Study of Micra Transcatheter Pacing System shows success rate in patients with arrhythmias- Medtronic

Medtronic has announced preliminary results for the Medtronic Micra Transcatheter Pacing System (TPS) Post-Approval Registry, revealing a 99.6 percent implant success rate and a low rate of major complications (1.51 percent) at 30 days in a diverse, real-world patient population.

The global Micra Post-Approval Registry is an ongoing, prospective single-arm observational study designed to assess the safety and effectiveness of the Micra TPS in the post-approval setting. More than 20 percent of patients in the Micra Post-Approval Registry study had at least one condition that did not allow the use of a transvenous pacemaker including history of infection or compromised venous access. Nearly 87 percent of the physicians in the analysis were new implanters with no previous experience with Micra.

Major complications were low, with 1.51 percent of patients experiencing a major complication at 30 days post-implant (95 percent CI: 0.78 percent to 2.62 percent). There were low rates of cardiac perforation or prefusion (0.13 percent), device dislodgement (0.13 percent), and infection (0.13 percent), and no (0 percent) major complications related to battery or telemetry issues. When compared to the IDE study, the rate of major complications in this real-world registry trended lower after adjusting for differences in baseline patient characteristics (1.51 percent vs. 2.89 percent; Odds Ratio=0.59, 95 percent CI: 0.27, 1.27; P=0.18). The study was presented in a late-breaking clinical trial session at Heart Rhythm 2017 and simultaneously published in Heart Rhythm.