Details

Autor(en) / Beteiligte

• Roberts, Paul R., MD
• Clementy, Nicolas, MD
• Al Samadi, Faisal, MD
• Garweg, Christophe, MD
• Martinez-Sande, Jose Luis, MD
• Iacopino, Saverio, MD
• Johansen, Jens Brock, MD, PhD
• Prat, Xavier Vinolas, MD
• Kowal, Robert, MD, PhD, FHRS
• Klug, Didier, MD, PhD
• Mont, Lluis, MD, PhD
• Steffel, Jan, MD, FHRS
• Li, Shelby, MD
• Van Osch, Dirk, MPH
• El-Chami, Mikhael F., MD, FHRS

Titel

A Leadless Pacemaker in the Real-World Setting: The Micra Transcatheter Pacing System Post-Approval Registry

Ist Teil von

• Heart rhythm, 2017-09, Vol.14 (9), p.1375-1379

Ort / Verlag

United States: Elsevier

Erscheinungsjahr

2017

Link zum Volltext

Quelle

Elsevier ScienceDirect Journals Complete

Beschreibungen/Notizen

• Abstract Background First-in-man studies of leadless pacemakers have demonstrated high implant success rates, and safety and efficacy objectives were achieved. Outside of the investigational setting, there are particular concerns over cardiac effusion/perforation, device dislodgement, infection, telemetry, and battery issues. Objective The acute performance of the Micra transcatheter pacemaker from a worldwide post-approval registry is reported. Methods The registry is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of Micra in the post-approval setting. The safety endpoint was system- or procedure-related major complications at 30 days post-implant. We compared the major complication rate to that of the 726 patients from the investigational study. Electrical performance was also characterized. Results The device was successfully implanted in 792 of 795 registry patients (99.6%) by 149 implanters at 96 centers in 20 countries. Through 30 days post-implant, a total of 13 major complications occurred in 12 patients for a major complication rate of 1.51% (95% CI: 0.78% to 2.62%). Major complications included cardiac effusion/perforation (1, 0.13%), device dislodgement (1, 0.13%), and sepsis (1, 0.13%). After adjusting for baseline differences, the rate of major complications in the registry trended lower than the investigational trial (Odds Ratio=0.59, 95% CI: 0.27, 1.27; P=0.18). Early pacing capture thresholds were low and stable. Conclusion Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high 99.6% implant success rate and low (1.51%) major complication rate through 30 days post-implant. In particular, the rates of pericardial effusion, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.