Valvular & structural heart disease

A novel device for atrial septal defect occlusion (GORE CARDIOFORM)

EuroInterventionPublished Retrospective multicentre review

Authors' conclusion

With growing experience using GCA, the device can be applied to a wide variety of ASD sizes and morphologies.

Study context

Population
Paediatric and adult patients undergoing atrial septal defect (ASD) device closure with GCA, 4 UK centres, January 2020–January 2023
Participants
135 participants
Outcome
Implantation success
Methodological details4 UK centres
  • 4 UK centres

Main finding

As reported in the abstract

Successful ASD device closure

GCA

95%

128 events

Observational data: associations, not effects.

Secondary outcomes

Baseline characteristics (age, defect size, device size)

Median patient age (years)
49
Median defect size (mm)
18
Median device size (mm)
37

Follow-up time

Median follow-up (months), IQR 1-14
6

Safety

OutcomeValues
Device embolisationGCA 1 events
New onset arrhythmiaGCA 12%
  • New onset arrhythmia: 12% of GCA implantations

New onset arrhythmia

Not related to patient age, defect diameter or device oversizing; positively associated with device size

Original publication

A novel device for atrial septal defect occlusion (GORE CARDIOFORM). EuroIntervention. Published 17 November 2023. doi:10.4244/eij-d-23-00378

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