The geko™ Electro-Stimulation Device for Venous Thromboembolism Prophylaxis: A NICE Medical Technology Guidance

Abstract

The geko™ device is a single-use, battery-powered, neuromuscular electrostimulation device that aims to reduce the risk of venous thromboembolism (VTE). The National Institute for Health and Care Excellence (NICE) selected the geko™ device for evaluation, and invited the manufacturer, Firstkind Ltd, to submit clinical and economic evidence. King’s Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by the NICE, independently assessed the evidence submitted. The sponsor submitted evidence related to the geko™ device and, in addition, included studies of other related devices as further clinical evidence to support a link between increased blood flow and VTE prophylaxis. The EAC assessed this evidence, conducted its own systematic review and concluded that there is currently limited direct evidence that geko™ prevents VTE. The sponsor’s cost model is based on the assumption that patients with an underlying VTE risk and subsequently treated with geko™ will experience a reduction in their baseline risk. The EAC assessed this cost model but questioned the validity of some model assumptions. Using the EACs revised cost model, the cost savings for geko™ prophylaxis against a ‘no prophylaxis’ strategy were estimated as £197 per patient. Following a second public consultation, taking into account a change in the original draft recommendations, the NICE medical technologies guidance MTG19 was issued in June 2014. This recommended the adoption of the geko™ for use in people with a high risk of VTE and when other mechanical/pharmacological methods of prophylaxis are impractical or contraindicated in selected patients within the National Health Service in England.

A feasibility randomised controlled trial to evaluate the effectiveness of a novel neuromuscular electro-stimulation device in preventing the formation of oedema following total hip replacement surgery

“…In addition, the use of compression stockings is contra-indicated in patients with leg oedema, cardiac failure, peripheral vascular insufficiency, and venous ulceration, which can limit their applicability, particularly in elderly populations who frequently have hip replacements procedures. Indeed, for patients where mechanical/pharmacological methods of prophylaxis are impractical or contraindicated, NICE medical technologies guidance recommend the adoption of NMES ( Summers et al., 2015 ) and this study further supports the NICE position. Incorrectly fitted compression stockings have also been associated with ischemia and increased risk of DVT and a recent study has found a significant increase in skin problems, including breaks, ulcers, blisters, and necrosis in patients who were fitted with compression stockings.…”

The use of a novel in-bed active Leg Exercise Apparatus (LEX) for increasing venous blood flow

“…The causes of DVT are not clearly understood. Generally, Virchow’s triad (abnormalities in blood flow, blood constituents, and the vessel wall) is thought to be relevant 13 ) . To better understand blood flow during active ankle exercises, Sochart et al .…”

The effect of calf neuromuscular electrical stimulation and intermittent pneumatic compression on thigh microcirculation

“…They are often used post-surgery to prevent deep vein thrombosis (DVT) (Goldhaber & Morrison, 2002), in procedures such as total hip replacement (Doran & White,1976); and have been found to reduce oedema in the thigh of total hip replacement patients post-surgery (Faghri et al, 1997). (Summers et al, 2015).…”