B-PO05-040 P-WAVE VISIBILITY IN ECGS OF A NEW IMPLANTABLE CARDIAC MONITOR (BIOMONITOR III)

Background: Implantable Cardiac Monitors (ICM) are used for long-term heart rhythm monitoring. They freeze single-lead ECG snapshots when the heart rhythm is suspicious, but verification of the arrhythmia in this snapshot is required for the diagnosis. The presence of discernible P-waves is very helpful for this purpose. Objective(s): To report about the visibility of P-waves in remote monitoring transmitted ECG shapshots of the new BIOMONITOR III / IIIm ICM (BM III; Biotronik, Germany) from the BIOCONCEPT BM III (completed) and the BIOMASTER BM III (ongoing) studies. Method(s): The BM III transmits once per day up to six ECG snapshots of one minute to the Home Monitoring Service Center. Devices were programmed to transmit one "scheduled" ECG at a fixed time each day. The study protocols defined that at two follow-ups, a total of three periodic ECG were evaluated, if they showed regular 1:1 conducted rhythm. Investigators then counted numbers of heart cycles and discernible P-waves in the remote monitoring transmitted ECGs. Result(s): From 27 investigational sites in 6 countries, we included 150 patients with at least one follow-up, at which ECGs were to be evaluated. The patients were 63 +/- 16 years old and 39% were women. The 150 patients visited 237 FUs, at which 387 ECGs were scheduled. Sixty-three scheduled ECGs were not available due to errors in scheduling. In the 324 available ECGs, 62 were not suited for analysis because the rhythm did not have 1:1 AV conduction (PVCs or other arrhythmias). The remaining 262 ECGs of 112 patients were analysed. On average, the ECG snapshots showed 64.5 heart cycles with 59.9 visible P-waves, resulting in a gross visibility of 92.8% (15,685 P-waves in 16,899 heart cycles). Of the 112 patients, 76 (68%) had all P-waves visible in their ECGs, and 100 (89%) more than 80% of all P-waves. The visibility did not depend on the position of the inserted device (either parallel to the heart's long axis or parasternally). Conclusion(s): The remote monitoring ECG snapshots of the new BM III have a good visibility of P-waves. Given the clinical requirement to base diagnostic decisions on one or a few single lead 1-minute ECG snapshots, this appears very relevant for the clinical application.Copyright © 2021