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Meta-Analysis Comparing Percutaneous Closure Versus Medical Therapy for Patent Foramen Ovale

      Patent foramen ovale (PFO) is the most common congenital heart defect with an estimated prevalence of 1 in 4 adults. The optimal treatment strategy for patients with PFO with cryptogenic stroke has long been debated. Early clinical trials, including Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) (NCT00465270), Patent Foramen Ovale and Cryptogenic Embolism (PC) (NCT00166257), and 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 (CLOSER) I (NCT00201461), did not show benefit for PFO closure in the reduction of recurrent embolic stroke and/or systemic embolism compared with medical therapy. More recent trials, including Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale (DEFENSE-PFO) (NCT01550588), GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients (REDUCE) (NCT00738894), and Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE) (NCT00562289) trials and the 10-year results of the RESPECT trial, demonstrated that PFO closure with a variety of devices in combination with medical management reduced recurrent stroke and/or systemic embolism compared with medical therapy alone. Given these new findings, society guidelines have been updated to reflect improved outcomes with device closure of PFO in patients 60 years or younger with a PFO-related stroke diagnosed by a neurologist with vascular expertise.
      • Messé SR
      • Gronseth GS
      • Kent DM
      • Kizer JR
      • Homma S
      • Rosterman L
      • Carroll JD
      • Ishida K
      • Sangha N
      • Kasner SE.
      Practice advisory update summary: patent foramen ovale and secondary stroke prevention: report of the Guideline Subcommittee of the American Academy of Neurology.
      ,
      • Pristipino C
      • Sievert H
      • D'Ascenzo F
      • Mas JL
      • Meier B
      • Scacciatella P
      • Hildick-Smith D
      • Gaita F
      • Toni D
      • Kyrle P
      • Thomson J
      • Derumeaux G
      • Onorato E
      • Sibbing D
      • Germonpré P
      • Berti S
      • Chessa M
      • Bedogni F
      • Dudek D
      • Hornung M
      • Zamorano J
      European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Stroke Organisation (ESO), European Heart Rhythm Association (EHRA), European Association for Cardiovascular Imaging (EACVI), Association for European Paediatric and Congenital Cardiology (AEPC), ESC Working group on GUCH, ESC Working group on Thrombosis, European Haematological Society (EHA)
      European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism.
      Based on this subsequent favorable data, the Food and Drug Administration has approved PFO for cryptogenic stroke in patients 60 years or younger. However, given the differences in outcomes of these trials, the optimal treatment strategy in patients with PFO (percutaneous closure vs medical therapy) remains controversial.
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