Immediate outcomes after transcatheter atrial septal defect closure by Amplatzer septal occluder in a large single centre cohort: The ASOlong study

Abstract

Transcatheter closure of ostium secundum atrial septal defects (ASDs) with Amplatzer septal occluder (ASO) is the preferred technique when anatomically feasible. New devices, reported to be softer or with new design have been developed aiming to reduce the risk of adverse events. We aimed to assess the procedural outcomes after transcatheter closure of ASD with the ASO device in a large single centre registry including consecutively all children and adults ( n = 2280, median age, 27 years [11; 49]; weight, 56 kg [32; 70]) from 1998 to 2021 (ASOlong registry). Most patients had balloon ASD sizing using the pull-through technique. Since 2005, nearly all procedures were guided using transthoracic echocardiography allowing procedures under local anesthesia in older children and adults. In four (0.2%) patients, ASD was closed from a jugular approach. Median ASO size was 22 mm [18; 28]. ASD closure was obtained with two and three devices in 71 and 1 cases respectively. Device/weight ratio was 0.4 [0.3–0.6], with a ratio ≥ 1.5 in 25 children (0.1%). Overall procedural success rate was 97.1% (95% CI: 96.4–97.8%) underestimated by patients with ASD considered not eligible after balloon calibration only. Device migration occurred in 17 (0.7%) patients successfully retried transcatheter in 13 cases and surgically in 4. No death was observed. Major peri-procedural adverse events occurred in 7 (0.3% 95% CI: 0.1–0.6) patients including 4 repaired arteriovenous fistulas. Life-threatening adverse events occurred in 3 patients (2 acute aortic erosion with haemopericardium, on day 2 after catheterization and 1 sigmoid colon dissection of unclear mechanism, requiring emergency surgery). There was a trend toward a higher rate of major events among children with device/weight ratio ≥ 1.5 (4.0% versus 0.4%, P = 0.1). Transcatheter ASD closure using ASO is efficient in a large spectrum of patients. Long-term outcomes are awaited from this study.