Chapter 7 118 success rate (97.3%, 95% confidence interval [CI] 96.6–97.8%), complete lead removal rate (96.2%, 95% CI 95.6–96.7%), in-hospital procedure-related major complications (1.5%, 95% CI 1.1–2.0%) and in-hospital procedure-related death (0.4%, 95% CI 0.2–0.7%) (11). In contrast, our median procedure time was higher than in the ELECTRa registry (102 versus 83 min). This may be related to the relative higher proportion of patients with lead malfunction as these patients require CIED reimplantation during the same procedure (Fig. 3). Our TLE outcome was also comparable to a recently published European registry, the PROMET (Patient-Related Outcomes of Mechanical lead Extraction Techniques) study, which was focused on the use of rotational TLE tools in 6 high-volume centers (22). In the PROMET study, clinical success was obtained in 97.0% of procedures (present study 97.7%), and complete lead removal was achieved in 96.5% of targeted leads (present study 94.1%). Whether a liberal combined approach is costeffective should be further investigated. Despite similarities in TLE outcomes with 2 large European registries, certain centers have demonstrated a higher complete procedural and clinical success rate (23). We report our single-center experience with TLE tools from Cook Medical. Perhaps the availability of a wider range of TLE tools (e.g. TightRail, laser sheath) may further improve our TLE results but this should be evaluated. 4.4 Study limitations This was an observational study without a control group. Therefore, it is difficult to draw firm conclusions whether this approach is better than other techniques. Considering the stepwise approach, selection bias is an issue when comparing the different techniques (superior of femoral approach only versus combined approach) in our study population. In the field of TLE, there is a paucity of randomized controlled trials with regard to comparison between different techniques. Nevertheless, the use of standard definitions of TLE outcome and complications ensures reliable comparison to TLE studies. Finally, the single-center design impacts the generalizability of the data.
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