PFO closure and recurrent stroke - beyond the ROPE score

Introduction

Patent foramen ovale (PFO) is a recognized potential source of paradoxical embolism and has been implicated in cryptogenic stroke and transient ischemic attack (TIA). Percutaneous PFO closure reduces recurrent events in carefully selected patients; however, the degree of benefit may vary with individual clinical and anatomical characteristics. In routine practice, treatment decisions are increasingly guided by risk evaluation tools, such as the Risk of Paradoxical Embolism (ROPE) score, which estimates the likelihood of a causal PFO–stroke relationship.

Aim

To assess the long-term effectiveness of percutaneous PFO closure and explore outcomes across varying levels of PFO–stroke causal probability as defined by the ROPE score.

Methods

We conducted a retrospective cohort study of patients who underwent percutaneous PFO closure between 2011 and 2023. Baseline characteristics and follow-up data on recurrent TIA or stroke were extracted from medical records.

To illustrate expected recurrence, a simulated dataset was created using actual follow-up times truncated at 2 years, assigning each patient a 2-year recurrence probability based on published estimates. Kaplan–Meier and Cox analysis compared time to TIA / stroke recurrence between the simulated and study groups.

Results

A total of 271 patients were included (mean age 50 years, 51% female). Hypertension, diabetes and smoking history were present in 35%, 7% and 7% of patients, respectively; cortical infarct was detected in 64%. The mean ROPE score was 6.

Recurrent TIA / stroke occurred in 4 patients, compared with 24 expected. The study group demonstrated a significantly longer time-to-event than the simulation group [HR 0.155 CI 0.054-0.047, p<0.001]. Interestingly, when stratified by ROPE score, patients with higher scores (≥7) had recurrence rates comparable to expected values, whereas those with lower scores (<7) had only one event [HR 0.051 CI 0.007-0.382, p=0.004).

Conclusion

Recurrent stroke or TIA after PFO closure was markedly lower than expected, particularly among patients with lower ROPE scores. These findings support the effectiveness of PFO closure across the whole cohort and suggest benefit even in patients with lower causal probability, provided treatment is individualized within the broader clinical context. More robust, prospective studies are needed to confirm these findings.Figure 1For image description, please refer to the figure legend and surrounding text.