Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker

BACKGROUND Leadless intracardiac pacemakers were developed to avoid the complications of transvenous pacing systems. The Medtronic Micra (TM) transcatheter pacemaker is one such system. We found an unexpected number of major adverse clinical events (MACE) in the Food and Drug Administration's Manufacturers and User Facility Device Experience (MAUDE) database associated with Micra implantation. OBJECTIVE The purpose of this study was to describe these MACE and compare them to implant procedure MACE in MAUDE for Medtronic CapSureFix (TM) active-fixation transvenous pacing leads. METHODS During January 2021, we queried the MAUDE database for reports of MACE for Micra pacemakers and CapSureFix leads using the simple search terms " death," "tamponade," and "perforation." Reports from 2016-2020 were included. RESULTS The search identified 363 MACE for Micra and 960 MACE for CapSureFix leads, including 96 Micra deaths (26.4%) vs 23 CapSureFix deaths (2.4%) (P<.001); 287 Micra tamponades (79.1%) vs 225 tamponades for CapSureFix (23.4%) (P<.001); and 99 rescue thoracotomies for Micra (27.3%) vs 50 rescue thoracotomies for CapSureFix (5.2%) (P<.001). More Micra patients required cardiopulmonary resuscitation (21.8% vs 1.1%) and suffered hypotension or shock (22.0% vs 5.8%) than CapSureFix recipients (P<.001). Micra patients were more likely to survive a myocardial perforation or tear if they had surgical repair (P=.014). CONCLUSION Micra leadless pacemaker implantation may be complicated by myocardial and vascular perforations and tears that result in cardiac tamponade and death. We estimate the incidence is low (<1%). Rescue surgery to repair perforations may be lifesaving. MACE are significantly less for implantation of CapSureFix transvenous ventricular pacing leads.