Role of antimicrobial central venous catheters for the prevention of associated infections

Tom S. J. Elliott

Department of Clinical Microbiology, University Hospital Birmingham NHS Trust, Queen Elizabeth Hospital, Edgbaston, Birmingham B15 2TH, UK

Central venous catheters (CVCs) are being increasingly used, both in the hospital and in the community. Despite the considerable experience now gained in their use, they remain a major source of sepsis, accounting for over half of all bacteraemias and candidaemias. 1 The reported incidence of these infections is very variable, ranging from <1% to 18%2 with a frequency of bacteraemia of between <0.1 and 0.96 per 100 catheter days. 3 In England and Wales, >4000 patients with bacteraemias are notified to the CDSC per annum.4 In comparison, in the USA approximately 850,000 catheter-related infections occur annually and of these >50,000 are bacteraemias,5 most occurring in patients in intensive care units.1

Many approaches have been made to reduce the incidence of these infections. 5,6 These can be broadly classified into either patient management or catheter development. The former include improvements in skin antisepsis, care on insertion, non-occlusive permeable dressings and the development of antiseptic cuffs.1 The polymers used to make catheters have also been improved by the development of pliable non-deforming polyurethanes with decreased plasticizer content, extrusion of polymers under high temperature control, resulting in ultra-smooth surfaces, and the use of hydrophilic coatings. All these modifications have reduced microbial colonization, a pre-requisite of infection. However, despite these endeavours, CVC-related sepsis (CRS) occurs at a relatively high frequency and continues to be a significant burden on healthcare resources.7

Another, more recent, approach for the prevention of CRS is the use of antimicrobials which have either been incorporated into, or used to coat, catheter polymers. One of the earliest antimicrobials to be incorporated into a polymer for the prevention of infection was gentamicin, bound to polymethyl methacrylate. Gentamicin has also been incorporated into bone cement or formulated as beads for the prevention of infections of prostheses. 8 Dacron grafts have also been loaded with various antibiotics, but these have not been widely adopted.9,10 More recently, intravascular catheters have been coated with antimicrobial drugs, including antibiotics, antiseptics and metallic ions. When the devices are immersed in fluids, the antimicrobial is released, usually resulting in a high concentration initially being attained near the surface of the device, exceeding the MIC and MBC for potential pathogens.

Various attempts to develop a CVC composed of polymer material bonded to antibiotics have been made. This follows studies that have demonstrated that antimicrobial prophylaxis, including novobiocin, rifampicin11 and cephalosporins, 12 can prevent CRS. Vancomycin prophylaxis has also been shown to prevent coagulase-negative staphylococcal bacteraemia in premature neonates 13,14 and cancer patients with CVCs in situ. Intra-lumenal colonization of CVCs was also inhibited by low-dose vancomycin.15 However, in some studies prophylaxis has failed; for example there was no reduction in CRS after vancomycin prophylaxis in oncology patients.16 Polymers bonded with antibiotics have been developed in an attempt to provide a prolonged and continuous delivery of prophylactic antimicrobials at the potential site of infection. Trooskin et al., 17 for example, used tridodecylmethyl-ammonium chloride to increase the bonding of penicillin to polyethylene catheter segments. More than 60% of the bound penicillin remained on the catheter surface after 2 weeks in plasma, an improvement compared with other available coating techniques. The antimicrobial efficacy of these catheters was also confirmed in a rat model challenged with penicillin-sensitive Staphylococcus aureus. Solovskj et al.18 similarly prepared polymer catheters to which ampicillin and penicillin were covalently bonded. These catheters inhibited the growth of S. aureus in in-vitro experiments.

Most studies have concentrated on surface coating of catheters with antimicrobials, rather than on chemically bonded formulations. Teicoplanin-coated catheters have been extensively investigated. Romano et al.19 studied Hydrocath (Ohmeda, Swindon, UK) CVC coated with both hydromer and teicoplanin. These devices were inserted into mice and challenged with staphylococci. The coating prevented the formation of the abscesses that occurred around uncoated catheters. Jansen and colleagues20 described the teicoplanin-coating technique and also demonstrated in vitro the prevention of colonization when the catheters were challenged with various micro-organisms. The efficacy of teicoplanin in hydromer-coated CVC was also evaluated in a prospective randomized pilot study in patients undergoing major abdominal surgery. 21 However, approximately 75% of the initial teicoplanin coating was released during the first day of catheterization, and after 36 h no antibiotic was retained. No differences were subsequently detected in the degree of bacterial colonization between the teicoplanin-coated catheters and uncoated, control, catheters. This suggested that the retention of teicoplanin and the protection offered was only short-term when the catheter was intravenously placed. These results also served to demonstrate the difficulties in retaining antimicrobial activity when compounds were not chemically bonded on to polymer surfaces.

In an in-vitro susceptibility study of 197 catheter-related staphylococcal isolates, the efficacy of other antimicrobial agents, including vancomycin, clindamycin, minocycline, oxacillin and rifampicin, when used alone or in combination for the prevention of microbial colonization of catheters, was also studied.22 A combination of minocycline and rifampicin was found to have antimicrobial activity at least equivalent to that of vancomycin and other glycopeptide antibiotics. A similar trend was reported when the inhibitory activity of polyurethane catheters coated with minocycline and rifampicin was compared with catheters coated with other antimicrobial agents. In these tests the inhibitory activity of the catheters coated with minocycline and rifampicin was significantly better than those coated with vancomycin. Of particular interest was the similar inhibitory activity of the minocycline and rifampicin catheters against Gram-negative aerobic bacilli and Candida albicans when compared with catheters coated with ceftazidime and amphotericin B, respectively. 23,24 These findings have provided substantial laboratory evidence of the efficacy of Bio-Guard Spectrum catheters (Cook Critical Care, Bloomington, IN, USA) which contain minocycline and rifampicin. The in-vivo efficacy of these catheters coated with minocycline and rifampicin has also been determined. In a rabbit model, catheters coated with minocycline and rifampicin were significantly more efficacious than those coated with chlorhexidine gluconate and silver sulphadiazine (CG-SS) in preventing colonization and infection with S. aureus. 25 The minocycline and rifampicin catheters also had an enhanced inhibitory activity. Raad et al.26 have further evaluated the minocycline and rifampicin catheter in a double blind, randomized clinical trial. In this study, 281 hospitalized patients received either coated catheters (147) or untreated, uncoated catheters (151). Colonization occurred in 36 (26%) of uncoated catheters and 11 (8%) of coated catheters (P < 0.001). Catheter-related bloodstream infections developed in seven patients with uncoated catheters but in no patients with coated catheters. Multi-variant logistic regression analysis demonstrated that the coated catheter was an independent protective factor against catheter-related colonization. No adverse effects were related to the coated catheters. In a further multicentre matched clinical trial, 27 the minocycline- and rifampicin-coated catheter was compared with CVCs coated with CG-SS. Of 743 evaluable catheters studied, 357 were impregnated with minocycline and rifampicin, and 386 with CG-SS. The CVCs impregnated with minocycline and rifampicin were three times less likely to be colonized than those with CG-SS, and were 12 times less likely to produce catheter-related bacteraemia. Antimicrobial activity remained in the CVCs coated with minocycline and rifampicin for at least 2 weeks, 28 thereby offering protection from initial colonization and subsequent infection during this period.

Cefazolin-bonded CVCs have also been investigated.29 In a clinical study on a surgical intensive care unit, catheters were pre-treated with cefazolin bonded with a cationic surfactant. There were significantly fewer infections associated with catheters coated with this cephalosporin than with control catheters (2% and 14% respectively). In a more extensive study that compared cefazolin-coated catheters with standard non-antimicrobial catheters, again in patients on an intensive care unit, a significant reduction in catheter-associated bacteraemia was noted for the antibiotic-coated catheters.30 Other ß-lactam antibiotics have also been used to coat catheters: dicloxacillin coating reduced colonization and infections in a mouse model.31

The possibility exists, as has been shown with many topically applied antimicrobials, that emergence of resistance may be encouraged by the use of these catheters, particularly when only a single antibiotic is present. It has been claimed, however, that the use of antibiotic combinations such as minocycline and rifampicin to prevent catheter-related sepsis should reduce the likelihood of the emergence of antimicrobial resistance.32,33 The protective action of minocycline has been related to its lipophilic nature and its ability to penetrate into tissues and biofilms accessed by rifampicin.

Interest has also been focused on the use of antiseptics as alternatives to reduce catheter-related sepsis. In an early study, 2,4,4'-trichloro-2'-hydroxyphenyl ether (Irgasan, Ciba-Geigy) was incorporated into plastic washers made of ethylvinyl acetate, polyethylene or polypropylene. Irgasan resulted in zones of inhibition against a range of microorganisms. 34 These polymers were also tested in a rabbit model challenged with S. aureus and again protection was demonstrated with the Irgasan. However, the Irgasan appeared to be released relatively rapidly, resulting in only short-term antimicrobial protection.35 Another approach for producing antiseptic polymers has been the use of iodine complexed with polyvinylpyrrolidone. 36 When challenged with microorganisms, microbial adhesion and growth were inhibited by the iodine-complexed polymers.36 These antiseptic catheters have not yet been clinically evaluated.

The use of CG-SS has been extensively studied. These catheters are coated on the external surface only (Arrow International Inc, Reading, PA, USA). A synergic effect of CG-SS was demonstrated by Modak & Sampath.37 The chlorhexidine affects the bacterial membrane, thereby facilitating entry of silver ions into the cell. These then bind to the bacterial DNA and interfere with replication. In an early clinical investigation with these catheters, 40 post-operative cardiac surgical patients were studied. There was a significantly lower incidence of microbial colonization of catheter tips with the antiseptic-bonded catheters.38 Clemence et al.39 also reported a reduction in catheter-related bloodstream infections with these catheters in a crossover study of patients on intensive care units. There was a 60% reduction in the rate of primary bacteraemia. Maki et al.40 also reported the results of a large comparative clinical study using the CG-SS catheters compared with control non-antimicrobial devices. The antimicrobial catheters significantly decreased the number of colonized catheters and CVC-related bacteraemia in intensive care unit patients. Conversely, Logghe et al.41 reported that the CG-SS catheters did not reduce the risk of bacteraemia or septicaemia in patients with haematological malignancy. In a further clinical study, Heard et al.42 demonstrated a decrease in bacterial colonization of the CG-SS catheters but there was no significant effect on the incidence of catheter-related bacteraemia. These different results may be due to several factors, including the types of patient studied, differences in skin preparations, post-operative wound care and types of bandage selected. In the study by Maki et al.40 patients had an average duration of catheterization of only 6 days, whereas in the Logghe et al. study 41 the duration of catheterization was 20 days: the increased elution of CG-SS during 20 days as compared with 6 days offers a further possible explanation for the reduced efficacy noted.

Hypersensitive reactions are known to occur when patients are exposed to chorhexidine or silver sulphadiazine. The possibility that such reactions might occur after the use of a catheter with a relatively small amount of both antiseptics is extremely remote. In the clinical trials of CG-SS catheters, and after extensive use in the USA, this has been borne out. However, anaphylactic reactions have been reported with chlorhexidine43,44 and, more recently, with CG-SS-coated catheters in Japan.45 Possible explanations for these rare events include (i) increased exposure to chlorhexidine-containing products, resulting in heightened sensitivity, or, perhaps, (ii) genetic pre-disposition. Awareness of this, albeit rare, side effect, is important. A CVC coated with silver alone (Pellethane, Fresenius AG, Bad Homburg, Germany) has also been produced and clinically assessed in oncology patients.46 There was a significant reduction in catheter-related infections. This catheter lacks chlorhexidine, which may reduce the likelihood of anaphylactic reactions, but it awaits further clinical evaluation.

More recently, a triple-lumen polyurethane catheter with hydromer has had a benzalkonium chloride (BZC) coating added. BZC is a quaternary ammonium compound which inhibits both the microbial membrane activity and DNA replication. Unlike the CG-SS catheter, the BZC catheter is coated on both the internal and external surfaces (Becton Dickinson Ltd, Swindon, UK).47 It has been clearly demonstrated that the hub and the internal lumen of a catheter, as well as the external surface, are primary sources of microorganisms causing colonization and infection. 48,49,50,51 Coating both surfaces is therefore potentially of importance for the prevention of CVC infection. In an in-vitro assessment this catheter resulted in a significant reduction in microbial colonization, both on the internal and external surfaces, when challenged with a range of microorganisms.6 Colonization is considered to be a prerequisite of infection,1 so these results suggest that this catheter may offer protection from infection derived from microorganisms present both inside and outside the catheter. In an ongoing clinical trial comparing the BZC catheter with a non-antimicrobial device, reduced colonization has been demonstrated (Elliott, T. S. J., unpublished observations). The catheter has also been shown to have no adverse effects in over 150 patients in whom it has been used to date. This is not entirely surprising, as BZC is already widely used as a preservative in many medicines. The BZC catheter should not be confused with the BZC- heparin bonded catheter (AMC Thromboshield; Baxter Healthcare Corporation, Irvine, CA, USA). This catheter is also coated on both the internal and external surfaces, 52 but contains BZC bound to heparin, unlike the BZC catheter, which is coated unbound. The BZC- heparin bound catheter awaits clinical evaluation.

In a further innovative approach to prevent catheter-related sepsis, we have applied low amperage electrical current to carbon-impregnated catheters. In in-vitro studies, the electrical catheters repelled microorganisms when they were negatively charged, by small electrical currents.53,54 The antimicrobial activity of this low amperage current results from the production of hydrogen peroxide and free chlorine by electrolysis at the catheter surface.55 These antimicrobials were actively bactericidal. In a further study, Raad et al. 56 demonstrated that silver iontophoretic catheters were effective at preventing infection when challenged with S. aureus. Costerton et al.57 have further shown that the bactericidal activity of antibiotics against biofilm-embedded bacteria, including the activity of tobramycin against Pseudomonas aeruginosa, is greatly enhanced by the application of an electric field. The use of low amperage electrical current, perhaps in combination with an antimicrobial, offers a novel method for protection from infection not only for CVC but also for other prostheses.

The use of antiseptic-impregnated catheters appears, from the clinical data available, to offer a means to reduce microbial colonization and infections associated with catheters. Although the number and spread of bacteria and fungi with multiple antibiotic resistance are increasing, which may limit the use of antibiotics incorporated into catheters, this does not appear to be the case for antiseptics. Indeed, the widespread emergence of antiseptic-resistant microorganisms is less likely, because they act through basic chemical reactions, unlike antibiotics which are generally under genetic and hence mutable and transmissible control.58,59 It would also appear that the use of antiseptic-impregnated CVCs offers a cost benefit.60 However, the current data are still limited, with some unexplained differences in findings. This probably reflects the multitude of factors which can influence the risk of CRS, including catheter care, insertion protocols and antiseptic policies. Even the results of the extensive, well controlled trials such as those by Maki et al. 40 and Raad et al.26 are difficult to translate to other clinical situations.61 These two studies were carried out in teaching hospitals which had relatively high rates of CRS, above other published rates, 62 and the efficacy and value of antimicrobial catheters in units with lower rates of sepsis is, therefore, unclear. The question that remains to be addressed is where these antimicrobial catheters should be used. It is important that existing recommendations for good practice63 are followed with good aseptic techniques, and that the practices are amended appropriately when new data become available. Antimicrobial catheters should be considered as an adjunct to this approach rather than trying to conceal poor practice. The antimicrobial catheters should perhaps be reserved at present for high-risk patients such as those on intensive care units with short-term catheters, particularly in situations where the background rates of CRS are high.

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