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Letter to the Editor| Volume 57, e31-e33, November 2018

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Transcatheter patent foramen ovale closure versus standard medical therapy for prevention of recurrent stroke: Updated Meta-analysis with an importance on shunt size

Published:August 23, 2018DOI:https://doi.org/10.1016/j.ejim.2018.08.009
Transcatheter patent foramen ovale closure versus standard medical therapy for prevention of recurrent stroke: Updated Meta-analysis with an importance on shunt size
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      Presence of patent foramen ovale (PFO) has been associated with increased risk of cryptogenic stroke [
      • Kernan W.N.
      • Ovbiagele B.
      • Black H.R.
      • Bravata D.M.
      • Chimowitz M.I.
      • Ezekowitz M.D.
      • et al.
      Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: A guideline for healthcare professionals from the American Heart Association/American Stroke Association.
      Stroke. 2014; 45: 2160-2236
      ]. PFO is present in about 25% of the general adult population but is found in upto 40% of patients with cryptogenic stroke [
      • Kernan W.N.
      • Ovbiagele B.
      • Black H.R.
      • Bravata D.M.
      • Chimowitz M.I.
      • Ezekowitz M.D.
      • et al.
      Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: A guideline for healthcare professionals from the American Heart Association/American Stroke Association.
      Stroke. 2014; 45: 2160-2236
      ]. Three previously published randomized controlled trials (RCTs) did not demonstrate the superiority of transcatheter PFO closure over standard medical therapy (SMT) [
      • Furlan A.J.
      • Reisman M.
      • Massaro J.
      • Mauri L.
      • Adams H.
      • Albers G.W.
      • et al.
      Closure or medical therapy for cryptogenic stroke with patent foramen ovale.
      N Engl J Med. 2012; 366: 991-999
      ,
      • Carroll J.D.
      • Saver J.L.
      • Thaler D.E.
      • Smalling R.W.
      • Berry S.
      • MacDonald L.A.
      • et al.
      Closure of patent foramen ovale versus medical therapy after cryptogenic stroke.
      N Engl J Med. 2013; 368: 1092-1100
      ,
      • Meier B.
      • Kalesan B.
      • Mattle H.P.
      • Khattab A.A.
      • Hildick-Smith D.
      • Dudek D.
      • et al.
      Percutaneous closure of patent foramen ovale in cryptogenic embolism.
      N Engl J Med. 2013; 368: 1083-1091
      ]. Recently, long-term outcomes of a previously negative RCT (RESPECT trial) and three other RCTs have shown a benefit of PFO closure in the terms of reduction in the recurrent strokes compared to SMT [
      • Saver J.L.
      • Carroll J.D.
      • Thaler D.E.
      • Smalling R.W.
      • MacDonald L.A.
      • Marks D.S.
      • et al.
      Long-term outcomes of patent foramen ovale closure or medical therapy after stroke.
      N Engl J Med. 2017; 377: 1022-1032
      ,
      • Mas J.L.
      • Derumeaux G.
      • Guillon B.
      • Massardier E.
      • Hosseini H.
      • Mechtouff L.
      • et al.
      Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke.
      N Engl J Med. 2017; 377: 1011-1021
      ,
      • Sondergaard L.
      • Kasner S.E.
      • Rhodes J.F.
      • Andersen G.
      • Iversen H.K.
      • Nielsen-Kudsk J.E.
      • et al.
      Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke.
      N Engl J Med. 2017; 377: 1033-1042
      ,
      • Lee P.H.
      • Song J.K.
      • Kim J.S.
      • Heo R.
      • Lee S.
      • Kim D.H.
      • et al.
      Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial.
      J Am Coll Cardiol. 2018; 71: 2335-2342
      ]. However, current guidelines do not recommend the PFO closure in the patients with cryptogenic stroke and PFO [
      • Kernan W.N.
      • Ovbiagele B.
      • Black H.R.
      • Bravata D.M.
      • Chimowitz M.I.
      • Ezekowitz M.D.
      • et al.
      Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: A guideline for healthcare professionals from the American Heart Association/American Stroke Association.
      Stroke. 2014; 45: 2160-2236
      ,
      • Whitlock R.P.
      • Sun J.C.
      • Fremes S.E.
      • Rubens F.D.
      • Teoh K.H.
      Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines.
      Chest. 2012; 141: e576S-e600S
      ,
      • Messe S.R.
      • Gronseth G.
      • Kent D.M.
      • Kizer J.R.
      • Homma S.
      • Rosterman L.
      • et al.
      Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology.
      Neurology. 2016; 87: 815-821
      ]. Hence, we performed an updated meta-analysis of all the RCTs of PFO closure and cryptogenic stroke by including a recent DEFENCE-PFO trial by Lee et al. [
      • Lee P.H.
      • Song J.K.
      • Kim J.S.
      • Heo R.
      • Lee S.
      • Kim D.H.
      • et al.
      Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial.
      J Am Coll Cardiol. 2018; 71: 2335-2342
      ].

      Keywords

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      References

        • Kernan W.N.
        • Ovbiagele B.
        • Black H.R.
        • Bravata D.M.
        • Chimowitz M.I.
        • Ezekowitz M.D.
        • et al.
        Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: A guideline for healthcare professionals from the American Heart Association/American Stroke Association.
        Stroke. 2014; 45: 2160-2236
        View in Article
        • Furlan A.J.
        • Reisman M.
        • Massaro J.
        • Mauri L.
        • Adams H.
        • Albers G.W.
        • et al.
        Closure or medical therapy for cryptogenic stroke with patent foramen ovale.
        N Engl J Med. 2012; 366: 991-999
        View in Article
        • Carroll J.D.
        • Saver J.L.
        • Thaler D.E.
        • Smalling R.W.
        • Berry S.
        • MacDonald L.A.
        • et al.
        Closure of patent foramen ovale versus medical therapy after cryptogenic stroke.
        N Engl J Med. 2013; 368: 1092-1100
        View in Article
        • Meier B.
        • Kalesan B.
        • Mattle H.P.
        • Khattab A.A.
        • Hildick-Smith D.
        • Dudek D.
        • et al.
        Percutaneous closure of patent foramen ovale in cryptogenic embolism.
        N Engl J Med. 2013; 368: 1083-1091
        View in Article
        • Saver J.L.
        • Carroll J.D.
        • Thaler D.E.
        • Smalling R.W.
        • MacDonald L.A.
        • Marks D.S.
        • et al.
        Long-term outcomes of patent foramen ovale closure or medical therapy after stroke.
        N Engl J Med. 2017; 377: 1022-1032
        View in Article
        • Mas J.L.
        • Derumeaux G.
        • Guillon B.
        • Massardier E.
        • Hosseini H.
        • Mechtouff L.
        • et al.
        Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke.
        N Engl J Med. 2017; 377: 1011-1021
        View in Article
        • Sondergaard L.
        • Kasner S.E.
        • Rhodes J.F.
        • Andersen G.
        • Iversen H.K.
        • Nielsen-Kudsk J.E.
        • et al.
        Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke.
        N Engl J Med. 2017; 377: 1033-1042
        View in Article
        • Lee P.H.
        • Song J.K.
        • Kim J.S.
        • Heo R.
        • Lee S.
        • Kim D.H.
        • et al.
        Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial.
        J Am Coll Cardiol. 2018; 71: 2335-2342
        View in Article
        • Whitlock R.P.
        • Sun J.C.
        • Fremes S.E.
        • Rubens F.D.
        • Teoh K.H.
        Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines.
        Chest. 2012; 141: e576S-e600S
        View in Article
        • Messe S.R.
        • Gronseth G.
        • Kent D.M.
        • Kizer J.R.
        • Homma S.
        • Rosterman L.
        • et al.
        Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology.
        Neurology. 2016; 87: 815-821
        View in Article

      Article info

      Publication history

      Published online: August 23, 2018
      Accepted: August 14, 2018
      Received: August 9, 2018

      Identification

      DOI: https://doi.org/10.1016/j.ejim.2018.08.009

      Copyright

      © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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