CIED lead extraction saves lives, yet patients are undertreated.
By Philips ∙ Featuring Suzanne, Pacemaker Patient ∙ dec 21, 2020 ∙ 2 min read
New German data shows that prevalence of device infection is at least 2 times higher than previously reported.1 JAMA Cardiology data found that < 2 in 10 patients needing CIED infection treatment are treated according to Class 1 guidelines (from a 100% Medicare sample). Yet, CIED lead extraction within 6 days of diagnosis is associated with a 42.9% lower risk of death2.
Article at a glance
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 the risk for the patient of developing a device infection2. If patients are not treated promptly there is a significant risk of mortality and associated costs increase significantly3. Left untreated, device infections can lead to endocarditis and death4.
A patient story
Suzanne is a pacemaker patient who experienced a 10 year journey with device infection and endocarditis. Along the way, Suzanne was managed with antibiotics alone and her health continued to deteriorate until eventually she found a physician who could help her. Watch this amazing story to discover what device infection meant for Suzanne’s and how her case was finally resolved.
“Based on where I was then, I feel like I’ve been given my life back!”.
Suzanne
CIED patient
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 infection may include 6:
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:
Identifying the source of 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. New data presented at AHA in November 2022 confirms a gap in guideline driven knowledge and care for CIED infections.2 Only 29% of cardiologists are familiar with CIED infection guidelines and 30% of physicians have protocols for managing CIED infection at their institution.
Over a 10-year period there has been a 320% increase in CIED infection rates and over 31,000 of US device patients are diagnosed with an infection each year.2,5,8 CIED infection can be fatal if not treated appropriately and currently more than 80% of CIED infection patients fall into this category. 9 CIED infection is a Class I indication for complete system extraction.3
320%
Increase in CIED infection rates over a 10-year period5
>31,000
US device patients diagnosed with an infection each year2,8
<2 in 10
Patient 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 has a 97.7% clinical success rate and a 99.72% procedural safety rate,10,11 which is why all major cardiac society guidelines recommend complete system removal of hardware and leads when an infection is present.12
97.7%
Clinical success rate10,11
99.72%
Procedural safety rate10,11
Consequences of improper treatment
In many cases, infections are caused by antibiotic-resistant staphylococcal bacteria that live in colonies called biofilms. 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 a range of 0% to 4.2%, or compared to maximum 4.2%.7,14-17 There is also a 7-fold increase in 30 day-day mortality for antibiotic treatment with device removal and a 42.9% lower risk of death when a patient’s leads are extracted within 6 days of CIED infection diagnosis.7,9
7x increase in mortality
7-fold increase in 30-day mortality for antibiotic treatment without device removal7
42.9% lower risk of death
When leads are extracted within 6 days of CIED infection diagnosis9
Article
New data: Only 50% of cardiologists recommend guideline-driven care for CIED infections2
Footnotes
[1].Baldauf et al. Device infection is a bigger problem than you think. Poster presented at EHRA 2024.
[2].Pokorney SD, Zepel L, Greiner MA, et al. Lead Extraction and Mortality Among Patients With Cardiac Implanted Electronic Device Infection. JAMA Cardiol. Published online October 18, 2023. doi:10.1001/jamacardio.2023.3379
[3].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
[4].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).
[5].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.
[6].Dai, Mingyan, et. al. “Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study.” JACC: Clinical Electrophysiology(September2019).
[7].Tarakji, K, et al. Cardiac implantable electronic device infections: presentation, management, and patient outcomes, Heart Rhythm, Vol. 7, No. 8, 2010: 1043-7.
[8].Sohail MR, et al. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859.
[9].Data on file, D021403-04 Infection InfoGraphic
[10].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].
[11].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)
[12].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
[13].Kusumoto, et al. (2017). 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart rhythm, 14(12),e503-e551.
[14].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
[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 latentsystemic infection. Heart, 90(8), 882-886.
[17].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
[18].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.
[19].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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