Key takeaways
Regular in-clinic visits to check the functioning of pacemakers and implantable cardioverter defibrillators is burdensome for patients and the healthcare system.
A virtual e-health system (VIRTUES) designed to check the status of devices remotely was compared with regular clinic visits.
The VIRTUES system was as safe and effective as usual care, with the benefits of cost savings and good patient satisfaction.
This system represents a patient-centric digital health approach that could be implemented more widely following further studies.
Munich, Germany – 29 August 2026: A virtual e-health system (VIRTUES) was as safe and effective as standard care for monitoring the function of cardiac implantable electronic devices, with the benefit of cost savings and patient satisfaction. These were the main findings of the VIRTUES trials presented in a Hot Line session today at ESC Congress 2026.1
The use of pacemakers and implantable cardioverter defibrillators (ICDs) is increasing due to expanding indications and the ageing population. Principal Investigator, Professor Ratika Parkash from Dalhousie University, Halifax, Canada, explained why the VIRTUES PM and ICD trials were carried out: "Globally, around 1.25 million people are implanted with devices like pacemakers every year. It is important to follow these patients over their lifetimes to check their devices are working well; however, this entails regular visits to specialist clinics, which can be burdensome for the patient and healthcare system."
The VIRTUES virtual e-health system uses transmission reports sent from the patient's implanted device to the physician, who then reviews the data and sends messages to the patient on how well their device is working. The VIRTUES PM and ICD trials explored the use of this platform with pacemakers and ICDs, respectively, evaluating safety and efficacy, and also cost effectiveness.
Two randomised trials in 13 centres in Canada included a total of 1,115 patients with either a compatible pacemaker or an ICD. Patients were randomised (1:1) to the VIRTUES platform (remote monitoring with virtual care communications only) or to standard care (in-clinic visits with or without remote monitoring) for 18 months. Unscheduled in-clinic visits were used as needed in both arms to address device-related concerns. The mean age of participants was 67 years and 27% were women.
The researchers found that the VIRTUES system was as safe and as effective as standard care. There was noninferiority for the primary safety outcome of death, stroke, cardiovascular- or device-related hospitalisation over 18 months in both the ICD trial (11.0% vs. 11.2%; p=0.007 for noninferiority) and the pacemaker trial (6.1% vs. 7.4%; p=0.0213 for noninferiority).
Similarly, there was no difference for the primary efficacy endpoint of time from a clinically important event to a clinic decision in response to arrhythmias or device issues in the ICD trial (median difference +1 day; p<0.0001 for noninferiority), with a signal for superiority in the pacemaker trial (median difference −3.25 days; p<0.0001 for noninferiority).
Of note, there was a significant reduction in costs to the healthcare system and to patients. "We estimate this system could save around $10 million annually in Canada alone," noted Professor Parkash. An adjusted total difference of $77 Canadian dollars per patient was observed with the VIRTUES platform, primarily due to lower costs to the healthcare system and to patients due to fewer in-clinic visits.
Professor Parkash considered these results to be overwhelmingly positive for patients: "In addition to similar safety and efficacy and the cost savings, patients were strongly supportive of this digital approach." She highlighted that the VIRTUES system gave patients a sense of control – they liked to know directly how well their device was working – and most said they would keep using it if given the opportunity. "We have shown that the VIRTUES system is both patient centric and reduces the clinic burden, which can be challenging to demonstrate in digital health studies," she noted, concluding: "The VIRTUES system could be scalable for use globally although it has only been tested in Canada so far and further studies would be needed in other regions."
