Key result
Subsequent EV-ICD implantations show ~33% shorter procedural times versus initial cases.
Why the study?
Adoption of the EV-ICD requires an entirely new implantation technique, motivating an assessment of the learning curve for implanters.
Does the learning curve for EV-ICD implantation improve procedural times and sensing parameters in patients requiring ICDs?
Observational (n=28)
No
Does the learning curve for EV-ICD implantation improve procedural times and sensing parameters in patients requiring ICDs?
The learning curve for EV-ICD implantation is relatively short, with procedural and fluoroscopic times significantly improving and stabilizing after the first 14 cases.
May streamline EV-ICD implantation in select centers; leaves open generalizability and safety in larger prospective studies.
Background The ExtraVascular-Implantable Cardioverter Defibrillator (EV-ICD) has been recently introduced to overcome the complications related to transvenous leads and the limitations of the Subcutaneous-ICD (S-ICD), thanks to the possibility of effectively treating ventricular tachycardia via anti-tachycardia pacing and provide backup anti-bradicardia pacing. Adoption of the EV-ICD requires an entirely new implantation technique. The aim of this single-center study was to assess the learning curve for EV-ICD implanters. Methods We retrospectively collected data of the first 28 cases of EV-ICD (Aurora EV-ICD, Medtronic, Minneapolis, USA) implantation at our institution from January 2024 to April 2025. All implantations were performed by two experienced electrophysiologists (PM, MD) not previously involved in the pivotal trial, whether for primary or secondary prevention. The learning curve was evaluated considering procedural (skin-to-skin) and fluoroscopic time, R-Wave Sensing and implant-related complications. A general linear model was fit for the procedural outcomes (scatter plot). The learning curve was also evaluated by comparing the procedural outcomes between two subgroups of the population (G1: the first 14 cases; G2: the subsequent 14 cases. Student's t-test was adopted for comparison of continuous variables, while the Chi-Quadro Test was used for categorical variables. Results Procedural data are illustrated in Table 1. Respect to G1, the G2 showed a significant reduction in procedural time (65.8 ± 25.1 vs. 98.2 ± 31.3 min, p = 0.003,), fluoroscopic time (5.23 ± 2.4 vs. 8.07 ± 3.5 min, p=0.012) and R-wave sensing (3.15 ± 1.44 vs 2.0 ± 1.15 mV, p = 0.015). Scatter plot documents the progressive reduction case-by-case of procedural and fluoroscopic time , with a stabilization of the endpoints after the first 14 implants. Also, R-wave Sensing shows a progressive case-by-case improvement (Fig.1). At 6 months follow-up, three implant-related complications were reported (two early lead dislodgements requiring repositioning in G1 and one pocket hematoma in G2). Electrical parameters remained stable at follow-up. Conclusion Our experience reports a short and significant learning curve for EV-ICD implanters. Performance tends to stabilize after 14 implants.Table 1Figure 1
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Baroni et al. (2026) conducted an observational in Ventricular arrhythmia (primary or secondary prevention) (n=28). EV-ICD implantation (subsequent 14 cases) vs. EV-ICD implantation (first 14 cases) was evaluated on Procedural time (minutes) (p=0.003). Compared to the first 14 cases, the subsequent 14 EV-ICD implantations had significantly shorter procedural time (65.8 vs 98.2 min, p=0.003) and fluoroscopic time (5.23 vs 8.07 min, p=0.012).
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