Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device Related Adverse Events in a National Registry

There has been a recent emergence of novel minimally invasive surgical therapies (MIST) for the treatment of benign prostatic hyperplasia (BPH). Prostatic urethral lift (PUL, Urolift) and transurethral water vapor therapy (TWVT, Rezum) are performed in the ambulatory setting and offer superior preservation of sexual function and less risk of retrograde ejaculation. Aquablation offers short treatment time, fewer sexual side effects, and possible same-day hospital discharge. As each of these technologies has gained rapid adoption, we identified a need for further evaluation of procedural complications in broader clinical practice.

We reviewed reports submitted to the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) Database between 2015 and 2020. A total of 391 adverse events were reported: Aquablation (n=102), PUL (n=132), and TWVT (n=157). We applied a validated classification system and identified severe or life-threatening events in Aquablation (79), PUL (69), and TWVT (24). Notable severe complications associated with Aquablation were bleeding and several reports of rectal perforation due to the transrectal ultrasound probe. Severe complications of PUL were related to improper landing of the implant and bleeding. TWVT had the least severe complications reported of the three procedures.

Our findings are clinically relevant for several reasons. First, they reinforce the need for ongoing review of procedural complications as new devices are integrated into clinical practice. This process may identify previously unreported adverse events as products are used outside of the trial setting. Second, this work highlights the critical importance of the MAUDE database in the medical device ecosystem. The data is publicly available and easily accessible allowing any interested parties including practitioners, researchers, or patients to advance the collective understanding of the benefits and risks of surgical devices. Third, the review identifies several clinically significant complications associated with the novel MIST technologies for BPH. Even though the procedures are less-invasive and performed rapidly, there is still a wide spectrum of adverse events that may occur after implementation.

The new landscape of MIST for BPH offers many more options for the surgical treatment of BPH. The long-term success of each technique will be determined by both the inherent features of the technology and correct use by the properly trained operating surgeon.

Written by: Elie Kaplan-Marans, MD, & Ariel Schulman, MD, Maimonides Medical Center, New York, NY, USA

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