Endothelialization of Amplatzer PFO Occluder Device 12 Months After Implantation: First-in-Human Angioscopic Assessment

The current guidelines recommend at least 6 months of antithrombotic and antibiotic prophylaxis following atrial septal occluding device placement using the phrase "until endothelialization." However, neo-endothelialization has not been assessed in vivo in humans. Considering the atrial septal defect occluding device, several autopsy cases and device extraction cases only demonstrated insufficient endothelialization beyond 6 months after implantation caused endocarditis and thrombosis. Accordingly, we have successfully developed a method for determining device endothelialization using angioscopy. This method helped us evaluate the endothelialization of a 25 mm Amplatzer PFO occluder device (Abbott) in a 40-year-old man 12 months after implantation. This is the first report evaluating the PFO occluder device in vivo.