Key result
Gore Cardioform linked to ~11-fold higher post-PFO-closure atrial fibrillation or flutter vs. Amplatzer devices.
Why the study?
The incidence of postclosure atrial fibrillation, atrial flutter, and arrhythmias across different patent foramen ovale closure devices remains uncertain.
Does closure device type, device size, and patient sex predict the incidence of postclosure atrial fibrillation or atrial flutter in patients undergoing percutaneous PFO closure?
Observational (n=445)
No
Does closure device type, device size, and patient sex predict the incidence of postclosure atrial fibrillation or atrial flutter in patients undergoing percutaneous PFO closure?
Odds Ratio: 11.36 (95% CI 3.11–41.59)
Absolute Event Rate: 16.8% vs 2%
p-value: p=0.0002
The Gore Cardioform device, while highly effective for PFO closure, acts as an independent predictor of postclosure transient atrial fibrillation or flutter, particularly in males and with larger device sizes.
Gore Cardioform was associated with higher post-PFO closure AF odds; leaves open whether device choice should be altered pending randomized confirmation.
Background: Patients with a patent foramen ovale (PFO) who undergo percutaneous PFO closure are at a greater risk of developing atrial fibrillation (AF) compared with patients whose PFOs are managed medically. Postclosure AF appears to be well tolerated if treated but may increase the risk for stroke. Postclosure AF is reported to occur in 3.7% to 7.4% of patients; however, incidence across devices remains uncertain. This study aims to evaluate the frequency of postclosure AF, atrial flutter, and arrhythmias in 6 PFO closure devices. Methods: Four hundred forty-five patients underwent percutaneous PFO closure with appropriate follow-up between 2001 and 2021. The procedure was performed using Abbott Amplatzer PFO, Amplatzer ASD, Amplatzer Cribriform, NMT CardioSEAL, Gore Helex, or Gore Cardioform devices. Incidence of AF, atrial flutter, and arrhythmias were assessed by electrocardiogram within 6 months from closure. Multivariate logistic regression evaluated potential predictors of postclosure AF or atrial flutter. Results: Postclosure AF or atrial flutter occurred in 30 patients (6.7%) within 6 months, and its incidence was significantly different across devices. Gore Cardioform had the greatest frequency of postclosure AF or atrial flutter events (16.8%) compared with other devices. The Gore Cardioform device, larger device sizes, and male sex were associated with greater risk of postclosure AF or atrial flutter. Conclusions: Postclosure AF or atrial flutter was more likely to occur in the Gore Cardioform device, in males, and in patients who underwent PFO closure with larger devices. Although it is more effective for complete closure, the Gore Cardioform device was shown to be an independent predictor of postclosure AF or atrial flutter.
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Ravellette et al. (2023) conducted an observational in Patent foramen ovale (PFO) (n=445). Gore Cardioform PFO closure device vs. Amplatzer devices (ASD, Cribriform, PFO combined) was evaluated on Incidence of atrial fibrillation or atrial flutter within 6 months from PFO closure (OR 11.36, 95% CI 3.11-41.59, p=0.0002).
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