Hilde Skuterud Wik

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.

Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study

Objectives To investigate whether additional catheter-directed thrombolysis (CDT) improves long-term quality of life (QOL) compared with standard treatment with anticoagulation and compression stockings alone in patients with proximal deep vein thrombosis (DVT). Design Open-label randomised controlled trial. Setting 19 Hospitals in the Norwegian southeastern health region. Participants Patients (18–75 years) with a high proximal DVT, symptoms <21 days and no increased risk of bleeding were eligible. 189 of 209 recruited patients completed 24 months of follow-up. Interventions Participants were randomised to additional CDT with alteplase for 1–4 days or to standard treatment only with 6 months of anticoagulation and 24 months of compression stockings. Primary and secondary outcome measures Planned secondary outcome measures included QOL as assessed with the generic instrument EQ-5D and the disease-specific instrument VEINES-QOL/Sym. Primary outcome measure was post-thrombotic syndrome (PTS) after 24 months. Results After 24 months there were no differences in QOL between the additional CDT and standard treatment arms; mean difference for the EQ-5D index was 0.04 (95% CI −0.10 to 0.17), for the VEINES-QOL score 0.2 (95% CI −2.8 to 3.0) and for the VEINES-Sym score 0.5 (95% CI −2.4 to 3.4; p values>0.37). Independent of treatment arms, patients with PTS had poorer outcomes than patient without PTS; mean difference for EQ-5D was 0.09 (95% CI 0.03 to 0.15), for VEINES-QOL score 8.6 (95% CI 5.9 to 11.2) and for VEINES-Sym score 9.8 (95% CI 7.3 to 12.3; p values<0.001). Conclusions QOL did not differ between patients treated with additional CDT compared with standard treatment alone. Patients who developed PTS reported poorer QOL and more symptoms than patients without PTS. QOL should be included as an outcome measure in clinical studies on patients at risk of PTS. Trial registration NCT00251771

Cost‐effectiveness of additional catheter‐directed thrombolysis for deep vein thrombosis

Additional treatment with catheter‐directed thrombolysis (CDT) has recently been shown to reduce post‐thrombotic syndrome (PTS).

Long-term impact of pregnancy-related venous thrombosis on quality-of-life, general health and functioning: results of a cross-sectional, case-control study.

Objectives To evaluate the long-term consequences of pregnancy-related venous thrombosis (VT) by the assessment of generic quality-of-life (QOL), well-being, general health and daily-life functioning. We also wanted to evaluate the impact of the frequently occurring complication post-thrombotic syndrome (PTS) after that of deep vein thrombosis (DVT). Design Population-based cross-sectional, case–control study. Setting 18 Norwegian hospitals during 1990–2003. Participants The study population comprised 559 cases with a validated first-ever, pregnancy-related VT and 1229 controls naïve for VT at the time of index pregnancy. Cases were identified using the Norwegian Patient Register and the Medical Birth Registry of Norway and the latter was used to select as controls women who gave birth at the same time as a case. After exclusion of two cases with missing location of VT, the final study population comprised 311 cases and 353 controls. Methods Self-completion of a comprehensive questionnaire in 2006. Main outcome measures Generic QOL and well-being assessed by the Ferrans and Powers QOL Index (QLI) and the General Health Questionnaire (GHQ-20). Results QOL assessed by QLI did not differ between cases and controls; mean score 23.1 (95% CI 22.7 to 23.5) vs 23.7 (23.3 to 24.0), neither did well being assessed by GHQ-20; 18.7 (18.0 to 19.4) vs 17.9 (17.3 to 18.4). However, cases reported pain other than in the lower limbs and muscle–skeletal problems more often and were more often physically worn out after work compared with controls. Cases which developed PTS reported poorer health, had pain more often, developed skin and psychiatric problems, used analgesic drugs more frequently and were more often on sick leave as compared to those without PTS. Conclusions Long-term generic QOL and subjective well-being 3–16 years after a pregnancy-related VT were not different from a reference population, but women with PTS after DVT seemed to have poorer QOL and an impaired general health.

Long-term quality of life after pregnancy-related deep vein thrombosis and the influence of socioeconomic factors and comorbidity.

Summary.  Background: Little is known about the long‐term impact of pregnancy‐related deep vein thrombosis (DVT) of the lower limbs. Objectives: To evaluate the long‐term consequences of pregnancy‐related DVT by assessment of self‐reported, disease‐specific quality of life (QOL) and symptom severity using the Venous Insufficiency Epidemiological and Economic Study (VEINES)‐QOL/Sym questionnaire, and to investigate the influence of socioeconomic factors and comorbidity. Patients/Methods: In this cross‐sectional case–control study, 313 women with validated pregnancy‐related DVT and 353 controls completed a comprehensive questionnaire, including the disease‐specific VEINES‐QOL/Sym questionnaire. After exclusion of DVT outside the lower limbs and missing scores, the study population comprised 208 patients and 347 controls. A VEINES‐QOL/Sym score < the 25th percentile was defined as a clinically relevant reduced outcome compared with scores ≥ the 50th percentile. Predictors for low scores were identified in multivariate logistic regression models. Results: Cases reported lower mean VEINES‐QOL/Sym scores than controls, 45.6/45.4 vs. 52.8/52.7, respectively (P < 0.001), and QOL among cases was still reduced compared with controls when adjusted for possible confounders. Low education was an independent predictor for both low VEINES‐QOL and VEINES‐Sym scores, and in addition being married/cohabitating predicted low VEINES‐Sym scores. Conclusions: Long‐term QOL and symptom scores as assessed with the VEINES‐QOL/Sym questionnaire were lower in women with previous pregnancy‐related DVT than in controls, and also when adjusted for possible confounders. By logistic regression, low education was an independent predictor for low scores. This supports the use of the VEINES‐QOL/Sym questionnaire in studies on pregnancy‐related DVT.

Recurrent venous thrombosis, post-thrombotic syndrome and quality of life after catheter-directed thrombolysis in severe proximal deep vein thrombosis.

W. GHA NIMA,* I . W. K LEVEN ,* T . ENDEN, A. ROSALES ,§ H . S . WIK ,– L . PEDERSTA D, ** P . A . HOLME and P . M. SANDSET– *Department of Medicine, Østfold Hospital Trust Fredrikstad, Fredrikstad; Departments of Haematology, Radiology and §Vascular Surgery, Oslo University Hospital, Oslo; –Institute of Clinical Medicine, University of Oslo, Oslo; and **Department of Radiology, Østfold Hospital Trust Fredrikstad, Fredrikstad, Norway

Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome

Post-thrombotic syndrome (PTS) is a long-term complication of deep-vein thrombosis (DVT). The Villalta scale is the recommended tool for diagnosing PTS, but requires a clinicians assessment in addition to patient self-assessment. In the present study, we validated a self-administered tool for patient reporting of leg symptoms and signs as a mean to assess PTS. We first validated a form for patient self-reported Villalta (PRV1), then developed and validated a visually assisted form (PRV2). The validity of PRV1 and PRV2 was assessed in patients diagnosed with DVT between 2004 and 2012. Median time from DVT to inclusion was 5.1 and 3.5 years for PRV1 (n=162) and PRV2 (n=94), respectively. Patients were requested to complete the PRV form before a scheduled visit. PTS diagnosed by the original Villalta scale during the visit served as the reference method. PRV1 showed only moderate agreement for diagnosing PTS compared with the original Villalta scale (kappa agreement 0.60, 95% CI 0.48-0.72), whereas PRV2 showed very good agreement (0.82, 95% CI 0.71-0.94). In the validation of PRV2, PTS was diagnosed in 54 (57%) patients according to the original Villalta scale and in 60 (64%) by PRV2. The sensitivity of PRV2 to detect PTS was 98% and the specificity was 83%. We conclude that the visually assisted form for PRV is a valid and sensitive tool for diagnosing PTS. Such a tool could be applied in further clinical studies of PTS, making studies less resource demanding by reducing the need for in-person clinic visits.

Health-related quality of life after pulmonary embolism: a cross-sectional study

Objectives The psychological effects of acute pulmonary embolism (PE) have scarcely been studied. The aims of this study were to evaluate health-related quality of life (HRQoL) in patients with a history of PE compared with that of the general population and buddy controls, and to explore factors that may predict impaired HRQoL. Design Cross-sectional. Setting Haematology and thrombosis unit in Fredrikstad, Norway. Participants 213 consecutive patients treated for PE were identified from hospital registries. Eligible patients were scheduled for a single study visit, including a functional capacity test (6 min walking test). HRQoL was assessed using the EuroQol 5D dimensions 3-level (EQ-5D-3L) questionnaire, of which the results were compared with Danish population norms and age-matched and sex-matched buddy controls. The buddy controls were recruited by asking every patient to hand over the EQ-5D questionnaire to 2 age-matched and sex-matched friends or relatives. Multivariable regression analyses were used to examine possible determinants of reduced HRQoL. Results Mean age was 61 years (SD 15), 117 (55%) were males, and median time since diagnosis was 3.8 years (range 0.3–9.5). Mean EuroQol visual analogue scale (EQ VAS) was 67 in PE as compared with 81 in the general population (p<0.005) and corresponding EQ-5D index values were 0.80 and 0.86 (p<0.005). Patients reported more problems in all 5 EQ-5D compared with both the buddy controls and the general population, p<0.05. Shorter 6 min walking distance (β=0.09, p<0.005) and patient-reported dyspnoea (β=11.27, p<0.005) were independent predictors of lower EQ VAS scores. Conclusions Our findings show that patients with a history of PE have impaired HRQoL when compared with the general population and buddy controls. Reduced functional capacity and persistent dyspnoea were the main predictors of this impairment.

t(12;13)(q14;q31) leading to HMGA2 upregulation in acute myeloid leukaemia

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Scoring Systems for Postthrombotic Syndrome

Abstract Postthrombotic syndrome (PTS) is the most common long‐term complication after deep vein thrombosis (DVT) and is associated with reduced quality of life. There is no single objective test to diagnose the presence of PTS and it is usually diagnosed on the basis of typical symptoms and signs in a limb previously affected by DVT. Scoring systems for PTS are primarily developed as research tools, but could possibly also be useful in the clinical setting. A main advantage of a good scoring system is standardization of the diagnostic process. An optimal scoring system should be both sensitive and specific for PTS, but this has been difficult to achieve because the symptoms and signs of PTS can be similar to other conditions leading to complaints in the lower limb. In an effort to standardize the definition of PTS, in 2009, the International Society on Thrombosis and Haemostasis Subcommittee on Control of Anticoagulation reviewed available scales and recommended use of the Villalta scale as the most appropriate measure to diagnose and grade the severity of PTS. The aim of this article is to review the existing scoring systems for PTS and to present our view on the advantages and disadvantages of these diagnostic tools.