VIRTUES ICD/PMDigital HealthOpen Access
Remote Digital Monitoring for Implantable Defibrillators and Pacemakers
Digital platforms for patients with implantable cardioverter defibrillators and pacemakers
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
Key result
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.
Authors
Discussion
Member takes
Overview
Supports shifting device follow-up to virtual monitoring to reduce visits and costs; extends RCT evidence for remote care in ICD and pacemaker patients.
Key Points
- To evaluate the safety and cost impact of a virtual e-health remote monitoring system compared with standard in-clinic care for patients with cardiac implantable electronic devices.
- Comparison of a virtual e-health remote monitoring system with standard in-clinic care across two separate trials for implantable cardioverter defibrillators (ICD) and pacemakers.
- Follow-up conducted over 18 months to assess primary safety endpoints and healthcare costs.
- Virtual monitoring was noninferior for the composite safety outcome of death, stroke, or cardiovascular- or device-related hospitalization 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).
- Digital care generated an adjusted total cost difference of CAD $77 per patient in favor of the virtual system, driven primarily by fewer in-clinic visits.
Evidence details
What drove the result?
| 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 | ||
Limitations & tradeoffs
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.
Structured PICO
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?
P
Population
Patients with implantable cardioverter defibrillators and pacemakers followed for 18 months.
I
Intervention
Virtual e-health system for remote monitoring of cardiac implantable electronic devices
C
Comparator
Standard in-clinic care
O
Outcome
Primary safety outcome of death, stroke, or cardiovascular- or device-related hospitalisation over 18 monthscomposite
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.
Main Result
Absolute Event Rate: 11% vs 11.2%
p-value: p=0.007 for noninferiority
Limitations
- No simultaneous results paper was available at presentation
Cite This Study
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.