A leadless pacemaker in the real‐world setting: Patient profile and performance over time
Key result
Micra leadless pacemaker achieves high implant success with a ~3% 30-day major complication rate.
- n=928
Why the study?
While prior Micra trials demonstrated favorable safety and efficacy, changes in implant populations and safety over time were not well studied.
Does the Micra leadless pacemaker maintain a low complication rate and stable electrical performance in real-world European and Middle Eastern patients?
Population
928 European and Middle Eastern patients receiving a Micra leadless pacemaker
Comparison
MAP EMEA cohort vs Micra IDE and Micra PAR studies
Design
Prospective, single-arm registry
Follow-up
Average of 9.7 ± 6.5 months
Authors
Discussion
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Member takes
Implication
Supports Micra safety in real-world EMEA patients; extends pivotal trials but leaves open randomized confirmation.
Study Design
Type
Observational (n=928)
Multicenter
Yes
Structured PICO
Does the Micra leadless pacemaker maintain a low complication rate and stable electrical performance in real-world European and Middle Eastern patients?
P
Population
928 patients from Europe and the Middle East receiving a Micra leadless pacemaker
I
Intervention
Micra leadless pacemaker implantation
C
Comparator
Historical cohorts (Micra Investigational Device Exemption [IDE] and Micra Post Approval Registry [PAR] studies)
O
Outcome
Acute (30-day) major complicationssafety
In a real-world EMEA registry, the Micra leadless pacemaker showed a 99.9% implant success rate and a low complication rate comparable to prior pivotal trials.
Cite This Study
Roberts et al. (2023) conducted an observational in Indication for pacemaker (n=928). Micra leadless pacemaker vs. Historical IDE and PAR cohorts was evaluated on Acute (30-day) major complications. The Micra leadless pacemaker had a 99.9% implant success rate and a 30-day major complication rate of 2.59%, with 12-month complication rates not significantly different from prior IDE and PAR studies.