Real-World Patent Foramen Ovale Closure in Japan - Results From 1-Year Follow-up of the AmplatzerTM PFO Occluder Japan Post-Marketing Surveillance Study.

Background: The Amplatzer^TMPFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-Marketing Surveillance (PFO Japan PMS) study started in December 2019. This analysis presents clinical outcomes of study patients through 1 year of follow-up.

Methods and results: PFO Japan PMS is a prospective single-arm multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the Amplatzer^TMPFO Occluder, with no age restrictions. PFO closure was evaluated at 1 year via a bubble study, and patients will be followed for 3 years. From December 2019 to July 2021, 500 patients were enrolled across 53 sites. The mean (±SD) patient age was 52.7±15.4 years, with 29.8% of patients aged >60 years. Low adverse event rates were observed through 1 year of follow-up, including atrial fibrillation (2.4%; predominantly transient and within the first 30 days) and ischemic stroke (0.6%). Among patients in whom a 1-year bubble study was performed, a high rate (91.5%) of clinically relevant PFO closure (<20 bubbles) was achieved.

Conclusions: Through 1 year of follow-up in this real-world Japanese study with 30% of patients aged >60 years, a high degree of closure was achieved with the Amplatzer^TMPFO Occluder, along with low rates of atrial fibrillation, ischemic stroke, and overall adverse events.