Diagnostic Impact
Despite the significant EGM burden reduction achieved by this key EGM
selection tool, the number of days with a TP EGM available for review
did not drop significantly: 0.8%, 2.1%, 0.2%, and 0.0%,
respectively. As a consequence, 99.2% of patients diagnosed with an
arrhythmia were diagnosed on the same day as they would have been if all
EGMs were reviewed. Of the remaining patients with more than one TP day,
but their first TP day was missed by key EGM selection, no diagnostic
delay for AF, 9.5 day delay for tachycardia, 6.0 day delay for
bradycardia, and no diagnostic delay for pause was observed. Note that
these diagnostic delays assume a daily EGM review, with a diagnosis
occurring on the first day a TP EGM is available. Therefore, such delays
may not be observed if transmitted EGMs were reviewed monthly. The
rarity and negligible magnitude of diagnostic delays was also supported
by Kaplan-Meier analysis, which demonstrated nearly identical freedom
from diagnosis trends in the first-year post-implant when reviewing all
vs. key EGMs.