile cut‐off level seems more sensitive than the >40 GPL value for APS classification, as it includes subjects with aCL positivity alone as well as patients with pregnancy morbidity.     

Women’s views on and adherence to low‐molecular‐weight heparin therapy during pregnancy and the puerperium

Summary. Background: Non‐adherence to prescribed medication represents a significant factor associated with treatment failure. Pregnant women identified at risk of venous thromboembolism are increasingly being prescribed low‐molecular‐weight heparin (LMWH) during pregnancy and the puerperium. It is important to understand women’s views on and adherence to LMWH during pregnancy and the puerperium, so that women gain maximum benefit from the treatment. Objectives: To monitor women’s adherence to enoxaparin, when prescribed during pregnancy and the puerperium, and explore their beliefs about the enoxaparin therapy prescribed. Patients/Methods: A prospective cohort study involving 95 nullparous and multiparous women prescribed enoxaparin for recognized antenatal indications. Adherence to enoxaparin was assessed through self‐completion of a diary, additionally verified through laboratory tests. An adapted beliefs about medication questionnaire was administered to women during their pregnancy. Results: Women were highly adherent to enoxaparin: antenatally, mean percentage adherence 97.92%; postnatally, mean percentage adherence 93.37% (paired t‐test, P = 0.000). In the cohort of women we followed, their perceived necessity for enoxaparin therapy outweighed any concerns they had regarding enoxaparin antenatally, necessity‐concerns differential 2.20. In some women, however, this perceived necessity does decrease postnatally. Conclusions: Our results suggest that most women prescribed enoxaparin are highly adherent to their therapy during the antenatal period and that women’s antenatal beliefs about enoxaparin are able to predict a decrease in postnatal adherence. Our results have important clinical implications, particularly when women are initiated on LMWH just during the postnatal period.