Leadless versus transvenous single‐chamber ventricular pacemakers: 3 year follow‐up of the Micra CED study

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 administrative claims data. To compare chronic complications, device reinterventions, heart failure hospitalizations, and all‐cause mortality after 3 years of follow‐up. Methods US Medicare claims data linked to manufacturer device registration information were used to identify Medicare beneficiaries with a de novo implant of either a Micra VR leadless VVI or transvenous VVI pacemaker from March 9, 2017 to December 31, 2018. Unadjusted and propensity score overlap‐weight adjusted Fine‐Gray competing risk models were used to compare outcomes at 3 years. Results Leadless VVI patients (N = 6219) had a 32% lower rate of chronic complications and a 41% lower rate of reintervention compared with transvenous VVI patients (N = 10 212) (chronic complication hazard ratio [HR] 0.68; 95% confidence interval [CI], 0.59−0.78; reintervention HR 0.59; 95% CI 0.44−0.78). Infections rates were significantly lower among patients with a leadless VVI (