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.

Infrainguinal inflow assessment and endovenous stent placement in iliofemoral post-thrombotic obstructions.

PURPOSE: To assess the technical success, patency, and clinical outcome, following assessment of inflow and infrainguinal endovenous stent placement in patients with iliofemoral post-thrombotic obstruction with infrainguinal involvement. METHODS: A retrospective analysis of 39 patients with iliofemoral post-thrombotic venous obstruction accepted for infrainguinal stent placement in the period November 2009-December 2016. The clinical status was categorized according to the Clinical Etiological Anatomical Pathophysiological (CEAP) classification and symptom severity was assessed using Venous Clinical Severity Score (VCSS). The inflow was categorized as "good", "fair", or "poor" depending on vein caliber and extent of post-thrombotic changes in the inflow vessel(s). Stent patency was assessed by duplex ultrasound. Median follow-up was 44 months (range 2-90 months). RESULTS: Stent placement was successful in all 39 patients. Primary patency after 24 months was 78%. Thirty of 39 patients (77%) had open stents at final follow-up. Re-interventions were performed in four patients and included catheter-directed thrombolysis (CDT) in all and adjunctive stenting in two. Twenty-eight of 39 patients (72%) reported a sustained clinical improvement. Patients with "good" inflow had better patency compared to those with "fair"/"poor" (p = 0.01). One patient experienced acute contralateral iliofemoral thrombosis; this segment was successfully treated with CDT and stenting. No other complications required intervention. CONCLUSION: Infrainguinal endovenous stent placement was a feasible and safe treatment with good patency and clinical results, and should be considered in patients with substantial symptoms from post-thrombotic obstructions with infrainguinal involvement. Stents with good inflow have better patency and inflow assessment is essential in deciding the optimal stent landing zone.

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.