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Canadian Journal of Cardiology
Clinical Research| Volume 36, ISSUE 10, P1608-1615, October 2020

Periprocedural Outcomes of Fluoroscopy-Guided Patent Foramen Ovale Closure With Selective Use of Intracardiac Echocardiography

Published:January 13, 2020DOI:https://doi.org/10.1016/j.cjca.2019.12.032

      Abstract

      Background

      Recent randomized trials have confirmed the role of patent foramen ovale (PFO) closure in the secondary prevention of cryptogenic stroke. Guidelines have suggested a central role for intraprocedural imaging using intracardiac echocardiography (ICE). However, this modality may not be required to achieve safe and effective closure. We aimed to examine the periprocedural outcomes of PFO closure retrospectively, using fluoroscopic guidance in patients with cryptogenic stroke, with provisional ICE guidance driven by anatomic and procedural factors.

      Methods

      A retrospective chart review of consecutive patients who underwent PFO closure in a single centre using the Amplatzer PFO occluder (AGA Medical Corporation, Plymouth, Minnesota) for cryptogenic stroke was conducted. Outcomes analyzed included procedural data, periprocedural complications, length of stay, and factors contributing to the use of intraprocedural imaging.

      Results

      Between 2006 and 2017, 467 patients underwent PFO closure for cryptogenic stroke with the Amplatzer PFO occluder; 381 patients underwent closure with fluoroscopy alone, and 86 with ICE and fluoroscopic guidance. Periprocedural arrhythmic complications occurred in 1.3% in the fluoroscopy group and 1.2% in the ICE group (P = 1.000). Vascular complications occurred in 0.5% in the fluoroscopy group and 2.3% (P = 0.323) in the ICE group. One device embolized requiring surgical intervention. There was no in-hospital mortality or stroke. Same-day discharge occurred in 97.6% of patients.

      Conclusion

      Our single-centre experience suggests that PFO closure can be safely conducted under fluoroscopic guidance alone with provisional adjunctive ICE use limited to specific anatomic situations.

      Résumé

      Introduction

      De récents essais à répartition aléatoire ont confirmé le rôle de la fermeture du foramen ovale perméable (FOP) dans la prévention secondaire de l’accident vasculaire cérébral (AVC) d’origine cryptogénique. Les lignes directrices ont montré le rôle central de l’imagerie intraprocédurale au moyen de l’échocardiographie intracardiaque (EIC). Toutefois, cette modalité ne devrait pas être nécessaire pour obtenir une fermeture sûre et efficace. Nous avions pour objectif d’examiner rétrospectivement les résultats périprocéduraux de la fermeture du FOP sous guidage fluoroscopique chez les patients ayant subi un AVC d’origine cryptogénique, et sous guidage provisoire de l’EIC motivé par les facteurs anatomiques et procéduraux.

      Méthodes

      Nous avons réalisé une revue rétrospective des dossiers de patients consécutifs d’un seul centre qui subissaient une fermeture du FOP au moyen de l’obturateur de FOP Amplatzer (AGA Medical Corporation, Plymouth, Minnesota) en raison d’un AVC d’origine cryptogénique. Parmi les résultats analysés, on trouvait les données procédurales, les complications périprocédurales, la durée du séjour et les facteurs contribuant à l’utilisation de l’imagerie intraprocédurale.

      Résultats

      Entre 2006 et 2017, 467 patients ont subi une fermeture du FOP en raison d’un AVC d’origine cryptogénique au moyen de l’obturateur de FOP Amplatzer; 381 patients ont subi une fermeture par fluoroscopie seule et 86 par EIC et guidage fluoroscopique. Des complications arythmiques périprocédurales sont survenues chez 1,3 % dans le groupe de la fluoroscopie et chez 1,2 % dans le groupe de l’EIC (P = 1,000). Des complications vasculaires sont survenues chez 0,5 % dans le groupe de la fluoroscopie et chez 2,3 % (P = 0,323) dans le groupe de l’EIC. Un dispositif embolisé nécessitant l’intervention chirurgicale. Il n’y a eu ni mortalité intra-hospitalière ni AVC. La sortie de l'hôpital le jour même a eu lieu chez 97,6 % des patients.

      Conclusion

      Notre expérience dans un seul centre suggère que la fermeture du FOP peut être réalisée de manière sécuritaire sous guidage fluoroscopique seul et l’utilisation provisoire de l’EIC d’appoint restreinte à des situations anatomiques particulières.
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      Linked Article

      • Fluoroscopy-Only Guided Patent Foramen Ovale Device Closure: Will It Cut Ice With the Interventionalist Community?
        Canadian Journal of CardiologyVol. 36Issue 10
        • Preview
          One-third of all ischemic strokes are of unknown cause.1 Patent foramen ovale (PFO) closure, for the prevention of stroke recurrence in patients with cryptogenic stroke (CS), has evolved from a putative therapy to one grounded in clinical trial evidence.1 Earlier “negative” trials comparing the efficacy of PFO closure with medical therapy for preventing stroke recurrence had limitations. Those trials used older-generation devices,2 had lower-than-expected event rates, or included patients with a transient ischemic attack as the index event.
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