Outcomes of transvenous lead extraction of very old leads using bidirectional rotational mechanical sheaths: Results of a multicentre study

Abstract

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.

Success and Complication Rates of Transvenous Lead Extraction in a Developing High-Volume Extraction Center: The Zurich Experience

“…Similarly, our clinical success rate of 94.0% was lower than reported success rates from larger established high-volume centers with 96.7–98.7% [ 5 , 7 , 15 , 16 , 17 ]. Regarding complications, we found a slightly higher rate of procedure-related major complications (3.7%) and a higher rate of minor complications (19.4%) compared to reported rates from most large registries (procedure-related major complications 0.4–2.6%, minor complications 1.4–7.2%) [ 5 , 6 , 7 , 8 , 9 , 15 , 16 , 17 , 18 , 19 ]. While there are also studies with a higher rate of procedure-related major complications, these often concern specific leads with known increased extraction difficulty [ 20 ].…”

“…This may be an important difference in the interpretation of our results, since longer lead dwelling time is a predictor of clinical and radiological failure, as well as complications [ 5 , 8 ]. Additionally, methods concerning the definition of complications and the timeframe of annotated complications vary between registries and publications [ 5 , 6 , 7 , 8 , 9 , 15 , 16 , 17 , 18 , 19 ]; we reported all complications during the hospital stay without adjudication in relation to the TLE procedure, which may also partially explain our higher rate of major and minor complications compared to previous publications.…”

“…Our retrospective analysis from a developing high-volume TLE center demonstrated a combined radiological success rate of 96.9% (complete and partial radiological success) and a complete radiological success rate of 92.3%. In comparison, the recent large single or multicenter registries demonstrated slightly higher rates of combined radiological success rate ranging from 98.5 to 99.3%, and complete radiological success ranging from 94.8 to 96.5% [ 5 , 6 , 7 , 15 , 16 , 17 ]. While there are also studies with lower radiological success rates, different definitions of success and failure complicate comparison [ 8 , 16 ].…”

“…In comparison, the recent large single or multicenter registries demonstrated slightly higher rates of combined radiological success rate ranging from 98.5 to 99.3%, and complete radiological success ranging from 94.8 to 96.5% [ 5 , 6 , 7 , 15 , 16 , 17 ]. While there are also studies with lower radiological success rates, different definitions of success and failure complicate comparison [ 8 , 16 ]. Similarly, our clinical success rate of 94.0% was lower than reported success rates from larger established high-volume centers with 96.7–98.7% [ 5 , 7 , 15 , 16 , 17 ].…”

“…While there are also studies with lower radiological success rates, different definitions of success and failure complicate comparison [ 8 , 16 ]. Similarly, our clinical success rate of 94.0% was lower than reported success rates from larger established high-volume centers with 96.7–98.7% [ 5 , 7 , 15 , 16 , 17 ]. Regarding complications, we found a slightly higher rate of procedure-related major complications (3.7%) and a higher rate of minor complications (19.4%) compared to reported rates from most large registries (procedure-related major complications 0.4–2.6%, minor complications 1.4–7.2%) [ 5 , 6 , 7 , 8 , 9 , 15 , 16 , 17 , 18 , 19 ].…”