J Endourol. 2021 Jul 27. doi: 10.1089/end.2021.0455. Online ahead of print.
ABSTRACT
PURPOSE: Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance.
MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015 and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups.
RESULTS: A total of 391 adverse events were reported: Aquablation (n=102), PUL (n=132), and TWVT (n=157). There were 79 (78%) severe or life threatening adverse events for Aquablation vs. 69 (52%) for PUL vs. 24 (15%) for TWVT (p < 0.001). There were 4 cases of rectal perforation with Aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were: Aquablation – 32 (31%), PUL – 21 (16%), TWVT – 1 (1%). The most common device malfunctions were: Aquablation – motion error (n=8), handpiece fracture/attachment malfunction (n=8); PUL – device misfire (n=27), needle fragmentation (n=21); TWVT – unresolvable error message (n=19).
CONCLUSIONS: In a national database, Aquablation and PUL had noteworthy complications or device related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.
PMID:34314240 | DOI:10.1089/end.2021.0455
