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Patent Foramen Ovale Closure—When Number Needed to Treat and Number Needed to Harm Do Not Tell the Whole Story

Published:February 13, 2018DOI:https://doi.org/10.1016/j.amjcard.2018.02.003
      We read with interest the thorough meta-analysis of Ando et al
      • Ando T.
      • Holmes A.A.
      • Pahuja M.
      • Javed A.
      • Briasoulis A.
      • Telila T.
      • Takagi H.
      • Schreiber T.
      • Afonso L.
      • Grines C.L.
      • Bangalore S.
      Meta-analysis comparing patent foramen ovale closure versus medical therapy to prevent recurrent cryptogenic stroke.
      comparing patent foramen ovale (PFO) closure against medical therapy. The authors showed that PFO closure reduced the risk of recurrent stroke by 58%, with a number needed to treat of 38. PFO closure plus medical therapy, however, conferred a significant increase in risk of newly detected atrial fibrillation (AF), with a number needed to harm (NNH) of 29. With 4.3%, the prevalence of newly detected AF after PFO closure was similar to the one of 3.7% (95% confidence interval 2.9 to 4.6) in a recent large retrospective cohort study of 1,887 patients.
      • Merkler A.E.
      • Gialdini G.
      • Yaghi S.
      • Okin P.M.
      • Iadecola C.
      • Navi B.B.
      • Kamel H.
      Safety outcomes after percutaneous transcatheter closure of patent foramen ovale.
      At a first glance, the overall results are disappointing as the NNH is lower than the number needed to treat. Why should one consider PFO closure, if the odds of benefit are lower than the odds of harm?
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