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. |
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. |
1 Introduction
2 Background
2.1 Catheter Securement
2.2 National Institute for Health and Care Excellence Scope
2.2.1 Population
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Access for drugs and nutrition
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Infusion of irritant drugs, for example, chemotherapy
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Total parenteral nutrition
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Poor peripheral access
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Long-term administration of drugs, such as antibiotics
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Access for extracorporeal blood circuits
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Renal replacement therapy
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Plasma exchange
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Extracorporeal membrane oxygenation
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Monitoring or interventions
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Central venous pressure
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Central venous blood oxygen saturation
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Pulmonary artery pressure
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Temporary transvenous pacing
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Targeted temperature management
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Repeated blood sampling
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2.2.2 Intervention
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Skin integrity is deemed unfavourable by the operator, for example, friable skin as a result of long-term corticosteroid use or the presence of cellulitis or rashes at the desired site of catheter insertion;
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Local tissue factors will prevent proper device stabilisation and/or access;
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The presence of device-related infection, bacteraemia or septicaemia is known or suspected;
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The patient’s body size is insufficient to accommodate the size of the implanted device;
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The patient is known or is suspected to be allergic to materials contained in the device;
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The prospective insertion site has previously received irradiation.
2.2.3 Comparators
2.2.4 Outcomes
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Rates of migration and dislodgement;
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Rates of catheter-related infection (including CRBSI, local infection/inflammation and thrombophlebitis);
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Unplanned removals and reinsertions;
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Time taken to secure catheter;
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Patient and clinician satisfaction scores;
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Pain while in situ and on insertion and removal;
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Quality-of-life measures;
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Device-related adverse events, e.g. catheter malfunction, thrombosis and vessel erosion.
3 Review of Clinical and Economic Evidence
3.1 Clinical Effectiveness
3.1.1 Meta-Analysis
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Migration;
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Dislodgement;
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Catheter-related infection;
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CRBSI;
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Unplanned removals;
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Unplanned reinsertions.
3.1.2 Results
Outcome | SecurAcath results n/N (%) | StatLock results n/N (%) | Individual relative risk SecurAcath/StatLock (95% CI) |
---|---|---|---|
Migration | 3/51 (5.9) | 2/51 (3.9) | 1.50 (0.31–7.35) |
Dislodgement | 3/51 (5.9) | 2/51 (3.9) | 1.50 (0.31–7.35) |
Total catheter infection | 1/51 (2.0) | 1/51 (2.0) | 1.00 (0.11–9.50) |
CRBSI | 1/51 (2.0) | 1/51 (2.0) | 1.00 (0.11–9.50) |
Outcome | Intervention | No. of studies | Proportion (%) | 95% CI |
---|---|---|---|---|
Migration | SecurAcath | 3 | 4.0 | 1.5–8.5 |
StatLock | 4 | 4.7 | 2.3–8.5 | |
Suture | 2 | 11 | 6.3–18.1 | |
Dislodgement | SecurAcath | 9 | 0.6 | 0.3–1.0 |
StatLock | 7 | 4.1 | 3.3–5.0 | |
Suture | 3 | 8.7 | 4.8–14.2 | |
Total catheter infections | SecurAcath | 5 | 0.8 | 0.3–1.7 |
StatLock | 6 | 1.6 | 1.1–2.4 | |
Suture | 3 | 6.8 | 3.5–11.95 | |
CRBSI | SecurAcath | 2 | 1.68 | 0.2–5.9 |
StatLock | 2 | 1.47 | 0.2–5.2 | |
Suture | na | |||
Unplanned removals | SecurAcath | 3 | 15.53 | 10.3–22.6 |
StatLock | na | |||
Suture | na | |||
Unplanned reinsertions | SecurAcath | 1 | 0 | 0–97.5a |
StatLock | na | |||
Suture | na |
3.2 Economic Evidence
Parameter | Manufacturer assumption | EAC assumption (if different) |
---|---|---|
Cost of PICC securement | £250 [10] | £274 conventional blind placement [32] |
Cost of CICC placement | £440 after inflation (£150 by nurse on ward, £312 blind insertion, £382 image guided, by nurse) [33] | |
Minute of nurse time | £0.60 [35] | £2.08 [36] |
Minute of doctor time | £1.47 [35] | |
StatLock placement nurse time | 3 min [35] | |
SecurAcath placement nurse time | 0.5 min [35] | |
Suturing doctor time | 4.7 min [35] | In the UK, suturing would be done by a nurse |
Migration | £250 | £134 [33] |
CRBSI episode | £9900 [37] | (EAC noted a wide range £812–71,000 [38]) |
Catheter-related thrombosis | £250 [37] | The figure is actually for local site infections |
Cost per needle-stick injury | £312 [39] | (EAC noted a wide range £48–1516 [40]) |
List price SecurAcath | £16 | |
Adhesive device | £12 for 4 devices in 25-d indwell time | |
Sutures | £5 |
Parameter | Value (base case) | Value (sensitivity analysis) |
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Routine placement and maintenance times
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SecurAcath placement | 3 min | 0.5 min |
StatLock placement | 3 min | |
Suture placement | 4.7 min | |
SecurAcath maintenance | 4.3 min | |
StatLock maintenance | 7.3 min | |
Suture maintenance | 4.3 min | 7.3 min |
Hazard ratios (SecurAcath vs. StatLock)
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Migration | 0.8443 | |
Dislodgement | 0.1424 | |
CRBSI | 1.1441 | |
Complication rates per 1000 catheter days
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SecurAcath migration | 0 | 1.52 |
StatLock migration | 0 | 1.8 |
Suture migration | 0 | 3.1 |
SecurAcath dislodgement | 0 | 0.51 |
StatLock dislodgement | 0 | 3.6 |
Suture dislodgement | 0 | 4.1 |
SecurAcath CRBSI | 0 | 0.80 |
StatLock CRBSI | 0 | 0.7 |
Suture CRBSI | 0 | 3.4 |
Needle-stick injury (suture)a | 1.2 | |
Unit costs
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Nurse time per minute | £2.08 | |
Cost of CRBSI | £9900 | |
Cost of needle-stick Injury | £312 | |
Cost of migration of CICC line | £134 | |
Cost of migration of PICC line | £134 | |
Cost of dislodgement of CICC line | £440 | |
Cost of dislodgement of PICC line | £274 |
3.2.1 Results
Scenario | SecurAcath (£) | StatLock (£) | Sutures (£) | Cheapest option | Saving (£) |
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CICC line for 5 d | 22 | 10 | 15 | StatLock | 5 |
PICC line for 5 d | 22 | 10 | – | StatLock | 12 |
CICC line for 25 d | 49 | 66 | 42 | Sutures | 7 |
PICC line for 25 d | 49 | 66 | – | SecurAcath | 17 |
CICC line for 120 d | 174 | 268 | 167 | Sutures | 7 |
PICC line for 120 d | 174 | 268 | – | SecurAcath | 94 |
Scenario | SecurAcath (£) | StatLock (£) | Sutures (£) | Cheapest option | Saving (£) |
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CICC line for 5 d | 64 | 53 | 193 | StatLock | 11 |
PICC line for 5 d | 64 | 50 | – | StatLock | 14 |
CICC line for 25 d | 256 | 281 | 902 | SecurAcath | 25 |
PICC line for 25 d | 254 | 267 | – | SecurAcath | 13 |
CICC line for 120 d | 1130 | 1246 | 3696 | SecurAcath | 116 |
PICC line for 120 d | 1120 | 1188 | – | SecurAcath | 68 |
4 Conclusions of the EAC
5 NICE Guidance
5.1 Draft Recommendations
5.2 Consultation Response
5.3 Final Guidance
6 Challenges
“I realised that we were able to cleanse the exit site more effectively without the fear of pulling the line out.”
“Given there is no adhesive required it has a major advantage over competitors and allows cleansing of the skin to be undertaken between dressing changes.”
“Its unique design means it provides securement of a CVC and does not require changing has resulted in a huge reduction malpositioned PICCs.”
“Previous securement methods have involved the use of adhesive plasters which are placed on the skin. In our experience these were unreliable and lead to many instances of catheter migration.”
“There are various other devices for securing PICCs but unlike SecurAcath they are adhesive devices which have to be changed once a week. Changing the dressing and the device carries a high risk of dislodgement.”
“There is no doubt in my mind that this product has produced significant benefits to our patients in terms of the outcome measures.”
“There are costs involved with regularly changing PICC adhesive securement devices—these would be reduced by using this technology.”
“In situations where it replaces Statlock, the cost of a SecurAcath and tissue adhesive will quickly be saved within a few weeks for a given patients because Statlock has to be replaced weekly.”
“Removal of the device can cause pain in about half of patients. Local anaesthetic can be used if they experience discomfort when the device is wiggled but local anaesthetic itself causes brief pain when administered.”
“Some patients may have an allergy to nickel—not many in our experience.”
“The success of this device relies on proper training of those inserting and removing it and those providing line care … Another potential obstacle is that removing the device can be daunting to those with no experience.”