Key result
PFO closure with the Figulla occluder was associated with a lower rate of supraventricular arrhythmias compared to the AMPLATZER device (9% vs. 17%, p=0.02), with similar overall safety and efficacy.
Why the study?
Does the Figulla occluder device improve procedural success, residual shunt, or safety compared to the AMPLATZER device in patients undergoing percutaneous PFO closure after stroke or TIA?
Observational (n=406)
Yes
Does the Figulla occluder device improve procedural success, residual shunt, or safety compared to the AMPLATZER device in patients undergoing percutaneous PFO closure after stroke or TIA?
Absolute Event Rate: 9% vs 17%
p-value: p=0.02
The Figulla occluder is as effective as the AMPLATZER device for PFO closure in preventing residual shunt, but is associated with a significantly lower rate of post-procedural supraventricular arrhythmias.
Figulla may lower post-PFO closure arrhythmia risk versus AMPLATZER; leaves open device superiority in randomized trials.
AIMS: The aim of this observational study was to compare acute and 12-month results of percutaneous closure of patent foramen ovale (PFO) with two occluder devices. METHODS AND RESULTS: Between June 2007 and October 2014, 406 consecutive patients (48.1±13.3 years, 243 women) underwent percutaneous PFO closure with either the AMPLATZER (n=179) or the Figulla (n=227) device after a stroke or a transient ischaemic attack ascribed to the PFO. A right-to-left shunt grade >1 was previously detected in all patients and atrial septal aneurysm was present in 111 (27.5%) patients. Patients were followed up with a contrast transthoracic echocardiogram and clinically at 24 hours, six months, and 12 months after the procedure. A high procedural success was observed in both groups. Despite a trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 right-to-left shunt was observed in 4.5% of patients, independently of the device used for PFO closure. The only difference reported after Figulla device implantation was a lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02). CONCLUSIONS: According to this two-centre study, PFO closure appears safe and effective with the Figulla occluder as well as with the AMPLATZER device.
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Trabattoni et al. (2017) conducted an observational in Patent foramen ovale (PFO) after stroke or transient ischaemic attack (n=406). Figulla occluder vs. AMPLATZER device was evaluated on Supraventricular arrhythmias (p=0.02). PFO closure with the Figulla occluder was associated with a lower rate of supraventricular arrhythmias compared to the AMPLATZER device (9% vs. 17%, p=0.02), with similar overall safety and efficacy.
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