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Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
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The new patent foramen ovale occluder FIGULLA in complex septal anatomy: a case series

Roberto Baglini1, Duccio Baldari, Andrea Amaducci

  • 1Department of Interventional Cardiology, IsMeTT, University of Pittsburgh European Centre, via Tricomi 1, 90100 Palermo, Italy. rbaglini@ismett.edu

Therapeutic Advances in Cardiovascular Disease
|December 15, 2012
PubMed

Insights

The FIGULLA septal occluder (FSO) effectively treats cryptogenic stroke in patients with complex patent foramen ovale (PFO) anatomy. This device demonstrates high performance and safety, comparable to other occluders in simpler cases.

Area of Science:

  • Cardiology
  • Neurology
  • Medical Devices

Background:

  • Secondary stroke prevention in cryptogenic stroke with patent foramen ovale (PFO) is challenging.
  • Complex septal anatomy in PFO presents unique treatment difficulties.

Purpose of the Study:

  • To evaluate the percutaneous closure of PFO with complex septal anatomy using the FIGULLA septal occluder (FSO).
  • To compare the outcomes of FSO in complex PFO cases with standard PFO closure using the Amplatzer septal occluder (ASO).

Main Methods:

  • A case series of 10 patients with complex PFO anatomy treated with FSO was compared to 25 patients with typical PFO anatomy treated with ASO.
  • Transesophageal echocardiogram (TEE) was used to define complex septal anatomy.

Main Results:

  • Both FSO and ASO demonstrated similar high success rates and low complication rates at 12-month follow-up.
  • The FSO group required a larger delivery sheath size and had a higher incidence of local hematoma, but without clinical impact.

Conclusions:

  • The FSO is a high-performing device for PFO closure in patients with complex septal anatomy.
  • The device's fabric features, including metal content and titanium, may contribute to its favorable behavior.
Abstract

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