Ventricular assist devices (VAD)s are a well-established surgical therapy for patients with advanced heart failure (HF). VAD associated complications including driveline infections are relatively common, but are potentially preventable.[1, 2] The International Society for Heart and Lung Transplant (ISHLT) recently published a consensus document for the prevention and management of VAD infections.[3] However, this document does not offer a rigorous standard of care for driveline site management. Therefore, each VAD implanting center uses their own site-specific driveline management protocols. The purpose of this study was to examine driveline dressing change protocols from high-volume VAD centers across the U.S. to identify similarities and differences.
We performed content analysis [4] of inpatient driveline dressing change protocols from 15 academic advanced heart failure/heart transplant centers that implant a high number of VADs. Each center provided their dressing change protocol used for clean, dry driveline exit sites in non-allergic patients for maintenance dressing changes. The Northwestern University Institutional Review Board approved this study as exempt.
We collected demographic data from each center including number of VADs implanted between January 1, 2017 and December 31, 2018, VAD types, and implant strategy. A deductive approach was used to create a codebook relevant to VAD site dressing changes by a subset of authors (JEW, KAC, RSH, KBS KLG, ERC, JHB). Two authors (JHB, JEW) coded all 15 protocols blinded to center; disagreements were resolved by consensus. We calculated inter-rater reliability on initial coding using Cohen’s Kappa and report frequencies for each code identified after consensus was achieved.
A total of 1388 VADs were implanted at the 15 centers, with a median of 95 (IQR 72, 107) at each center during the study period. VAD type was evenly split between HeartMate™ and HeartWare™ and slightly more VADs were implanted as destination therapy compared with bridge to transplant. The inter-rater reliability between the two reviewers was high (K=0.80). Ten VAD dressing change codes were identified with frequencies reported in the Table.
Table.
Items identified using the codebook on n=15 institutional dressing change protocols.
| Item, n (% of 15) | N=15** institutional dressing change protocols |
|---|---|
| 1. The protocol states how often the dressing should be changed for a dry non-draining wound* | 12 (80) |
| a. Once a week (7 days) | 5 (33) |
| b. Two times a week | 5 (33) |
| c. Three times a week | 3 (20) |
| d. One to three times a week | 1 (7) |
| 2. Patient positioning: The Protocol states the appropriate/allowable position(s) for the patient to be in while the dressing change is being performed* | 2 (13) |
| a. Laying down | 2 (13) |
| 3. Set up | |
| a. The protocol state that the surface being used is clean | 12 (80) |
| i. ii. Disinfectant (alcohol, bleach, ammonia) | 9 (60) |
| ii. iii. Does not specify how to clean surface | 3 (20) |
| b. Protocol lists all needed supplies | 14 (93) |
| c. Protocol states to collect all supplies before starting the dressing change (or before putting on sterile gloves) | 11 (73) |
| d. Uses a dressing change kit | 10 (67) |
| e. Everyone in room dons masks | 6 (40) |
| f. Only the procedure performer dons a mask | 1 (7) |
| g. The patient and procedure performer wear a mask | 8 (53) |
| 4. Sterile technique | 15 (100) |
| a. Protocol includes reminders on how to correctly maintain sterile technique | 8 (53) |
| b. Hand Washing: protocol states must wash hands at some point | 14 (93) |
| i. Specifies duration of hand washing | 6 (40) |
| 1. > or = 15 seconds <20 seconds | 2 (13) |
| 2. > or = 20 seconds less than 30 seconds | 2 (13) |
| 3. > or = to 30 seconds | 2 (13) |
| ii. Specifies solution* | 10 (67) |
| 1. Soap and water | 8 (53) |
| 2. Alcohol based solution | 6 (40) |
| 3. Hand wipe | 1 (7) |
| 4. Packet provided | 1 (7) |
| iii. Timing of hand washing specified* | 14 (93) |
| 1. Before starting the entire procedure | 14 (93) |
| 2. Before getting sterile | 12 (80) |
| 3. After completing the procedure | 3 (20) |
| c. Protocol states to wear gloves when removing old dressing | 15 (100) |
| d. Protocol states to put on sterile gloves prior to placing new dressing | 15 (100) |
| e. Protocol states to clean skin around driveline exit site | 15 (100) |
| i. Solution types specified* | 15 (100) |
| 1. CHG | 15 (100) |
| a. Specify motion used for cleaning as back and forth | 5 (33) |
| b. Specify motion used for cleaning as outward circles | 7 (47) |
| c. Does not specify motion for cleaning | 3 (20) |
| d. Specify must scrub for 30 seconds or more | 4 (27) |
| e. Does not specify length of scrub | 11 (73) |
| f. Specify must let dry for at least 30 seconds (for this part) | 6 (40) |
| g. Specifies must let dry | 13 (87) |
| h. Does not specify drying time | 9 (60) |
| 2. Saline and Gauze | 1 (7) |
| a. Specify motion used for cleaning as outward circles | 1 (7) |
| b. Does not specify length of scrub | 1 (7) |
| c. Does not specify drying time | 1 (7) |
| f. Protocol states to clean driveline itself | 5 (33) |
| i. Specifies Solution type | 5 (33) |
| 1. CHG | 5 (33) |
| a. Does not specify length of scrub | 5 (33) |
| b. Specify must let dry for 15 seconds or more(for this part) | 3 (20) |
| c. States must dry completely | 5 (33) |
| d. Does not specify time | 2 (13) |
| g. Protocol describes placing antimicrobial or antiseptic covering | 10 (67) |
| i. Biopatch® | 7 (47) |
| ii. Silver | 3 (20) |
| 5. Protocol states type of dressing to use* | 15 (100) |
| a. Sorbaview® | 10 (67) |
| b. Tegaderm™ (clear dressing) | 5 (33) |
| c. Mepilex® | 2 (13) |
| d. Gauze/sponge | 3 (20) |
| e. Medipore™ | 1 (7) |
| 6. Protocol discusses how to manage the driveline during dressing changes | 10 (67) |
| a. Holds driveline sterilely while cleaning | 6 (40) |
| b. Avoids pulling on driveline/driveline trauma | 6 (40) |
| 7. Protocol specifies the use of a skin anchor* | 15 (100) |
| a. Centurion Foley Anchor | 13 (87) |
| b. Securement device | 2 (13) |
| c. Hollister | 1 (7) |
| d. Clear dressing | 1 (7) |
| 8. Protocol specifies when to change the anchor changes* | 2 (13) |
| a. When the anchor looks dirty or compromised in some way | 1 (7) |
| b. Between 4 and 7 days | 1 (7) |
| c. Greater or equal to 7 days | 1 (7) |
| 9. Protocol describes the method for attaching the anchor | 8 (53) |
| 10. Protocol mentions discarding used materials | 10 (67) |
A single protocol may indicate multiple responses
Sites included in study: Advocate Christ Medical Center, Columbia University Medical Center, Mayo Clinic-Arizona, Northwestern Memorial Hospital, NYU Langone Health, Spectrum Health, The Ohio State University Wexner Medical Center, Tufts Medical Center, University of California - San Diego Medical Center, University of Kansas Health System, University of Michigan Medical Center, University of Minnesota Health, University of Nebraska Medical Center, University of Washington Medical Center, Vanderbilt University Medical Center
Note: Only items present on one or more of the protocols are listed
While each center had a protocol for driveline exit site dressing change, only 80% explicitly stated how often the dressing should be changed with a wide range of time frames for how often dressing changes should occur. Utilization of sterile technique was required in 100% of programs. Although sterile technique includes handwashing before donning sterile gloves, only 80% of programs stated the performer must wash hands before putting on gloves, only 27% specified duration (e.g., ≥ 20 seconds) of handwashing and 67% specified the solution.
All 15 protocols stated the need to clean the skin around the driveline exit site using chlorhexidine gluconate (CHG). However, there were differences regarding specific motion used for cleaning and 20% of protocols did even specifically how to clean the skin around the exit site. The vast majority of protocols did not specify the length of time to scrub using CHG (73%) or length of drying time (60%). Over half of the protocols (67%, 10/15) referenced a dressing change kit, as well as an antimicrobial covering such as a Biopatch® 70% (7/10) or silver-based covering 30% (3/10).
Although we found commonalities in all fifteen protocols including use of sterile technique and CHG to clean around the driveline exit site, several differences were identified. Only 67% of protocols included a kit and/or Biopatch®/silver-impregnated dressing despite the use of a kit with an antimicrobial skin covering having been shown to reduce driveline exit site infections. [5] Additionally, customized VAD procedure kits that contain all of the supplies needed for a dressing change may facilitate accuracy of following protocols,[6] and also may save both time and money.[7]
Other important findings included the lack of specificity in terms of 1) explicitly describing how to perform sterile technique, 2) detailed instructions regarding CHG use and 3) timing and duration of handwashing. Current best practices for CHG use on a dry skin site include using a back and forth scrubbing motion for at least 30 seconds, and then allowing the CHG to completely dry for at least 30 seconds.[8, 9] Despite these best practices, many sites used a circular outward motion for CHG cleaning. Additionally, several protocols did not specify timing and techniques for hand washing. Data clearly demonstrate that 20 to 30 seconds of proper handwashing with soap and water eradicates the most skin flora.[10]
In conclusion, we found substantial heterogeneity in VAD driveline dressing protocols among 15 high-volume VAD centers. This wide variability in care highlights the lack of a standard against which current practices can be assessed. Inclusion of existing best practices may reduce driveline associated infections.
Acknowledgments
Funding Source: National Institute of Health, National Institute of Nursing Research, Grant number 1R21NR016745-0.
Footnotes
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