We thank Dr Lin and Dr Ju for their thoughtful letter 1 regarding our report of post-Aquablation bleeding outcomes using global post-market surveillance data 2. We welcome the opportunity to clarify the points raised. Regarding the outcome definition and assessment window, we focused on clinically meaningful severe bleeding endpoints—blood transfusion and return to the operating room for haemostatic fulguration—because these events are consistently reportable across surveillance sources and are most comparable internationally. We agree that less-severe bleeding events (e.g., clot retention managed conservatively, prolonged irrigation, emergency visits, or re-admissions) are clinically relevant; however, such outcomes are not systematically or reliably captured in Manufacturer and User Facility Device Experience (MAUDE) reporting and are inconsistently available across jurisdictions in post-market datasets. As stated in the manuscript, the outcome assessment window is 30-days perioperative/early postoperative. This is the case in prospective Aquablation trials whereby severe bleeding events occurred predominantly in the immediate postoperative period 3, 4. Pertaining to data linkage, denominators, and duplicate handling, we agree that transparent description of data integration is essential. Our analysis combined a prospective manufacturer case-detail database with MAUDE reports, using manufacturer-reported global procedure counts as denominators. Potential duplicate reports across sources were reconciled through internal case review, using concordance of procedure timing, geography, and event descriptors to identify instances likely representing the same clinical episode. We acknowledge the inherent limitations of passive reporting systems, including underreporting, variable completeness, and the possibility of residual duplication despite reconciliation processes. Lastly, as it relates to temporal trends and prostate size considerations, we agree that causal attribution for temporal changes should be made cautiously. The observed year-by-year changes are descriptive, and we have shown that prostate size distribution remained stable over time, supporting interpretation that bleeding risk decreased over time in the context of a relatively consistent case mix. We appreciate the authors’ comments 1 that further improve the transparency and interpretability of this real-world safety analysis. Mario Bitar reports no relevant conflicts of interest for this work. Dean Elterman is a consultant/investigator for PROCEPT BioRobotics and Boston Scientific.
Bitar et al. (Tue,) studied this question.