Beyond Hysterectomy: Uterine Artery Embolization - American ...

Beyond Hysterectomy:
Uterine Artery Embolization
Kelvin Hong MD
Division of Vascular and Interventional Radiology
1

Who Gets Fibroids?
• Incidence increases with age
• 20% of women in their 20’s
• 40% of women in their 40’s
• Genetic predisposition
• African-American women at higher risk
• Familial tendencies

Waiting
2.9 Million
Women with Fibroids in US
5 Million U.S. Women
UFE
22,000
560,000
Fibroid Related
Interventions
225,000 hysterectomies
50,000 myomectomies
285,000 other procedures
Drug Therapy
1.4 Million
(Patients/Procedures)
Source: Management of Uterine Fibroids; US Dept of HHS, US Markets for Gynecology Devices, Millenium
Research US Opportunities in the Management of Benign Uterine Conditions, Health Research International

UTERINE
LEIOMYOMATA
U.S. STATISTICS
Most common pelvic mass in women
- prevalence: 20-40% (= millions)
- 75%: asymptomatic
- 25%: menorrhagia, pain, mass effect
600,000 Hysterectomies annually
- approximately 1/3 for fibroids
- cost: $4 Billion
Nat’l Ctr for Health Stats. Vital Health Stat Series No. 13 (92). 1987

Pelvic Embolizations:
Over TWO DECADES
Postpartum hemorrhage
Post-abortion, cesarean section
Bleeding ectopic pregnancy
Post-surgical hemorrhage
Trophoblastic disease
HIGH RATE OF SUCCESS
86-100% for all indications
Curr Opin Obstet Gynecol 1998;10:475-479
AJR 1979;133:152-154
Am J Obstet Gynecol 1997;176:938-948

PreviousTREATMENT OPTIONS
• Hysterectomy
• - curative, but irreversible
• Myomectomy
• - maintains fertility potential
• - more invasive
• - may not treat culprit fibroid
• Hormonal therapy
• - fibroids recur after discontinuation
J Obstet Gynecol Neonatal Nurs 1999;28:23-31
Obstet Gynecol Clin North Am 1995;22:781-789
J Am Assoc Gynecol Laparosc 1997;4:425-433

UTERINE ARTERY EMBOLIZATION
1995 - First reports from France
Ravina et al.
- preoperative embolization to decrease blood loss was
curative in many cases
1997 - Report of first U.S. experience
Goodwin et al.
- 11 Patients who failed conventional therapies
- 7 of 9 had clinical improvement
Controversial?
Lancet 1995;346:671-672
JVIR 1997;8:517-526

Pivotal change in 2008
- ACOG Guideline
The following
recommendations and
conclusions are based on
good and consistent scientific
evidence
(Level A):
“Based on long- and short-term
outcomes, uterine artery
embolization is a safe and
effective option for appropriately
selected women who wish to
retain their uteri.”

Common Fibroid Treatment Options
• Hormonal: GnRH agonist (Lupron)
• Open surgery (Hysterectomy, Myomectomy
• Minimally—invasive surgery (Lap
Myomectomy, hysteroscopic hysterectomy)
• UAE – Uterine Artery Embolization
• MRgUS – MR + HiFU

Causes
• Exact cause currently unknown
• Fibroids linked to estrogen
• Evidence that progesterone may stimulate
fibroid growth
• Genetic Predisposition ?
• Strong racial predilection

Symptoms
• Menorrhagia, Anemia
• Bulk symptoms: Pain, pressure, or feeling of fullness
• Frequent urination or constipation
• Bladder pressure leading to a constant urge to
urinate
• Dysparunia
• Infertility or miscarriage

UAE Eligibility considerations:
1. Are the fibroids causing the patient’s symptoms (many
causes of pain)?
2. Need to preserved Fertility? Then myomectomy
3. Are there any contraindications?
4. Patient’s personal /cultural wishes?

Ideal candidates for UAE:
• Most patients with symptomatic fibroids
• Patients with symptomatic fibroids and not
pregnant
• Patients wishing to avoid surgery and/or long
recovery
• Patients desiring uterine preservation
• Perimenopausal patients
• Poor surgical candidates
• Patients who do not desire future fertility

Contra-indications:
• Active Pelvic infection
• Uncorrectable coagulopathy
• Endometrial cancer
• Pedunculated Submucosal fibroid with narrow stalk
• Pedunculated Subserosal fibroid with narrow stalk
• Desire for fertility preservation
11/8/2012 14

Contra-indications
11/8/2012 15

Procedure basics:
Mechanism of Action

Embospheres (Merit):
FDA approval, on label for UAE

POST-PROCEDURE:
Overnight stay
15% of early d/c will need readmission
Opioid PCA
pelvic pain/ cramps
Anti-inflammatory medication
Fever control
JVIR 1997;8:517-526
Curr Opin Obstet Gynecol 1998;10:315-
320

Follow-up:
1. One month: looking for complications of procedure
2. 6 months: MRI short term outcome
3. 12 months: MRI Radiological, failures
– document size and number of fibroids
– check on symptom improvement
– bleeding may persist for several weeks
– patient may pass submucosal fibroids

Complications:
• Fibroid expulsion 3-7%
• Vaginal discharge 0-5%
• Endometritis/Infection 0-3%
• Ovarian failure 1-2%
• Contrast, medication allergies

RESULTS
Over 50,000 treated in U.S.
Technical success rates = average 98%
High rate of clinical success
- > 90% require no further treatment
- > 85% significant decrease bleeding
- > 90% decrease mass-effect
Average volume reduction
- uterus 35-40%
- fibroids 40-50%
Am J Obstet Gynecol 1997;176:938-948
Radiology 1998;208:625-629

UAE and Outcomes
• Satisfaction with UFE >90%
• Bleeding & Pain Improvement 80-96%
• Bulk Sx Improvement 80-96%
• Mean 50% reduction in fibroid
(range 20-78%)
Cumulative data results from 9 series >1200 pts

UAE Evidence:
• 23 articles from randomized studies
• 13 articles results of comparison to other
therapies
– REST Trial (UK trial-UFE vs Surgery,
primarily hysterectomy)
– Emmy Trial (Dutch_UFE vs Hysterectomy)
– Pinto Trial (UFE vs Hysterectomy)
– Mara Trial (UFE vs Myomectomy) Prague
Fertility 2008
– Hald Trial (Lap. UA occlusion vs UFE)

UFE, 37 y.o.

UFE, 42 y.o.

• Uterine Fibroid Embolization
Appeal::
• Treats all fibroids simultaneously
• Minimally invasive, complications infrequent
• Recurrence of treated fibroids rare
• Short recovery period, 1 week
• Minimal blood loss
• Conscious sedation – ‘twilight’ sedation
• Personal/ Cultural: Emotionally, physically, and
sexually

UAE for Adenomyosis
11/8/2012 30

UAE for Adenomyosis
benign disease with invasion
of endo- into myometrium
- diffuse or focal
- broadening of the junctional zone
exceeding 12 mm in
thickness
- with or without high intensity foci
(T2)
- enlarged uterus
11/8/2012 31

Types of Adenomyosis
benign disease with invasion
of endo- into myometrium
- diffuse or focal
- broadening of the junctional zone
exceeding 12 mm in
thickness
- with or without high intensity foci
(T2)
- enlarged uterus
11/8/2012 32

Types of Adenomyosis
•suffer dysmenorrhea and menorrhagia
- incidence in woman 40-55 yrs 20-30%
-accompanied with fibroids 15-50%
•Diagnose with imaging:
-TVUS quite reliable 70%
-MRI reliable 80%
-TVUS + MRI most reliable 90%
11/8/2012 33

Adenomyosis treatment options:
1. Medical treatment
- IUD (Mirena ®)
- hormon therapy
-GnRH-agonists
2. Surgery
- excision or enucleation (focal adenomyosis)
- hysterectomy (deep myometrial involvement)
3. Uterine artery embolization
4. Focused Ultrasound MR guided (future)
11/8/2012 34

Adenomyosis treatment options:
Uterine artery embolization: Indication
similar as for symptomatic fibroids
no relief of symptoms after
- medical therapy
- minimal surgery
ongoing symptoms
- menorrhagia
- dysmenorrhea and/or pelvic pain
- (mass effect)
Essentially Uterus preserving option; ‘stepping stone’
11/8/2012 35

Adenomyosis treatment options:
Uterine artery embolization
1. Technique almost indentical to Fibroids
2. End point of embolization is deeper penetration and slower
stagnantion of flow (complete stasis)
3. Infarction of abnormal myometrial tissue
11/8/2012 36

Adenomyosis treatment options:
Uterine artery embolization: evidence
effective therapy in fibroids: success (80-90%)
12 single center outcome studies: mostly mixed fibroid/
Adenomyosis setting
Overall 70-85% outcome success
11/8/2012 37

Adenomyosis treatment options:
Uterine artery embolization: evidence
Popovic et al. J Vasc Interv Radiol 2011: Jul;22(7):901-9
Uterine artery embolization for the treatment of adenomyosis: a review
-15 studies with a total of 511 patients
-results show significant improvements:
- 83% @ 1yr, 65% @ 3yrs of pure adenomyosis
- 93% @ 1yr, 82% @ 3 yrs of mixed adeno/ fibroids
11/8/2012 38

MR Guided Focused
Ultrasound (MRgFUS)

Treatment Options for
Symptomatic Fibroid
• Medical Treatment:
• Surgical Treatment:
- Open-myomectomy
- Laparoscopic-myomectomy
- Hysteroscopic myomectomy
- Hysterectomy
• Percutaneous Treatment (interventional radiology):
- Embolization
- MR guided focused Ultrasound
Surgery (MRgFUS)

Comparison of Treatment Options
Spectrum of Invasiveness
Expectant
Management Drug Therapy MRgFUS UAE Myomectomy Hysterectomy
Return to normal activity -- 1 -5 Day 5-7 Days 28-56 Days 28-56 Days
Hospital Days 0 0-1 1 Day 1-3 Days 2-5 Days
Procedure time 0 1-3 Hours 0.5-2 Hours 1-3 Hours 1.5-3.0 Hours

MR Guided Focused
Ultrasound
Non invasive focusing of sound waves
• FDA approved 2004
– Focused sound beam; like magnifying glass burning leaf
– Tissue traversed unaffected
– Thermal Energy tissue coagulates at temp 65-85
degrees C
• Hopkins Phillips MRgFUS 3T Achiva
system
– State of the Art: Volumetric treatment rather than single
point
– Shorter treatment times- 8hrs to 3 hrs

Advantage of MRgFUS Treatment
• Patient retains uterus
• Avoid open operation for catheters
• Avoid general anesthesia; Conscious
sedation
• Less invasive
• Less cost
• Potentially for uterus preservation and
fertility? No Uterine Artery

MR Findings
Pre-MRgFUS Immediately Post

Pre-MRgFUS

Post HIFUS

Conclusion:
• Increasing options for patients : spectrum of treatments
• UAE accepted treatment option with Level 1 evidence for
Fibroids, Level 2b for Adenomyosis
• Effective option with high efficacy :Uterus preserving
treatment option for Fibroids
• Patient requiring fertility preservation: surgical
myomectomy