Comparison of a Novel Occluder Versus Traditional Occluder in Atrial Septal Defect: A Randomized Trial

Abstract

Background Traditional occluders for atrial septal defect have 2 drawbacks: incomplete endothelialization and difficulty in achieving atrial septum puncture post implantation. The novel occluder ReAces was designed to address these 2 clinical pain points. In this study, we aimed to compare the efficacy and safety of ReAces with a traditional Amplatzer‐like atrial septal defect occluder. Methods This was a multicenter, randomized, parallel‐controlled, noninferiority clinical trial. Patients with atrial septal defects were enrolled and randomly implanted with a ReAces or a traditional Amplatzer‐like occluder. The primary outcome was complete closure rate at 12 months post implantation. The Migraine Disability Assessment scores before and after the procedure were recorded. Results Sixty‐two patients were implanted with ReAces and 64 patients with a traditional occluder. At the 12‐month follow‐up, complete closure was achieved in 61 patients in the trial group (98.4%) and 63 patients in the control group (98.4%), which demonstrated noninferiority (95% CI, −4.4% to 4.3%). No severe adverse events occurred during 12 months of follow‐up except a case of device dislodgement in the trial group. The thickness of the central region of ReAces at the 12‐month follow‐up was significantly lower than that of the traditional device (6.8±3.7 mm versus 12.2±5.2, P <0.0001). The trial group showed a significantly lower Migraine Disability Assessment score (0.4±2.4 versus 1.4±4.1, P =0.042) and a lower proportion of patients with a nonzero Migraine Disability Assessment score (5.6% versus 18.2%, P =0.042) at the 1‐month follow‐up. Conclusions The efficacy of ReAces was noninferior to that of a traditional Amplatzer‐like occluder for transcatheter atrial septal defect closure. ReAces had a thinner central region during the follow‐up and a lower Migraine Disability Assessment score at the 1‐month follow‐up. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05371366.