The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance

Jennifer A Summers, James Clinch, Muralikrishnan Radhakrishnan, Andy Healy, Viktoria McMillan, Elizabeth Morris, Tiago Rua, Mercy Ofuya, Yanzhong Wang, Paul W Dimmock, Cornelius Lewis, Janet L Peacock, Stephen F Keevil, Jennifer A Summers, James Clinch, Muralikrishnan Radhakrishnan, Andy Healy, Viktoria McMillan, Elizabeth Morris, Tiago Rua, Mercy Ofuya, Yanzhong Wang, Paul W Dimmock, Cornelius Lewis, Janet L Peacock, Stephen F Keevil

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.

Figures

Fig. 1
Fig. 1
The geko™ device [32]
Fig. 2
Fig. 2
Location of application of the geko™ device [32]. The primary fitting location is for the geko™ device to be positioned over the top of the fibula. Alternative fitting locations are aligned with the outer tendon, below or above the crease of the knee

References

    1. National Institute for Health and Care Excellence. 2014. Available from: . Accessed June 2014.
    1. National Institute for Health and Care Excellence. NICE medical technologies evaluation programme (MTEP). 2014. Available from: . Accessed June 2014.
    1. National Institute for Health and Care Excellence. Medical technologies evaluation programme: process guide. 2011. Available from: . Accessed July 2014.
    1. National Institute for Health and Care Excellence. Medical technologies evaluation programme. NICE medical technologies guidance [MTG19]. The geko device for reducing the risk of venous thromboembolism. 2014. Available from: . Accessed June 2014.
    1. Radhakrishnan M, et al. E-vita open plus for treating complex aneurysms and dissections of the thoracic aorta: a NICE medical technology guidance. Appl Health Econ Health Policy. 2014;12(5):485–95.
    1. Willits I, et al. WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension: a NICE medical technology guidance. Appl Health Econ Health Policy. 2014;12(3):255–265. doi: 10.1007/s40258-014-0096-7.
    1. Withers K, Carolan-Rees G, Dale M. Pipeline™ embolization device for the treatment of complex intracranial aneurysms: a NICE medical technology guidance. Appl Health Econ Health Policy. 2013;11(1):5–13. doi: 10.1007/s40258-012-0005-x.
    1. White J, Carolan-Rees G. PleurX peritoneal catheter drainage system for vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites: a NICE medical technology guidance. Appl Health Econ Health Policy. 2012;10(5):299–308. doi: 10.1007/BF03261864.
    1. Campbell B, Campbell M. NICE medical technologies guidance: a novel and rigorous methodology to address a new health technology assessment challenge. Appl Health Econ Health Policy. 2012;10(5):295–297. doi: 10.1007/BF03261863.
    1. National Institute for Health and Care Excellence. NICE guidelines [CG92]. Venous thromboembolism: reducing the risk: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. 2010. Available from: . Accessed July 2014.
    1. National Health Service. Blood clots. 2013. Available from: . Accessed July 2014.
    1. House of Commons Health Committee. HC99: the prevention of venous thromboembolism in hospitalised patients. London: The Stationery Office Limited; 2005.
    1. Office for National Statistics. Deaths in England and Wales due to deep vein thrombosis and pulmonary embolism, 2006–10. 2012. .
    1. Kopcke D, et al. Mortality from pulmonary embolism is decreasing in hospital patients. J Soc Med. 2011;104(8):327–331. doi: 10.1258/jrsm.2011.100395.
    1. Torbicki A, et al. Guidelines on the dianosis and management of acute pulmonary embolism. Eur Heart J. 2008;29(18):2276–2315. doi: 10.1093/eurheartj/ehn310.
    1. Royal College of Nursing. Understanding VTE. 2014. Available from: . Accessed July 2014.
    1. Kahn S. How I treat postthrombotic syndrome. Blood. 2009;114(21):4624–31.
    1. Vazquez S, Kahn S. Postthrombotic Syndrome. Circulation. 2010;121:a217–a219. doi: 10.1161/CIRCULATIONAHA.109.925651.
    1. Makin A, Silverman SH, Lip GYH. Peripheral vascualr disease and Virchow’s triad for thrombogenesis. QJM. 2002;95(4):199–210. doi: 10.1093/qjmed/95.4.199.
    1. Anderson FA Jr, Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003;107:I-9–16.
    1. National Institute for Health and Care Excellence. Pulmonary embolism. 2013. Available from: . Accessed June 2014.
    1. Department of Health. Risk assessment for venous thromboembolism (VTE). 2010. Available from: . Accessed June 2014.
    1. National Institute for Health and Care Excellence. NICE pathways: venous thromboembolism overview. 2014. Available from: . Accessed June 2014.
    1. National Institute for Health and Care Excellence. NICE pathways: diagnosing venous thromboembolism in primary, secondary and tertiary care. 2014. Available from: . Accessed June 2014.
    1. Wells PS, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003;349:1227–1235. doi: 10.1056/NEJMoa023153.
    1. National Health Service. Deep vein thrombosis: diagnosis. 2014. Available from: . Accessed June 2014.
    1. Qaseem A, et al. Current diagnosis of venous thromboembolism in primary care: a clinical roactise guideline from the American Academy of family physicians and the American College of Physicians. Ann Fam Med. 2007;5(1):57–62. doi: 10.1370/afm.667.
    1. National Health Service. Deep vein thrombosis: treatment. 2014. Available from: . Accessed July 2014.
    1. FirstKind Ltd. Neuromuscular electrostimulation geko™ T-1: specifications. 2013. Available from: . Accessed June 2014.
    1. FirstKind Ltd. DVT prevention geko device designed to increase venous circulation for VT prophylaxis: what it does and how it works. 2013. Available from: . Accessed June 2014.
    1. National Institute for Health and Care Excellence. Medical technology guidance MT196—scope. The geko device for venous thromboembolism prophylaxis. 2013. Available from: . Accessed June 2014.
    1. FirstKind Ltd. Sponsor submission of evidence: the geko™ device for venous thromboembolism (VTE) prophylaxis. In: National Institute for Health and Care Excellence, editor. Medical Technologies Evaluation Programme (MTEP). London; 2013.
    1. FirstKind Ltd. geko ciruclation support: insturctions for use. 2013. Available from: . Accessed June 2014.
    1. Jawad H. The effect of a novel electrical stimulation method for improving lower limb blood flow in healthy volunteers. London: Queen Mary, University of London; 2012.
    1. Jawad H. Coagulation, in the effect of a novel electrical stimulation method for improving lower limb blood flow in healthy volunteers. London: Queen Mary, University of London; 2012.
    1. Jawad H. Geko vs IPC, in the effect of a novel electrical stimulation method for improving lower limb blood flow in healthy volunteers. London: Queen Mary, University of London; 2012.
    1. Williams KJ, et al. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. (Manuscript in preparation).
    1. Tucker A, et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010;19(1):e31–e37. doi: 10.1055/s-0031-1278361.
    1. Jawad H. Cardiac, in the effect of a novel electrical stimulation method for improving lower limb blood flow in healthy volunteers. London: Queen Mary, University of London; 2012.
    1. Williams KJ, et al. Intermittent pneumatic compression and neuromuscular electrical stimulation of the leg: venous haemodynamic effects. In: 14th Annual Meeting of the European Venous Forum in collaboration with the Balkan Venous Forum and the Serbia College of Phlebology. 2013.
    1. Broderick BJ, et al. Hemodynamic performance of NMES in the early post operative period following orthopaedic surgery. In: Annual International Conference of the IEEE Engineering in Medicine and Biology Society-EMBC; 2011. p. 7630–7633.
    1. Broderick BJ, et al. A pilot evaluation of a neuromuscular electrical stimulation (NMES) based methodology for the prevention of venous stasis during bed rest. Med Eng Phys. 2010;32(4):349–355. doi: 10.1016/j.medengphy.2010.01.006.
    1. Broderick BJ, et al. Venous emptying from the foot: Influences of weight bearing, toe curls, electrical stimulation, passive compression, and posture. J Appl Physiol. 2010;109(4):1045–1052. doi: 10.1152/japplphysiol.00231.2010.
    1. Katz RT, et al. Functional electric stimulation to enhance systemic fibrinolytic activity in spinal cord injury patients. Arch Phys Med Rehabil. 1987;68(7):423–426.
    1. Lindstrom B, et al. Prediction and prophylaxis of postoperative thromboembolism: a comparison between peroperative calf muscle stimulation with groups of impulses and dextran 40. Br J Surg. 1982;69(11):633–637. doi: 10.1002/bjs.1800691102.
    1. Nicolaides AN, et al. Optimal electrical stimulus for prevention of deep vein thrombosis. Br Med J. 1972;3(5829):756–758. doi: 10.1136/bmj.3.5829.756.
    1. Velmahos GC, et al. Electrostimulation for the prevention of deep venous thrombosis in patients with major trauma: a prospective randomized study. Surgery. 2005;137(5):493–498. doi: 10.1016/j.surg.2005.01.010.
    1. Moloney GE, Morrell MT, Fell RH. The effect of electrical stimulation of the legs on postoperative thrombosis. Br J Surg. 1972;59(1):65–68. doi: 10.1002/bjs.1800590118.
    1. Browse NL, Negus D. Prevention of postoperative leg vein thrombosis by electrical muscle stimulation: an evaluation with 125I-labelled fibrinogen. BMJ. 1970;3(5723):615–618. doi: 10.1136/bmj.3.5723.615.
    1. Rosenberg IL, Evans M, Pollock AV. Prophylaxis of postoperative leg vein thrombosis by low dose subcutaneous heparin or peroperative calf muscle stimulation: a controlled clinical trial. Br Med J. 1975;1(5959):649–651. doi: 10.1136/bmj.1.5959.649.
    1. Curtis L. Unit costs of health and social care. 2012. Available from: . Accessed June 2014.
    1. Department of Health. NHS reference costs: financial year 2011–2012. 2012. Available from: . Accessed June 2014.
    1. Caprini JA, et al. Economic burden of long-term complications of deep vein thrombosis after total hip replacement surgery in the United States. Value Health. 2003;6(1):59–74. doi: 10.1046/j.1524-4733.2003.00204.x.
    1. Dai G, Gertler JP, Kamm RD. The effects of external compression on venous blood flow and tissue deformation in the lower leg. J Biomech Eng. 1999;121:557–564. doi: 10.1115/1.2800853.
    1. Morris RJ, Woodcock JP. Evidenced-based compression: prevention of stasis and deep vein thrombosis. Ann Surg. 2004;239(2):62–71.
    1. Ciani O, et al. Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study. BMJ. 2013;346:f457. doi: 10.1136/bmj.f457.
    1. National Institute for Health and Care Excellence. MT196 draft guidance: the geko device for venous thromboembolism prophylaxis: consultation document. 2013. Available from: . Accessed June 2014.
    1. Unknown. Study 8.1.1: the geko™ device vs Intermittent Pneumatic Compression (IPC) of the foot following elective Total Hip Replacement (THR). Medical Technologies Evaluation Programme: MT196. The geko device for reducing the risk of venous thromboembolism: consultation comments table for MTCD2 2014. Available from: . Accessed July 2014.
    1. Unknown. Study 8.1.2: the geko™ device vs TEDS following elective THR. Medical Technologies Evaluation Programme: MT196. The geko device for reducing the risk of venous thromboembolism: Consultation Comments table for MTCD2 2014. Available from: . Accessed July 2014.
    1. FirstKind Ltd. Geko post market surveillance (PMS). Medical Technologies Evaluation Programme: MT196. The geko device for reducing the risk of venous thromboembolism: consultation comments table for MTCD2 2014. Available from: . Accessed July 2014.
    1. Barnes R, et al. Haemodynamic efficacy of the GEKO™ electrical euromuscular stimulation device in claudicants. In: Society of Academic and Research Surgery. Cambridge: UK; 2014.
    1. Wells PS, et al. Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer. Thromb Haemost. 2000;83(3):416–420.
    1. Warwick D, et al. Neuromuscular electrostimulation via the common peroneal nerve promotes lower limb blood flow in a below knee cast: a potential for thromboprophylaxis. Bone Joint Res. 2013;2(9):179–85.
    1. Corley GJ, et al. Hemodynamic effects of habituation to a week-long program of neuromuscular electrical stimulation. Med Eng Phys. 2012;34(4):459–465. doi: 10.1016/j.medengphy.2011.08.005.
    1. Czyrny JJ, et al. Electrical foot stimulation: a potential new method of deep venous thrombosis prophylaxis. Vascular. 2010;18(1):20–27. doi: 10.2310/6670.2010.00001.
    1. Faghri PD, et al. Electrical stimulation-induced contraction to reduce blood stasis during arthroplasty. IEEE Trans Rehabil Eng. 1997;5(1):62–69. doi: 10.1109/86.559350.
    1. Broderick B, et al. Haemodynamic performance of neuromuscular electrical stimulation (NMES) during recovery from total hip arthroplasty. J Orthop Surg Res. 2013;8:3.
    1. Broderick BJ, et al. Patient tolerance of neuromuscular electrical stimulation (NMES) in the presence of orthopaedic implants. Med Eng Phys. 2011;33(1):56–61. doi: 10.1016/j.medengphy.2010.09.003.
    1. Griffin M, et al. The efficacy of a new stimulation technology to increase venous flow and prevent venous stasis. Eur J Vasc Endovasc Surg. 2010;40(6):766–771. doi: 10.1016/j.ejvs.2010.06.019.
    1. Izumi M, et al. Prevention of venous stasis in the lower limb by transcutaneous electrical nerve stimulation. Eur J Vasc Endovasc Surg. 2010;39(5):642–645. doi: 10.1016/j.ejvs.2009.11.035.
    1. Kaplan RE, et al. Electrical foot stimulation and implications for the prevention of venous thromboembolic disease. Thromb Haemost. 2002;88(2):200–204.
    1. Nicolaides AN, Miles C, Hoare M. Intermittent sequential pneumatic compression of the legs and thromboembolism-deterrent stockings in the prevention of postoperative deep venous thrombosis. Surgery. 1983;94(1):21–25.
    1. Santori FS, et al. Prophylaxis against deep-vein thrombosis in total hip replacement. Comparison of heparin and foot impulse pump. J Bone Joint Surg Br. 1994;76(4):579–83.
    1. Sobieraj-Teague M, et al. Randomized controlled trial of a new portable calf compression device (Venowave) for prevention of venous thrombosis in high-risk neurosurgical patients. J Thromb Haemost. 2012;10(2):229–235. doi: 10.1111/j.1538-7836.2011.04598.x.
    1. Warwick D, et al. A randomised comparison of a foot pump and low-molecular-weight heparin in the prevention of deep-vein thrombosis after total knee replacement. J Bone Joint Surg Br. 2002;84(3):344–350. doi: 10.1302/0301-620X.84B3.12372.
    1. Kurtoglu M, et al. Intermittent pneumatic compression in the prevention of venous thromboembolism in high-risk trauma and surgical ICU patients. Ulusal Travma Acil Cerrahi Derg. 2005;11(1):38–42.
    1. Pitto RP, Young S. Foot pumps without graduated compression stockings for prevention of deep-vein thrombosis in total joint replacement: efficacy, safety and patient compliance. A comparative, prospective clinical trial [published erratum appears in Int Orthop. 2008;32(3):337] Int Orthop. 2008;32(3):331–336. doi: 10.1007/s00264-007-0326-9.
    1. Nicolaides AN, et al. Venous stasis and deep-vein thrombosis. Br J Surg. 1972;59(9):713–717. doi: 10.1002/bjs.1800590908.

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