3.1 The key clinical outcomes for SecurAcath given in the decision problem were:
rates of catheter migration and dislodgement
rates of catheter-related infection, including catheter-related bloodstream infection, local infection or inflammation and thrombophlebitis
number of unplanned catheter removals and reinsertions
time taken to secure the catheter
patient and clinician satisfaction scores
pain while in position and on insertion and removal
device-related adverse events, for example catheter malfunction, thrombosis and vessel erosion.
3.2 The external assessment centre assessed 11 studies on SecurAcath, 9 submitted by the company and 2 identified independently. Three SecurAcath studies were published as peer-reviewed journal articles (Cordovani and Cooper 2013; Egan et al. 2013; Hughes et al. 2014), the remaining 8 studies were unpublished manuscripts, poster presentations, audit reports or conference abstracts (Janssens et al. 2016b; Djurcic-Jovan et al. 2016; Dougherty et al. 2013; Hill et al. 2014; Misericordia et al. 2015; Zerla et al. 2016; Stone et al. 2013; McParlan et al. 2016). The external assessment centre also identified 6 studies on a comparator, StatLock (Fang et al. 2011; Teichgräber et al. 2011; McMahon et al. 2002; Yamamoto et al. 2002; Zerla et al. 2016; Venturini et al. 2011). During the evaluation, Zerla et al. 2016 was published as a peer-reviewed article (Zerla et al. 2017).
3.3 Cordovani and Cooper (2013) is a prospective multicentre cohort study done in Canada, which investigated 74 adults who had central venous catheters (CVCs) secured with SecurAcath. The primary outcome was device securement success, which was reported in 72 patients (97%). Mean catheter securement time was 62.5 seconds and the mean dwell time was 3.1 days. Discomfort was measured on a 1 to 10 scale (with 10 being most discomfort): mean scores were 0.9 in situ and 1.6 at removal. Of the 15 patients who had previously had a sutured catheter, 14 found SecurAcath 'as or more comfortable'. Six out of 8 healthcare professionals found maintenance 'somewhat' or 'much easier' than sutures.
3.4 Egan et al. (2013, and its earlier iteration Sansivero ) investigated peripherally inserted central catheters (PICCs) secured with SecurAcath in 68 adults in intensive care units, transplant units or outpatient clinics at 3 centres in the US. The primary end point was device securement success, defined by the absence of device-related malfunctions and adverse events. Secondary end points included securement time, patient comfort and ease of maintenance. Mean dwell time was 22.6 days and mean securement time was 31 seconds. Securement-related malfunctions were seen in 6 patients (8.8%), with 20 (22.1%) adverse events reported. Pain scores were measured on a 0 to 10 scale: immediately after device removal, the mean pain score was 1.5. In situ mean pain score was 0.7 and 91.2% of patients were either neutral, satisfied or very satisfied with SecurAcath. Use of SecurAcath did not influence placement or maintenance techniques. The authors concluded that SecurAcath performed favourably when compared with StatLock (on the basis of historical data for StatLock reported by Yamamoto et al. : respective rates of migration and dislodgement of 2.9% and 0% for SecurAcath and 6% and 12% for StatLock).
3.5 Hughes et al. (2014) prospectively evaluated PICCs with SecurAcath in 31 adults at a single UK centre. Mean dwell time was over 30 days in 45% of patients. The study reported 100% successful device placement; 11% were placed with 'difficulty' and 19% with 'slight difficulty'. Staff reported difficulty with removal 'fairly frequently'. One patient experienced catheter migration of 1 cm. Pain scores were measured on a 0 to 10 scale. At placement, pain scores were 0 in all patients; in situ, 5 patients' scores were over 5, and at removal over half of patients' scores were over 3. PICCs were removed in 3 patients because of severe or unresolved pain. The study reported a PICC-related infection rate of 12% (n=31), which was reduced to 2% in a subsequent cohort (n=100).
3.6 Zerla et al. (2017; and the earlier unpublished extract Zerla et al. 2016) is a single-centre prospective study done in Italy without a comparator. It investigated 30 adults needing chemotherapy who had a PICC in place for over 2 months, secured with SecurAcath. The median dwell time was 145 days. Skin integrity issues were reported in 32.2% of patients. Pain scores were measured on a 0 to 10 scale: at placement, pain scores were less than or equal to 2 in 90% of patients, in situ they were less than or equal to 2 in 95% of patients and at removal they were less than or equal to 2 in 43.33% of patients. The authors report a median insertion site maintenance time of 10 minutes for SecurAcath, which compared favourably with a median of 20 minutes maintenance time for an adhesive device in a historical cohort of patients. No cases of dislodgment, infection and thrombotic episodes were reported. There were 2 unplanned catheter removals. The authors concluded that, after effective training, SecurAcath is comfortable for the patient, reduces catheter movements, and is more effective in comparison to adhesive devices in oncology patients with long-term catheterisation and ambulatory maintenance.
3.7 Janssens (2016b) is a Belgian-based, single-centre, prospective, unblinded, randomised controlled trial comparing PICCs secured with SecurAcath and PICCs secured with StatLock in adults. The outcomes included time spent on dressing changes, catheter migration, accidental dislodgement and laboratory-confirmed catheter-related bloodstream infection. The study was submitted as an unpublished manuscript which was available to the committee as academic in confidence.
3.8 Djurcic-Jovan et al. (2016) is a single-centre retrospective, observational, comparative, longitudinal study done in Canada comparing PICCs placed with and without SecurAcath in 54 patients needing complex continuing care. The primary outcome measure was unplanned catheter reinsertion. Mean dwell time was over 31 days. There were 60 unplanned catheter reinsertions reported without using SecurAcath compared with 3 unplanned reinsertions with SecurAcath. There was no catheter migration reported. The authors saw substantial time savings for nurses and clinicians after the introduction of SecurAcath. Qualitative outcomes were collected retrospectively. For SecurAcath, catheter migration was rated 'very good' or 'good' in 88% of cases, and catheter stability while doing insertion site maintenance, ease of dressing, and overall use of the device were rated as 'very good' or 'good' in 95% of cases.
3.9 Dougherty et al. (2013) is a UK-based single-centre prospective study without a comparator which evaluated PICCs secured with SecurAcath over 1 month in 30 patients. Qualitative data were gathered from nurses and patients. There was a reduction in malposition and catheter damage compared with previous practice and no skin reactions were seen. Nurses reported increased confidence in doing insertion site maintenance but also reported some difficulty removing the device. Patients reported pain at insertion ('if incorrectly placed and the anchor was too superficial') and pain at removal.
3.10 Hill (2014) is a Canadian-based single-centre pilot evaluation of PICCs secured with SecurAcath in 60 patients without a comparator. The author reported no malpositions but accidental dislodgement in 2 agitated patients. The author described dressing changes as being done by 'general unit staff, not IV team staff': SecurAcath gave staff increased confidence, fewer anxieties and increased efficiencies. The author described the successful use of SecurAcath in patients with skin integrity issues, when the device was used without adhesive dressing. The author concluded that overall patient satisfaction was achieved.
3.11 Misericordia et al. (2015, reported as Anonymous 2015 in the assessment report) is an unpublished report provided by the company. This is a retrospective, comparative audit done by the parenteral therapy team at the Misericordia Community hospital in Canada which evaluated 164 unanchored PICCs placed during 2013 and 542 PICCs placed during 2014 and secured with SecurAcath. The average dwell time was 29 days. The report also evaluated using a PICC designed to reduce catheter-related thrombosis. Six different operators took part in the evaluation. The primary outcomes were catheter-related thrombosis, PICC occlusion, catheter malposition, local infection and catheter-related bloodstream infection. In the SecurAcath cohort, there were no confirmed catheter-related bloodstream infections. From 2013 to 2014, the rate of catheter-related thrombosis decreased from 3.75% to 3.69%, PICC occlusion increased from 14.35% to 16.97%, and malposition decreased from 10.98% to 1.66%. The authors concluded that without using SecurAcath, around 60 of the 542 patients would have otherwise needed catheter replacements.
3.12 Stone et al. (2013) is a prospective, single-centre study done in the US which included PICCs secured with SecurAcath in 42 children with previous skin problems, irritation or allergic reactions to standard dressings. The authors compared outcomes with historical data on 17 patients with catheter migration in the same centre (undefined cohort). In the SecurAcath cohort, there were no catheter migrations, complications or unplanned catheter removals. The authors concluded that further research was needed to optimise dressings in patients with skin integrity issues.
3.13 McParlan et al. (2016) is a single-centre, UK prospective cohort study comparing PICCs secured with SecurAcath and with StatLock in haematology and oncology patients, published as a conference abstract. The full study was submitted as an unpublished poster which was available to the committee as academic in confidence. The abstract states that, during the study, there were no reported incidences of migration or PICC removal. This was associated with a reduction in chest X-rays to verify the location of migrated catheter tips (and therefore decreased exposure to radiation). There was also a reduced need for reinsertions, and reduced delays to therapy. The study reported significant financial benefits because of fewer PICC reinsertions and more efficient dressing changes. Additional benefits include reduced skin reactions, improved cleaning of the catheter site and greater user satisfaction. The abstract authors concluded that using SecurAcath had prevented PICC migration and improved patient outcomes.
3.14 The external assessment centre noted the lack of comparative published evidence between SecurAcath and its comparators. It considered the unpublished randomised controlled trial (Janssens et al. 2016b) to be the most relevant evidence to inform the decision problem.
3.15 The external assessment centre did a meta-analysis using data from 16 studies on 5 clinical outcomes that it considered appropriate: migration, dislodgement, catheter-related infection, catheter-related bloodstream infection and unplanned removals/reinsertions. Because of the limited evidence base, there was significant uncertainty in the results, reflected in wide 95% confidence intervals (95% CI). The meta-analysis reported the following results comparing SecurAcath with StatLock: migration: 4.00% (95% CI: 1.48 to 8.50) and 4.72% (95% CI: 2.28 to 8.50); dislodgment: 0.59% (95% CI: 0.3 to 1.03) and 4.07% (95% CI: 3.29 to 4.97); catheter-related infection: 0.77% (95% CI: 0.28 to 1.66) and 1.64% (95% CI: 1.10 to 2.35); catheter-related bloodstream infection: 1.68% (95% CI: 0.20 to 5.94) and 1.47% (95% CI: 0.18 to 5.21). The external assessment centre considered the meta-analysis to be supportive of the results of Janssens et al. 2016b (except dislodgement, where the meta-analysis showed a difference in dislodgement rates), with similar clinical outcomes between devices. The external assessment centre concluded that there is not enough evidence to show that SecurAcath is clinically superior in effectiveness and adverse events to StatLock, but there is some evidence that SecurAcath is non-inferior to StatLock.
3.16 The committee considered that the available evidence, despite its limitations, was enough to conclude that SecurAcath was associated with a high rate of successful device placement, a low incidence of catheter-related complications and does not usually need replacing while the catheter is in place. The committee also considered that the emerging comparative evidence suggested that SecurAcath is at least as effective as other devices for securing PICCs, with the added benefit of not needing to be replaced at weekly dressing changes.
3.17 The committee received advice from experts who use SecurAcath to secure PICCs in haematology and oncology patients in both inpatient and outpatient settings. The experts highlighted that PICCs in these patients have long dwell times of at least 6 months, and can be in place for up to 1 year.
3.18 The committee was advised by the experts that SecurAcath is well tolerated by patients when placed by an experienced healthcare professional. Pain on insertion is rare, because local anaesthetic is used anyway during the initial PICC placement. Pain is also rare while the device is in place, as long as it has been placed correctly. SecurAcath removal involves using scissors to cut the device in half and local anaesthetic administration is rarely needed. One expert stated that any discomfort patients experienced with using SecurAcath was countered by a reduction in anxiety linked with a lower likelihood of catheter displacement during dressing changes.
3.19 The committee was told by the experts that it is routine practice to anticipate the likely dwell time of PICCs at the time of insertion, based on the individual patient and clinical circumstances. It is possible that this consideration would inform the securement method selected in normal clinical practice. Although PICCs are sometimes in place for less time than anticipated, this is usually because of unexpected complications that necessitate early removal or replacement.