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Canadian Journal of Cardiology

Outcomes Following Patent Foramen Ovale Percutaneous Closure According to the Delay From Last Ischemic Event

Published:March 31, 2022DOI:https://doi.org/10.1016/j.cjca.2022.03.018

      Abstract

      Background

      Randomised controlled trials evaluating percutaneous closure of patent foramen ovale (PFO) have included only patients with a recent embolic event. We aimed to evaluate outcomes after percutaneous PFO closure according to the delay from the last embolic episode.

      Methods

      This international ambispective cohort included consecutive patients from 2 centres in France and Canada undergoing PFO closure for secondary prevention of a paradoxical embolic event. The primary end point was the composite of stroke or transient ischemic attack (TIA). A logistic regression model was used to evaluate determinants of late PFO closure procedures.

      Results

      A total of 1179 patients (mean age 49 ± 12.7 years; 44.4% female) underwent PFO closure from 2001 to 2021. The median delay from last embolic event to procedure was 6.0 (interquartile range 3.4-11.2) months. The determinants of late PFO closure procedure were the centre (France vs Canada; adjusted odds ratio [aOR] 1.65, 95% confidence interval [CI] 1.25-2.19), year of procedure (since 2018 vs before 2018; aOR 1.43, 95% CI 1.08-1.90), female sex (aOR 1.63, 95% CI 1.28-2.07), and lower risk of paradoxical embolism score (aOR 1.10, 95% CI 1.03-1.19). After a median follow-up of 2.61 (1.13-7.25) years, the incidence rate of first stroke or TIA did not differ between early and late PFO procedures, with 0.51 vs 0.29 events per 100 patient-years, respectively (incidence rate ratio 1.74, 95% CI 0.66-5.08; P = 0.24), and the timing of PFO closure was not associated with the occurrence of stroke or TIA in univariate analysis (hazard ratio 0.54, 95% CI 0.22-1.34) for late vs early closure).

      Conclusions

      This analysis provides indirect evidence that the delay from the last ischemic event does not affect outcomes after PFO closure for secondary prevention.

      Résumé

      Contexte

      Les essais contrôlés randomisés visant à évaluer la fermeture percutanée du foramen ovale perméable (FOP) ont été menés uniquement auprès de patients chez qui était survenu un événement embolique récent. Nous avons voulu évaluer l’issue de cette intervention en fonction du temps écoulé depuis le dernier épisode embolique.

      Méthodologie

      La cohorte ambispective internationale qui a été l’objet de notre analyse regroupait des patients consécutifs de deux établissements situés en France et au Canada chez qui avait été réalisée la fermeture du FOP en prévention secondaire d’un événement embolique paradoxal. Le paramètre d’évaluation principal mixte comprenait l’accident vasculaire cérébral (AVC) et l’accident ischémique transitoire (AIT). Un modèle de régression logistique a servi à évaluer les déterminants de la fermeture tardive du FOP.

      Résultats

      La fermeture du FOP a été réalisée chez 1 179 patients (âge moyen : 49 ± 12,7 ans; 44,4 % de femmes) de 2001 à 2021. Le temps médian écoulé entre le dernier événement embolique et l’intervention était de 6,0 mois (intervalle interquartile de 3,4 à 11,2 mois). Les déterminants de la fermeture tardive du FOP étaient l’emplacement de l’établissement (France vs Canada; rapport des cotes ajusté [RCa] : 1,65, intervalle de confiance [IC] à 95 % : 1,25-2,19), l’année durant laquelle a été réalisée l’intervention (depuis 2018 vs avant 2018; RCa : 1,43, IC à 95 % : 1,08-1,90), le sexe féminin (RCa : 1,63, IC à 95 % : 1,28-2,07) et l’obtention d’un score peu élevé lors de l’évaluation du risque d’embolie paradoxale (RCa : 1,10, IC à 95 % : 1,03-1,19). Après un suivi médian de 2,61 ans (1,13-7,25 ans), le taux d’incidence du premier AVC ou AIT ne différait pas selon que la fermeture du FOP avait été précoce ou tardive, soit 0,51 vs 0,29 événement pour 100 années-patients, respectivement (rapport des taux d’incidence : 1,74, IC à 95 % : 0,66-5,08; P = 0,24). De plus, aucune association entre le moment de la fermeture du FOP et la survenue d’un AVC ou d’un AIT n’est ressortie d’une analyse univariée (rapport des risques instantanés : 0,54, IC à 95 % : 0,22-1,34) dans les cas de fermeture tardive comparativement aux cas de fermeture précoce.

      Conclusions

      Notre analyse démontre de façon indirecte que le temps écoulé depuis le dernier événement ischémique n’influe pas sur l’issue de la fermeture du FOP en prévention secondaire.
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      Linked Article

      • Patent Foramen Ovale Closure for Remote Stroke: Better Late Than Never?
        Canadian Journal of CardiologyVol. 38Issue 8
        • Preview
          Cryptogenic stroke accounts for one-sixth of all patients with ischemic stroke, and an estimated 200,000 to 300,000 cases occur annually in North America.1,2 A patent foramen ovale (PFO) is thought to play a pathophysiological role in cryptogenic stroke by acting as a tunnel for passage of paradoxical emboli from the venous to the cerebrovascular system. In the absence of other identifiable causes of cryptogenic stroke, PFO closure has been advocated as a therapy to reduce risk of recurrent neurologic events.
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