Arrhythmias & electrophysiology
Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation
Authors' conclusion
RM may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.
Study context
- Population
- Patients with a cardiovascular implantable electronic device under active remote monitoring, April 2019–April 2021
- Participants
- 48,191 patients
- Outcome
- Incident lead abnormalities detected by RM and verified structural lead failure
Main finding
As reported in the abstract
- Incident lead abnormalities detected by remote monitoring (RM)
- 1170 (2.4%)
- RM abnormality with administrative codes: structural lead failure verified
- 233 of these 409 patients (57.0%)
- RM abnormality without administrative codes: structural lead failure verified
- 167 (21.9%)
- RM transmissions suggestive of lead abnormalities with structural lead failure
- 400 (34.2%)
- Leads abandoned/extracted for structural failure without preceding abnormal RM transmissions
- 200
- Total lead failure cohort (66.7% with RM abnormalities, 33.3% without)
- 600
Observational data: associations, not effects.
Further findings
Isolated right atrial or LV lead failure
- Less likely to have lead replacement and administrative codes reflective of lead failure
Original publication
Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation. Heart Rhythm. Published 28 December 2022. doi:10.
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