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Current Patient Management Issues, Clinical Trial Design Challenges, and the Pathway Forward

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Abstract

Following the diagnosis and acute treatment of ischemic strokes, patients routinely undergo testing to classify the stroke in terms of potential causes. Ischemic strokes in the setting of a detected PFO may be differentiated into two major categories: (1) the negatively-defined cryptogenic category (i.e. the lack of a definitive cause with detection of a PFO) and (2) the cardio-embolic category where additional evidence supports a potential causal relationship with a paradoxical embolism related to PFO.

Uncertainty is common, both in determining the etiology of ischemic stroke and the management of patients with ischemic stroke who are found to have a PFO. Observational and some randomized clinical trial data provide supportive but not definitive data on the added benefits of PFO closure in secondary stroke prevention of select patients. Patients can be stratified as those most likely to benefit from PFO closure, those least likely, and those in whom uncertainty of the benefit of closure remains. The clinician must therefore provide an individualized approach to therapy in secondary stroke prevention strategies.

Clinical trials investigating the efficacy of PFO closure in the setting of secondary stroke prevention have faced numerous challenges, but the lessons learned have nonetheless been valuable. Additional focused research should lead to greater clarity as to the role of PFO closure.

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Author information

Authors and Affiliations

  1. Division of Cardiology, University of Colorado Denver, Anschutz Medical Campus, Mail Stop B132, 12401 East 17th Avenue, Room 524, Leprino Building, Aurora, CO, 80045, USA

    John D. Carroll MD, FACC, FSCAI & Michael S. Kim MD, FACC, FSCAI

  2. Division of Cardiology, Department of Neurology, University of Colorado Denver, Anschutz Medical Campus, Mail Stop B132, 12401 East 17th Avenue, Room 524, Leprino Building, Aurora, CO, 80045, USA

    Sharon Poisson MD, MAS

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  1. John D. Carroll MD, FACC, FSCAI
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  2. Sharon Poisson MD, MAS
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  3. Michael S. Kim MD, FACC, FSCAI
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Corresponding author

Correspondence to John D. Carroll MD, FACC, FSCAI .

Editor information

Editors and Affiliations

  1. Children's Hospital of Georgia, Augusta, Georgia, USA

    Zahid Amin

  2. UCLA, Los Angeles, California, USA

    Jonathan M. Tobis

  3. CardioVascular Center, Frankfurt, Germany

    Horst Sievert

  4. University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA

    John D. Carroll

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Carroll, J.D., Poisson, S., Kim, M.S. (2015). Current Patient Management Issues, Clinical Trial Design Challenges, and the Pathway Forward. In: Amin, Z., Tobis, J., Sievert, H., Carroll, J. (eds) Patent Foramen Ovale. Springer, London. https://doi.org/10.1007/978-1-4471-4987-3_11

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  • DOI: https://doi.org/10.1007/978-1-4471-4987-3_11

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