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.