Feasibility, safety and midterm follow‐up of patients after nonsurgical closure of atrial septal defects using very large 40–46 mm nitinol septal occluders

OBJECTIVES: To study the feasibility of closure of large atrial septal defects (ASDs) using occluder devices >38 mm and assess the midterm complications. BACKGROUND: Feasibility and safety of large occluders >38 mm and their follow-up are largely unknown. METHODS: All patients with ASDs closed using devices >38 mm were retrospectively analyzed. Since outcome of patients receiving 40 mm devices were known before, patients receiving 40 mm devices were compared with those receiving 42-46 mm devices on demographic, hemodynamic parameters and procedural characteristics. RESULTS: A total of 17 patients with 40-mm device and 31 patients with >40-mm device formed the cohort. The mean echocardiographic defect size was 36.3 ± 3.7 mm. In total 19 patients had deficient retroaortic margin; inferior margin was deficient in one. Larger defects needed special deployment techniques more often. There was acute technical success in all patients. Two procedures failed; one device embolization next day in a patient with deficient inferior margin needed surgery. Another elderly patient with restrictive left ventricular physiology died of multiorgan dysfunction. Two late deaths on follow-up were unrelated to the procedure. All other patients had symptom improvement. There were no erosions, thromboembolism or valvar regurgitation at a median follow-up of 39 (1-60) months. Apart from late-onset atrial flutter in one, there were no arrhythmias on follow-up. CONCLUSIONS: Occluders larger than 38 mm in appropriately selected patients are feasible, successful and safe in majority and often require special deployment techniques. Complications during and after the procedure were infrequent. Very large defects with any deficient margin except retroaortic rim should be excluded from device closure.