In
July 1997, the Vascular and Interventional Radiology Section of Georgetown
University Medical Center began a protocol to study uterine artery embolization
as a treatment for fibroids. Our initial focus was on the safety, effectiveness,
and durability of the procedure in controlling symptoms. For a summary
of our initial patient outcomes, please review the section of Georgetown
Experience. In recent years, uterine embolization has become an accepted
part of the management of fibroids in our practice. We believe that our
own initial results and those published by others have established the
safety and effectiveness of this treatment. It is important for us to
determine whether uterine embolization permanently relieves symptoms,
whether the fibroids can grow back, and whether there are any other long-term
effects. We continue to follow the first 200 patients we have treated
to obtain detailed information on the long-term outcome of this procedure.
We also continue to research specific questions about the technique of
uterine embolization and we continue to study and refine outcome measures
for therapies for fibroids. In addition we are one of the leading sites
contributing data to the national uterine FIBROID Registry, which will
help determine the effectiveness of UAE.

Georgetown University Pre-Procedure Evaluation
Potential
candidates for uterine embolization include those patients with symptomatic
fibroids. Whether UAE is the best option for an individual patient can
only be determined after a preliminary evaluation is completed.

Pre-Procedure Gynecologic Evaluation:
- Each patient
should have a pelvic examination by her gynecologist within six months
of the procedure. We will need a copy of the records for the most
recent gynecology office visit.
- We also need
the results of the most recent Pap smear, which must be within the
last year and should be normal.
- For patients
with abnormal uterine bleeding (periods lasting longer than 10 days
or periods more frequently than every 21 days) , an endometrial biopsy
should be done, preferably within the preceding 3 to 6 months. This
is to be certain that endometrial carcinoma or hyperplasia is not
present. We usually decide if an endometrial biopsy is needed at the
time of the interventonal radiology consultation.
- If the patient
has a history of pelvic infection within 2 years, cultures for Gonorrhea
and Chlamydia should be obtained.
This evaluation may be done by your
gynecologist: you do not need to be seen by a Georgetown Gynecologist.

Pre-Procedure Radiology Evaluation:
- All patients
will be required to have a pre-procedure evaluation by the interventional
radiology staff at Georgetown. This allows us to obtain a gynecologic
and general medical history, perform a brief physical examination,
review the imaging findings and to discuss the procedure with the
patient.
- The patient must
not be pregnant. We will confirm this with a pregnancy test the day
of the procedure.
- A blood count
and follicle stimulating hormone blood test will be obtained on the
day of the procedure. If the patient has a history of kidney disease
or coagulation defect, further laboratory testing may be required.
- An MRI of the
pelvis must be obtained. We prefer that this be done at Georgetown
to ensure uniformity of imaging. We have instituted a reduced charge
for this study. If the MRI is done at another site, the study must
be done with and without contrast and include length, width, and depth
of the uterus and the dimensions of the identifiable dominant fibroids.
The study must also be of sufficient quality to allow adequate detail
of the fibroids and the lining of the uterus. If these are not done,
the study will have to be repeated.
Preparing for the Procedure
On
the day of your procedure, you should not have anything to eat or drink
by mouth (unless we have given you special instructions to the contrary).
This will allow us to give medication to sedate you during the procedure.
You may take any prescription medications by mouth with a sip of water.

We will give you a specific time to arrive, usually 2 hours before your
procedure is to start. This will allow time for you to register and
to be changed into a hospital gown. We will need time to start an intravenous
line, to obtain blood and urine tests, and to answer any last minute
questions you may have.

We usually obtain a blood sample to check your blood count on the day
of the procedure. In special circumstances, we might obtain other blood
tests. If you are more than 10 days from the start of your last period,
we will need to confirm you are not pregnant with a urine pregnancy
test.

We also need to place a catheter in your bladder, so that the bladder
will remain empty during the procedure. Since the bladder is directly
in front of the uterus, it is important that it does not fill during
the procedure or it would obscure our view.

The
Procedure
The
procedure is usually done in the hospital with an overnight stay post-procedure.
The patient is sedated and very sleepy during the procedure. Initially,
a needle is used to enter the artery to provide access for the catheter.
Local anesthesia is used, so the needle puncture is not painful. The
catheter is advanced over the branch of the aorta and into the uterine
artery on the side opposite the puncture. At Georgetown, a second arterial
catheter is placed from the opposite femoral artery to the other uterine
artery and the embolizaton of the fibroids is done from both sides simultaneously.

We routinely use polyvinyl alcohol particles or Embospheres to block
the fibroid arteries. In recent months, we have begun to favor Embospheres
as they allow for a more controlled embolization and it is easier to
preserve flow to the normal parts of the uterus. We have used gelfoam
for uterine embolization in only one patient and it was in a patient
with primary adenomyosis. While others have used it more frequently,
there is not yet any data that confirms that the uterine artery is likely
to open up after embolization. For a more detailed discussion of the
various substances used to block the arteries, please review the page
on embolic agents.

After the embolization is complete, a final arteriogram is performed
to be sure the fibroid flow is blocked. Usually we will obtain images
of the ovarian arteries in addition to be sure there is no contribution
of blood flow to the fibroids.

When the procedure is finished, the catheters are removed and the puncture
sites are compressed for 15 to 20 minutes. The patient must remain at
bedrest for 6 hours after the procedure in order to prevent bleeding
from the puncture sites. As an alternative to compression and bed rest,
we are now on some occasions using a closure device to seal the puncture
sites. If these devices are used, no compression is needed and the patient
is able to get up 2 hours after the procedure.

Post-Procedure:
What to expect
Pain
Most patients will experience several hours of moderate to severe pain
after the procedure. It is believed that this pain is due to the death
(infarction) of the fibroids, similar to a heart attack. Temporary decrease
in the blood supply to the normal portions of the uterus may also contribute
to the pain.

The severity of pain is quite variable. Approximately 20% of patients
have little or no pain after the procedure. About 20% of patients will
have severe pain that may last for several hours. Most patients have
pain some where in between the two extremes. We have completed a study
at Georgetown to determine the severity of the pain after UAE and whether
its severity can be predicted. Unfortunately, the severity of pain is
not predictable based on the size of the uterus or the size of the fibroids.
Some patients with very large fibroids have minimal pain and some with
small fibroids have severe pain. The pain usually begins to diminish
after 4 to 6 hours. Parenthetically, the severity of the pain also does
not predict outcome. Severe pain does not correlate with a better outcome.

Since pain does not have any value in predicting outcome, it should
be treated aggressively to ensure that the patient has a tolerable procedure.
Most centers use a combination of anti-inflammatory medicines (such
as Motrin) and narcotics (such as morphine) to control the pain. The
most common means of providing the narcotics is via a PCA pump, which
is a device attached to the patient's intravenous line. PCA stands for
patient controlled analgesia. If pain occurs, the patient is able to
press a button and administer a dose of pain medication. Many studies
have demonstrated that PCA pumps are more reliable in controlling pain
than nurse administered doses. The large majority of patients at Georgetown
and elsewhere are managed with PCA pumps after the procedure. This is
not to say that there are not effective alternatives. There has been
research on the effectiveness of using an "all oral" medication regimen,
without any injected drugs.

Some centers, including Georgetown, offer the alternative of epidural
pain control. With epidural pain control, a tiny tube is placed in the
spinal canal outside the sac where the nerves lie. This is usually done
by an anesthesiologist. It is the same procedure that is commonly used
during labor, but the legs are not numbed. After the procedure, pain
medications are given via the epidural catheter. Although the use of
an epidural catheter is more invasive than an intravenous line, the
pain control may be better. As of yet a study has not been completed
comparing the two methods of pain management.

Nausea and Vomiting
Another frequent side effect of uterine embolization is nausea and vomiting.
This may be caused by the death of the fibroid tissue or as a result
of the pain control medications. The nausea can usually be controlled
by medications and most physicians performing uterine embolization provide
standing orders for nausea medicine if needed.

Because the severity of the symptoms from uterine embolization is very
variable, many centers routinely observe patients in the hospital overnight.
Under most insurance plans, this is still considered an outpatient procedure,
because the length of stay is less than 24 hours.

After
discharge from the hospital: What to expect
Most
patients will have recurrent cramping pelvic pain over several days
after discharge. Usually this pain feels like menstrual cramps. On occasion,
the pain may become severe. At Georgetown, patients are given an anti-inflammatory
medicine to take continuously for four days. This is supplemented by
oral narcotics as needed.

Nausea may also recur and medication is also provided for this. Fever
is common and is a side effect of the death of the fibroid tissue. Most
patients feel as if they have the flu for several days. All these symptoms
begin to improve after 4 to 5 days and most patients are ready to return
to work 7 to 10 days after the procedure.

For a more detailed discussion of the post-procedure recovery, review
our post-discharge instructions.

Georgetown
University Follow-up Protocol
We
call the patient the day after discharge to be sure that there are no
unusual problems and to answer any questions the patient may have. We
will also arrange for a follow-up visit 1 week after the procedure.
At that visit we will check the puncture sites and intravenous site
to be sure they have healed and we will review the progress of your
recovery. At that time we usually release a patient to return to full
activity. We will call the patient 30 days after the procedure to be
sure that no problems or gynecologic procedures have been required.

To follow the progress of the symptoms, we will send questionnaire 3
months post-procedure. Follow-up imaging with MRI is at 3 months. If
symptom improvement has occurred and the images shows the fibroids have
died and are shrinking, then further follow-up is on an as needed basis.
For many of our research protocols, we have longer and more detailed
follow-up.

We ask that all the patients we treat allow us to anonymously submit
baseline and procedure data to the national FIBROID
registry. A fibroid-specific symptom and quality of life questionnaire
and a short questionnaire will be sent to a randomly selected group
of patients at 6 months, 12 months and 24 months after the procedure.
We hope to obtain federal funding to continue follow-up for up to five
years in this registry.

We consider this procedure and the MRI before and 3 months after the
procedure to be standard medical care and therefore bills will be submitted
to the patient's insurance as usual. Any additional imaging that is
done for research purposes will be provided at no charge to the patient.

For
more information

If you would like
to consider this procedure or would like more information, you may call
James B. Spies M.D. of Georgetown Interventional Radiology at (202)
784-5478 to make an appointment. You may also contact him via email
FIBROIDINFO@gunet.georgetown.edu.
We would also be happy to discuss uterine embolization with your gynecologist.
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