MP46-11 TOTAL PROCEDURAL CONTEXT IS CRUCIAL IN UNDERSTANDING BPH TREATMENT DEVICE SAFETY IN THE FDA’s MAUDE DATABASE

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III (MP46)1 May 2024MP46-11 TOTAL PROCEDURAL CONTEXT IS CRUCIAL IN UNDERSTANDING BPH TREATMENT DEVICE SAFETY IN THE FDA's MAUDE DATABASE Rajesh Shinghal, Matt Ashley, and Gregg Eure Rajesh ShinghalRajesh Shinghal , Matt AshleyMatt Ashley , and Gregg EureGregg Eure View All Author Informationhttps://doi.org/10.1097/01.JU.0001008668.53858.38.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The FDA's MAUDE database of medical device reports (MDRs) provides valuable information regarding safety and patient experience for BPH treatment devices. Evaluating MDRs in the context of the total number of procedures performed may provide a more accurate and complete understanding of the safety profiles emerging from the MAUDE database. In this analysis, we examine the number and severity of MDRs for BPH treatment devices in MAUDE and contextualize those entries in the broader landscape of total procedures performed annually. METHODS: A search of the FDA's MAUDE database was conducted using the terms "UroLift," "Rezum," and "Aquabeam" for entries between January 1, 2019 and December 31, 2022. An independent physician arbitrator adjudicated the entries and assigned event timing and severity scores to post-operative events using the Clavien-Dindo (CD) scale; irrelevant and duplicate entries were excluded from analysis. An independent market model utilizing Medicare data and CPT codes yielded an estimated total number of UroLift System, Rezum, and Aquablation procedures performed in the US in 2019, 2020, 2021, and 2022. RESULTS: UroLift System was the most frequently performed procedure in all years analyzed; Aquablation had the greatest increase in total procedures (2019: 291, 2022: 8400). The estimated numbers of procedures were consistent with independently published procedure volume analyses.1,2 The number of MDRs submitted between 2019 and 2022 increased for all devices analyzed. In the first year (2019), 15% of Aquablation patients experienced serious events (CD3+, Figure 1A). The rate of serious events for the UroLift System (∼2 per 10,000) was significantly lower than Aquablation (p<0.001) or Rezum (∼1 per 1,000, p<0.001) in 2022 (Figure 1B). Between 2019 and 2022, the rate of mild to moderate events (CD 1-2) was stable and lowest for UroLift (2019: 2.0 per 10,000; 2022: 1.7 per 10,000) compared to Rezum (2019: 4.5 per 1,000; 2022: 3.7 per 1,000) and Aquablation (2019: 4.5 per 100; 2022: 3.7 per 1,000). CONCLUSIONS: The yearly rates of mild, moderate and severe events are significantly higher for Aquablation than the minimally invasive surgical therapies analyzed. PUL has the lowest rates of mild, moderate, and severe complications year over year in the MAUDE database. Download PPT Source of Funding: Neotract, Inc./Teleflex © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e757 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Rajesh Shinghal More articles by this author Matt Ashley More articles by this author Gregg Eure More articles by this author Expand All Advertisement PDF downloadLoading ...