The new patent foramen ovale occluder FIGULLA in complex septal anatomy: a case series

Abstract

Background: The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. The aim of this study was to describe a case series of patients with PFO and complex septal anatomy who underwent percutaneous correction using a FIGULLA (Occlutech®) septal occluder (FSO). Patients: Ten consecutive patients (6 females, 4 males, mean age 41.6 ± 16.0 years, range 17–52 years; Group 1) with cryptogenetic stroke and/or transient cerebral ischemia and complex septal anatomy, as defined by intraprocedural transesophageal echocardiogram (TEE) were compared with a group of 25 patients (10 females, 15 males, mean age 43.7 ± 12.3 years; Group 2) with usual tunnel-like PFO anatomy in whom PFO was closed by an Amplatzer septal occluder (ASO; AGA®). Results: No significant differences were noted between Group 1 and Group 2 for immediate success rate, residual intraprosthetic shunt at the end of the procedure, discharge, 1, 6 and 12 months follow up, number of attempts, procedure time, fluoroscopy time, or cardiac complication (atrial arrhythmias, device embolism). The only significant difference was shown for delivery sheath size (11 ± 2 versus 9 ± 1 F) and incidence of local hematoma (30% versus 12 %) between Group 1 and Group 2, without any clinical consequence (need of transfusion) or increase in length of stay. Conclusion: FSO shows high performance in patients with PFO and complex septal anatomy when compared with patients with PFO and uncomplicated atrial anatomy treated by ASO. Its favorable behavior is probably related to fabric features such as the total amount of metal and the presence of titanium.