Transcatheter closure of patent foramen ovale (PFO) with or without an atrial septal aneurysm using a new double-disk-PFO occluder in patients after paradoxical embolism. Comparison of Safety, technical efficacy using contrast-TEE of 25/25mm (PFO only) versus 30/30mm occluder (PFO-ASA)
Zickwolf1, M Steeg1, S Fateh-Moghadam1, W Bocksch1, Medical University Lausitz-Carl Thiem, Cottbus, Germany
Background: PFO-closure using the Amplatzer-occluder is an evidence-based effective treatment for prevention of recurrent stroke after paradoxical embolism (PE). The Cocoon-PFO-Occluder is a new generation self-expanding double-disk Occluder, constructed from a nitinol wire mesh coated with nanoplatinium. Systemic TEE follow-up data is missing for this new occluder.
Purpose:The aim of our study was to evaluate the safety and technical efficacy evaluated by contrast-TEE up to 6 months after implantation of a new double-disk PFO-occluder for in patients with or with out an atrial septal aneurysm (ASA) after PE.
Methods: At our hospital, from April 2021 to July 2025, 115 patients post-PE with a PFO underwent flouroscopy-guiden PFO-closure with Cocoon occluder. Pts with a PFO and an ASA (n=55, 48%) received a 30/30mm Occluder for septum stabilization, pts. without an ASA recieved a 25/25mm occluder. PFO-occlusion was performed in both groups using only fluoroscopc/angiographic guidance only. Complete contrast-TEE-follow-up was done after 6 weeks and 6 months post procedure in 101 pts.(88,6%).
Results:The study included a total of 115 patients (55 pts with ASA 48%) , composed of 43 (63%) women with a mean age of 58.8 (SD: 11.9) years and 72 men (37%) with a mean age of 53.5 (SD: 11.0) years. The median and interquartile range (IQR) for intervention’s skin-to-skin duration were 26 min (IQR: 18 – 39 min), for fluoroscopy time 4 min (3.1 – 5.4 min), for the area dose product 1354 cGym2 (IQR: 942 – 1931 cGym2) and for the amount of contrast medium used 100 ml (IQR: 82.5 – 120 ml).The Cocoon-occluder was technically successful implanted in 114 out of 115 (99.1%) pts. Postinterventional complications were only minor (4 pts (3,5%) had mild bleeding from the puncture site, 1 pat. (0,8%) developed external iliac vein thrombosis, 3 pts (2,6%) experienced paroxysmal atrial fibrillation). After six months, complete PFO-occlusion without residual shunt by contrast-TEE was achieved 96/101 patients (95%), a small shunt grade I/II was detected in three pts, whereas shunt grade 3 was detected in two of the patients. None of the pts experienced thrombus formation on the device after 6 weeks or 6 months, respectively. Procedural data, safety profile and residual shunt grade by TEE did not differ significantly between groups.
Conclusion: Angiography guided PFO-closure with the Cocoon PFO-occluder (30/30mm PFO+ASA, 25/25 mm PFO w/o ASA) showed excellent safety and clinical efficay with complete Shunt occlusion in 95% of all pts. after 6 months.
