Choose your Region

Are you sure you want to proceed?

You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. Not all products are approved in all regulatory jurisdictions. The product information on these websites is intended only for licensed physicians and healthcare professionals.

‘A major advance in TLE’: Study finds rotational TLE tools associated with low incidence of acute injury to superior vena cava

A recently published retrospective multicenter study conducted by Starck et al., the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET), focused on efficacy and safety outcomes in rotational lead extraction techniques compared to laser extraction methods.1

The PROMET study includes the “largest series of data published on clinical outcomes of a rotational lead extraction tool.” “Data were collected from 2,205 patients […] with 3,849 leads […] in six European lead extraction centres.”

Clinical success (if the procedure had the “intended clinical outcome”) occurred in 97.0% of procedures. And 96.5% of the leads were completely extracted.1

The study shows similar outcomes to other large transvenous lead extraction (TLE) trials. According to the study’s authors, “rotational TLE tools and techniques match laser methods in efficacy and surpass them in safety.”

“The Evolution rotational extraction sheath shows a good safety and efficacy performance, especially in long implanted leads,”1 said the study’s authors.

Leads removed by Evolution or Evolution RL rotational devices had a median implant duration of 106 months, longer than leads removed without Evolution.1 Despite this difference, complete procedural success using Evolution occurred in more than 95% of extractions.

The study authors also found that one of the key advantages of rotational TLE tools is the low incidence of acute injury to the superior vena cava (SVC).1 In the PROMET study, there were zero instances of acute injury to the extrapericardial portion of the SVC.1

Two additional studies also reflected the safety of rotational tools. Migliore et al. mentioned only one major complication consisting of an injury to the SVC, and no procedure-related deaths were reported.

Additionally, based on the Diaz et al. study, with laser lead extraction, there was an almost seven-times greater risk of mortality compared to rotational lead extraction.3

Learn more about Evolution® RL and lead extraction devices here.

More on Evolution RL

  1. Starck C, Gonzalez E, Al-Razzo O, et al. Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques. EP Europace. 2020;22(7):1103–1110.
  2. 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.
  3. 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.