Venowave

Post-thrombotic syndrome (PTS) is a prevalent and chronic complication of deep vein thrombosis (DVT). It is characterized by symptoms such as chronic leg pain, edema, brown pigmentation and thickening of the skin. More severe symptoms and complications, such as ulceration, can occur in certain cases and result in significant long-term consequences, including delayed healing, recurrence and ultimately amputation. R esearchers have identified PTS of the lower extremity as a major clinical sequelae affecting a given individual’s quality of life.1 It has been estimated that as many as 50% of those diagnosed with DVT will develop signs and symptoms of PTS within a period of two years.

Graduated elastic compression stockings (ECS) and leg elevation have been utilized for many years and are often cited as the gold standard for the management of PTS.3 The benefits of ECS have been well-established; however, they are not without their shortcomings. It is apparent throughout the published research data that compliance is low within the PTS patient population. A 2007 study conducted by Raju et al., examined 3144 patients diagnosed with chronic venous disease (CVD) to identify compliance rates with ECS. All participants were under the care of a primary physician or specialist, and were either past or present ECS users. The results indicated that 63% did not use the stockings at all, or abandoned them after a trial period.4 A large scale study conducted by Zaija et al. in 2011 investigated the reasons behind non-compliance with ECS in the PTS population. Of the 16,770 participants involved in the study, 30% could not specify a reason for non-usage. Other common reasons for non-compliance included: binding/”cutting off” of circulation (14%), discomfort from excessive heat (13%), limb soreness (8%), poor cosmetic appearance (2%), unable to apply independently (2%), contact dermatitis or itching (2%), and various other reasons such as cost or work interference (2%). There were also no significant differences in compliance rates between men and women.5 As documented in the biomedical research literature, noncompliance is an ongoing concern faced by many health practitioners involved in the treatment and management of PTS.

An alternative to traditional ECS therapy is intermittent pneumatic compression (IPC) devices. IPC devices are strapped around the bulk of the patient’s calf and mechanical compression is provided through air-inflatable sleeves or jackets. The sleeves are inflated at various rates to mimic the pumping action of the vascular system. IPC devices have demonstrated widespread clinical efficacy in the research literature for a number of conditions related to impaired circulation.6 Additionally, IPC devices have proven to mitigate the risk of more invasive procedures such as surgery and amputation (Labropoulos et al., 2002).7 However, these devices are large and cumbersome, and are typically quite costly. Furthermore, IPC devices require an external power source rendering the patient immobile during treatment periods.

The Venowave is a promising new cost-effective solution for patients suffering from PTS. The Venowave is a tubeless, sequential compression calf-pump that affixes to the posterior region of the calf. In contrast to traditional IPC units, the Venowave is portable, lightweight, quiet and cordless; thereby allowing patients to remain mobile and functional during periods of usage. It generates a unique wave-form motion that increases venous flow through upwards volumetric displacement. It can also be used in conjunction with ECS therapy. The Venowave was objectively tested at the annual meeting of the American College of Phelobology by Dr. Hugo Partsch in 2009, where it was found to generate the same levels of peak pressure (130mmHg) as larger IPC devices. In a randomized clinical trial conducted by O’Donnell et al. in 2002, it was reported that the Venowave increased peak venous flow (PVF) by 64% in the popliteal vein after two minutes of use, and by 88% in the common femoral vein after 50 minutes of use. Almost 40% of the patients reported a significant improvement in the severity of PTS symptoms.

Unlike traditional IPC devices, the Venowave is very well-tolerated. In a study conducted by Sobieraj-Teague et al. in 2012 with high-risk neurosurgical patients, it was concluded that the vast majority of participants (97%) reported that the Venowave did not limit their mobility. Furthermore, most participants (75%) reported that they would continue to use the Venowave for venous thrombosis prophylaxis in the future.

PTS is a debilitating disease that can adversely affect quality of life for many patients and increase the financial strain bourne by healthcare systems. The Venowave is an innovative, clinically-proven treatment solution offering a number of advantages over conventional therapies for patients suffering from the debilitating effects of post thrombotic syndrome. The Venowave offers a new tool in the treatment and management of PTS; it has been statistically proven to improve circulation in the lower extremities, and several medical case studies have demonstrated significant results in healing diabetic, arterial and venous wounds.

According to the Pew Research Center population projections, it is estimated that by the year 2030 baby boomers will represent 18% of the U.S. population. This represents roughly 10,000 baby boomers turning 65 every day for the next 15 years.9 With the predicted increase in the aging population, we can expect the number of lower limb circulatory disorders to increase. Unlike the current aging population, baby boomers will be much more tech savvy, spry and less likely to age without a fight. It will be imperative that this group of cohorts has options and the ability to sustain an active lifestyle. Having as many options available to patients now and in the future will be imperative.

References
1 Kahn S, Shbaklo H, Lamping D, Holcroft C, Shrier I, Miron M.,… Ginsberg J. (2008). Determinants of health-related quality of life during the 2 years following deep vein. J Thromb Haemost, 6: 1105–12.
2 Prandoni P and Kahn SR. (2009). Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol, 145(3): 286–295.
3 Kahn SR. (2009). How I treat post thrombotic syndrome. Blood, 114:4624–4631.
4 Raju S, Hollis K, Neglen P. (2007).Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg., 21:790-795. doi: 10.1182/asheducation-2010.1.216.
5 Ziaja D, Kocełak P, Chudek J, Ziaja K. (2011). Compliance with compression stockings in patients with chronic venous disorders. Phlebology, 26:353-360.
6 Urbankova J, Quiroz R, Kucher N, Goldhaber S. (2005) Intermittent pneumatic compression and deep vein thrombosis prevention: A meta-analysis in postoperative patients. Venous Health DOI: 10.1160/TH05–04–0222.
7 Labropoulos N, Wierks C, Suffoletto B. (2002) Intermittent pneumatic compression of the lower extremity arterial disease: a systemic review. Vascular Medicine. Available at: http//vmj.sagepub.com/content/7/2/141. Accessed October 28, 2012.
8 O’Donnell M, Ginsberg JS, Saringer J, et al. (2002) Effects of a novel Venous-return assist device (‘Venowave’) on lower limb venous flow in Subjects with postthrombotic syndrome. Blood; 100 (11 Suppl): 3950.
9 Cohn D and Taylor P. (2010, December, 10). Baby Boomers Approach 65 – Glumly. Retrieved from http:// http://www.pewsocialtrends.org/2010/12/20/baby-boomers-approach-65-glumly/


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