Comparison of a Novel Occluder Versus Traditional Occluder in Atrial Septal Defect: A Randomized Trial.
Yanxing Fang, Mingfei Li, Zhihui Zhang et al.
✦ AI-curated · Sources linked
In 30 seconds
This multicenter, randomized, parallel-controlled noninferiority trial compared the ReAces occluder with a traditional Amplatzer-like device in patients undergoing transcatheter closure of atrial septal defects. At 12 months, complete closure was achieved in 61 of 62 patients with ReAces (98.4%) and 63 of 64 with the traditional device (98.4%); noninferiority was demonstrated (95% CI, -4.4% to 4.3%). No severe adverse events occurred during follow-up, although one ReAces device dislodged. ReAces also had a thinner central region at 12 months and lower migraine disability scores at one month.
Key findings
- At 12 months, complete closure rates were 98.4% with ReAces and 98.4% with the traditional occluder; noninferiority was demonstrated (95% CI, -4.4% to 4.3%).
- One device dislodgement occurred in the ReAces group; no other severe adverse events were reported during 12 months of follow-up.
- At 12 months, central-region thickness was 6.8±3.7 mm with ReAces versus 12.2±5.2 with the traditional device (P <0.0001).
- At one month, migraine disability scores were 0.4±2.4 versus 1.4±4.1 (P =0.042), and nonzero scores occurred in 5.6% versus 18.2% (P =0.042), respectively.
Why it matters
The trial provides comparative evidence that ReAces can achieve atrial septal defect closure at a rate noninferior to a traditional Amplatzer-like occluder, while showing differences in device thickness and short-term migraine disability measures. These findings help characterize the device’s performance and safety over the reported follow-up, but do not establish longer-term advantages.
What to keep in mind
Follow-up was limited to 12 months, and the trial enrolled 126 patients; longer-term outcomes are not reported in the abstract.