Remote Monitoring of Pacemakers Safely Cuts Clinic Visits

December 08, 2011

December 8, 2011 (Rennes, France) — Remote monitoring of patients with dual-chamber pacemakers "was a safe substitute for conventional follow-ups, decreased the number of [clinic] visits, and enabled the early detection of important clinical and device-related adverse events" over a follow-up averaging about 18 months in a multicenter, randomized study [1].

The Comparative Follow-up Schedule with Home Monitoring (COMPAS) trial conducted at 43 centers in France enrolled exclusively non–pacemaker-dependent patients recently implanted with first or replacement devices. Presented in preliminary form at Cardiostim 2010 and covered then by heartwire , it was published online November 29, 2011 in the European Heart Journal with lead author Dr Philippe Mabo (Centre Hospitalier Universitaire de Rennes) and essentially the same results.

The Biotronik-sponsored trial randomized 538 patients to remote monitoring or follow-up by standard care; all had received the company's Philos II DR-T pacemaker.

The hazard ratio (HR) for major adverse events (all-cause death or hospitalization due to device-related or cardiovascular events) in the remote-monitoring group vs controls was 0.90 (95% CI 0.59–1.41). The nonsignificant reduction easily met the noninferiority requirement that the rate of major adverse events not be >7% higher in the monitoring group.

The risk of hospitalization for pacing-system–related complications was 0.14 (95% CI 0.02–0.86). No difference in quality of life was evident on standard tests.

Outcomes of the COMPAS Trial

End point Remote monitoring Control p
Major adverse events* (%) 17.3 19.1 0.63
Hospitalization for major adverse cardiac events (%) 11.7 11.8 0.66
Hospitalization for pacing-system-related complications (%) 0.4 2.8 0.03
Follow-up visits (per patient-year) 0.51 1.15 0.001
Programming or medication changes (% of visits) 62 29 0.002

*All-cause death or hospitalization due to device-related or cardiovascular events

Although guidelines recommend regular clinic follow-ups, "in the majority of scheduled visits, the device programming or drug regimen is left unchanged," Mabo et al write. Those "unproductive" follow-up visits "impose a heavy burden on the healthcare system."

In COMPAS, "remote monitoring safely eliminated unnecessary follow-up visits and allowed the early detection of events, prompting more appropriate follow-up visits," according to the group. "It is noteworthy that over 40% of the overall population transmitted no warning messages and >50% of patients in the [remote-monitoring] group needed no interim follow-ups."

COMPAS was supported by an unrestricted grant from Biotronik. "Funding to pay the open-access publication charges for this article was provided by Biotronik." Mabo discloses receiving consulting fees and research grants from Biotronik, Boston Scientific/Guidant, Medtronic, St Jude Medical, and the Sorin Group. Disclosures for the coauthors are listed in the paper.