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RM-ALONE: Remote monitoring protocol safe, efficient
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.
Perspective
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This is the first randomized clinical trial to evaluate an approach to routine pacemaker or ICD follow-up involving only remote monitoring at the exclusion of in-person visits. It was designed as a non-inferiority trial to show that this approach could achieve similar clinical outcomes while reducing physician and nursing time requirements associated with in-person visits.
Remote interrogations are replacing in-office visits in the real world to a large extent. This extraordinary real-world growth appears to be driven by a number of clinical and technical factors. No. 1, better technology has opened the doors to a larger number of patients thru the use of cellular networks, and to user interface improvements for patients, doctors and nurses. No. 2, some professional organizations, including the Heart Rhythm Society, now endorse the routine use of remote monitoring on the basis of solid clinical outcomes data, effectively making this a standard of care. No. 3, patients seem to prefer a workflow where routine checks can be done from home to obviate sitting the waiting room at their doctor’s office.
These findings are highly generalizable, and arguably increasingly so amidst a shift towards digital health and telemedicine where cost-effective, high-quality clinical care is being delivered remotely. That’s only going to become easier as the health care infrastructure, public and private payer reimbursements and expectations from patients, doctors and nurses continue to evolve.
One important limitation is that the investigators did not include patients with cardiac resynchronization therapy (CRT) devices, a unique type of pacing for patients with congestive HF who typically require more labor-intensive clinical care, and have unique care pathways designed to prevent readmissions while identifying nonresponders to the pacing. That’s not to say that one day such a care model couldn’t be successfully applied to such patients, it’s just that the study investigators decided not to take that on — and probably wisely so, as one could imagine such patients requiring greater support with virtual visits, for example.