Uterine Fibroid Embolization (UFE)


An Introduction to UFE


Uterine fibroid embolization (UFE) is a minimally invasive procedure performed regularly by the Interventional Radiologists of Interventional Care. Embolization, however, is a procedure that has been performed in other parts of the body for more than 3 decades. All embolization procedures are similar in that they involve injection of a substance into a blood vessel in order to stop the flow of blood in that vessel.

It is easy to imagine this treatment being used in patients experiencing internal bleeding due to trauma, where the injured vessels is identified and embolized in order to stop the bleeding. It is less intuitive to understand why embolization can be applied to tumors such as uterine fibroids.

When the flow of blood to a tumor is interrupted, the tumor undergoes changes that lead to improvements in tumor-related symptoms. Therefore, if the uterine arteries, which are the blood vessels supplying blood to uterine fibroids, can be identified, catheterized, and embolized (blocked) then the symptoms associated with the fibroids can be improved. This is what our practices and practices throughout the world have seen in patients undergoing the uterine fibroid embolization procedure.

UFE was first offered in France in the early 1990s. We have been offering UFE to patients in and around the Capital Region of New York State since 1998 and have since developed one of the busiest UFE practices in the country. Our experience has been published in several articles in medical journals and our physicians have lectured on this procedure nationally. In addition, we have had the opportunity to lead national teaching programs on UFE and other gynecologic interventions through our involvement with the Society of Interventional Radiology. We have participated in all clinical trials evaluating embolic agents for use during UFE procedures and were designated as a core site in the Fibroid Registry, a study sponsored by the Cardiovascular and Interventional Radiology Research and Education Foundation (CIRREF) and the Society of Interventional Radiology (SIR) in cooperation with the Duke Clinical Research Institute.

The experience we have developed with this procedure pertains not only to the physicians performing the procedure but also to the nurses and technological staff that are integral members of the entire team involved in the care of patients undergoing the UFE procedure. As a result, gynecologists in this region have been supportive of our role in the care of patients with uterine fibroids and support their patients as they seek information about the treatment options available to them. It is our hope that this section of our web site will provide information on uterine fibroids, on the treatment options available for uterine fibroids, and on the UFE procedure as it is performed by the Interventional Radiologists of Interventional Care.

What are Uterine Fibroids?


Uterine fibroid tumors are extremely common, benign growths of the muscular wall of the uterus (smooth muscle); they are also known as myomas, leiomyomas, or leiomyomata. Fibroids occur in approximately 20-25% of women of childbearing age and are more common in African-American women. Fibroids are the most common reason for women to have a hysterectomy in the United States.


Cause of Fibroids

While the cause of fibroid development is not known, studies have suggested that estrogen contributes to their growth and development since they tend to develop during adolescence and regress after menopause. While it is not exactly known what initially causes a fibroid to develop, it is known that the growth of fibroids depends on hormones such as estrogen. However, the rate that a fibroid grows is extremely variable among women. Some fibroids remain small while others can grow much larger and reach the size of a 5-month pregnancy or more.

In pregnancy, pre-existing fibroids can increase 3-5 times in size, due to high levels of estrogen present during pregnancy. After pregnancy, these same fibroids can shrink to their pre-pregnancy size. Because fibroids are dependent upon estrogen for growth, they tend to gradually shrink on their own after menopause (when the ovaries stop producing estrogen).


Symptoms of Fibroids

Most fibroids do not cause symptoms and in fact, most women with fibroids do not know that they have fibroids until they are told about their diagnosis by their gynecologist. However, 10-20% of patients with fibroids will develop significant symptoms:


Heavy Bleeding

This is the most common complaint associated with fibroids and typically presents as heavy flow during the menstrual period (with or without the passage of clots). In cases of severe bleeding, it is possible to develop an iron-deficiency anemia and to even require a transfusion.


Pelvic Pain/Pressure

It is common for an enlarged uterus with fibroids to result in the sensation of pelvic heaviness, fullness, and bloating. This pain is commonly associated with exercise and sexual intercourse. Rectal pressure along with constipation may also be a consequence of uterine enlargement. Continuing enlargement of fibroids can lead to back or leg pain due to compression of nerves located within the pelvis. Back pain can particularly be associated with fibroids located in the back (posterior) of the uterus.


Frequent Urination

Large fibroids can be responsible for urinary symptoms due to bladder compression. This most commonly leads to increased frequency of urination or urinary incontinence (leakage of urine). With extremely large fibroids, it is possible that the tube connecting the kidneys and the bladder, the ureters, can become compressed leading to blockage to the flow of urine from the kidneys.


Classification of Fibroids

There are three types of fibroids based on their location within the wall of the uterus.


Submucosal Fibroids

These are located inside the lining of the uterine cavity and can grow into the uterine cavity. If these fibroids grow into the uterine cavity on a stalk, they are known as pedunculated fibroids. Submucosal fibroids are the least common type of fibroid and are often associated with heavy and prolonged menstrual periods. Submucosal fibroids are also associated with miscarriages.


Intramural Fibroids

These fibroids develop within the wall of the uterus. As they grow, they increase the size of the uterus. This can result in abdominal swelling and compression on the urinary bladder, which is located next to the uterus; bladder compression can result in frequent urination. Heavy menstrual bleeding can also result from an intramural fibroid.


Subserosal Fibroids

These fibroids develop in the outer portion of the uterus and can potentially grow into the abdomen. If they grow on a stalk, these fibroids are also considered to be pedunculated. Due to the large space available for these fibroids to grow into, they can potentially become quite large. They are therefore associated with symptoms such as abdominal swelling and bladder compression. They can even block the flow of urine from the kidneys into the bladder. They do not typically change menstrual flow and are not associated with an increased miscarriage rate.


Leiomyosarcoma

It is common to be concerned about the presence of cancerous fibroids but the good news is that cancer in a fibroid, which is also known as leiomyosarcoma, is extremely rare, which is why treatment options such as UFE can be safety considered in these patients. Malignant tumors do not usually arise from a fibroid that has been followed for several years by a gynecologist. Instead, they often are rapidly growing lesions that arise separately from fibroids. This type of cancer is a difficult one to diagnose since there are no imaging tests that can accurately diagnose this problem and reliably distinguish a cancer from a benign fibroid. Surgery is the only reliable way to diagnose this type of uterine cancer and in fact, is the recommended treatment for rapidly growing fibroids.


Treatment Options for Fibroids

Observation

Remember that most uterine fibroids do not cause symptoms and therefore do not necessarily require treatment. In many patients, fibroids are diagnosed by physical examination and their growth can be monitored with periodic ultrasound examinations.


Hormonal Therapy

Initially, the symptoms associated with fibroids can be managed with birth control pills and non-steroidal anti-inflammatory medication similar to ibuprofen. Often times, patients may be put on medication known as a gonadotropin releasing hormone (GnRH) agonist such as Lupron. These medications address symptoms by preventing the ovaries from producing estrogen. Without estrogen, fibroids will shrink in size and the associated symptoms will lessen as well. However, these medications will also cause symptoms which are similar to those experienced by women entering menopause (such as hot flashes). In many patients, stopping this medication will cause the fibroids to regrow, typically within 12 weeks. This medication is commonly used as a way to reduce the size of fibroids prior to surgery.


MRI-Guided Focused Ultrasound Surgery

This is new therapy that uses ultrasound waves to destroy fibroid tissue. By performing this procedure inside an MRI scanner, physicians are able to determine exactly where the fibroids are located. This allows them to direct the ultrasound beam towards the fibroid and the energy of the ultrasound beam is able to heat the fibroid tissue enough to kill the cells of the fibroid. At the present time, this is offered at limited centers throughout the world but has certainly shown promise as a non-invasive treatment option.


Myomectomy

This procedure is designed to remove fibroids while leaving the uterus and ovaries intact. This procedure can be performed through the use of open, traditional surgery or can be performed through scopes using a more minimally invasive approach. A hysteroscope is a scope that is introduced through the vagina and into the uterus. This can be used to remove submucosal fibroids. A laparoscope is a scope that is introduced into the abdomen that can be used to remove subserosal fibroids on the outside of the uterus. Myomectomy is most commonly offered to patients who wish to preserve their fertility since many reports have shown a 40-60% pregnancy rate after myomectomy. Since the uterus is kept in place, it has been shown that almost 30% of patients will develop new fibroid-related symptoms within 5 years of the procedure.


Hysterectomy

This is the most definitive treatment for uterine fibroids since it involves removal of the uterus and at the present time, is considered the standard among gynecologists for women with symptomatic fibroids who are beyond their childbearing years. Fibroids continue to be the most common reason for a hysterectomy to be performed; an estimated 600,000 hysterectomies are performed in the United States annually and at least one-third are for fibroids. Depending on the approach utilized, hysterectomy can be associated with a recovery period lasting from 4-6 weeks. There is no disputing the fact that hysterectomy is extremely effective at addressing the symptoms associated with uterine fibroids and is associated with significant quality of life improvement in most patients.

How is UFE Performed?


Patients undergoing UFE procedures by our interventional radiologists of Interventional Care at Albany Medical Center, are typically scheduled to arrive at the hospital at 7:00 AM. Once they have checked in at the reception desk, patients are escorted to the Radiology Observation Area where they are prepared for the procedure. After speaking with one of our physicians and signing the forms needed for consent, an IV will be placed within a vein of the arm. The IV is needed so that antibiotics can be administered before the procedure, sedation can be administered during the procedure, and medications to address pain and nausea can be administered after the procedure.

In addition to the IV, a Foley catheter is placed within your bladder. This is done for your comfort during and after the procedure and to eliminate the build-up of x-ray dye in the bladder during the procedure. Finally, anti-nausea medication is given to our patients in order to prevent some of the nausea experienced after the procedure. Once these steps have all been completed, you will be taken to one of the angiography suites within the Department of Radiology. In the procedure room, one of our technologists will clean and prep both the right and left groin areas prior to the start of the procedure.

The first part of the UFE procedure involves entering the arterial system of the body. This is done via the right common femoral artery, which is the artery responsible for the pulse that you can feel in the right groin. Local anesthesia (lidocaine) is used to numb the area surrounding this artery and once this has been administered, a very small incision is made in the groin and a skinny needle is place into the common femoral artery. Once the needle is inside the artery, a wire is advanced through the needle into the artery. This allows us to remove the needle and place a catheter, which is approximately the size of a piece of spaghetti, inside the artery. An angiogram is then performed by injecting X-ray dye into the catheter. This lets us see the arteries of the pelvis, including the right and left uterine arteries.

Once the uterine arteries have been identified, the catheter is repositioned under X-ray guidance and moved into the left uterine artery. X-ray dye is once again injected in order to confirm the position of the catheter. Once this is done, an embolic agent is injected into the catheter in order to stop the flow of blood within the left uterine artery. When flow has stopped in the left uterine artery, the catheter is moved into the right uterine artery and the procedure is repeated in order to embolize the right uterine artery. In our experience, most patients can be embolized with a single catheter entering the arterial system on the right side; a second catheter placed into the left common femoral artery is necessary in only the most difficult cases.

Once the right and left uterine arteries have been embolized, a final angiogram is performed in order to confirm the absence of flow in these vessels and to make sure that no other vessels are seen that may be supplying blood to the fibroids. If additional arteries are seen (including the ovarian arteries) then consideration may be given to embolizing these vessels as well. Once the blood supply to the fibroids has been eliminated, the catheter is removed and a physician will press down on the groin for approximately 10-15 minutes until there is no evidence of bleeding from the site. On average this procedure takes less than an hour to complete.

Many patients are interested in knowing as much as they can about the embolic agents that are injected into the uterine arteries during a UFE procedure. Our interventional radiologists utilize many of the agents available on the market that have been approved by the FDA for use during UFE procedures. These agents include Contour SE Microspheres (Boston Scientific Corporation) and Embosphere Microspheres (Biosphere Medical Inc.). Both agents are injected into the uterine arteries through a catheter as described above.

Once the agent has been injected, they cause inflammation, slow blood flow, and clot formation within the artery. The clot that forms within the uterine arteries stays within the uterine arteries because the vessel beyond the clot is to small for it to pass further into the system. In addition, the clot formed in response to embolization with this agent has been shown to dissolve over the course of several weeks but the agent itself permanently remains within the artery. While complications relating to the use of these agents have been reported, they appear to be related to the effects of the embolization procedure and not to the agents themselves.

UFE Results & Success Rate


To date, there have been several hundred articles in the medical literature that have demonstrated the success of UFE in treating patients with symptomatic fibroids. The technical success rate, which is the ability of an interventional radiologist to successfully embolize the uterine arteries, is greater than 95% and has been shown to be higher at centers with significant experience with this procedure.

Clinically, the success of UFE is best measured by its ability to address the symptoms experienced by our patients. These results have been consistent throughout the many studies evaluating this procedure, with 85-95% of patients citing significant improvement in either abnormal uterine bleeding or bulk-related symptoms such as abdominal distension, frequent urination, or pelvic pain. Most importantly, studies have demonstrated that UFE has been associated with improvements in health-related quality of life.

The success of UFE can also be measured in its ability to reduce the volume of the uterus and dominant fibroids. Most studies have shown an average decrease in uterine and fibroid volume of 40-65%. It is important to remember, however, that this procedure is best evaluated by its ability to address symptoms and not by its ability to reduce the size of the fibroids. The size reduction seen after UFE is somewhat variable and does not necessarily correlate with its ability to reduce symptoms and improve patient comfort.

Recent data has suggested that the ability of UFE to completely devascularize a fibroid (eliminate its blood supply and destroy the tissue) may be the most important effect of UFE as it relates to long-term control of symptoms. If a fibroid has been successfully devascularized, it will demonstrate the signs of tissue death (infarction) on the post-procedure MRI, which is what we look for on the 6-month follow-up MRI that we routinely recommend for all of our patients.

When evaluating the results seen after UFE, it is important to remember that while 85-95% of patients receiving significant clinical benefit, there are 5-15% of patients that do not. Possible explanations for treatment failure include incomplete embolization, extremely large uterine fibroids, the presence of a uterine cancer (leiomyosarcoma) or coexisting disorder such as adenomyosis, and the persistence of alternative sources of blood for the fibroids (such as the ovarian artery and the round ligament artery). Many of these possible causes of treatment failure are actively sought out on images obtained before and during the procedure.

Recovery Period After UFE


It is common for us to hear from our patients that the recovery after UFE is often the most difficult part of the entire experience surrounding this procedure. Following UFE, patients return to the Radiology Observation Area, where they recover with our nursing staff for at least 4-6 hours. During that time, most patients experience pain and nausea due to the effects of the procedure.

The pain and cramping after this procedure can range in severity from very mild to quite severe. This pain is most likely due to the effect that the procedure has on both the fibroids and the normal uterus. Immediately after the procedure, IV medication is given for pain relief and is effective at increasing the comfort of our patients. The medications we use for pain control include an opioid analgesic or narcotic (such as Morphine) as well as a non-steroidal anti-inflammatory agent called Toradol, which is similar to Ibuprofen. Depending on the degree of discomfort, these medications are given either upon request to our nursing staff or on-demand by a patient-controlled device. As a result of these medications and the medications given for sedation during the procedure, most patients are drowsy for several hours after the procedure.

Nausea can cause a great deal of discomfort to our patients after this procedure and is due to both the effect of the procedure on the fibroid and to the medications given to our patients for pain relief. We have found that this side effect of the procedure can typically be controlled with medication given prior to the start of the procedure.

After 4-6 hours, a discharge plan is established for each patient with input from our physicians, our nursing staff, and the patient and her family. An inpatient observation bed is reserved for every patient undergoing UFE but a decision as to whether or not a patient will stay overnight is made at this time. Patients who are anxious about home recovery, patients travelling a significant distance to get to Albany, or patients requiring large doses of medication for pain relief are all observed overnight. Currently, most of our patients stay overnight after UFE. The remaining patients elect home recovery and many of patients relate to us that the ability to recover at home is one of the main reasons why they selected UFE to treat their fibroids.

Antibiotics and pain medication are supplied to patients upon discharge with a detailed schedule as to when to take each medication. Once discharged, they are taken home by a family member. Bed rest is recommended for the first evening. The next day, patients move on to limited activity around their home without any heavy lifting or exercise. The recovery period and the way patients feel during the recovery period have varied greatly among the women that we have treated. Normal activity is permitted two days after the procedure. However, an individual patient’s activity will be limited by the degree of pelvic cramping and nausea experienced during the recovery period. After two days, individual tolerance for activity is the best indicator of what a patient can and cannot do.

During the first 5 days after discharge, most patients experience additional episodes of pain during the first 5 days. This can catch some patients by surprise as it frequently occurs after 1-2 relatively pain-free days. We therefore recommend that patients follow our pain medication schedule for at least 3-4 days so that they are not caught “off-guard” by these episodes. As the pain improves, narcotics are discontinued and patients are maintained on over-the-counter medications such as ibuprofen. Most of our patients have been able to return to work within 10 days of the procedure. We do recommend that patients abstain from sexual intercourse for at least 2 weeks after the procedure or until any post-procedure discharge they may have been experiencing has stopped.

Potential Complications of UFE


UFE is a nonsurgical procedure but is still an invasive procedure, and as an invasive procedure, there are potential complications that all patients need to be aware of when considering this treatment option. Serious complications have been reported in 2-3% of patients undergoing this procedure worldwide.


Angiographic Complications

As a diagnostic test, angiography is performed routinely throughout the world. The potential complications of angiography are well established and include bleeding (around the groin where the catheter enters the artery), clot formation inside the artery which can potentially block the flow to the leg, and reactions to the X-ray contrast material used to take the pictures of the arteries. The X-ray contrast that is used is iodine-based and a variety of reactions to contrast are possible, including hives, coughing, and breathing difficulties.


Uterine Infection

This is one of the earliest reported complications of UFE. Since then, other infections have been reported with some patients successfully treated with antibiotics and others requiring a hysterectomy. In very rare cases, a severe infection can lead to uterine rupture or death. Given the potential severity of an infection, antibiotics are given to all of our patients in association with UFE. In addition, all patients with a prolonged fever (>7 days) are evaluated for a possible uterine infection with a pelvic examination, pelvic imaging, and blood work.


Uterine Injury (Ischemia)

The goal of embolization is to reduce the flow of blood to the fibroids while allowing flow to continue to the normal parts of the uterus. If normal flow is not maintained to the uterus, there is a chance that this muscle can be injured due to a lack of oxygen (uterine ischemia). These patients can present with pelvic pain that persists for several weeks beyond the expected post-embolization syndrome. A hysterectomy may be required for pain relief due to this complication.


Early Onset of Menopause

2-14% of patients report significant alterations in their menstrual cycles after UFE that ranges from temporary to permanent loss of normal menstrual cycles. The existence of the blood vessels connecting the circulation of the ovaries and uterus (collateral pathways) makes it possible for the embolic materials injected into a uterine artery during this procedure to enter the ovarian arterial circulation. This may potentially result in ovarian failure, the risk of which has been shown to increase in patients older than 45 years of age.


Transcervical Fibroid Passage

It is known that submucosal fibroids are at increased risk for being passed out of the uterus and vagina after UFE. This has been reported in 1-2% of patients and may not require any additional treatment or problems. Some patients may require further treatment to remove parts of the fibroid that are retained within the uterus in order to minimize the possibility of infection. Therefore, imaging is recommended in this situation in order to determine if any fibroid tissue has been retained within the uterine cavity. Importantly, good imaging is recommended prior to UFE because it may enable our physicians to assess the risk of this potential complication for each patient undergoing this procedure.


Deep Venous Thrombosis and/or Pulmonary Embolus

Blood clots in the veins of the leg and the lung have been rarely reported after UFE. It is felt that this complication is not unique to UFE but is rather a risk of any invasive procedure requiring some bed rest during the recovery period. As a result, we encourage our patients to walk within several hours of the procedure and to avoid prolonged bed rest. Additional preventative measures can be taken in patients felt to be at increased risk for blood clot formation.

Can UFE Affect Fertility?


The decision to undergo UFE if future pregnancy is desired is a complex one to make and should be made only after consultation with your gynecologist, an infertility specialist (if applicable), and an interventional radiologist. One of the reasons why this decision is so difficult is that so much of the information needed to make a truly informed decision is not yet known. Fibroids can cause infertility, but infertility due solely to the presence of fibroids is uncommon and it is often difficult to determine the contribution that fibroids are making to an individual patient’s infertility. If fibroids are thought to be responsible for infertility, than reducing the size of the fibroids may help improve chances for conception and a successful pregnancy, although this has not been proven or supported by any studies performed to date.

It is well known that many patients worldwide have become pregnant after UFE, including several patients who have undergone UFE at our institution. One problem with establishing a "pregnancy rate" after UFE is that it is difficult if not impossible to determine the number of patients actively trying to become pregnant after this procedure. However, several articles have now been published in the literature which have reported successful pregnancies thereby confirming the fact that UFE by no means automatically interferes with a patient’s ability to become pregnant and to carry a pregnancy successfully to term.

While this is encouraging, we also know that many things can happen after UFE that can potentially affect future pregnancy. The goal of UFE is to block the flow of blood in the uterine arteries and blood flow to the uterus is required for a successful pregnancy. While we know that flow does return in these arteries, the degree to which this happens varies among individual patients and may or may not be sufficient for pregnancy. After UFE, the wall of the uterus may potentially be weakened and it is not possible to know if this weakness will become a problem during pregnancy or during delivery.

It is also known that UFE can potentially result in decreased blood flow to the ovaries, which in some patients can lead to reduced ovarian function and loss of normal menstrual cycles or menopause. While this is a rare event in patients <45 years of age, it can be devastating to a patient planning on pregnancy after UFE. Ultimately, it is safe to say that at the present time, the long-term effects of UFE on the preservation of fertility and the ability of a patient to become pregnant and carry a pregnancy to term is not yet fully known.

For these reasons, we recommend that most patients desiring future fertility should seek an opinion regarding the role of myomectomy in their care. We consider myomectomy to be the first choice to consider in patients desiring future fertility because the ability of this procedure to both address symptoms and preserve fertility has been established in several reports published in the medical literature. While our own experience and the experience of almost every other high volume center in the country has been very encouraging, it is difficult to primarily recommend UFE in any patient wishing to preserve their fertility. That said, this experience does allow us to confidently offer UFE to patients that are not candidates for or do not wish to undergo a myomectomy.