Key result
Ceraflex and Figulla atrial septal defect occluders had comparable safety to the Amplatzer occluder, with early complication rates of 5.56%, 0%, and 3.83%, respectively.
Why the study?
The Ceraflex and Figulla atrial septal defect occluders offer a pivoting mechanism and softer architecture, prompting evaluation of their safety and efficacy compared to the Amplatzer septal occluder.
Do the Ceraflex and Figulla atrial septal defect occluders have comparable safety and efficacy to the Amplatzer septal occluder in patients undergoing atrial septal defect occlusion?
Observational (n=407)
Do the Ceraflex and Figulla atrial septal defect occluders have comparable safety and efficacy to the Amplatzer septal occluder in patients undergoing atrial septal defect occlusion?
The Ceraflex and Figulla atrial septal defect occluders demonstrate comparable safety and efficacy to the standard Amplatzer septal occluder for ASD closure.
Answers are grounded in this paper and cite their sources.
May guide ASD occluder selection in select cases; leaves open need for randomized confirmation of safety and efficacy.
BACKGROUND: Ceraflex septal occluder and the Figulla atrial septal defect occluder have the advantage of a pivoting mechanism and softer device architecture. This study sought to examine the safety and efficacy of these occluders compared to the Amplatzer septal occluder. METHODS: This was a retrospective study. Between January, 2013 and April, 2020, patients with at least 6 months of follow-up were included. Early and late-onset outcomes were examined. RESULTS: Four hundred seven patients (range: 0.17-70.72 years; 53.1% >18 years; male: 29.2%) underwent atrial septal defect occlusion using Amplatzer septal occluder (n = 313), Ceraflex septal occluder (n = 36) and FSO (n = 58). A longer procedure time was observed in the Amplatzer septal occluder group. Early-onset complication rates in Amplatzer septal occluder, Ceraflex septal occluder and Figulla atrial septal defect occluder were 3.83%, 5.56% and 0%. Ten (2.46%) patients developed delayed complications (2.56%, 0% and 1.72% in the Amplatzer septal occluder, Ceraflex septal occluder and Figulla atrial septal defect occluder groups). Device erosion rate was not different between groups. The occlusion rates were comparable among all the devices. CONCLUSION: There is no significant difference in safety and efficacies between the novel atrial septal defect occluding devices compared to Amplatzer septal occluder.
No takes yet. Share an insight, caveat, or question.
A 2022 study conducted an observational in Atrial septal defect (n=407). Ceraflex and Figulla atrial septal defect occluders vs. Amplatzer septal occluder was evaluated on Early-onset complication rates. Ceraflex and Figulla atrial septal defect occluders had comparable safety to the Amplatzer occluder, with early complication rates of 5.56%, 0%, and 3.83%, respectively.
Synapse has enriched 10 related papers. Consider them for comparative context: