Leadless pacemakers in TAVI patients with conduction disturbances: insights from a real-world analysis

Abstract Background The use of leadless pacemakers (LPs) in clinical practice is expanding beyond the traditional indications for patients with increased infectious risk or those requiring vascular access preservation. However, the safety, efficacy and mid- to long-term performance of these devices in specific populations, such as patients undergoing transcatheter aortic valve implantation (TAVI) who develop conduction disturbances requiring urgent pacing, remain incompletely established. Objective To perform a real-world analysis of the safety, efficacy and mid-term stability of LPs in patients with severe aortic stenosis undergoing TAVI. Methods This was a single-center retrospective study including consecutive patients who received a leadless pacemaker after TAVI from September 2016 to September 2024. Results A total of 32 patients (71.8% male, mean age 81.0 ± 5.4 years) who developed conduction disturbances after TAVI were included. The mean time from TAVI to LP implantation was 3.3 ± 2.9 days. The primary indications were complete AV block (n=22, 68.8%), atrial fibrillation with bradycardia (n=6, 18.8%), left bundle branch block with PR prolongation (n=3, 9.4%) and sinus node dysfunction (n=1, 3.1%). A total of 14 (43.8%) cases were programmed in VDD mode and the remaining 18 (56.2%) in VVI mode. All LPs were successfully implanted, and no major peri-procedural complications were observed, including major access-site bleeding, cardiac tamponade or device displacement. The median follow-up (FUP) from LP implantation to the latest device interrogation was 1.22 years (IQR 0.66–2.57). RV pacing thresholds and R-wave sensing remained stable with no significant changes from implantation to the last FUP. The initial pacing threshold was 0.50V IQR 0.28–0.73 at 0.24 ms vs. 0.50V IQR 0.38–0.63 at 0.24 ms at FUP (p=0.301). The initial R-wave amplitude was 12.6mV IQR 8.1–19.8 vs. 15.0mV IQR 10.6–19.7 at FUP (p=0.056). Impedance values were lower at FUP compared to implantation (775Ω IQR 600–907 vs. 580Ω IQR 522–732, p0.001). Ventricular pacing appeared numerically lower at FUP, though not statistically significant (85.1% IQR 12.5–94.7 vs. 46.5% IQR 11.4–90.0, p=0.241) – Figure 1 Conclusions In this real-world analysis of post-TAVI patients requiring leadless pacing, LPs demonstrated a favorable safety profile, with no peri-procedural complications, a high implantation success rate, and good mid-term parameters stability. Despite these encouraging results, further studies in larger cohorts with extended follow-up periods are required.