Background: Remote monitoring (RM) is not routinely deployed in patients with low-energy devices, but there are limited efficacy and safety data in this population. In response to the COVID-19 pandemic, our institution enrolled all low-voltage devices onto RM to reduce clinic footfall.
Purpose: To assess the efficacy and safety at 1 year of RM in patients with low-voltage devices.
Methods: All patients implanted (Group 1) or with a scheduled follow-up (Group 2) with a pacemaker (PPM) or cardiac resynchronisation therapy pacemaker (CRTP), April to November 2020, were prospectively enrolled. Patients who were transferred to another centre were excluded. Group 1 had 1-month and 12-month virtual follow-up and Group 2 had 12-month virtual follow-up, with alerts or patient request triggering earlier review. The number, reason, outcome and time to remote or in-person clinic review were assessed. The 1-year mortality was assessed and compared with a historic cohort without RM between April and November 2018.
Results: A total of 263 patients were enrolled (28% males, mean age 75 (SD 14) years; 63% Group 1 and 37% Group 2). This included 201 patients with PPM and 62 with CRTP. Overall, 390 scheduled remote reviews, 180 alerts and 173 clinic reviews took place. Per patient median (IQR) scheduled remote reviews, alerts and clinic reviews were: Group 1 1 (1–2), 2 (1–2.5), 1 (1–1.5), respectively; Group 2 1 (1–2), 1 (1–2), 1 (1–2), respectively. Overall, across both groups, 82 medical reviews were requested (median 1 [1–1] per patient), with 33% resulting in a change in clinical management, and 24 patients were referred to a specialist clinic. In Group 1, 17% had alerts before the 1-month review and 64% required early review (arrhythmia and heart failure management 50%, anticoagulation 12%, device reprogramming 12% and lead issue 22%). Between 1 and 12 months, 68% of patients had a remote or clinical review, median (IQR) 101 (31–364) days, and 51% required review outside the routine review (arrhythmia and heart failure management 27%, anticoagulation 6%, device reprogramming 32%, lead revision 1% and wound revision 2%). In Group 2, the median time to first follow-up was 141 (80–357.5) days, and 66% required clinical intervention prior to the 12-month review (arrhythmia and heart failure management 23%, anticoagulation 3%, device reprogramming 8%, lead revision 5%, generator change 21% and device upgrade 2%). Overall, 66% had a change in follow-up schedule. There was no significant difference in 12-month mortality overall when compared with a historical cohort without RM (deaths 6% (16/263) in the RM cohort and 6% (13/213) in the historical non-RM cohort (p=0.99). No device-related deaths were seen in the RM cohort.
Conclusion: The use of RM was both efficacious and safe in patients with low-voltage devices at 1 year. In both de novo and routine follow-up cohorts, RM identified important findings in patients requiring intervention prior to routine review. This tailored strategy was not associated with a difference in mortality when compared with a local matched historical cohort without RM. ❑