Evaluation of a VENOus-Return Assist Device (Venowave™) To Treat Severe Post-Thrombotic Syndrome (VENOPTS): A Randomized Controlled Trial.

Abstract

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™.

Post‐thrombotic syndrome: prevalence, prognostication and need for progress

“…In a randomized clinical trial conducted in a small number of patients with severe PTS, the adoption of cycles of intermittent pneumatic compression was found to reduce both intractable oedema and leg swelling (Ginsberg et al , 1999). In another more recent randomized trial, a novel lower‐limb venous‐return assist device (VENOPTS) was found to considerably improve the clinical manifestations of severe PTS both alone and in combination with compression stockings (O’Donnell et al , 2008).…”

Prevention and treatment of the post‐thrombotic syndrome

“…At this stage the overall conclusion is that the quality of evidence is low, but that the overall direction of the effect is more towards a favourable effect of ECS as an intervention with a potential for PTS prevention (RR 0.62, 95% CI 0.38-1.01; P = .05). 35 In addition, most investigated interventions for established PTS were directed at the reduction of edema and enhancement of calf muscle pump action including complex lymphedema therapy, 36 veno-wave therapy, 37 or exercise therapy, 38,39 all with or without additional elastic compression therapy. All interventions resulted in an improvement in the severity of PTS, [36][37][38][39] and all but one resulted also in an improved health-related quality of life (HRQoL).…”

“…35 In addition, most investigated interventions for established PTS were directed at the reduction of edema and enhancement of calf muscle pump action including complex lymphedema therapy, 36 veno-wave therapy, 37 or exercise therapy, 38,39 all with or without additional elastic compression therapy. All interventions resulted in an improvement in the severity of PTS, [36][37][38][39] and all but one resulted also in an improved health-related quality of life (HRQoL). 36 Complex lymphedema therapy on top of elastic compression therapy was only superior in patients with severe PTS 36 while other studies such as the veno-wave study were solely directed at patients with severe PTS.…”

“…36 Complex lymphedema therapy on top of elastic compression therapy was only superior in patients with severe PTS 36 while other studies such as the veno-wave study were solely directed at patients with severe PTS. 37 In addition to these mechanical studies, a limited number of pharmacological studies in which veno active drugs (VADs) were investigated for their properties of edema reduction and improvement of PTS symptomatology have been performed; the quality of evidence is, however, deemed to be low. 40…”

Interventional approaches to deep vein thrombosis

“…Currently, ECS are the most frequently applied treatment, presumably because of their availability and safety; however, compression is inconvenient and uncomfortable for many patients and the available evidence does not support its efficacy once PTS has already developed [18]. Venoactive medications such as aescin and rutosides can be used in some countries, and certain mechanical–physiological compression devices and exercise regimens have shown promise to reduce PTS symptoms in some patients in very limited studies [16, 51–53]. However, no treatment has been shown to be consistently effective for the management of established PTS.…”