5970Morbidity and mortality in patients precluded for transvenous pacemaker implantation: experience with the Micra transcatheter pacemaker

Abstract Background The Micra transcatheter pacemaker has proven to be a safe and effective alternative to transvenous pacemakers (TVPs). However, the safety profile after Micra implantation in patients deemed poor candidates for TVPs is poorly understood. Purpose To evaluate the safety and all-cause mortality outcomes in Micra recipients stratified by whether or not they were precluded for therapy with TVP. Methods Micra patients from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were divided into groups based upon whether or not the implanting physician considered the patient to be precluded from receiving a transvenous pacing system. All-cause mortality was compared between the Micra patient groups and patients receiving a single-chamber transvenous pacing system (SC-TVP) since 2010 from the Medtronic product surveillance registry using univariate and multivariate Cox models. Results Among 2,819 patients who underwent a Micra implant attempt, the overall major complication rate through 24 months was 3.5%. In these patients, 548 were deemed precluded from TVP implantation. Prior device infection or bacteremia (38.9%), venous access issues (36.1%) and thrombosis (10.2%) were amongst the most common causes of preclusion for TVP implantation. These patients were younger (71.7 vs. 76.7 years), more frequently on hemodialysis (26.3% vs. 2.5%), and more often had a prior CIED implanted (38.4% vs. 4.4%) than non-precluded patients. Over an average follow-up of 13.5±11.1 months, all-cause mortality was significantly higher in precluded Micra patients compared with SC-TVP patients (HR: 2.16, 95% CI: 1.54–3.2, P<0.001) (Figure 1). However, there was no significant difference in all-cause mortality when comparing non-precluded Micra patients and SC-TVP patients (HR: 1.12, 95% CI: 0.86–1.44, P=0.401). Acute all-cause death (within 1 month) among Micra patients was 2.74% and 1.32% in the precluded and non-precluded TVP groups, respectively. The procedure-related death rate was 0.55% for the TVP precluded group and 0.13% for the not precluded group (P=0.092). The major complication rate through 24-months was similar between the two Micra groups (4.0% vs 3.4%, P=0.630). All-cause mortality for Micra and SC-TVP Conclusion The overall safety profile of Micra remains is in line with previously reported data. All-cause mortality risk (both acute and long term) appears to be higher in patients who were precluded from receiving TVP. Acknowledgement/Funding Supported by Medtronic