Does the Villalta scale capture the essence of postthrombotic syndrome? A qualitative study of patient experience and expert opinion.

BACKGROUND: The Villalta scale is recommended for diagnosing and grading of postthrombotic syndrome (PTS) in clinical studies, but with limitations in specificity and sensitivity. OBJECTIVES: To explore the typical complaints of PTS through patients experience and expert opinion and relate this to the items of the Villalta scale. PATIENTS/METHODS: A qualitative study design with focus group interviews including patients with PTS and health care workers experienced in PTS patient care. RESULTS: Typical PTS complaints were reflected within four main domains: (a) agonizing discomforts; patients without venous ulcers often described other discomforts than pain; (b) skin changes; these were common and sometimes present before deep vein thrombosis (DVT). Except for venous ulcers, skin changes were considered of less importance; (c) fluctuating heaviness and swelling during the day and with activity; (d) post-DVT concerns; fear of DVT recurrence, health services failing to meet the patients' expectations, and psychological and social restrictions. These findings are not necessarily captured or well reflected in the Villalta scale. CONCLUSION: Our findings indicate that the Villalta scale does not capture typical PTS complaints or their importance to the patients. A revision of the diagnosis and grading should be considered.

[Clinical efficacy of electric stimulation of crural muscles in comprehensive treatment of post-thrombotic disease]. / Klinicheskaia éffektivnost' élektricheskoi stimuliatsii myshts goleni v kompleksnom lechenii posttromboticheskoi bolezni.

The purpose of the study was to evaluate clinical efficacy of electromyostimulation (EMS) of the crural muscles as part of comprehensive therapy for post-thrombotic disease in patients with residual venous obstruction in the femoropopliteal segment. We carried out a prospective comparative clinical study enrolling patients having endured a fist episode of clinically unprovoked venous thrombosis of the femoropopliteal segment and completed the standard 6-month course of anticoagulant therapy and presenting with ultrasonographic signs of complete recanalization of the proximal venous segments (stenosis of 20% and more from the vessel's initial diameter), as well as scoring 5 points and more by the Villalta scale. The study included a total of 60 patients (38 men and 22 women, mean age 58.5±11.4 years) subdivided into two groups consisting of 30 patients each. Patients of both the Study and Control Groups underwent comprehensive therapy including wearing a compression knee sock (23-32 mmHg), a course phlebotrophic drugs, and dosed walking (not less than 5,000 steps a day). The Study Group patients were additionally subjected to daily electrical stimulation of the crural muscles with the "Veinoplus VI" unit (three 30-minute sessions a day). The duration of the follow up amounted to 12 months. The criteria for assessing therapeutic efficacy were as follows: severity of the disease by the VCSS and Villalta scales, quality of life as assessed by the CIVIQ-20 questionnaire, and lack of relapses of the venous thrombus. Clinical and instrumental assessment of the patients' condition was carried out monthly, with the disease's severity and quality of life assesses each 6 months. Relapses of venous thrombosis were registered in 7 (23.3%) patients from the Control Group and were not observed in patients undergoing EMS (p=0.011). In 5 cases, thrombosis was asymptomatic and in 4 cases it was presented by reocclusion of the involved venous segments. Patients of the Study Group were found to have a decrease in the disease's severity, reflected in points: VCSS (9.9±1.6 - 7.8 ± 1.6 - 6.1±1.5 (p <0.0001)); Villalta scale (18.9±3.9 - 12.8±4.0 - 8.3±2.7 (p<0.0001)); CIVIQ-20 score (67.8±8.4 - 51.3±8.4 - 40.0±10.5 (p<0.001)). The Control Group patients showed a similar tendency for the disease's severity: 8.1±2.8 - 7.3±2.1 - 7.2±2.1 points by the VCSS (p=0.014); 12.7±6.7 - 10.9±5.6 - 10.2±5.4 points by the Villalta scale (p=0.002), but not for quality of life: 48.2±19.3 - 46.7±17.3 - 47.4±16.2 points by the CIVIQ-20 (p>0.05). On the background of using EMS, the alterations in the studied parameters were characterized by higher velocity and intensity (p<0.05). The use of electromyostimulation as part of comprehensive treatment for post-thrombotic disease makes it possible to efficiently eliminate both subjective and objective signs of venous insufficiency, improve patients' quality of life and decrease the risk for the development of relapsing venous thrombosis.

Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis: 1-year follow-up data of a randomized-controlled trial.

Essentials Acute iliofemoral deep vein thrombosis can be treated with catheter-directed thrombolysis (CDT). We performed a randomized trial comparing conventional CDT versus ultrasound-assisted CDT (USAT). Clinical and duplex sonographic outcomes at 12 months were similar in the CDT and USAT groups. In both groups, incidence of postthrombotic syndrome was very low with good quality of life. SUMMARY: Background In patients with acute iliofemoral deep vein thrombosis (IFDVT), catheter-directed thrombolysis (CDT) aims to prevent the postthrombotic syndrome (PTS). Adding intravascular high-frequency, low-power ultrasound energy to CDT does not seem to improve the immediate thrombolysis results but its impact on clinical outcomes at 12 months is not known. Patients/Methods In this randomized-controlled trial, 48 patients (mean age 50 ± 21 years; 52% women) with acute IFDVT were randomized to conventional CDT (n = 24) or ultrasound-assisted CDT (USAT; n = 24). In both groups, a fixed-dose thrombolysis regimen (20 mg r-tPA over 15 h) was used, followed by routine stenting of residual venous obstruction. At 12 months, PTS and venous disease severity (Villalta score and revised Venous Clinical Severity Score [rVCSS]), disease-specific quality of live (QOL; CIVIQ-20) and duplex-sonographic outcomes were assessed. Results Among the 45 surviving patients, 40 (89%; 95% confidence interval [CI] 76-96%) patients were free from PTS (defined as Villalta score < 5 points; 83%, 95% CI 61-95% in the USAT and 96%, 95% CI 77-100% in the CDT group), with a similar mean total Villalta score of 2.3 ± 2.9 vs. 1.7 ± 1.6, and a mean total rVCSS of 3.0 ± 3.5 vs. 2.7 ± 2.9 in the USAT and the CDT groups, respectively. Both groups had good disease-specific QOL with a CIVIQ-20 score of 29.4 ± 11.8 vs. 26.1 ± 7.8, respectively. Primary (100% vs. 92%) and secondary (100% vs. 96%) iliofemoral patency rates and presence of femoro-popliteal venous reflux (39% vs. 33%) were similar in both groups. Conclusion The addition of intravascular ultrasound energy to conventional CDT for the treatment of acute IFDVT did not have any impact on relevant clinical or duplex sonographic outcomes, which were favorable in both study groups. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier:NCT01482273.

[Efficacy of Venarus in treatment of patients with post-thrombotic disease of lower limbs].

The authors studied efficacy of Venarus in comprehensive treatment of patients presenting with post-thrombotic disease. An open multicenter retrospective study included a total of 110 patients subdivided into two groups. Group One (Study Group) consisted of 51 patients with post-thrombotic syndrome, undergoing comprehensive medical treatment with the use of phlebotonic agent Venarus. Group Two (Control Group) comprised 59 patients with post-thrombotic syndrome undergoing similar conservative treatment but without taking phlebotonics. It was proved that Venarus included into comprehensive treatment of patients with post-thrombotic syndrome led to a statistically significant increase of both psychological and social activity and improved patients' quality of life. During the standard term of administration (2 months) Venarus levelled subjective symptoms and certain objective symptoms (according to the Villalta Scale) of post-thrombotic syndrome. After 2-month use Venarus demonstrated the highest efficacy in treating patients with mild-to-moderate post-thrombotic syndrome. The maximal efficacy was observed after 3 months of administration in standard doses. No side effects were noted during the whole period of the study.

Health-related quality of life in children and young adults with post-thrombotic syndrome: results from a cross-sectional study.

OBJECTIVE: While post-thrombotic syndrome (PTS) is increasingly recognized in children with a history of deep vein thrombosis (DVT), its impact on the health-related quality of life (HRQoL) is unknown. Our objective was to evaluate the association between the PTS and HRQoL by surveying a cohort of patients treated at our institution for DVT. MATERIALS/METHODS: All unique pediatric patients (0-18 years) treated for a DVT at the Mayo Clinic during the 15-year period, 1995-2009 were identified. A previously validated PTS survey instrument and age appropriate Pediatric Quality of Life inventory, version 4 (PedsQL 4.0) were mailed to eligible patients. Linear regression models were fit to compare the HRQoL scores between PTS groups (none, mild, moderate/severe), after adjusting for the presence of potential covariates. RESULTS: Of the 90 respondents, 65 (72%) reported signs and/or symptoms of PTS. Mean age (± SD) at DVT diagnosis and survey completion were 12.8 (± 6.1) and 19.3 (± 7.7) years, respectively. Self-report PedsQL 4.0 module was completed by 79 patients, and 34 guardians completed the parent-proxy module. Patients with moderate to severe PTS reported significantly worse total HRQoL score (mean ± SD, 71.3 ± 13.4) as compared to patients with mild PTS (84.8 ± 14.2) and no PTS (83.4 ± 14) (P = 0.001). CONCLUSION: Moderate to severe PTS has a significant impact on self-reported HRQoL as measured using the generic PedsQL 4.0. Further research is warranted to develop a venous disease-specific quality of life measure for children with a history of DVT.

[Influence of pathology-based surgical treatment on quality of life in patients with postthrombotyc disease of lower extremities].

Quality of life (QOL) in patients with posttrombotyc disease (PTD) of lower extremity after surgical treatment due to the pathogenetic features of the disease was investigated. In 27 patients, combined with crosectomy and venexeresis the paratibial fasciotomy and closed separation perforante veins were performed. QOL was studied CIYIQ questionnaire before surgery and at 1 year after it. According to morphological studies revealed fragments leg fascia chronic destructive processes that cause disruption of normal functioning "muscle pump". The results marching samples marked venous dysfunction that manifested a significant increase in the volume of tibia during passive standing and maintaining venous stasis after walking, indicating a lack of functioning "muscle pump". The amplitude of movements in talocrural joint in 1.4 times less than the total amount of flexion and extension of the foot in patients with PTD than in the control group. According to electromyography during PTD average amplitude was reduced by 1.5 times, maximum--1.8 times than that of the control group, indicating a significant reduction in functional capacity and tone leg muscles. QOL of patients after surgery improved to 2.1 times.

Scoring systems for the post-thrombotic syndrome.

OBJECTIVE: To assess each of the scoring systems used to diagnose and classify post-thrombotic syndrome, a common chronic complication of deep vein thrombosis. The design of the study was a systematic review of the literature pertaining to post-thrombotic syndrome. METHODS: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines by a search of PubMed (1948 to September 2011) using the search terms "post-thrombotic syndrome," "postthrombotic syndrome," "post-phlebitic syndrome," and "postphlebitic syndrome." A manual reference list search was also carried out to identify further studies that would be appropriate for inclusion. The various scoring systems in use were identified and assessed against a list of criteria to determine their validity for use. For outcome measures, each scoring system was assessed for specific criteria, including interobserver reliability, association with ambulatory venous pressures, ability to assess severity of post-thrombotic syndrome, ability to assess change in condition over time, and association with patient-reported symptom severity. RESULTS: The Villalta, Ginsberg, Brandjes, Widmer, CEAP, and Venous Clinical Severity Score systems all were assessed for the stated outcome measures. From their use in the literature, only the Villalta score was able to fulfill all the criteria described. The main criticism of the Villalta score in the literature appears to be its use of subjective measures. To that end, we propose that use of a venous disease-specific quality-of-life questionnaire in combination with the Villalta score may help standardize the subjective criteria. CONCLUSIONS: The Villalta score, combined with a venous disease-specific quality-of-life questionnaire, should be considered the "gold standard" for the diagnosis and classification of post-thrombotic syndrome.

Impact of the postthrombotic syndrome on quality of life after primary upper extremity deep venous thrombosis.

BACKGROUND: To determine the impact of the postthrombotic syndrome (PTS) on quality of life after primary upper extremity deep venous thrombosis (UEDVT). PATIENTS AND METHODS: Twenty-five patients with a history of primary UEDVT, treated with anticoagulation alone, and twenty healthy controls were retrospectively identified and prospectively assessed for health-related quality of life (SF-36 and VEINES-QOL-questionnaire) and upper extremity functional impairment (DASH-score). Presence of PTS was classified according to the modified Villalta-score. Comparisons between patients and controls and between patients with and without PTS were performed using Fisher`s exact test (categorical variables) and Mann-Whitney-U-test (continuous variables). RESULTS: According to the modified Villalta-score, 32 % of the patients suffered from mild to moderate PTS. None of the patients developed severe PTS. Compared to healthy control subjects, patients with a history of primary UEDVT reported on considerably worse health-related quality of life and significantly stronger upper extremity functional impairment. Within the cohort of patients with UEDVT, subjects with PTS had a significantly reduced quality of life and a more severe functional limitation. CONCLUSIONS: Quality of life and functional performance are impaired in patients with a history of conservatively treated primary UEDVT. Impairment is most pronounced in patients with mild to moderate PTS occurring in every third patient.

Quality of life and economic costs associated with postthrombotic syndrome.

PURPOSE: Published evidence on quality-of-life (QOL) outcomes and health care costs in patients with postthrombotic syndrome (PTS), a common and difficult-to-diagnose complication of venous thromboembolism (VTE), is reviewed. SUMMARY: Occurring in as many as 70% of patients with VTE, PTS remains a challenging and costly disorder, partly due to the lack of a standard diagnostic definition and varying classification systems. Searches of Medline and EMBASE identified 12 articles on humanistic and economic outcomes associated with PTS. The results of U.S. and international studies indicate that PTS is a key determinant of long-term QOL among patients with VTE. In one large study, 37% of patients with VTE developed PTS within two years of a diagnosis of deep venous thrombosis (DVT), and 4% developed severe PTS, with the occurrence of PTS linked to clinically relevant declines in measures of physical and mental health. Research indicates that the economic burden of PTS in the United States may be as high as $200 million annually. Recent progress in efforts to develop standard PTS terminology may facilitate the dissemination of clear consensus guidelines to assist in timely PTS detection and optimal care. CONCLUSION: Appropriate measures to decrease PTS-related burdens may include the prevention of DVT, clear diagnostic criteria for PTS, and an education campaign aimed at increased standardization in the management of DVT. Gaps in the current understanding of the risk factors, diagnostic criteria, preventive strategies, and even treatment modalities for PTS hamper the ability of clinicians to employ measures that could reduce the occurrence of this disorder and the associated morbidity.

Common femoral endovenectomy with iliocaval endoluminal recanalization improves symptoms and quality of life in patients with postthrombotic iliofemoral obstruction.

BACKGROUND: The postthrombotic syndrome is a debilitating condition occurring in 30% to 50% of patients with lower extremity deep vein thrombosis (DVT). Following iliofemoral DVT, however, postthrombotic morbidity is especially severe, due to occlusion of the common femoral vein (CFV) and iliac veins. While endoluminal recanalization appears effective in restoring patency to the iliac venous system, infrainguinal obstruction of the CFV remains a problem. The purpose of this study is to report preliminary observations of common femoral endovenectomy and intraoperative endoluminal recanalization of the iliac veins in patients with incapacitating postthrombotic iliofemoral obstruction. METHODS: Ten patients underwent common femoral endovenectomy with endoluminal iliocaval recanalization. The Venous Clinical Severity Score (VCSS), a validated tool to assess chronic venous disease, the Villalta scale, a validated tool to quantify postthrombotic syndrome, the clinical classification of CEAP, and the Venous Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL)/Sym questionnaires were completed preoperatively and readministered postoperatively at 8.8 months (mean). RESULTS: Five patients were followed for more than 6 months and form the basis of the long-term analysis. All demonstrated significant improvement in their venous scores postoperatively. The VCSS preoperatively was 17 and fell to 9.8 postoperatively (P = .02). The Villalta scale dropped from 13.6 preoperatively to 6.0 postoperatively (P = .002). The VEINES-QOL/Sym questionnaire, a sensitive marker of patient quality of life and symptom status, was improved (P = .01 and .02, respectively). CONCLUSION: Chronic postthrombotic iliofemoral venous obstruction treated with common femoral endovenectomy and endoluminal recanalization improves objective outcome measures of patients with chronic postthrombotic obstruction. By restoring unobstructed venous drainage through the CFV to the vena cava, patients' postthrombotic morbidity is reduced and quality of life is improved.

Impact of venous thromboembolism, venous stasis syndrome, venous outflow obstruction and venous valvular incompetence on quality of life and activities of daily living: a nested case-control study.

The role of venous stasis syndrome (VSS) mechanisms (i.e. venous outflow obstruction [VOO] and venous valvular incompetence [VVI]) on quality of life (QoL) and activities of daily living (ADL) is unknown. The objective of this study was to test the hypotheses that venous thromboembolism (VTE),VSS,VOO and VVI are associated with reduced QoL and ADL. This study is a follow-up of an incident VTE case-control study nested within a population-based inception cohort of residents from Olmsted County, MN, USA, between 1966 and 1990. The study comprised 232 Olmsted County residents with a first lifetime VTE and 133 residents without VTE. Methods included a questionnaire and physical examination for VSS; vascular laboratory testing for VOO and VVI; assessment of QoL by SF36 and of ADL by pertinent sections from the Older Americans Resources and Services (OARS) and Arthritis Impact Measurement Scales (AIMS2) questionnaires. Of the 365 study participants, 232 (64%), 161 (44%), 43 (12%) and 136 (37%) had VTE, VSS, VOO and VVI, respectively. Prior VTE was associated with reduced ADL and increased pain, VSS with reduced physical QoL and increased pain, and VOO with reduced physical QoL and ADL.VVI was not associated with QoL or ADL. In conclusion,VSS and VOO are associated with worse physical QoL and increased pain. VOO and VTE are associated with impaired ADL. We hypothesize that rapid clearance of venous outflow obstruction in individuals with acute VTE will improve their QoL and ADL.