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Published in: Journal of Neurology 6/2018

01-06-2018 | Review

Closure of patent foramen ovale for cryptogenic stroke patients: an updated systematic review and meta-analysis of randomized trials

Authors: Xuan Niu, Guang Ou-Yang, Peng-fei Yan, Shu-lan Huang, Zhen-tao Zhang, Zhao-hui Zhang

Published in: Journal of Neurology | Issue 6/2018

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Abstract

Objective

This systematic review and meta-analysis was performed to investigate the efficacy and safety of transcatheter device closure (TDC) plus anti-thrombotic drugs over medical management alone for patients with cryptogenic stroke and patent foramen oval.

Methods

PubMed, Embase and Cochrane Library database were searched for randomized controlled clinical trials (RCTs). The primary endpoint is the composite of stroke and transient ischemic attack. The secondary endpoints are all-cause mortality, total serious adverse events, atrial fibrillation and bleeding.

Results

Five RCTs with a total of 3440 participants were included. TDC significantly decreased the risk of primary endpoint when compared to medical therapy alone (RR 0.54, 95% CI 0.43–0.69). Further subgroup analyses showed that patients with male gender and with substantial shunt size of foramen ovale significantly benefited from TDC as compared to those with female gender and with no substantial shunt size of foramen oval separately. Moreover, TDC was superior to medical therapy with anti-platelet drug alone (not with anti-coagulation). On the other hand, the incidence of atrial fibrillation was higher in TDC group (RR 4.49, 95% CI 2.02–9.97), with the risk of other adverse events equivalent between the two groups.

Conclusions

TDC plus anti-thrombotic drugs is superior than medical therapy alone for secondary prevention of stroke, especially for those with male gender and with substantial shunt size of foramen ovale. Though it may increase the risk of postoperative atrial fibrillation, it would not bring higher risk of all-cause mortality, total adverse events and bleeding.
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Literature
1.
go back to reference Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB (2015) Heart disease and stroke statistics—2015 update a report from the American Heart Association. Circulation 131(4):e29–e322. https://doi.org/10.1161/CIR.0000000000000152 CrossRefPubMed Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB (2015) Heart disease and stroke statistics—2015 update a report from the American Heart Association. Circulation 131(4):e29–e322. https://​doi.​org/​10.​1161/​CIR.​0000000000000152​ CrossRefPubMed
5.
go back to reference Amarenco P, Bogousslavsky J, Caplan LR, Donnan GA, Hennerici MG (2009) Classification of stroke subtypes. Cerebrovasc Dis 27(5):493–501CrossRefPubMed Amarenco P, Bogousslavsky J, Caplan LR, Donnan GA, Hennerici MG (2009) Classification of stroke subtypes. Cerebrovasc Dis 27(5):493–501CrossRefPubMed
11.
go back to reference Finsterer J (2010) Management of cryptogenic stroke. Acta Neurol Belg 110:135–147PubMed Finsterer J (2010) Management of cryptogenic stroke. Acta Neurol Belg 110:135–147PubMed
18.
19.
go back to reference Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Béjot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guérin P, Piot C, Rossi R, Dubois-Randé JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G (2017) Patent foramen ovale closure or anticoagulation vs antiplatelets after stroke. N Engl J Med 377:1011–1021. https://doi.org/10.1056/NEJMoa1705915 CrossRefPubMed Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Béjot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guérin P, Piot C, Rossi R, Dubois-Randé JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G (2017) Patent foramen ovale closure or anticoagulation vs antiplatelets after stroke. N Engl J Med 377:1011–1021. https://​doi.​org/​10.​1056/​NEJMoa1705915 CrossRefPubMed
28.
go back to reference Braun M, Gliech V, Boscheri A, Schoen S, Gahn G, Reichmann H, Haass M, Schraeder R, Strasser RH (2004) Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism: periprocedural safety and mid-term follow-up results of three different device occluder systems. Eur Heart J 25(5):424–430. https://doi.org/10.1016/j.ehj.2003.10.021 CrossRefPubMed Braun M, Gliech V, Boscheri A, Schoen S, Gahn G, Reichmann H, Haass M, Schraeder R, Strasser RH (2004) Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism: periprocedural safety and mid-term follow-up results of three different device occluder systems. Eur Heart J 25(5):424–430. https://​doi.​org/​10.​1016/​j.​ehj.​2003.​10.​021 CrossRefPubMed
29.
go back to reference Cillis ED, Basile DP, Acquaviva T, Blasi RD, Petruzzellis M, Bortone AS (2010) Abstract 8807: efficacy and effectiveness evaluation of secondary prevention of cryptogenic stroke or TIA in patients with PFO successfully treated by percutaneous approach: six years follow-up. Circulation 21:A8807 Cillis ED, Basile DP, Acquaviva T, Blasi RD, Petruzzellis M, Bortone AS (2010) Abstract 8807: efficacy and effectiveness evaluation of secondary prevention of cryptogenic stroke or TIA in patients with PFO successfully treated by percutaneous approach: six years follow-up. Circulation 21:A8807
30.
go back to reference Hong TE, Thaler D, Brorson J, Heitschmidt M, Hijazi ZM (2003) Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder: initial and intermediate-term results of the US multicenter clinical trial. Catheter Cardiovasc Interv 60(4):524–528. https://doi.org/10.1002/ccd.10674 CrossRefPubMed Hong TE, Thaler D, Brorson J, Heitschmidt M, Hijazi ZM (2003) Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder: initial and intermediate-term results of the US multicenter clinical trial. Catheter Cardiovasc Interv 60(4):524–528. https://​doi.​org/​10.​1002/​ccd.​10674 CrossRefPubMed
Metadata
Title
Closure of patent foramen ovale for cryptogenic stroke patients: an updated systematic review and meta-analysis of randomized trials
Authors
Xuan Niu
Guang Ou-Yang
Peng-fei Yan
Shu-lan Huang
Zhen-tao Zhang
Zhao-hui Zhang
Publication date
01-06-2018
Publisher
Springer Berlin Heidelberg
Published in
Journal of Neurology / Issue 6/2018
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-018-8766-2

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