APCU25OS14 Safety outcome of the micra leadless transcatheter pacemaker: real-world insights from northern centre of Malaysia in comparison with the global experience

Introduction The Micra™ Leadless Trans-catheter Pacing System (TPS) was developed to overcome lead- and device pocket-related complications associated with the more conventional trans-venous approach. The first successful Micra implantation in the world was performed in 2013, while the inaugural procedure in northern region of Malaysia took place at Hospital Sultanah Bahiyah (HSB) in 2016. There are numerous previous Micra trials that demonstrated its efficacy and high implant success rate. However, real-world data about its safety over time in the northern region of Malaysia is not well reported.Objective To evaluate the local epidemiological characteristics and safety outcome of Micra Leadless Trans-catheter pacemaker 12-months post-implantation in Hospital Sultanah Bahiyah (HSB), Kedah.Methods In this retrospective, single-centre study, patients with class I or II ESC guideline recommendation implanted with Micra leadless pacemaker between 1 January 2018 to 31 August 2024 were included. The primary outcomes were acute complications within 30 days post-implant, and any system- or procedure-related major complications 12 months post-implantation.Results & Discussion The mean age group of the subjects was 64.7 years, comprising of 16 males (51.6%) and 15 females (48.4%). Majority of them (87%) have ≥3 co-morbidities, out of which 24% were patients with underlying end-stage renal failure (ESRF). Pacemaker indications included complete heart block (51.6%), sick sinus syndrome (22.5%), second degree heart block (12.9%), and atrial fibrillation with bradyarrhythmia (12.9%). 4 subjects (12.9%) had infections related to the previous placement site of conventional pacemakers. All of the patients were successfully implanted with the device without the need for revision. Importantly, there were no device- or procedure-related major complications like infections, dislodgements or pericardial effusion reported at 30-days/ 1-year post implantation. Our safety results are in line with the global Micra IDE and PAR studies, which reported major complication rate of 4% and 2.7% respectively 12 months post-implantation. Future multi-centre prospective trials of micra TPS with longer duration of follow up is needed to further assess its efficacy and durability.Conclusion From our northern single-centre experience, Micra leadless pacemaker can be safely implanted with in patient with multiple comorbidities, with low incidence of major complications through 12 months post-implantation comparable to that of global trials.