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Lead management devices and extraction

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Take the lead, advance patient care

Cardiac implantable electronic device (CIED) patients are at the core of what you do. Our lead management devices allow safe and effective extraction of CIED leads, providing improved outcomes for patients.  Philips is dedicated to helping physicians and patients manage every lead – safely, responsibly, predictably.

Demonstrated results in lead management devices and extraction

  1. 84%

    of patients are capped

    84%

    of patients are capped

     Of patients with a noninfectious indication for lead extraction are capped, leading to increased risk for infection, higher risk future extraction [1], contraindication for MRI [2], and increased venous burdens [3,4].

  2. 97.7%

    clinical success rate

    97.7%

    clinical success rate

    of laser lead extraction [5]

  3. 88.2%

    increase in SVC tear survival rate from 56.4%

    88.2%

    increase in SVC tear survival rate from 56.4%

    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% [6].

Lead extraction is life-saving, yet patients are undertreated

New data in JAMA Cardiology found that >8 in 10 patients with CIED infection are not treated according to Class 1 guidelines. Yet, lead extraction within 6 days of diagnosis is associated with a 42.8% lower risk of death [7]. 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.

Benefits

  • With early diagnosis and appropriate treatment, cardiac device infections can be cured [7].
  • Lead extraction is proven to be safe [5,8] and all major cardiac society guidelines recommend complete system removal of hardware and leads when an infection is present [9,10].
  • Lead extraction has a 97.7% clinical success rate [5].

Improved patient outcomes with Philips lead management portfolio of safe and effective tools

  • A multi-year study showed proper Bridge utilization increased SVC tear survival from 56.4% to 88.2% [6].
  • Lead extraction has a 99.72% procedural safety rate [5].

By removing the pacemaker, I’ve been able to get on with my life and be more optimistic about tomorrow, and I can live again.

Jerry
Patient
Jerry CIED patient

Documentation

Lead Extraction in the Contemporary Setting: The LExICon Study
PDF|(873.77 KB)
2017 expert consensus-cardiovascular implantable electronic device lead management & extraction
PDF|(1.21 MB)
HeartModel innovation proofpoints
PDF|(407.43 KB)
Footnotes
  1. Pokorney et al. Outcomes Associated with Extraction versus capping and Abandoning Pacing and Defibrillator Leads Circulation 2017 Oct 1O; 136(15): 1387-1395. doi: 10.1161 /CIRCULATIONAHA.117.027636. Epub2017 Aug 22.
  2. 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.
  3. Oginosawa Y, Abe H, Nakashima Y. The incidence and risk factors for venous obstruction after implantation of transvenous pacing leads. Pacing Clin Electrophysiol 2002;2 5: 1605-1611.
  4. Kutarski, A., Pietura, R., Mtynarczyk, K., Matecka, B., & Gtowniak, A. (2012). Pacemaker lead extraction and recapture of venous access: technical problems arising from extensive venous obstruction. cardiology journal, 19(5), 513-517.
  5. Wazni 0, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the LExlCon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll cardiol. 2010;55(6):579-586.
  6. 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.
  7. Pokorney SD, Zepel L, Greiner MA, et al. Lead Extraction and Mortality Among Patients With Cardiac Implanted Electronic Device Infection. JAMA Cardiol. Published on line October 18, 2023. doi:10.1001 /jamacardio.2023.3379.
  8. 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.
  9. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.
  10. Blomstr6m-Lundqvist, C. et al. European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAH RS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for cardio-Thoracic Surgery (EACTS). Europace (2020) 22, 515-516 and European Heart Journal (2020) 41, 2012-2032.
  11. Comparison of average peak push forces required to advance Laser Sheath at 40Hz vs. 80Hz Pulse Repetition Rate through simulated fibrosis material at an advancement rate of 1.0 mm/second. 0015722, Data on file at Philips.
  12. Comparison of ablation force vs. advancement rate of Laser sheath 40Hz vs. 80Hz by use of the data collected in 0015786, Data on file at Philips.
  13. 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.
Disclaimer
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. Always read the label and follow the directions for use.
Philips medical devices should only be used by physicians and teams trained in interventional techniques, including training in the use of this device.
Products subject to country availability. Please contact your local sales representative.
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