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Multicenter Study
. 2024 Aug 19;20(16):1029-1038.
doi: 10.4244/EIJ-D-24-00156.

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

Julio I Farjat-Pasos  1   2 , Paul Guedeney  3 , Eric Horlick  4 , Jeremie Abtan  5 , Luis Nombela-Franco  6 , Benjamin Hibbert  7 , Lars Sondergaard  8 , Xavier Freixa  9 , Jean-Bernard Masson  10 , Ignacio Cruz-González  11 , Rodrigo Estévez-Loureiro  12 , Laurent Faroux  13 , Ashish H Shah  14 , Lusine Abrahamyan  4 , Jules Mesnier  5 , Adrián Jerónimo  6 , Omar Abdel-Razek  7 , Troels Højsgaard Jørgensen  8 , Mike Al Asmar  10 , Samuel Sitbon  5 , Mohammed Abalhassan  7 , Mathieu Robichaud  1 , Christine Houde  2 , Mélanie Côté  1 , Angel Chamorro  15 , Sylvain Lanthier  16 , Steve Verreault  17 , Gilles Montalescot  3 , Josep Rodés-Cabau  1   2   9
Affiliations
Multicenter Study

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

Julio I Farjat-Pasos et al. EuroIntervention. .

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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Conflict of interest statement

J. Abtan reports consulting fees from Abbott, Gore Medical, and Occlutech. B. Hibbert has received institutional research support from Abbott and Occlutech. L. Sondergaard has received consultant fees and institutional research grants from Abbott and W.L. Gore & Associates. E. Horlick has received research grants from Abbott and Occlutech. G. Montalescot reports research funds for the institution or fees from Abbott. J. Rodés-Cabau received an institutional research grant from Abbott. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Clinical outcomes among older patients undergoing transcatheter patent foramen ovale closure.
Time-to-event curves of clinical outcomes among older patients undergoing transcatheter patent foramen ovale closure: (A) recurrent combined (stroke or transient ischaemic attack) cerebrovascular events; (B) recurrent ischaemic stroke; (C) new-onset atrial fibrillation; (D) bleeding events; (E) death.
Figure 2
Figure 2. Cerebrovascular events during follow-up in older patients undergoing transcatheter patent foramen ovale closure.
Time-to-event curves of cerebrovascular events following transcatheter patent foramen ovale closure among older patients: (A) cerebrovascular events according to the presence of atrial septal aneurysm; (B) cerebrovascular events according to the presence of diabetes; (C) stroke according to the presence of atrial septal aneurysm; (D) stroke according to the presence of diabetes. ASA: atrial septal aneurysm
Figure 3
Figure 3. Cumulative incidence function curves of cerebrovascular events among elderly patients.
Cumulative incidence curves of cerebrovascular events and stroke among elderly patients undergoing transcatheter patent foramen ovale closure: (A) cerebrovascular events (stroke or transient ischaemic attack) in patients with atrial septal aneurysm (red), diabetes (orange), and both (yellow); (B) stroke in patients with atrial septal aneurysm (red), diabetes (orange), and both (yellow). Both probabilities consider the possibility that a death event could occur instead. ASA: atrial septal aneurysm; DM: diabetes mellitus
Central illustration
Central illustration. Patent foramen ovale closure among older patients: incidence and predictors of adverse clinical events.
A) Older (>60 years) patients undergoing patent foramen ovale (PFO) closure due to cryptogenic thromboembolic events (cryptogenic stroke, transient ischaemic attack, or peripheral embolism) had an overall high prevalence of atrial septal aneurysm. After a median follow-up of 2.21 years following PFO closure, the incidence of cerebrovascular events (stroke or transient ischaemic attack) (B), stroke (C), and new-onset symptomatic atrial fibrillation (D) were 1.21, 0.55, and 3.30 per 100 person-years, respectively. After multivariable analysis, the predictors of recurrent cerebrovascular events were diabetes mellitus and atrial septal aneurysm; however, the only remaining predictor of recurrent stroke was diabetes mellitus. The only predictor of new-onset atrial fibrillation was increasing age, whereas hypertension under medical treatment was associated with a decreased incidence of events. Created with BioRender.com. CI: confidence interval; HR: hazard ratio
See this image and copyright information in PMC

References

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