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Lead extraction is life-saving, yet patients are undertreated

New 2022 data performed by the American College of Cardiology (ACC) and presented at the American Heart Association (AHA) confirms discrepancies in physician knowledge and treatment of CIED infections. Among other significant gaps, the data indicates only 50% of cardiologists recommend guideline-driven care for CIED infections.1

    What is a CIED infection?

    Cardiac implantable electronic device (CIED) infection occurs when an infection – either in the pocket or blood stream – has attached to the device or leads. Once an infection is in the blood stream, leads act as a highway to the heart and can spread the infection.


    The risk of CIED infection is rising, and the longer a device is implanted, the higher risk patients are for developing a device infection.2 If patients are not treated appropriately with prompt lead extraction, there is significant mortality and associated costs.3 Left untreated, device infections can lead to endocarditis and death.4

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    A real patient story

    When Jerry, a pacemaker patient, experienced a sudden negative turn in his health, he and his wife Helane sought out answers. After working with multiple doctors and trying different treatments, it was finally determined Jerry had an infection of his heart device. Watch Jerry's incredible story and learn more about CIED infection.

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    Understanding signs and symptoms

    There are two types of CIED infection: pocket infection or systemic infection.

    Pocket infection

    A pocket infection begins in the pocket (where the generator is implanted) and attaches to the leads. A pocket infection can occur at the time of implantation or any time thereafter. The risk of infection increase  every time the pocket is manipulated.5

    Symptoms of pocket infections may include:6


    • Redness of the skin
    • Pain/tenderness
    • Swelling/warmth
    • Drainage
    • Skin ulceration
    • Device/lead erosion

    Systemic infection

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

    Symptoms of systemic infections may be more elusive and general in nature, such as:6


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

    Identifying the source of the infection

    Identifying the source of a CIED infection can be difficult. However, with the incidence of infection on the rise,5 it is important to investigate the device if an infection is present. CIED infection can be fatal if not treated appropriately.7

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    Increase in CIED infection rates over a 10-year period5

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    > 31,000

    US device patients diagnosed with an infection each year2,8

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    > 8 in 10

    Patients not treated appropriately9

    (from a 100% Medicare sample)

    Recommended CIED infection treatment

    With early diagnosis and appropriate treatment, cardiac device infections can be cured.9 Lead extraction is proven to be safe,10,11 and all major cardiac society guidelines recommend complete system removal of hardware and leads when an infection is present.12

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    Clinical success rate10,11

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    Procedural safety rate10,11

    Consequences of improper treatment

    In many cases, infections are caused by antibiotic-resistant staphylococcal bacteria that live in colonies called biofilm. The biofilm forms a thick coating around the device or leads that is nearly impossible to cure with antibiotic treatment alone.13


    Infection relapse occurs in 50% to 100% of cases with partial removal or antibiotic treatment alone, compared to 0% to 4.2% relapse with complete system removal.7,14-17

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    7 x increase in mortality

    7-fold increase in 30-day mortality for antibiotic treatment without device removal7

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    42.9% lower risk of death

    When leads are extracted within 6 days of CIED infection diagnosis9

    Implementing a CIED infection care pathway

    Philips is helping facilities around the world implement CIED infection care pathways, successful extraction programs, and EMR alert programs. Read this case study to learn more about how we can partner with you.


    Discover why a CIED care pathway is important and how to create your own team.

    Doctor checks screen with Ipad

    Implementing a CIED infection care pathway

    Philips is helping facilities around the world implement CIED infection care pathways, successful extraction programs, and EMR alert programs. Read this case study to learn more about how we can partner with you.


    Discover why a CIED care pathway is important and how to create your own team.

    Additional resources

    Patient with infection


    Low rates of guideline-directed care associated with higher mortality in patients with infected CIEDs

    Recent 2022 ACC late-breaking data found that 8 in 10 patients with CIED infections are not treated according to Class I guidelines. Yet, lead extraction within 6 days of diagnosis is associated with a 42.9% lower risk of death.9  

    Doctor checks screen


    Salvage failure of CIED infection

    Read results from a multicenter study attempting to find clinical factors for device salvage with CIED infection.   

    Artery animation

    Featured product 

    Philips Laser Sheath – GlideLight

    Discover how laser lead extraction works.

    Patient with infection

    Featured product 

    Philips Occlusion Balloon – Bridge

    Learn how SVC tear survival has increased from 50% to 88.2% with Bridge.18    

    Doctors checking patient
    Aha logo

    The American Heart Association’s  National CIED Infection Initiative,  supported by Philips Image Guided Therapy

    Explore the association’s CIED Infection Report, watch webinars, listen to podcasts, and find other information on addressing the gaps in awareness, detection, and appropriate treatment of CIED infection. 

    This website is for healthcare providers to learn about the signs and symptoms of device infection, know the Class I indications around system removal and offer resources to further educate the community on how to identify and refer patients for potentially life-saving lead extraction.


    Members in your medical community that may need to be involved in diagnosis and treatment of CIED infections include:

    • Electrophysiologists
    • Cardiologists
    • Hospital administration

    • Nephrologists
    • Cardiac surgeons
    • Infectious disease specialists

    • Device clinic staff
    • Primary care physicians

    We are always interested in engaging with you.

    Let us know how we can help.

    Select your area of interest
    Contact details

    1. Birgersdotter-Green, Ulrika, et al. “Contemporary Management of Cardiac Implantable Electronic Device Infection – A Survey of American College of Cardiology Members and Primary Care Physicians (COGNITO Study)” AHA 2022 Clinical Study Presentation.  November 5, 2022.
    2. 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
    3. Sohail, M Rizwan, et al. Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation. Circ Arrhythm Electrophysiol. 2016; 9(8).
    4. 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.
    5. Dai, Mingyan, et. al. “Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study.” JACC: Clinical Electrophysiology
    6. Tarakji, K, et al. Cardiac implantable electronic device infections: presentation, management, and patient outcomes, Heart Rhythm, Vol. 7, No. 8, 2010: 1043-7.
    7. Sohail MR, et al. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859.
    8. Data on file, D021403-04 Infection InfoGraphic
    9. Pokorney SD. Low Rates Of Guideline Directed Care Associated With Higher Mortality In Patients With Infections Of Pacemakers And Implantable Cardioverter Defibrillators.American College of Cardiology (ACC) Late Breaking Clinical Trials. Washington, DC, USA April 2022 [presentation].
    10. Wilkoff, B.L., et al. (1999). Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, 33(6)
    11. Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-586
    12. Kusumoto, et al. (2017). 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart rhythm, 14(12),e503-e551.
    13. Chen L. and Wen, Y. “The role of bacterial biofilm in persistent infections and control strategies.” Int J Oral Sci, 2011, DOI: 10.4248/IJOS11022
    14. Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604-608.
    15. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latentsystemic infection. Heart, 90(8), 882-886.
    16. 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
    17. del Rio A, AngueraI, 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.
    18. Ryan Azarrafiy, BA; Darren C. Tsang, BS; Bruce L. Wilkoff, MD, FHRS; Roger G. Carrillo, MD, MBA, FHRS. The Endovascular Occlusion Balloon for Treatment of Superior VenaCava Tears During Transvenous Lead Extraction: A Multi-Year Analysis and An Update to Best Practice Protocol. Circulation: Arrhythmia and Electrophysiology, August 2019

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