Although the number of patients affected by heart failure has increased over the past 2 decades, the number of heart transplants has remained relatively constant at about 3,500–4,000 per year because of the shortage of donor organs. This shortage has increased the use of mechanical circulatory support devices for patients with advanced heart failure refractory to treatment, particularly, left ventricular assist devices (LVADs).1 The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) reports 5,408 such devices implanted between January 2012 and the end of the first quarter of 2014. Of these, 42.9% were considered destination therapy for patients not listed for heart transplant.2
As more devices have been implanted, LVAD infections, which are associated with substantial morbidity and mortality, have become an increasingly important problem. The definitive treatment, removing the device, is often not feasible, thus making LVAD infections a devastating complication for affected patients. One prospective study showed a 22% overall infection rate of LVADs and a 1 year mortality 5.6 times greater in patients with infections.3 Besides mortality, LVAD infections are associated with increased risk of pump thrombosis, bleeding complications, longer hospital stay, need for LVAD exchange, and failure to transplant.4 As more patients have LVAD support for longer periods, developing effective prevention and treatment strategies will become even more crucial.
The International Society for Heart and Lung Transplantation (ISHLT) defines an LVAD infection as an infection occurring in the presence of an LVAD that may or may not be attributable to the LVAD but that may warrant special consideration if an LVAD is in place. This definition includes several types of infections besides those directly associated with the device, such as catheter-related bloodstream infection or bacteremia attributable to pneumonia or urinary tract infection. LVAD infections can be further classified as follows: driveline related with accompanying soft tissue, pump pocket, LVAD-associated bloodstream infection, and endocardial infection with direct evidence of vegetation or infection on the internal surface of the pump.5
Earlier systematic reviews of LVAD infections have examined prophylactic strategies,5,6 tools for diagnosis and management,5 risk factors, and the microbiology of infections. The purpose of this systematic review is to analyze published studies regarding the incidence and risk factors for LVAD infections and describe the impact of each on patient-level outcomes.
Inclusion and Exclusion Criteria
Our protocol was registered with PROSPERO (registration number: CRD2014014114). We identified studies that described either the microbiology of continuous-flow LVAD infections or outcomes of these infections (mortality, length of stay, or costs of care). We included the following epidemiologic and experimental study designs: controlled trials, quasi-experimental designs, before-and-after studies, prospective and retrospective studies, and cross-sectional studies. We excluded individual case reports; review articles; basic science papers; animal studies; case–control studies (as our outcomes of interest are epidemiologic); studies primarily describing outcomes of right ventricular assist devices, biventricular assist devices, pneumatic LVADs (as infection rates were significantly higher in these first-generation devices); and pneumatic total artificial hearts. For mixed-population studies, authors were contacted to determine whether a subset of data for patients who received continuous-flow devices could be obtained. Finally, pediatric studies were also excluded, as the indications and use of LVADs in adult and pediatric populations are distinct.
When a study was reported as both a preliminary and final analysis, preliminary analyses were excluded. For studies in which there was substantial, secondary data analysis reported separately for new outcomes, the results were combined for reporting purposes to minimize duplication.
Outcomes of Interest
Infections were the primary outcomes of interest in this study. We abstracted data regarding type of infection; microorganisms isolated; attempted therapies; patient-level outcomes of relapse or reinfection, or both; treatment failures; length of stay; and mortality. Infections were defined from individual studies; these definitions were abstracted and compared.
With the assistance of a professional medical librarian at our institution, we determined our strategy for the literature search. We did not apply any language restrictions and searched the electronic databases of Medline (PubMed), Web of Science, EMBASE, Ovid, and CINAHL. We attempted to ensure a complete search of the health-related gray literature through searches of pertinent conference proceedings and abstracts. We manually reviewed the included references for other potentially relevant records.
Study Quality Assessment
Studies were assessed for methodologic quality by using the risk-of-bias assessment tool described in the Cochrane Handbook for Systematic Reviews.7 This tool allows for subjective assessment of bias across six domains, including selection, performance, attrition, detection, and reporting. The data were summarized using Review Manager 5 software (Cochrane Collaboration, Nordic Cochrane Center, Copenhagen, Denmark).
Data were abstracted using a standard REDCap form (Research Electronic Data Capture, Vanderbilt University; see Supplemental Digital Content 1, http://links.lww.com/ASAIO/A188) by two independent reviewers. Disagreements were resolved by discussion. Data were synthesized qualitatively by category and, when sufficient data were available, quantitatively using the DerSimonian and Laird random-effects method for meta-analysis and Cochrane Review Manager 5 software.
Ninety distinct studies were included in our final synthesis (Figure 1). Study characteristics, patient comorbidities, and infection data are summarized in Tables 1–3 (Supplemental Digital Content, http://links.lww.com/ASAIO/A206).
Definitions for LVAD infection were not consistent among the various registries, including in INTERMACS (10 studies), J-MACS (three studies), and ISHLT (nine studies). One study used the Centers for Disease Control/National Healthcare Network Surveillance definitions for reporting on bloodstream infection. Two studies used their own definitions for percutaneous site infection. The remaining studies did not include precise definitions for LVAD infections.
Devices and Procedure Characteristics
The most extensively studied device was the HeartMate II, with 32 studies reporting on it exclusively. Thirteen studies described the HeartWare HVAD alone. A mix of HVAD and HeartMate II data was reported in 21 studies. Other combinations of VentrAssist, HeartMate II, Evaheart, DuraHeart, and the Micromed DeBakey were reported in 11 studies. Two reported exclusively on the DuraHeart. Three studies reported results of Jarvik 2000 implantations. One study reported on the Evaheart alone. The remaining 13 studies specified continuous-flow devices but did not specify the type of device.
Three studies directly compared infection rates between the HeartMate II and the HeartWare HVAD. In the first study, overall infections were significantly higher (p = 0.02), as were percutaneous infections (p = 0.01) associated with the HeartMate II.8 The second study found the opposite, that is, a higher rate of infection for the HVAD than the HeartMate II.9 In another study that compared the HeartMate II to the Evaheart LVAD, the HeartMate II was associated with lower infection rates.10 These results are shown in the forest plot in Figure 2. However, the heterogeneity and small numbers of patients in these studies limited the conclusions that could be drawn from the pooled estimate. Several strategies for prophylaxis and wound dressing were discussed (see Supplemental Digital Content 2, http://links.lww.com/ASAIO/A189), but none were clearly superior.
Fifty-two studies showed driveline infections to be the most common infection associated with LVADs, and it was the only infection described in several studies. Two studies found that the prognosis for a driveline infection was not particularly poor, and these infections were not associated with pump thrombosis or stroke.11,12 Another study found that driveline infections tended to occur late, at a median of 190 days postoperatively.13 In general, these infections were managed successfully with a combination of local debridement and antimicrobial therapy; LVAD removal was not necessary in most cases.
Infection of the pump pocket was the predominant infection reported in a series of patients treated with antibiotic beads plus debridement.14 Pump pocket infection was nearly as common as driveline infection in one study15 and was usually the second most common infection in studies reporting both pump pocket infection and driveline infection.15–18 The prognosis for patients with pump pocket infection was not studied specifically in any of the included reports.
Although less frequently reported overall, bloodstream infections were reported in one study to be the most common infectious complication of LVAD implantation.19 In addition, Aggarwal et al.20 found bloodstream infections to be associated with increased risk of both hemorrhagic and ischemic stroke; however, transient bacteremia, which was not defined, was excluded. Aldeiri et al.21 also reported an association between bloodstream infection, specifically Pseudomonas bacteremia, and stroke. The risk of increased mortality, stroke, and Pseudomonas bacteremia was also reported by Trachtenberg et al.22
Sources of bacteremia were not clear. Forest et al.23 reported that 43% of patients had secondary bacteremia from driveline infections. They also noted that patients with bloodstream infections were hospitalized longer than patients with driveline infections. Fungemia was not studied. Bloodstream infections were the predominant infection reported in a study by Schulman et al.24 comparing pulsatile and axial flow devices. However, they did not speculate on a reason for this finding. Starling et al.25 also reported a similar predominance of bloodstream infection in their LVAD patients. One study reported 10 cases of asymptomatic bacteremia, which were most often Gram positive (90%) but had no other clearly unifying characteristics.26
Infection Outcomes and Treatment
Studies reporting an association between infection and mortality are summarized in Figure 3. Infection incidence and mortality associated with LVAD infections appeared to decrease over time, as noted in a registry study that compared rates of complications in those who received a HeartMate II before and after the device’s approval by the US Food and Drug Administration. This trend appeared to be associated with a Center’s increased experience in implanting and subsequently managing the devices, as well as with the use of smaller devices with better flow dynamics.
Chamogeorgakis et al.27 noted that the most important risk factor for infection reported was a continued need for LVAD support. These authors recommended careful evaluation of the patient to ensure that support was still necessary before considering explantation followed by reimplantation.
The effect of infection on long-term patient outcomes was described in 11 studies with varying results, and two studies noted no impact of infection on long-term outcomes.28,29 Another noted a high rate of infection-associated deaths in a cohort of patients who were substance abusers. One registry study showed LVAD infections to be significantly associated with poor survival after adjusting for age and comorbidities, with 19% of patients experiencing an LVAD infection during their first year of support.30 However, two other studies did not find infection to be associated with increased mortality, although they did show increased hospital length of stay in patients with infection.23,31 LVAD infections were reported as a leading cause for readmission in five studies.17,32–35
The necessity of pump exchange is not clear. One study noted a particularly poor prognosis with candidemia and concomitant implantation of a cardiac implanted electronic device (CIED), and failure to remove the device during pump exchange was associated with poor outcomes.36 Another investigation noted good outcomes with pump exchange for treatment of driveline infections and pump pocket infections, with no mortality and low recurrence rates.37
One study reported a salvage protocol where, when infection was suspected, the driveline and pocket were debrided and antibiotic beads placed, followed by subsequent debridement of all infected tissues and replacement of the LVAD.14 When the culture no longer showed infection, the surgeons proceeded to definitive closure of the incision and possible flap coverage. This protocol was successful in clearing infection in 65% of patients. However, lower success rates were noted for Pseudomonas species compared with infections caused by Staphylococcus aureus, Candida species, and other Gram-negative organisms, which were more likely to resolve.14 Causative microorganisms are discussed in Supplemental Digital Content 3 (http://links.lww.com/ASAIO/A190). Other demographic risk factors examined are discussed in Supplemental Digital Content 4 (http://links.lww.com/ASAIO/A191).
Assessments of study quality are summarized in Table 4 (Supplemental Digital Content, http://links.lww.com/ASAIO/A207). In general, we found a low risk for selection, performance, and detection bias. Reporting bias was more common. Attrition bias was rated as low or unclear in most studies.
Despite substantial heterogeneity across studies, we can draw a few conclusions from the data. First, driveline infections are the most common type of LVAD infection described in the literature. This finding is consistent with what is reported in the INTERMACS database, where driveline infections in continuous-flow LVADs are reported to occur at 1.31 per 100 patient months early (first 3 months post-implantation) and 1.42 per 100 patient months late. The most common types of infections are early pulmonary infections (4.58 per 100 patient months) and early urinary tract infections (3.36 per 100 patient months), neither of which are strictly device-related.38
Second, bloodstream infection is a serious complication of LVAD implantation. Two studies found an association between stroke and bloodstream infection.20,21 Managing bloodstream infections in LVAD recipients are controversial. Most treating physicians opt for chronic, suppressive antibiotic therapy when the LVAD is clearly the source of infection; however, the best approach for managing a severe bloodstream infection from secondary sources in LVAD recipients is unclear. There is also no data to guide selection of agents for chronic suppression.
Third, and perhaps most important, we have identified a number of knowledge gaps that need to be addressed in future research. Most patients were white men; therefore, more research is needed to determine the incidence and outcomes of infections in women and minorities. The only study to specifically describe sex differences reported that women had fewer infections, but the reasons were not known.39 Preventive strategies were also not well defined. A chlorhexidine disc and sutureless fixation device appeared promising in one study, but the patient cohort was too small to generalize the conclusions.40 Likewise, the degree of detail in the study about silver dressings41 make it difficult to form a strong conclusion about the true benefit of this preventive strategy. Finally, demographic risk factors are poorly understood. Hyperbilirubinemia (>6 mg/dL) was associated with 100% mortality in one study (103). The variable immunologic effects related to foreign material in the devices also complicates understanding of these effects on LVAD patients. One study, for example, found that procalcitonin values were of limited use because of the systemic inflammatory response syndrome (SIRS) type most patients have after initial LVAD implantation.42
Drawing conclusions was difficult because existing data reporting standards and criteria used for defining LVAD infections are somewhat disparate. INTERMACS tracks major infections, defined as fever, drainage, or leukocytosis treated with nonprophylactic antimicrobial agents. Infections are classified into four general categories: localized nondevice infection, percutaneous/pocket infection, internal pump-component infection, and sepsis. The ISHLT provides the second, most commonly used set of definitions, where infections are generally classified as ventricular assist device (VAD)-specific, VAD-related, and non-VAD infections; and they further categorize infection by the area affected. However, this classification scheme does not differentiate between a bloodstream infection where a VAD is the definite source of bacteremia (LVAD-related bloodstream infection) and cases where the source of bloodstream infection in LVAD recipients is unclear (LVAD-associated bloodstream infection). More precise definitions are needed to accurately classify these complex infection syndromes.
The strategy for treating infection varied among the studies. We did not include one study in the review because it did not specify whether pulsatile devices were used. In that study, however, transvenous lead extraction was associated with improved survival to transplant for those with bloodstream infection related to CIED infections or lead endocarditis.43 Levy et al.44 reported that pump exchange was effective in eliminating persistent driveline infection. In this case series, antimicrobial beads were not efficacious. In general, data suggested that driveline infections can be managed in most patients with local debridement of the exit site combined with a defined course of pathogen-directed antimicrobial therapy. Device or pocket infections are typically managed with chronic, suppressive antimicrobial therapy. Emerging strategies may make more conservative local debridement with the use of negative-pressure wound dressing or other such interventions viable options in the near future. However, an LVAD exchange may be necessary if infection cannot be controlled, if relapses occur while the patient is taking suppressive antibiotic therapy, or if oral suppressive therapy is not feasible (e.g., a resistant organism). There are not enough published data to make recommendations for managing bloodstream infections in patients with LVADs.
Two important factors impacted study quality: the lack of uniform criteria to define LVAD infections and the reuse of existing data in the published literature, leading to substantial duplication of results. Study duplication is acknowledged by most investigators. In this extensive, secondary data analysis of the literature for LVAD infections, most of the published data on epidemiology and management are drawn from a relatively small number of patients. By contacting the authors and combining studies whenever duplication could be identified, we attempted to limit this effect. However, especially for the registry studies, this is a major limitation in this meta-analysis.
LVAD infections are a significant cause of morbidity and mortality in LVAD recipients. Most published data describe driveline infections. Bloodstream infections have not been well studied and may be linked to poorer outcomes. Current evidence is inadequate to rationally guide prevention, treatment, and chronic suppression of infections. With the approval of more continuous-flow pumps, the numbers of patients with implanted LVADs will certainly increase, as will LVAD-related and LVAD-associated infections. How to manage infectious complications definitely needs further study. Collaborative initiatives and registries that track infections and treatments may yield insights into how to address this growing problem.
We would like to thank Drs. Andrea Baronnetto, Laura Chan Lihua, Finn Gustaffson, Teruhiko Imamura, Kory Lavine, and Athanasios Tsiouris for providing unpublished data for this review.
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