By: Jean Johnson for Fibroids1Condoleezza Rice’s uterine fibroid embolization (UFE) performed in November 2004 was one of many James Spies, M.D., professor of radiology at Georgetown University School of Medicine, chief of service, department of radiology, has undertaken since 1997 when Georgetown started doing the procedures.
Spies specializes in gynecologic intervention and over the course of his 25 year career as is evidenced by the number of times his name turns up in the literature and on conference agendas, has become one of the leading lights in UFE. He credits Georgetown University Hospital for much of that.
“We’re clearly in the top two facilities in the country in terms of numbers,” Spies said. “Since 1997 when we started doing them here we’ve done around 400 embolizations and I’ve probably done two-thirds of those.” More, Spies’ name comes up in the literature because his research interests include monitoring the outcome of uterine fibroid embolization as well as measuring health outcomes associated with interventional radiology generally. Fibroids1 caught up with Spies in October 2005, and it turns out the timing was right.
“There are several studies being published over the course of a six-month interval that further establish the degree of symptom control and improvement in quality of life for uterine artery embolization,” said Spies. [UFE was originally called uterine artery embolization since what interventional radiologists do is embolize the uterine artery. Over time the nomenclature switched to uterine fibroid embolization to more clearly link the arterial procedure to the fibroids it focuses on treating.)
Whatever the acronym, however, Spies thinks the current studies attest to the idea that embolization has attained credible stature in the field of medicine. “It’s becoming a mature technology. We understand much better how to measure outcomes and are doing better studies than we were a few years ago. This series is a result of that effort.”
FIBROID Registry
Spies explains that the various researchers have drawn on data being accumulated in what’s known as the FIBROID Registry, collaboration between the Society of Interventional Radiologists and Duke University Hospital, with Federal Drug Administration representation. The registry had been collecting data on approximately 3,000 patients with longitudinal follow-up on 900 patients annually.
Large Numbers of Interventional Radiologists Adept at UFE
Spies references the first papers, published in 2005 in Obstetrics and Gynecology, as studies that first detail the methods of data collection and structure of the FIBROID registry, and secondly analyze outcomes based on the data.
“What the studies that came out in July demonstrated is that UFE, when performed in wide variety of settings, is safe. There are a total of 72 contributing sites reporting data of 3,000 patients. Thirty day follow ups on 2,729 showed that complications were low and serious complications quite low.”
Spies says one of the studies in particular was designed to see if UFE results tended to be practitioner dependent or if the procedure is relatively stable regardless of the particular interventional radiologist performing the procedure. “One of the key findings is that there is no difference in complication rates related to the physician’s prior experience. That’s good since it means you don’t need to go to a specialist with a long track record to get embolization done.”
How to choose an interventional radiologist
When asked what type of experience patients should look for in interventional radiologists, Spies said it was difficult to quantify. “The study results don’t mean that women can go to anybody. They need to look for physicians with reasonable experience that have a program with a nursing staff that understands the treatment protocols and can manage outpatient issues in order to personalize care.”
“Twenty-five procedures is a reasonable track record and moderate number of patients to have embolized. But that doesn’t mean 10 is not good and 50 is good. It’s the overall level of experience that patients need to look for,” said Spies.
“What I think patients should do go to the physician finders on either the Society of Interventional Radiology or the Fibroids1 Web site. There are several hundred people doing this around the country.” Spies also suggests that once a woman interested in UFE has located an interventional radiologist (specialists that are medical doctors), going in and discussing her case with the physician is a good, appropriate next step. “That way patients can see if they are comfortable with the interventionalist’s knowledge as well as their interest in providing personal care.”
Longterm Georgetown study to publish five-year follow-up results on UFE
“Our own results at Georgetown on five year follow-up – which is to my knowledge the first study that tracks long-term data on patients – looked at 200 patients,” Spies said, “We found that a relatively small 20 percent had recurrence of symptoms and required additional therapies. Seventy-three percent of the women had continued symptom control.”
[The study Spies refers to was published in the November 2005 issue of Obstetrics and Gynecology.]
Embolization compares favorably with myomectomy
Spies also explained that “we know women can grow new fibroids after the procedure and also that women can develop other gynecologic problems. Thirteen to 14 percent of the patients in this study went on to have hysterectomies. So compared to what’s been published with myomectomies [surgical removal of fibroids], embolization is at least equivalent to myomectomy or better. We still need a study that directly compares these two approaches to treating fibroids, but these results do show that embolization is in the same range as myomectomy.”
Upcoming studies do take further steps toward analyzing and comparing success rates related to embolization and myomectomy.
“Scott Goodwin at UCLA has a paper coming out shortly in which comparisons between outcomes from emobolization and myomectomy are reported,” said Spies. “Again, the study demonstrates very good comparative improvement with embolization.”
Spies also mentions another paper that looks at one-year outcomes which was published in December. “This study is following roughly 1,700 patients, and it will continue for three years. At one year, however, the larger majority had dramatic improvement; a small number, 10 percent, did not improve, and a very small number – 2.88 percent – had hysterectomies,” Spies said.
“Again this shows that over the course of a year, most women’s symptoms get better. The bottom line is that this study and the others coming out over the course of this six month window further establish the degree of symptom control and improvement in quality of life for this treatment.”
Physician insights on interventional radiology
“A lot comes down to the process of physician and patient awareness. Medicine is very slow to change, and a procedure has to be around for a long time to gain acceptance. In the case of uterine arterial embolization, it’s even more difficult since it’s not performed by gynecologists,” said Spies. “There has been substantial progress, but there is a continued need for informing patients. Still, many come in and say ‘I had no idea about it.’
“My view is that interventionists need to do a better job of explaining embolization to physicians that treat women so practitioners are better informed and thus in a better position to counsel patients. It used to be that my patients self-referred, but now roughly 90 percent are referred by their gynecologists. We’ve been doing uterine fibroid embolization for about eight years, and so have built up a relationship and knowledge base within our community,” he said. “It’s been very slow – almost imperceptible, but we had people that used to be downright hostile who now refer patients.”
Is interventional radiology revolutionizing medicine?
“I don’t think of it as revolutionary. I’ve been doing this for 20 to 25 years – maybe not UFE, but we’ve been using interventional radiology to treat a wide range of problems for a long time. The things we did back when we started to some degree are different, but it’s essentially the same technique,” said Spies. “When you step back and take an objective view, I guess it is pretty revolutionary compared to the old scalpel and suture approach.”
“But I’m so close to it, I don’t see us as being that more innovative than other fields of medicine,” Spies concluded. “Although clearly our work is a trend toward a less invasive, less disfiguring way to treat problems associated with the breast and abdomen. The down side to innovation, however, is that it does come at more cost. The processes we do are generally more expensive, even though for patients is usually evens out because they end up spending less time in the hospital.”
