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.