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MY CONFLICTS OF INTEREST ARE

Consulting Spectranetics, St Jude Research Support Spectranetics Advisory Board Spectranetics

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When Devices Go Bad!!

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ICD Erosion Secondary to Pocket Infection

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Extreme ICD Erosion

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Bird’s Nest!

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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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Why are CIED Infections often Underrecognized?

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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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Pocket Infection

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Lead Vegetation

Courtesy of Steven P Kutalek

A. ICE image. B. TEE image.

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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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Barriers to Appropriate Care of These Patients?

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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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Use of Previously Abandoned Epicardial Pacing Lead

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Goal is to Save Lives!

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