Key result
NLP classifies complication profiles across ~57,000 MAUDE reports for SAPIEN and Evolut TAVR platforms.
Observational (n=56,806)
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Natural language processing can be utilized to classify unstructured free-text adverse event reports for transcatheter aortic valve replacement platforms in the FDA MAUDE database.
The FDA Manufacturer and User Facility Device Experience (MAUDE) database is the primary repository for post-market adverse event reports on transcatheter aortic valve replacement (TAVR). Reports are submitted as unstructured free-text narratives, limiting large-scale analysis. We used natural language processing (NLP) to classify complications reported for Edwards SAPIEN and Medtronic Evolut platforms.
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Mainali et al. (2026) conducted an observational in Transcatheter aortic valve replacement (TAVR) (n=56,806). Transcatheter aortic valve replacement (Edwards SAPIEN and Medtronic Evolut) was evaluated on Complication profiles. Natural language processing was used to classify complication profiles from 56,806 FDA MAUDE adverse event reports for Edwards SAPIEN and Medtronic Evolut TAVR platforms.
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