Various traits define a competent surgeon, including such characteristics as acute tactile sense, excellent manual dexterity, and a particularly discerning eye for anatomical subtleties and for where and how to cut tissue. Nowhere are such characteristics more important than in the performance of the radical prostatectomy (RP). But how much does experience, as measured by the number of RPs performed, matter?
Mounting evidence suggests that experience is an important contributor to outcomes. For example, based on a recent review, researchers at Vanderbilt University Medical Center in Nashville, Tenn., led by Daniel A. Barocas, MD, found a “pervasive association” between higher hospital RP case volume and improved outcomes, according to report in Urologic Oncology (2009; published online ahead of print). “Increasing individual surgeon volume may also portend better outcomes, not only perioperatively but even with respect to long-term cancer control and urinary function,” the authors wrote.
In another study, a team, led by Andrew J. Vickers, PhD, of Memorial Sloan-Kettering Cancer Center (MSCC) in New York, showed that a typical patient undergoing RP with a surgeon who reached a learning curve plateau of 250 prior RPs had a 10.9% risk of recurrence at five years compared with a 17.7% rate for men treated by a surgeon who had performed only 10 such procedures previously, according to a report in the Journal of the National Cancer Institute (2007;99:1171-1177). The learning curve for open radical prostatectomy—the point at which recurrence rates started falling—started to flatten when the surgeon hit 250 operations, although for organ-confined disease “the learning curve continues to lead to improving results until well more than 1,000 surgeries,” the authors wrote. For laparoscopic surgery, the curve “really didn't flatten at all,” Dr. Vickers, an associate attending research methodologist, told Renal & Urology News. “It very, very slowly increased up to about 750 prior surgeries.”
Few surgeons, however, perform anywhere near this many RPs in the course of their career. In fact, in a study published recently in the Journal of Urology (2009;182:2677-2681), Dr. Vickers and an MSCCC colleague, Caroline J. Savage, MPH, found that 82.9% of 933 surgeons surveyed perform 10 or fewer RPs per year. They concluded that low annual RP caseloads likely result in poorer outcomes.
Dr. Vickers emphasized that “250 is not an absolute cut point. It doesn't mean that above it, you're fine, and below it, you're useless.” He added: “It seems intuitive that there are some good surgeons with low volume/low experience, and there are some highly experienced surgeons who are just repeating the same mistakes over and over again.”
Does practice make perfect?
David Y.T. Chen, MD, Director of the Urologic Oncology Fellowship Program at Fox Chase Cancer Center in Philadelphia, said he does not believe 250 RPs is a magic threshold for defining competence, but “intuitively, it makes sense to have a number indicating when somebody becomes good or excellent or outstanding. This is not necessarily unique to radical prostatectomy or urology or surgeons. Like anything else humans do, practice makes perfect.”
Charles J. Rosser, MD, MBA, Section Chief of Urologic Oncology at the M.D. Andersen Cancer Center branch in Orlando, Fla., has a different view. “Practice doesn't make perfect. Practice makes permanent,” he declared. “So if someone does 250 surgeries poorly, the 251st surgery is likely to be poor as well.”
This is not to say an observant mind cannot learn something with routine practice, Dr. Rosser conceded. “We must look more at outcomes than at volumes,” he said. “Favorable outcomes are the ultimate goal.”
Dr. Rosser coauthored a paper in BMC Surgery titled, “Radical Prostatectomy: Hospital Volumes and Surgical Volumes – Does Practice Make Perfect?” (2009; published online ahead of print). His group found that most of the 307 urologists surveyed were in favor of requiring surgeons to meet a minimum volume threshold (MVT) for difficult procedures. The urologists assigned the lowest MVTs to the most complex surgeries. For example, RP was rated only the third most complex surgery, but was given the highest MVT (more than 20 per year). In contrast, radical cystectomy with continent urinary diversion had the lowest MVT (one to five per year).
According to Dr. Rosser, items that should factor in to calculating MVT include, but are not limited to:
· percentage of urologists performing (or who can perform) the operation
· reported complication rates (intraoperatively and postoperatively), including erectile dysfunction, incontinence, tumor control
· reported length of stay
· estimated blood loss
· transfusion rates.
Dr. Rosser's group believes urologic oncology fellowships can improve RP competency among urologists. “The ultimate goal of RP is cancer control with little or no morbidity,” Dr. Rosser and his colleagues wrote. “The specialized training obtained during a urologic oncology fellowship affords surgeons an opportunity to study in depth the art and science of prostate cancer treatment, and thus achieve cancer control rates and surgical outcomes similar to those of more experienced surgeons.”
In an interview, Dr. Rosser observed: “It is critical for someone interested in performing robotic RP or open RP to undergo fellowship training. It is this intense training that can shorten the learning curve for these procedures.”
Michael P. Esposito, MD, of the New Jersey Center for Prostate Cancer & Urology in Maywood, said he does not think the number of previously performed RPs is an accurate predictor of successful outcomes, but “you probably have to go by a number to make a point. However 250 is a huge number for any urologist in 85% of the country, and that will be skewed even more in the future because I think people are doing more research on their surgeons, and they want experienced surgeons.”
An early user of the da Vinci robotic surgical system, Dr. Esposito is at the high end of the robotic RP experience scale; he has performed more than 2,000 of these procedures since the end of 2001. Still, he said he is impressed with the competency of one of his partners, who, despite having performed “only” 200 such operations in six years, is “fantastic. He is an extraordinary surgeon. He's just got the magic.”
Dr. Esposito and practice co-founder Vincent Lanteri, MD, began amassing their staggering robotic RP caseload when Hackensack (NJ) University Medical Center, with which they are affiliated, bought the 11th and 12th da Vinci systems coming off the production line. “We immediately became a teaching center, one of only three surgeon-led teaching programs in the country from 2002 until now,” said Dr. Esposito, Director of Hackensack's Center for Robotic/Laparoscopic and Minimally Invasive Urologic Surgery/Endourology.
Urologists who perform robotic RP may see growing caseloads because the procedure is minimally invasive, involves nerve- and muscle-sparing techniques, and is associated with low blood-transfusion rates, shorter hospital stays, and shorter catheter times compared with open operations. “There isn't so much an age cutoff anymore,” Dr. Esposito said. “Now, instead of an absolute, ‘Beyond age 65, we're not doing the operation,' if we see a 65-year-old in really good health, with disease that can be cured, and a 15-year life expectancy, then we would consider him for robotic procedure. I'd say one of every 25 RP patients we have now is in his later 60s.”
Despite all the robotic RPs they have performed, neither Dr. Esposito nor his partners have become complacent. They continue to share ideas and modify vascular-, nerve-, and muscle-sparing methods, all while working within the constraints of a bloodless surgery program. “It's a constant evolution,” Dr. Esposito said.
According to Dr. Vickers, research is needed to determine the best way to speed surgeons along the learning curve. He has a few suggestions that he believes are worth exploring, including:
· Changes in reimbursement. “There are presumably incentives in the [health care] system for surgeons who don't do many radical prostatectomies to do them, and the question is, can we reorganize the system so there are incentives for patients to be treated by the surgeons who are likely to [achieve] the best results? Studies show that low-volume surgeons cost [the health system] far more than high-volume surgeons.” One possible way to address this is to compensate low-volume surgeons less than high-volume surgeons.
· Specialization. “If you have fewer surgeons doing more cases, then you're going to have fewer surgeons and patients on the learning curve. Our data show that you have to be very experienced to be good at this operation, and that an awful lot of surgeons out there are just never going to be able to get sufficient levels of experience. So it seems reasonable to suppose that we should really have people who focus on this operation doing it.”
Dr. Chen said he believes board certification in urologic oncology might be a way to address the specialization issue. “Although there is certification for surgical oncology, there's no board-certification now in urologic oncology,” Dr. Chen said. “There is no other certification in urology at all outside of being a specialist in pediatric urology.”
In Dr. Chen's view, this reflects longstanding conflicts inherent in the relatively small field of urology. “On the one hand, there's a rationale for having urologic cancer specialists, but there's also historically been a sense that people in urology can do everything: Take care of cancer, take care of kidney stones, take care of various [other] types of urologic problems, and be equally good at all these things,” he explained. “There's truth to both of those statements, and ultimately from a social standpoint it's not really feasible to have as many dedicated cancer specialists because it would ultimately compromise the availability of other [urologic services]. There really isn't a way to have both worlds—that is, to have unlimited numbers of generalists but also unlimited number of specialists.”
Fox Chase urologic oncology fellows are learning how to perform RPs, but the number of times they have been involved in performing such operations is not well-quantified. “Now certainly, they're learning it as an apprentice might. They're not doing it on their own, but are assisting or watching an independent, skilled surgeon,” Dr. Chen said.
In a training program emphasizing RP, residents could rack up as many as 150 experiences with this operation before going out on their own, he said. “Does that mean they only need another 100 to be proficient, or do they need to do 250 operations as independent urologists?” he asked. “Those are hard questions to answer, but hopefully [fellowship training] gets the person moving along the learning curve before [he or she] even starts.”
The Largest Cancerous Prostate Ever?
In more than 2,000 robotic radical prostatectomies (see main story), neither Michael P. Esposito, MD, nor his team had ever seen anything like it until they had already started this particular operation: A diseased prostate gland the size of not one, but two, grapefruits.
“Had I known it was as big as it was, I wouldn't have done it,” Dr. Esposito told Renal & Urology News. “The normal prostate is about 20, 25 grams, and the biggest one that we've [removed] up until this one was about 275 grams, which is the size of a grapefruit. That's huge.”
Yet that record was shattered just last fall, when a man who was unable to urinate came into Dr. Esposito's New Jersey Center for Prostate Cancer & Urology in Maywood.
“The ultrasound said his prostate was bigger than 300 grams—how much bigger, we didn't know, and we had no idea it would be as big as it was,” Dr. Esposito said. “The gland was filling up the entire pelvis and it was hard to get a good volume study on it.”
Not only did the patient have an enormous prostate, but as a Jehovah's Witness, his religious convictions prevented him from taking blood. “Because of our bloodless-surgery program, we operate on Jehovah's Witnesses all the time without worry, and we've never had to transfuse them,” Dr. Esposito said.
So he and his partner, Vincent Lanteri, MD, proceeded with the robotic RP. Instead of lasting the usual hour and 20 minutes, the operation took about 4 hours. And instead of losing less than 50 ccs of blood, the patient lost about 700 ccs of blood.
“At the end of the surgery, instead of using a prostate bag, we had to use a kidney bag, because the prostate was the size of a kidney,” Dr. Esposito remembers. “And it still had to come out of the incision. The patient had an umbilical hernia so we extended the umbilical incision to remove the prostate.”
After removing the gland and weighing it, the surgeons finally learned just how big it was: 508 grams.
“But that's where your level of experience takes over,” Dr. Esposito observed. “You just know you can do whatever comes your way. Not being cocky, but you just know you can do it—even though had I known beforehand how big the gland was, and that the patient was a Jehovah's Witness who would not accept a blood transfusion, I never would have attempted it.”
Dr. Esposito doubts he and his colleagues will ever be faced with a prostate that size again. “But if we are, we know now we can operate on it—it just takes longer.”