Chronic Hemodialysis Catheters: Does Design Matter? Hans Van Der Meersch, AZ Sint-Jan Brugge and UZ Gent

Transcription

1 Chronic Hemodialysis Catheters: Does Design Matter? Hans Van Der Meersch, AZ Sint-Jan Brugge and UZ Gent

2 Vascular Access and Mortality Ravani et al. JASN. Feb 2013

3 Vascular Access and Patient Characteristics * * * * 20 * * Fistula Catheter 10 * P Value < incident patients in DOPPS I-III

4 Vascular Access and Mortality 5-year mortality by vascular access type (USRDS data; incident HD patients aged years) Model HR (95% CI) P-value Catheter vs fistula Catheter vs fistula Unadjusted 1.95 ( ) <0.001 Adjusted 1.54 ( ) <0.001 Adjusted for age, gender, race, BMI, comorbidity, Medicaid insurance and nephrology care prior to dialysis initiation; health status (functional status and hospital days 2 years prior to dialysis initiation) Grubbs et al. Nephrol Dial Transplant Nov 2013

5 Catheter Use in Prevalent HD Patients 60 DOPPS 4 (2011): Catheter use at cross-section K/DOQI guideline <10% 0

6 Vascular Access in Vlaanderen (2010) Catheter Graft AV fistel 50% 47% 3%

7 Chronic Hemodialysis Catheters: Multiple Options Evidence?

8 Catheter(tip) Design Dual catheter system (e.g. Tesio ) Split Tip catheter (e.g. Ash Split Tip ) Staggered tip (e.g. Hemostar, Optiflow ) Symmetrical tip catheter (e.g. Palindrome )

9 Side Holes vs. No Side Holes Tal et al. Hemodialysis Int 2006 Side hole catheters: more adherent clots on removal higher CRBI ~ reduced catheter survival higher blood flow rates (NS)

10 Catheter Design KDOQI Catheter choice should be based on local experience, goals for use, and cost (2006) KDIGO No recommendation ERBP No recommendation

11 Catheter Use RIZIV (Vlaanderen, 2012): new tunneled cuffed hemodialysis catheters Estimate Vlaanderen 31% 29% 4% 36% Dual catheter Staggered tip Split tip Symmetric tip

12

13 HD Catheter Design and Performance: a RCT Van Der Meersch H et al. Am J Kidney Dis, in press Inclusion criteria All patients (male or female, age 18 years) on hemodialysis who required a TCC as temporary or definite vascular access were eligible 302 TCC randomized Hemostar (n=151) - Lumen: double D - Diameter: 14,5 Fr - Material: carbothane - Tip: 3cm stepped tip - Side holes: machine punched Palindrome (n=151) - Lumen: double D - Diameter: 14,5 Fr - Material: carbothane - Tip: symmetrical - Side holes: laser cut Mean follow up period: days Hemostar : catheterdays / Palindrome : catheterdays

14 Palindrome vs Hemostar Hemostar Palindrome Palindrome Hemostar Machine punched side hole Laser cut side slot Symmetric tip Step tip

15 Machine-punched vs Laser-cut Side Holes Rugged surface of the machine drilled side hole Melted surface of laser cut side slot

16 HD Catheter Design and Performance: a RCT Van Der Meersch H et al. Am J Kidney Dis, in press Primary endpoint Event-free catheter survival Incidence of CRBI (/1000 catheterdays) Incidence of thrombosis requiring removal (/1000 catheterdays) Secondary endpoints Mean blood flow rate Need for thrombolysis in dysfunctional catheter Rheological performance

17 Outcome Palindrome Hemostar Recovery of renal function Transfer to PD Maturation vascular access Kidney transplant Death Lost to follow up Accidental removal/damage Removal for thrombosis Removal for infection

18 Removal for Infection or Thrombosis Hemostar (n= 151) Palindrome (n= 151) Catheter removal for - total infection (number) - definite CRBI (number) 3 (2.0%) 2 (1.3%) 10 (6.6%) 5 (3.3%) P=0.09 P=0.5 Total infection rate Definite CRBI rate (/1000 catheter days) P=0.08 P=0.3 Catheter removal for thrombosis (number) 9 (6.0%) 11 (7.3%) P=0.82 Thrombosis rate (/1000 catheter days) P=0.69 Reported incidence of CRBI: Lafrance et al. (AJKD 2008): /1000 catheterdays Reported incidence of thrombosis: Lee et al. (AJKD 2005): 1.1/1000 catheterdays Xue et al. (AJKD 2013): 1.05/1000 catheterdays

19 Infection- and Thrombosis-free Catheter Survival Mean primary assisted patency: Hemostar: days Palindrome: days

20 Rheological Performance Hemostar (n= 151) Palindrome (n= 151) Blood flow rate, ml/min Mean (SD) Urokinase use /1000 catheter days Never need of urokinase, number (32.3) (24.2) P< P< (45.0%) 88 (58.3%) P=0.03

21 Conclusions Van Der Meersch H et al. Am J Kidney Dis, in press Catheter survival excellent no statistical difference between both groups Incidence of CRBI and thrombosis very low in both catheter types compared to literature data no statistical difference between both groups Rheological performance: better for Palindrome higher blood flow rates less thrombolysis for patency

22 Strategies to Prevent Catheter Dysfunction / Infection Catheter care~ Chlorexidine 2% S aureus carriage => Mupirocin CATHETER MANAGEMENT Lock solution~ Citrate 30% Pre-emptive catheter salvage

23 Catheter Care Beathard. Catheter managment protocol for catheter-related bacteremia profylaxis. Seminars in Dialysis. Sept 2003

24 Catheter Care: Chlorhexidine 2% in 70% alcohol CDC guideline 2011: 2% chlorhexidine Rosenblum et al. AJKD 2014 Adams et al. J Hosp Infect 2005

25 S. aureus Carriage Eradication PRO Theoretical rationale S. aureus nasal carriage in HD: 35 62% S. aureus ~ 20% to 68.6% of CRBI Nasal and infectious strain mostly identical Observational studies Boelaert (NDT 1993): Fourfold reduction in S. aureus bacteremia Kluytmans (Infect Control Hosp 1996): Fivefold reduction in S. aureus bacteremia CONTRA No RCT s Frequent recolonisation 3 month post-therapy: relapse rate 20-77% Emergence of mupirocin resistance Cost-effective

26 Catheter Locking Agents Catheter Dysfunction

27 Catheter Locking Solution: Antimicrobial Activity Weijmer et al. NDT 2002

28 Catheter Locking Agents: CRBI Allon et al. AJKD 2008, 51,

29 Catheter Locking Agents: Thrombolytics Pre-CLOT study: Heparin lock 5000IU/ml 3x/week vs. rt-pa 1mg for midweek session Hemmelgarn et al. NEJM 2011 rt-pa: Citrate 30%: 46/lock 1/lock

30 Pre-emptive Catheter Salvage: K-DOQI guidelines Prepump -250mmHg to achieve BFR 300 ml/min Unable to attain BFR 300 ml/min for >30 min Decrease in blood flow >10% =CATHETER DYSFUNCTION

31 Pre-emptive Catheter Salvage No Lumen open Unsuccesfull Lumen open Unsuccesfull Urokinase infusion protocol 1 flacon IU over 30min IV per lumen Urokinase lock protocol 1 flacon IU divided over both lumina Yes

32 Future in HD Catheter Design Surface-treated Catheters? Surface-treated Catheters Antithrombotic coating ~Heparin coating Carmeda Bioactive Surface (CBAS) Heparin molecules covalently bonded in an endpoint fashion to surface Antimicrobial coating -Antibiotic: minocycline/rifampicin -Chlorhexidine/silver sulfadiazine -Silver impregnation Trillium Biosurface Hydrophilic polyethylene oxide layer with heparin covalently bonded

33 Surface-treated Catheters EVIDENCE in HAEMODIALYSIS SETTING?? *Most data from critical care community *Lack of data long-term catheterization

34 Conclusions Catheter design No proven impact on catheter survival, infection rate or thrombosis rate Impact on rheological performance Future: coated catheter? Catheter management more important in reducing complications Optimal catheter care Nasal decontamination Lock solution Pre-emptive salvage of mechanical catheter dysfunction

35

36 Cost Chlorhexidine 2% in isopropanol Firma: Fagron NV Kostprijs / per stuk: 1,54. Citralock Firma Dirincro Per stuk: 1 Actosolv (1 flacon IU) In case of hospitalisation: for patient Ambulant: for patient Chronic dialysis catheters article 35 Implants and long term invasive medical devices ( KB 02/04/2009) U230= 237,55 under closed envelop Palindrome 171 euro + 6% btw = 181,26 euro Hemostar 171,36 euro + 6% btw= 181,64 euro

37 RCT s comparing catheters Atherikul etl al. (1998): RCT of PermCath, Tesio, VasCath Permcath and Tesio had comparable blood flows (383 and 396 ml/min), significantly higher than Vas Cath (320 ml/min) No data on catheter survival Trerotola et al. (1999): RCT of Hickman and Ash split Split-tip catheter is capable of higher flow rates (QbMax 422 vs. 352 ml/min) Richard et al. (2001): RCT of Tesio (36), Opti-flow (39) and Ash-split (38) Opti-Flow and Ash split catheters were faster and easier to place than Tesio catheters No significant difference in flow rates No significant difference in catheter survival Trerotola et al. (2002): RCT of Opti-flow and Ash-split Higher blood flow rates with Opti-Flow (QbMax 433ml/min vs. 414ml/min) Lower recirculation with Ash-Split Better survival with Ash-Split (although no significant reduction in thrombosis or infection)

38 Palindrome catheter Kakkos et al. (J Vasc Interv Radiol 2008) Retrospective HemoSplit TCC with BioBloc (silver sulfadiazine) coating (n = 100, control group) and the Tal Palindrome Ruby TCC (silver antimicrobial sleeve) (n = 100, study group) Primary-assisted TCC patency was significantly reduced with the BioBloc TCC (71% and 61% at 90 and 180 days) compared with the Palindrome Ruby TCC (94% at 90 and 180 days, P <.0001) The infection-free rates of the two TCC types were similar (P =.36) Spector et al. (J Vasc Interv Radiol 2008) Observational study Catheter-related infections occurred in 16 of the 115 catheters (13.9%) during the study period and cultureproved bacteremia occurred in four (3.5%). Seven exit site infections were recorded, and 10 catheters (8.7%) developed fibrin sheaths that necessitated catheter exchanges. Hwang et al. (Semin Dial 2012) RCT (97 patients: palindrome catheter group (PC, n = 47) and step-tip catheter group (SC, n = 50)) effective blood flow rates at different pump speeds were comparable between the two groups Line reversal=>the recirculation was significantly increased in SC, it was not increased at all in PC overall catheter survival rate was also higher in PC than in SC (90.6% vs. 68.8% at 2 months, p = 0.015)

39 Use of urokinase in restoration catheter patency Twardowski Am J Kidney Dis 1998

40 Weijmer et al. (JASN 2005): RCT comparison of TSC 30% and heparin Multicenter double blind RCT 291 patients (98 tunneld cuffed catheters; 193 untunneled); total of catheterdays Heparin: 46% of catheters removed because of any complication TSC 30%: 28% of catheters removed because of any complication Heparin: TSC 30%: CRBI 4.1/1000 catheter days CRBI 1.1/1000 catheter days Risk reduction for CRBI in tunneled cuffed catheters: 87% Risk reduction for CRBI in untunneled catheters: 64% No difference in catheter flow problems and thrombosis

41 Weijmer et al. (JASN 2005): RCT comparison of TSC 30% and heparin

42 Catheter Locking Solution: Biofilm Formation Influence of catheter locking solution on S. aureus biofilm formation Reduction of biofilm formation in HD catheters: a RCT Heparin Heparin Citrate 30% Citrate 30% Average Biofilm coverage 63% Average Biofilm coverage 62% Shanks et al. Infect Immun 2005 Shanks et al. NDT 2006 Bosma et al. NDT 2010 Average Biofilm coverage 16%

43 Catheter Locking Solutions Gentamycin-Resistant bacteremia in HD patients Receiving Gentamicin Lock Profylaxis Landry et al. CJASN 2010

44 Citrate containing catheter locks CRBI

45 Citrate containing catheter locks: thrombolysis

46 Cochrane: preventing infectious complications in HD patients with central venous catheters *Mupirocin ointment -reduced the risk of catheter-related bacteraemia (RR 0.17, 95% CI 0.07 to 0.43) -reduces catheter-related infections caused by S. aureus. *Polysporin and povidone-iodine -reduces the risk of catheter-related bacteraemia (lack of high quality evidence; need of larger RCT) polysporin (RR 0.40, 95%CI 0.19 to 0.86) povidone-iodine ointment (RR 0.10, 95%CI 0.01 to 0.72) *Topical honey did not reduce the risk of exit site infection (RR 0.45, 95%CI 0.10 to 2.11) or catheter-related bacteraemia (RR 0.80, 95%CI 0.37 to 1.73). *Transparent polyurethane dressing compared to dry gauze dressing did not reduce the risk of CVC or exit site infection, or catheter-related bacteraemia.

47 Surface-treated Catheters ICU setting or (haemato-) oncology Short CVC dwell time (mean 4 to 22 days) CDC guidelines 2011 Use a chlorhexidine/silversulfadiazine or minocycline/ rifampin -impregnated CVC in patients whose catheter is expected to remain in place >5 days if, after successful implementation of a comprehensive strategy to reduce rates of CRBI, the CRBI rate is not decreasing. (category IA) Gilbert et al. Cur Opin Infect Dis 2008

48 Bambauer et al. (Int J Nephrol 2012): silver-coated catheters showed no significantly reduction in infection rate in this retrospective study. Coated Catheters in Hemodialysis * Heparin coated tunneled HD catheters * Silver coated tunneled HD catheters Trerotola et al. (Radiology 1998): Infection and colonization rates were slightly but not significantly higher in the treatment group than in the control group. Silver-coated catheters in two (4%) patients were removed due to reaction to the coating.