David Samadi, MD, has performed his 550th robotic prostatectomy since joining Mount Sinai Medical Center (New York) in May 2007, which he says is "a massive volume in one year." In those cases, Samadi, chief of the division of robotics and minimally invasive surgery in the department of urology at Mount Sinai, said there have been no deaths and no major complications.

According to an article written by Robert Wheeler, MD, medical director at the Diagnostic Center for Disease (Sarasota, Florida) and a urologist of 22 years, there were an estimated 50,000 robotic prostatectomies performed last year and it is projected that the number could double in 2008.

But while the procedure is clearly growing in popularity, Wheeler's article, "Robotic Prostatectomy – A Race to Failure?" suggests that a higher volume of these operations does not necessarily translate into better patient outcomes. The article was posted last week on the Diagnostic Center for Disease website.

"As much as we'd like to think that the robotic procedure has its advantages — and I won't disagree that it does – we need to look at it specifically with the outcome data," Wheeler told Medical Device Daily.

His article notes that robot-assisted laparoscopic prostatectomy is now generally accepted as the gold standard of curative treatment for prostate cancer. The procedure is possible, he notes, thanks to some "amazing technology."

A robotic prostatectomy consists of two cameras inserted into the abdomen, which provide multiple views and simulate 3-D vision. The robot consists of small, articulating arms, which can perform multiple tasks, Wheeler's article notes.

One widely used device for this procedure is the da Vinci system from Intuitive Surgical (Sunnyvale, California).

"Promoters of robotic prostatectomy routinely use the term 'promising' in their expectation that this device and procedure will eventually demonstrate improvement in the cure rate for prostate cancer. Their enthusiasm is generated by the awareness that other curative treatments have a poor track record to cure prostate cancer," Wheeler wrote. "This procedure is also accompanied in far too many cases, by other negative side effects such as incontinence and permanent erectile dysfunction."

According to Wheeler, a typical robotic surgery device costs $1.2 million, with annual maintenance of about $120,000 a year.

"There exists no compelling evidence at this time that robotic prostatectomy will deliver any improvement whatsoever over the current poor rate of cure for all other radical, curative treatments," Wheeler concluded in his article. "What is truly alarming is that the effort to find more cancers by more than doubling the rate of biopsy, will only serve to increase the devastation that exists today. Ironically, increasing the number of insignificant cancers included for treatment, will only serve to (falsely) indicate better cure rates for robotic prostatectomies. Of course, this will only incentivize urologists to treat even more cancers."

Wheeler also noted a concern over the trend to treat more aggressive cancers, Gleason 8 and above.

"In far too many cases, it is not confirmed prior to actual surgery that the cancer is organ-confined. The number of failures, exceeding 1,000,000 men, could easily double within the next few years," he wrote.

Because Wheeler's article was just released, he said he has not yet received much of a reaction from others in the field.

"Mum's been the word," Wheeler told MDD. "And usually when that happens it means that you're probably right on target."

Wheeler stresses the importance of using MR-Spectroscopy (MRI-S) at (3.0 Telsa resolution) as a qualifier before exposing a patient to robotic surgery. That, he said, would be a "quantum leap" for prostate cancer.

Samadi, who has been performing robotic prostatectomies for seven years, offered his point of view on the procedure, from the perspective of "three surgeons in one head" because he first started out performing open prostate surgery, then started doing laparoscopic prostatectomies, before doing robotic prostatectomies.

With open surgery, which he said was "the way to go" for years, surgeons had to rely on tactical feedback because they couldn't really see what they were doing and they were working in a very narrow space where the prostate is under the bone. Then, in the late 1990s, laparoscopic surgery became popular and revolutionized the procedure with the use of a camera to help surgeons see what they were doing, Samadi said.

"Historically, urologists are not well-trained in laparoscopic surgery," he told MDD, adding that there is a "steep learning curve" with the procedure.

For that reason, about five or six years ago urologists began using a robot to perform prostatectomies and "lower their learning curve," Samadi said, because it is easier.

"The problem is that when you have open surgeons that don't have a lot of laparoscopic surgery experience, they're not going to be really good at it," he said.

In inexperienced hands, the robotic prostatectomy procedure has a high complication rate, Samadi said. In fact, he said, in the hands of a surgeon who is not qualified or very experienced, the procedure is "actually very dangerous.

"I use the robot to fine-tune the experience of open surgery and fine-tune the skills of laparoscopy," Samadi said. "In our hands, the blood loss is minimal, patients have not had major complications and they are being discharged within a day. That is not the case everywhere."

Unfortunately, he said, a lot of robotic surgeons are simply not experienced enough to be doing the procedure. He told MDD that he just recently saw a patient who had undergone a six-hour prostatectomy and the whole prostate was left behind.

"That's a bad reputation for the ones who know what they're doing," Samadi said. "It's very delicate work because you're dealing with sexual function ... in order to get good results you have to have volume expertise."

Wheeler agrees that those are the types of horror stories that affect the entire industry.

"The bottom line is, I'm not against robotic prostatectomy ... I'm for better outcomes," he said.