You always pursue what’s best for your CIED patients. In many cases, early lead extraction may actually be what’s best.5,9,16 The procedure results in extremely high success.1 When you partner with skilled extractors or perform more procedures yourself, you take the lead to secure healthier and happier lives for your patients.
Manage every lead. Safely, predictably, responsibly.
84%
Of patients with a noninfectious indication for lead extraction are capped6, leading to increased risk for infection6, higher risk future extraction7, contraindication for MRI13, and increased venous burdens.17-19
97.7%
Clinical success rate of laser lead extraction1
88.2%
Recent innovations have significantly advanced lead extraction. Proper use of the Philips Bridge occlusion balloon has contributed to increased SVC tear survival rates from 56.4% to 88.2%15
Lead extraction.
Life saving.
More than 6 in 10 patients suffering from cardiac device infections are treated with anitibiotics alone or not treated at all4, leading to significant mortality2 and costs4
All leading cardiac societies including the Heart Rhythm Society (HRS) and American Heart Association (AHA) agree that safe, cost-effective and life-saving treatment for CIED infection is complete removal of the device, including leads. Any patient with an implanted cardiac device and a suspected infection should be screened immediately for extractor consultation.10 Philips is dedicated to helping you recognize and treat implanted cardiac device infections by providing expert tools, training and support that help you save lives and vastly improve the quality of life for your patients.
Treating CIED infection with antibiotics alone has a 50% to 100% relapse rate, compared to 0% to 4.2% relapse with complete system removal.5-9
There are 30 HRS indications for lead extraction and lead management.10 Pocket and systemic infections are Class I indications for complete removal of hardware, including leads.10
Ways to extract
Lead extraction achieved >96% clinical success rates and >99% survivability rates when performed by skilled physicians working with advanced technology in experienced extraction centers.1,2
Philips provides tools specifically designed to help achieve the clinical goals while allowing the highest level of confidence. Learn about lead extraction tools offered by Philips.
Delaying lead extraction because the risks associated with the procedure seem too great and the outcomes too uncertain, is rarely the best choice.5,9,16 However in the majority of cases, outcomes are successful when the procedure is performed by highly experienced extractors in patients for whom lead extraction is indicated.1,2 Take the lead by referring your patients to skilled extractors in your area and help pave the way to better outcomes and healthier, happier lives.
When CIED patients present with infection, immediate referral to a lead extraction specialist is now the established standard of care, as infection is a class I indication to remove leads and all other hardware to cure the infection and preserve patient health.10 Also, it is a Class I indication to discuss the risks of lead abandonment and the risks of lead extraction with patients10. Know the guidelines, and incorporate shared decision-making into your practice.
Education resources
Philips ELIITE Academy is focused on delivering high value and real-time strategic educational programs that meet the evolving needs of our customers. For more information on the available courses, please visit www.philipseliiteacademy.com.
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GlideLight laser sheath important safety information
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.
RX Use Statement
Caution: Federal law restricts this device to sale by or on the order of a physician.
1. Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol. 2010;55(6):579-586.
2. Bongiorni MG, Kennergren C, Butter C, et al. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) registry of transvenous lead extraction outcomes. Eur Heart J. 2017;38(40):2995-3005.
3. Larry M. Baddour, Andrew E. Epstein, et al. Update on Cardiovascular Implantable Electronic Device Infections and Their Management. A Scientific Statement from the American Heart Association. Circulation 2010; 121:458-477.
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. CircArrhythmElectrophysiol. 2016; 9(8).
5. Sohail MR, et al. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am CollCardiol. 2007;49:1851–1859.
6. Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604- 608.18.
7. 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.
8. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.20.
9. 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
10. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.
11. Pokorney et al. Outcomes Associated with Extraction versus Capping and Abandoning Pacing and Defibrillator Leads Circulation 2017 Oct 10;136(15):1387-1395. doi: 10.1161/CIRCULATIONAHA.117.027636. Epub2017 Aug 22.
12. Hussein, Ayman A., et al. “Cardiac Implantable Electronic Device Infections: Added Complexity and Suboptimal Outcomes With Previously Abandoned Leads.” JACC: Clinical Electrophysiology (2016).
13. Mattei, E., Gentili, G., Censi, F., Triventi, M. and Calcagnini, G. (2015), Impact of capped and uncapped abandoned leads on the heating of an MR-conditional pacemaker implant. Magn Reson Med, 73: 390–400. doi: 10.1002/mrm.25106
14. de Cock CC, et al. Long-term outcome of patients with multiple (> or = 3) noninfected leads: a clinical and echocardiographic study. PACE, Vol 23, No 4, 2000, 423-6
15. 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 Vena Cava Tears During Transvenous Lead Extraction: A Multi-Year Analysis and An Update to Best Practice Protocol. Circulation: Arrhythmia and Electrophysiology, August 2019.
16. 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.
17. Sohail, M. et al. (2014). Laser lead extraction to facilitate cardiac implantable electronic device upgrade and revision in the presence of central venous obstruction. Europace, 16(1), 81-87.
18. Oginosawa Y, Abe H, Nakashima Y. The incidence and risk factors for venous obstruction after implantation of transvenous pacing leads. Pacing Clin Electrophysiol 2002;25:1605–1611.
19. Kutarski, A., Pietura, R., Młynarczyk, K., Małecka, B., & Głowniak, A. (2012). Pacemaker lead extraction and recapture of venous access: technical problems arising from extensive venous obstruction. Cardiology journal, 19(5), 513-517.