Quality Improvement Project to Assess the Impact of Gum Mastic Liquid Adhesive on the Integrity and Durability of Driveline Dressings, Risk of Infection, and Patient Satisfaction

Heart failure is a major public health issue in the United States. It affects an estimated 6 million American adults over age 20, and incidence is projected to escalate fueled by the epidemics of diabetes and obesity as well as lack of exercise, poor dietary habits, and the aging of the Baby Boomer population.¹ 

Alongside heart transplants, left ventricular assist devices (LVADs) have become the standard of care for patients with advanced heart failure, serving as a bridge to transplant, a bridge to recovery, or more often today, destination therapy.²  More than 2000 implants have been performed each year in the United States since 2012,³  and 2-year survival now approaches 73%.²  However, major bleeding and infection continue to be significant adverse events, with 1 in 6 patients developing an LVAD-related infection within the first year.⁴ 

In lieu of universal guidelines for driveline (DL) exit-site dressing changes, which do not exist, our group wanted to establish a culture of safety with standard best practices within the LVAD program. Within the facility, dressing changes for vascular access device sites follow guidance from the Centers for Disease Control and Prevention which recommend dressing replacement “at least every 7 days.”⁵  Based on Standard 42 of the Infusion Therapy Standards of Practice (Standards), dressings are changed immediately if dressing integrity is disrupted (i.e., lifted or partially detached borders) due to soiling, moisture, drainage, or blood, or if the skin barrier beneath the dressing is compromised.⁶  Furthermore, Standard 42 recommends considering gum mastic liquid adhesive to improve dressing integrity.

The Standards further emphasize the need for dressing integrity as an increasingly important aspect of infection prevention efforts to reduce the number of device-related infections.⁶  In most cases, the consequences of compromised dressing integrity—more dressing changes, increased risk of medical adhesive-related skin injuries, greater potential for infection, and even mortality—are preventable with proper aseptic techniques, surveillance, and management strategies, including patient and clinician education.

After identifying parallels in management, infection sources, infection prevention, and goals of care, the LVAD team decided to create a quality improvement project to see if applying the same standard practices for vascular access device dressing changes could improve DL exit-site dressing integrity. Our goal was to undertake a quality improvement project to assess the use of gum mastic adhesive on improving dressing adherence and patient satisfaction.

A qualitative improvement project was initiated in the LVAD program at Dignity Health/Mercy General Hospital, in Sacramento, CA. The overall objective of the project was to improve the program’s preexisting DL exit-site maintenance protocol, which included training patients and/or their caregivers prior to discharge.

At-home DL exit-site care training for patients and caregivers is standard protocol in the LVAD program. As a part of this training, patients are instructed on how to properly clean the site, use best practices to apply and remove the LVAD securement dressings, and monitor for signs of infection or changes in DL/cannula site appearance.

Only patients who received previous DL exit care training within the LVAD program were allowed to participate in the current quality improvement project. No new patients were recruited. Based on these criteria, hospital policy did not require the investigators to obtain Institution Review Board approval for the quality improvement project.

Twenty LVAD patients were divided into 2 groups. The control group (n = 10) used a standard DL dressing kit but was asked to extend dressing maintenance from every 3–4 days (2×/week) to 1× every 7 days; this kit contained a securement patch, but no additional products for securement or removal were provided.

For the intervention group, gum mastic liquid adhesive and liquid adhesive remover (Mastisol^® Liquid Adhesive and ­Detachol^® Adhesive Remover; Eloquest Healthcare; Ferndale, MI) was provided along with their current DL dressing kits ­(Figure 1). The intervention group also received 2 full days of live hands-on training with patients and caregivers, and they were provided instructional handouts and training videos for reference.

Intervention products were provided for this quality improvement project by Eloquest Healthcare, Inc.

Data were collected weekly over a 14-week period. Patients reported via phone and email, including sending photographs of their current dressing, their exit site, and the new dressing. With each dressing change, the patient completed a dressing assessment questionnaire. They were asked to provide their personal information, the date of last dressing change, the date of the assessment, and to indicate whether Mastisol was used. Patients were also asked to comment on the integrity of the dressing (i.e., intact, edges lifting, or detached), the condition of the skin (i.e., intact, redness/rash, or blister/skin tear), and the appearance of the exit site (i.e., clean/dry/intact [C/D/I], redness, or drainage). The age of the dressing (in days) was also recorded. Patients also reported any skin sensitivities or application issues to the LVAD coordinators. At the end of the project, patients in the intervention group were asked to comment on their experience with the Mastisol and Detachol products.

Investigators assessed the LVAD dressings and DL exit sites for each patient every week and at the end of the 14-week project. The procedure for assessment was the same as the one used by participants. Investigators assessed dressing integrity/adherence as (1) intact, (2) edges lifting, or (3) detached. Skin condition was assessed as intact or if there was presence of ­redness/rash or blisters/skin tears. Exit-site assessment included notation of redness or drainage. If none present, it was noted as C/D/I.

The demographics of the participants are shown in Table 1. Twenty LVAD patients participated in the quality improvement project. The range in ages of the patients was 44–82 years. The mean age ± SD was 65.6 ± 12.05 years. Sixteen of the study participants were male, and 4 were female. The average number of years with an LVAD ± SD was 2.8 ± 1.64.

At the end of 14 weeks, dressing integrity at 7 days was improved in the intervention group compared with the control group: intact dressings, 96% versus 44%; edges lifting, 4% versus 48%; detachments, 0% versus 8% (Figure 2).

Average dressing durability was 7.01 days in the intervention group versus 4.9 days in the control group (Figure 3a). Furthermore, 98% of the intervention group achieved 7 days with intact dressing compared with 32% of the control group ­(Figure 3b). Across the 14-week period of the quality improvement project, the intervention group required fewer dressing changes compared with the control group.

Skin condition was comparable across all 3 measured parameters (Figure 4b). Exit-site condition assessment was comparable in terms of C/D/I and redness, except there was no drainage in the intervention group versus 10.7% in the control group (Figure 4c). Furthermore, no bleeding was observed in the intervention group compared with 12% in control group.

Training was deemed sufficient as patient understanding of the bundled procedure improved quickly: 80% of dressings were judged intact week 1, rising to 96% weeks 2–15 ­(Figure 5). However, 3 patients required additional training.

Table 2 shows comments from patients regarding the use of gum mastic liquid adhesive and liquid adhesive remover. ­Patient satisfaction was evident in patient comments such as: “It was nice to only change the dressing every 7 days. Loved the [liquid adhesive remover]; it made it much easier to remove the bandage and the anchor. As far as the [gum mastic liquid adhesive] goes, during the project trial, the DL exit site never was crusty or scabby due to the seal.”

The components and costs of the kits for both the intervention and control groups are listed in Table 3. Cost savings were apparent from the first week of the quality improvement project. Despite the increased cost of the intervention kit (Table 3), the reduced number of dressing changes (1×/week [$34.17] versus 2×/week [$45.70]) led to overall cost savings ($11.53/week). The total cost savings for the 14-week project period were $161.42 per patient. By extrapolating the cost savings from the 14-week project, we estimated that these interventions could lead to an annual cost savings of ($11.53 × 52 weeks) $599.56 per patient (Figure 6). Our facility treats, on average, 21 patients per year, which could potentially yield an annual overall savings of ($599.56 × 21) $12,590.76 for our LVAD program.

Since no national guidelines for DL exit-site dressing changes exist, we applied standard practices for vascular access device dressing changes to improve DL exit-site dressing integrity. Our findings show the addition of gum mastic liquid adhesive plus liquid adhesive remover with patient-appropriate training improved daily DL dressing integrity and durability and required fewer dressing changes. Patient skin conditions were judged comparable for intact, redness/rash, and blister/skin tears, with no drainage using the intervention. These improvements led to reduced DL infection risk, enhanced patient satisfaction (less time changing dressings, ability to maintain active lifestyle), and $161.42 per-patient savings over 14 weeks.

Current LVADs are connected to an external power source via a tunneled subcutaneous DL. DL infections are the most common type of all LVAD-related infections, as the prosthetic material makes it an ideal medium for biofilm formation while the exit site, typically in the abdominal wall, creates an entryway for bacteria.⁷  Preventing infection is particularly important in LVAD patients because they are more likely to be colonized with multidrug resistant bacteria.⁸  A 2020 study from Belgium reported that the incidence of DL infections is highest in the first year after LVAD implantation and that most events occur after discharge from the hospital.⁹  Approximately 50% of patients have recurrent infections, typically with Staphylococcus bacteria. Based on this evidence, the authors recommended preventive measures be focused on the outpatient setting.

Despite the increased risk of DL-associated infections, there are no universally established guidelines for DL dressing changes. In a recent systematic review comprising 1602 patients with LVADs, median frequency of DL infections ranged from 0% to 52%.¹⁰  The review also noted “marked variability in DL exit-site care protocols without a [DL] dressing technique.” Indeed the 2020 ICCAC Best Practice Consensus Guidelines for Driveline Management¹¹  captures the exit-site care variability challenge citing one study of 68 patients who received DL dressing changes daily, 3×/week, and weekly after transferring out of the intensive care unit. None had a DL infection 30 days postimplant. By incorporating evidence-based guidelines for vascular access device site dressings, our team was able to meet our objective of increasing dressing durability to 7 days and reducing risk of infection.

While LVADs allow patients to live their lives outside the hospital, LVAD therapy requires patients and their caregivers to manage and maintain the DL exit site. The exit site requires patients to perform routine sterile dressing changes, typically once the dressing is compromised (i.e., edges lifted or partial detachment). Our project used a 2-pronged approach for improving outpatient management of DL exit sites: (1) incorporating gum mastic liquid adhesive plus liquid adhesive remover as recommended by Standard 42.⁶  The location of the DL exit site leaves the securement dressing vulnerable to friction from clothing and movement. Gum mastic liquid adhesive is recommended in areas like these that would benefit from enhanced adhesive adherence. Furthermore, having an intact dressing for longer periods of time reduces the likelihood of infection that can be introduced via lifted or partially detached dressing borders or through unnecessary dressing changes. (2) Training patients and caregivers to properly remove dressings reduced the amount of time spent on dressing changes, thereby enhancing patient satisfaction. As Rossi Ferrario et al.¹²  noted, the impact of LVAD on patient and caregiver quality of life (QoL) cannot be overstated. The psychological stress and sleep disruption are often felt by both patients and caregivers over 1 year after discharge.¹²  Many patients are overwhelmed by the complexity of daily self-management tasks.¹³  Fortunately, patients like the ones who participated in the current quality improvement project report feeling empowered by standardized, high-quality self-management training.¹⁴  As evident from the patient quotes in Table 2, the bundled procedure that included the gum mastic liquid adhesive plus liquid adhesive remover was easy to follow and allowed for fewer dressing changes, and training helped to alleviate the constant worry about performing the dressing change correctly and the risk of infection.

Authors of a recent study assessed the cost effectiveness of LVADs as destination therapy in ambulatory patients with advanced heart failure.¹⁵  In this study, Shreibati et al.¹⁵  estimated the cost of LVADs to be $726,200 over 6 years. While the authors assert that LVAD therapy improves QoL for patients with heart failure, they contend that the lifetime costs and readmission rates could significantly lower the cost effectiveness of this therapy. However, they suggest that LVADs may “provide good value if outpatient costs and adverse events can be reduced.”¹⁵  The results of the current quality improvement project demonstrate favorable outcomes with outpatient management of DL exit-site dressing changes with the addition of gum mastic liquid adhesive plus liquid adhesive remover. In addition, extending the integrity and durability of DL dressings resulted in a cost savings due to fewer dressing changes.

Our results should be considered within the context of the main limitations of this quality improvement project: (1) the sample size was small, and (2) the project was nonrandomized and not powered to show effectiveness. Although we observed favorable results, additional studies are required to assess the effectiveness of the use of gum mastic adhesive on dressing integrity and adhesion compared with usual practice within this population group.

In conclusion, the number of patients using LVADs is expected to rise dramatically. Without universal guidelines for DL exit-site dressing changes, patients are at a greater risk for poor outcomes, including infection. The current project findings suggest that applying evidence-based approaches for vascular access device site dressing changes can effectively improve the integrity and durability of DL dressings leading to fewer dressing changes. Also, the addition of gum mastic liquid adhesive plus liquid adhesive remover resulted in a cost savings for the facility. Larger clinical trials are needed to further elucidate the impact of this approach in the growing populations of LVAD patients.

The author wishes to thank all the patients and caregivers who participated in this quality improvement project. Thanks to Janice T. Radak and Aisha Cobbs, PhD, for their medical editorial assistance.