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Published in: Neurological Sciences 1/2021

Open Access 01-01-2021 | Stroke | Review Article

Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?

Authors: Leonardo Varotto, Gianni Bregolin, Mariemma Paccanaro, Antonella De Boni, Carlo Bonanno, Francesco Perini

Published in: Neurological Sciences | Issue 1/2021

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Abstract

Objective

Systematic reviews suggest that patent foramen ovale closure (PFOc) is performed percutaneously with low complication rates. We did a network meta-analysis (NMA) comparing devices for PFO closures, evaluating safety and efficacy of transcatheter PFOc in preventing neurological events in patients with stroke when compared with medical therapy (MT), and assessing risk of atrial fibrillation (AF).

Methods

We searched 3 databases (MEDLINE, EMBASE, CENTRAL/CCTR) identifying six randomized controlled trials from 2012 until December 2019. We performed a Bayesian NMA; number-needed-to-treat and number-needed-to-harm were derived by applying the estimated odds ratios (ORs). The likelihood of being helped or harmed (LHH) was evaluated to estimate the risk-effectiveness balance.

Results

The 3560 patients allocated to PFOc were less subject to a stroke than patients with MT. The overall ORs of PFOc versus MT were 0.41 with fixed-effects, and 0.22 with random-effects model. NMA proves that PFOc induces AF episodes significantly higher than MT, even when analysis is limited to only new episodes of “serious AF.” LHH (0.68 fixed-effects, 0.79 random-effects) showed that strokes saved are less than cases of AFs added. By considering only serious AF, strokes saved are higher than serious AFs induced by the PFOc (LHH was 3.46 and 4.00 respectively).

Conclusions

NMA supported PFOc in patients with cryptogenic stroke, confirming that devices are better than MT, but increase the risk of AF by over 2/4 times (serious or unserious AF). Considering serious AFs (real risky clinical condition), patients have more advantages in being treated, since LHH is ≥ 3–4.
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Literature
3.
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, Investigators CLOSE (2017) Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. CLOSE Investigators. N Engl J Med 377:1011–1021. https://doi.org/10.1056/NEJMoa1705915CrossRefPubMed 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, Investigators CLOSE (2017) Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. CLOSE Investigators. N Engl J Med 377:1011–1021. https://​doi.​org/​10.​1056/​NEJMoa1705915CrossRefPubMed
4.
go back to reference Søndergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjöstrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L, Gore REDUCE Clinical Study Investigators (2017) Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. Gore REDUCE Clinical Study Investigators. N Engl J Med 377:1033–1042. https://doi.org/10.1056/NEJMoa1707404CrossRefPubMed Søndergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjöstrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L, Gore REDUCE Clinical Study Investigators (2017) Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. Gore REDUCE Clinical Study Investigators. N Engl J Med 377:1033–1042. https://​doi.​org/​10.​1056/​NEJMoa1707404CrossRefPubMed
7.
go back to reference Elgendy AY, Elgendy IY, Mojadidi MK, Mahmoud AN, Barry JS, Jneid H, Wayangankar SA, Tobis JM, Meier B (2019) New-onset atrial fibrillation following percutaneous patent foramen ovale closure: a systematic review and meta-analysis of randomised trials. EuroIntervention 14:1788–1790. https://doi.org/10.4244/EIJ-D-18-00767CrossRefPubMed Elgendy AY, Elgendy IY, Mojadidi MK, Mahmoud AN, Barry JS, Jneid H, Wayangankar SA, Tobis JM, Meier B (2019) New-onset atrial fibrillation following percutaneous patent foramen ovale closure: a systematic review and meta-analysis of randomised trials. EuroIntervention 14:1788–1790. https://​doi.​org/​10.​4244/​EIJ-D-18-00767CrossRefPubMed
8.
go back to reference Taaffe M, Fischer E, Baranowski A, Majunke N, Heinisch C, Leetz M, Hein R, Bayard Y, Büscheck F, Reschke M, Hoffmann I, Wunderlich N, Wilson N, Sievert H (2018) Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). Am J Cardiol 101:1353–1358. https://doi.org/10.1016/j.amjcard.2007.12.040CrossRef Taaffe M, Fischer E, Baranowski A, Majunke N, Heinisch C, Leetz M, Hein R, Bayard Y, Büscheck F, Reschke M, Hoffmann I, Wunderlich N, Wilson N, Sievert H (2018) Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). Am J Cardiol 101:1353–1358. https://​doi.​org/​10.​1016/​j.​amjcard.​2007.​12.​040CrossRef
13.
19.
29.
go back to reference 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) (2019) European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. EuroIntervention 14:1389–1402. https://doi.org/10.4244/EIJ-D-18-00622CrossRefPubMed 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) (2019) European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. EuroIntervention 14:1389–1402. https://​doi.​org/​10.​4244/​EIJ-D-18-00622CrossRefPubMed
Metadata
Title
Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?
Authors
Leonardo Varotto
Gianni Bregolin
Mariemma Paccanaro
Antonella De Boni
Carlo Bonanno
Francesco Perini
Publication date
01-01-2021
Publisher
Springer International Publishing
Published in
Neurological Sciences / Issue 1/2021
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI
https://doi.org/10.1007/s10072-020-04922-4

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