Letter by Zaman et al Regarding Article, “Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale”
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To the Editor:
We read with interest the recent article by Merkler et al.1 In a retrospective cohort study, the authors investigated the safety of transcatheter patent foramen ovale (PFO) closure in patients with ischemic stroke/transient ischemic attack who underwent PFO closure within 1 year. The study concluded that closure was associated with adverse events in 7% of patients; the rate of events was higher in patients >60 years old compared with those aged ≤60 years (10.9% versus 4.9%; P<0.001). We commend the authors for their work and describe lessons learned from 5 randomized trials, which add to our interpretation of these results.
Contrary to prior observational studies, the CLOSURE I 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 PFO) failed to demonstrate superiority of PFO closure for secondary stroke prevention in patients with …