Long-Term Stroke Recurrence and Safety After Percutaneous Patent Foramen Ovale Closure: Results From the Lucerne Registry.

BACKGROUND: Percutaneous patent foramen ovale (PFO) closure is established for selected patients with PFO-associated cryptogenic stroke and other dedicated indications; however, long-term outcome data remain limited. AIMS: Evaluate procedural, echocardiographic, and long-term clinical outcomes after percutaneous PFO closure. METHODS: Consecutive patients undergoing PFO closure at Heart Center Lucerne between February 2017 and December 2024 were analyzed. The primary endpoint was a combined endpoint of recurrent cerebrovascular events and death. Follow-up included 6-month echocardiography and clinical follow-up up to 8 years using electronic health records and structured telephone interviews. RESULTS: A total of 331 patients (mean age 51 ± 12 years, 39% women, 80% prior cryptogenic stroke) were analyzed. Atrial septal aneurysm was present in 31%, grade 3 shunt in 72%, and the median RoPE score was 7 (IQR 6-7). Technical success was 99%. Devices used were Amplatzer (52%), Figulla Flex (42%), NobleStitch (6%), and Gore (1%). Double-disc devices achieved higher effective closure (residual shunt ≤ grade 1) than suture-based closure (97% vs. 68%; p < 0.001); a double-disc closure for relevant residual shunt was required after 7/21 suture-based closures. During a median follow-up of 3.7 years (IQR 2.1-5.7) 12 patients had a primary outcome (three ischemic strokes, two hemorrhagic strokes, five transient-ischemic-attacks, and two deaths). The primary outcome rate was 0.93/100 patient-years and stroke recurrence rate was 0.39 per 100 patient-years. Residual shunt grade ≥ 2 showed a trend toward increased cerebrovascular risk (HR 4.3, 95% CI 0.9-20.9; p = 0.068). Atrial fibrillation was documented in 5.4% of patients during long-term follow-up. CONCLUSIONS: Percutaneous PFO closure showed high technical success and low long-term ischemic stroke recurrence. Double-disc devices provided higher effective closure than suture-based closure, and residual shunt may indicate increased cerebrovascular risk. A considerable proportion of patients developed atrial fibrillation following PFO closure.