Safety and efficacy of Cardi-O-fix occluder for percutaneous closure of a patent foramen ovale

Abstract

Background: Amplatzer occluder and Cardio-O-fix occluder are currently used in percutaneous closure of patent foramen ovale. However, there is still a lack of relevant reports comparison the differences between them. The aim of this study was to evaluate the short-term and mid-term safety and efficacy of the Cardi-O-fix occluder in preventing recurrent cerebrovascular events in patients with a patent foramen ovale (PFO).Methods: We enrolled 246 patients (105 men) with a PFO from May 30, 2013 to March 30, 2015 in this single-center prospective study. All patients were treated by PFO interventional closure, with the Cardi-O-fix PFO occluder being used in 180 patients and the Amplatzer PFO occluder being utilized in the remaining 66 patients. After the procedure, we verified the safety and efficacy of different devices using contrast transthoracic echocardiography.Results: Neither recurrent stroke nor death was encountered during the follow-up of 12 months. Transient ischemic attack (TIA) was noted in 2 patients (1.1%) in the Cardi-O-fix PFO occluder group, and 1 patient suffered from TIA (1.5%) in the Amplatzer PFO occluder group. Among them, only 1 patient exhibited a small right to left shunt (RLS). There was no statistical difference in recurrent cerebral ischemic events. Three cases of paroxysmal atrial fibrillation were observed in the Cardi-O-fix PFO occluder group. One reverted spontaneously to sinus rhythm and the other 2 cases had pharmacologic conversion to sinus rhythm. One case of paroxysmal atrial fibrillation occurred in the Amplatzer group, which underwent pharmacologic conversion to sinus rhythm. There was no significant difference between the 2 groups regarding incidence of arrhythmia. No occluder translocation, erosion, pericardial effusion, and puncture site bleeding were observed in the 2 groups within 12 months of follow-up. The complete closure rates of the Cardi-O-fix and Amplatzer PFO occluder devices at the 12 months after the procedure were 73.9% and 63.6%, respectively, and the effective closure rates were 90.6% and 86.4%, respectively. There was no statistically significant difference in the complete closure rate and effective occlusion rate (P > 0.05) between the devices.Conclusions: There was no significant difference in the short-and mid-term efficacy and safety between the Cardi-O-fix PFO occluder and Amplatzer PFO occluder. The efficacy and safety of the Cardi-O-fix occluder were comparable to those of the Amplatzer PFO occluder.Abbreviations: CS = cryptogenic stroke, PFO = patent foramen ovale, RLS = right to left shunt, TIA = transient ischemic attack.

A Prospective, Single-Center, Phase I Clinical Trial to Evaluate the Value of Transesophageal Echocardiography in the Closure of Patent Foramen Ovale With a Novel Biodegradable Occluder

“…All patients were treated by PFO interventional closure, with the Cardi-O-fix PFO occluder being used in 180 patients and the Amplatzer PFO occluder being utilized in the remaining 66 patients. The effective closure rates of the Cardi-O-fix and Amplatzer PFO occluder devices at the 12 months after the procedure were 90.6 and 86.4%, respectively ( 30 ). In many other clinical studies, residual shunt may be observed in up to 25% of patients after PFO closure, and nearly 10% show moderate to large residual shunting ( 15 , 16 , 31 ).…”

Application of Transesophageal Echocardiography in Amplatzer Atrial Septal Defect Occluder for Percutaneous Closure of Large Patent Foramen Ovale

“…All patients received aspirin 3-5 mg/kg/day and clopidogrel 75 mg/day up to 48 hours before the procedure, and all procedures were performed under general anesthesia under digital subtraction angiography and TEE guidance. The specific interventional procedures were performed as previously described [ 21 ]. The PFO-stretch diameter (SD) was measured using TEE after the delivery sheath passed the PFO in all patients.…”