Amplatzer and Figulla Devices Prove to Be Safe for Percutaneous Patent Foramen Ovale Closure

Courtesy of Dr. José Álvarez.

In patients with presumed paradoxical embolism through a patent foramen ovale (PFO) who are at high risk of recurrent thromboembolic events, percutaneous PFO closure is an alternative to pharmacological treatment. This closure has been shown to be safe and feasible with different devices including various technologies based on an umbrella, a disc or a bioresorbable design. Whether these differences (even the slightest) in structure, design, and composition have an impact on clinical outcomes is still unknown.

The aim of this study was to compare procedural and clinical results after a 1-year follow-up of the two most popular PFO closure devices: Amplatzer and Figulla.

While their design is similar (they both have two nitinol discs), the Figulla device features a 2-mm diameter smaller left atrial disc, and a different mesh pattern (with a polyethylene layer) that favors faster endothelialisation process.

This study consists in an observational registry in two Italian sites, which recruited 406 patients between 2007 and 2014. Patients included presented a previous stroke in 66% of all cases and a transient ischaemic attack (TIA) in the remaining 34%. Furthermore, they presented right-to-left-shunt as detected through transoesophageal echocardiography with a grade of microbubbles detected in the left atrium higher than 1 (less than 10 microbubbles observed in the left atrium during the first five cardiac cycles).

Intracardiac ultrasound was the procedural guiding strategy in one of the sites, while fluoroscopic and transoesophageal echocardiography monitoring was the technique applied in the other. Patients were followed up with a transthoracic echocardiogram at 24 hours, 6 months, and 1 year after the procedure.

The study endpoint was the presence of major adverse cardiac events (MACE), including death, stroke, or TIA at 12 months.

An AMPLATZER device was implanted in 179 patients and a Figulla device was implanted in 227 patients. The baseline characteristics of the groups were similar in terms of age, gender, interatrial shunting grade and septal anatomy, indication to closure, and device size. There were no significant differences concerning cardiovascular risk factors, except for a higher incidence of hypertension and smoking habit among patients treated with an AMPLATZER device. Septal atrial aneurysm was present in 27.5% of patients.

The procedure was successful in 99.5% of patients, with an average time of 29.41 minutes and a fluoroscopy time of 4.6 minutes. The incidence of device embolisation (0.5%), vascular complications, pseudoaneurysms, arteriovenous fistula, and major haematoma >5 cm was very low and there were no significant differences between groups.

There were no MACE in any of the groups.

Despite a non-determinant trend towards a higher incidence of acute residual shunt immediately after device deployment among Figulla occluder patients, a residual grade ≥2 shunt was observed in 4.5% of patients with both devices. The only difference found after implantation was a lower rate of supraventricular arrhythmias with the Figulla device (9% vs. 17%, p = 0.02).

The study concluded that percutaneous PFO closure appears safe and effective with both the Figulla and the Amplatzer device.

Editorial

This is the largest comparative study of two devices used for PFO closure. Its lack of randomization means that the presence of bias inherent to these studies cannot be ruled out. Additionally, this is a short-term study, so the existence of differences beyond this follow-up period is unknown. It is not powerful enough, either, to find divergence as regards the endpoint.

However, the safety and efficacy of these devices for PFO closure is confirmed.

Courtesy of Dr. José Álvarez.

Original title: Amplatzer Versus Figulla Occluder for Transcatheter Patent Foramen Ovale Closure.

Reference: Trabattoni D et al. Eurointervention 2017;12:2092-2099.

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