Post-Market Clinical Follow-Up With the Patent Foramen Ovale Closure Device IrisFIT (Lifetech) in Patients With Stroke, Transient Ischemic Attack, or Other Thromboembolic Events

• Published in: Cardiovascular revascularization medicine 2021-09, Vol.30, p.72-75
• Main Authors: Sievert, Kolja, Yu, Jiangtao, Bertog, Stefan, Hornung, Marius, von Bardeleben, Ralph Stephan, Gafoor, Sameer, Reinartz, Markus, Matic, Predrag, Hofmann, Ilona, Grunwald, Iris, Schnelle, Nalan, Sievert, Horst
• Format: Article
• Language: English
• Subjects: Cryptogenic stroke; IrisFIT; Lifetech; Migrane; Occluder; Paradoxical embolism; PFO; PFO closure; Stroke; TIA
• ISSN: 1553-8389; 1878-0938
• DOI: 10.1016/j.carrev.2020.09.031

A patent foramen ovale (PFO) has been associated with embolic strokes and transient ischemic attacks (TIAs). Catheter closure of PFO is effective in preventing recurrent events. Residual shunts and procedure or device related complications can occur, including atrial fibrillation and thrombus formation. This study examines the initial experience with a new PFO closure device, the IrisFIT PFO-Occluder (Lifetech Scientific, Shenzhen, China). 95 patients with indications for PFO closure underwent percutaneous closure with the IrisFIT PFO-Occluder. The primary endpoint was the rate of accurate device placement with no/small residual shunt at 3 or 6 months follow-up. All patients underwent transoesophageal echocardiography (TEE) after 1 to 6 months. In case of a residual shunt, an additional TEE was performed after 12 months. Clinical follow-up was performed up to a mean of 33.1 ± 3.6 months. The device was successfully implanted in 95 (100%) patients with no relevant procedural complications. At final TEE follow-up (7.6 ± 3.9 months) the effective closure rate was 96.8% with 1 moderate and 2 large residual shunts. There were 8 cases of new onset atrial fibrillation and 2 TIAs. There were no cases of device embolization or erosion. The IrisFIT occluder is a new PFO closure device with several advantages compared to other devices. In this small study cohort, technical success rate, closure rate and adverse event rate were comparable to other devices. The rate of new onset atrial fibrillation was higher in comparison to other studies and warrants further investigation. •The IrisFITTM PFO occluder performs well in patients with cryptogenic embolic events and PFO with low complication rate•The IrisFITTM PFO occluder showed an effective closure rate of 96.8%.•The IrisFITTM PFO occluder showed an incidence of 8.4% new onset atrial fibrillation•The IrisFITTM PFO occluder showed no device embolization•The IrisFITTM PFO occluder showed no cases of intracardiac thrombus