Valvular & structural heart disease
A novel device for atrial septal defect occlusion (GORE CARDIOFORM)
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
| Outcome | Values |
|---|---|
| Device embolisation | GCA 1 events |
| New onset arrhythmia | GCA 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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