Introduction
The Micra Coverage with Evidence
Development (CED) Study is a novel comparative analysis of Micra
(leadless VVI) and transvenous single-chamber ventricular pacemakers
(transvenous VVI) using Medicare administrative claims data. This unique
study allows the Centers for Medicare and Medicaid Services (CMS) to
provide coverage for leadless pacemakers while continuing to assess the
performance of the technology as it becomes more widely implemented in
real-world practice.1 The acute (30-day), 6-month, and
2-year outcomes have been previously reported,2,3 with
leadless VVI associated with higher rates of acute pericardial effusion
(0.8% vs. 0.4%), but lower rates of chronic complications and
reinterventions at both 6 months and 2 years of follow-up (31% lower
rate of chronic complications (3.6% vs. 6.5%) and 38% lower rate of
device reintervention (3.1% vs. 4.9%) at 2 years). The Micra CED Study
results have been consistent with the findings of the Micra
transcatheter pacing system (TPS) investigational device exemption (IDE)
study4 and Micra leadless pacemaker post-approval
registry (Micra PAR),5 demonstrating the utility of
real-world data in complementing traditional clinical and registry
studies as a source of evidence for insight into utilization, safety,
and outcomes in general practice. The Micra CED Study will continue to
follow leadless pacing patients in the Medicare population until CMS
determines there is enough evidence to support or negate national
coverage, making it a valuable source of evidence for comparative
performance of leadless and transvenous pacemakers into the medium- and
long-term. The study design also allows for the comparison of relevant
health care utilization endpoints. In the present analysis, we compare
for the first time rates of heart failure hospitalization between
patients implanted with a leadless VVI vs. transvenous VVI pacemaker.
The objective of this analysis is to compare and report on chronic
complications, device reinterventions, heart failure-related
hospitalizations, and all-cause mortality between leadless VVI and
transvenous VVI pacemakers after 3-years of study follow-up.