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MY CONFLICTS OF INTEREST ARE
Consulting Spectranetics, St Jude Research Support Spectranetics Advisory Board Spectranetics
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0,50
1,00
1,50
2,00
2,50
3,00
3,50
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
National Hospital Discharge Survey Increase in CIED Implants and Hospitalizations for Infected CIEDs (Indexed to 1996)
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.
Infected CIEDs
Implanted CIEDs
Device Infection Rate Rising
Device infection increased over 3-fold in 10 year period
1.Voigt, Andrew, et al. Rising Rates of Cardiac Rhythm Management Device Infections in the United States: 1996 through 2003. JACC Vol. 48, No. 3, 2006: 590-1. 2. 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: 414-9
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Clinical Manifestations
CIED Infections
Pocket Infection Pocket Infection
with Endovascular Infection
With Lead or Valve Vegetation
Endovascular Infection with Intact Pocket
With Lead or Valve Vegetation
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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;104:1029-1033 2.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;49:1851–9
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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 18 2007 1851 - 1859
Microbiology of CIED Infections
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Clinical Presentation
• 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%)
Local Findings Systemic Symptoms Lab Abnormalities
Muhammad R. Sohail et al. Management and Outcome of Permanent Pacemaker and Implantable Cardioverter-Defibrillator Infections. JACC Vol 49 (8); 1851-1859.
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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), 882-886.
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CIED Infections are Life-threatening!!
Increased risk of in-hospital death by > 2-fold1,2
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 2003. JACC Vol. 48, No. 3, 2006: 590-1. 2. De Bie, Mihály K., et al. "Cardiac device infections are associated with a significant mortality risk." Heart Rhythm 9.4 (2012): 494-498. 3.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;49:1851–9
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Antibiotics are Adjuvant Therapy
• Antibiotic therapy without device removal is associated with a 7-fold increase in 30-day mortality1
• Immediate system removal is associated with a 3-fold decrease in 1-year mortality as compared to preliminary antibiotic treatment and delayed system removal1
• 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;8:1678 – 85. 2. Sohail, MR, et al. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859
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Exceptions
• Patient not a candidate for extraction • Superficial Incision or skin erythema after recent surgery
• Treat with antibiotic • Do Not aspirate pocket for culture
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Biofilm
Antimicrobial Resistance Enhanced Adherence
SEM Staphylococcus Biofilm
A. Biofilm. B Substrate. Attached Cell
Requiring Complete System Removal.
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Risk of Relapse Without Complete System Removal
0,9% 1,0% 1,1% 0% 4,2%
50% 50% 60% 67%
100%
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)
Relapse Rates by Treatment
Complete System Removal
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.
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Indications for Complete Device Removal
Valvular endocarditis, lead endocarditis, sepsis with or without definitive lead involvement
Pocket abscess, device erosion, skin adherence, chronic draining sinus
Occult gram-positive bacteremia
Class I Indication Class IIa Indication
Persistent occult gram-negative bacteremia
“Complete removal of all hardware, regardless of location, is the
recommended treatment for patients with established CIED infection”
–HRS Consensus Document
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Antibiotic Therapy Duration in CIED Infection
Larry M. Baddour et al. Circulation. 2010;121:458-477 Copyright © American Heart Association, Inc. All rights reserved.
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Timing of Implantation of CIED After Extraction
Larry M. Baddour et al. Circulation. 2010;121:458-477 Copyright © American Heart Association, Inc. All rights reserved.
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Pacer-Dependent Patients
• Temporary Pacing Wire from Femoral Approach
• Externalized Active Fixation
Lead to Pacer Generator
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