Successful Treatment of a LifeSite Hemodialysis Access System Pocket Infection With Large-Volume Kanamycin Solution Irrigation John R. Ross Bridge devices— dialysis catheters and subcutaneous access devices—play a critical role in increasing the placement of arteriovenous (AV) fistulas by providing hemodialysis vascular access while AV fistulas mature. The LifeSite Hemodialysis Access System (Vasca Inc, Tewskburg, MA), a fully implantable, subcutaneous dual valve access system, has been shown to have lower complication rates, higher blood flow rates, and better long-term device survival than conventional tunneled hemodialysis catheters, indicating it may better meet the requirements for optimally bridging to a fistula. This case study of a 48-year-old black man undergoing chronic hemodialysis for renal failure because of insulin-dependent diabetes describes a simple approach for resolving localized pocket infections associated with the LifeSite System by drip irrigation of the valves and tissue pockets with an antibiotic solution. Eight weeks after implantation of the LifeSite System, the patient exhibited symptoms of infection of the lateral LifeSite valve tissue pocket, which on culture was shown to be caused by Staphylococcus aureus. Flushing the LifeSite valve and tissue pocket with a large volume of kanamycin solution, in conjunction with intravenous vancomycin and routine irrigation of the valve with isopropyl alcohol, resolved the infection after 1 treatment. The LifeSite System successfully bridged the patient to a transposed basilic vein fistula created through a 2-stage surgical procedure. The LifeSite System provided uninterrupted access for hemodialysis over a period of 6 months while the fistula matured. The LifeSite System should allow surgeons to attempt fistula construction in more patients, including diabetics, access-challenged patients, and patients with small vessels, who may benefit from a nontraditional surgical approach toward fistula creation. Index Words: Hemodialysis; LifeSite; Subcutaneous access device © 2003 by the National Kidney Foundation, Inc.
ridge devices play a critical role in increasing the placement of arteriovenous (AV) fistulas by providing hemodialysis vascular access while AV fistulas mature. An optimal bridge device will provide a high blood flow rate, a low complication rate, and a high device survival rate, ensuring effective vascular access with no need to remove or replace the bridge device before the AV fistula matures and can be successfully cannulated. An effective bridge device is particularly important in patients who experi-
From the Department of General Surgery, Bamberg County Hospital, Bamberg, SC. Address reprint requests to John R. Ross, MD, Bamberg County Hospital, General Surgery, PO Box 507, Bamberg, SC 29003. © 2003 by the National Kidney Foundation, Inc. 1073-4449/03/1003-0012$30.00/0 doi:10.1053/j.arrt.2003.08.004
ence prolonged fistula maturation time before use of a new AV fistula. Current guidelines suggest a minimum fistula maturation time of 3 to 4 months,1 with many patients requiring a longer bridge period. The requirement for a longer maturation period may result from the need to place a second fistula when a primary fistula fails to mature or from the use of alternative fistula approaches such as an autogenous upper arm brachial-basilic transposition (basilic vein transposition) or a nontraditional (eg, 2-stage) fistula. These alternative approaches may be appropriate in patients generally considered ineligible for fistula placement such as patients with poor vasculature because of diabetes or patients with diminutive vessels.2,3 Several authors have recently reported improved outcomes with the LifeSite Hemodialysis Access System, a fully im-
Advances in Renal Replacement Therapy, Vol 10, No 3 (July), 2003: pp 248-253
LifeSite Hemodialysis Access System
plantable, subcutaneous dual valve system.4-12 Reports to date have suggested that the use of this device is associated with a lower complication rate,6,8-11 higher blood flow rates,9,10 and better long-term device survival compared with tunneled hemodialysis catheters.7-9,11 These results indicate that the LifeSite System may better meet the requirements for optimally bridging to a fistula, particularly those that require longer maturation periods.7,9,11,12 The subcutaneous placement of the LifeSite System combined with the localized irrigation of the LifeSite valve and valve pocket with 70% isopropyl alcohol before and after each hemodialysis session account for the lower rate of infectious complications with this device compared with tunneled hemodialysis catheters.9-11 Recent reports have also indicated that many LifeSite device-related infections can be resolved effectively without the removal or exchange of the LifeSite valve or cannula,11,13 whereas catheter infections generally require catheter removal.1,14-16 A 3-step algorithm has been described for treating through infections without the need for removal of the LifeSite device.13,17 This case study describes a novel approach for resolving localized pocket infections associated with the LifeSite System by flushing the valve and tissue pocket with a large volume of antibiotic solution via drip irrigation (Fig 1). This approach has prevented the need for removal of the LifeSite device in patients with pocket infections and allowed for the maintenance of functional vascular access without the need for a surgical procedure. We have performed this procedure when a local pocket infection is suspected as a result of positive cultures being obtained from the LifeSite valve or tissue pocket. The 3-step algorithm for treating through LifeSite-related bacteremias should be fol-
Figure 1. Flow chart for treatment of localized LifeSite value or tissue pocket infection by largevolume kanamycin solution irrigation.
lowed as well if blood cultures are positive.13,17 Patient History The patient was a 48-year-old black man undergoing chronic hemodialysis for renal failure because of insulin-dependent diabetes. Concurrent conditions included coronary artery disease and peripheral vascular disease. The patient experienced multiple hemodialysis access failures over the previous 2 years, including a failed Cimino fistula, an infected polytetrafluoroethylene AV graft, and 2 dialysis catheters. After his most recent access failure, the patient was reassessed for fistula creation. The patient had very small veins; the basilic vein diameter was 2 mm as deter-
John R. Ross
mined by duplex ultrasound. A standard (1-step) fistula creation was attempted in the antecubital area with an end-to-side anastomosis between the basilic vein and brachial artery, with the assumption that if this first fistula did not develop sufficiently, the partially matured fistula could be transected subsequently and the dilated basilic vein dissected and mobilized up to the axilla for use in the construction of a transposed basilic fistula (2-stage procedure). This was indeed the scenario that developed. At 2 months after the initial fistula creation, the second stage procedure was performed. The dialysis catheter initially used as a bridge device developed recurrent problems with low flow rates (⬍200 mL), limiting dialysis adequacy. At 3 months after initial fistula creation, the decision was made to implant the LifeSite System as a bridge device to allow high-flow hemodialysis access while awaiting maturation of the fistula. The LifeSite System was implanted under conscious sedation using sterile technique according to the manufacturer’s guidelines.17 LifeSite valves were implanted side-by-side below the right clavicle. The cannulas were inserted using the Seldinger technique and tunneled to the right internal jugular vein; the tips were positioned in the right atrium. There were no untoward events associated with implantation, and the patient achieved a flow rate of 450 mL/min immediately postoperatively; the patient proceeded to conventional high flux, incenter hemodialysis. Eight weeks after implantation of the LifeSite System, the patient developed a fever of 101.5°F and localized symptoms of infection (tenderness and purulent exudation) of the lateral LifeSite valve tissue pocket after moderate subcutaneous fluid collection above the valve. Exudate expressed from the pocket was cultured and found positive for Staphylococcus aureus. Blood cultures were negative, indicating
the infection was localized and not systemic. Systemic antibiotic administration was begun with intravenous vancomycin, 1 g/wk for 3 weeks. To accelerate recovery and reduce the risk of device removal, a novel technique was used to flush the LifeSite valves and tissue pockets with a large volume of antibiotic solution. Although only 1 valve site showed evidence of infection, both valves were flushed with antibiotics to avoid the possibility of overflow contamination from 1 valve pocket to the other during irrigation. Before and after the irrigation procedure, the valves were disinfected with 70% isopropyl alcohol according to the manufacturer’s instructions. Methods Procedure Description Large-volume drip irrigation of the LifeSite valves with kanamycin solution was performed as follows. The contents of a 1 g vial of kanamycin were added to a 500-mL bag of normal saline and mixed thoroughly. Two 3-mL syringes with 1-inch 25-gauge needles were filled with 1 ml of 70% isopropyl alcohol. Each access site was cleansed with a topical disinfectant according to standard procedure for the LifeSite System. The valve and valve pockets were then irrigated with approximately 1 mL of 70% isopropyl alcohol with a 1-inch 25-gauge needle connected to sterile syringes following the manufacturer’s instructions.17 After isopropyl alcohol disinfection, a 25-gauge needle connected via standard intravenous tubing to one of the 500 mL bags containing 1 g kanamycin was inserted into the each LifeSite valve through the established valve access (buttonhole) site. The solution was allowed to drip freely by gravity, flushing the valve and tissue pocket with the entire volume. The fluid that flushed back out through the needle tract was absorbed by multiple
LifeSite Hemodialysis Access System
chux throughout the procedure. This procedure was performed on both valves simultaneously, with the 500-mL bag hung on a standard intravenous pole at a height of 1.0 to 1.2 m and the patient in a supine recumbent position. It is essential that only 25-gauge needles be used because a larger gauge needle (eg, 21-gauge needle, Huber needle, standard dialysis needle) may partially or fully actuate the LifeSite valve’s internal pinch clamp. Some larger gauge needles may also become lodged in the valve mechanism. Unintended opening of the LifeSite valve’s pinch clamp would allow for the inadvertent systemic administration of the antibiotic solution. It is important that this scenario be avoided because there is an increased risk of ototoxicity with the systemic use of aminoglycosides in patients with impaired renal function in conjunction with vancomycin. After the valves were flushed with 500 mL of the antibiotic solution, the valves, tissue pockets, and needle tracts were again cleansed with isopropyl alcohol as described earlier. The total procedure takes approximately 3 hours and can be performed by a physician or an appropriately trained nurse in the dialysis unit or an outpatient area. Results Flushing the infected LifeSite valve and tissue pocket with a large volume of kanamycin solution, in conjunction with intravenous vancomycin and routine irrigation of the valve with isopropyl alcohol, resolved the infection after 1 treatment. No recurrence of infection was seen. The patient was able to continue using the LifeSite System for an additional 4 months while the transposed fistula matured. The LifeSite System successfully bridged the patient to a transposed basilic vein fistula, providing uninterrupted access for hemodialysis over a period of 6
months, permitting development of a high-flow native fistula created with a 2-stage surgical procedure in a challenging patient. Discussion Ideally, a bridge device should not need to be replaced during the time when a patient’s AV fistula is maturing. The device should bridge the patient to the clinical goal—a successful fistula— even when many months of fistula maturation are required. The time period for successful placement and maturation of AV fistulas may be extended in late referral patients who receive minimal pre– end-stage renal disease care and access planning before the start of dialysis and in patient groups who may have a high primary AV fistula failure rate. Of the bridge devices currently available, the LifeSite System comes closest to this ideal. A lower rate of infection is seen with the LifeSite device as compared with hemodialysis catheters.6,8-11 When infections occur with the LifeSite System, they are typically with less virulent organisms,9 and clinicians have the ability to treat through most infections without removing or exchanging the device.11,13 The procedure described in this report offers another means to treat through localized tissue pocket infections associated with the LifeSite System without device removal. This procedure can be used in patients with localized valve or pocket infections. It may be particularly useful when valve pocket cultures are positive for S aureus and blood cultures are negative. If blood cultures are positive, indicating bacteremia, the 3-step algorithm should be applied with sound clinical judgment regarding device removal.13,17 The success of the procedure should be determined by examination of subsequent
John R. Ross
cultures of exudate expressed from the tissue pocket. Ultimately, the final measure of success is achieving the goal of an uninterrupted bridge to a mature fistula. This report describes the successful use of large-volume drip irrigation with kanamycin solution to treat localized infection of the LifeSite valve and tissue pocket in a single patient. We have successfully used this same technique in 9 other patients (infecting microorganisms included S aureus, n ⫽ 7, one of which was methicillinresistant; Enterococcus sp, n ⫽ 1; Pseudomonas aeruginosa, n ⫽ 1). Additional studies will be required to determine when to repeat the procedure (if necessary), when to remove the device (if necessary), and when to apply this protocol in conjunction with the treat-through algorithm described by Moran et al.13 The efficacy of other irrigation solutions could also be assessed by further studies. It is possible that the large-volume irrigation is the critical factor in the success of this technique, and large-volume irrigation with normal saline or other antimicrobial solutions may be equally effective. In conclusion, by using a simple flushing protocol in conjunction with intravenous vancomycin administration, we were able to resolve localized infection of the LifeSite valve and tissue pocket without the need for device removal and maintain high-flow vascular access over 4 months while a 2-stage transposed basilic vein fistula matured. Optimizing this protocol should allow more bridge devices to be maintained over longer periods of time. The LifeSite System, with its low infection rate and protocols to treat through infections, should allow surgeons to attempt fistula construction in more patients, including diabetics, access-challenged patients, and patients who have small vessels requiring longer fistula maturation times.
References 1. NKF-K/DOQI clinical practice guidelines for vascular access: Update 2000. Am J Kidney Dis 37:S137-181, 2001 2. Ascher E, Hingoran A, Gunduz Y, et al: The value and limitations of the arm cephalic and basilic vein for arteriovenous access. Ann Vasc Surg 15:89-97, 2001 3. Dixon BS, Novak L, Fangman J: Hemodialysis vascular access survival: upper-arm native arteriovenous fistula. Am J Kidney Dis 39:92-101, 2002 4. Kameneva MV, Marad PF, Brugger JM, et al: In vitro evaluation of hemolysis and sublethal blood trauma in a novel subcutaneous vascular access system for hemodialysis. ASAIO J 48:3438, F-P0844, Nov 1, 2002 5. Khilnani R, Fox D, Giangola G, et al: Rates of infection and efficacy of the Lifesite威 Hemodialysis Access System (abstract). American Society of Nephrology Annual Meeting, Philadelphia, PA, F-P0844, Nov 1, 2002 6. Moran J, Pedan A, Patz M: Device related infection rate: a comparison of the LifeSite威 Hemodialysis Access System versus the Tesio-Cath hemodialysis catheter (abstract). American Society of Nephrology Annual Meeting, Philadelphia, PA, F-P0822, Nov 1, 2002 7. Moran J, Pedan A, Patz M: LifeSite威 Hemodialysis Access System versus the Tesio-Cath hemodialysis catheter: A comparison of one year device survivals (abstract). American Society of Nephrology Annual Meeting, Philadelphia, PA, F-P0823, Nov 1, 2002 8. Capling RK, Ziyad AAM, Gellens M, et al: Clinical utility of LifeSite威 Hemodialysis Access Systems: Comparison of outcomes between LifeSites and tunneled catheters (abstract). American Society of Nephrology Annual Meeting, Philadelphia, PA, 2002 9. Schwab SJ, Weiss MA, Rushton F, et al: Multicenter clinical trial results with the LifeSite威 Hemodialysis Access System. Kidney Int 62: 1026-1033, 2002 10. Moran JE: Subcutaneous vascular access devices. Semin Dial 14:452-457, 2001 11. Haynes BJ, Quarles AW, Vavrinchik J, et al: The LifeSite威 Hemodialysis Access System: Implications for the nephrology nurse. Nephrol Nurs J 29:27-33, 2002 12. Ross J: Bridging to a high flow upper arm
LifeSite Hemodialysis Access System
native fistula for hemodialysis with the LifeSite威 Hemodialysis Access System. J Vasc Access 2:139-144, 2001 13. Moran J, et al: Effectiveness of a treatment algorithm for treating through infections in patients implanted with the LifeSite威 Hemodialysis Access System. J Am Soc Nephrol 12: 298A, 2001 (abstr) 14. Marr KA, Sexton DJ, Conlon PJ, et al: Catheter-related bacteremia and outcome of attempted catheter salvage in patients under-
going hemodialysis. Ann Intern Med 127:275280, 1997 15. Saad TF: Bacteremia associated with tunneled, cuffed hemodialysis catheters. Am J Kidney Dis 34:1114-1124, 1999 16. Saad TF: Central venous dialysis catheters: catheter-associated infection. Semin Dial 14:446-51, 2001 17. Vasca, Inc.: LifeSite威 Hemodialysis Access System—Instructions for Implantation and Use. 1-22, 2002