A remote monitoring protocol with remote instead of in-office interrogations every 6 months was safe and reduced hospital visits and staff workload at 2 years, according to the results of the RM-ALONE trial.
“The 2-year results from RM-ALONE demonstrate that remote monitoring with remoteinterrogations may be a safe substitute for conventional in-person follow-ups of patients with cardiac implants,” Francisco Javier García-Fernández, MD, PhD, from the arrhythmia unit, department of cardiology, Hospital Universitario de Burgos in Spain, said in a press release. “Our results now raise the question of whether the current guidelines for [cardiac implantable electronic devices] should be adjusted according to our latest research findings.”
The researchers randomly assigned 445 patients (mean age, 73 years; 64% men) with a pacemaker or implantable cardioverter defibrillator to home monitoring only, with remote monitoring supplemented by remote interrogations every 6 months (Biotronik Home Monitoring, Biotronik), or home monitoring plus in-office visits, with remote monitoring supplemented by in-office visits every 6 months.
At 2 years, the groups had similar rates of major adverse cardiac events, defined as all-cause death, stroke, hospitalization caused by the device or a cardiac issue and device-related surgical infection (home monitoring-only group, 20%; office visit group, 19.5%; P for noninferiority = .006), the researchers wrote.
Among those with pacemakers, 15.2% of the home monitoring-only group and 16.1% of the office visit group had at least one major adverse cardiac event during the study period (HR = 0.95; 95% CI, 0.53-1.7), whereas among those with ICDs, the rates were 29.3% for the home monitoring-only group and 26.3% for the office visit group (HR = 1.15; 95% CI, 0.62-2.1), according to the researchers.
There were 136 in-office evaluations for the home monitoring-only group vs. 653 for the office visit group, a reduction of 79.2% (P < .001), García-Fernández and colleagues found.
Unscheduled in-office visits did not differ between the groups (home monitoring only, 122; office visit, 101; P = .15).
Mean time spent by physicians per patient on the total amount of follow-ups was 5.9 minutes in the home monitoring-only group and 10.2 minutes in the office visit group (P < .0001), whereas mean time spent by nurses per patient on the total amount of follow-ups was 6.3 minutes in the home monitoring-only group and 11.1 minutes in the office visit group (P < .0001), according to the researchers. The trends were similar in the pacemaker cohort and the ICD cohort. – by Erik Swain
Disclosures: The study was funded by Biotronik. García-Fernández reports he received a research grant from Biotronik and consultant/adviser fees from Boston Scientific and Medtronic. Please see the study for all other authors’ relevant financial disclosures.