Key result
Virtual e-health is noninferior to standard care for major events in ICD and pacemaker trials.
Why the trial?
Routine in-clinic follow-up of implantable defibrillators and pacemakers burdens patients and device clinics alike. VIRTUES asked whether a virtual e-health platform for remote device management is as safe as standard in-clinic care.
Does a virtual e-health system for remote monitoring reduce death, stroke, or cardiovascular- or device-related hospitalisation in patients with implantable cardioverter defibrillators and pacemakers compared to standard in-clinic care?
Population
Patients with ICDs and pacemakers (two trials; sample sizes not reported)
Comparison
Virtual e-health remote monitoring vs standard in-clinic care
Design
Two randomised noninferiority trials (ICD and pacemaker); details not reported
Follow-up
18 months
Authors
No takes yet. Share an insight, caveat, or question.
Supports shifting device follow-up to virtual monitoring to reduce visits and costs; extends RCT evidence for remote care in ICD and pacemaker patients.
| Outcome | Remote | In-clinic |
|---|---|---|
| Death, stroke, or CV-/device-related hospitalisation (ICD trial) | 11.0% | 11.2% |
| Noninferior · p=0.007 for noninferiority | ||
| Death, stroke, or CV-/device-related hospitalisation (pacemaker trial) | 6.1% | 7.4% |
| Noninferior · p=0.0213 for noninferiority | ||
Statistical certainty
sample sizes, confidence intervals and noninferiority margins are not reported (press-release record), and the cost finding (adjusted difference CAD 77 per patient favouring remote care) is reported without any measure of uncertainty.
Design limitations
no simultaneous results paper was available at presentation.
Does a virtual e-health system for remote monitoring reduce death, stroke, or cardiovascular- or device-related hospitalisation in patients with implantable cardioverter defibrillators and pacemakers compared to standard in-clinic care?
Absolute Event Rate: 11% vs 11.2%
p-value: p=0.007 for noninferiority
A virtual e-health system for remote monitoring of ICDs and pacemakers is noninferior to standard in-clinic care for clinical safety outcomes and reduces costs.
Ratika Parkash (2026) conducted an RCT in implantable cardioverter defibrillators and pacemakers. virtual e-health system for remote monitoring vs. standard in-clinic care was evaluated on death, stroke, or cardiovascular- or device-related hospitalisation (p=0.007 for noninferiority). A virtual e-health system was noninferior to standard care for death, stroke, or cardiovascular/device-related hospitalization in the ICD (11.0% vs 11.2%) and pacemaker (6.1% vs 7.4%) trials.
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