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CONTEMPORARY

OB/GYN�

Translating science into sound clinical practice

Supplement to

J U N E 2 0 0 6 • w w w . c o n t e m p o r a r y o b g y n . n e t

Uterine FibroidEmbolization for the Management

of Uterine Fibroids

Funded by and produced with the assistance of

ADV-267 supplement.rev1 6/5/06 3:51 PM

Expert Interviews With:

DAVID SIEGEL, MDChief, Division of Vascular and

Interventional RadiologyLong Island Jewish Medical CenterNew Hyde Park, New York

NEIL SLOANE, MDPrivate PracticeParkview OB/GYNPhiladelphia, Pennsylvania

RON CLAUHS, MDPrivate PracticeWest Chester, Pennsylvania

ROBERT WORTHINGTON-KIRSCH, MD, FSIR

Image Guided Surgery Associates, PCPhiladelphia, Pennsylvania

JOHN C. LIPMAN, MD, FSIRDirector, Atlanta Interventional Institute Adjunct Clinical Assistant ProfessorDepartment of Obstetrics

and GynecologyMorehouse School of MedicineAtlanta, Georgia

Since the late 1970s, interventional radiolo-gists have been treating postmyomectomy orpostpartum uterine bleeding by embolizingthe uterine arteries. In France during themid 1980s, Jacques Ravina, MD, observedthat some of his patients receiving uterinefibroid embolization (UFE) as a preoperativemaneuver before myomectomy experienceda resolution of their symptoms and cancelledtheir surgeries. He subsequently published abrief report in 1995 documenting 16 cases ofwomen who had UFE without further sur-gery and who experienced durable relief oftheir symptoms. Later that same year, BruceMcLucas, MD, an American gynecologistfrom the University of California at LosAngeles (UCLA), met with Dr. Ravina. Soonthereafter, Dr. McLucas and Scott Goodwin,MD, the director of Interventional Radiologyat UCLA, initiated the use of UFE as a pri-mary treatment for uterine fibroids.

In 1996, UFE became available in the UnitedStates. It is estimated that more than 100,000women have undergone this treatment world-wide. Currently about 15,000 to 18,000 casesare performed each year in the United States.Recently, a group of experts answered aContemporary OB/GYN interviewer’s ques-tions about their experiences with thisprocedure. The physicians focused on patientselection, pain management, UFE as a treat-ment option, and strengthening relationshipswith interventional radiologists. Highlightsfrom those conversations follow.

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Uterine Fibroid Embolizationfor the Management of

Uterine Fibroids

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Patient Selection for UFEAn Interview With David Siegel, MD

Interviewer: What preoperative evaluations are neces-sary to determine if a patient is a candidate for UFE?

Dr. Siegel: An evaluation for UFE should begin with a com-plete medical history, a physical examination, including arecent gynecologic examination with Pap smear, anddepending on the clinical indications, appropriate laboratorytests such as a complete blood count and follicle-stimulatinghormone (FSH) level. In most patients, especially those with bleeding symptoms, an endometrial biopsy should be done as well.

The most important evaluations in the triage of fibroid patientsfor the various minimally invasive treatments are thoseobtained from imaging studies, because the size of the fibroidmasses and their location relative to the uterine layers aremajor determinants of UFE candidacy. There is some contro-versy among clinicians on whether patients being consideredfor UFE should routinely undergo magnetic resonance imag-ing (MRI)—clearly the best test we have for defining fibroids.Ultrasounds or sonograms are the most common screeningtests for fibroids; they are routinely performed in gynecologyand radiology offices for evaluating patients who have pelvicpain, bleeding, or a history of fibroids. If a complete pelvicultrasound examination is performed and the details of theuterus and all the other associated structures are able to beidentified and evaluated appropriately, then an MRI may notbe necessary, especially in a nonbleeding patient where adeno-myosis is not an issue. Having said that, more than 85% of mypatients get MRIs because of variability in the quality or doc-umentation of sonography.

Interviewer: Which patients are candidates for UFE?

Dr. Siegel: It is estimated that about 80% of women whohave fibroids with symptoms are candidates for UFE.Patients should be symptomatic with respect to theirfibroids. Bulk symptoms include pain or urinary frequency,excessive bleeding, or both. Beyond that, the location and configuration of the fibroids establish the therapeuticoptions, including UFE. For instance, fibroids sitting on theoutside of the serosa but bulging outside of the contour ofthe uterus are generally acceptable to embolize. If the stalkattaching the fibroid to the uterus is narrow (ie, <50% of thediameter of the entire fibroid), there is a reasonable chanceof treatment failure, however. These patients are usuallygood candidates for laparoscopic myomectomy.

Interviewer: Which other patients are not candidatesfor UFE?

Dr. Siegel: Patients with unfavorable fibroid anatomy willnot benefit from UFE. The size of the fibroids and whether

they are in the uterine cavity are important factors. Largefibroids that sit inside the uterine cavity may be difficult topass if they detach after embolization, so these patients maybe better served with hysteroscopic therapy.

The overall size of the uterus is not an absolute contraindi-cation to the procedure. However, when the uterusbecomes larger than a 20 weeks’ pregnancy size, or as I liketo describe it, “the uterus becomes an abdominal ratherthan a pelvic organ,” patients will not respond as well toUFE as would those with smaller uterines. Thus, they areoften counseled to consider other options.

Most patients with bleeding secondary to adenomyosis maynot benefit from UFE in the long term. An article by JP Pelageof France, published in a 2005 issue of Radiology, reported a very high recurrent bleeding rate in cases of symptomaticadenomyosis. Those with chronic pelvic inflammatory diseaseor active sexually transmitted diseases or other infectiousprocesses also should not be treated with UFE.

Because Lupron® (leuprolide acetate) can cause spasm inblood vessels, making it more difficult to catheterize the ves-sels and perform the procedure, patients on this agentshould be weaned off the medication at least a month beforethe UFE procedure. Women with endometriosis andfibroids, both of which cause pain, will not get pain reliefwith UFE. Also, we must use caution in patients who haveallergies to the dyes or contrasts used in UFE. Most of theseallergies are minor, and patients can be pretreated withsteroids. Rarely, however, the allergies can be life-threaten-ing, and these patients should not be treated with UFE.

Interviewer: What should gynecologists be aware ofwhen recommending UFE to a patient?

Dr. Siegel: The gynecologist should know the importantdata about UFE—success and failure rates; fertility data;exclusion criteria such as infection, adenomyosis, andpedunculated fibroids; and inclusion criteria in terms ofsymptoms. There are many patients who have fibroids butdo not have symptoms; these patients do not need to betreated. A patient with symptoms should be referred to aninterventional radiologist, who in turn will make the evalua-tion to determine if she is a candidate for the procedure.

Interviewer: What should patients be aware ofregarding UFE?

Dr. Siegel: Patients should be aware that UFE may be anoption for them and that interventional radiologists who dothis procedure are available for consultation to review theircases and make a recommendation. Patients need to knowthat UFE is not a surgical procedure and that it has lowerrisks than available surgical therapies for fibroids. Havingsaid that, patients should also understand that UFE is a“real” procedure and that they will probably not be able to

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return to work or to resume routine activities for the next 5to 10 days. As with any procedure that requires an informedconsent, they need to know the risks, benefits, and potentialcomplications of UFE.

With regard to fertility, there are now enough reports ofpregnancy after UFE to present to patients to help themchoose the direction of their therapy. Several studies havereported that about a quarter to a third of patients were ableto become pregnant after UFE. However, it is not knownwhat percentage of the total number of women in the studywere trying to become pregnant. The effects of UFE on theability to become pregnant and carry a fetus to term and onthe development of the fetus have not been determined.

Interviewer: What are the expected outcomes forpatients treated with UFE?

Dr. Siegel: Approximately 90% of patients will have resolu-tion of their heavy bleeding and/or pelvic pain and pressure.Symptom relief is the goal of therapy. By 3 months afterUFE, most patients’ symptoms are better even though animaging study will not show the fibroids to be completelyresolved. Fibroids will continue to shrink beyond this time,and the patient will continue to improve. Of course, the big-ger the fibroid, the longer it will take to shrink and for thepatient to achieve symptom relief.

Interviewer: What should patients expect during theUFE procedure?

Dr. Siegel: UFE itself, from puncture to removal of thecatheter, takes about 25 or 30 minutes to perform. In gen-eral, some form of sedation is used during the procedure. Igive my patients the option of a deep twilight sleep or ofbeing awake. Some patients are very nervous and anxiousand prefer heavy sedation; others are interested in viewingthe procedure and require only little sedation.

UFE is essentially painless except for the puncture of the groin, for which a local anesthetic is used. The crampyabdominal pain after UFE comes about as a result of theprocedure and is caused by the fibroids being starved forblood and oxygen.

Interviewer: What should patients expect during therecovery period?

Dr. Siegel: Most patients have some crampy abdominalpain, the duration and severity of which varies dramaticallyfrom patient to patient. Some patients will have a littlecramping for a few hours after the procedure and maybeone episode the next day and can be managed with ibupro-fen. Other patients may have terrible abdominal pain for 5or 6 days and require daily narcotics.

In my experience, most women will have some cramping,which tends to be the worst within 8 to 12 hours after the

procedure. For this reason, UFE is generally not done as anoutpatient procedure. Rather, most physicians will do it asan overnight stay or a 23-hour admission. Intravenous nar-cotics are used for pain control for the first 8 to 12 hoursafter the procedure. Pain will then gradually resolve in thenext several days.

In the first few days after the procedure, some women may experience postembolization syndrome, ie, generalizedmalaise with occasional low-grade fever or night sweats.

Interviewer: When can patients resume their normalactivities or return to work?

Dr. Siegel: The vast majority of patients will be back at workin a week to 10 days. There are plenty of patients who areready to be back to full activity or nearly full activity in about3 or 4 days, and then there are others who need 2 weeks.Heavy lifting and deep bending are avoided for a few daysafter the procedure, as is routine after any arterial puncture.

Interviewer: What types of adverse events or compli-cations may occur with UFE?

Dr. Siegel: Complications that would lead to a hysterec-tomy after UFE, which is obviously what most patients aretrying to avoid, occur in <1% of patients. The most com-mon reason for hysterectomy after UFE is infection.

Premature menopause or ovarian failure is very rare inpatients younger than 45 years, but occurs in probably 10% or 12% of patients who are older than 47 years. Obviously, thecloser a woman is to reaching menopause, the more likely theUFE procedure will push her over into that state. Many of mypatients who have bleeding symptoms would welcomemenopause, although this is never the goal of the procedure.

The most common vascular complication with UFE is agroin hematoma, which is usually self-limited and resolvesspontaneously. Bleeding complications from the groin punc-ture and complications from the angiographic portion of theprocedure may also occur, and rarely, arterial damage orperforation of the treated vessels.

Some patients may also experience urinary retention afterUFE, which is addressed with a Foley catheter. A persistentvaginal discharge that is clear, yellow, nonfoul smelling, andlasts for more than 3 months is a minor complication thatmay occur in some patients. Dilatation and curettage is cur-ative for nearly all of these cases.

Interviewer: What studies are being conducted toevaluate patient selection for UFE?

Dr. Siegel: There are many ongoing studies at institutionsall over the United States examining various aspects ofUFE. I think the best study currently being conducted toanswer many questions relating to UFE is the FIBROID

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Registry established by the Society of InterventionalRadiology. Twenty-five high-volume core sites and 50 to 60other participating sites enrolled more than 3300 patients.The FIBROID Registry should give us valuable dataregarding the types of patients who did well with UFE andthose who did not. Such information can obviously be usedto guide future patient selection.

Offering UFE as a Treatment Option and Strengthening Relationships WithInterventional RadiologistsInterviews With Neil Sloane, MD, and Ron Clauhs, MD

Interviewer: Although UFE has been performedsafely and effectively in the United States for morethan a decade, hysterectomy still appears to be therecommended treatment for uterine fibroids, with40% of hysterectomies performed due to fibroids.Why has the acceptance of UFE in the gynecologiccommunity been so slow?

Dr. Sloane: There are several reasons for the slow accept-ance of UFE. First, over the past 50 years, the generalcommunity has been accustomed to having its gynecologicneeds met by women’s specialists, who have developed closerelationships with their patients over the years. Second, bythe time a woman decides to consult her physician abouther symptoms, usually pain and bleeding, she may want adefinitive procedure that will cure those symptoms. Third,UFE is a relatively new procedure; therefore, patients areslow to accept it as mainstream.

Dr. Clauhs: UFE is still considered a new procedure bymany gynecologists, who may be reluctant to recommend it.Also, gynecologists may be resistant to referring a patientelsewhere for a condition that they themselves are capableof treating.

Interviewer: What are the obstacles for includingUFE as an option for uterine fibroids in a privategynecology practice?

Dr. Sloane: It’s a time and education factor. Gynecologistsmust first learn all about a procedure they are about to rec-ommend. They must take time out of their busy schedulesto consult with an interventional radiologist to learn the insand outs of UFE. They should also visit patients who havehad UFE soon after their procedures to view firsthand apatient’s condition during the recuperative period.

Dr. Clauhs: The biggest obstacle is that gynecologists arefaced with sending patients with a medical problem thatthey themselves can handle on to another physician.

Interviewer: How can gynecologists overcome theseobstacles and offer UFE as a treatment option fortheir patients?

Dr. Sloane: Overcoming the obstacles I mentioned aboveis a matter of education. It is essential that the gynecologistinclude consultation with an interventional radiologist sothat patients obtain the necessary information about UFE.Although time consuming, the patient should return to hergynecologist and integrate what she learned from the inter-ventional radiologist into her decision-making process. Thegynecologist should then be able to answer any final ques-tions that she has concerning the procedure.

Dr. Clauhs: You need to show the gynecologist that thisnew emerging technology is better for the patient. It offersa higher level of patient satisfaction, fewer complications,and lower morbidity and mortality compared with other sur-gical treatments for fibroids.

Interviewer: What advice would you give colleaguesregarding the addition of UFE in their treatmentarmamentarium for uterine fibroids?

Dr. Sloane: My advice is to consider the fact that in a mod-ern-day practice, gynecologists must inform patients of alloptions available to them for treating fibroids. An example I can give is breast care. Although we gynecologists are usu-ally not in the position to treat most breast cancers, we stillexamine a patient’s breasts and take charge of her findingthe proper physician to treat her.

Dr. Clauhs: Gynecologists have to look long and hard at theoutcomes of UFE and at the level of patient satisfaction,which is extremely high in my practice. I’ve been fortunateto find an interventional radiologist (Dr. Worthington-Kirsch) who is very competent in performing UFE, and I can comfortably inform my patients of that fact. I alsoinform them of the length of the procedure, recovery expe-rience of my other patients, and the level of satisfaction thatthey can expect. It sounds very good to patients when youcan offer a procedure that is relatively minimally invasiveand has a high degree of satisfaction and success.

Interviewer: What are the necessary steps for gyne-cologists to successfully include UFE as a treatmentoption?

Dr. Sloane: The first step involves investigating whichinterventional radiologists in the area are performing theprocedure, and then meeting with these physicians to deter-mine their personal philosophies on the procedure and theirthoughts on which patients are and which are not candidatesfor UFE. Gynecologists must remember that any referralout of their practice is a direct reflection on themselves andshould therefore select an interventional radiologist whothey feel is compatible with their own style of practice.

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Finally, once an appropriate interventional radiologist whohas performed a large number of procedures successfullyhas been found, various education materials describingUFE and its benefits and risks should be obtained from thisphysician. The materials need be only an introduction toUFE, as the referral to the interventional radiologist willcomplete the education process.

Dr. Clauhs: First, gynecologists need to be aware of UFEand second, they need to understand how the procedure isperformed, its benefits and risks, recovery period, and qual-ity of outcomes expected for a particular patient. When thisinformation is presented to physicians, it will be difficult for them not to appreciate the patient benefits. The biggestchallenge for the gynecologist is, How do I take this proce-dure out of my own hands, put it into someone else’s hands,and feel good about it?

Interviewer: What is the role of the interventionalradiologist in UFE?

Dr. Sloane: The interventional radiologist should spend thenecessary time to learn the procedure well. As with mostprocedures, practice makes perfect. He or she needs todetermine who is a good candidate for the procedure andmust involve the gynecologist in all facets of the procedure.Should there be setbacks or complications, the gynecologistmust be notified immediately and encouraged to be involvedin the postprocedure care. Finally, the interventional radiol-ogist should strongly encourage the patient to return to thereferring gynecologist after the immediate postprocedurecare. No one wants to lose a patient.

Dr. Clauhs: When beginning my association with Dr. Worthington-Kirsch, we talked about the type of patientwork-up that would be most beneficial to him in helping todetermine whether a patient was a good candidate for UFE.After completing the agreed-upon work-up, I then refer thepatient to him. He sees her, reviews my work-up and makesa decision at that time as to whether she is or is not a candi-date for UFE. If she is a candidate, he does the procedure,then typically visits her immediately postprocedure and seesher at least once, possibly twice, thereafter, following upwith a pelvic ultrasound at about 3 months to confirm thatthe procedure worked correctly. At that point, the patient is sent back to me; I usually see her once and then do a follow-up later. I feel comfortable that I’m involved in thepatient’s care every step along the way. The only thing thatI’m not physically doing is the UFE procedure itself.

Interviewer: How can gynecologists strengthen theirrelationships with interventional radiologists?

Dr. Sloane: Gynecologists can strengthen the relationshipwith an interventional radiologist by carefully choosing onewho has the same goals and philosophies as they do. If theinterventional radiologist is dedicated to the procedure,

selective in the patients he or she will treat, and careful withpatient care and follow-up, then he or she will win over thegynecologist.

Dr. Clauhs: Gynecologists and interventional radiologistshave to communicate and talk with each other. I want tomake sure that whoever is doing UFE on my patients is verycompetent at doing it and has performed many of them. Mypatients come back very satisfied with the procedure andthey’re comfortable with my practice, knowing that I ammaking wise recommendations to them.

Interviewer: What is the best way to communicatepatient history and evaluation to the interventionalradiologist?

Dr. Sloane: Communication between the two specialists isessential. The gynecologist must communicate and forwardto the interventional radiologist all available office notes andprocedures performed on the patient prior to the referralappointment. After consultation with the interventionalradiologist, a prompt telephone call and follow-up lettershould be made to the gynecologist, including any reserva-tions the patient may have had concerning the procedure.

Next, the patient should return to the gynecologist’s office tocompare the information received from the interventionalradiologist with any other treatment options the gynecolo-gist had suggested. The patient should be allowed to makeher own decision without any persuasion. If she choosesUFE, a letter needs to be sent to the interventional radiolo-gist, and the gynecologist should facilitate the procedure.

Dr. Clauhs: There are several different approaches. If agynecologist has a very close working relationship with theinterventional radiologist, information about the patient canbe conveyed via the work-up that is provided—physicalexamination, endometrial biopsy results, and MRI scan—essentially the same as that for a myomectomy orhysterectomy, with the exception of the MRI. On the otherhand, if the gynecologist doesn’t know the interventionalradiologist, a letter of introduction would be proper, outlin-ing the patient’s information and history, the physicalfindings, and the laboratory results.

Interviewer: What is the best way to communicatepatient follow-ups with the interventional radiologist?

Dr. Sloane: After the UFE procedure is performed, theinterventional radiologist should make a prompt telephonecall to the gynecologist describing how the procedure went and what the follow-up care will entail. Gynecologistsshould be familiar with the ins and outs of the postproce-dure care and must encourage the patient to feel free to calltheir offices or the office of the interventional radiologist ifthere are any problems. Interventional radiologists shouldbe very receptive to giving patients good follow-up care.

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Those who perform UFEs but then are not immediatelyavailable to patients to address any problems are not idealchoices for good working relationships.

Dr. Clauhs: In terms of communication from the inter-ventional radiologist to the gynecologist, I recommend aletter from the referral consultation, outlining the assess-ment of the gynecologist’s work-up, appropriateness ofUFE, and its plans and timing. After the procedure, Iexpect a letter explaining what was done and how well thepatient did, and later, another letter stating that thepatient was seen after the procedure, whether it was suc-cessful, and the recommended postprocedure care.

Interviewer: There’s a perception that UFE shiftsincome from the gynecologist to the interventionalradiologist. Can you provide some insight on whythis is not necessarily the case?

Dr. Sloane: A shift in income from the gynecologist tothe interventional radiologist need not be the case. In mypractice, there’s probably a greater shift in the otherdirection. Not all patients seen by the interventional radi-ologist are good candidates for UFE. If the patient hasany significant adenomyosis, she will be sent back to thegynecologist for probable hysterectomy. If her gynecolo-gist does not perform surgery, the interventionalradiologist could refer her to another gynecologist withwhom he or she has a working relationship. In addition,in our practice, an MRI is always obtained before theUFE is performed. Very often other pathology is noted onthe MRI that needs to be treated by the gynecologist orby a combination procedure with both the interventionalradiologist and gynecologist.

Dr. Clauhs: In my part of the country, gynecologists arestruggling with income-related issues. On one side, they’rebeing pressured by managed care organizations payingreduced fees—on the other side, by overhead costs andmedical malpractice insurance. In general, every penny ina practice counts; therefore, when a patient is referred outof the practice, there’s loss of potential income.

Having said that, gynecologists need to offer appropriatetechnology to their patients. Health care is now beingmarketed directly to patients, and patients today are verysmart and savvy. Word of new treatment gets aroundquickly, and soon a gynecologist may be labeled old fash-ioned because he or she doesn’t believe in new technology.

In referring my patients for UFE, I’m not relinquishing thepatient to someone else and losing her. I participate in thereferral and see the patient postprocedure. As a result, shefeels good about my participation in the procedure andreturns to me knowing that I presented her with a wiseoption. The situation is similar to sending a patient withbreast cancer to an oncologist. General practitioners deal

with this type of referral all the time when their patientsdevelop liver or heart disease; they get referred to a special-ist and then return to the general practitioner for continuednormal care.

UFE: An OverviewAn Interview With Robert Worthington-Kirsch, MD

Interviewer: How many women suffer from uterinefibroids?

Dr. Worthington-Kirsch: Fibroids run in families. It isestimated that about 30% of reproductive-age women in theUnited States have fibroids. The incidence is considerablyhigher in African American women and lower in Asians.About half of the patients who have fibroids will experiencesymptoms, which include abnormal bleeding; pressuresymptoms, in which the enlarged uterus pushes against adja-cent structures; and subfertility or repeated miscarriages.

Interviewer: How many women seek treatment foruterine fibroids?

Dr. Worthington-Kirsch: One of the problems withuterine fibroids is that they often cause only gradualchanges. Thus, many women do not realize that they havedeveloped abnormally heavy bleeding or that their bleed-ing has changed over time. Probably only half of thewomen with symptomatic fibroids actively seek treat-ment. As more minimally invasive therapies are offeredand women become aware of them, more patients willseek treatment.

Interviewer: How does UFE compare with some ofthe surgical treatments for uterine fibroids?

Dr. Worthington-Kirsch: Myomectomy is the standardof care for fibroid treatment in women who want to pre-serve fertility. Compared with myomectomy, UFE issuperior in terms of durability and relieving bleedingsymptoms and some types of pain. However, it is not quiteas effective as myomectomy for relief of pressure symp-toms, at least initially: It takes a bit longer to seeimprovement because volume reduction after UFE is agradual process, rather than immediate as it is aftermyomectomy. One drawback of myomectomy is thatalthough the larger fibroids are removed, small “seed”fibroids are left behind and can continue to grow. Therecurrence rate of fibroid symptoms after myomectomy is10% per year, cumulative. Therefore, 3 years after theprocedure, about a third of patients will experience symp-toms again, and by 10 years, most patients who have notyet entered menopause will have at least some of theirsymptoms return. There are no comparable 10-year datafor recurrence of symptoms after UFE.

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Hysterectomy is the only procedure that cures uterinefibroids in every patient; however, there are legitimatereasons why women may want to avoid it. Some womenmay suffer surgical complications or hormonal distur-bances. Others may want to avoid a lengthy postprocedurerecovery period.

The newest therapy available for treating uterine fibroids isExAblate®, or magnetic resonance-guided focused ultra-sound therapy. It can be applied only to fibroids of specificsize and location and to uteri of certain sizes. It is currentlyexpensive and lengthy and can treat only a small number of fibroids. Recent data from Europe and Japan show thatabout 60% to 70% of patients have improvement withExAblate®, and the procedure is associated with very highrates of symptom recurrence and complication.

Interviewer: How is UFE performed?

Dr. Worthington-Kirsch: UFE is performed as any otherangiogram. After prepping the skin and administering localanesthesia, a needle is placed into the femoral artery andthen switched for a diagnostic catheter. Fluoroscopy is usedto guide the catheter into the uterine artery where tinyround particles (ie, embolic material) are injected directlyinto the main uterine artery segment; individual fibroids arenot injected. There are a variety of embolic materials usedfor this procedure; Embosphere® Microspheres is the mostcommon one used in the United States.

Blood flow carries the particles into the uterus, where theypermanently lodge in the small vessels around the fibroidsto block the flow of blood and oxygen to these fibroids. Thefibroids choke, shrink, and die, and the body converts theminto scar tissue. This process is called hyaline degeneration,and is similar to what occurs naturally after menopause.Fibroids need estrogen as much as oxygen to live; aftermenopause, they stop receiving any estrogen and turn intoscar tissue.

Since the entire uterus is embolized, every fibroid, includ-ing seed fibroids, is infarcted. Clinical studies have shownthat UFE does not affect the rest of the uterus becausethere is sufficient collateral blood flow to maintain a healthymyometrium. There are women who have had successfulpregnancies after UFE, and most women continue to havemenstrual periods on a normal schedule after the proce-dure. That said, the advisability of UFE in women whodesire future fertility currently remains unresolved.

Interviewer: What are the advantages of UFE?

Dr. Worthington-Kirsch: Patients are typically dischargeda day after having the procedure. Recovery time with UFEis more rapid than with surgery. Typically, patients are backto full activity levels in 10 to 14 days after UFE versus 35 to40 days with surgery, and miss about 5 to 8 days of work

versus 20+ days with surgery. In addition, risk of significantor severe complications after UFE is half that of hysterec-tomy or myomectomy.

Interviewer: What are the potential complicationsof UFE?

Dr. Worthington-Kirsch: The most significant complica-tion with UFE is infection, which fortunately is relativelyuncommon. About 5% of patients will slough a fibroid.Complications associated with the arteriography itself areabout 1 in 1000 to 1 in 500.

Interviewer: Are there limitations to UFE?

Dr. Worthington-Kirsch: Yes. As fibroids get larger andthe uterus increases in size, the degree to which the uteruswill return to normal after UFE decreases. Some veryrespected interventional radiologists will not perform UFEon a uterus greater than 20 weeks in size. I find that ifpatients clearly understand that their uteri will remain fairlylarge after embolization, but that they should get relief of atleast some of the pressure symptoms and of their bleeding,they will be happy with those outcomes as a means of avoid-ing major abdominal surgery.

Interviewer: What long-term data are available tosupport UFE?

Dr. Worthington-Kirsch: In addition to several case serieswith about 1000 patients followed for 5 years and a few recentprospective, randomized trials in Europe, there exists a reg-istry sponsored by the Cardiovascular and InterventionalRadiology Research and Education Foundation of theSociety of Interventional Radiology that is following a largegroup of women treated with UFE for fibroids. The FibroidRegistry for Outcomes Data (FIBROID) is the largest studyever done to investigate any treatment for fibroids. I am one of the physicians who designed the study and am on itssteering committee.

Interviewer: What is the purpose of the FIBROIDRegistry?

Dr. Worthington-Kirsch: There have been four previousattempts at conducting randomized controlled trials toexamine UFE for uterine fibroids in the United States; how-ever, patients were unwilling to be randomized betweenUFE and a major surgical procedure. The FIBROID Registrywas therefore initiated to obtain rapid and reliable data onUFE. We are looking at a large number of patients treatedwith UFE. We are examining the different technical meth-ods used and analyzing patient outcomes to determinewhich patient types do better, which do worse, what the truecomplication rate is, and what the long-term effects are.Unfortunately, there will not be enough data to determinethe effects of UFE on fertility.

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Interviewer: What have been the findings thus far?

Dr. Worthington-Kirsch: About 3300 patients havebeen enrolled in the entire registry. Currently, at 2 to 3years follow-up, there are between 1300 and 1500patients who continue to provide additional data annuallythrough self-reporting questionnaires. The remainder ofpatients either did not qualify for longer follow-up orwere lost due to inevitable attrition.

Data analyzed thus far from the FIBROID Registry havebeen published in the gynecologic literature and are rea-sonably well known in the interventional radiologycommunity. Based on 30-day and 1-year data, close to90% of patients responded to UFE during this time.Most patients, particularly older ones, experience durableresponses to the treatment. Recurrence of symptoms andrepeat procedures occur in about 10% of patients by 3 years, and we predict that about 20% of patients will have another procedure after UFE by 5 years. Theserates are the same as or better than the rates seen withmyomectomy.

Interviewer: What are the limitations of theFIBROID Registry?

Dr. Worthington-Kirsch: The limitations are the sameas those of any other registry. There is no comparisongroup, and so it does not constitute a controlled prospec-tive trial. We do worry about attrition; patients drop outfor a variety of reasons over which we have no control.However, overall, the study is well designed, and theanswers it provides are very valuable.

Pain Management for UFEAn Interview With John C. Lipman, MD

Interviewer: What can patients expect in terms ofpain during and after UFE?

Dr. Lipman: Despite the myriad anecdotes and misinfor-mation, pain after UFE is typically easily tolerated,particularly after the first 24 hours. Most patients describethe pain as heavy, menstrual-like, crampy discomfort. Thispain begins after the procedure and improves each dayover the next several, with the average recovery in 4 to 5days after UFE. The most important aspects of UFE painmanagement are that the patient has a thorough under-standing of what to expect, and that there is a painmanagement regimen in place beginning prior to theonset of the pain (ie, preprocedure). More severe pain canbe felt in the following three scenarios: 1) Too small anembolic is used (<500 microns); 2) Overembolization byan inexperienced operator; 3) Insufficient or nonexistentpain regimen protocol.

Interviewer: What type of pain management is usedfor UFE?

Dr. Lipman: We have a specific pain protocol in place atour institution and have skilled nurses who implement thisprotocol. We also have a 1:1 patient:nurse ratio at our cen-ter, which is unique and allows for continual surveillanceand immediate attention to any potential pain issues.

There are a number of medications we can use before,during, and after the UFE procedure. Of the last 250UFE procedures performed at our center, only sixpatients have needed to stay overnight, and none beyondovernight. Those who stayed overnight were placed on aDilaudid® (hydromorphone hydrochloride) patient-con-trolled analgesia pump and were discharged the followingmorning. Two of the 250 patients required 2-day readmis-sions for pain control.

A few days prior to the procedure, the patient takesColace® (docusate sodium), because constipation is com-mon due to the narcotic medication administered duringboth the procedure and recovery. Activia™ yogurt fromDannon is a new product that is a natural way to keeppatients regular in the postprocedural period.

Before entering the angiography suite, the patient willreceive an intravenous line with Zofran® (ondansetronhydrochloride) injection 4 mg and Toradol® (ketorolactromethamine injection) 30 mg, as well as a 1-time dose ofAtivan® (lorazepam) 2 mg, either sublingually or intra-venously. She also wears a low-dose scopolamine patch.As we prep the patient, we begin administering fentanyl,Versed™ (midazolam HCl injection), and Dilaudid®, allthree of which are continued during the procedure for anaverage total dose of 75 µg, 3 mg, and 1 mg, respectively.Often, 12.5 mg of Phenergan® (promethazine hydrochlo-ride) is given intravenously during the procedure and inthe immediate postrecovery period, as well.

When the patient is discharged, she goes home on an oral regimen of naproxen (550 mg po bid x 7 days) and Colace® (100 mg po qD x 5 days). Lortab®

(hydrocodone bitartrate and acetaminophen) is pre-scribed prn and is usually needed only for 24 to 48 hourspostprocedure. Occasionally, Phenergan® suppositoriesare needed for nausea or to promote sleep on the firstpostprocedural night.

Interviewer: What is the recovery time after UFE?

Dr. Lipman: I tell my patients to take 1 week off fromwork or from routine activities. The average recoverytime is 4 days. Almost every patient who is not back tobaseline in 4 to 5 days is constipated, and this condition isa major factor in their discomfort at that time.

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Interviewer: Are there guidelines for the type of painmanagement that works best for different patienttypes or different fibroid types?

Dr. Lipman: The same protocol is followed for everypatient, regardless of fibroid size or location. When we triedto predict which types of patients would have more pain, wecouldn’t. Having said that, in general, when fibroids are verylarge (>10 cm), patients will tend to have more postproce-dural issues, and this can mean more pain.

Interviewer: How satisfied are your patients with painmanagement for UFE?

Dr. Lipman: Extremely satisfied. Patients will come in say-ing that they heard the UFE procedure was painful, andthey are very pleased that it was not as bad as they thoughtit might be.

Interviewer: Have there been any studies conductedevaluating pain and pain management for UFE?

Dr. Lipman: There have been several UFE pain studiesperformed. Worthington-Kirsch and Koller looked at thetime course of pain after UFE. They showed that after theprocedure, the pain tends to increase over the first 2 post-procedural hours, plateaus for several hours, and thendeclines. It is the length of the plateau that determines if thepatient will need to be admitted overnight. As stated earlier,98% of our patients are discharged the day of the UFE procedure.

Another study of note was one by Roth that looked atwhether the severity of postprocedural symptoms had aneffect on clinical outcome. No predictors were found forthose patients who had increased pain after UFE, and thedegree of their pain had no impact on clinical outcome.

The Ontario Uterine Fibroid Embolization Trial publishedin the Journal of Vascular and Interventional Radiology in2003 reported on 555 women who had undergone UFE ina number of different centers in Canada by interventionalradiologists of varied clinical skill and experience. Patientshad a planned overnight admission with an average lengthof stay of 1.3 days. Recovery time was also longer (13 days).The readmission rate due to pain control issues was 3%.Postprocedural pain varied considerably and most likelyreflected varied operator experience and lack of a uniformpain regimen.

The last study I want to mention is one by Rasuli reportingon 139 consecutive UFE patients who underwent ahypogastric nerve block prior to UFE. All patients were discharged on the day of the procedure. This group had a

set postprocedural pain regimen of long-acting morphinetablets for baseline pain and short-acting morphine tabletsand naproxen rectal suppositories for breakthrough pain.

Interviewer: How would you describe the level ofpain with UFE compared with that of myomectomy orhysterectomy?

Dr. Lipman: Universally, patients who have had bothmyomectomy and UFE report that the pain after myomec-tomy was much greater than that after UFE. Intuitively, it is not difficult to understand why this is so. Studies havedemonstrated a lower pain control requirement for patientsrecovering from UFE than for those recovering frommyomectomy or hysterectomy.

Interviewer: What are the similarities and/or differ-ences in pain management for UFE, myomectomy,and hysterectomy?

Dr. Lipman: Types of pain medications, such as nar-cotics, given after all three procedures are the same. It isnot difficult to understand why the level of pain is muchhigher after the two surgical procedures than after UFE,which is nonsurgical. After an open surgical procedurelike myomectomy or hysterectomy, there is a 2- to 3-dayhospitalization and a 6- to 8-week recovery period athome. An open surgical procedure obviously requiresmuch more pain medication in the postprocedural periodthan UFE does.

Interviewer: What contributes to your success inUFE?

Dr. Lipman: Two important factors contribute to success inour facility. First, I spend a great deal of time with eachpatient. Every patient has been seen in the office for a 45minute consult, and candidates for UFE leave with a thor-ough understanding of what to expect after UFE. Second,we have a great team of nurses and technologists who haveas deep regard for patient care as I do.

In our center, the same corps of nurses who perform the preadmission testing help medicate patients duringthe procedure. They also participate in postproceduralrecovery. They all have participated in the care of hun-dreds of UFE patients and are very knowledgeable aboutall aspects of the procedure.

I work very closely with a large number of gynecologists whoknow that they can entrust me with the care of theirpatients. Every patient has my cell phone number, so shecan call—day or night—with any question or concern abouther care. Many patients are surprised by this, but they donot abuse the privilege.

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Suggested Reading

ACOG Committee Opinion. Uterine artery embolization.Obstet Gynecol. 2004;103:403-404.

Bachmann G. Expanding treatment options for women withsymptomatic uterine leiomyomas: timely medical break-throughs. Fertil Steril. 2006;85:46-7; discussion 48-50.

Goodwin SC. Uterine artery embolization: a legitimateoption for the treatment of uterine fibroids. Fertil Steril.2006;85:48.

Goodwin SC, Bradley LD, Lipman JC, et al; UAE versusMyomectomy Study Group. Uterine artery embolizationversus myomectomy: a multicenter comparative study.Fertil Steril. 2006;85:14-21.

Huang JYJ. Valenti D, Tulandi T. Treatment of uterinefibroids for the interest of patients not specialists. FertilSteril. 2006;85:50.

Lipman JC, Smith SJ, Spies JB, et al. IV. Uterine fibroidembolization: follow-up. Tech Vasc Interv Radiol. 2002;5:44-55.

Mara M, Fucikova Z, Maskova J, Kuzel D, Haakova L.Uterine fibroid embolization versus myomectomy inwomen wishing to preserve fertility: Preliminary results of arandomized controlled trial. Eur J Obstet Gynecol ReprodBiol. 2005 Nov 14; [Epub ahead of print].

Pelage JP, Jacob D, Fazel A, et al. Midterm results of uter-ine artery embolization for symptomatic adenomyosis: initialexperience. Radiology. 2005;234:948-953.

Pron G. New uterine-preserving therapies raise questionsabout interdisciplinary management and the role of surgeryfor symptomatic fibroids. Fertil Steril. 2006;85:44-45; dis-cussion 48-50.

Pron G, Bennett J, Common A, et al; Ontario UFECollaborative Group. Technical results and effects of opera-tor experience on uterine artery embolization for fibroids:the Ontario Uterine Fibroid Embolization Trial. J VascInterv Radiol. 2003;14:545-554.

Roth AR, Spies JB, Walsh SM, Wood BJ, Gomez-Jorge J,Levy EB. Pain after uterine artery embolization for leiomy-omata: can its severity be predicted and does severitypredict outcome? J Vasc Interv Radiol. 2000;11:1047-1052.

Spies JB, Bruno J, Czeyda-Pommersheim F, Magee ST,Ascher SA, Jha RC. Long-term outcome of uterine arteryembolization of leiomyomata. Obstet Gynecol. 2005;106:933-939.

Spies JB, Cooper JM, Worthington-Kirsch R, Lipman JC,Mills BB, Benenati JF. Outcome of uterine artery emboliza-tion and hysterectomy for leiomyomas: results of amulticenter study. Am J Obstet Gynecol. 2004;191:22-31.

Spies JB, Myers ER, Worthington-Kirsch R, Mulgund J,Goodwin S, Mauro M; FIBROID Registry Investigators.The FIBROID Registry: symptom and quality-of-life status1 year after therapy. Obstet Gynecol. 2005;106:1309-1318.

Worthington-Kirsch R, Spies JB, Myers ER, et al; FIBROIDInvestigators. The Fibroid Registry for outcomes data(FIBROID) for uterine embolization: short-term outcomes.Obstet Gynecol. 2005;106:52-59. Erratum in: ObstetGynecol. 2005;106:869.

Worthington-Kirsch RL, Koller NE. Time course of painafter uterine artery embolization for fibroid disease.Medscape Womens Health. 2002;7:4.

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Activia is a trademark of Compagnie Gervais Danone.Ativan and Phenergan are registered trademarks of American Home Products Corporation.Colace is a registered trademark of Roberts Laboratories Inc.Dilaudid and Lupron are registered trademarks of Abbott Laboratories.Embosphere is a registered trademark of Biosphere Medical Inc.ExAblate is a registered trademark of Insightec–Image Guided Treatment Ltd.Lortab is a registered trademark of UCB Phip Inc.Toradol is a registered trademark of Syntex (U.S.A.) Inc.Versed is a trademark of Hoffman-LaRoche Inc.Zofran is a registered trademark of Glaxo Group Limited.


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