Lead extraction is
life-saving

Recent ACC late-breaking data found that 8 in 10 patients are not treated according to Class I guidelines. Yet, lead extraction within 6 days is associated with a 42.9% lower risk of death.¹

What if a CIED was the source of the infection?

Identifying the source of a cardiac implantable electronic device (CIED) infection can be difficult, however the incidence of infection is on the rise.² With 8 in 10 CIED patients not treated¹ according to Class I guidelines from leading medical societies³, it is important to investigate the device if an infection is present.

Under treated

>8 in 10 patients are not treated according to Class I guidelines for CIED infection (full system removal).¹ When treated with antibiotics alone, mortality rates can be as high as 31% to 66% in device related endocarditis.⁴

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

If you are a patient seeking to learn more about CIED infection, please click here.

What is CIED infection?

CIED 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 infection can lead to endocarditis and death.⁵

Antibiotic therapy without device removal is associated with a 7-fold increase in 30-day mortality.⁶

Understanding signs and symptoms

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

Pocket infection
Pocket infection
A pocket infection begins in the pocket (where the generator is implanted) and then attaches to the leads. A pocket infection can occur when thedevice is implanted or any time thereafter. The risk of infection increases every time there is a pocket manipulation.⁷

Local symptoms of pocket infections are obvious indicators of infection. They may include:⁸

Redness of the skin

Pain/tenderness

Swelling/warmth

Drainage

Skin ulceration

Generator/lead erosion

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.
Systemic infection
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.

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

What is the impact of CIED infection?

Vast under treatment

CIED infection jumped 320% in a 10 year period^6,9 and affects >31,000 patients in the US each year,¹⁰ yet >8 in 10 patients are not treated appropriately.¹

High mortality

CIED infection is a Class I indication for complete removal and fatal for patients if not treated appropriately,¹¹ with a 26-35% 1-year all-cause mortality.^12,13

Graph of infection probability over time (years)

Recommended CIED infection treatment

Complete device removal is a Class I indication for CIED infection. With early diagnosis and appropriate treatment, cardiac device infections can be cured.

Guidelines
Guidelines

All major cardiac society guidelines recommend complete system removal of all hardware and leads when an infection is present. Extractor consult for CIED patients with documented infection is also a Class I indication.¹¹

Download the 2017 HRS Consensus Pocket Guide.
Includes diagnosis charts for identifying device infection.

Following the guidelines could save a life.
What is recommended and why?
What is recommended and why?

Antibiotics alone are not enough

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.^6,17-20
Antibiotic therapy without device removal is associated with a 7-fold increase in 30-day mortality.⁶

Infection + device = removal

Lead extraction has a 97.7% clinical success rate and 99.72% procedural safety rate.¹⁴ With the Philips Occlusion Balloon – Bridge – SVC tear survival has increased from 50% to 88.2%.²²

Safety of lead extraction

Lead extraction, when indicated, is a highly successful, potentially life-saving procedure, with a clinical success rate of 97.7% and a procedural safety rate of 99.72%.¹⁵

Learn how laser lead extraction works

The Philips Occlusion Balloon – Bridge – works for supporting SVC tear rescue.

Learn how

Philips is committed to safe, predictable, and responsible lead management.

Clinically proven safety of laser assisted lead extraction^14,15,16

Bar graph (Percentage versus laser extractions)

*The LExiCon study reports a procedural MAE rate of 1.4% as defined by the 2000 NASPE Policy Statement. However, 0.3% (n=4) of the MAEs were bleeding requiring transfusion which is no longer defined as a MAE by the 2009 HRS Expert Consensus Document.

Consequences of improper treatment

Among patients with CIED infection, there is a lack of guideline adherence and a need to improve guideline-directed care. In the largest ever real-world analysis of CIED infection treatment, data showed >8 in 10 patients are not treated according to Class I guidelines for CIED infection (full system removal), and found that extraction within 6 days of infection diagnosis was associated with a 42.9% lower risk of death compared to no extraction.¹

Antibiotics only = relapse

Antibiotics or partial device removal are often the first lines of defense with device infection. In many cases, however, these infections are caused by antibiotic-resistant staphylococcal bacteria that live in bacterial colonies called biofilm.^23,24The biofilm forms a thick coating around the device or leads that is nearly impossible to cure with antibiotic treatment alone.^24,25 Biofilms that cause antibiotic resistance are present in up to 85% of microbial infections.²⁶

A recent multicenter study²⁷ attempted to find clinical factors for device salvage with CIED infection and found:

No predictors for what could be salvaged.
Of the patients discharged with an infected CIED, 26% died within 6 months.
80% of the device salvage attempts failed within 6 months.

View a free summary of the study (166.0KB)

Patient mortality
Patient mortality

A large study in 100% medicare population and presented as an ACC 2022 late-breaker showed >8 in 10 patients are not treated according to Class I guidelines for CIED infection (full system extraction), and found that extraction within 6 days of infection diagnosis was associated with a 42.9% lower risk of death compared to no extraction. The study was conducted independently by Duke with 14 years of data and over 1 million patients, making it the largest ever real-world analysis of CIED infection treatment.¹

Without proper referral and/or identification of infection, patients may swirl in the hospital system on multiple rounds of antibiotics and see multiple physicians.²⁸ HRS guidelines state it is a Class I indication to refer patients with documented CIED infection to a physician who specializes in lead extraction.¹¹

42.9%

Extraction within 6 days of infection diagnosis is associated with a 42.9% lower risk of death compared to no extraction¹

Procedural mortality from extraction¹⁴

1-year mortality rate with CIED infection^13,14

Mortality from device related endocarditis¹⁷

“Delaying the definitive operation with removal of all of the components of the CIED system can be a fatal choice for the patient” ‑ HRS consensus documents¹¹
Increased cost
Increased cost
Quickly diagnosing CIED infection and extracting all hardware is vital to reducing hospital costs.

Early removal reduces length of hospital stay and increases survival.^2,4

Under-treating CIED infection is an enormous economic burden on hospitals and the healthcare system.²⁹

$52,000-$146,000 - Cost to treat a single CIED infection patient^30,31

$72,000 - Average cost of a hospital-acquired infection³⁰

Payment eliminated: CMS no longer pays for the additional costs of hospital-acquired infection and will only pay for the original surgery³⁰

Patients extracted within 10 days may save the hospital system $56,470 in costs due to shorter hospital stays³¹

Download one-pager to view the impact of improper treatment.

Implementing a CIED infection care pathway

Philips is helping facilities around the country implement CIED infection care pathways, successful extraction programs, and EMR programs. Read the case studies to learn more about how we can help you.

Download collection of case studies (403.0KB)

Download EMR infection case study (362.0KB)

Download Hospital Toolkit (346.0KB)

Implementing electronic medical records (EMR), conducting hospital and community education, and setting up a process for streamlining patient identification can help patients get the care they need.³²

In one center, EMR was shown to reduce days to device removal by 27% and reduce days to cardiology consult by 71%.³²

EMR study shows reduction in days to consult and extraction

4.9 to 1.4 days is a

Time to cardiology consult may equal$ 7,500 in hospital savings*

3.6 to 1.4 days is a

Time to infectious diseases consult may equal $4,750 in hospital savings*

7.8 to 5.7 days is a

Time to device removal may equal $4,500 in hospital savings*

*Difference between average hospital days (x) $2,157 average inpatient per day hospital cost (U.S.)

Download one-page summary of the study (399.0KB)

Interesting in getting more information about CIED infection or lead extraction programs?

Contact us today and download our grand rounds presentation to educate your local community about CIED infection treatment. Philips can also support you in starting a lead extraction program.

1. 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].

2. Greenspon, Arnold J., et al. “16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States1993 to 2008.” Journal ofthe American College of Cardiology 58.10 (2011): 1001-1006.

3. American Heart Association (AHA), American College of Cardiology (ACC), Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA)

4. Lin, Andrew, et al. “Early Versus Delayed Lead Extraction in Patients with Infected Cardiovascular Implantable Electronic Device.” Moderated ePoster Presentation. 2020 HeartRhythm Society Annual Abstract Presentations Online.

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 undergoingtransvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace doi:10.1093/ europace/euu147.

6. 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.

7. Dai, Mingyan, et. al. “Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study.” JACC: Clinical Electrophysiology (September2019).

8. 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, 2009doi:10.1093/ europace/eup362.

9. Voigt, Andrew, et al. Continued Rise in Rates of Cardiovascular Implantable Electronic Device Infections in the United States: Temporal Trends and Causative Insights. PACEVol. 33, No. 4, 2010: 414-9.

10. Data on file, D021403-04 Infection InfoGraphic

11. Kusumoto, et al. (2017). 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart rhythm, 14(12),e503-e551.

12. Maytin M, Jones SO, Epstein LM. Long-Term Mortality After Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2012;5:252-257.

13. Sohail MR, Henrikson CA, Braid-Forbes M, Forbes K, Lerner DJ, Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Inern Med/Vol171 (No. 20). Nov 14, 2011.

14. Wazni, O. et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter observational RetrospectiveStudy of Consecutive Laser Lead Extractions, J AmColl Cardiol, 55:579-586.

15. 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 AmericanCollege of Cardiology, 33(6).

16.Byrd, C., et al. (2002). Clinical study of the laser sheath for lead extraction: The total experience in the United States. Journal of Pacing and Electrophysiology, 25(5).23.

17. Rungpradubvong, V et al. Outcomes of early and delayed removal in patients with cardiac implantable electronic device infection. Poster Presentation. 2014 Heart RhythmSociety Annual Scientific Sessions, San Francisco, CA

18.Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604-608.

19. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.

20. Sohail, MR, et al. Management and outcome of permanent and implantable cardioverterdefibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859

21. 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. Chest2003;124:1451

22. 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.

23. Wilkoff, B.L., et al. (2009). Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications and patient management. HeartRhythm, 6,1085-1104

24. Klug, Didier, et al. “Involvement of adherence and adhesion Staphylococcus epidermidis genes in pacemaker lead-associated infections.” Journal of clinical microbiology 41.7(2003): 3348-3350.

25. Lazãr, Veronica, and C. Chifiriuc. “Medical significance and new therapeutical strategies for biofilm associated infections.” Rom Arch Microb & Immunol 69 (2010): 125-138.

26. 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.

27. Peacock Jr, James E., et al. “Attempted salvage of infected cardiovascular implantable electronic devices: Are there clinical factors that predict success?.” Pacing and ClinicalElectrophysiology 41.5 (2018): 524-531.

28. Hussein et al. Microbiology of Cardiac Implantable Electronic Device Infections. J Am CollCardiolEP 2016;2:498–505 CircArrhythmElectrophysiol.

29. Inpatient Prospective Payment System (IPPS) Final Rule FY13.

30. Centers for Medicare & Medicaid Services, US Department of Health and Human Services. Medicare Program; Hospital Inpatient Prospective Payment Systems for AcuteCare Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals Resident Caps for Graduate Medical Education PaymentPurposes; Quality Reporting Requirements for Specific Providers and for Ambulatroy Surgical Centers. Baltimore, MD: Centers for Medicare & Medicaid Services; 2012. CMSpublication CMS-1588-P.

31. Difference between average hospital days from reference #20 (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 www.ahaonlinestore.com.

32. Paz Rios, Luis, et al. “Effect Of An Electronic Medical Alerts For Patients With Positive Cultures And Cardiovascular Implantable Electronic Devices.” Moderated ePosterPresentation. 2020 Heart Rhythm Society Annual Abstract Presentations Online.

GlideLight Laser Sheath
The GlideLight Laser Sheath is intended for use with other lead extraction tools in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the GlideLight Laser Sheath may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead extraction with the GlideLight laser sheath.

Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung. Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications associated with anesthesia, stroke or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

Bridge Occlusion Balloon
The Bridge Occlusion Balloon is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Use of the Bridge occlusion balloon in procedures other than those indicated is not recommended. The adverse events associated with an occlusion balloon procedure include, but are not limited to allergic reactions, death, embolization, hematoma, hemorrhage, sepsis/infection, short-term hemodynamic deterioration, thromboembolic episodes, vascular thrombosis, vessel dissection, vessel perforation, vessel spasm. In order to facilitate rapid delivery, it is recommended that a guidewire is in place in the superior vena cava prior to beginning the lead extraction procedure. Attempting to place the guidewire after a tear has occurred may:

• Result in an inability to traverse the superior vena cava with the guidewire
• Result in the guidewire exiting the vasculature at the tear site
• Result in an inability to place the Bridge occlusion balloon catheter
• Delay or prevent the ability to achieve occlusion

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

Lead extraction is life-saving

Recent ACC late-breaking data found that 8 in 10 patients are not treated according to Class I guidelines. Yet, lead extraction within 6 days is associated with a 42.9% lower risk of death.1