Safety and efficacy of the new bidirectional rotational Evolution® mechanical lead extraction sheath: results from a multicentre Italian registry
Why the study?
Does the bidirectional rotational mechanical lead extraction sheath safely and effectively remove chronically implanted leads in patients requiring lead extraction?
Structured PICO
Does the bidirectional rotational mechanical lead extraction sheath safely and effectively remove chronically implanted leads in patients requiring lead extraction?
P
Population
124 consecutive patients with 238 chronically implanted leads (>1-year-old) requiring lead extraction for indications including cardiac device infection, lead malfunction, upgrade, or other reasons.
I
Intervention
Bidirectional rotational mechanical lead extraction sheath (Evolution RL)
O
Outcome
Safety and efficacy (complete extraction success rate, clinical success rate, and complications)safety
The bidirectional rotational mechanical lead extraction sheath is highly effective and safe for removing chronically implanted leads, achieving a 100% clinical success rate with no major complications.
Authors
Discussion
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Implication
Supports rotational sheath use in chronic lead extraction; leaves open randomized comparisons to laser or other methods.
Cite This Study
Mazzone et al. (2017) studied this question.