Arrhythmias & electrophysiology
Failure to defibrillate or cardiovert due to premature truncation of biphasic shocks from implantable defibrillators
Authors' conclusion
GFT-T1 and SCP-T2 shocks can result in failure to terminate VF/VT, but they may be preventable.
Study context
- Population
- Medtronic implantable defibrillators (recalled 2022 and 2023) delivering truncated shocks, reported in the FDA MAUDE database
- Participants
- 132 devices
- Exposure
- GFT-T1 vs SCP-T2 truncated shocks
- GFT-T1n = 27
- SCP-T2n = 103
- BOTH-T1&2n = 2
- Outcome
- Consequences of GFT-T1 and SCP-T2 shocks and their estimated incidences
Methodological detailsMAUDE database, supplemented by Medtronic data, lead failures excluded, Incidences estimated using USA volumes for devices with glassed feedthroughs
- MAUDE database
- Supplemented by Medtronic data
- Lead failures excluded
- Incidences estimated using USA volumes for devices with glassed feedthroughs
Main finding
As reported in the abstract
Failure to defibrillate VF with truncated shocks
- Ventricular fibrillation (VF) patients not defibrillated by truncated shocks
- 21 of 54 (38.9%)
- Ventricular tachycardia (VT) patients converted
- 79.1%
- VT conversions by SCP-T2 shocks
- 94.1%
- Estimated incidence GFT-T1
- 0.0078%-0.0088%
- Estimated incidence SCP-T2
- 0.1062%-0.1110%
Observational data: associations, not effects.
Safety
Outcomes of VF patients not defibrillated
- Unrelated deaths
- 2
- Externally rescued
- 1
- Outcome unknown
- 1
- Others defibrillated by subsequent shocks or terminated spontaneously
Original publication
Failure to defibrillate or cardiovert due to premature truncation of biphasic shocks from implantable defibrillators. Heart Rhythm. Published 11 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →