Methods
The overall Micra CED Study design has been described
previously.2,3,6 The purpose of the study is to
evaluate complications, utilization, and outcomes of the leadless VVI
pacing system in the US Medicare population. The primary objectives of
the Micra CED study were to estimate the acute (30-day) complication
rate and the 2-year survival rate associated with the leadless pacing
system. The study uses manufacturer device registry information to
identify Medicare beneficiaries implanted with a Micra leadless
pacemaker (Model MC1VR01, Medtronic, Inc) using a previously-described-
linking algorithm.6 The study also identifies a
contemporaneous cohort of patients implanted with a transvenous VVI
pacemaker from any manufacturer during the study period directly from
their Medicare claims. The study was approved by the Western
Institutional Review Board with a waiver of informed consent and is
registered on ClinicalTrials.gov (NCT03039712).