6/24/2013 1 John C. Lipman, MD, FACR, FSIR Atlanta, Georgia Disclosure Educational grant: Merit Medical, Boston Scientific Urban Myths 1. Need bilateral embolization. 2. Contraindicated to treat large fibroids/large uterus. 3. UAE won’t work (contraindicated) in adenomyosis. 4. Need calibrated microsphere. 5. Menopause will occur if OAE. 6. Contraindicated to embolize pedunculated fibroids. 7. Patients must be observed overnight. 8. Procedural or post-procedural Abs required. 9. Sexual dysfxn will result from embolization proximal to cv branch. 10. Can’t embolize patients c pre-existing hydrosalpinx. 11. Foley catheter required. 12. Contraindicated to embolize intracavitary fibroids.
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Disclosure · PDF file · 2013-06-266/24/2013 4 UFE: Does size matter? Avoidance of UFE for large fibroids/large ut vol arose from early case reports describing serious complications.
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6/24/2013
1
John C. Lipman, MD, FACR, FSIR
Atlanta, Georgia
Disclosure Educational grant: Merit Medical, Boston Scientific
Urban Myths 1. Need bilateral embolization.
2. Contraindicated to treat large fibroids/large uterus.
3. UAE won’t work (contraindicated) in adenomyosis.
4. Need calibrated microsphere.
5. Menopause will occur if OAE.
6. Contraindicated to embolize pedunculated fibroids.
7. Patients must be observed overnight.
8. Procedural or post-procedural Abs required.
9. Sexual dysfxn will result from embolization proximal to cv branch.
10. Can’t embolize patients c pre-existing hydrosalpinx.
11. Foley catheter required.
12. Contraindicated to embolize intracavitary fibroids.
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2
Need Bilateral Embolization Based on early reports:
-Ravina et al Lancet 1995, 346: 671-2 uni emboclin failure based on post-op dye studies showing tumor supply from both UAs.
-Goodwin et al JVIR 1997, 8: 517-26 “one pt (the only woman who underwent uni embo) demonstrated no response to therapy.”
-Several case studies supported this but uni embo due to technical failure.
Need Bilateral Embolization McLucas et al Br J Rad 2002, 75: 122-6
-12 pts c uni embo
-Broke out anatomic uni embo from technical failures.
-4 pts c no UA on one side (3/4 responded, 4th lost)
-8 pts c technical failure: 5 of 8 had 2nd embo (4/5 responded, 5th lost).
Need Bilateral Embolization Bratby et al CVIR 2008, 31: 254-9.
-30 pts with elective uni embo vs 12 technical failure uni embo.
-86% clinical response @ 1yr in elective group
-58% for technical failure group
Spies et al JVIR 2011, 22(5): 716-22.
-28 elective uni embo vs. bilateral embo controls
-Similar clin results & degree of fibroid infarction
-Potential benefits: dec ut ischemiadec pain, dec potential ov risk, dec procedure timedec rad dose.
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Pre & 3 mos post Left UAE
Pre & 3 mos post Left UAE
Pre Left UAE
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UFE: Does size matter? Avoidance of UFE for large fibroids/large ut vol arose
from early case reports describing serious complications.
Vashisht A et al Lancet 1999, 354:307-8
Pelage et al Radiology 2000, 215: 428-31
-Reported ut fib diameter can be predisposing factor for rare but serious complications.
-Recommended UAE not be performed for fib >10cm.
Does size matter? con’t 1. Katsumori et al AJR 2003, 181: 1309-14 -47 pts c large fibroids from cohort of 152 pts
-X f/u 17 mos
-No increased risk based on size
2. Smeets et al CVIR 2010, 33:943-48 -71 consecutive pts, fib in 3 groups (>10cm and/or ut.vol >
700cm3)
-X age 42.5y, X f/u 2y
-Vast majority had substantial clinical sx improvement
-Rate of AE low, freq of additional treatments necessary no different than unselected pts
Does size matter ? con’t 3. Parthipun et al CVIR 2010, 33:955-59
-Prospective, single ctr, 121 pts, PVA & TAGM used
-Looked at complications
-3 tables: relationship of large fib size (>10cm), large ut. vol (>750cm3), and vials of embolic (>4) to complications.
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Parthipun et al Fibroid size >10cm <10cm
Complication 1 5 6
No complication 29 86 115
Total 30 91 121
Parthipun et al Fibroid vol >750cm3 <750cm3
Complication 2 4 6
No complication 50 65 115
Total 52 69 121
Parthipun et al Vol of embolic >4 vials <4 vials
Complication 1 4 5
No complication 50 24 74
Total 51 28 79
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Does Size Matter con’t 4. Choi HJ et al JVIR 2013, 24:772-8.
-Retrospective, single ctr, 323 pts
-2 grps: 63 pts (longest axis > 10cm or vol > 700cm3 ) & 260 pts control group.
-No difference in:
-Vol. reduction of dominant fibroid
-%volume reduction of uterus
-Symptom satisfaction scores (@ 1 & 3mos)
-Complication rate
Adenomyosis Presence of endometrial islets in sub-
endometrium/myometrium (usu >2.5mm deep to junctional zone)
Present in up to 40% hysterectomy specimens
75% asymptomatic
Similar sxs to fibroids (pain, bleeding) also dyspareunia.
Adenomyosis Pelage et al Radiology 2005, 234: 98-53.
mg bid or levofloxacin 500 mg qd and metronidazole
500 mg bid
• > 102 oF + constitution symptoms
– Seen in IR clinic or ED
– MRI
– UA, CBC, Gyn
• Consider admission for IV antibiotics: Cefoxitin, 2 g
intravenously every 6 hours, or cefotetan, 2 g every 12
hours, plus doxycycline, 100 mg intravenously or orally
every 12 hours.
• Read more: Pelvic Inflammatory Disease (PID;
Salpingitis, Endometritis) -Gynecology articles -
http://www.health.am/gyneco/more/pelvic_inflam
matory_disease_pid_salpingitis_endometritis/#ix
zz2C9CWb4e6
*Walker and Pelage BJOG 2002; 109:1262
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Post embolization late fever
• Endometritis
• Pyometra
• Myometritis
• TOA
• UTI
• Post- embo syndrome
Pre UFE Post UFE day 12
with fever 102oF
IV antibiotics
Post-embo pain and fever
Pre embo 5 days post embo with pain & 104o F
Serosal surface
Endometrial surface
AJR 2005 184:555
Partial infarction
Pre UAE Post 2 weeks
Complaints of malaise and low grade fever
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Partial infarction
Patient was stable, with intermittent fevers and malaise
3 weeks post, normal wbc, decided to have hysterectomy
Fibroid expulsion
• Submucosal/ transmural fibroids
• Asymptomatic to cramps ± low grade fever
– Bulk versus sloughing
– Weeks to years post UAE in 5% of pts
• Infection from bacterial reflux through the cervix
Endometrium
Myometrium
submucosal/
transmural fibroid
sloughing
bulk expulsion
Afebrile Febrile
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HUP expulsion study
• 37/759 patients: 12 nulliparous; 25 parous
• Time to expulsion: ~ 3 months
• Average fibroid size ~ 8.3 cm. (1.6 -15 cm)
• 35 had clinical symptoms
– 4 sloughing fibroids complaining primarily of a
discharge
– 31 had bulk expulsion with cramps +/- fever
JVIR 2011; 22:1586
Outcomes
• 20 @ home or office (54%), 10
transvaginal myos, 3 hysteroscopies
• 4 emergent hysterectomies (infection)
–All bulk expellers
–3 nulliparous (3/12),1 parous(1/25)
–25% vs 4% p= 0.09 Fisher’s exact
• 2 late hysterectomies due to
discharge/sloughing (elective)- 1.3, 2 yrs
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Frequency of expulsion/months
after UAE
JVIR 2011; 22:1586
Expulsion: Bulk
Endometrium
Myometrium
Cause of expulsion: Infection with endometrial contact due to
reflux of bacteria thru cervix
submucosal/
transmural
fibroid
Bulk expulsion
Pre UAE 2 months post
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Fibroid expulsion
Post-TVM
Bulk expulsion over several weeks managed with antibiotics
Saggital MR post gad, initial 6 weeks
Multiparous women with persistent 102 fever on antibiotics
Sag T2 Pre Post with fever and *pus
*
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Expulsion: Sloughing
Endometrium
Myometrium
cause of expulsion: Infection with endometrial contact due to
reflux of bacteria thru cervix
submucosal/
transmural
fibroid
Sloughing expulsion
sag T2 pre-UAE 6 months post-UAE
3 months post-UAE 15 months post-UAE
How sick is the patient?
How concerned/conservative is
the your surgeon?
How resolved/prepared is the
patient?
Hysterectomy risk ~1%
(recommend/urge surgery)
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UAE complications: Conclusions
• Infections and expulsion are the most
likely complications that need to be
managed by IR.
• Expulsion is relatively infrequent with a
range of symptoms.
• Generally expulsion is well tolerated but
may need other procedures.
• Parous patients with expulsion seem to
do better than nulliparous patients.
1
UFE Practice Building: A Fifteen Year Experience
Northwestern IR UFE History
Began UFE practice in 1996
Slow growth of UFE volume 1996-1999
25-40 annually
Principally based on Northwestern gyne referrals
Many talks given to hospital and local gynecologists
Northwestern IR UFE History
Many internal discussions about how to achieve UFE growth:
Patient-centric vs.
Gynecologist-centric (Spies)
NMH Ad campaign….
2
NMH Ad campaign
Volume of patient calls quadrupled
UFE volume doubled year-over year
Answered “the question” for our practice definitively
Does Ford Refer Customers to General Motors?
3
Targeted marketing for Uterine Fibroid Patients
Targeted marketing for Uterine Fibroid Patients
Target market: African-American women age 35-45
Local weekly magazine—8 weeks worth of ads
Tracked outcome
Targeted UFE marketing: Results
90 calls
35 clinic visits 17 UFEs—27% increase in volume over three
months
Cost: $8000
Professional revenue (includes MR): $58,000
Rate of return: 625%
Conclusion: Patient-oriented advertising has an immediate positive effect on a UFE practice
4
Phase 2—Radio advertising
Radio ad targeted at A-A women using a local station whose principal demographic is Black women
5 days/ week for 12 weeks (2-3 spots/day)—Cost $40,000
Phase 2—Radio advertising Results
361 calls resulting in:
58 evaluative pelvic MRIs
53 clinic visits with E&M billing
32 UFE procedures
32 follow-up MRIs
11 new patient referrals to gyne
Conclusion
UFE is an ideal model for patient-targeted marketing of new medical procedures Most patients know their diagnosis
Common disease
UFE readily managed by IRs
Very positive for IR and DR IO and UFE practice docs now in top 10 of
referring MDs for imaging studies
5
Northwestern UFE Program
2 MDs
3 full-time staff
1 APN
1 secretarial staff
1 medical assistant
Currently performing 350 UFEs per year
65% are self-referred
The Impact of Direct Consumer Marketing on a Uterine Fibroid Embolization(UFE) Program
Chrisman HB, Omary RO,Nemcek A, et al
Northwestern University Medical School
Background
IR: Historic reliance on referrals from “competitors”.
Recognition that gynecology referrals at NMH were decreasing
Belief that a strategy based on
“competitor” referrals is flawed
6
Purpose
Test hypothesis that direct consumer marketing minimizes need for gynecologist’s referrals
Materials and Methods
Prospective UFE database (1998) including origin of referral
Strategy A (1998-2000) : Educating Gynecologists
Strategy B (2001-present): Direct Consumer Marketing
Chi-Square test
Results
Gynecology referrals
1998---20/24(83%)
2001---14/160(9%)
Self Referral (Media/Family)
1998---4/24(17%)
2001---142/160(89%)
Chi-Square test p<0.001
7
Results
Gynecology referrals decreased numerically and as an overall percentage
Self-referral increased numerically and as an overall percentage
Percentage referrals from Gynecology
0
10
20
30
40
50
60
70
80
90
1 2 3 4
Year
perc
en
t
Series1
NMH ANNUAL UFE VOLUMES
0
20
40
60
80
100
120
140
160
180
1 2 3 4
year
tota
l
Series1
Linear (Series1)
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Conclusions
Direct consumer marketing is a successful alternative strategy
Sole reliance on gynecological referrals may not allow for a successful, sustainable UFE program
Fibroids: “To Compete or not to compete…”
Questions
How many IRs get the majority of referrals from gynecology?
Do you ask the patient if UFE was given as an option?
How many IRs get majority of referrals from primary care or other specialties?
How many IRs have shared clinic? Shared marketing? Shared economics?
9
Northwestern UFE Program
Established in 1996 Two dedicated IRs, full-time nurse, medical
assistant, administrative assistant Annual volume ranges between 280-320 UFEs Program volume and growth related to direct
consumer marketing Good relationship with gynecology, but limited
referral Top referring gynecologist works at free
women’s clinic
What they really think about IR
What do we mean by Competition
Limited resources, survival of species (Darwin) Market Share and Profitability (economics) In health care, the role of competition is good in a broad sense to help control cost, but in specific disease states not good for the patient Patients have limited ability to understand product and limited ability to “try” product Unfortunately many physicians are still driven by their own compensation and patients left vulnerable I believe that many gynecologists are unwilling to consider UFE as a true option for their patients
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Competition
All successful UFE programs are competing
Attempts to initiate UFE program without effective “competitive” model is doomed to fail.
Successful competitive model leads to successful collaboration
e.g. NW Vein center
Collaborate with Competitors
Shared marketing
Promote women's health care and fibroid therapy
Cross-promotion
Acknowledge options
Shared expertise
Referrals
Expense sharing
Clinic space, staff
Integrated Service Model
Shared economics!
The simplest model--a true integrated service model will allow for the removal of any economic incentives and align economics
11
Life Cycle of a Successful UFE Program
Competition
Collaboration with Competitors
Integrated Service Model
Successful for the patient
Question is not whether competition is the right approach but when can you begin considering collaboration and integration