Virtual Integrated Reliable Transformative User-driven E-health System for Implantable Cardioverter Defibrillators (VIRTUES ICD) and for Pacemakers (VIRTUES PM) — listed in the programme as "VIRTUES ICD / VIRTUES PM"

VIRTUES

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 1,963 patients with an ICD or pacemaker, remote-only device management via an e-health platform was non-inferior to scheduled in-clinic follow-up for major adverse cardiac events at 18 months.

N

1 963patients

Schéma

two parallel investigator-initiated, open-label, randomised 1:1 trials across Canadian device clinics (12 sites ICD, 11 sites PM; PM trial stratified by site and pacemaker dependence); remote patient management via the CANet VIRTUES platform without routine in-clinic device visits vs standard of care; 18-month follow-up

Critère

VIRTUES ICD — co-primary: time to major adverse cardiac event (safety: death, stroke, hospitalisation for device-system complications, cardiovascular hospitalisation, syncope, device-related emergency visits) and time from device-detected event to clinical decision (efficacy), at 18 months. VIRTUES PM — co-primary: time to major adverse cardiac event (death, stroke, unplanned cardiovascular hospitalisation) and cost-effectiveness (incremental cost per QALY), at 18 months

Pertinence

3Complémentaire — du contexte, pas un incontournable.

RésultatTwo parallel trials, both non-inferior. VIRTUES ICD (n = 1,115): primary safety composite 11.0% vs 11.2% (P = 0.007 for non-inferiority); primary efficacy, time from clinically important event to clinical decision, median difference +1 day (P < 0.0001 for non-inferiority). VIRTUES PM (n = 848): safety composite 6.1% vs 7.4% (P = 0.0213 for non-inferiority); efficacy median difference −3.25 days favouring VIRTUES (P < 0.0001 for non-inferiority, with a signal for superiority). Adjusted total cost was CAD 77 lower per patient with VIRTUES, driven by fewer in-clinic visits and lower patient travel costs (projected ~CAD 10 million/year saving in Canada); patients reported high acceptance.

Parkash R, Wells G, Tang A, et al. Presented at ESC Congress 2026, Hot Line 5, 29 August.

Discussion et critique

Two non-inferiority trials asking whether a digital platform on top of remote monitoring can replace the routine device clinic, and both clear their margins on safety with a saving of about CAD 77 per patient over 18 months. The margins were generous — a 7% absolute difference for pacemakers, 5% for defibrillators — and the observed event rates came in below assumption, so the intervals are wide: the pacemaker safety interval runs to 1.39. Efficacy is where the platform gives ground rather than gains it: the median time from a device-detected event to a clinical decision was a day longer with VIRTUES, non-inferior but not faster. Canadian single-payer care, 18 months, and a full cost-effectiveness analysis still to come.