Percutaneous Closure of Patent Foramen Ovale in Patients Over 60 Years Old With Cryptogenic Stroke: A Safe and Effective Strategy?

Cryptogenic stroke accounts for up to one-third of all ischemic strokes and remains strongly associated with the presence of a patent foramen ovale (PFO), suggesting paradoxical embolism as a central pathophysiological mechanism. Randomized trials demonstrated the benefit of percutaneous PFO closure compared with medical therapy in patients younger than 60 years, which is why current guidelines recommend this strategy in that age group. 

However, evidence in patients older than 60 years remains limited, despite the fact that these patients may have an even higher risk of paradoxical embolism due to increased rates of deep vein thrombosis, larger PFO size, and age-related hemodynamic changes. In this context, the present Swedish nationwide retrospective study evaluated the short- and long-term safety and efficacy of percutaneous PFO closure in patients ≥60 years old with a history of cryptogenic stroke, comparing them with patients younger than 60 years.

The primary endpoint was the incidence of recurrent stroke or transient ischemic attack (TIA), as well as the occurrence of atrial fibrillation following percutaneous closure. Secondary endpoints included peripheral embolism, procedure-related complications, need for reintervention, and mortality during follow-up.

A total of 1,101 adult patients treated with percutaneous PFO closure in Sweden between December 2001 and April 2023 after confirmed cryptogenic stroke were included. Of these, 134 patients (12%) were ≥60 years old and 967 (88%) were younger than 60 years. Mean follow-up was 7.1 ± 5.8 years, with a median of 4.9 years. Women represented 38% of the population. The prevalence of cardiovascular comorbidities was low in both groups; only deep vein thrombosis was more frequent among patients ≥60 years old (3% vs. 1%; p=0.023). A higher history of smoking was also observed in the ≥60-year-old group (28.7% vs. 19.8%; p=0.041).

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The most commonly used device was the Amplatzer PFO Occluder in 620 patients (56%), with greater use among patients ≥60 years old (66% vs. 55%; p=0.012). The GORE® Cardioform Septal Occluder was used more frequently in patients younger than 60 years (32% vs. 21%; p=0.008). Devices larger than 25 mm were more common in elderly patients (38% vs. 29%; p=0.030). In addition, both procedure time and fluoroscopy time were significantly longer in patients ≥60 years old: 60 vs. 55 minutes (p=0.030) and 11 vs. 9 minutes (p<0.001), respectively. The closure success rate was 96.5%. Only one patient experienced device embolization and required corrective surgery.

During follow-up, 71 patients (6.4%) developed post-procedural atrial fibrillation. Overall incidence was significantly higher in patients ≥60 years old (11.9% vs. 5.7%; p=0.013), although no differences were observed in early onset within the first 3 months after the procedure (3.0% vs. 2.4%; p=0.229). The incidence of late atrial fibrillation (>3 months) was 9.5 per 1,000 patient-years in patients ≥60 years old versus 4.6 per 1,000 patient-years in patients younger than 60 years. Furthermore, atrial fibrillation was more frequent in patients treated with devices ≥20 mm (p=0.037).

Regarding neurological events, only 20 patients (1.8%) experienced recurrent stroke or TIA after closure: 16 strokes and 4 TIAs. Incidence was low and similar between both age groups: 2.7% in patients ≥60 years old versus 1.5% in those <60 years old (p=0.697). The stroke recurrence rate was 2.8 per 1,000 patient-years in patients older than 60 years and 2.5 per 1,000 patient-years in younger patients. All events occurring within the first year after the procedure were recorded in patients younger than 60 years.

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Anticoagulant therapy was more frequent in patients ≥60 years old both before the procedure (30% vs. 22%; p=0.017) and after closure (23% vs. 15%; p=0.009), while antiplatelet use was similar between groups. During follow-up, 27 patients (2%) died, with a mean time of 9 ± 4.9 years after closure; no significant differences in cardiac mortality were observed between age groups.

Conclusion: PFO Closure in Elderly Patients Demonstrated Safety and Long-Term Effectiveness

In summary, this Swedish nationwide study with long-term follow-up demonstrated that percutaneous PFO closure in patients ≥60 years old with cryptogenic stroke and low comorbidity burden is associated with a very low incidence of recurrent stroke/TIA and a complication rate comparable to that observed in younger patients. Although elderly patients showed a higher incidence of late atrial fibrillation, no increase in recurrent neurological events was observed, supporting percutaneous PFO closure as a safe and potentially effective strategy also in carefully selected patients over 60 years old.

Original Title: Percutaneous closure of patent foramen ovale after cryptogenic stroke – a comparison between patients <60 versus ≥60 years-of-age.