Malfunctioning and Infected Tunneled Infusion Catheters: Over-the-Wire Catheter Exchange versus Catheter Removal and Replacement

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1 CLINICAL STUDY Malfunctioning and Infected Tunneled Infusion Catheters: Over-the-Wire Catheter versus Catheter Removal and David M. Guttmann, BS, Scott O. Trerotola, MD, Timothy W. Clark, MD, Mandeep Dagli, MD, Richard D. Shlansky-Goldberg, MD, Maxim Itkin, MD, Michael C. Soulen, MD, Jeffrey I. Mondschein, MD, and S. William Stavropoulos, MD ABSTRACT Purpose: To compare the safety and effectiveness of over-the-wire catheter exchange (catheter-exchange) with catheter removal and replacement (removal-replacement) at a new site for infected or malfunctioning tunneled infusion catheters. Materials and Methods: Using a quality assurance database, 61 patients with tunneled infusion catheters placed during the period July 2001 to June 2009 were included in this study. Patients receiving hemodialysis catheters were excluded. exchange was performed in 25 patients, and same-day removal-replacement was performed in 36 patients. Data collected included demographic information, indication for initial catheter placement and replacement, dwell time for the new catheter, and ultimate fate of the new device. Statistical comparisons between the two cohorts were analyzed using the Kaplan-Meier technique and Fisher exact test. Results: Catheters exchanged over the wire remained functional without infection for a median of 102 days (range, days), whereas catheters removed and replaced were functional for a median 238 days (range, days, P.12). After catheter replacement, there were 11 instances of subsequent infection in the catheter-exchange group and 7 instances in the removalreplacement cohort, accounting for infection rates of 4.4 and 2.3 per 1,000 catheter days (P.049). Patients in the catheter-exchange group had 3.2 greater odds of infection compared with patients in the removal-replacement group. Five malfunction events occurred in each group, accounting for 2.0 and 1.7 malfunctions per 1,000 catheter days in the catheter-exchange and removal-replacement groups (P.73). Conclusions: exchange of tunneled infusion catheters results in a higher infection rate compared with removal-replacement at a new site. The rate of catheter malfunction is not significantly different between the two groups. exchange is an alternative for patients with tunneled infusion catheters who have limited venous access, but this technique should not be expanded for use in all patients. Because of the size of this initial study, further investigation is needed to verify the results in a larger sample size. ABBREVIATION tpa tissue plasminogen activator Long-term tunneled infusion catheters are commonly used to access the central venous system to administer drugs, deliver total parenteral nutrition, obtain samples for clinical From the Department of Radiology, Division of Interventional Radiology, Hospital of University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA Received September 14, 2010; final revision received January 18, 2011; accepted January 21, Address correspondence to S.W.S.; stav@uphs.upenn.edu None of the authors have identified a conflict of interest. SIR, 2011 J Vasc Interv Radiol 2011; 22: DOI: /j.jvir testing, and perform plasmapheresis. Despite their utility, these central venous catheters carry with them known risk of infection and catheter malfunction (1). related infection can manifest in various forms, the most serious of which is catheter-related bloodstream infections leading to bacteremia and sepsis (2 4). The standard of care for infected tunneled infusion catheters in the setting of bacteremia indicates that they be removed and replaced at a new site (5). Noninfected tunneled infusion catheter malfunction includes intraluminal thrombus, catheter tip occlusion, kinks in the catheter, malposition of catheter tip, and fibrin sheath formation not amenable to tissue-plasminogen activator (t-pa) administration via an indwelling catheter or via

2 Volume 22 Number 5 May infusion. These issues pose additional impediments to the long-term use of central venous catheters and usually result in tunneled infusion catheters being removed and replaced at another site (6,7). Current standards for managing infection of tunneled infusion catheters indicate that over the wire catheter exchange (catheter-exchange) is inappropriate treatment (5). However, in hemodialysis patients, catheter-exchange is considered appropriate for bacteremic patients with tunneled dialysis catheters following an initial trial of parenteral antibiotics, and prior analysis has shown the effectiveness of this technique (6,8). This approach preserves potential future insertion sites and avoids known risks of additional catheter placement (8). Concerns regarding preservation of potential future insertion sites and risks of additional catheter placement raise the question whether catheter-exchange would present an appropriate treatment in certain subsets of patients with tunneled infusion catheters, for whom the concern to preserve venous access may also apply. These subsets include patients requiring long-term total parenteral nutrition (eg, patients with Crohn s disease and short gut syndrome) and patients requiring long-term venous access for antibiotics and other medications (eg, patients with cystic fibrosis and sickle cell anemia). This study aims to assess the safety and effectiveness of catheter-exchange of tunneled infusion catheters by comparing outcomes of patients who had undergone catheter-exchange for catheter infection or malfunction with outcomes of patients who underwent catheter removal and replacement at a new site (removal-replacement). MATERIALS AND METHODS Approval for this retrospective study was granted from the institutional review board at our institution. Using a quality assurance database representing patients from July 2001 to June 2009, 25 patients were identified as having undergone an initial catheter-exchange of a tunneled infusion catheter for infection or malfunction. All patients with complete documentation of catheter-exchange of a tunneled infusion catheter for catheter infection or malfunction within the specified dates were included. Infection was defined as documented catheter tip infection, tunnel infection, or bacteremia. Patients with catheter malfunctions were referred to interventional radiology after t-pa administration via an indwelling catheter was attempted and failed. Chest radiographs were obtained before patients came to interventional radiology to determine if the catheters were malpositioned. Patients with hemodialysis catheters were not included in this study. These were all unique patients undergoing an initial catheter-exchange, and repeat events in same patient were not included in this study. Demographic information for patients is presented in Table 1. Our patients were not found to be statistically different with regard to gender Table 1. Patient Demographics Men Women Mean age (y) Age range (y) Hematologic malignancies Gastrointestinal 9 0 disease (requiring total parenteral nutrition) Plasmapheresis 4 5 Other 2 0 Total indwelling catheter time after exchange (days) 2,509 2,998 distribution (P 1.0, Fisher exact test) or age (P.53, Student t test). exchange for tunneled infusion catheters was done at our institution only in patients with chronic venous occlusions owing to multiple catheter placements and very limited sites for additional venous access who nonetheless also needed long-term access in the future. If removalreplacement would have been done in these patients, loss of a valuable access site would have been extremely likely. Over the same time interval, we identified 36 patients who had undergone removal-replacement of the tunneled infusion catheter (which was our standard method for managing patients with catheters that malfunctioned or were infected) to provide the best comparison with patients undergoing catheter-exchange. All procedures were conducted by attending physicians (with experience ranging from 1 20 years in practice) and supervised interventional radiology fellows in the Division of Interventional Radiology at our institution. The catheter-exchange cohort consisted of 12 men and 13 women with a mean age of 56 years (range, y) (Table 1). Catheters were required in 10 patients for a hematologic malignancy necessitating chemotherapy, bone marrow transplant, or plasmapheresis; in nine patients for a gastrointestinal disorder requiring total parenteral nutrition; in three patients for plasmapheresis for an autoimmune disorder; in one patient for plasmapheresis for heart transplant rejection; and two patients for long-term access for other medications. exchange was done using a standard technique under sterile conditions at our institution. Antibiotics were given (1 g cefazolin intravenously; GlaxoSmithKline, Research Triangle Park, North Carolina) before the procedure. If the catheter was malfunctioning, contrast agent was injected into the malfunctioning catheter to check for fibrin

3 644 versus Guttmann et al JVIR sheath formation. After this, a inch diameter hydrophilic guide wire (Roadrunner; Cook, Inc, Bloomington, Indiana) was placed though the malfunctioning catheter, and the catheter was removed over the wire. If a fibrin sheath was present, over the wire disruption of the fibrin sheath was performed using an occlusion balloon (Flow Directed Balloon Catheter; Cook). Removed catheters included Hickman or Broviac double-lumen or triple-lumen tunneled catheters. A new single-lumen, double-lumen, or triple-lumen tunneled catheter (Hickman central venous catheter; Bard Access Systems, Salt Lake City, Utah) was placed over the wire with the tip of the catheter placed such that it would be positioned at the caval-atrial junction (9). In bacteremic patients with functioning catheters that were suspected to be infected, catheter-exchange was done using the same technique but without contrast agent injection or fibrin sheath disruption. If a tunnel infection was present, the existing venotomy was preserved, and a new tunnel was created (10). The removal-replacement cohort comprised 18 men and 18 women with a mean age of 57 years (range y). Only patients who underwent removal-replacement at a new site on the same day for catheter infection or malfunction were included to provide a closer comparison with the catheter-exchange procedure. As with the catheter-exchange cohort, patients with hemodialysis catheters were excluded from the study. Before the catheters were removed, ultrasonography was performed on the jugular vein to ensure its patency. The catheters were removed, and a new tunneled venous catheter was placed using a new puncture site. In this group, 35 patients had a hematologic malignancy, and one patient with a heart transplant had a catheter placed for transplant rejection. Catheter removals were done using local anesthesia and the traction technique (11) following a sterile preparation. The new tunneled catheters (Hickman central venous catheter) were placed using a separate sterile preparation under sterile conditions as described previously. No procedural complications occurred in either cohort. Hospital charts for each patient were retrospectively reviewed for demographic information, indication for initial catheter placement and replacement, dwell time for the new catheter, and ultimate fate of the new device. Indications for initial catheter replacement were recorded either as infection or as catheter malfunction. Infection included exit site infection, tunnel infection, and bacteremia. Malfunction included catheter breakage, leakage, extrusion, occlusion, and fibrin sheath formation. At our institution, initial treatment for catheter occlusion and fibrin sheath formation is t-pa dwell via the indwelling catheter (12), followed by infusion (13) if needed. Catheter exchange was done only when these treatments failed. Transfemoral fibrin sheath stripping was not attempted, in accordance with current guidelines (6,14). Subsequent catheter events after replacement were recorded as infection, malfunction, successful completion of therapy, patient death, or catheter still in use. Data were analyzed to determine how the replaced Table 2. Catheter Placement (Initial Catheter) (Final Catheter) RIJ LIJ IVC LS RS IVC inferior vena cava, translumbar, LIJ left internal jugular vein, LS left subclavian vein, RIJ right internal jugular vein, RS right subclavian vein. catheters fared over time, and the incidence of catheter infection or malfunction per 1,000 catheter days after replacement was determined. Statistical comparisons between the two cohorts were analyzed using the Kaplan-Meier technique and Fisher exact test, in which infection and malfunction were considered failure events, and successful completion of therapy, patient death, and catheter still in use were considered censored events. Survival comparisons between Kaplan-Meier estimates were performed using the log-rank test. All statistical analyses were performed using GraphPad Prism (GraphPad Software, San Diego, California). RESULTS In both patients with catheter-exchange and patients with removal-replacement, most catheter replacements were due to catheter malfunction after failed repair with tpa administration via an indwelling catheter and infusion, accounting for 21 of 25 (84%) exchanges in the catheter-exchange group and 33 of 36 (92%; P not significant) removals in the removal-replacement group. Of 31 catheters in the removal-replacement cohort, 15 (48.3%) were placed via the opposite-side internal jugular vein. Because of the nature of the procedure, there were no venous access site changes in the catheter-exchange group. Data on location and specifications of catheters placed in each group are presented in Table 2. New catheters lasted a median of 102 days (range, days) in the catheter-exchange cohort, and new catheters placed via removal-replacement lasted a median of 238 days (range days) until a subsequent event (Table 3). However, this difference was not statistically significant (P.12, log-rank test). In both cohorts, most of these events required catheter removal for infection, malfunction, or completion of therapy. Regarding the fates of the new catheters, there were 11 instances of catheter infection in the catheter-exchange group and seven instances in the removal-replacement cohort, accounting for infection rates of 4.4 and 2.3 per 1,000 catheter days (Table 3). This difference was found to be

4 Volume 22 Number 5 May Table 3. Fate of d Catheters Removal for infection 11 7 Removal for malfunction 5 5 Removal for completion of 5 14 therapy Patient death 2 9 Still in place 2 1 Infection rate per 1, catheter days Malfunction rate per 1, catheter days Median catheter dwell (days) until removal for infection or malfunction statistically significant (P.049, Fisher exact test). The odds of catheter infection were 3.2 times higher in the catheter-exchange group than the removal-replacement group (95% confidence interval of odds ratio, ). Five malfunction events occurred in each group, accounting for 2.0 and 1.7 malfunctions per 1,000 catheter days in the catheter-exchange and removal-replacement groups (Table 3). There was no statistically significant difference in malfunction rates between the two cohorts (P.73, Fisher exact test). DISCUSSION exchange is an acceptable treatment for dialysis patients with infected or malfunctioning tunneled dialysis catheters, although it is avoided in patients with tunneled infusion catheters (5,6). This distinction is made because patients with tunneled infusion catheters are often immunocompromised and may be more prone to infection than dialysis patients (5,15). However, in patients with tunneled infusion catheters and poor venous access owing to chronic venous occlusions, catheter removal-replacement may not be a viable option. Removing a tunneled catheter in a patient with limited venous access could risk losing a valuable, and possibly final remaining, venous access site. We sought to determine whether catheter-exchange is a viable option for patients with tunneled infusion catheters and catheter infection or malfunction along with poor venous access. The malfunction rates in catheter-exchange versus removal-replacement do not differ significantly, confirming that catheter-exchange does not pose a substantial risk of catheter malfunction compared with removal-replacement. The malfunction rates we observed in this study compare favorably with data on malfunction rates in new catheter placement from other studies, which report rates ranging from per 1,000 catheter days (16 19). Our data suggest a statistically significant increased infection rate for tunneled infusion catheters exchanged over the wire compared with catheters removed and replaced and a 3.2-fold higher odds of infection. However, the higher infection rate we observed in catheter-exchange remains only marginally beyond the upper limits of infection in new catheter placement reported elsewhere (16 19). Also, although we observed longer median catheter dwell times before infection or malfunction in the removal-replacement group, this difference was not statisitically significant. exchange may be considered acceptable in subsets of patients with a need for long-term venous access who may have limited venous access elsewhere because of chronic venous occlusions from placement of prior central venous catheters. These subsets could include patients needing long-term venous access for short gut syndrome, certain malignancies, and plasmapheresis, among other conditions. Given that our patient population remains largely immunocompromised, our findings might have been expected. It is reasonable to assume that our patients would be slightly more susceptible to infection because their immune function is impaired. Our study compares two fairly wellmatched patient populations who do not differ significantly by age, gender distribution, or indwelling catheter time. There are limitations to this study, however, because of the small sample size and retrospective design. A study with higher power from a larger sample size might reveal statistically significant differences that we could not achieve in this study. In addition, the two cohorts are not perfectly matched by diagnosis. Such a comparison would help to compare patient survival and susceptibility to infection or malfunction better between the two groups. In conclusion, catheter-exchange of tunneled infusion catheters results in a higher infection rate compared with removal-replacement at a new site. The rate of catheter malfunction is not significantly different between the two groups. exchange presents a reasonable alternative for patients with tunneled infusion catheters who have limited venous access, but this technique should not be expanded for use in all patients. Because of the size of this initial study, further investigation is needed to verify the results in a larger sample size. 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5 646 versus Guttmann et al JVIR 5. O Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. MMWR Recomm Rep 2002;51: National Kidney Foundation. K/DOQI clinical practice guidelines for vascular access. Am J Kidney Dis 2006;48:S Naufel D, Salazar-Bianco G, Faintuch S, Rabkin D. Malfunction of dialysis catheters: management of fibrin sheath and related problems [abstract]. J Vasc Interv Radiol 2009;20:S Tanriover B, Carlton D, Saddekni S, et al. Bacteremia associated with tunneled dialysis catheters: comparison of two treatment strategies. Kidney Int 2000;57: Schutz J, Patel A, Clark T, et al. Relationship between chest port catheter tip position and port malfunction after interventional radiologic placement. J Vasc Interv Radiol 2004;15: Beathard GA. Management of bacteremia associated with tunneledcuffed hemodialysis catheters. J Am Soc Nephrol 1999;10: Kohli MD, Trerotola SO, Namyslowski J, et al. Outcome of polyester cuff retention following traction removal of tunnelled central venous catheters. Radiology 2001;219: Savader SJ, Ehrman KO, Porter DJ, Haikal LC, Oteham AC. Treatment of hemodialysis catheter-associated fibrin sheaths by rt-pa infusion: critical analysis of 124 procedures. J Vasc Interv Radiol 2001;12: Semba CP, Deitcher SR, Li X, Resnansky L, Tu T, McCluskey ER. Treatment of occluded central venous catheters with alteplase: results in 1,064 patients. J Vasc Interv Radiol 2002;13: Gray R, Levitin A, Buck D, et al. Percutaneous fibrin sheath stripping versus transcatheter urokinase infusion for malfunctioning well-positioned tunneled central venous dialysis catheters: a prospective, randomized trial. J Vasc Interv Radiol 2000;11: Rotstein C, Brock L, Roberts RS. The incidence of first Hickman catheter-related infection and predictors of catheter removal in cancer patients. Infection Control Hosp Epidemiol 1995;16: Kaufman LJ, Clark TW, Roberts DA, et al. Do simultaneous bilateral tunneled infusion catheters in patients undergoing bone marrow transplantation increase catheter-related complications? J Vasc Interv Radiol 2004;15: Lee SH, Hahn ST. Comparison of complications between transjugular and axillosubclavian approach for placement of tunneled, central venous catheters in patients with hematological malignancy: a prospective study. Eur Radiol 2005;15: Robertson LJ, Mauro MA, Jaques PF. Radiologic placement of Hickman catheters. Radiology 1989;170: Trerotola SO, Kuhn-Fulton J, Johnson MS, Shah H, Ambrosius WT, Kneebone PH. Tunneled infusion catheters: increased incidence of symptomatic venous thrombosis after subclavian versus internal jugular venous access. Radiology 2000;217: CME TEST QUESTIONS The CME questions in this issue are derived from the article Malfunctioning and Infected Tunneled Infusion Catheters: Over-the-Wire Catheter versus Catheter Removal and by Guttmann et al. 1. Over-the-wire catheter exchange: a) Is considered appropriate for tunneled infusion catheters, according to current standards. b) Is suitable treatment for septic patients with tunneled hemodialysis catheters. c) May be a reasonable alternative for patients with tunneled infusion catheters who have limited venous access. d) Is a safe and effective technique for all patients with tunneled venous catheters. 2. The main goal of over-the-wire catheter exchange is: a) To reduce risk of infection. b) To preserve venous access sites for future catheters. c) To reduce risks of central venous puncture in highrisk patients. d) To reduce procedural costs by performing only one procedure, instead of two. 3. In this study: a) Only catheter-exchange patients were given preprocedure antibiotics. b) Fibrin sheath disruption was always performed on catheter-exchange patients. c) A new tunnel was routinely created in the catheterexchange group. d) In the remove-replace group, only those having both procedures the same week were included. 4. Findings of this study include: a) The most common indication for placement of a new catheter was infection in both groups. b) Newly placed catheters lasted a similar amount of time in both groups. c) Catheter infection was significantly higher in the catheter-exchange group. d) There was a significantly higher rate of catheter malfunction in the catheter-exchange group.