Systematic Review of the Safety and Efficacy of Central Vascular Access Device Securement^CE

Eligibility Criteria

The first search was conducted in January of 2021, and a final search was conducted in January 2022 to include recently published data. The initial broad search included over 8000 titles, and these articles were filtered quickly based on obvious disqualification down to 1127 potentially relevant articles, see Figure 1.

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Using Rayyan, a Web application for systematic review by multiple researchers, all authors independently screened articles for eligibility based on the remaining abstracts.³² From the abstract review, 117 remaining studies were independently evaluated using the full text for final inclusion or exclusion. Inclusion disagreements were resolved by the authors using Rayyan. The final exclusion of full-text articles was conducted if the study did not have appropriate data for the summary table.

Inclusion Criteria

Original research articles were included if the following were present:

• discussion of CVAD securement;

• English or English translation available;

• randomized controlled trials, retrospective studies, or prospective studies;

• human subjects; and

• all age groups.

Exclusion Criteria

Articles were excluded if one or more of the following were present:

• conference abstracts, explanatory articles, teaching books, and expert opinions;

• specific CVAD securement device absent from the data;

• securement for vascular access devices other than CVADs; or

• missing or inconsistent data to enter into the summary table.

Data Collection Process

The following data were extracted from each article: study type and design, characteristics of the CVAD (location, tunneling, cuffed), age of the patient population, securement type, safety outcomes, and efficacy outcomes. Due to the significant heterogeneity in study designs, a systematic review was conducted, and a descriptive synthesis and approach were applied.

Eligible studies were divided among the authors for data extraction and insertion into the summary table. The lead researcher assessed the consistency of terms to create a table of like comparisons and standard terminology. However, many data points were absent due to the narrow focus of securement assessment on one outcome, either efficacy or safety, and rarely a broad assessment.

Data Items

The decisions to include specific data points resulted from the discussion between researchers, evaluation of similar systematic reviews, available data, aspects of safety, and efficacy as it relates to catheter securement. In Table 1, 3 general headings were established: demographics, safety, and efficacy.

Table 1. Systematic Review of Securement

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Table 1. (Continued)

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Table 1. (Continued)

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Table 1. (Continued)

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Table 1. (Extended)

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Table 1. (Extended)

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Table 1. (Extended)

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Table 1. (Extended)

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Demographics chosen for this study had 6 categories: lead author and year of publication for an additional reference to the complete article and age of the study; an indication of the study design retrospective (Retro), prospective nonrandomized (PNR), or prospective randomized control trial (RCT). Whether the study was conducted at a single center (SC), multiple centers (MC), or was a pilot study is noted. The specific CVAD used in the study is identified as CICC, PICC, or FICC.

The placement and catheter characteristics of the CVAD were defined as tunneled (T) or tunneled with an integrated cuff (TC). For example, the acronym CICC indicates a percutaneous insertion, a T-PICC is tunneled only, and TC-FICC denotes a tunneled and cuffed catheter. One older SBS-related study compared different CVADs based on catheter material.³³ All cohorts were combined to assess SBS effectiveness, as catheter material was not considered a safety or efficacy issue for securement.

The securement and dressing specifications are often combined in studies, as most researchers do not consider these two components as separate entities to be investigated. Securement options in the summary table are coded as follows: SASS, ASD, ISD, TA, and SBS.¹² Although many studies specified dressing material, we did not indicate which transparent semipermeable membrane (TSM) was used. This review did not include any study that indicated no use of a TSM or site coverage of any kind.

The specific coated or impregnated catheters or antimicrobial discs were not specified in a review focused on securement. Age categories in the accepted studies range from neonates to geriatrics. Premature infant studies on securement data did not have sufficient or specific data related to CVADs.

The category of safety refers to those outcomes that would deem the device safe or unsafe to the clinician or patient. According to the FDA, the safety of a medical device must demonstrate that the use as intended outweighs the possible risks.²⁵ Safety in the data table was split between clinician and patient. Sutures create an unnecessary risk to the clinician and violate the OSHA and Needlestick Safety and Prevention Act¹³ standards.^16,20 Patient safety issues include medical adhesive-related skin injury (MARSI) or catheter-associated skin injury (CASI), site infections, bloodstream infections (BSI), and thrombus. BSIs were not always distinguished between suspected or confirmed. For this reason, the data on central line-associated bloodstream infection (CLABSI) is marginally useful. These safety issues may have elements explicitly related to securement but may also be influenced by dressing adhesives, care, maintenance, patient history, and insertion practices.^2,34

Efficacy is related to medical device performance under its FDA labeled indications.^25,35 To demonstrate efficacy, studies must show that the product does what it was intended to do. Therefore, migration or dislodgement outcomes serve as a primary measurement of securement performance.

Dwell time was included when available to put the efficacy assessment into perspective. Catheters remaining in place for less than 7 days were likely to have fewer overall issues related to catheter days. Long-term catheters may require a new securement device or reapplication at 7-day intervals as opposed to 1 device for the duration of therapy. When SBS was used, there was no indication of removal after 7–10 days, as indicated in the wound closure instructions for use (IFU).^36,37 Sutures are also well understood to lose tensile strength over time which may be accelerated by moisture, saline, and antiseptic solutions; these issues have not been studied relative to securement of external medical devices.³⁷

Performance includes the ease of placement and replacement. The assessment of efficacy issues during the deployment of various securement devices is not consistently measured. When available, the information was placed in the table. Some articles had testimonials of staff or patients; those subjective assessments could not be included in the table.

Other performance issues included in the study were placed in the last column. One issue frequently mentioned was catheter occlusion. The ability of securement to limit kinking of the external portion of the catheter is a way to remove mechanical occlusion. However, thrombotic occlusions are a reportable event for the catheter and not securement. Precipitate and lipid buildup are related to drug compatibility and flushing protocols but have not been linked to securement. The report of occlusions was not specified as to the type, and the information is marginally useful.

Risk of Bias Assessment

A summary of the risk of bias assessment can be found in Table 2. Each study is identified by its potential bias in selection, performance, detection, attrition, or reporting according to an assessment of each article and its stated limitations.

Table 2. Risk of Bias Assessment

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Synthesis of Methods

The demographics and data points were chosen before searching for relevant articles. Each assessment by the research team included a search for the article’s attention to each data point listed previously. Although the chosen data points reflect safety and efficacy issues that should be assessed in every study of securement, only 5 studies assessed each securement-related outcome.^37–41

All other studies addressed at least 1 of the outcomes and the demographics required to identify the study as securement related. One study included inappropriate data for this analysis, i.e., PVADs. In this study, the only data extracted were the percutaneous or tunneled CVAD securement outcomes.⁴²

Several studies included securement with a variety of TSM configurations. In these cases, cohorts with the same securement but different TSMs are combined into a single securement group.^43,44

Effect Measures

The prevalence of each safety and efficacy outcome is expressed as a percentage of the total number of subjects with a particular securement device. Referring to Table 1, under the heading of safety, the risk to the clinician for NSI is marked yes or no. Whether or not a clinician-reported a needlestick during the study is less significant than the element of unnecessary risk.¹³

The 4 patient safety outcomes are calculated as the prevalence of the issue reported in the study. When a study did not monitor a safety-related data point, the entry is marked as not reported (NR). The numerical entries of 0 or 0.00% indicate that the outcome was measured in a particular study, but no subject experienced that safety-related issue.

Multiple studies monitored the outcome of CLABSI but did not consistently indicate whether the infection was laboratory confirmed or suspected. Therefore, both suspected, confirmed, and unspecified CLABSI outcomes were counted in this safety data point for this analysis. Likewise, a report of thrombus was not often classified as clinically indicated or diagnosed; all reported thrombus was marked in this safety-related data point.

Efficacy for securement devices at a minimum should secure the catheter until the end of need or completion of therapy. Migration and dislodgement are combined into 1 column, as many studies did not indicate the degree of migration or the probable tip position of the CVAD. Dwell time was reported in most of the studies, although the report of this information varied. The researchers in these studies reported the mean, median, and total number of days. The context of catheter dwell time is a significant factor in assessing migration and dislodgement. Although the movement of the catheter out of its optimal position can occur at any time and may cause safety issues, delays in treatment, and further vein trauma, it may be more likely to occur the longer the catheter remains in situ.

Application and removal assessment was often not assessed or was explicitly aimed at the new, unfamiliar device. When measured, the results were placed in the evaluation of efficacy. If application or removal testimonials were described numerically, the table indicated that information. SBS was not reported as a standard method, and the learning curve for use was not quantified, although there are many variations.⁴⁵

Securement device replacement information was usually not reported. In the case of sutures, the IFU for nonabsorbable wound closure should be removed at 7–10 days.⁴⁶ No discussion of removal or replacement of SBS appeared in the study articles. One study by Silva et al.⁴⁷ reported that 12 subjects had their sutures “fall out” without indicating the securement employed after the sutures failed.

ASD and ISD are scheduled to be replaced every 7 days routinely or earlier for dressing or adhesive failures. When TA is used for securement, it should be reapplied every 7 days. In the studies employing TA, reapplication of the securement liquid was not indicated.²

The study table reports other efficacy issues. These concerns included dressings lifting, detached, or loose which may affect adhesive-based securement. In addition, occlusions were reported in some dressing and securement studies. Although more likely to be a catheter or care and maintenance issue, securement may play a role by decreasing catheter movement or mechanical occlusions such as kinking. No studies are available to affirm this theory, but the information is reported as a possible efficacy issue.

Certainty Assessment

Four independent authors assessed the articles that qualified for this systematic review of securement to increase interrater reliability. Once the data were extracted, an independent statistician was sent the full text of all accepted research studies and the data table. The meta-analysis yielded an interquartile range for the primary endpoints of migration and CLABSI to be discussed in the results section.

Study Selection

Selection began with a broad search by a research librarian associated with a university library system. Rayyan intelligent systematic review software was employed to assess the 8274 articles for inclusion or exclusion by the 4 researchers.³² The PRISMA flow chart for article inclusion can be found in Figure 1.

Screening of the articles took place over months, and complete agreement was obtained for the final 49 articles. However, the data extraction process reduced that number to 39 and excluded studies for further evaluation secondary to inadequate data reporting.

Study Characteristics

The 39 studies chosen included 29 prospective trials, 12 randomized, and 11 retrospective studies. In addition, a study by Waterhouse et al.⁵³ included retrospective information on SBS and a prospective comparison using ASD. Most, 33 Single Center, 6 Multi-center used in 39 studies, with the highest number being 23 that included CICCs, followed by 21 studies assessing PICCs.

Only 1 study represented securement with tape and a TSM.⁵⁴ There were only a few studies with engineered securement using ISD and TA at 5 and 8, respectively. Top engineered securement studies were ASD, 22, and SASS, 13. SBS had 19 qualified articles with all clinicians in these studies at unnecessary risk for NSI. Specific age groupings included 4 neonatal, 11 pediatric, 4 adolescent, and 29 adult studies, often with overlapping age ranges.

A total of 23,959 subjects were assessed throughout all 39 included studies. The patient-related safety and efficacy issues were entirely assessed in 5 studies. ^{37,40,41,54,55} Those reporting signs and symptoms of infection at the insertion site were 24; CLABSI, suspected or confirmed, data were reported in 33 studies. Indications of data collected on thrombus or MARSI were reported in 18 and 33 studies, respectively. However, the length of dwell time for a catheter would be significantly affected by the ability of the securement to anchor the catheter; this information was recorded in only 33 studies.

Migration and dislodgement were reported in all studies but 1. Rowe et al.⁵⁶ focused retrospectively on laboratory-confirmed CLABSI outcomes in 2 different securement devices, ASD and SASS. Other efficacy outcomes, including ease of application and removal and replacement information, were recorded in 19 and 10 articles. Replacement information as a function of efficacy should be assessed by the number of securement devices required to complete the therapy as in ASD, ISD, and TA every 7 days or more and SASS for the duration of the catheter implant. Sutures were either not removed as indicated by the IFU for nonabsorbable wound closure or lacked an indication of replacement with an alternative device.

Results Syntheses

The prevalence of a particular data point can be viewed as a percentage of the total number of subjects with each securement device and sutures in Table 1. Analysis of the primary safety endpoint of CLABSI was marginally useful, as some studies did not report suspected versus laboratory confirmed. Table 3 shows the median incidence and inter-quartile range for CLABSI in the 5 securement types. For nonzero values, SBS had the lowest incidence. In the same table, the migration and dislodgement primary endpoint for efficacy showed a significant decrease associated with SASS use.

A Forest plot of CVAD securement type and migration incidence can be viewed in Figure 2. The lowest incidence of migration or dislodgement is found in the SASS and the highest incidence in the various ASDs.

Table 3. Primary Endpoints. Median Incidence and Interquartile Range of Migration and Dislodgement (M&D) and Central Line-Associated Bloodstream Infections (CLABSIs) for 5 Different Securement Types

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Certainty of Evidence

Four researchers working independently through Rayyan assessed the articles for inclusion in this systematic review.³² Once the articles were limited to the 48 securement-related studies, researchers scrutinized each article for appropriateness of research strategies and data collection. An additional 9 articles were eliminated during the process of extracting data for the summary Table 1. All researchers assessed the table information for the certainty of evidence and accuracy. Additionally, an independent statistician was sent the summary table and corresponding articles for a critique of data extraction accuracy.

Due to the assortment of the studies included in this review, a summary of consistently reported data was only accomplished on the primary efficacy endpoint by combining migration and dislodgement. Migration measurements varied significantly between studies and as a percentage of the total catheter. For example, a 2 cm migration in an adult may equate to total dislodgement from the SVC in a neonate.

As reported previously, CLABSI, a significant catheter-related safety issue, was not consistently reported between and even within studies. In addition, the certainty that the reported data were laboratory-confirmed CLABSIs was not available in every study.

To ensure evidence certainty in future securement-related studies, researchers should report on all aspects of safety and efficacy reported in this review. Additionally, thrombus should be confirmed with diagnostic testing rather than noting a clinical suspicion, as the diagnosis or lack thereof changes patient management.

Several studies demonstrated the correlation between specific securement and complications. Chan et al.⁵⁷ found that “Poor securement potentiates all complication types.” Cotogni et al.⁵⁸ noted that, “There was a significant correlation between the use of suture and dislocation.” (p. 382). Furthermore, “in Hohn catheters, securement using a sutureless device reduces the risk of CRBSI and dislocation.” Dolcino et al.⁵⁹ concluded that the “use of SASS significantly reduces the incidence of dislodgment in high-risk patients, particularly in the very first postoperative period.”