Study Design
This was a retrospective study of all Merlin.net transmissions
associated with 1,000 randomly selected U.S. Abbott Confirm
RxTM devices with SharpSenseTMtechnology (Abbott, Abbott Park, IL) implanted between April 2018 and
March 2020, with transmission data downloaded from Merlin.net in June
2020. The population included all reasons for monitoring reported at
implant: AF management, cryptogenic stroke, palpitations, post-AF
ablation, seizures, suspected AF, syncope, ventricular tachycardia, and
other. To capture a patient population with a representative monitoring
experience, devices with fewer than 90 days of transmission history
(i.e., from implant to last available transmission) were excluded.
For each transmission, all episode EGMs and associated data were
extracted, and each EGM was adjudicated as either true or false. Key EGM
selection rules were then retrospectively applied, and the clinical
impact was evaluated relative to reviewing all available EGMs, as
described in the sections that follow.