MY CONFLICTS OF INTEREST ARE

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1 MY CONFLICTS OF INTEREST ARE Consulting Spectranetics, St Jude Research Support Spectranetics Advisory Board Spectranetics S L I D E 1

2 When Devices Go Bad!! S L I D E 2

3 ICD Erosion Secondary to Pocket Infection S L I D E 3

4 Extreme ICD Erosion S L I D E 4

5 Bird s Nest! S L I D E 5

6 Device Infection Rate Rising Device infection increased over 3-fold in 10 year period 3,50 3,00 2,50 2,00 1,50 National Hospital Discharge Survey Increase in CIED Implants and Hospitalizations for Infected CIEDs (Indexed to 1996) Infected CIEDs 1,00 0,50 Implanted CIEDs Proportional increase in the number of cardiac rhythm management devices (CRMD) implanted and those infected by the year of hospitalization, normalized to the number of devices implanted and infected in the year 1996, respectively. 1.Voigt, Andrew, et al. Rising Rates of Cardiac Rhythm Management Device Infections in the United States: 1996 through JACC Vol. 48, No. 3, 2006: Voigt, Andrew, et al. Continued Rise in Rates of Cardiovascular Implantable Electronic Device Infections in the United States: Temporal Trends and Causative Insights. PACE Vol. 33, No. 4, 2010: S L I D E 6

7 S L I D E 7

8 Why are CIED Infections often Underrecognized? S L I D E 8

9 Clinical Manifestations CIED Infections Pocket Infection Pocket Infection with Endovascular Infection Endovascular Infection with Intact Pocket With Lead or Valve Vegetation With Lead or Valve Vegetation S L I D E 9

10 Pocket Infection S L I D E 10

11 Lead Vegetation Courtesy of Steven P Kutalek A. ICE image. B. TEE image. S L I D E 11

12 Not All CIED Infections are Obvious 70% of patients with Staph. Aureus bacteremia had no clinical evidence of pocket infection 50% of patients with positive blood cultures had vegetations seen on there device Up to 50% of the time infections are concealed! 1. Anna Lisa Chamis, MD; Gail E. Peterson, MD; Christopher H. Cabell, MD; G. Ralph Corey, MD; Robert A. Sorrentino, MD; Ruth Ann Greenfield, MD; Thomas Ryan, MD; L. Barth Reller, MD; Vance G. Fowler, Jr, MD, MHS. Staphylococcus aureus Bacteremia in Patients With Permanent Pacemakers or Implantable Cardioverter-Defibrillators. Circulation. 2001;104: Muhammad R. Sohail, MD, Daniel Z. Uslan, MD, Akbar H. Khan, MD, Paul A. Friedman, MD, David L. Hayes, MD, Walter R. Wilson, MD, James M. Steckelberg, MD, Sarah Stoner, MS, Larry M. Baddour, MD. Management and Outcome of Permanent Pacemaker and Implantable Cardioverter-Defibrillator Infection. J Am Coll Cardiol 2007;49: S L I D E 12

13 Microbiology of CIED Infections Muhammad R. Sohail, Daniel Z. Uslan, Akbar H. Khan, Paul A. Friedman, David L. Hayes, Walter R. Wilson, Jame. Management and Outcome of Permanent Pacemaker and Implantable Cardioverter-Defibrillator Infections Journal of the American College of Cardiology Volume 49, Issue S L I D E 13

14 Clinical Presentation Local Findings Systemic Symptoms Lab Abnormalities Erythema (68%) Pain (49%) Swelling (67%) Warmth (38%) Tenderness (46%) Drainage (50%) Ulceration (31%) Erosion (25%) Fever (43%) Chills (39%) Malaise (42%) Anorexia (17%) Nausea (8%) Sweating (18%) Hypotension (10%) Murmur (35%) CHF (28%) Leukocytosis (43%) Anemia (50%) ESR (25%) Positive Blood Cultures (40%) Muhammad R. Sohail et al. Management and Outcome of Permanent Pacemaker and Implantable Cardioverter-Defibrillator Infections. JACC Vol 49 (8); S L I D E 14

15 Barriers to Appropriate Care of These Patients? S L I D E 15

16 Pocket Infection is a Systemic Infection 72% of patients with pocket infection had positive cultures of intravascular lead segments 50% of patients presented with findings only limited to pocket site 50% relapse rate in patients without complete extraction Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), S L I D E 16

17 CIED Infections are Life-threatening!! Increased risk of in-hospital death by > 2-fold 1,2 1 year mortality even after removal of the device is 17% 3 1.Voigt, Andrew, et al. Rising Rates of Cardiac Rhythm Management Device Infections in the United States: 1996 through JACC Vol. 48, No. 3, 2006: De Bie, Mihály K., et al. "Cardiac device infections are associated with a significant mortality risk." Heart Rhythm 9.4 (2012): Muhammad R. Sohail, MD, Daniel Z. Uslan, MD, Akbar H. Khan, MD, Paul A. Friedman, MD, David L. Hayes, MD, Walter R. Wilson, MD, James M. Steckelberg, MD, Sarah Stoner, MS, Larry M. Baddour, MD. Management and Outcome of Permanent Pacemaker and Implantable Cardioverter-Defibrillator Infections. J Am Coll Cardiol 2007;49: S L I D E 17

18 Antibiotics are Adjuvant Therapy Antibiotic therapy without device removal is associated with a 7-fold increase in 30-day mortality 1 Immediate system removal is associated with a 3- fold decrease in 1-year mortality as compared to preliminary antibiotic treatment and delayed system removal 1 Mortality)rates)in$pa'ents$with$endocardi's$who$had$ systems$removed$are$less$than$18%,$compared$with$up)to) 66%)with)an3bio3cs)alone. 2$ 1. Le KY, Sohail MR, Friedman PA, et al. Impact of timing of device removal on mortality in patients with cardiovascular implantable electrophysiologic device infections. Heart Rhythm 2011;8: Sohail, MR, et al. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49: S L I D E 18

19 Exceptions Patient not a candidate for extraction Superficial Incision or skin erythema after recent surgery Treat with antibiotic Do Not aspirate pocket for culture S L I D E 19

20 Biofilm Antimicrobial Resistance Enhanced Adherence A. Biofilm. B Substrate. Attached Cell SEM Staphylococcus Biofilm Requiring Complete System Removal. S L I D E 20

21 Risk of Relapse Without Complete System Removal Relapse Rates by Treatment Complete System Removal 50% 50% 60% 67% 100% 0,9% 1,0% 1,1% 0% 4,2% Chua, J.D., et al. (2000) Klug, D., et al. (2004) Sohail, M.R., et al. (2007) Margery, R. et al. (2009) Del Rio, A., et al. (2003) n=123 Cardiac device infection patients n=105 Patients with local pocket symptoms or overt infections n=185 Cardiac device infection patients n=39 Cardiac device infection patients n=31 Device related endocarditis patients Infection relapse occurs in 50% to 100% of cases with partial removal or antibiotic treatment alone, compared to relapse of 0% to 4.2% with complete system removal. S L I D E 21

22 Indications for Complete Device Removal Class I Indication Class IIa Indication Valvular endocarditis, lead endocarditis, sepsis with or without definitive lead involvement Persistent occult gramnegative bacteremia Pocket abscess, device erosion, skin adherence, chronic draining sinus Occult gram-positive bacteremia Complete removal of all hardware, regardless of location, is the recommended treatment for patients with established CIED infection HRS Consensus Document S L I D E 22

23 Antibiotic Therapy Duration in CIED Infection Larry M. Baddour et al. Circulation. 2010;121: Copyright American Heart Association, Inc. All rights reserved. S L I D E 23

24 Timing of Implantation of CIED After Extraction Larry M. Baddour et al. Circulation. 2010;121: Copyright American Heart Association, Inc. All rights reserved. S L I D E 24

25 Pacer-Dependent Patients Temporary Pacing Wire from Femoral Approach Externalized Active Fixation Lead to Pacer Generator S L I D E 25

26 Use of Previously Abandoned Epicardial Pacing Lead S L I D E 26

27 Goal is to Save Lives! S L I D E 27

28 S L I D E 28

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