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Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
10:52

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence

Published on: December 23, 2022

Cryptogenic stroke in a patient with a PFO: a decision analysis

Sagit Stern1, Matan J Cohen, Dan Gilon

  • 1Center for Clinical Quality and Safety, Hebrew University, Jerusalem, Israel.

The American Journal of the Medical Sciences
|June 17, 2008
PubMed
Abstract

Insights

Managing stroke risk in patients with a patent foramen ovale (PFO) involves complex decisions. Treatment effectiveness is highly sensitive to individual risk factors and therapy efficacy, making a definitive "best" approach uncertain.

Area of Science:

  • Cardiology
  • Neurology
  • Medical Decision Making

Background:

  • A high-profile stroke case involving a patient with a patent foramen ovale (PFO) highlighted public and expert debate on stroke management options.
  • The patient experienced a transient ischemic attack, followed by anticoagulation, and subsequently a major intracerebral hemorrhage after PFO closure was considered.

Purpose of the Study:

  • To systematically review the clinical case and perform a formal decision analysis.
  • To identify the optimal management strategy for stroke prevention in patients with PFO, comparing anticoagulation, antiplatelets, PFO closure, and no treatment.

Main Methods:

  • A decision tree analysis was constructed using the best available evidence.
  • Sensitivity analyses were performed to assess the impact of various assumptions on the optimal treatment strategy.

Main Results:

  • Optimal management decisions were critically sensitive to assumptions regarding stroke etiology, treatment efficacy, safety, recurrence risk, and patient utility values.
  • No treatment was preferred when the annual risk of recurrent stroke was below 0.12. PFO closure was favored only when recurrence risk exceeded 0.12 and closure effectiveness was less than 0.28.
  • PFO closure was inferior to anticoagulation or antiplatelet therapy when closure effectiveness exceeded 0.6.

Conclusions:

  • Significant uncertainties exist regarding the optimal management of stroke in PFO patients, leading to controversy.
  • Utilizing novel therapies like PFO closure outside of clinical trials does not resolve uncertainties about their efficacy.

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