Postapproval Registry Data Presented for Medtronic's Micra TPS

May 11, 2017—Medtronic announced preliminary results for the Medtronic Micra transcatheter pacing system (TPS) postapproval registry, which demonstrated a 99.6% implantation success rate and a low rate of major complications at 30 days in a diverse, real-world patient population. The study was presented in a late-breaking clinical trial session at Heart Rhythm 2017, the Heart Rhythm Society's 38th Annual Scientific Sessions in Chicago, Illinois, and simultaneously published in the journal Heart Rhythm.

In Medtronic's announcement, Mikhael El-Chami, MD, commented, "It is encouraging to see these strong outcomes with such a novel technology in the hands of new implanting physicians. The high implantation success and low major complication rates in a real-world patient population reinforce the positive results seen in the investigational Micra clinical trial." Dr. El-Chami is Director of Electrophysiology at Emory Midtown and associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia.

According to the company, the global Micra postapproval registry is an ongoing, prospective single-arm observational study designed to assess the safety and effectiveness of the Micra TPS in the postapproval setting. The Micra TPS was approved by the US Food and Drug Administration in April 2016 for patients who need a single-chamber pacemaker.

Data presented at HRS were from an interim analysis of 795 patients treated by 149 physicians at 97 centers across 20 countries worldwide, which assessed system or procedure-related major complications through 30 days after implantation. These rates were then compared to the major complication rates of the Micra investigational device exemption study.

In the Micra postapproval registry study, more than 20% of patients had at least one condition that did not allow the use of a transvenous pacemaker, including history of infection or compromised venous access. Approximately 87% of the physicians in the analysis were new implanters with no previous experience with Micra.

There was a 1.51% rate of major complications at 30 days after implantation (95% confidence interval, 0.78–2.62). There were low rates of cardiac perforation or perfusion (0.13%), device dislodgment (0.13%), and infection (0.13%), and no (0%) 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% vs 2.89%; odds ratio = 0.59; 95% confidence interval, 0.27–1.27; P = .18), reported Medtronic.