MANAGING CIED INFECTION RISK TYRX Absorbable Antibacterial Envelope

A NEW STANDARD FOR REDUCING INFECTION IN HIGH-RISK PATIENTS

Bacterial infection is one of the most common causes of cardiac implantable electronic device (CIED) complications, and the standard antibiotic prophylaxis have significant deficiencies when used as a single agent to prevent infection.1-2

The TYRX™ Absorbable Antibacterial Envelope helps reduce infection in high-risk patients and is more effective when combined with the standard treatment.3

The Problem. The Impact. The Solution.

Infections are Increasing at a Faster Rate than CIED Implants1

Change in CIED implants and infections between 1993-2008

Contributing factors for this increase:

  • Older patients receiving devices
  • More patient co-morbidities
  • Longer procedures
  • Changing mix of CIEDs
  • Increasing number of pulse generator replacements and upgrades
  • Revision Procedures
  • More resistant S aureus & coagulase (-) Staphylococcus species (e.g., S epidermidis)

Standard Antibiotic Prophylaxis Is Falling Short

Bacteria Responsible for Many CIED Infections

Typically, the same anti-infective measures are used for all patients regardless of their risk of infection.17-18 Pre-operative IV antibiotic prophylaxis is routinely given one hour before first incision. Ninety percent of patients receive cephalosporin and/or vancomycin.

Perioperatively, the tissue pocket is typically irrigated with antibiotic agents.

Approximately 45% of the time, oral antibiotics are prescribed after the procedure. IV antibiotics may be administered for 24 hours after the initial implant.17-18

  • Cefazolin and vancomycin can have important clinical limitations when used as a single agent to prevent CIED infection.2
  • Coagulase(-) Staphylococcus species and S aureus are responsible for approximately 70% of CIED infections and are increasingly resistant to methicillin.10-16

The TYRX Antibiotic Envelope Offers More Coverage Combined with Standard Treatment3

  • Cefazolin and vancomycin are rarely used in combination and have important clinical deficiencies when used as a single agent to prevent CIED infections.2
  • Both have activity against gram (+) organisms; there is substantial overlap.2
  • Neither has a strong profile against gram (-) organisms.2
  • Gentamicin has variable activity against coagulase (-) Staphylococcus, MSSA, and MRSA, and may be effective in some infections, but not reliably effective in others.2
  • Topical ionic silver does not have activity against coagulase (-) Staphylococcus and has no data to support coverage in M catarrhalis or Corynebacterium jeikeium.19-22
Adjunctive Antibiotic Prophylaxis with TYRX Helps Prevent Infection

*

Infection rate is an aggregation of data; see Data on file at Medtronic TYRX.


1

Greenspon A et al. J Am Coll Cardiol. 2011;58(10):1001-1006.

2

The Sanford Guide to Antimicrobial Therapy. Web Edition. 2015: Antimicrobial Therapy Inc.; Hyde Park, VT.

3

Mittal S et al. Heart Rhythm. 2014; 11(4):595-601.

4

Sohail MR et al. PACE. 2015;38(2):231-239.

5

Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services Inpatient Prospective Payment System (IPPS) Final Rule FY13.

6

Bloom HL et al. Pacing Clin Electrophysiol. 2011; 34(2):133-142.

7

Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116.

8

Shariff N et al. J Cardio Electrophysiol. 2015;26(10):783-789.

9

Henrikson CA et al. JACC EP 2017; 3 (10): 1158-1167.

10

Wisplinghoff H et al. CID. 2004;39(3):309-317.

11

NNIS System Report. Am J Infect Control. 2004;32(8):470-485.

12

Klug D et al. Circulation. 2007;116(12):1349-1355.

13

Lekkerkerker JC et al. Heart. 2009;95(9):715-720.

14

de Oliveira JC et al. Circ Arrhyth Electrophysiol. 2009;2(1):29-34.

15

Da Costa A et al. Circulation. 1998;97(18):1791-1795.

16

Chua J et al. Ann Intern Med. 2000;133(8):604-608.

17

MEDACorp. Survey of 42 EPs and 30 cardiac lab supervisors, 2007. Sponsored by TYRX, Inc.

18

Easton Assoc. Survey of 24 EPs, 6 EP lab managers and RNs, 2008. Sponsored by TYRX, Inc.

19

Lansdown A et al. Issues in Toxicology. 2010; 5.3:123.

20

Percival SL et al. Wound Repair Regeneration. 2011; 19(6); 769-770. Online publication.

21

Argentum Medical. Silverlon® Product Brochure.

22

Townsend Letter for Doctors & Patients. April 2006; Issue 273: 66-72.

23

Zinner SH et al. J Infect Dis. 1981;144(4):365-371.

24

Darouiche RO et al. Int J Antimicrob Agents. 1995;6(1):31-36.

25

Segreti J et al. Diagn Microbiol Infect Dis. 1989;12(3):253-255.