Comparison of safety and short-term outcomes of septostomy and direct tunnel passage techniques in percutaneous patent foramen ovale closure: a multicenter experience

Background – Percutaneous closure of a patent foramen ovale (PFO) is an established therapeutic strategy for patients with cryptogenic stroke (CS). This study aimed to compare the procedural safety, efficacy, and short-term clinical outcomes of atrial septostomy vs. standard direct tunnel passage techniques for PFO closure. Methods – We retrospectively analyzed consecutive patients who underwent PFO closure for CS at four centers between January 2010 and December 2020. Demographic characteristics, vascular risk factors, Risk of Paradoxical Embolism (RoPE) scores, PFO anatomical features, procedural details, and clinical outcomes were compared between patients treated with atrial septostomy and those undergoing direct tunnel passage. Continuous variables are presented as mean ± standard deviation or median [interquartile range], and categorical variables as counts and percentages. Results – A total of 246 patients were included (mean age 40.5 ± 9.8 years), of whom 69.9% presented with ischemic stroke and 30.1% with transient ischemic attack (TIA). Atrial septostomy was performed in 106 patients (43.1%), while 140 patients (56.9%) underwent direct tunnel passage. Baseline clinical characteristics were comparable between groups; however, the septostomy group exhibited significantly more complex PFO anatomy, including atrial septal aneurysm (69.8% vs. 39.3%), septal hypermobility (62.3% vs. 34.3%), and spontaneous shunting at rest (85.8% vs. 50.7%; all p < 0.001). Procedure duration was similar between groups (41.1 ± 10.2 vs. 40.7 ± 13.8 min; p = 0.83), and technical success was achieved in nearly all cases. No major procedural complications occurred. Minor adverse events were infrequent and comparable (8.4% vs. 4.3%; p = 0.20). At six-month follow-up, residual shunt rates were numerically lower in the septostomy group (6.6% vs. 11.4%; p = 0.27). No TIAs were observed in the septostomy group, whereas a 3.6% incidence was noted in the direct passage group (p = 0.08). New-onset atrial arrhythmia occurred in two patients (1.9%) in the septostomy group and in none of the direct passage group (p = 0.18). Conclusion – Despite being applied in patients with more complex PFO anatomy, atrial septostomy demonstrated comparable procedural safety, technical success, and short-term efficacy to standard direct tunnel passage. Tunnel length emerged as an independent predictor of residual shunt, regardless of closure technique. In experienced centers, atrial septostomy appears to be a safe and practical alternative for anatomically challenging PFO closures.