Lead management

An old patient talking to doctor

Lead extraction is life-saving.


CIED infection is a Class I indication for complete removal of all system hardware, including leads, the wires that connect to the heart.4 Despite the guidelines, most patients receive inappropriate treatment or no treatment at all.7-8 Antibiotics alone are often given, which can lead to delayed or non-definitive treatment, in the case of CIED infection, lead extraction can be life-saving.

 

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COVID notice on society guidelines

HRS COVID guidelines state that lead extraction for CIED infection is still an urgent procedure and should not be delayed. Click here to download the HRS COVID guidelines.24

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Vast under treatment

CIED infection jumped 320% in a 10 year period1-2 and affects >31,000 patients in the US each year,8 yet >6 in 10 patients are not treated appropriately.7-8

Fatality percentage icon

High mortality

CIED infection is a Class I indication for complete removal and fatal for patients if not treated appropriately,4 with a 26-35% 1-year all-cause mortality.9-10

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High costs

Delaying CIED removal can dramatically increase costs and length of hospital stay,11 with $56,470 of potential increased cost per patient.12

What is CIED infection?


CIED (Cardiac Implantable Electronic Device) infection is when an infection, either in the pocket (location on the chest where the generator is implanted) or in the blood stream, has attached to the device or leads (the wires that deliver energy from the generator to the heart). Once an infection is in the blood stream, leads act as a highway to the heart. Left untreated, device nfection can lead to endocarditis and death.3

 

Multiple studies show patients are 2x more likely to die with a device infection compared to patients without infections.1,23

 

CIED infection can be a pocket infection or a systemic infection.

Click below to learn more about each

Lead management infection animation
An old patient with his hand on his chest talks to doctor

Pocket infection

A pocket infection begins in the pocket and then attaches to the leads.

A pocket infection can occur when the device is implanted or any time thereafter.

 

Mortality: pocket infections have a 12% 1 year mortality rate.3

 

Importance of full device & lead removal: even when infection symptoms are limited to the pocket, the intravascular segments of the leads will have positive blood cultures in 72% of patients.17

 

Local symptoms of pocket infections are obvious indicators of infection. They may include:18

  • Redness of the skin
  • Pain / tenderness
  • Swelling / warmth
  • Drainage
  • Skin ulceration
  • Generator / lead erosion
A doctor talks to a patient

Systemic infection

Systemic infection may first develop elsewhere in the body – from a cut or wound that becomes infected and enters the bloodstream, eventually working its way to infect the leads.

 

Significant mortality: systemic infections have 31% 1 year mortality rate3

 

May be difficult to diagnose: 41% of device infections are not visible from the pocket, and have a source other than the device2

  • In 70% of patients with staphylococcus aureus bacteremia (SAB), the device was also shown to be infected. 60% of these patients had no clinically detectable signs of infection near the generator pocket.13
  • One study showed that 27.3% of patients had a device infection that originated from a distant or unknown source (other than device or leads)13

 

Potential causes of secondary infection (hematogenous seeding):14

  • Catheter bloodstream infection
  • Intravascular catheters (dialysis catheters)
  • Decubitus ulcers
  • Septic arthritis
     

72% of patients with symptoms limited to the pocket have leads with positive blood cultures.17

 

Symptoms of systemic infections may be more elusive and general in nature, such as:18

  • Fever / chills
  • Malaise
  • Nausea
  • Hypotension (systolic <90 mm Hg)
  • Murmur on examination
  • Symptomatic heart failure

Understand the potential signs and symptoms

An old patient lying on bed and smiling
Pocket Infection signs and symptoms
An old patient listening with her hand on her chest
Systemic Infection signs and symptoms

Tip

Encourage patients to take a picture of their pocket from time to time. It’s an easy way to monitor suspicious changes.

 

Symptoms can be subtle, vigilance is the best defense. Partner with your patients to watch for signs of infection.

Left side of a chest with a lump under skin
Left side of a chest with a lump under skin and rash
Left side of a chest with a lump under skin, severe rash and a little hole
Left side of a chest with a lump under skin, severe darkening rashes and a slit

Device infection occurrence is significant and increasing

 

  • The CIED infection rate has grown by 320% in 10 years and shows no sign of slowing, and the rate of device infection is outpacing the increase in implants.1-2

  • The rate of device infection is now outpacing the increase in device implants.

  • >65% may be undertreated and at risk for recurring infection, endocarditis or death.7-8
A doctor checks a patient using a stethoscope
Watch this video to see how the rate of CIED infection is outpacing implants
Click here to see Mayo clinic data on rising rates of CIED infection23
Sign up for updates and help fight device infection

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Infection plus device equals to removal
  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.
  3. Tarakji KG, Wazni OM, Harb S, Hsu A, Saliba W, Wilkoff BL. Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace doi:10.1093/ europace/euu147.
  4. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.
  5. Baddour, Larry M., et al. “Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association.” Circulation 121.3 (2010): 458-477.
  6. Bongiorni, Maria G., et al. “2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS.” Ep Europace 20.7 (2018): 1217-1217.
  7. Sohail, M. Rizwan, et al. “Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection.” Circulation: Arrhythmia and Electrophysiology 9.8 (2016): e003929.
  8. Data on file, D021403-04 Infection InfoGraphic
  9. Maytin M, Jones SO, Epstein LM. Long-Term Mortality After Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2012;5:252-257.
  10. Sohail MR, Henrikson CA, Braid-Forbes M, Forbes K, Lerner DJ, Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Inern Med/Vol 171 (No. 20). Nov 14, 2011
  11. Rungpradubvong, V et al. Outcomes of early and delayed removal in patients with cardiac implantable electronic device infection. Poster Presentation. 2014 Heart Rhythm Society Annual Scientific Sessions, San Francisco, CA.Dai, Mingyan, et. al. “Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study.” JACC: Clinical Electrophysiology (September 2019).
  12. Difference between average hospital days from study above (x) $2,157 average inpatient per day hospital cost (U.S.), which is from 1999 -2013 AHA Annual Survey, Copyright 2015 by Health Forum, LLC, an affiliate of the American Hospital Association. Special data request, 2015. Available at http://www.ahaonlinestore.com.
  13. Chamis AL., et al. Staphylococcus aureus Bacteremia in Patients with Permanent Pacemakers or Implantable Cardioverter- Defibrillators. Circulation. 2001;104:1029-1033. doi:10.1161/hc3401.095097
  14. Wilkoff BL., Hands On, How to treat and identify device infections. Heart Rhythm 2007;4:1467-1470.
  15. Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604-608.
  16. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.
  17. Sohail, MR, et al. Management and outcome of permanent and implantable cardioverterdefibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859.
  18. Margey, R. et al. Contemporary management of and outcomes from cardiac device related infections Europace (2010) 12 (1): 64-70 first published online November 11, 2009 doi:10.1093/ europace/eup362.
  19. del Rio, A, Anguera I, Miro JM, et al. Surgical treatment of pacemaker and defibrillator lead endocarditis: the impact of electrode lead extraction on outcome. Chest 2003;124:1451–9.
  20. Tarakji, K, et al. Cardiac implantable electronic device infections: presentation, management, and patient outcomes, Heart Rhythm, Vol. 7, No. 8, 2010: 1043-7. 12.
  21. Hussein et al. Microbiology of Cardiac Implantable Electronic Device Infections. J Am CollCardiolEP 2016;2:498–505 CircArrhythmElectrophysiol.
  22. de Bie, Mihály K., et al. “Cardiac device infections are associated with a significant mortality risk.” Heart Rhythm 9.4 (2012):494-498.
  23. Dai, Mingyan, et. al. “Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study.” JACC: Clinical Electrophysiology (September 2019).
  24. Lakkireddy DR, et al.. Guidance for cardiac electrophysiology during the coronavirus (COVID-19) pandemic from the Heart Rhythm Society COVID-19 Task Force; Electrophysiology Section of the American College of Cardiology; and the Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology, American Heart Association. Heart Rhythm. doi: 10.1016/j.hrthm.2020.03.028

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