Long-term outcome of atrial septal defect (ASD) repair by the figulla flex II ASD occluder: A retrospective cohort study at a referral heart center in Iran

Abstract

Background: By developing the third generation of occluders such as the Figulla Flex II ASD occluder for Atrial Septal Defect (ASD) repairing, the risk of post-procedural adverse events has been significantly reduced. We evaluated the long-term results of ASD device closure using the Figulla Flex II ASD occluder in a tertiary heart center in Iran to assess the brief consequences of the device and procedure.Methods: Three hundred and sixty-five patients undergoing Figulla Flex II ASD occluder insertion for ASD repair at Shahid Rajaee Cardiovascular Medical and Research Center in Tehran reviewed retrospectively. The patients were followed for a mean time of 31.7months (ranged 12 to 51months) to assess the long-term outcome and the patients' complicationfree survival. Results:The most common post-procedure complications within the follow-up time included cardiac arrhythmia [Premature Ventricular Contraction (PVC) in 18 patients and Paroxysmal Supraventricular Tachycardia (PSVT) in 5 patients], erosion in 2 patients and clot on device in 2 patients. The patients' functional status significantly improved after ASD device closure. The overall Major Adverse Cardiac Event (MACE) rate was indicated to be 4.9%. Among baseline variables, the size of ASD and the size of the device could effectively predict the likelihood of long-term MACE. According to the survival analysis, 1, 2, and 3-year free-MACE survival rates were 99.7%, 99.1%, and 90.6%, respectively. Conclusion:ASD repair by the Figulla Flex II ASD occluder leads to a favorable long-term outcome with a three-year free MACE survival rate of more than 90%. This proper outcome may be adversely affected by a large ASD size.