In 2019, a retrospective study by Diaz, et al1, compiled and analyzed data from 50,545 lead extraction cases from 2011-2016. The authors compared mortality rates for laser sheaths and rotational sheaths. A retrospective analysis comparing these two treatment modalities had never before been conducted.
Using device procedure data provided by a third party, the authors estimated that physicians performing lead extractions chose laser sheaths for 64% of procedures, compared to using rotational sheaths 36% of the time.
The study showed that lead extraction with laser sheaths appears to be associated with a higher risk of mortality when compared to rotating sheaths. Patients treated with laser sheaths had a mortality rate 7.2 times greater than those whose leads were extracted using rotational sheaths. The authors called for further studies to confirm the results1.
History of Lead Extraction Devices
The first devices indicated for lead extraction procedures were launched by Cook in 1989. The locking stylet and Byrd Dilator Sheaths created mechanical lead extraction. Typically, all devices without a direct external energy source (i.e., lasers and radio frequency sheaths) have been classified as mechanical extraction tools. Rotational tools have taken the principles of mechanical extraction and evolved them into the newest technology available in lead extraction.
What is Rotational TLE?
Rotational transvenous lead extraction (TLE) devices have a proven track record of safety and efficacy2,3. 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 and direction of the sheath’s rotation.
The amount of sheath rotation is directly proportional to the length of the trigger pull by the physician, while powered devices have a preset energy that is triggered upon activation.
Evolution® RL Controlled-Rotation Dilator Sheath Set
The Evolution RL is flexible enough to allow for the extraction of any lead, including in difficult vasculature. The RL gives the physician the strength and control needed when engaging with dense and calcified adhesions2,3,4,5.
The 10-sided tip allows the physician to peel the leads away from scar tissue and only engages the tissue directly surrounding the tip. The tip also allows for disrupting the tissue while rotating in either direction. The bladeless tip and bidirectional extraction mechanism have shown no occurrences of lead wrap or damage to companion leads2,4,5.
A lot has changed in lead extraction technology over the last three decades. With the input of physicians, the Evolution RL has built upon the principles of the original mechanical dilator sheaths and has been proven to be safe and effective2,3,4. Cook Medical is continuously working to provide physicians with the technology they need to keep patients safe and get them back to living.
Vista® Education and Training
To get training on the Evolution RL or any other Cook Medical devices, physicians can sign up here for our educational training courses. Renowned physicians will work shoulder-to-shoulder with you to improve outcomes. Training is typically a one- or two-day course on a specific procedure or family of procedures. Courses may include presentations, case discussions, and lectures on the indications, complications, and limitations of the procedures. Some courses may include live observations.
- Diaz C, Guo X, Whitman I, et al. Reported mortality with rotating sheaths vs laser sheaths for transvenous lead extraction. Europace. 2019;0:1-7.
- 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;1-9.
- Sharma S, Ekeruo I, Nand N., et al. Safety and efficacy of transvenous lead extraction utilizing the Evolution mechanical lead extraction system. JACC. 2018;4(2):212-220.
- 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. 2017;1-6.
- Stark CT, Steffel J, Caliskan E, et al. Clinical performance of a new bidirectional rotational mechanical lead extraction sheath. Europace. 2016;18(2):253-256.