Short- and Mid-term Results of Atrial Septal Defect and Patent Foramen Ovale Occlusion with Starway Septal Occluder Device

Background: With a prevalence of almost 7% of all congenital heart diseases, atrial septal defect (ASD) is a common condition. Patent foramen ovale (PFO) is also a congenital heart disease which is frequently sustained into adulthood.

Objectives: To study the feasibility of closure of ASD and PFU by Starway septal occluder device and the incidence of its inherent complications and procedural failure in 62 patients referred to our center.

Methods: Starway septal occluder device was used for closure of ASD and PFO in 62 patients. After left and right heart catheterization, transesophageal echocardiography-guided closure was done for the patients with immediate recording of the results. Patients were followed for 6 months by transesophageal echocardiography for observing short- and mid-term complications.

Results: The 62 studied patients were categorized into 2 groups. Group 1 included 31 patients (64% females) with ASD (mean±SD age: 26.7±7.6 years). Group 2 consisted of 31 patients (35.6% females) with PFO (mean±SD age: 53.5±12.4 years). Size of the right ventricle (RV) annulus was significantly (P=0.005) decreased after the intervention in the ASD group. Overall 5 (8%) patients developed post-intervention complications (transient ischemic attack, leg edema, and residual shunt) and procedural failure—4 (13%) in ASD group and 1 (3%) in PFO group. None of the patients developed device-related thrombosis, significant arrhythmia, aortic regurgitation and pericardial effusion after intervention.

Conclusion: Starway occluder device is effective and safe with very low short- and mid-term complication rates.