A Wearable Alternative for Thrombosis Prevention

One in four deaths worldwide is related to thrombosis, which is a major contributor to the global disease burden. In the U.S. alone, up to 900,000 people are affected by blood clots, leading to approximately 300,000 venous thromboembolism (VTE) related deaths each year¹.
 
The risk of developing a blood clot increases when a patient is in the hospital, particularly after surgery. Hospital-acquired VTE causes more deaths than traffic accidents, prostate cancer, AIDS, and breast cancer combined.
 
Preventive measures are usually necessary only when there is an increased risk of a patient developing VTE. Prevention can include early walking after surgery, a choice of mechanical compression devices, or anticoagulants. Anti-embolism stockings compress the limb to prevent the veins in the leg from expanding, stopping blood from pooling and forming a clot. Intermittent pneumatic compression devices use an electrical pump to fill a sleeve with compressed air to sequentially inflate and deflate the sleeve, increasing blood flow and allowing the veins to refill. Anticoagulants, a class of drug given as an injection or a tablet, prevent coagulation (clotting) of blood. Not all patients, however, are able to tolerate these forms of prophylaxis. For many, the current methods are either contraindicated, poorly tolerated, or simply impractical to prescribe, leading to poor compliance and leaving a sizable population receiving no VTE prophylaxis.
 
New Innovation
New strategies and products to address unmet VTE prevention are emerging, and it is in the area of neuromuscular electrostimulation (NMES) that one new technological advance has broken through. Named the geko device, the unit places a gentle electrical stimulus on the surface of the skin, via the nerve, causing the muscles in the calf and foot to contract. The muscle contraction alternatively stretches and compresses the veins, increasing lower limb blood flow. The increase in circulation prevents the blood from pooling and clotting. The mechanism of action is pain free, unlike other NMES devices that place electrical stimulus in direct proximity to muscle, which can be painful.
 
The size of a small wrist-watch and worn at the knee, the battery-powered geko is fitted over the center of the fibula head at the top of the fibula bone. The disposable device gently stimulates the common peroneal, stimulating the calf and foot muscles to increase venous, arterial, and microcirculatory blood flow. The increase in blood flow is similar to what’s achieved by walking—up to 60 percent—without requiring a patient to move or exert energy and without discomfort.
 
In a recent published study by Professor Andrew Nicolaides, the effect of the geko on blood flow was measured in the deep veins of the calf. The study found significant volume and velocity increases within the gastrocnemius, peroneal, and posterior tibial veins, which are of particular clinical importance as early thrombi often form in these veins². This is the first time that a mechanical device has been reported to enhance  blood flow for the prevention of stasis in the deep veins of the calf, and is the result of the unique dorsiflexion achieved by the geko device. With this proven ability to prevent stasis in the deep veins, the study strongly supports use of the geko device for VTE prevention.
 
The geko has secured UK National Institute of Clinical Excellence guidance (MTG19), recommending its use for patients with a high risk for VTE and for whom pharmacological and other mechanical methods of VTE prevention are impractical or contraindicated. When used for a period of six days, the geko provides a cost saving of £197 per patient³.
 
References
¹ U.S. Department of Health and Human Services. Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism 2008. Available at: http://www.surgeongeneral.gov/topics/deepvein.
² A. Nicolaides, M Griffin, Measurement of blood flow in the deep veins of the lower limb using the geko device neuromuscular electro-stimulation device, accepted for publication, August 2016.
³ NICE Guidelines (CG92). Published date January 2010.

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Anthony Kjenstad is the founder and president of Athletic Recovery and Performance. Athletic Recovery & Performance is the U.S. distribution partner for Firstkind Ltd., a subsidiary of Sky Medical Technology Ltd.—a UK based medical devices company that has developed a neuromuscular electrostimulation technology platform, OnPulse.