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  • Closure of Patent Foramen O...
    Carroll, John D; Saver, Jeffrey L; Thaler, David E; Smalling, Richard W; Berry, Scott; MacDonald, Lee A; Marks, David S; Tirschwell, David L

    The New England journal of medicine, 03/2013, Volume: 368, Issue: 12
    Journal Article

    In this study, closure of a patent foramen ovale versus medical therapy alone after cryptogenic stroke was not effective in preventing recurrent stroke. Secondary analyses suggested a possible benefit, but the study did not permit a definitive conclusion. It is unknown whether closure of a patent foramen ovale is effective in the prevention of recurrent stroke after a cryptogenic ischemic stroke. Observational studies and meta-analyses have suggested that closure is associated with a benefit; however, a randomized trial, Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale (CLOSURE I), failed to show the superiority of closure over medical therapy alone. 1 – 3 In observational studies, the Amplatzer PFO Occluder has been shown to have advantageous safety features as a closure device. 4 – . . .