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Updated: Mar 9, 2026
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure
Daniela Trabattoni1, Achille Gaspardone, Gregory A Sgueglia
1Centro Cardiologico "Monzino" IRCCS and Department of Cardiovascular Sciences, University of Milan, Milan, Italy.
Insights
Percutaneous closure of patent foramen ovale (PFO) using either the AMPLATZER or Figulla device is safe and effective. Both PFO closure devices demonstrated comparable long-term results for stroke patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Patent foramen ovale (PFO) is a potential cause of cryptogenic stroke.
- Percutaneous closure is a common treatment for PFO.
- Comparing different PFO occluder devices is crucial for clinical decision-making.
Purpose of the Study:
- To compare the acute and 12-month outcomes of percutaneous PFO closure using AMPLATZER and Figulla occluder devices.
- To evaluate the safety and efficacy of two distinct PFO closure devices.
Main Methods:
- An observational study involving 406 patients undergoing percutaneous PFO closure.
- Patients received either the AMPLATZER (n=179) or Figulla (n=227) device.
- Follow-up included clinical assessments and contrast transthoracic echocardiography at 24 hours, six months, and 12 months.
Main Results:
- High procedural success rates were observed for both devices.
- A comparable incidence of residual shunt (≥2 grade) at 12 months was noted (4.5%) regardless of the device used.
- The Figulla device showed a significantly lower rate of supraventricular arrhythmias (9% vs. 17%, p=0.02).
Conclusions:
- Percutaneous PFO closure with both AMPLATZER and Figulla devices is safe and effective.
- The choice of device may influence the rate of supraventricular arrhythmias post-procedure.
- Both devices offer comparable long-term efficacy in preventing residual shunts.
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.
