15-Year Outcomes of PFO Closure in Patients With Cryptogenic Embolism: Insights From the PROLONG Registry.

BACKGROUND

Transcatheter patent foramen ovale (PFO) closure has become the gold-standard treatment for patients with cryptogenic embolism and PFO, but long-term outcomes data are limited.

OBJECTIVES

The aim of this study was to report the extended clinical outcomes of patients who underwent transcatheter PFO closure for cryptogenic embolism.

METHODS

PROLONG (PFO Transcatheter Occlusion Long-Term Outcomes National Group) is an investigator-initiated, multicenter, retrospective registry that enrolled patients who underwent transcatheter PFO closure between 1999 and 2013 at 12 centers in Italy. This analysis included only patients who underwent PFO closure for cryptogenic embolism, defined as cryptogenic ischemic stroke, transient ischemic attack, systemic embolism, or silent ischemic lesions on magnetic resonance imaging. Clinical, imaging, procedural, and follow-up data were collected from electronic health records and telephone interviews.

RESULTS

The study included 1,245 patients (mean age 47 ± 12 years, 56% women), with a mean follow-up duration of 14.5 ± 2.4 years. During follow-up, 34 patients (2.7%) experienced recurrent ischemic stroke, transient ischemic attack, or systemic embolism (0.19 per 100 patient-years). Predictors of recurrent events were Risk of Paradoxical Embolism (RoPE) score ≤ 7 (HR: 3.44; 95% CI: 1.06-11.3; P = 0.041), nonprobable PFO-Associated Stroke Causal Likelihood (PASCAL) classification (HR: 2.72; 95% CI: 1.17-6.34; P = 0.020), and new-onset atrial fibrillation (HR: 7.01; 95% CI: 2.45-20.1; P < 0.001). Serious complications were rare (0.4% in hospital, 0.4% during follow-up) and nonfatal.

CONCLUSIONS

This study confirms the long-term efficacy and safety of transcatheter PFO closure for patients with cryptogenic embolism and PFO in a real-world setting. (PFO Transcatheter Occlusion Long-Term Outcomes National Group [PROLONG] Registry; NCT06504121).