Beyond Hysterectomy: Uterine Artery Embolization - American ...
Beyond Hysterectomy: Uterine Artery Embolization - American ...
Beyond Hysterectomy: Uterine Artery Embolization - American ...
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
<strong>Beyond</strong> <strong>Hysterectomy</strong>:<br />
<strong>Uterine</strong> <strong>Artery</strong> <strong>Embolization</strong><br />
Kelvin Hong MD<br />
Division of Vascular and Interventional Radiology<br />
1
Who Gets Fibroids?<br />
• Incidence increases with age<br />
• 20% of women in their 20’s<br />
• 40% of women in their 40’s<br />
• Genetic predisposition<br />
• African-<strong>American</strong> women at higher risk<br />
• Familial tendencies
Waiting<br />
2.9 Million<br />
Women with Fibroids in US<br />
5 Million U.S. Women<br />
UFE<br />
22,000<br />
560,000<br />
Fibroid Related<br />
Interventions<br />
225,000 hysterectomies<br />
50,000 myomectomies<br />
285,000 other procedures<br />
Drug Therapy<br />
1.4 Million<br />
(Patients/Procedures)<br />
Source: Management of <strong>Uterine</strong> Fibroids; US Dept of HHS, US Markets for Gynecology Devices, Millenium<br />
Research US Opportunities in the Management of Benign <strong>Uterine</strong> Conditions, Health Research International
UTERINE<br />
LEIOMYOMATA<br />
U.S. STATISTICS<br />
Most common pelvic mass in women<br />
- prevalence: 20-40% (= millions)<br />
- 75%: asymptomatic<br />
- 25%: menorrhagia, pain, mass effect<br />
600,000 Hysterectomies annually<br />
- approximately 1/3 for fibroids<br />
- cost: $4 Billion<br />
Nat’l Ctr for Health Stats. Vital Health Stat Series No. 13 (92). 1987
Pelvic <strong>Embolization</strong>s:<br />
Over TWO DECADES<br />
Postpartum hemorrhage<br />
Post-abortion, cesarean section<br />
Bleeding ectopic pregnancy<br />
Post-surgical hemorrhage<br />
Trophoblastic disease<br />
HIGH RATE OF SUCCESS<br />
86-100% for all indications<br />
Curr Opin Obstet Gynecol 1998;10:475-479<br />
AJR 1979;133:152-154<br />
Am J Obstet Gynecol 1997;176:938-948
PreviousTREATMENT OPTIONS<br />
• <strong>Hysterectomy</strong><br />
• - curative, but irreversible<br />
• Myomectomy<br />
• - maintains fertility potential<br />
• - more invasive<br />
• - may not treat culprit fibroid<br />
• Hormonal therapy<br />
• - fibroids recur after discontinuation<br />
J Obstet Gynecol Neonatal Nurs 1999;28:23-31<br />
Obstet Gynecol Clin North Am 1995;22:781-789<br />
J Am Assoc Gynecol Laparosc 1997;4:425-433
UTERINE ARTERY EMBOLIZATION<br />
1995 - First reports from France<br />
Ravina et al.<br />
- preoperative embolization to decrease blood loss was<br />
curative in many cases<br />
1997 - Report of first U.S. experience<br />
Goodwin et al.<br />
- 11 Patients who failed conventional therapies<br />
- 7 of 9 had clinical improvement<br />
Controversial?<br />
Lancet 1995;346:671-672<br />
JVIR 1997;8:517-526
Pivotal change in 2008<br />
- ACOG Guideline<br />
The following<br />
recommendations and<br />
conclusions are based on<br />
good and consistent scientific<br />
evidence<br />
(Level A):<br />
“Based on long- and short-term<br />
outcomes, uterine artery<br />
embolization is a safe and<br />
effective option for appropriately<br />
selected women who wish to<br />
retain their uteri.”
Common Fibroid Treatment Options<br />
• Hormonal: GnRH agonist (Lupron)<br />
• Open surgery (<strong>Hysterectomy</strong>, Myomectomy<br />
• Minimally—invasive surgery (Lap<br />
Myomectomy, hysteroscopic hysterectomy)<br />
• UAE – <strong>Uterine</strong> <strong>Artery</strong> <strong>Embolization</strong><br />
• MRgUS – MR + HiFU
Causes<br />
• Exact cause currently unknown<br />
• Fibroids linked to estrogen<br />
• Evidence that progesterone may stimulate<br />
fibroid growth<br />
• Genetic Predisposition ?<br />
• Strong racial predilection
Symptoms<br />
• Menorrhagia, Anemia<br />
• Bulk symptoms: Pain, pressure, or feeling of fullness<br />
• Frequent urination or constipation<br />
• Bladder pressure leading to a constant urge to<br />
urinate<br />
• Dysparunia<br />
• Infertility or miscarriage
UAE Eligibility considerations:<br />
1. Are the fibroids causing the patient’s symptoms (many<br />
causes of pain)?<br />
2. Need to preserved Fertility? Then myomectomy<br />
3. Are there any contraindications?<br />
4. Patient’s personal /cultural wishes?
Ideal candidates for UAE:<br />
• Most patients with symptomatic fibroids<br />
• Patients with symptomatic fibroids and not<br />
pregnant<br />
• Patients wishing to avoid surgery and/or long<br />
recovery<br />
• Patients desiring uterine preservation<br />
• Perimenopausal patients<br />
• Poor surgical candidates<br />
• Patients who do not desire future fertility
Contra-indications:<br />
• Active Pelvic infection<br />
• Uncorrectable coagulopathy<br />
• Endometrial cancer<br />
• Pedunculated Submucosal fibroid with narrow stalk<br />
• Pedunculated Subserosal fibroid with narrow stalk<br />
• Desire for fertility preservation<br />
11/8/2012 14
Contra-indications<br />
11/8/2012 15
Procedure basics:<br />
Mechanism of Action
Embospheres (Merit):<br />
FDA approval, on label for UAE
POST-PROCEDURE:<br />
Overnight stay<br />
15% of early d/c will need readmission<br />
Opioid PCA<br />
pelvic pain/ cramps<br />
Anti-inflammatory medication<br />
Fever control<br />
JVIR 1997;8:517-526<br />
Curr Opin Obstet Gynecol 1998;10:315-<br />
320
Follow-up:<br />
1. One month: looking for complications of procedure<br />
2. 6 months: MRI short term outcome<br />
3. 12 months: MRI Radiological, failures<br />
– document size and number of fibroids<br />
– check on symptom improvement<br />
– bleeding may persist for several weeks<br />
– patient may pass submucosal fibroids
Complications:<br />
• Fibroid expulsion 3-7%<br />
• Vaginal discharge 0-5%<br />
• Endometritis/Infection 0-3%<br />
• Ovarian failure 1-2%<br />
• Contrast, medication allergies
RESULTS<br />
Over 50,000 treated in U.S.<br />
Technical success rates = average 98%<br />
High rate of clinical success<br />
- > 90% require no further treatment<br />
- > 85% significant decrease bleeding<br />
- > 90% decrease mass-effect<br />
Average volume reduction<br />
- uterus 35-40%<br />
- fibroids 40-50%<br />
Am J Obstet Gynecol 1997;176:938-948<br />
Radiology 1998;208:625-629
UAE and Outcomes<br />
• Satisfaction with UFE >90%<br />
• Bleeding & Pain Improvement 80-96%<br />
• Bulk Sx Improvement 80-96%<br />
• Mean 50% reduction in fibroid<br />
(range 20-78%)<br />
Cumulative data results from 9 series >1200 pts
UAE Evidence:<br />
• 23 articles from randomized studies<br />
• 13 articles results of comparison to other<br />
therapies<br />
– REST Trial (UK trial-UFE vs Surgery,<br />
primarily hysterectomy)<br />
– Emmy Trial (Dutch_UFE vs <strong>Hysterectomy</strong>)<br />
– Pinto Trial (UFE vs <strong>Hysterectomy</strong>)<br />
– Mara Trial (UFE vs Myomectomy) Prague<br />
Fertility 2008<br />
– Hald Trial (Lap. UA occlusion vs UFE)
UFE, 37 y.o.
UFE, 42 y.o.
• <strong>Uterine</strong> Fibroid <strong>Embolization</strong><br />
Appeal::<br />
• Treats all fibroids simultaneously<br />
• Minimally invasive, complications infrequent<br />
• Recurrence of treated fibroids rare<br />
• Short recovery period, 1 week<br />
• Minimal blood loss<br />
• Conscious sedation – ‘twilight’ sedation<br />
• Personal/ Cultural: Emotionally, physically, and<br />
sexually
UAE for Adenomyosis<br />
11/8/2012 30
UAE for Adenomyosis<br />
benign disease with invasion<br />
of endo- into myometrium<br />
- diffuse or focal<br />
- broadening of the junctional zone<br />
exceeding 12 mm in<br />
thickness<br />
- with or without high intensity foci<br />
(T2)<br />
- enlarged uterus<br />
11/8/2012 31
Types of Adenomyosis<br />
benign disease with invasion<br />
of endo- into myometrium<br />
- diffuse or focal<br />
- broadening of the junctional zone<br />
exceeding 12 mm in<br />
thickness<br />
- with or without high intensity foci<br />
(T2)<br />
- enlarged uterus<br />
11/8/2012 32
Types of Adenomyosis<br />
•suffer dysmenorrhea and menorrhagia<br />
- incidence in woman 40-55 yrs 20-30%<br />
-accompanied with fibroids 15-50%<br />
•Diagnose with imaging:<br />
-TVUS quite reliable 70%<br />
-MRI reliable 80%<br />
-TVUS + MRI most reliable 90%<br />
11/8/2012 33
Adenomyosis treatment options:<br />
1. Medical treatment<br />
- IUD (Mirena ®)<br />
- hormon therapy<br />
-GnRH-agonists<br />
2. Surgery<br />
- excision or enucleation (focal adenomyosis)<br />
- hysterectomy (deep myometrial involvement)<br />
3. <strong>Uterine</strong> artery embolization<br />
4. Focused Ultrasound MR guided (future)<br />
11/8/2012 34
Adenomyosis treatment options:<br />
<strong>Uterine</strong> artery embolization: Indication<br />
similar as for symptomatic fibroids<br />
no relief of symptoms after<br />
- medical therapy<br />
- minimal surgery<br />
ongoing symptoms<br />
- menorrhagia<br />
- dysmenorrhea and/or pelvic pain<br />
- (mass effect)<br />
Essentially Uterus preserving option; ‘stepping stone’<br />
11/8/2012 35
Adenomyosis treatment options:<br />
<strong>Uterine</strong> artery embolization<br />
1. Technique almost indentical to Fibroids<br />
2. End point of embolization is deeper penetration and slower<br />
stagnantion of flow (complete stasis)<br />
3. Infarction of abnormal myometrial tissue<br />
11/8/2012 36
Adenomyosis treatment options:<br />
<strong>Uterine</strong> artery embolization: evidence<br />
effective therapy in fibroids: success (80-90%)<br />
12 single center outcome studies: mostly mixed fibroid/<br />
Adenomyosis setting<br />
Overall 70-85% outcome success<br />
11/8/2012 37
Adenomyosis treatment options:<br />
<strong>Uterine</strong> artery embolization: evidence<br />
Popovic et al. J Vasc Interv Radiol 2011: Jul;22(7):901-9<br />
<strong>Uterine</strong> artery embolization for the treatment of adenomyosis: a review<br />
-15 studies with a total of 511 patients<br />
-results show significant improvements:<br />
- 83% @ 1yr, 65% @ 3yrs of pure adenomyosis<br />
- 93% @ 1yr, 82% @ 3 yrs of mixed adeno/ fibroids<br />
11/8/2012 38
MR Guided Focused<br />
Ultrasound (MRgFUS)
Treatment Options for<br />
Symptomatic Fibroid<br />
• Medical Treatment:<br />
• Surgical Treatment:<br />
- Open-myomectomy<br />
- Laparoscopic-myomectomy<br />
- Hysteroscopic myomectomy<br />
- <strong>Hysterectomy</strong><br />
• Percutaneous Treatment (interventional radiology):<br />
- <strong>Embolization</strong><br />
- MR guided focused Ultrasound<br />
Surgery (MRgFUS)
Comparison of Treatment Options<br />
Spectrum of Invasiveness<br />
Expectant<br />
Management Drug Therapy MRgFUS UAE Myomectomy <strong>Hysterectomy</strong><br />
Return to normal activity -- 1 -5 Day 5-7 Days 28-56 Days 28-56 Days<br />
Hospital Days 0 0-1 1 Day 1-3 Days 2-5 Days<br />
Procedure time 0 1-3 Hours 0.5-2 Hours 1-3 Hours 1.5-3.0 Hours
MR Guided Focused<br />
Ultrasound<br />
Non invasive focusing of sound waves<br />
• FDA approved 2004<br />
– Focused sound beam; like magnifying glass burning leaf<br />
– Tissue traversed unaffected<br />
– Thermal Energy tissue coagulates at temp 65-85<br />
degrees C<br />
• Hopkins Phillips MRgFUS 3T Achiva<br />
system<br />
– State of the Art: Volumetric treatment rather than single<br />
point<br />
– Shorter treatment times- 8hrs to 3 hrs
Advantage of MRgFUS Treatment<br />
• Patient retains uterus<br />
• Avoid open operation for catheters<br />
• Avoid general anesthesia; Conscious<br />
sedation<br />
• Less invasive<br />
• Less cost<br />
• Potentially for uterus preservation and<br />
fertility? No <strong>Uterine</strong> <strong>Artery</strong>
MR Findings<br />
Pre-MRgFUS Immediately Post
Pre-MRgFUS
Post HIFUS
Conclusion:<br />
• Increasing options for patients : spectrum of treatments<br />
• UAE accepted treatment option with Level 1 evidence for<br />
Fibroids, Level 2b for Adenomyosis<br />
• Effective option with high efficacy :Uterus preserving<br />
treatment option for Fibroids<br />
• Patient requiring fertility preservation: surgical<br />
myomectomy