Lead management

Take the lead. 
Advance patient care.

 

You always pursue what’s best for your CIED patients. In many cases, early lead extraction may actually be what’s best.7,11,19 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.

Lead person icon
84%
Of patients with a noninfectious indication for lead extraction are capped8, leading to increased risk for infection8, higher risk future extraction9, contraindication for MRI10, and increased venous burdens.11
Lead chart icon
97.7%
Clinical success rate of laser lead extraction12
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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%13
Older lady having chest pain
Lead extraction.
Life saving.
More than 6 in 10 patients suffering from cardiac device infections are  treated with anitibiotics alone or not treated at all1, leading to significant  mortality2 and costs1
People 6 and 10

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.

 

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.

Designed with safety in mind. Philips Lead Management Solutions

Laser sheath
Mechanical rotating dilator sheath
Occlusion balloon
Ttl antibiotic
Treating CIED infection with antibiotics alone has a 50% to 100% relapse rate, compared to 0% to 4.2% relapse with complete system removal.2-6
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There are 30 HRS indications for lead extraction and lead management.7 Pocket and systemic infections are Class I indications for complete removal of hardware, including leads.7
TightRail rotating dilator sheath
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.
Carl having a visit with doctor

How lead extraction has led one man to a life of zero restrictions

 

Delaying lead extraction because the risks associated with the procedure seem too great and the outcomes too uncertain, is rarely the best choice.7,11,19 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.

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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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Key thought leaders

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Clinical expertise

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Product knowledge

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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.Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.

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. 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. 

6. 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).”

7. Sohail MR, et al. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am CollCardiol. 2007;49:1851–1859.

8. 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.

9. 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.

10. Klug, D., et al. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.20.

11. 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

12. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.

13. 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.

14. Hussein, Ayman A., et al. “Cardiac Implantable Electronic Device Infections: Added Complexity and Suboptimal Outcomes With Previously Abandoned Leads.” JACC: Clinical  Electrophysiology (2016).

15. 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

16. 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

17. Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExIConStudy: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J  Am Coll Cardiol, 55:579-586.

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 Vena  Cava Tears During Transvenous Lead Extraction: A Multi-Year Analysis and An Update to Best Practice Protocol. Circulation: Arrhythmia and Electrophysiology, August 2019.

19. 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.

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Final CEE consent