Background: Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence. Methods: Data from patients undergoing PFO closure between 2010 and 2015 were collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up. Results: 330 patients were included, mean age was 49 (±12) years, and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; p = 0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; p = 0.042), and a history of prior neurological events (adjHR: 9.94; p < 0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes. Conclusion: In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score, and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.
Background: Elevated levels of lipoprotein(a) [Lp(a)] are an independent risk factor for the development of atherosclerotic cardiovascular disease (ASCVD). However, there is only limited data investigating the role of elevated Lp(a) levels in patients with patent foramen ovale (PFO)-associated embolic stroke of undetermined source (ESUS). Methods: We included 266 patients with PFO-associated ESUS who underwent percutaneous PFO closure and had Lp(a) measurements available. These patients were matched according to age, sex and previously documented statin treatment to 947 hospital controls without stroke. Results: Median age was 51 years (IQR 43–59) and 40% were female. Median Lp(a) levels were higher in cases (24 IQR 12–88 nmol/L) than in controls (21 IQR 7–75 nmol/L; p = 0.003). This association appeared more pronounced in men than in women. In males, patients with Lp(a) in the second tertile had an odds ratio (OR) of 1.64 (95% CI, 1.03–2.62) and patients with Lp(a) in the third tertile had an odds ratio of 2.18 (95% CI 1.38–3.44) independent of age, statin use, HbA1c and eGFR. In contrast, in females the second (OR 2.08 [95% CI 1.22–3.54]) but not the third tertile (OR 0.88 [95% CI 0.49–1.59]) of Lp(a) was associated with case status. Conclusions: In this retrospective matched case–control study, higher Lp(a) concentrations were associated with case status in a selected cohort of patients with PFO-associated ESUS, particularly in men. These findings should be considered hypothesis-generating and require confirmation in prospective studies with more representative comparison cohorts.