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Learn about lead extraction

  • 1.2-1.4 million cardiac implantable electronic devices (CIEDs) are implanted annually worldwide.1
  • Estimated 22,000 lead extraction procedures are performed yearly.2
  • 52.8% of procedures are due to infection – the #1 indication.11
  • 38.1% of procedures not due to infection are due to lead dysfunction.11

To learn more about lead extraction including indications and treatment options please view our patient resource.

Lead Extraction patient information

Abandonment vs extraction

Lead extraction procedures in patients with previously abandoned leads have shown worsened clinical outcomes, increased procedural time, and increased rates of complication and mortality4 when compared with patients who did not have abandoned leads.

A lead extraction program using Evolution® RL can achieve clinical success rates of greater than 98% with low complications.5,6,7,8 Cook Medical rotational lead extraction can help your patients get back to living.

Cook history in lead extraction

Rotational TLE

What is rotational TLE?

Rotational TLE devices have a proven track record of safety and efficacy.6,7,8,10 The rotational system utilizes a hand-powered flexible sheath with a specialized dissection tip. The inner sheath is activated with a trigger handle, allowing the user to control the amount, speed, and direction of the sheath’s rotation.

Why choose Rotational TLE?

Safety

A 2019 study that reviewed the MAUDE Database for a six-year period stated that lead extraction with rotational sheaths is 7.2 times less likely to result in mortality compared to laser lead extraction.9

“Patient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety.”10

SVC tears are the leading cause of mortality in lead extraction.14 Using the Evolution RL as a primary approach to lead extraction has shown that it may lower the risk of an SVC injury.8,10 Both the PROMET and RELEASE studies resulted in zero isolated extrapericardial SVC injuries using the Evolution RL.

Efficiency

In the 2021 RELEASE study,8 exclusively using the Evolution RL, extraction times were recorded for 98% of leads (451/460). Those leads had a median implant duration of 7.4 years. The median procedure time was 10 minutes with a median extraction time per lead of 4 minutes.8 The ELECTRa study, which used various device platforms for lead extraction, reported a median extraction time of 19 minutes with a median implant duration of 5 years.11

Control

Rotational lead extraction provides control over the activation of the sheath that is not possible with externally powered devices. The unique trigger mechanism delivers tactile feedback to the physician throughout the procedure.

The amount of sheath rotation is directly proportional to the length of the trigger pull with the Evolution RL, while externally powered devices have a preset energy upon activation. This allows users of rotational devices to have improved feedback and control.

Devices

Evolution RL Controlled-Rotation Dilator Sheath Set

The most recent studies in lead extraction have shown Evolution RL to be safe and effective.5,6,7,8,10

Flexibility

  • Allows for the extraction of any lead, including those in difficult vasculature
  • Gives physicians the strength and control needed when engaging with dense and calcified adhesions5,6,7,15

Bidirectional extraction

  • Actively extract leads when rotating in either direction
  • The unique tip allows for disrupting the tissue while rotating in either direction, competitive tools only extract in one direction and unwind in the opposite
  • User selects the direction of rotation

Protect companion leads with no lead wrap or damage.5,7,15

Evolution Shortie RL Controlled-Rotation Dilator Sheath Set

Access every lead.

The Evolution Shortie RL is built specifically for vessel entry into the subclavian veins. The Shortie RL combines all the control features of the full-length Evolution with a shorter, stiffer sheath and enhanced tip. These features enable the Evolution Shortie RL to create vessel entry through dense scar tissue and calcification. In some instances, the lead may be removed after achieving vessel entry.

Comprehensive product portfolio

Cook Medical provides the only full product portfolio to support your entire procedure. Lead extraction guidelines3,13 recommend having a full toolbox of devices for any clinical scenario you may encounter. Our comprehensive offering comes without costly capital equipment and service fees. We’re here to help you improve patient outcomes while reducing procedure cost.

Recent studies have shown extremely high success rates when following a step-wise approach to lead extraction,7,10 performing the same steps in a controlled manner for each procedure. Our devices help you navigate each step of the procedure:

Lead preparation

Preparing the lead to be removed may consist of cutting off the connector(s), expanding the inner coil, clearing the inner lumen of the lead, and/or holding the lead without damaging the inner lumen.

Lead control

Using specialized devices to strengthen the lead and allow it to be used as a rail during extraction. Controlling both the distal and proximal ends of the lead can prevent stretching and breaking of leads.

Vessel entry

Gaining access to the subclavian vein and navigating through the clavicular region. Typically, the fibrotic tissue and calcification found in this area are the most dense.

Manual sheath extraction

A full-length sheath that follows the length of the lead separating it from any fibrotic tissue and/or calcification. The sheath is rotated manually by the physician.

Rotational lead extraction

A full-length sheath that follows the length of the lead, separating it from any fibrotic tissue and/or calcification. Rotational devices allow the user to control the amount, speed, and direction of rotation.

Femoral/jugular extraction

These may be used as a primary approach to lead extraction or to remove broken or fragmented leads. Additionally, difficult-to-remove leads are often retrieved through the femoral approach.

 

Educational resources

Vista® Education and Training

Collaborate with your peers and learn from the experts, who share their experience and knowledge to assist you in learning about lead extraction. Visit the Vista website for more information and to register for an upcoming course.

Cook Vista site

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References

  1. MedMarket Diligence LLC Report C500.
  2. Bracciodieta EJ. Medtech 360: Cardiac Rhythm Management Devices | Market Analysis | Global | 2016. Toronto, Canada: Millennium Research Group; 2016.
  3. Bongiorni MG, Burri H, Deharo JC, et al. 2018 EHRA expert consensus statement on lead extraction: Recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: Endorsed by APHRS/HRS/LAHRS. Europace. 2018;20:1217a-j.
  4. Hussein A, et al. Cardiac Implantable Electronic Device Infections: added complexity and suboptimal outcomes with previously abandoned leads. JACC Clin Electrophysiol. 2017; 3(1):1-9.
  5. Mazzone P, Migliore F, Bertaglia E, et al. Safety and efficacy of the new bidirectional rotational Evolution mechanical lead extraction sheath: results from a multicentre Italian registry. Europace. 2018;20(5):829–834.
  6. Sharma S, Ekeruo IA, Nand NP, et al. Safety and efficacy of transvenous lead extraction utilizing the Evolution mechanical lead extraction system: a single-center experience. JACC Clin Electrophysiol. 2018;4(2):212–220.
  7. Migliore F, Testolina M, Sagone A, et al. Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: safety, effectiveness, and outcome. Pacing Clin Electrophysiol. 2019;42(7):989–997.
  8. Sharma S, Lee BK, Garg A, et al. Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study. Heart Rhythm O2. 2021;2(2):113–121.
  9. Diaz CL, Guo X, Whitman IR, et al, Reported mortality with rotating sheaths vs laser sheaths for transvenous lead extraction. Europace. 2019;21(11):1703–1709.
  10. Starck CT, Gonzalez E, Al-Razzo O. Results of the patient-related outcomes of mechanical lead extraction techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques. Europace. 2020;22(7):1103–1110.
  11. 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.
  12. 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.
  13. Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017;14(12):e503–e551.
  14. Hauser RG, Katsiyiannis WT, Gornick CC, et al. Deaths and cardiovascular injuries due to device-assisted implantable cardioverterdefibrillator and pacemaker lead extraction. Europace. 2010;12(3):395–401.
  15. Starck CT, Steffel J, Caliskan E, et al. Clinical performance of a new bidirectional rotational mechanical lead extraction sheath. Europace. 2016;18(2):253–256.