Amplatzer patent foramen ovale occluder: safety and efficacy

Expert Rev Med Devices. 2019 Mar;16(3):173-182. doi: 10.1080/17434440.2019.1581060. Epub 2019 Feb 18.


The patent foramen ovale (PFO) is a common anatomical variant in humans (prevalence 25%). Most often asymptomatic, it may engender paradoxically embolic strokes, myocardial infarctions, or visceral or peripheral ischemia. It is causatively related to migraine, positional or exertional hypoxemia with dyspnea, diving incidents, high altitude edema, and sleep apnea. Percutaneous closure of atrial septal defects was first performed in the seventies. A dedicated PFO occluder (Amplatzer PFO Occluder) was first used on 10 September 1997 by Kurt Amplatz and Bernhard Meier. Since, percutaneous PFO closure has evolved into one of the most common and the simplest and safest catheter-based intervention in adult cardiology. Randomized studies have proved its benefit for prevention of recurrent ischemic events (particularly strokes) in patients without competing stroke etiology. There are also supportive clinical data for PFO closure in other situations. Areas covered: The Amplatzer PFO Occluder, the first, most implanted, and best-studied PFO occluder, is reviewed, presenting implantation technique, possible complications, and pertinent scientific data of efficacy and safety. Expert commentary: Percutaneous PFO closure has grown to one of the most common procedures in interventional cardiology. Implantation of the Amplatzer PFO Occluder is simple, safe, and effective.

Keywords: Amplatzer PFO Occluder; cryptogenic stroke; embolic myocardial infarction; nickel allergy; paradoxical embolism; stroke of undetermined source (ESUS).

Publication types

  • Review

MeSH terms

  • Follow-Up Studies
  • Foramen Ovale, Patent / etiology
  • Foramen Ovale, Patent / surgery*
  • Humans
  • Septal Occluder Device / adverse effects*
  • Treatment Outcome