Original Research

DOI: 10.4244/EIJ-D-24-00156

Determinants of adverse outcomes following patent foramen ovale closure in elderly patients

Julio I. Farjat-Pasos1,2, MD, MSc; Paul Guedeney3, MD; Eric Horlick4, MD, PhD; Jeremie Abtan5, MD, PhD; Luis Nombela-Franco6, MD, PhD; Benjamin Hibbert7, MD, PhD; Lars Sondergaard8, MD, DMSc; Xavier Freixa9, MD, PhD; Jean-Bernard Masson10, MD; Ignacio Cruz-González11, MD, PhD; Rodrigo Estévez-Loureiro12, MD, PhD; Laurent Faroux13, MD, MSc; Ashish H. Shah14, MD; Lusine Abrahamyan4, MD, MPH; Jules Mesnier5, MD, PhD; Adrián Jerónimo6, MD; Omar Abdel-Razek7, MD, MSc; Troels Højsgaard Jørgensen8, MD, PhD; Mike Al Asmar10, MD; Samuel Sitbon5, MD; Mohammed Abalhassan7, MD; Mathieu Robichaud1, MD, PharmD; Christine Houde2, MD; Mélanie Côté1, MSc; Angel Chamorro15, MD, PhD; Sylvain Lanthier16, MD; Steve Verreault17, MD; Gilles Montalescot3, MD, PhD; Josep Rodés-Cabau1,2,9, MD, PhD

Abstract

BACKGROUND: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly.

AIMS: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events.

METHODS: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted.

RESULTS: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF.

CONCLUSIONS: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.

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Volume 20 Number 16
Aug 19, 2024
Volume 20 Number 16
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