Arrhythmias & electrophysiology
New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice: results from the international prospective observational SMART Registry
Authors' conclusion
The evaluated ICM is associated with an excellent safety profile and high diagnostic yield. Patients reported positive experiences associated with the use of their smartphone for the device remote monitoring.
Study context
- Population
- Patients with ICM indications (syncope 49.1%, atrial fibrillation (AF) 18.8%, unexplained palpitations 13.6%, risk of ventricular arrhythmia 6.6%, cryptogenic stroke 6.0%)
- Participants
- 1,400 patients
- Outcome
- ICM safety (SADEs at 1 month), ICM clinical value (device-detected true arrhythmias, clinical diagnoses and interventions) and PREMs
- Follow-up
- 1 month (safety); 6-month monitoring period
Methodological detailsinternational
- International
Main finding
As reported in the abstract
True cardiac arrhythmias detected by the ICM
45.7%
Pacemaker implant after bradycardia detection (syncope indication)
8.9%
OAC indicated after AF detection (cryptogenic stroke)
15.7%
Satisfied with the remote monitoring patient app (patient-reported experience measurements (PREMs))
78.2%
Observational data: associations, not effects.
Safety
Freedom from serious adverse device and procedure-related events (SADEs) · 1 month
- Freedom from SADEs at 1 month
- 99.4% (95% CI 98.8-99.7%)
Original publication
Summarised from the published abstract; every number is checked against it