OUTCOMES | RATE |
---|---|
Procedure success rate* | 96% |
24-hour closure rate† | 99.6% |
Major adverse events‡ | 1.1% |
Minor adverse events§ | 4.8% |
* Successful occluder implantation
† Defined as no to a small residual shunt
‡ Includes device embolization with surgical removal
§ Includes procedure-related arrhythmias, device embolization with percutaneous retrieval, heparin over-dosage that required reversal, asymptomatic thrombus in the pulmonary artery that resolved with heparin therapy over 24 hours