Dr. Elterman on real-world trends with Aquablation

In this video, Dean S. Elterman, MD, MSc, FRCSC, highlights the background and key findings from the abstract, “Aquablation Real-World Prostate Size Utilization and Reported Bleeding Events Across 5 Years,” which was presented at the 2024 American Urological Association Annual Meeting in San Antonio, Texas. Elterman is a urologist at the University of Toronto in Canada.

Video Transcript:

Could you describe the background for this study?

The background for this work is that we've really seen an expansion of the use of Aquablation across the world over the last 5 years. The clinical studies in a controlled setting have been looking at prostates between 30 to 80 [grams], and 80 to 150 [grams], in the WATER and WATER II studies. So, what we wanted to do was to evaluate the technology in the real-world setting by taking a look at all of the cases that have been done over the past number of years to see how patients do and the types of patients that we’re performing Aquaablation on.

What were the key findings?

At the AUA, we presented some very interesting data looking at Aquablation cases performed around the world. These are cases from Asia, Europe, and North America. What we were able to do was take a look at the prostate size treated year over year to observe the trends of the types of prostates being performed. What we were also able to do was take a look at the risk of bleeding as defined as either blood transfusion or takeback for fulguration from the FDA MAUDE database. So, that was the key methodology that we performed for that study.

In terms of the findings, what we were able to do is evaluate nearly 32,000 procedures that were performed over this timeframe. What was really interesting is that the plot for the types and sizes of prostates was identical between 2019, 2020, 2021, 2022, and 2023. On average, prostates were 89 mL in volume. They were very normally distributed between 30- to 100-gram prostates. What we're really seeing, interestingly, is that average sized prostates that we see for surgical resection of BPH are the ones that are being done with Aquablation. Yes, we have a bit of a longer tail, meaning Aquablation has the ability and really shines in its use in larger prostates bigger than 100 [grams] – we certainly see prostates being done at 100, 200, even 300 cc – but the normal distribution of prostates being done is really average, between, again, 30 to 100 [gram] range.

Also, when we looked at the risk of bleeding and takeback for fulguration, the reported rate was 0.46%. Less than 1% of patients had any significant bleeding. That's a real nice takeaway in terms of number 1, we're seeing normal sized prostates, enlarged prostates between 30 to 100 grams with a normal distribution being done year after year after year. And also, the reported incidence of blood transfusions or takeback is very low. Now, of course, not every blood transfusion or takeback would be reported to the FDA. But even if we were to multiply that number by 2-, 3-, 4-, 5-fold, it still remains an exceptionally low number, because that number was 0.46%.

This transcription has been edited for clarity.