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

Abstract

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.

Experience with the largest custom-made 48 mm fenestrated atrial septal occluder device and its 4-year follow-up

“…[ 1 ] Defects beyond this size are referred as extremely large ASD. [ 2 , 3 ] Such defects are often associated with rim deficiencies. Devices larger than 40 mm but up to 46 mm have been shown to be safe and effective, without any significant increase in the incidence of erosions, atrial arrhythmias and AV nodal conduction blocks, thromboembolism, and postprocedural headaches.…”

“…Devices larger than 40 mm but up to 46 mm have been shown to be safe and effective, without any significant increase in the incidence of erosions, atrial arrhythmias and AV nodal conduction blocks, thromboembolism, and postprocedural headaches. [ 2 ]…”

“…[ 1 ] Availability of 42–46 mm occluders allowed the inclusion of defects up to 42 mm. [ 2 ] A custom fenestrated 48 mm septal occluder was used to successfully treat an elderly hypertensive male with a large 44 mm secundum ASD and restrictive left ventricular (LV) physiology. This report presents the 4-year follow-up imaging of the largest device used in clinical practice in the literature.…”