Leadless versus Transvenous Single-Chamber Ventricular Pacemakers: Three
Year Follow-Up of the Micra CED Study
Abstract
Background: 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. Objective: To compare chronic
complications, device reinterventions, heart failure hospitalizations,
and all-cause mortality after 3 years of follow-up. Methods:
U.S. 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-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=6,219) 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% 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 (<0.2% versus 0.7%, P<0.0001). Patients with a
leadless VVI also had slightly lower rates of heart failure
hospitalization (HR 0.90; 95% CI 0.84-0.97). There was no difference in
the adjusted 3-year all-cause mortality rate (HR 0.97; 95% CI,
0.92-1.03). Conclusion: This nationwide comparative evaluation
of leadless VVI versus transvenous VVI de novo pacemaker implants
demonstrated that the leadless group had significantly fewer
complications, reinterventions, heart failure hospitalizations, and
infections than the transvenous group at 3 years, confirming that the
previously reported shorter-term advantages associated with leadless
pacing persist and continue to accrue in the medium-to-long-term.