Abstract

Background: This study aims to systematically define and analyze the studies on driveline exit site care methods for patients with a ventricular assist device.

Methods: The studies related to driveline exit site care of the patients with a ventricular assist device published in English and Turkish between 2008 and 2017 were reviewed from the international Science Direct, PubMed, Web of Science, Scopus, and the national databases. Of a total of 83 articles, a total of seven research articles which met the inclusion criteria were included in the study.

Results: Findings related to the agents used in the cleaning of the driveline exit site, dressing closures, dressing change frequency, and use of driveline anchoring devices were obtained from studies included in the research. It was found that chlorhexidine solution for skin cleaning and sterile gauze sheets and transparent covering for dressing closure were the most preferred methods for the driveline exit site care. Dressing change frequency varied considerably from center to center and anchoring devices were used in all studies.

Conclusion: There is no gold standard method for the driveline exit site care of patients with a ventricular assist device and researches on the driveline exit site care seem to be limited. It is recommended that large-scale, randomized-controlled studies should be conducted which would provide a stronger proof of the driveline exit site care.

Ventricular assist devices have become important treatment options as the bridge to destination therapy or transplantation for end-stage heart failure patients. These devices considerably increase the functional capacity, quality of life, and duration in this patient population.[1-3] Despite favorable results, device-related infections following implantation are challenging and increase the risk of morbidity and mortality in these patients.[4,5] Ventricular assist device-related infections are reported at rates up to 30 to 50 and the most common ones are pneumonia (23%), sepsis (20%), and driveline exit site infections (19%).[6] A center in Turkey has reported the driveline exit site infection rate as 22.9% and 50% depending on the device used.[7]

The ventricular assist devices consist of a pump connected to the ventricle, a small external control unit after the pump (controller), a cable connecting the pump to the control unit (driveline: power transmission line), and the power sources (batteries) operating the pump and the control unit. The driveline is extended from the pump implanted to the ventricle, passes through the skin, and is connected to the control unit.[8,9] The driveline exit site on the skin poses a huge risk of infections for patients undergoing ventricular assist device implantation. Therefore, the surgical techniques used for securing the driveline and the care of the driveline exit site play an important role in post-implantation infection control.[8,10,11] The surgical technique preferred in securing the driveline, the incision and suture materials used, and the minimization of tissue damage are reported to decrease the risk of developing driveline exit site infection.[11,12] The solution used in the cleaning of the site, the materials used to secure the driveline, the dressing materials and their change frequency are the important factors in driveline exit site care. Materials used in driveline exit site care vary according to the preferences of the institution performing the implantation. A review of the studies in the international literature reveals that a gold standard method for driveline exit site care has not been yet identified.[10,13-18] Local infections at the driveline exit site can be controlled with wound site care and the importance of such care, and the importance of patient training in this matter has been emphasized in the Cardiology-Cardiovascular Surgery Consensus Report for the use of ventricular assist devices in Turkey.[19] On the other hand, we did not find any study from Turkey on the care protocols, and the effectiveness of the method, material and solution used for care in Turkey. In addition, we observed that driveline care protocols differ between the centers where ventricular assist device implantation is performed in Turkey. Octenidine dihydrochloride, chlorhexidine, and povidone-iodine solutions are usually used in skin cleaning, while the dressing change frequency is daily or weekly. Sterile gauze can be also used for the closure of the dressing and adhesive plaster as an anchoring device.

Performing driveline exit site care within the scope of a standardized protocol or by developing a gold standard is thought to be effective in preventing or decreasing infections related to ventricular assist devices. In this review, we aimed to systematically define and analyze the studies on driveline exit site care methods for patients with a ventricular assist device. We believe that this review would guide healthcare professionals in developing a standard care protocol for the driveline exit site.

Methods

Data sources and literature screening
The studies related to driveline exit site care in patients with a ventricular assist device were reviewed from the international Science Direct, PubMed, Web of Science, Scopus and national databases (National Turkish Medical Directory and National Thesis Center databases). The “ventriküler destek cihazları/ventricular assist device”, “driveline/driveline”, “bakım/care”, “pansuman/dressing” search words were used in Turkish and English. Inclusion criteria were as follows:

• Articles published between 2008 and 2017;
• The driveline care protocol for patients with a ventricular assist device which is explicitly defined;
• Full text articles written in Turkish or English;
• Reviews and reports were excluded.

Study selection and data analysis
A standard data summary form was developed for study selection and data analysis. The articles found in databases with the Turkish and English search words were examined nationally, internationally and under thesis titles. No studies were found in the National Database and National Thesis Center, while a total of 83 research articles and abstracts from the International Databases were evaluated with these search words. Of these 83 international articles, 12 were potentially related to the study and the full texts were accessible. Of 12 articles for which the full text was evaluated, seven research articles which met the inclusion criteria were included in the study and reviewed systematically (Figure 1). All articles included in the review based on the content of the data summarization form were classified and summarized under the titles (i) the authors and year of the study, (ii) type of the study, (iii) subject/aim of the study, (iv) sample size of the study, (v) driveline infection diagnostic criteria, (vi) driveline dressing protocol, (vii) study findings, and (viii) study conclusion and recommendations (Table 1 and Table 2).

Figure 1: Study selection.

Results

A total of seven studies published between 2008 and 2017 were included in this study. All studies were international studies written in English. Six of these studies were cohort,[14,15,17,18,20,21] and one was an experimental study.[22] The studies included in the review compared the materials used in driveline exit site care and various methods in terms of care frequency, while reporting the standard driveline dressing protocols and driveline infection rates.

Table 1 presents the publication year and authors of the studies, study types, aims and sample sizes. The sample size was minimum 27 and maximum 266 with a total of 657. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS),[14,17,20] Cleveland Clinic Classification of Ventricular Assist Device Infections,[15] International Society for Heart and Lung Transplantation Consensus,[18] and the Hospital Infection Control Practices Advisory Committee surgical site infection criteria[21] were used in the diagnosis of driveline infection. A physical evaluation was conducted for driveline infection and drainage material for culture was taken from the site in a study.[15,18,21,22] A driveline dressing protocol was used in all studies; the dressings were placed under sterile conditions and in accordance with aseptic technique in these protocols and sterile gloves and a mask were used,[14,15,17,18,20-22] and a surgical cap was also used in one of the studies (Table 1).[22] The following findings regarding the agents used in cleaning of the site, dressing closures, dressing change frequency and driveline anchoring device use were obtained from the studies included in the review (Table 1).

Table 1: Included studies in this review

Agents used in cleaning of the driveline site
Chlorhexidine was used to clean the driveline site in four of the studies included in the review (Table 1).[14,17,20,22] Driveline infection was not reported or seen only in a low rate in these studies where chlorhexidine was used for the cleaning of the driveline site.[14,17,20,22] Menon et al.[15] compared a control group where octenidine dihydrochloride was used for skin cleansing and a study group where 2% merbromin was used and showed a statistically significant decrease in driveline infections with the use of 2% merbromin. Driveline infection rates were reported to be low, when skin cleansing was performed with soap and antimicrobial spray in the study of Hozayen et al.[18] Chlorhexidine was used in four of five centers and hydrogen peroxide in the remaining one for skin cleaning of the driveline exit site and the infection rate was low in the study conducted by Stahovich et al.[22] aiming to develop a percutaneous lead care kit. Hydrogen peroxide was used in the study of Hieda et al.[21] and the infection rate at the driveline exit site at the post-implantation 12^th month was over 90%.

Driveline dressing closures
The driveline exit site was reported to be covered with closure material in all studies included in the review.[14,15,17,18,20-22] The study of Cagliostro et al.[14] compared sterile gauze and a transparent film dressing with bacteriostatic silver gauze dressing and transparent film dressing use as a dressing closure and there was a significant decrease in driveline infections in the group, where bacteriostatic silver gauze dressing and a transparent film dressing was used (Table 2). Sterile gauze use was reported for dressing closure in the Minnesota protocol and absorbent foam sponge dressing and a transparent film dressing in the Utah protocol by Hozayen et al.[18] (Table 1). Although favorable results were reported with the use of either technique, the satisfaction of the caregivers was significantly high with the Utah protocol where an absorbent foam dressing and a transparent film dressing were used.[18] Driveline infection was reported not to develop in the study of Menon et al.[15] where they used Metalline dressing pads for closure in their protocol (Table 1). Hieda et al.[21] reported that antimicrobial occlusive dressings were used to cover the site (Table 1).

Table 2: Results Obtained From the Studies, Conclusions and Recommendations

Driveline dressing change frequency
The driveline dressing change frequency was seen to differ in the studies included in the review (Table 1). While the dressing on the driveline exit site was changed every day in the early postoperative period, it was changed every six to seven days later on in the study of Menon et al.[15] Dressing change was daily in the Minnesota protocol and every three days in the Utah protocol in the study of Hozayen et al.[18] ( Table 1). No significant difference was found between the two protocols, one performed daily and the other every three days, and both techniques resulted in good results in this study (Table 2). The effectiveness of dressings changed daily, three times a week or weekly was evaluated and driveline infection was not reported in any patient; therefore, concluding that driveline infection development was not associated with the dressing frequency in the study of Wus et al.[17] Dressing change was reported to be made daily,[20] two to three times a day,[21] daily and every two to three days[22] in these studies (Table 2). While the driveline infection rate was low in two of these studies,[20,22] the rate was high in the study of Hieda et al.[21]

Driveline anchoring device use
Anchoring devices with adhesive properties such as a securement tape, belt, patch or tape were used to stabilize the driveline in six of the studies included in the review (Table 1). A care kit with a driveline anchoring device was used, and the risk for developing a driveline infection decreased by 11% in the study of Cagliostro et al.[14] The care kit containing an anchoring device was found to be significantly effective in the study of Stahovich et al.[22] conducted to develop a percutaneous lead management kit.

Discussion

Ventricular assist device implantation is an invasive intervention, as the driveline extends from the pump implanted to the ventricle to the skin. One of the most important problems encountered in the long-term follow-up of these patients is, therefore, driveline related infections.[4-6,10,15] It may be possible to prevent or minimize the development of this problem with standardized driveline exit site care. In this review, we evaluated a total of seven original study articles discussing driveline care in patients with a ventricular assist device and assessed the driveline area infection rates. Most of these studies were retrospective and no randomized-controlled studies specific to the subject with an adequate evidence level was found.

Converting driveline care into a protocol is important in terms of standardizing the care. It is, therefore, necessary to establish an institutional stepby- step protocol for the care process of the driveline exit site, and all healthcare staff should provide care accordingly. Driveline care was implemented according to a protocol in all the studies included in this review.[14,15,17,18,20-22]

All the procedures for driveline exit site care should be performed in accordance with an aseptic technique; patients and their relatives who will continue the care at home after discharge should be also trained.[8] All the studies in this review emphasize providing the care by using sterile gloves, mask, and cap and complying with asepsis rules.

One of the most important issues in driveline care is the choice of the agents used in cleaning the region and these agents differ according to the institutional protocols. Chlorhexidine, octenidine dihydrochloride, 2% merbromin solution, hydrogen peroxide, soap and antimicrobial spray were used in skin cleaning of the driveline area in the studies included in this review. Chlorhexidine solution, recommended to be used in the perioperative process to prevent surgical site infections,[23] was also the preferred solution for s kin cleaning in driveline care protocols.[14,17,20,22] Reported driveline infection rates are quite low in studies where chlorhexidine is used in driveline exit site care.[14,17,20,22] In addition, 2% merbromin solution, hydrogen peroxide, soap and antimicrobial spray used in the care of the driveline exit site are also reported to contribute to decreased infection rates in other studies.[15,18,21,22] It can be concluded that the recommendations regarding the agent to be used in driveline skin cleaning are important based on the findings obtained from the studies included in the review, although they do not provide strong evidence.

Another issue to consider in driveline care is the dressing closures. Sterile gauze and transparent film dressing as well as bacteriostatic silver gauze dressing and foam based dressing are reported to be used often as driveline dressing closures.[14,15,17,18,20-22] The routine use of a standard care kit including bacteriostatic silver gauze dressing is particularly recommended for driveline care.[14]

The dressing change frequency is also an issue in driveline care that varies from institution to institution and should be considered in the care protocol. Regarding dressing change frequency, implementations in the form of two to three times per day, daily, every two to three days, once a week, and three times a week were used in the studies.[14,15,17,18,20-22] When the results of these studies with different protocol are evaluated, it can be suggested that the dressing change frequency is not directly associated with driveline infection development and further studies are required to be performed to identify the most appropriate frequency.

Another implementation required in the driveline care protocol is the use of driveline anchoring devices. Driveline anchoring device use was reported in the majority of studies examined in this review and it was found to decrease the risk for developing a driveline infection.[14,15,17,18,20,22] Although various anchoring devices were used, however, there was no reported finding indicating the superiority of any one of these.

Conclusion and recommendations
In conclusion, the findings of this systematic review show that driveline exit site care in patients with a ventricular assist device vary from institution to institution with no gold standard method, and the number of studies on such care is limited. The agent to be used in skin cleansing, the dressing closure, the dressing change frequency, and the driveline anchoring devices should be identified and included within the scope of a standardized driveline care protocol. However, further large-scale, randomized-controlled studies would provide stronger evidence.

Declaration of conflicting interests
The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.

Funding
The authors received no financial support for the research and/or authorship of this article.

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