The use of the geko™ device to serve an unmet VTE prevention need in acute stroke patients

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Overview summary:
NICE recommend Intermittent Pneumatic Compression (IPC) to reduce Venous Thromboembolism (VTE) risk in acute stroke patients. However around 30% of patients cannot be prescribed this modality. To serve this unmet need The Royal Stoke University Hospital has introduced a new VTE pathway which included neuromuscular electrical stimulation of the peroneal nerve using the NICE approved geko™ device (Firstkind Ltd UK). This pathway change also increased patient surveillance of both IPC & the geko™ device so to maximise the anti-stasis intervention.
Challenge identified and actions taken :
VTE prevention strategies available to high risk stroke patients are limited. NICE recommend IPC as the primary method of VTE prevention because the risk of symptomatic intracerebral haemorrhage with routine anticoagulation (including low molecular weight heparin) outweighs any potential benefit. Furthermore anti-embolism stockings are not recommended.

IPC reduces VTE risk by increasing venous return and preventing venous stasis in the veins of the calf. This modality, alongside standard measures of hydration, mobilisation and aspirin represents standard UK VTE prevention for high risk immobile acute stroke patients. The VTE consequence of no IPC intervention in this cohort was recorded in the CLOTS-3 study which showed a high resulting VTE incidence rate of 8.69%.

The geko™ device is an alternative anti-stasis device for use on patients who cannot be prescribed or tolerate IPC. The Royal Stoke University Hospital has recently introduced the device into the stroke pathway for patients who were either contraindicated or became intolerant to IPC and would otherwise have had no anti-stasis intervention.

Furthermore, nursing practice was amended to increase patient surveillance and maximise compliance for both IPC and the geko™ device. The objective was to maximise the anti-stasis intervention in this population.
Impacts / outcomes:
Blood clots, or venous thromboembolism (VTE), are a major risk to hospitalised patients. VTE leads to pain, swelling and potential death. While the full scale of the problem is not known, it is estimated that hospital-associated VTE leads to about 40,000 deaths in England per year, 25,000 of which may be preventable through proper risk management and care. This is about five times as many healthcare-associated deaths as from methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile combined. There is a strong quality and financial imperative for hospitals to prioritise VTE prevention.

National Institute for Health and Clinical Excellence (NICE) guidelines set out the preventative measures that should be implemented to reduce this risk. In 2014, new guidelines recommended the use of the geko™ device for use in people who have a high risk of venous thromboembolism and for whom other mechanical and pharmacological methods of prophylaxis are impractical or contraindicated.

The size of a wrist watch and worn at the knee, the easy-to-use geko™ device is a neuromuscular electro-stimulation (NMES) medical device that gently stimulates the common peroneal nerve (a nerve adjacent to the knee) activating the calf and foot muscle pumps. The device creates a painless contraction of these muscles every second resulting in the prevention of “venous stasis” or static blood in the deep veins of the calf.

The risk of venous thromboembolism (VTE) after stroke is increased in patients with restricted mobility and associated increase in venous stasis. The alteration in blood flow in weakened limbs may lead to vessel wall injury, whilst there is also an abnormal tendency for the blood to clot more after stroke. The results from the Royal Stoke University Hospital show that introducing the geko™ device into this pathway lowered the overall incidence rate of symptomatic VTE. The geko™ is as effective as IPC at reducing DVT, the device was well tolerated and offered an alternative prophylaxis strategy to IPC, ensuring that all patients received VTE prophylaxis, where previously no prophylaxis could be given.



A clinical audit reviewed 1,000 patients admitted to the acute stroke unit at Royal Stoke University Hospital between 1st Nov 2016 and 3rd March 2018.

Key impacts:
  • 188 patients were sufficiently mobile and did not require any form of VTE prophylaxis.
  • 125 were assessed and deemed suitable for anti-coagulant drug to reduce VTE risk
  • 687 patients were assessed as immobile and at high risk of VTE, were unsuitable for drug and required an anti-stasis intervention.
  • 21/687 patients refused any kind of anti-stasis VTE preventative treatment
  • Therefore 666 patients received an anti-stasis intervention in addition to standard measures.
  • 544/666 were initially prescribed IPC to reduce their VTE risk
  • 122/666 patients were immediately contraindicated to IPC and were prescribed the geko™ device.
  • 81 patients who were initially prescribed IPC but became intolerant to it and were switched to the geko™ device.
  • Accordingly, 203/687 or 29.5% of patients represented the unmet need as described above and required an alternative anti-stasis and were therefore served by the geko™ device.
  • The geko™ was used for a mean of 9 days/patient.
  • The geko™ device was well tolerated by patients.

Key outcomes:

This audit also reviewed the VTE (DVT or PE) incidence at 90 days post discharge for the 687 patients who needed an anti-stasis intervention.
  • 11 VTE occurred in patients treated with IPC
  • 1 VTE occurred in the group who were initially prescribed IPC but who were switched to the geko™ device.
  • 1 VTE occurred in the group who refused any form of anti-stasis intervention
  • There was no incidence of VTE in patients prescribed the geko™ device.
The above new VTE pathway in acute stroke patients, which increased patient surveillance and included IPC and the geko™ device to maximise the prescribed anti-stasis intervention, resulted in a low overall incidence of symptomatic VTE. The incidence in high risk immobile patients requiring an anti-stasis intervention was 1.9% (13/687), which is lower than the 6.6% in a comparable patient population in the CLOTS-3 study.
Supporting quote for the innovation from key stakeholders:
‘Following the positive results of our clinical audit within our acute stroke unit, the geko™ device is now in routine use and has marked a significant change to our nursing practice. The audit has shown a need to use the geko™ when other VTE prophylaxis strategies are contraindicated or impractical. This pathway enhancement ensures that all acute stroke patients now have another VTE prophylactic intervention option where previously patients would have had no other intervention available to them’.

Dr. Indira Natarajan FRCP (UK)
Consultant Stroke Physician
Clinical Director Neurosciences
The Royal Stoke University Hospital


Which local or national clinical or policy priorities does this innovation address:
National Institute for Health and Clinical Excellence (NICE) guidelines set out the preventative measures that should be implemented to reduce the risk of blood clots, or venous thromboembolism (VTE). In 2014, new guidelines recommended the use of the geko™ device for use in people who have a high risk of venous thromboembolism and for whom other mechanical and pharmacological methods of prophylaxis are impractical or contraindicated.
Plans for the future:
Whilst the above data has proven sufficient for the geko™ device to be adopted specifically to meet this unmet need, this audit will be extended as will the ongoing collation of associated quantitative & qualitative data.

Further support will be given to multiple trusts to further validate the use of the geko™ device to serve this large and meaningful unmet need in acute stroke patients

A publication strategy will also be formulated with the aim to present this data as appropriate.
Tips for adoption:
Firstkind are determined to remove any administration obstacles to accelerate the adoption process whilst fully respecting due process. We can assist the adoption process by offering the following:
  • The team at Royal Stoke Hospital are receptive to assist where possible in terms of process and sharing of experience
  • The sharing of all the relevant “committee” forms that allow for a new device to be considered and used within a trust. This common approach has created efficiency.
  • In terms of any device audit that has been conducted to quantify the size of any unmet need the audit collection forms have been shared between trusts to the reduce administrative burden.
  • Created a cross trust partnership approach to delivering patient benefit.
Adopting this approach has fast-tracked the implementation of this new technology into the stroke pathway in several centres across the U.K.

Contact for further information:
Firstkind Ltd
Hawk House
Peregrine Business Park
Gomm Road
High Wycombe
Bucks
HP13 7DL

E: geko.support@firstkindmedical.com
W: www.gekodevices.com

T: +44 (0)845 2222 920 (Orders)
T: +44 (0)845 2222 921 (Enquiries)
F: +44 (0)845 2222 820
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