SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance

Applied Health Economics and Health Policy https://doi.org/10.1007/s40258-018-0427-1 REVIEW ARTICLE SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance Tom Macmillan1 · Mark Pennington2 · Jennifer A. Summers3 · Kate Goddard1 · Darshan Zala2 · Naomi Herz1 · Janet L. Peacock3 · Stephen Keevil1 · Anastasia Chalkidou1 © The Author(s) 2018 Abstract Central venous catheters are commonly used to deliver therapies and to monitor patients, and require securing at the point of percutaneous entry to avoid dislodgement. SecurAcath is a catheter securement device designed for central venous catheters. The National Institute for Health and Care Excellence, as a part of its Medical Technologies Evaluation Programme, selected this device for evaluation and invited the manufacturer, Interrad Medical, to submit clinical and economic evidence. The King’s Technology Evaluation Centre, an External Assessment Centre commissioned by the National Institute for Health and Care Excellence, independently critiqued the manufacturer’s submissions. The External Assessment Centre found a lack of evidence comparing SecurAcath with alternative approaches to securement (StatLock, suturing, tape securement), with one unpublished randomised controlled trial providing the strongest evidence. The External Assessment Centre conducted a new systematic review and meta-analysis and concluded that there is some evidence indicating the non-inferiority of SecurAcath compared to StatLock. The External Assessment Centre considered the manufacturer’s economic model to be appropriate but made revisions to some parameters and noted significant heterogeneity in the included studies. The revised model indicated that StatLock was more cost effective than SecurAcath for catheter indwell times of up to 5 days; however, for medium- and long-term indwell times, SecurAcath was the most cost-effective option. The National Institute for Health and Care Excellence Medical Technologies Guidance MTG 34, issued in June 2017, recommended the adoption of SecurAcath for securing peripherally inserted central catheters within the National Health Service in England. Key Points for Decision Makers Available evidence suggests that SecurAcath is an effective catheter securement device and is easy to insert and maintain, well tolerated and associated with a low rate of catheter-related complications. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40258-018-0427-1) contains supplementary material, which is available to authorized users. * Tom Macmillan 1 King’s Technology Evaluation Centre, School of Biomedical Engineering and Imaging Sciences, King’s College London, 5th Floor, Becket House, 1 Lambeth Palace Road, London SE1 7EU, UK 2 King’s Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK 3 School of Population Health and Environmental Sciences, King’s College London, London, UK SecurAcath should be considered for any peripherally inserted central catheter with an anticipated indwell time of 15 days or longer. SecurAcath is cost saving compared with adhesive securement devices, when the peripherally inserted central catheter is in places for 15 days or longer. Cost savings range from £9 to £95 per patient with a minimum annual saving of an estimated £4.2 million in the National Health Service in England. Vol.:(0123456789) T. Macmillan et al. 1 Introduction The National Institute for Health and Care Excellence (NICE) promotes the adoption of clinically and cost-effective medical devices and diagnostics by the National Health Service (NHS) in England through the work of the Medical Technologies Evaluation Programme and Diagnostics Assessment Programme, which were established in 2009. Manufacturers of medical devices and diagnostics notify NICE when their product meets the eligibility criteria for entry to the programme. Technologies are selected for development of Medical Technologies Guidance by NICE’s Medical Technologies Advisory Committee (MTAC) if they have the potential to offer a significant clinical benefit to patients and the NHS, at the same or reduced cost when compared with current practice. Once a technology has been selected, NICE prepares a scope outlining the population and outcomes for which the manufacturer should submit clinical and economic evidence. A NICE-funded External Assessment Centre (EAC) independently critiques the submitted evidence and prepares an assessment report. The EAC is also required to provide additional evidence if there are gaps in evidence submitted by the manufacturer. The MTAC uses the EAC report, together with other sources of advice, to produce guidance on the proposed technology [1, 2]. This article presents a summary of the EAC report for the SecurAcath catheter securement device for medium- and long-term central venous catheters and the development of the NICE guidance. The article is one among the series of NICE Medical Technology Guidance summaries published in Applied Health Economics and Health Policy [3]. 2 Background 2.1 Catheter Securement Long-term central venous catheters (CVCs) allow access to large blood vessels and are often used in chemotherapy where the drug can cause damage to the blood vessel if infused in smaller veins. Peripherally inserted central catheters (PICCs) are typically inserted in the arm (basilic or cephalic vein) with the tip of catheter placed in the superior vena cava, the right atrium of the heart or the inferior vena cava, located using ultrasound. Centrally inserted central catheters (CICCs) are inserted in the chest. Optimum tip position is in the lower third of the superior vena cava or the cavoatrial junction or within the inferior vena cava above the level of the diaphragm [4, 5]. Once in position, the catheter is secured at the entry site by specialised adhesive devices (such as StatLock), sutures, surgical tape or steri-strips, or by a subcutaneous securement device such as SecurAcath. The insertion site should be cleaned thoroughly on a weekly basis, during which dressings and any adhesive securement devices are removed and discarded. However, unless there is an indication of device malfunction or insertion-site infection, SecurAcath does not need to be removed at this stage. Catheter removal before completion of the intended treatment is categorised as unplanned removal. This can occur as a result of migration, dislodgement, infection, phlebitis or thrombosis. In the case of catheter migration, the catheter may be repositioned or a new catheter may be put in place depending on how far the catheter has migrated: if a minor migration has occurred, the line can be salvaged. A malpositioned CVC is managed depending on the location of the CVC, the continued need for infusion therapy and the patient’s acuity. Infusion through a malpositioned CVC should be withheld until a proper tip pos (...truncated)