Cook Medical products

In the late 1980s, a team of product managers and engineers from Cook Medical began working with a small group of doctors to design medical devices. Their work helped to create the first devices for removing leads. We’ve continued to work with doctors around the world to offer new devices that help patients get back to living.

Subclavian approach

What is the Evolution RL?

The Evolution RL is a rotating sheath (hollow tube). When the doctor pulls the Evolution RL trigger, the inner sheath rotates to help separate the lead from the scar tissue.

Benefits of the Evolution RL

The Evolution RL gives the doctor full control over the sheath’s rotation. This helps protect the blood vessels and extra leads that may not be taken out.

Femoral approach

The Needle’s Eye Snare is a looped wire that is inserted into the blood vessel through a sheath. The loop is tightened around the lead, which gives the doctor a firm hold in order to pull it out.

Benefits of the Needle’s Eye Snare

The Needle’s Eye Snare is the only device cleared for femoral lead removal. The Needle’s Eye Snare tightens around leads that are either attached to the heart or abandoned, even if they are broken. Without the Needle’s Eye Snare, a broken or damaged lead may need to be removed through an open chest procedure.

Risks of lead extraction

Potential risks related to lead extraction procedures include:

• Chest wall hematoma (a bad bruise in the chest)
• Thrombosis (a blood clot that blocks the blood vessels)
• Arrhythmia (abnormal heartbeat)
• Acute bacteremia (sudden bacteria in the bloodstream)
• Acute hypertension (sudden rising of blood pressure)
• Pneumothorax (collapsed lung)
• Stroke (blockage of blood flow in the brain resulting in damage to brain tissue)
• Pulmonary embolism (a blockage in one of the blood vessels in the lungs)
• Cuts or tears in the blood vessels
• Hemopericardium/pericardial effusion (the presence of blood in the area surrounding the heart)
• Cardiac tamponade (blood or fluids fill the space between the sac that encases the heart and heart muscle)
• Hemothorax (when blood collects between the chest wall and lungs)
• Cardiac arrest (heart attack)
• Death

If you have concerns about any of these risks, ask your doctor.

Leaving old leads inside your body

If you don’t have an infection, your doctor could choose to abandon the lead (leave it in place) or have it removed. Abandoning the lead has a similar effect on long-term survival compared to lead extraction. But, if your doctor does remove the lead, there is a lower risk of device infection for the first five years.³

If you need your lead removed in the future, any abandoned leads that were left inside your body could make it more difficult or dangerous to remove your current lead.⁴

Rotational lead extraction procedures have clinical success rates of more than 99% and major complication rates between 0 and 1.5%.^5,6,7

Depending on your unique situation, you and your doctor will weigh the risks of abandoning or removing the lead to make the decision that is best for you.

References

1. Bracciodieta EJ. Medtech 360: Cardiac Rhythm Management Devices | Market Analysis | Global | 2016. Toronto, Canada: Millennium Research Group; 2016.
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. Pokorney SD, Mi X, Lewis RK, et al. Outcomes Associated With Extraction Versus Capping and Abandoning Pacing and Defibrillator Leads. Circulation. 2017;136:1387–1395.
4. Segreti L, Rinaldi CA, Claridge S, et al. Procedural outcomes associated with transvenous lead extraction in patients with abandoned leads: an ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) Registry Sub-Analysis. Europace. 2019;21(4):645–654.
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);20:829–834.
6. Sharma S, Ekeruo I, Nand N, et al. Safety and efficacy of transvenous lead extraction utilizing the Evolution mechanical lead extraction system: A single-Center Experience. JACC. 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. July 2019;42(7):989-997.