Ten-year follow-up of 565 Micra leadless pacemakers: Long-term data on safety and function
F Mendez Zurita, J Quispe Santos, B Campos Garcia, E Rodriguez Font, C Alonso Martin, Z Weidmann Moreno, J Guerra Ramos, O Rodriguez Queralto, G Gomez Duarte, E Fuentes Palza, D Majo Ramirez, I Ramirez De Diego, A Velasco Nieves, M Soto Gil, X Vinolas PratAbstract
Introduction
The Micra leadless pacemaker (LPM) has proven to be safe and effective, with fewer complications compared to conventional pacemakers. However, few studies have evaluated its long-term efficacy. This study aims to assess the performance of the leadless pacemaker over 10 years of follow-up period.
Method
Prospective, single-center study of patients with LPM implants between August 2015 - August 2025, followed through in-person and remote monitoring. We analyzed baseline characteristics and electrical performance at implantation and at each scheduled annual in-person follow-up until 2020, and remotely every 6 months thereafter.
Results
A total of 565 LPM were implanted (84.7±7.3 years, 82.5% being over 80 years old, range 43-104), 99.2% success rate (82.4% VR,17.6% AV). Implantation failed in four cases: two from severe bilateral femoral venous tortuosity and two from cardiac perforation. The clinical characteristics are summarized in Figure 1. The device was successful implanted on the first attempt in 77% of cases, while 18.2% required more than one reposition. Mean implantation measurements were: impedance 800.3±206.3Ω, threshold 0.6±0.4V at 0.24ms. These values remained stable during subsequent follow-up. Only 4.8% (n=27) had a threshold > 1.5V at 0.24ms at implant with four patients requiring a second device in the follow-up.
An analysis of battery longevity, in patients with more than 5 years of use, showed an mean time to ERI 7.26±1.05 years in patients with a threshold <1.5 V at 0.24 msec. A 60% of mortality was registered, with a mean device usage time of 30.8±28.9 months (IQR=37 months); 80% of deaths were due to non-cardiac causes. (see figure 2).
Conclusion
After a decade of follow-up, LPM confirms its appropriate safety profile and stable long-term performance; especially in elderly patients with multiple comorbidities, with a high implantation success rate, low complication rates, and stable performance.Figure 1Figure 2