Why the study?
Data on the efficacy and safety of transvenous lead extraction using bidirectional rotational mechanical sheaths in patients with very old leads (dwell time >10 years) were lacking.
Does transvenous lead extraction using bidirectional rotational mechanical sheaths provide high procedural success and safety in patients with very old leads (≥10 years)?
Does transvenous lead extraction using bidirectional rotational mechanical sheaths provide high procedural success and safety in patients with very old leads (≥10 years)?
Transvenous lead extraction using bidirectional rotational mechanical sheaths is highly successful and safe for very old leads (≥10 years dwell time) when performed at experienced centers.
Answers are grounded in this paper and cite their sources.
Supports safe use of rotational sheaths for leads ≥10 years at experienced centers; extends observational data but leaves open randomized confirmation.
INTRODUCTION: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years. METHODS: A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures. RESULTS: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up. CONCLUSION: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.
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Migliore et al. (2022) studied this question.
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