A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry

Area of Science:

• Cardiology
• Medical Devices
• Electrophysiology

Background:

• Leadless pacemakers have shown promise in initial studies.
• Concerns exist regarding complications like cardiac effusion, perforation, dislodgement, infection, and battery issues in real-world settings.

Purpose of the Study:

• To report the acute performance of the Micra transcatheter pacemaker from a worldwide Post-Approval Registry.
• To assess the safety and effectiveness of the Micra pacemaker in the post-approval setting.

Main Methods:

• Prospective, single-arm, observational study of the Micra transcatheter pacemaker.
• Assessed system- or procedure-related major complications at 30 days post implant.
• Compared complication rates with a prior investigational trial.

Main Results:

• Successful implantation in 99.6% of 795 patients across 96 centers in 20 countries.
• A low major complication rate of 1.51% (13 events in 12 patients) within 30 days.
• Specific major complications included cardiac effusion/perforation (0.13%), device dislodgement (0.13%), and sepsis (0.13%).

Conclusions:

• Real-world performance of the Micra transcatheter pacemaker demonstrates high implant success (99.6%) and a low major complication rate (1.51%) at 30 days.
• Low rates of pericardial effusion, device dislodgement, and infection were observed.
• Findings reinforce the positive safety and efficacy results from the investigational study.