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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

Journal of Cardiology & Current Research
Ata Firouzi,1 Aisha Siraj,2 Amir Masoud Jafari,Hamid Reza Sanati,1 Zahra Khajail,3 Ali Zahedmehr,1 Feridoun Noohi,1 Seddighe Saeidi,3 Hossein Ali Basiri,1 Mahmoud Momtahen,1 Ahmad Mohebbi,1 Farshad Shakerian,1 Bahram Mohebbi,1 Mohsen Madani,1 Majid Kiavar,1 Reza Kiani,1 Negar Salehi4

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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' complication-free 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.


atrial septal defect, figulla flex II ASD occlude, complications of percutaneous closure, ASD, atrial septal defect, PVC, premature ventricular contraction, PSVT, paroxysmal supraventricular tachycardia, MACE, major adverse cardiac event, CHDs, congenital heart diseases, ASO, amplatzer septal occluder, SD, standard deviation