VEINES-QOL Scores Research Articles

Rib-sparing subclavian vein decompression in venous thoracic outlet syndrome

ObjectiveVenous thoracic outlet syndrome (VTOS), a compression syndrome of the subclavian vein at the costoclavicular junction, is commonly treated with first rib resection. This invasive procedure carries a risk of serious complications. The purpose of this single-center cross-sectional study was to evaluate the long-term outcome of non-bony decompression by resection of the subclavius muscle and tendon and to provide a detailed description of the procedure. MethodsPatients who underwent rib-sparing decompression for VTOS between July 2014 and September 2023 were analyzed using clinical and radiological examinations. Patient-reported measures were used to assess functional disability and residual symptoms (DASH) and disease-specific quality of life and symptoms (VEINES-QOL/SYM). ResultsTen patients were included in the study. Seven were treated for Paget-Schroetter syndrome and 3 for McCleery syndrome. At mean follow up of 45.4 (SD 31.0) months, all patients reported significant resolution of initial symptoms with patent vasculature on Doppler ultrasonography. All patients had a Villalta PTS score <4, indicating the absence of post-thrombotic syndrome. A mean DASH score of 3.8 (SD 5.3) indicated minimal functional disability. Patients reported minimal overall impact on their quality of life as reflected by the mean VEINES-QOL score of 92.6 (SD 8.9) and low severity of venous symptoms as indicated by the mean VEINES-SYM score of 92.7 (SD 9.8). ConclusionOur analysis suggests that non-bony decompression with resection of the subclavius muscle and tendon is a safe and effective intervention for definitive treatment of VTOS that is less invasive than first rib resection.

Assessing outcomes after thrombectomy with or without iliac vein stenting for young provoked DVT patients with iliac vein stenosis

BackgroundThis study aimed to assess the outcomes of thrombectomy with/without iliac vein stenting for young and transiently provoked DVT patients with iliac vein stenosis.MethodsThis is a retrospective analysis of a prospectively collected multicenter database. Acute, transiently provoked DVT patients between 18 and 45 years old with iliac vein stenosis were included. All patients underwent thrombectomy. Outcomes including the Villalta score, the VEINES-QOL score, and adverse events were evaluated.ResultsThe data of 522 patients were collected of whom 75 were included, 58 underwent thrombectomy alone (nonstenting group) and 17 underwent thrombectomy and stenting (stenting group). Within 6 months, the Villalta score of patients in stenting group is lower than that of patients in nonstenting group (6 mo: 0.73 ± 0.77 vs. 1.41 ± 0.56, p = .0004), and the VEINES-QOL score of stenting group is higher than that of nonstenting group (6 mo: 89.00 ± 2.94 vs. 87.47 ± 3.72, p = .2141). At the following follow-ups, the Villalta score (12 mo: 0.56 ± 0.49 vs. 0.60 ± 0.58, p = .8266) and VEINES-QOL score (12 mo: 88.36 ± 2.29 vs. 88.31 ± 3.36, p = .9604) between the two groups are similar.ConclusionThe stenting group had better efficacy within 6 months after intervention, while there was no significant difference in the symptom, signs, and quality of life between two groups after 6 months within a 2-year follow-up.Trial registrationThis study was registered in the Chinese Clinical Trial Registry (Registration Number: ChiCTR2200056073).

Editor's Choice – Quality of Life after Stenting for Iliofemoral Venous Obstruction: A Randomised Controlled Trial with One Year Follow Up

Deep venous obstruction (DVO) is a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO. Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in score changes for EuroQoL 5-Dimension 5 Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score. After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n= 42) or control group (n= 21). Overall, 50patients had available data for primary outcome analysis. The adjusted mean difference between 12month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p= .026), respectively, in favour of the stent group. The differences were significant, but a pre-defined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p= .040), -11.83 (95% CI -20.81 - 2.86, p= .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p= .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p= .17) for the Villalta score. Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points. NCT03026049.

Abstract 580: Temporal Profile Of Catheter-directed Thrombolysis On Post-thrombotic Syndrome Outcomes In Iliofemoral DVT Patients: Post-hoc Analysis Of ATTRACT Trial

Introduction: Patients with iliofemoral deep vein thrombosis (IFDVT) may preferentially benefit from catheter-directed thrombolysis/thrombectomy (CDT) to reduce the post-thrombotic syndrome (PTS). Our prior analysis of the full NIH ATTRACT trial cohort demonstrated that the maximal benefit of CDT occurs at the day (D) 4-8 symptom-onset-to-randomization (SOR) timeframe (Circulation 2021; 143:1224-1238). However, the optimal time window for CDT benefit specifically for IFDVT patients has not been determined. Hypothesis: IFDVT patients may have a broader time window and greater magnitude for CDT benefit compared to all-comer DVT patients. Methods: We analyzed the IFDVT subgroup (N=391) of the NIH ATTRACT trial to assess optimal SOR timeframes for improved PTS outcomes (Villalta and VEINES-QoL scores). In a series of sensitivity analyses, IFDVT patients were non-prespecified divided into two (early, late) or three (early, intermediate, late) SOR groups. Mean scores were estimated by a piecewise linear-regression growth-curve model, with adjustment for strata including clinical center and baseline covariates (age, sex, BMI) by intention-to-treat analysis. Results: In the IFDVT patients, sensitivity analyses revealed that CDT significantly and maximally improved PTS outcomes in the intermediate D4-9 SOR [CDT +anticoagulation (AC) vs. AC alone; between-group difference= -2.54 (Villalta), +13.13 (VEINES-QoL), p&lt;0.0001 for each]. However, CDT did not provide a benefit at early SOR ≤D3 and later SOR ≥D10 (p&gt;0.05). Moreover, CDT effects differed across SOR 0-3, 4-9 and 10+ days (Villalta: -0.77, -2.54, -1.98; p=0.027), (VEINES-QoL: -1.89, +13.13, +1.92; p=0.022). Conclusions: CDT maximally improves PTS outcomes for IFDVT patients in the D4-9 timeframe, which is a more selective time window and of greater magnitude of PTS benefit than the full ATTRACT trial cohort. However, CDT does not improve outcomes beyond AC at early D0-3 and late D10+ timeframes. These findings may have practice implications to consider symptom duration to optimize AC and CDT therapies in IFDVT patients. Mechanisms underlying the benefit of AC and CDT on PTS outcomes need further study.

Exploring the Villalta scale to capture postthrombotic syndrome using alternative approaches: A subanalysis of the ATTRACT trial

BackgroundClinical trials that evaluated interventions to prevent postthrombotic syndrome (PTS) used the Villalta scale (VS) to define PTS, but there is a lack of consistency in its use. ObjectivesThis study aimed to improve the ability to identify patients with clinically meaningful PTS after DVT in participants of the ATTRACT trial. MethodsWe conducted a post hoc exploratory analysis of 691 patients from the ATTRACT study, a randomized trial evaluating the effectiveness of pharmacomechanical thrombolysis to prevent PTS in proximal deep vein thrombosis. We compared 8 VS approaches to classify patients with or without PTS in terms of their ability to discriminate between those with poorer vs better venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL]) between 6- and 24-months follow-up. The difference in the average area under the fitted curve of VEINES-QOL scores between PTS and no PTS (ΔAUC¯) were compared among approaches. ResultsFor any PTS (a single VS score ≥5), approaches 1 to 3 had similar ΔAUC¯ (−21.2, −23.7, −22.0, respectively). Adjusting the VS for contralateral chronic venous insufficiency (CVI) or restricting to patients without baseline CVI (approaches 7 and 8) did not improve ΔAUC¯ (−13.6, −19.9, respectively; P >.01). For moderate-to-severe PTS (a single VS score ≥10), approaches 5 and 6 requiring 2 positive assessments had greater but not statistically significant ΔAUC¯ than approach 4, using one single positive assessment (−31.7, −31.0, −25.5, respectively; P >.01). ConclusionA single VS score of ≥ 5 reliably distinguishes patients with clinically meaningful PTS as assessed by impact on QOL and is preferred because of greater convenience (only one assessment needed). Alternative methods to define PTS (ie, adjusting for CVI) do not improve the scale’s ability to identify clinically meaningful PTS.

Determinants of Quality of Life in Patients with Post-Thrombotic Syndrome

Chronic post-thrombotic syndrome (PTS) may develop in up to 50% of patients after deep vein thrombosis (DVT), and may reduce patients' quality of life (QoL). We aimed to evaluate the association of PTS severity with QoL in patients with proximal DVT submitted for medical treatment and also to identify modifiable and non-modifiable risk factors related to PTS. Patients with iliac or femoropopliteal DVT observed in Vascular Surgery consultation in our institution from 1year period with unilateral DVT were selected. Patients with total vein recanalization were excluded. Villalta scale was applied to assess PTS degree and VEINES-QoL/Sym questionnaire was used as a disease-specific QoL measure. Correlation between PTS degree and VEINES-QoL/Sym score and predictors of PTS were determined. Fifty-six patients were accepted to enter the study. From those, 66.1% were female, 64.3% (n=36) had iliac and 35.7% (n=20) femoropopliteal DVT. PTS was present in 52.8% of iliac and 65.0% of femoropopliteal DVT patients observed for consultation (P=0.41). There was a significant correlation with PTS degree and both VEINES-QoL and VEINES-Sym scores (P<0.01). Major depression (odds ratio OR=5.63, P=0.04) and regular wear of compressing stockings (OR=4.69, P=0.04) were the only independent factors associated with PTS. Patients with depression had lower QoL scores, while patients with PTS who wear compression stockings had similar QoL scores compared to patients without PTS. Ultrasound alterations (OR=3.28, P=0.17), age, gender, iliac DVT, multiple DVT and time after DVT (P>0.20) were not associated with PTS syndrome. VEINES-QoL/Sym had moderate inverse correlation with PTS degree. Depression was associated with both PTS and lower QoL scores. Patients with PTS criteria compliant to wearing compressing stockings had similar QoL scores to patients without PTS.

Elastic compression stockings to prevent post-thrombotic syndrome in proximal deep venous thrombosis patients without thrombus removal

ObjectiveTo evaluate the effectiveness of elastic compression stockings (ECS) in prevention of post-thrombotic syndrome (PTS) in patients suffering from proximal deep venous thrombosis (DVT) who did not undergo thrombus removal procedures. MethodsIn this randomized trial, patients with Iliofemoral venous thrombosis (IFDVT) and femoral-popliteal venous thrombosis who had not undergone thrombus removal procedures were screened at a single medical institution between December 2016 and June 2018. These patients were randomly assigned as an ECS group (wear ECS) and control group (not wear ECS). The primary end point was the incidence of PTS based on the Villalta scale at 24 months. The secondary end points included patient quality of life and symptom severity based on the VEINES-QoL/Sym questionnaire. Recurrent DVT in the same limb, compliance with ECS use, and other adverse events were also recorded. A logistic regression analysis was also performed to determine risk factors of PTS. ResultsTwo hundred thirty-two patients were included in this study. One hundred thirteen patients were in the ECS group and 119 in the control group. The incidence of PTS was 42.0% in the ECS group and 57.8% in the control group at 24 months (risk ratio [RR], 0.726; 95% confidence interval [CI] 0.547-0.964; P = .024). The VEINES-QoL score was 63.7 ± 4.6 in the ECS group, which was higher than in the control group (60.6 ± 6.9; P < .001). Moreover, the VEINES-Sym scores revealed that patients in the ECS group reported better symptom relief than those in the control group (45.8 ± 5.1 vs 43.8 ± 6.1; P = .014). According to Logistic regression analysis of the entire cohort, IFDVT was a risk factor for PTS (RR, 2.253; 95% CI, 1.136-4.468) and high compliance with the use of ECS was protect factor (RR, 0.516; 95% CI, 0.277-0.961). ConclusionsThese results suggest that ECS can prevent PTS in patients with IFDVT and femoral popliteal venous thrombosis who do not undergo thrombus removal procedures.

Performance of two clinical scales to assess quality of life in patients with post-thrombotic syndrome

ObjectiveWe directly compared the Villalta scale and the Venous Clinical Severity Score (VCSS) to determine which of the two measures would be better at capturing clinically important cases of post-thrombotic syndrome (PTS) and PTS severity compared with patient-reported quality of life (QOL) scores. MethodsWe performed a secondary analysis of the ATTRACT (acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) trial study population. We calculated the correlations of the Villalta scores and VCSSs with QOL scores (short-form 36-item health survey [SF-36] physical component summary [PCS] and mental component summary [MCS]; and VEINES [venous insufficiency epidemiological and economic study]-QOL/symptom [VEINES-QOL/Sym] questionnaire) at each study visit (6, 12, 18, and 24 months of follow-up). The correlation of the random intercept (mean scores) and random slope (rate of change of the scores) among the Villalta scores, VCSS, and VEINES-QOL/Sym scores was assessed using a multivariate longitudinal model. ResultsThe median correlation between Villalta scores and VCSSs was 0.72. The median correlation between the Villalta scores and VEINES-QOL and VEINES-Sym scores at all follow-up visits was −0.68 and −0.71, respectively. The median correlation between the Villalta scores and SF-36 PCS and MCS scores was −0.51 and −0.31, respectively. For the VCSSs, the median correlation with the VEINES-QOL and VEINES-Sym scores at all follow-up visits was −0.39 and −0.41, respectively. The median correlation between the VCSSs and SF-36 PCS and MCS scores was −0.32 and −0.13, respectively. The correlations between the random effects in the multivariate longitudinal models showed a similar pattern. The effect of covariate adjustment by age, sex, and body mass index was minor. ConclusionsThe Villalta scores and VCSSs correlated strongly. The Villalta scale showed a substantially greater correlation with venous disease-specific and general QOL scores compared with the correlation with the VCSS. Our findings suggest that when a single scale is used to assess for clinically meaningful PTS, the Villalta scale will better capture the effects of PTS on patient-reported QOL.

Quality of life outcomes for patients undergoing venous stenting for chronic deep venous disease

ObjectiveThe objective of the study was to evaluate change in venous disease-specific quality of life (QoL) after iliac vein stenting for chronic venous outflow obstruction. MethodsWe performed a retrospective analysis of all Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QoL/Sym) questionnaires completed at a single-center between 2016 and 2019 by patients treated with iliac vein stenting for chronic venous outflow obstruction. Patients were asked to complete the questionnaire at baseline (before stenting) and at subsequent follow-up appointments (after stenting), at 6, 12, 24, and 36 months. The Villalta score was recorded by a venous nurse specialist. The initial unpaired analysis compared all completed VEINES-QoL/Sym and Villalta scores at baseline to all follow-up time-points, and then compared them individually between baseline and each follow-up point. A secondary paired analysis included data only from patients who had completed the questionnaire at baseline and at least one follow-up. ResultsA total of 385 questionnaires from 187 patients who completed the VEINES-QoL/Sym between 2016 and 2019 were included. The median follow-up was 12 months, 127 patients (68%) were female, and 148 (79%) were treated for post-thrombotic syndrome. The median VEINES-QoL score at baseline was 35.69 (interquartile range [IQR], 20.85-46.67). Significant improvement was observed postoperatively and sustained throughout the study period (6 months, 64.81 [IQR, 38.12-83.88]; 12 months, 60.52 [IQR, 33.6-82.3]; 24 months, 60.37 [IQR, 34.31-80.65]; 36 months, 55.98 [IQR, 39.18-81.47]). The VEINES-Sym scores demonstrated similar improvement. A secondary analysis of paired baseline/follow-up data from 61 patients confirmed significant improvement from baseline for VEINES-QoL (6 months +26.45; 12 months, +25.81; 24 months, +30.09; P ≤ .0001), VEINES-Sym (6 months, +23.86; 12 months, +20.43; 24 months, +27.55; P > .001), and Villalta scores (6 months, –3.7; 12 months, –4.2; 24 months, –6.4; P < .0001). The median Villalta score was 14 (IQR, 10-16). This score improved to 9 (IQR, 5-13) at 6 months of follow-up; to 8 (IQR, 5-11) at 12 months; to 7 (IQR, 4-12) at 24 months; and to 6 (IQR, 3.75-10.25) at 36 months (P ≤ .0001). Good correlation between the Villalta and both VEINES-QoL and SYM scores was observed at follow-up (r = 0.69 and r = 0.71, respectively; P < .0001). ConclusionsVenous disease-specific QoL improves and severity of post-thrombotic syndrome is decreased after iliac vein stenting for chronic venous outflow obstruction. These improvements are sustained at 36-month follow-up.

Patient outcomes after radiofrequency ablation stratified by Clinical, Etiology, Anatomy, and Pathophysiology classification

ObjectiveVenous insufficiency is a prevalent and potentially debilitating disease. Treatment guidelines and techniques such as radiofrequency ablation (RFA) developed in the United States and Europe have been shown to provide significant improvements in quality of life; however, these have not been clearly assessed in the populations of developing nations. This study examined quality of life outcomes after RFA of patients treated at a single Jamaican vein center. MethodsIn this study, 100 patients who underwent RFA from 2007 to 2012 were evaluated. Patients answered the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire assessing quality of life before and after RFA. Improvements in specific categories, such as venous symptoms, work limitations, social limitations, and cosmetic concerns, were evaluated. Cumulative VEINES-Sym and VEINES-QOL scores were also assessed. ResultsPatients' quality of life responses were significantly improved in every individual VEINES question. Average cumulative VEINES-Sym t score improved 9.96 points (P < .01), and VEINES-QOL t score improved 11.15 points (P < .01). For patients with Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) C5 and C6 disease, the only questions that did not show significant improvement were limitations to daily workplace activity and impact on clothing after RFA. However, in this subset, the average VEINES-Sym t score improved 11.83 points (P < .01), and the VEINES-QOL t score improved 11.96 points (P < .01) after RFA. ConclusionsVenous disease is often overlooked, and access to treatment can be limited in developing nations. This study demonstrated that venous treatment guidelines and RFA techniques developed in the United States and Europe could be successfully applied to a Jamaican population, resulting in significant improvements in quality of life.

Quality of life in cancer patients undergoing anticoagulant treatment with LMWH for venous thromboembolism: the QUAVITEC study on behalf of the Groupe Francophone Thrombose et Cancer (GFTC).

BackgroundClinical guidelines recommend at least 3-months low molecular weight heparin (LMWH) treatment for established venous thromboembolism (VTE) in cancer patients. However, no study has analyzed the impact of 3–6 months of LMWH therapy on quality-of-life (QoL) in cancer patients.ResultsAmong 400 cancer patients included at M0, 88.8% received long-term LMWH. Using a random-effects linear regression model with time as covariate, QoL scores in the MOS SF-36 (Global HRQoL, 1.3-fold per month [95% confidence interval (CI) 0.81–1.79], p < 0.0001) and EORTC QLQ-C30 (global health status/qol, 2.25-fold per month [95% CI 1.63–2.88]; p < 0.0001) questionnaires significantly improved over the 6-month study period in patients treated with LMWH, while VEINES-QOL scores did not change. In the MOS SF-36 and EORTC QLQ-C30, the following factors were associated with change in QoL: symptomatic VTE, cancer dissemination and histological type. Factors pertaining to reduced mobility were also identified as significant predictors of QoL outcomes, including being bedridden in the MOS SF-36 and ECOG score ≥ 2 in the EORTC QLQ-C30. Presence of acute infection and not undergoing anti-angiogenic therapy were additional factors associated with QoL improvement in the EORTC QLQ-C30.MethodsQUAVITEC, a prospective, longitudinal, multicenter study, recruited all consecutive eligible adult cancer patients with objectively confirmed VTE between February 2011 and 2012. Patients were asked to answer three QoL questionnaires at anticoagulant treatment initiation (M0) and at 3 (M3) and 6 (M6)-month follow-ups.ConclusionQUAVITEC is the first study to show that QoL was improved in cancer patients receiving long-term LMWH treatment for established VTE.

Complex α-Lypoic Acid, Ginkgoselect Phytosome and Leucoselect Phytosome in Patients with Chronic Venous Insufficiency of the Lower Limbs: Therapeutic Effectiveness and Impact on Quality of Life

Background: Chronic venous disease (CVD) is a common clinical condition, especially relevant for its impact on public health and its related economic burden. Veno-Active Drugs (VAD) are an heterogeneous group of drugs, widely used in the treatment of CVD. In the last years some food supplements, similar to VAD but with different compounds concentrations raised some confusion in this field. The complex Lypoic acid, Ginkgoselect phytosome and Leucoselect phytosome is a food supplement based on molecules exhibiting different but synergic activities never prospectively tested in patients with CVD. Methods: Consecutive ambulatory patients with objectively documented CVD and a CEAP “C” up to 5 were eligible for the study. Patients were to take 1 fast-slow tablet of the complex twice-daily for 2 months, followed by 1 fast-slow tablet once-daily for other 4 months, for a total of 6 months. Presence and magnitude of CVD-related signs and symptoms (with “C” of the CEAP classification), evaluation of patients’ quality of life (with VEINES-QoL/Sym questionnaire) and assessment of safety and tolerability of the complex at baseline and after 2 and 6 months (with revised Venous Clinical Severity Score, rVCSS) were recorded. Results: 97 patients enrolled and evaluated. The proportion (65%) of the patients with a rVCSS score>5 at baseline decreased to 35% at 6 months (P <0.001). The number of patients with a scoring of “none” for the item “Pain or other discomfort” increased from 8% at baseline to 54% at 6 months (P=0.001). The pairwise comparison yielded significant results between the 3 time-points for the rVCSS (p<0.00001) and the VEINES-Sym (p<0.00001), while for the VEINES-QoL score between the baseline and the end of the study only (p=0.0016). Conclusion: The complex Lypoic acid, Ginkgoselect phytosome and Leucoselect phytosome seems beneficial for reducing leg complaints, and effectively improves QoL in patients with CVD.

VALIDATION OF A RUSSIAN-LANGUAGE VERSION OF THE VEINES-QOL/SYM QUESTIONNAIRE IN PATIENTS WITH RHEUMATIC DISEASES AND LOWER EXTREMITY CHRONIC VENOUS DISEASES

Objective: to assess the psychometric properties (reliability, sensitivity, and validity) of a Russian-language version of the VEINES-QOL/Sym questionnaire in patients with rheumatic diseases and lower extremity chronic venous diseases. Subjects and methods. The investigation enrolled 89 patients (66 (74%) women and 23 (26%) men) (their mean age was 46.3±13.4 years) with rheumatic diseases. The majority (n=62 (70%)) of patients were recorded to have a history of one case of venous thrombosis of the lower extremity; the others (n=27 (30%)) had more than one case of thrombosis. To calculate the scores the VEINES-QOL/Sym questionnaire, a standard method proposed by its authors was used. The patients filled out the VEINES-QOL/Sym questionnaire thrice: on inclusion, at 2 weeks, and at 6 months. Results and discussion. The internal consistency (Cronbach’s α coefficient) of VEINES-QOL and VEINES-Sym was equal to 0.973 and 0.975, respectively, which reflects the high level of reliability. The coefficient κ varied from 0.825 to 1, which indicates good reproducibility (p < 0.001). The correlation coefficients of VEINES-QOL and VEINES-Sym with the physical component of SF36 were 0.59 and 0.42, and those with its psychological component were 0.42 and 0.35, respectively (p<0.05). The correlation coefficients of VEINES-QOL and VEINES-Sym with general health assessment on the visual analogue scale were -0.41 and -0.36, with a pain intensity of -0.56 and -0.46, respectively (p<0.05). The moderate relationships of VEINES-QOL and VEINES-Sym to the above parameters, as well as to the SF36 physical and psychological components suggest that the questionnaire is able to display quality of life in patients with rheumatic diseases and lower extremity venous diseases. The sensitivity of the VEINES-QOL/Sym questionnaire was assessed after its completion, at baseline, and at 6 months. According to the presence or absence of positive postthrombotic changes, as evidenced by duplex ultrasound scanning (DUSS), all the patients were divided into two groups. Calculation of a 6-month change in VEINES-QOL scores revealed that Group 1 with positive DUSS changes showed better quality of life (ΔVEINES-QOL=0.95 [-2.8; 6.7]); at the same time, Group 2 with no or negative DUSS changes displayed worse quality of life (ΔVEINES-QOL=-1.71 [5.7; 3.27]; p = 0.06); this suggests that the questionnaire can be used for assessing the quality of life in patients with lower extremity venous diseases over time. Thus, the VEINES/Qol-Sym questionnaire is a reliable and valid tool. It can be used to assess quality of life over time in patients with rheumatic diseases and lower extremity chronic venous diseases. The investigation confirmed the good psychometric properties of the VEINES/Qol-Sym questionnaire.

Quality-of-life in interventionally treated patients with post-thrombotic syndrome.

New developments in the treatment of complex deep venous disease have become available in the last decade. Besides analysing patencies as a surrogate outcome for these treatments we analysed the Quality-of-Life (QoL) changes for successful and failed deep venous treatments. Patients with proven venous occlusive disease, referred to our department of Venous Surgery at the Maastricht University Medical Centre, were included. After inclusion patients were treated by percutaneous transluminal angioplasty and stenting and when indicated endophlebectomy with an arteriovenous fistula. QoL was assessed with the disease specific VEINES-QOL/Sym and the generic Short-Form (SF)-36 questionnaires preoperatively at baseline and post-operatively after 3, 12 and 24 months. One hundred fifty-three interventions were analysed, showing a primary, assisted primary and secondary patency of respectively 65%, 78% and 89% at 24 months. The VEINES-QOL and Sym scores improved at 3, 12 and 24 months. The overall improvement at 24 months is 22.7 for QoL and 18.18 for Sym with respective p values of 0.013 and 0.016. The improvement of the VEINES-QOL and Sym scores after a successful (patent) treatment remained highly significant (QoL: p < 0.001, Sym: p = 0.004). Also the generic QoL (Short-Form 36v2) shows significant improvement after 12 months for physical functioning (p = 0.004) and role physical (p = 0.004) scales. The overall patencies of interventions for deep venous pathology are exceptionally good after two years. Concomitantly the VEINES-Sym and VEINES-QOL scores improve significantly for 3, 12, and 24 months when compared to the baseline (T0) after treatment. Successful interventions showed, as expected, a significant greater QoL improvement between T0 and T3, T12, T24 for both VEINES-QOL and VEINES-Sym scores when compared to the failed interventions. The one-year linear improvement of two SF-36 scales (PF and RP) is also significant.

Quality of life following acute deep vein thrombosis: the cultural adaptation, reliability and validity of the VEINES-QOL/Sym scale: a Turkish version study

Background: This study aims to translate and make cultural adaptation of a widely used Venous Insufficiency Epidemiologic and Economic Study Quality-of-Life Questionnaire (VEINESQOL/ Sym) into Turkish according to international guidelines and to statistically evaluate its validity and reliability by administering it to Turkish-speaking patients with acute deep vein thrombosis (DVT). Methods: Translation and cultural adaptation of the questionnaire were performed. It was administered to 31 patients with acute DVT. The VEINES-QOL/Sym was performed 5-7 days after its initial application to evaluate its test-retest reliability. The internal consistency was assessed through Cronbach's alpha (including if item was deleted), test-retest reliability was assessed through the intraclass correlation coefficient. Validity was examined by correlation of VEINES-QOL/Sym with Nottingham Health Profile (NHP) and the distance of six-minute walk test (6MWT). Results: Cronbach&#8217;s alfa values were 0.96 for the VEINES-QOL and 0.94 for the VEINES-Sym. No problematic items were observed for the scale. Intraclass correlation coefficient score for test-retest reliability were 0.984 and 0.996 for VEINES-QOL and VEINES-Sym scores, respectively. The VEINES-QOL/Sym scale was considered highly reliable. When the relation between VEINES-QOL/Sym and the distance of 6MWT was investigated, the relation of VEINES-QOL was moderate (r=0.372; p

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

ObjectivesTo 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...

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

Little is known about the long-term impact of pregnancy-related deep vein thrombosis (DVT) of the lower limbs. 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. 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. 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. 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.

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change -3.6, SD 3.7 v. control mean change -1.6, SD 4.3; difference -2.0, 95% CI -4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Exercise training may improve post-thrombotic syndrome. It would be feasible to definitively evaluate exercise training as a treatment for post-thrombotic syndrome in a large multicentre trial.

Effectiveness of a Short Course of Complex Lymphedema Therapy or Graduated Compression Stocking Therapy In the Treatment of Post-Thrombotic Syndrome (PTS): A Randomized Control Trial.

AbstractAbstract 1087 Background:Investigations of treatment options for established PTS are limited. Graduated compression stocking therapy (GCS) is often used in clinical practice despite limited research on effectiveness. We postulated that the venous hypertension seen in PTS leads to lymphatic overload and secondary lymphedema. Therefore, in patients with established PTS, we compared the efficacy of GCS alone to complex lymphedema therapy, a treatment that includes compression stocking use, exercise, patient education, skin care and manual lymphatic drainage. Methods:In an investigator-blind randomized controlled trial of 31 patients with a clinical diagnosis of PTS and prior history of DVT, we compared GCS alone using 30–40 mm Hg compression to complex lymphedema therapy. Primary outcomes were the 1- and 3-month changes in PTS severity by the Villalta score (higher score indicates more severe PTS) and disease-specific quality of life by the VEINES QOL score (high score indicates better QOL). Analysis was by intent-to-treat. Results:Overall, 39% of patients enrolled in the study had moderate or severe PTS: baseline mean PTS severity score was 9.9 (SD 7.1) in the lymphedema group and 10.9 (SD 5.3) in the GCS group (p=0.66). The complex lymphedema therapy group had a reduction in mean PTS severity score of -2.4 (p=0.02) at 1 month and -2.3 (p=0.05) at 3 months follow-up. The GCS group had a reduction in PTS severity score of -2.1 (p=0.03) at 1 month and -3.3 (p=0.03) at 3 months. The improvement in PTS severity score did not differ significantly between treatment groups (p=0.61 at 3 months). Neither group had a significant change in VEINES QOL score. Patients not routinely using GCS prior to trial entry derived a greater benefit from either intervention with a decrease in PTS severity score (-8.8 in nonusers vs -1.5 in those using GCS at baseline, p=0.07) and an increase in VEINES QOL score (+1.9 vs -2.0, p=0.02). At 3 months, average self-reported GCS use was 6.7 days/wk (lymphedema therapy) and 5.9 days/wk (GCS) with 78% of patients in the lymphedema therapy group receiving manual lymphatic drainage (home or therapist). Four patients experienced recurrent thrombosis on the trial (3 in GCS group; 1 in lymphedema therapy group); 1 stocking allergy and ulcer formation was also seen in the GCS group with no cardiopulmonary complications reported in either group. Conclusion:In this first clinical trial of complex lymphedema therapy for patients with established PTS, a short course of lymphedema therapy was safe and had a similar effect on PTS severity as compression stocking use. Disclosures:No relevant conflicts of interest to declare.

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

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). 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. 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. 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.