Conclusion
In a real-world study of US Medicare patients, the leadless VVI pacemaker was associated with a 32% lower rate of chronic complications (4.9% vs. 7.1%) and a 41% lower rate of device reinterventions (3.6% vs. 6.0%) at 3 years. Rates of heart failure hospitalization were slightly lower among leadless VVI patients, and all-cause mortality rates were similar among leadless VVI and transvenous VVI patients at 3 years, suggesting no trade-off between lower rates of device reintervention and chronic right ventricular-only pacing outcomes for patients. Infections rates were remarkably lower in the leadless group. The Micra CED Study continues to illustrate the feasibility of utilizing real-world data to generate evidence measuring the safety and effectiveness of new technology and continues to complement existing clinical evidence demonstrating the benefits of leadless pacing.
Author Contributions: All authors met the IJCME criteria for authorship. All authors had access to the data according to the terms of the data use agreement with CMS and all authors fully reviewed and vouch for the accuracy of reported results. Academic authors had independent final review and approval of publication.
Data Availability Statement: The authors are not owners of the dataset (dataset is owned by the Centers for Medicare and Medicaid Services) and do not have the right to share the data.