Wayne Kuznar

	Minimally invasive water jet therapy (Aquablation) for the targeted removal of prostate tissue was safe and feasible in follow-up to 12 months in a multicenter clinical trial of men with lower urinary tract symptoms secondary to BPH.

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	In 57 men with a mean prostate size of 48 mL, no significant intraoperative complications occurred with image-guided water jet therapy, and procedural success was 100%, said first Peter Gilling, MD, at the AUA annual meeting in San Diego.

	The results “suggest that it’s a promising new technology,” he said. “Compared to freehand techniques, there’s no real technical difficulty because it’s all done in the set-up, and the procedure is much more reproducible. It’s almost urologist-free. In fact, some of the best procedures… have been done by the engineers.”

	The Aquablation System (PROCEPT BioRobotics) combines image guidance and robotics for targeted removal of prostate tissue. A high-velocity saline stream (AquaBeam) is generated using water jets driven by a high-pressure pump. The stream creates a cavity in prostatic glandular tissue without the production of heat. The flow rate generated by the pump (up to 10,000 PSI) dictates the depth of the stream’s penetration.

	The procedure is performed using real-time transrectal ultrasound image guidance, which allows conformal planning of the target region of the prostate to be treated. The target tissue contour and depth are programmed into the system by the surgeon.

	To obtain hemostasis, a low-power blue laser beam is captured in a low-pressure water column to perform surface coagulation of the fossa.

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	The 57 patients in the study were treated at four sites. The mean prostate size treated was 48 mL, with a maximum of 102 mL. About half (46%) of the men had a median lobe.

Next: "The actual ablation time is very short"

	The procedure time overall averaged 45 minutes, but the Aquablation time was only 7 minutes. “The combination of surgical mapping, high-velocity saline with the robotic guidance means that the actual ablation time is very short,” said Dr. Gilling, of Tauranga Hospital, Tauranga, New Zealand.

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	No patient had to be converted to another procedure. Over 12 months, the mean prostate volume reduction was 37%. The mean catheter withdrawal time was 1.2 days.

	Mean hospital time was 1.8 days. Two reoperations were required and the recatheterization rate was 12%. There were no significant intraoperative complications, no bleeding complications, and no clot retention. No blood transfusions were required. Postoperative dysuria was minimal, and adverse events were typically mild and transient.

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	The mean International Prostate Symptom Score declined from 23.2 preoperatively to 5.7 by 13 weeks, and remained at 6.0 or less throughout the rest of the 12-month follow-up. The mean Qmax increased predictably from 7.9 mL/sec at baseline to 16.8 mL at 13 weeks, “which is as much as you would see with a TURP with a cavity of this size,” he said.

Next: Mean quality of life score improved from 4.5 at baseline to 1.2 at 13 weeks

	The mean quality of life score improved from 4.5 at baseline to 1.2 at 13 weeks, and improved further to 1.1 by week 52. The mean postvoid residual declined from 98 mL preoperatively to 48 mL by 4 weeks, and was 52 mL at week 52.

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	No cases of urinary incontinence or erectile dysfunction were reported.

	A randomized study called WATER (Water Ablation Therapy for Endoscopic Resection of Prostate Tissue) will provide definitive clinical data to evaluate the efficacy of water ablation.

	The study was funded by PROCEPT BioRobotics. Dr. Gilling serves as an investigator and meeting participant/lecturer for the company.

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An image-guided technique for treating LUTS associated with BPH is reproducible and promising, researchers say.

Water ablation’s safety, efficiency in BPH assessed

Despite the near absence of intraoperative bleeding, bipolar vaporization of the prostate is associated with a higher rate of postoperative than bipolar loop resection for the treatment of lower urinary tract symptoms secondary to 

 reported Richard Santucci, MD, and colleagues at the AUA annual meeting.

Dr. SantucciIn particular, suggestions of late bleeding complications with bipolar vaporization were confirmed in a randomized clinical trial in which the two approaches were compared. “In clinical medicine, you often get the rumor of the problem before you get proof of the problem,” Dr. Santucci said. 

	In addition to an excess incidence of late bleeding, more irritative voiding symptoms in the early postoperative period surfaced with bipolar vaporization, which had also been the general impression all along.

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	“Everybody likes bipolar because it's speedy, easy, and causes no bleeding,” said Dr. Santucci, director of the Center for Urologic Reconstruction and specialist in chief, urology, at the Detroit Medical Center. “But you need to be aware that you may be trading a nice operation for a bad postoperative course including strictures, delayed bleeding, and increased urinary frequency. All surgeries have a cost-benefit ratio. This just better describes the cost-benefit ratio.”

	Both bipolar transurethral loop resection of the prostate and bipolar button vaporization are minimally invasive surgical methods that are considered standard of care. Bipolar vaporization has become increasingly popular because it allows for concomitant vaporization and coagulation, resulting in near-zero intraoperative bleeding.

NEXT: "A large randomized trial had not been done, and that's the value of this study."

	“No one knew if the benefits of bipolar vaporization-almost no bleeding and a pretty easy technique-made it better than bipolar loop, which possibly is faster and provides tissue for histopathology,” he said. “A large randomized trial had not been done, and that’s the value of the study.”

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	The relative safety profile of the two procedures was compared in 89 patients with BPH, who were randomized to surgery using either bipolar loop resection (44 patients) or bipolar button vaporization (45 patients). Eligible patients had a preoperative maximal flow rate (Q

) <10 mL/sec, an International Prostate Symptom Score (IPSS) >18, and a prostate volume >40 grams. Patients were evaluated preoperatively and at 1, 3, and 9 months postoperatively by IPSS, uroflowmetry, and prostate ultrasound.

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	Preoperative prostate volume was 59 grams and 58 grams (

=.52) in patients randomized to bipolar loop TURP and bipolar button vaporization, respectively, and IPSS was 19 and 20 (

NEXT: Mean oper. time significantly longer in vaporization group

	Mean operative time was significantly longer in the vaporization group compared with the bipolar loop resection group (81 vs. 55 minutes; 

<.001). Blood loss was less in patients randomized to bipolar vaporization compared with bipolar loop resection (0.8% vs. 2.0% drop in hemoglobin; 

	Bipolar vaporization was associated with increased rates of postoperative urinary frequency (80% vs. 50%, 

<.001), hematuria with clots up to 4 weeks after surgery (20% vs. 2%, 

<.001), and postoperative urethral stricture (11% vs. 0%) compared with bipolar loop resection.

	There were equivalent improvements in the bipolar vaporization and bipolar loop resection groups on the endpoints of postoperative Q

=.22), postoperative prostate volume (32 vs. 31 g; 

	Late postoperative bleeding with bipolar vaporization may be a function of the procedure, in which a 2- to 3-mm rind of highly coagulated prostate tissue remains after the prostate is vaporized, Dr. Santucci believes. “At 2 weeks, what may happen is that the rind of cooked tissue sloughs off, and then the fresh prostate underneath begins bleeding,” he told 

	The significantly increased rate of urethral stricture is “very disturbing,” he added. Although most operators would select the latest (fourth) button version of bipolar vaporization, “it could be that it’s not the right thing to do, and you should go back to version 3, which is bipolar loop,” he said.

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A large, randomized trial provides a head-to-head comparison of late complications involving the two approaches to BPH.

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A review of more than 650,000 non-metastatic 

patients “represents the best available evidence for the morbidity and cost profile” of 

robot-assisted radical prostatectomy (RARP)

 versus the open procedure (ORP), according to study author Jeffrey J. Leow, MBBS, MPH.

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	RARP is associated with less morbidity but at a higher cost than ORP. The cost efficiency of RARP can be improved by limiting operating room time, most likely achieved by high-volume surgeons, said Dr. Leow, a research fellow at the Center for Surgery and Public Health at Brigham and Women’s Hospital, Boston, who presented the findings at the Genitourinary Cancers Symposium in Orlando, FL.

	These findings come from a population-based retrospective cohort study of 654,030 patients with non-metastatic prostate cancer who underwent radical prostatectomy between 2003 and 2013 at 449 hospitals in the United States.

	“Our contemporary analysis found that RARP confers a perioperative morbidity advantage over ORP, but at higher costs, which are heavily contributed by supplies and OR costs,” said Dr. Leow, who worked on the study with Steven L. Chang, MD, MS, and colleagues.

Next - Dr. Thrasher: Advantages of robot must be weighed against higher costs

 Editorial Consultant J. Brantley Thrasher, MD, said the advantages conferred by the robotic procedure in this and other studies must be weighed against its higher costs.

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	RARP has been adopted rapidly in the United States over the past decade despite the lack of level 1 evidence, aided initially by results from single-institution studies showing benefits over ORP. Subsequent patient-driven marketing and inter-hospital competition contributed to its emergence, Dr. Leow said. Over the study period, the use of RARP grew from 2% to about 85% of radical prostatectomies.

	Using regression analysis, Dr. Leow and colleagues compared 90-day postoperative complications, blood transfusions, operating room time, and direct hospital costs between the two groups, using an all-payer discharge database (Premier Hospital Database).

	A unique feature of the study was the use of charge master descriptions to classify RARP by identifying supplies unique to robotic procedures.

	The median 90-day direct hospital costs exceeded $14,000 in patients undergoing RARP, with supplies contributing $4,267 of this cost and OR time contributing $7,013. The median 90-day direct hospital costs were a little more than $9,000 in the patients undergoing ORP, with supplies contributing $1,089 and OR time contributing $4,529 of this cost. The excess cost of RARP, therefore, was $5,339 compared with ORP.

	The adjusted odds ratio (OR) of any complication with RARP compared with ORP was 0.72 (94% CI, 0.6-0.87). Patients undergoing RARP had a lower risk of blood transfusion (OR: 0.3; 95% CI, 0.14-0.64).

	A sub-analysis of the highest volume robotic surgeons found no difference in the rate of complications but a reduced risk of transfusions compared with the entire cohort. The OR of transfusion was 0.11 for the highest volume surgeons performing RARP compared with ORP (95% CI, 0.03 to 0.42).

NEXT: Highest volume surgeons spend less time in OR

	The median OR time for the entire cohort was 155 minutes. Highest volume surgeons spent less time in the OR, and in this group, the difference in cost between RARP and ORP was $1,188, but it was no longer significant.

	“This suggests that there may be a role for centralization of robotic procedures to high-volume providers in the U.S.,” said Dr. Leow.

	“Surgeons need to hit a threshold OR time of about 145 minutes for robotic surgery to be more cost efficient than open surgery,” assuming a 10% complication rate (the average), he added.

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	The widespread adoption of RARP for the management of localized prostate cancer implies that a large randomized trial will not likely be conducted, so the current large retrospective study “represents the best available evidence for the morbidity and cost profile of RARP vs. ORP,” according to Dr. Leow.

 Dr. Thrasher said he found it interesting that the authors found fewer transfusions in patients treated robotically and no significant difference in other 90-day complications but that the robotic procedure’s costs were much higher.

	“Ultimately, what needs to be considered here is if fewer transfusions, earlier discharge in some studies, and less pain for the robotic group is enough to justify the higher cost. Other studies have shown that in the hands of expert surgeons, cancer outcomes, incontinence, and erectile function are very similar with both approaches, so the other variables I mention have to be weighed against the extra cost,” said Dr. Thrasher, professor and chair of urology at the University of Kansas, Kansas City, who was not involved with the study.

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The review “represents the best available evidence for the morbidity and cost profile” of robot-assisted versus open radical prostatectomy, says one of the study’s authors.

Wayne Kuznar

Articles

Water ablation’s safety, efficiency in BPH assessed

Bipolar vaporization: Do benefits outweigh risks?

RARP vs. open: Outcomes from 650,000 patients