Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety,...

Area of Science:

• Cardiovascular Medicine
• Medical Devices
• Surgical Procedures

Background:

• Limited data exists on the safety and effectiveness of Cook Medical's Evolution RL sheath for lead extraction (LE).
• Previous studies lack detailed outcome data for this specific LE tool.

Observation:

• A total of 393 leads were extracted from 198 patients using the Evolution RL sheath and ancillary tools in a stepwise manner.
• Infection was the primary indication for lead extraction (63.1%).
• The Evolution Shortie RL sheath was used in all cases, with complete lead extraction achieved in 12.2% of cases. The Evolution RL sheath was used in 87.8%, and the SteadySheath Evolution in 44% for challenging cases.

Findings:

• Complete procedural success was 97%, clinical success was 99%, and lead removal with clinical success was 99.5%.
• One major complication (0.5%) and 10 minor complications (5%) were recorded.
• Mortality predictors included impaired renal function, extraction due to infection, and diabetes.

Implications:

• The Evolution RL bidirectional rotational mechanical sheath and ancillary tools, when used in a systematic stepwise approach, demonstrate effectiveness and safety for lead extraction.
• This approach offers a high success rate for lead extraction, even in cases with tenacious fibrosis.
• Understanding mortality predictors is crucial for patient management following lead extraction.