2/29/2012

1

Bioactive Hemodialysis

Catheter Coatings: Latest Data

Amy Dwyer, MD

Associate Professor of Medicine

Director, Interventional Nephrology

University of Louisville

Causes of Catheter Failure

Infection Fibrin SheathThrombosis

It’s All About the Biofilm

Melbourne Dermatology

80% micro-organisms

20%

Normal Microbial Skin Counts

Antecubital space

10 colony-forming units/cm2

Subclavian and Internal Jugular veins

1000-10,000 colony-forming units/cm2

Ryder, MA. Topics in Advanced Practice Nursing Journal, 2005

Seminars in Dialysis, Volume 22 (3), 2009 PP. 297-299

3162 procedures

Prophylaxis probably not warranted except

PD catheter procedures

Accidently extruded tunneled catheter placement

2/29/2012

2

protein

Ou

ter C

ath

ete

r Su

rfac

e

B

platelet

B

Blood Space

WBC

SDS PAGE preparation of the outer membrane proteins of Pseudomonas aeruginosa cells in planktonic and biofilm states.

www.montana.biofilm.edu

Ryder, MA. Topics in Advanced Practice Nursing Journal, 2005

protein

Ou

ter C

ath

ete

r Su

rfac

e

B

platelet

WBC

B

Blood Space

BB

B

B

B

B

B

B

B

B

B

B

B

B

B

B

B

Medical Devices Associated with Biofilm Infections

Catheters Implants Devices

Central venous catheters Pacemaker and leads Biliary stents

Hemodialysis catheters Arteriovenous shunts Mechanical heart valves

Pulmonary artery catheters Spinal implants Fracture fixation devices

Arterial catheters Penile implants Joint prosthesis

Urinary catheters Breast implants Vascular grafts

Peritoneal dialysis catheters Orothopedic implants Intrauterine devices

Enteral feeding tubes Neurosurgical stimulators Vascular assist devices

Gastrostomy tubes Middle ear implants Coronary stents

Nasogastric tubes Dental implants Vascular shunts

Endotracheal tubes Voice prostheses Intracranial pressure devices

Umbilical tubes Implanted defibrillators Intraocular lens

Implanted monitors Suture material

Contact lens

Chronic Biofilm-Related Diseases

Cystic Fibrosis

Endocarditis

Otitis media

Prostatitis

Osteomyelitis

Chronic wounds

Myeloidosis

Tonsillitis

Periodontitis

Dental Caries

Necrotizing fasciitis

Biliary tract infection

Legionnaire’s disease

2/29/2012

3

Catheter Coating Types

Antibiotic Antithrombotic

Image from RadexImage from cox.miami..edu

Antisepticminocycline/rifampin

5-Fluorouracil

chlorhexidine + heparin

silver sulfadiazine

silver or other metals

Critical Care Literature

Systematic review 37 randomized, controlled trials involving 11,568 patients

Coated vs. non-coated catheters

Coated vs. coated catheters

Do coated CVC reduce:

1. CRB?

2. Bacterial colonization?

Gilbert and Harden, Curr Opin Infect Dis, 2008

Forest plot of meta-analysis showing the effect of impregnated or coated cvc on CRB

Heparin vs. standard

CH-SS vs. standard

Antibiotics vs. standard

Antibiotics vs. chlorhexidine

Antibiotics vs. silver

Silver vs. standard

Heparin vs. chlorhexidine

Study Conclusions

For central venous catheters in ICU patients, best options for reducing infection—

Heparin coated catheters

Antibiotic coated catheters

In addition(

Cost effective

if the incidence of bloodstream infections

> 3.3/1000 catheter-days

For every 300 catheters used

Approx $60,000 would be saved

7 CRB and 1 death prevented

CDC

2/29/2012

4

Coated hemodialysis

catheters?

Coated, Non-tunneled

Hemodialysis CathetersARROWGard Blue®• 12 and 14 French• 13,16, 20 and 25 cm• Chlorhexidine-SS• Exterior of catheter only

Heparin Coated• 12 French, 16 cm• Heparin bonded• Internal & external surfaces

No clinical trial data using these catheter coatings in dialysis patients.

Coated, tunneled

hemodialysis catheters

Surface-Treated Catheters

Dwyer. Surface-Treated Catheters – A review. Seminars in Dialysis, 2008

Palindrome® catheters(Kendall / Tyco Healthcare)

14.5 Fr Hemodialysis Catheter

Emerald®

Sapphire®

Duraspan®

The coating is a surfactant polymer that mimics the glycocalyx cells in the body, attempting to make the catheter

look like natural tissue to slow the clotting cascade

(r4 Vascular)

Ruby®

Data Using Surface-Treated Catheters in the

Hemodialysis Population

2/29/2012

5

HemoSplit®

BioBloc Coating(silver sulfadiazine)

vs.

(Kendall / Tyco Healthcare)Palindrome Ruby®

(CR Bard)

14.5 Fr Hemodialysis Catheter

Ruby® Silver polymer coating

Kakkos et al, 2008

HemoSplit® vs. Palindrome Ruby®

200 Catheters

in 163 Patients

100 catheters

HemoSplit(control group)

100 catheters

Palindrome Ruby(treatment group)

• 68% Internal Jugular Vein• 31% Femoral Vein

• 91% Internal Jugular Vein• 9% Femoral Vein

Kakkos et al, 2008

• case-controlled study

• new placements/exchanges

Patients followed for9,765 catheter days

Patients followed for11,173 catheter days

HemoSplit® Palindrome Ruby®

Thrombosis 32% 5%

Infection 18% 24%

Re-intervention (thrombosis/infection) 50% 29%

Exit Site Infection 1% 0

Tunnel Infection 0 1%

31% HemoSplit catheters inserted into femoral vein

9% Palindrome catheters inserted into femoral vein

HemoSplit® vs. Palindrome Ruby®

Decathlon® vs. Uncoated MedComp

175 Catheters

in 175 Patients

(New Insertions)

86 catheters

MedComp(non-coated)

89 catheters

Decathlon(Heparin-coated)

Retrospective Data collected:

• Time to catheter removal, failure, exchange

• Infection rates

• tPA instillations

• Blood flow rates

Jain et al, 2009

• retrospective study

• Internal jugular only

Heparin Coated

(Decathlon®)

Non-coated

(MedComp)

Number of Patients 89 86

Catheter Malfunction 17 (19%) 13 (15%)

Catheter-Related Bacteremia 30 (34%) 52 (60%)

Elective Removal 31 (35%) 17 (20%)

Remained Patent 11 (12%) 4 (5%)

tPA Instillations (per 1000 catheter days) 1.8 1.8

Catheter Outcomes

Cumulative catheter survival

p = 0.53 for coated vs. non-coated

Surface-Treated Catheters in Development

Bard: Carmeda® bioactive surface (heparin bonded)

MedComp: Ciprofloxacin bonding

Angiotech: 5- Fluorouracil coating

2/29/2012

6

Coated Catheters: Conclusions

Catheter coatings are a new technology

Antimicrobial, antiseptic and antithrombotic

Data supports the use of surface treated catheters in the ICU

They may decrease complication rates and improve catheter survival in dialysis patients

Randomized, controlled trials of all coating types are needed determine their full effectiveness