Arrhythmias & electrophysiology

Failure to treat ventricular tachycardia or ventricular fibrillation by implantable cardioverter-defibrillators

Heart RhythmPublished Retrospective analysis of the FDA MAUDE database

Authors' conclusion

In the largest reported series of failure-to-treat VT/VF by normally functioning ICDs, the most common cause was misclassification of VT as SVT/AF; the most common cause of death was undersensing of VF.

Study context

Population
Normally functioning implantable cardioverter-defibrillators (ICDs) with intact lead systems that failed to treat VT/VF, US FDA MAUDE database reports 2019–2023
Participants
854 reports
Outcome
Causes of ICD failure-to-treat VT/VF
Methodological detailsmanufacturer-verified reports
  • Manufacturer-verified reports

Main finding

As reported in the abstract

Causes of failure-to-treat VT/VF

Misclassification as supraventricular tachycardia (SVT) or atrial fibrillation (AF)

54.8%

Undersensing

21.1%

Failure to satisfy programmed rate/duration criteria

8.7%

Observational data: associations, not effects.

Further findings

Report classification

Deaths
96 [11.2%]
Injuries
585 [68.5%]
Malfunctions
173 [20.3%]

Arrhythmia type by cause

VT among events caused by misclassification as SVT/AF
89.5%
VT among events caused by failure to satisfy rate/duration criteria
70.3%
VF among events caused by undersensing
54.4%
Not specified as VT or VF among events caused by undersensing
19.4%

Deaths by cause

Deaths caused by undersensing
65.6%
  • Undersensing represented only 21.1% of reports

Trend in US reports

Number of reports increased faster than that of ICD patients

Original publication

Failure to treat ventricular tachycardia or ventricular fibrillation by implantable cardioverter-defibrillators. Heart Rhythm. Published 29 August 2024. doi:10.1016/j.hrthm.2024.08.055

Composed by AI from the published abstract and checked against it. How Briefs are made →

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