Background Remote monitoring (RM) enables convenient follow-up of patients with cardiac implantable electronic devices. In remote-only monitoring (RM-only) in-person visits are only scheduled if needed based on RM findings. This study evaluated the feasibility and safety of long-term RM-only of pacemaker (PM) patients. Methods All patients with Biotronik PM were included in the analysis. Data on the number and causes of additional in-office device interrogations, actions due to the transmissions, hospitalizations and performance of RM were collected from a large cohort of pacemaker patients followed by RM-only. Results In total 606 patients (302 female) with mean age of 78+/-12 years were included in the analysis. During the mean follow-up of 2.8 years 445 additional in-office device interrogations were made in 287 patients (0.3 interrogations / year), and in 110 (25%) of these cases changes to device programming were made. In a subgroup analysis of 100 patients with at least one year of prior appointment-based device monitoring, the need for in-office visits was 6.9 times higher per follow-up year than in RM (IRR=6.9, 95% CI 4.9-9.9; p<0.001). The hospitalization rate in the entire cohort during RM was 0.3 / year with no difference in the rate of hospitalizations between the two monitoring methods (IRR 1, 95% CI 0.8-1.4, p=0.8). The success of daily transmissions was 91.7 %. Conclusion Our real-word data indicate that RM-only offers an efficient and safe method for long-term follow-up of pacemaker patients.
Toward terminological clarity in digital biomarker research
Digital biomarker research has generated thousands of publications demonstrating associations between sensor-derived measures and clinical conditions, yet clinical adoption remains negligible. We identify a foundational




