Lead management

Doctor shows x-ray print to the patient lying on the bed

Clinical and economic impact of under treatment

"Device removal should remain a mandatory and early management intervention in patients with CIED infection.

James E. Peacock, MD

Treatment icon

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.1-5

Antibiotics icon

When treated with antibiotics alone, mortality rates can be as high as 31% to 66% in device related endocarditis cases.2

Dollar icon

$56,470 potential increased cost per patient with delayed CIED removal.23

Patient mortality increases when treated with antibiotics alone.


Patients may also swirl in the hospital system on multiple rounds of antibiotics and see multiple physicians.7 HRS guidelines state it is a Class I indication to refer a patient to a lead extractor for consultation with documented CIED infection.

 

Click here to find a physician that specializes in lead extraction.

Bob Kostoss
Watch the video to hear a patient story on delayed treatment
Mortality graphic

“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 documents24

A doctor and her patient checks a clipboard
Click here to learn more about how antibiotics alone are ineffective.

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.8-9 The biofilm forms a thick coating around the device or leads that is nearly impossible to cure with antibiotic treatment alone.10-11 Biofilms that cause antibiotic resistance are present in up to 85% of microbial infections.22

 

A recent multicenter study13 attempted to find clinical factors for device salvage with CIED infection and found:

  1. No predictors for what could be salvaged.
  2. Of the patients discharged with an infected CIED, 26% died within 6 months.
  3. 80% of the device salvage attempts failed within 6 months.

 

Click here to download a free summary of the study.

Dr. Roger Carillo
Click here to hear Dr. Roger Carrillo’s perspective on the risks of relapse with antibiotics therapy alone

Antibiotics only = increased risk

 

Antibiotic therapy without device removal is associated with a 7-fold increase in 30-day mortality.12

 

Immediate system removal is associated with a 3-fold decrease in 1-year mortality compared to preliminary antibiotic treatment and delayed system removal.12

 

Mortality rates in patients with endocarditis who had systems removed are less than 18%, compared with up to 66% with antibiotics alone.3

Cost of under treatment for hospitals


Quickly diagnosing CIED infection and extracting all hardware is vital to reducing hospital costs.

 

Early removal reduces length of hospital stay and increases

survival.20-21

 

  • Under-treating CIED infection is an enormous economic burden on hospitals and the healthcare system7

– $52,000-$146,000 - Cost to treat a single CIED infection patient17-18

– $72,000 - Average cost of a hospital-acquired infection17

– Patients extracted within 10 days may save the hospital system $56,470 in costs due to shorter hospital stays23

  • Payment eliminated: CMS no longer pays for the additional costs of hospital-acquired infection and will only pay for the original surgery19
Click here to download a brochure on the costs of CIED infection.

Timely extraction can reduce hospital costs*

Timing of lead removal
<10 days
>10 days
Length of hospital stay (LOHS)20
18+13
44+38
Survival (at one year)20
83.1%
66.1%
Length of hospital stay (LOHS)20
18+13 (Timing of lead removal <10)
44+38 (Timing of lead removal >10)
Survival (at one year)20
83.1% (Timing of lead removal <10)
66.1% (Timing of lead removal >10)

$56,470

potential cost of delayed treatment

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

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Infection plus device equals to removal
  1. Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604-608.
  2. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.
  3. Sohail, MR, et al. Management and outcome of permanent and implantable cardioverterdefibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859
  4. 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.
  5. 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.
  6. Tarakji, K, et al. Cardiac implantable electronic device infections: presentation, management, and patient outcomes, Heart Rhythm, Vol.7, No. 8, 2010: 1043-7. 12.
  7. Hussein et al. Microbiology of Cardiac Implantable Electronic Device Infections. J Am CollCardiolEP 2016;2:498–505 CircArrhythmElectrophysiol.
  8. 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.
  9. 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.
  10. Lazãr, Veronica, and C. Chifiriuc. “Medical significance and new therapeutical strategies for biofilm associated infections.” Rom Arch Microb & Immunol 69 (2010): 125-138.
  11. 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
  12. 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.
  13. Peacock Jr, James E., et al. “Attempted salvage of infected cardiovascular implantable electronic devices: Are there clinical factors that predict success?.” Pacing and Clinical Electrophysiology 41.5 (2018): 524-531.
  14. Wazni, O. et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter observational RetrospectiveStudy of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-586.
  15. Maytin M, Jones SO, Epstein LM. Long-Term Mortality After Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2012;5:252-257
  16. 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.
  17. Inpatient Prospective Payment System (IPPS) Final Rule FY13.
  18. Greenspon AJ, Patel JD, Lau E, et al. 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008. J Am Coll Cardiol. 2011;58(10):1001-1006. doi:10.1016/j.jacc.2011.04.033.
  19. Centers for Medicare & Medicaid Services, US Department of Health and Human Services. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatroy Surgical Centers. Baltimore, MD: Centers for Medicare & Medicaid Services; 2012. CMS publication CMS-1588-P.
  20. 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
  21. Lin, Andrew, et al. “Early Versus Delayed Lead Extraction in Patients with Infected Cardiovascular Implantable Electronic Device.” Moderated ePoster Presentation. 2020 Heart Rhythm Society Annual Abstract Presentations Online.
  22. Lazãr, Veronica, and C. Chifiriuc. “Medical significance and new therapeutical strategies for biofilm associated infections.”Rom Arch Microb & Immunol 69 (2010): 125-138.
  23. 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 http://www.ahaonlinestore.com.
  24. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.


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

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