Universal monitoring system vs conventional remote monitoring: 4-year extended follow-up from the nationwide EVIDENCE-RM study

Background Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is recommended to improve outcomes, yet long-term real-world evidence on its sustained survival benefit remains scarce. Purpose We aimed to evaluate the 4-year impact (2019-2023) of RM activation and the incremental benefit of a Universal Monitoring System (UMS) platform on all-cause mortality. Methods We conducted a retrospective longitudinal study using the French National Healthcare System database (SNDS). All patients implanted with an ICD or CRT-D between 2019 and 2023 were included. To eliminate immortal time bias, a Cox proportional hazards model with time-varying covariates was used, where RM exposure was treated as a time-dependent status initiated at the first RM activation. Two study cohorts were analysed RM vs. no-RM and UMS vs. Conventional RM. Models were adjusted for age, sex, device model, and the Elixhauser comorbidity index (37 variables). Results A total of 84,642 patients were included (CRT-D 33.2 %; mean age 66.6 ± 12.7/ male 79.0%). In the primary study, patients with RM (n=65,869) demonstrated significantly lower mortality compared to the no-RM group (n=18,773) (18.8% vs. 27.1%, respectively). Unadjusted time-varying Cox analysis showed a 35% reduction in the instantaneous risk of death (P< 0.001). After adjustment for confounders, the survival benefit remained highly significant with a 23.5% reduction in mortality risk (HR 0.765; CI [0.74 0.80]? P<0.001). In the platform-specific analysis, UMS (n=8,026) was associated with a lower mortality rate compared to Conventional RM (n=24,301) (13.1% vs. 25.9%, respectively). Unadjusted analysis indicated a 23% decrease in the risk of death (P<0.001). Following full adjustment for confounders, including device model, the use of UMS remained associated with a significant 18% reduction in the mortality rate (HR 0.82; CI [0.76 0.88]; P<0.001) compared to manufacturer-specific solutions Conclusion This 4-year nationwide retrospective analysis confirms that RM provides a robust and sustained survival benefit. Importantly, managing RM through a UMS offers a significant incremental survival advantage of 18%. The significant incremental benefit associated with UMS suggests that clinical outcomes in patients remote monitoring may vary depending on the management system used, beyond the simple transmission of device data.