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Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
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Amplatzer patent foramen ovale occluder: safety and efficacy

Raouf Madhkour1, Andreas Wahl1, Fabien Praz1

  • 1a Department of Cardiology , University Hospital of Bern , Bern , Switzerland.

Expert Review of Medical Devices
|February 12, 2019
PubMed
Abstract

Insights

Patent foramen ovale (PFO) closure using the Amplatzer device is a safe and effective treatment. This review covers the Amplatzer PFO Occluder, its implantation, and clinical data on efficacy and safety.

Area of Science:

  • Interventional Cardiology
  • Cardiovascular Medicine
  • Medical Device Technology

Background:

  • Patent foramen ovale (PFO) affects 25% of humans, potentially causing strokes, heart attacks, and other ischemic events.
  • PFO is linked to conditions like migraine, hypoxemia, and sleep apnea.
  • Percutaneous closure of atrial septal defects began in the 1970s, with dedicated PFO devices emerging later.

Purpose of the Study:

  • To review the Amplatzer PFO Occluder, the first and most widely used device for percutaneous PFO closure.
  • To present the implantation technique, potential complications, and scientific evidence regarding the efficacy and safety of the Amplatzer PFO Occluder.
  • To highlight the evolution and current status of percutaneous PFO closure in adult cardiology.

Main Methods:

  • Review of the Amplatzer PFO Occluder, including its history and development.
  • Analysis of implantation techniques and potential complications associated with the device.
  • Synthesis of scientific data from randomized studies and clinical experience regarding PFO closure efficacy and safety.

Main Results:

  • Percutaneous PFO closure, particularly with the Amplatzer device, has become a common, simple, and safe catheter-based intervention.
  • Randomized studies confirm the benefit of PFO closure in preventing recurrent ischemic events, especially strokes, in select patients.
  • The Amplatzer PFO Occluder is the most implanted and best-studied device, demonstrating high efficacy and safety.

Conclusions:

  • Percutaneous PFO closure is a well-established and highly successful procedure in interventional cardiology.
  • The Amplatzer PFO Occluder offers a simple, safe, and effective solution for patients with PFO-related conditions.
  • Continued research and clinical data support the expanding role of PFO closure in managing various cardiovascular and neurological conditions.
Keywords:
Amplatzer PFO Occludercryptogenic strokeembolic myocardial infarctionnickel allergyparadoxical embolismstroke of undetermined source (ESUS)

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