May 1, 2021EP Europace
A leadless pacemaker in the real-world setting: Patient profile and performance over time
Key result
The Micra leadless pacemaker demonstrated >99.0% implant success and low pericardial effusion rates (0.83%-1.79%) across three consecutive cohorts from 2013 to 2020 despite evolving patient profiles.
Why the study?
Whether the patient population and outcomes for leadless pacemakers have changed over time across pre-market and post-market environments was not well studied.
Population
3466 patients undergoing a Micra leadless pacemaker implant attempt across 3 consecutive studies
Comparison
Micra IDE (2013-2015) vs PAR (2015-2018) vs MAP (2018-2020) cohorts
Design
Pooled observational analysis of prospective clinical trial and registry cohorts
Authors
Discussion
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Member takes
Implication
Success and safety maintained as leadless pacing expands to complex patients; extends observational data but leaves open randomized confirmation.
Study Design
Type
Observational (n=3,466)
Multicenter
Yes
Structured PICO
P
Population
3,466 patients undergoing a Micra leadless pacemaker implant attempt across three consecutive cohorts from 2013 to 2020, followed for up to 12 months.
E
Exposure
Leadless pacemaker implantation
O
Outcome
Patient characteristics and pericardial effusions regardless of severitysafety
Over time, the patient profile for leadless pacemakers has shifted toward more patients precluded from transvenous pacing and more septal placements, while maintaining high implant success and low complication rates.
Cite This Study
Garweg et al. (2021) conducted an observational in Bradyarrhythmia or atrioventricular block requiring pacing (n=3,466). Micra leadless pacemaker vs. Consecutive historical cohorts (IDE vs PAR vs MAP) was evaluated on Implant success and pericardial effusion. The Micra leadless pacemaker demonstrated >99.0% implant success and low pericardial effusion rates (0.83%-1.79%) across three consecutive cohorts from 2013 to 2020 despite evolving patient profiles.