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.