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Severe post-thrombotic syndrome (PTS) is responsible for considerable disability, reduced quality of life and increased health care costs. Current therapies are limited and often ineffective. Methods: We performed a two-center, randomized, cross-over controlled trial to evaluate Venowave™, a novel lower-limb venous return assist device, for the treatment of severe PTS. Eligible subjects were allocated to receive, in randomized order, Venowave™ for 8 weeks and control-device for 8 weeks. Participants were crossed-over after a 4-week (wash-out) period. The primary outcome measure was a clinical success, defined as; 1) reported benefit from the device with; 2) moderate (or greater) improvement in symptoms of PTS; and 3) willingness to continue using the device long-term. Secondary outcome measures included venous disease-specific quality of life (QOL) (measured by VEINES-QOL questionnaire; higher scores indicate better QOL) and PTS severity (measured by the Villalta PTS scale; higher scores indicate more severe PTS). The study was registered with ClinicalTrials.gov (NCT00182208). Results: Thirty-two patients were enrolled. Of these, 26 (80%) were also using graduated compression stockings. Twenty-six participants completed both trial periods. The primary outcome measure occurred in 10 participants receiving Venowave and 4 participants receiving the control-device (P=0.1). Two participants reported a clinical success with both devices. Mean Villalta scale score at the end of treatment period was significantly lower for Venowave™ (12.2; SD 6.3) compared to control (15.0; SD 6.1). (P=0.004) Mean VEINES-QOL score at the end of treatment period was significantly greater for Venowave™ (52.5; SD 5.8) compared to control (50.2; SD 6.2). (P=0.004) Conclusions: Venowave ™ is a very promising new therapy for patients with severe PTS, which may be used alone or in combination with graduated compression stockings. In our study population of patients with severe PTS, refractory to standard therapies, almost one-third of patients reported clinical improvement with Venowave™.

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Documenting patterns and outcomes of venous thromboembolism (VTE) management and degree of adherence by clinicians to treatment guidelines could help identify remediable gaps in patient care. Prospective, clinical practice-based data from Canadian outpatient settings on management of VTE, degree of adherence with treatment guidelines and frequency of recurrent VTE and bleeding during follow-up was obtained in a multicentre, prospective observational study. From 12 Canadian centres, we assessed 868 outpatients with acute symptomatic VTE who received the low-molecular-weight heparin (LMWH) enoxaparin alone or with vitamin K antagonists (VKA), at baseline and at six months (or at the end of treatment, whichever came first). Index VTE was limb deep venous thrombosis (DVT) in 583 (67.2%) patients, pulmonary embolism (PE) with or without DVT in 262 (30.2%) patients, and unusual site DVT in 23 (2.6%) patients. VTE was unprovoked in 399 (46.0%) patients, associated with cancer in 74 (8.5%) patients, transient risk factors in 327 (37.7%) patients and hormonal factors in 68 (7.8%) patients.With regard to guideline adherence, 58 (7.3%) patients received <5 days LMWH and 114 (14.5%) had overlap <1 day. Among patients with cancer-related VTE, 59.5% were prescribed LMWH monotherapy and 43.2% received such treatment for >3 months. Only 38.1% of patients with transient VTE risk factors had received thromboprophylaxis. Our study provides useful information on clinical presentation, management and related outcomes in Canadian outpatients with VTE. Our results suggest there may be important gaps in use of thromboprophylaxis to prevent VTE and use of LMWH monotherapy to treat cancer-related VTE.