Reinterventions
Reintervention rates were also significantly lower in the patients
implanted with a leadless VVI pacemaker compared with the transvenous
(adjusted, 3.6%, vs. 6.0%, P=0.0002). System revisions, removals, and
upgrades to both dual chamber and CRT devices were significantly lower
in the patients implanted with a leadless VVI pacemaker compared with
the transvenous, while system replacements were significantly higher.
For the composite endpoint of reinterventions requiring a new device
(inclusive of system removal, system replacement, system switch or
upgrade to dual chamber or CRT), patients implanted with a leadless VVI
pacemaker had significantly fewer reinterventions requiring a new device
(adjusted, 3.6% vs. 5.0%, P=0.02). In the time-to-event model,
patients implanted with a leadless pacemaker had a lower rate of
reintervention compared with patients implanted with a transvenous
pacemaker (Figure 1B ; unadjusted HR 0.60; 95% CI 0.45–0.80,
P=0.0006; adjusted HR 0.59; 95% CI 0.44–0.78, P=0.0002). Unadjusted
reintervention rates are shown in Appendix Table 3.