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INTERVENTIONAL RADIOLOGY: U TERINE F IBROID E MBOLIZATION. David M. Hovsepian, M.D. Professor of Radiology Stanford University School of Medicine Chief Quality and Safety Officer Department of Radiology Stanford Hospital University Medical Center. What is IR ?. What is IR ?.
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INTERVENTIONAL RADIOLOGY:UTERINE FIBROID EMBOLIZATION David M. Hovsepian, M.D. Professor of Radiology Stanford University School of Medicine Chief Quality and Safety Officer Department of Radiology Stanford Hospital University Medical Center
What is IR ? • Consultation and evaluation • Interventional Radiology Clinic • Examining room • Diagnostic procedures and therapeutic interventions • NOT radiation treatments • Admissions, in-hospital rounds, and long-term management
Procedures • NON-VASCULAR • GI tract and biliary tree • Urinary tract • Drainage via US/CT/Fluoro • VASCULAR • Arteriography and embolization • Venous access • Thrombolysis • IVC Filters
The History of UFE • 1995 - First reports from France • Value of pre-operative embolization • Multicenter trial of 31 patients • Significantly decreased blood loss • Ravina et al. Contraception, Fertilité, Sexualité 1995: 23: 45-49. • Embolization for treatment of fibroids • 14 of 16 Patients had pain • Overall 70% fibroid volume reduction • Ravina et al. Lancet 1995; 356: 671-672.
Uterine Fibroid Embolization • Procedure takes approximately 1 hour • Done under conscious sedation • Standard fluoroscopy equipment • FDA-approved embolic agents • Covered by most insurance carriers
US Statistics • 20-40% of women affected • 1:4 are symptomatic • Menorrhagia/anemia • Mass effect: Pelvic pain • Urinary frequency • Constipation • 600,000 Hysterectomies/yr • Most common operation in U.S. • 1/3 done for fibroids • Cost: $4 Billion • 47,000 Myomectomies/yr • 15,000+ UFE’s per year
What are the symptoms ? • Abnormal Bleeding • Menometrorrhagia is atypical • Bulk-Related • Abdominal distension • Frequent urination • Bowel disturbance • Back pain • Dyspareunia
The question is really: Who are not candidates? • ABSOLUTE CONTRAINDICATIONS • Pregnancy • RELATIVE… • Renal insufficiency • Contrast allergy • Coagulopathy • DVT precautions? • Risk factors for pelvic infection • Partially treated infection • Steroids or immunocompromise • Prior pelvic radiation • Very large uterus • >20 weeks, >24 weeks?
Current Fibroid Treatments • HORMONAL THERAPY • Strategies • Regulate menses • OCPs • Stabilize endometrium • MPA • Stop menses • Lupron (GnRH analog) • Short-term only • (3-6 months) • Sig. side effects
Fibroid Treatments • HYSTERECTOMY • Plus side • 100% Curative • Minus side • Requires general anesthesia • Additional risks • Hospitalization • 4-6 week recovery • Irreversible loss of fertility • Affect on gender identity
Fibroid Treatments • MYOMECTOMY • Plus side • Preserves fertility potential • Invasive procedure of choice • Minus side • Challenging procedure • May result in significant blood loss • May escalate to hysterectomy • ~15% require future Rx • May miss culprit lesion
Recovery • “I’VE HEARD THIS IS REALLY PAINFUL” • Pain doesn’t start until uterine blood supply is • Most severe during first 4-6 hours • Turn the corner at 20 hours • 15% require readmission if done on an OP basis • NSAID (Toradol) given before, during, and after • PCA pump connected before end of procedure • Heating pad can work miracles • Conversion to oral meds the following morning • Narcotic usually discontinued day 2 or 3
Post-embolization syndrome • Different than the transient uterine ischemia of UFE • MRI after UFE typically shows uterine perfusion quickly restored to normal • Delayed constitutional symptoms, similar to spontaneously “degenerating” fibroid • Nausea, vomiting, fever, abd. pain, leukocytosis • Usually well-controlled by medication
Recovery after discharge • Prescriptions for narcotic and NSAID • Colace/Fleets to maintain regularity • Return to work within 2 weeks • Depending on how stressful or physical is her job • Healing takes great amount of energy • 30-Day visit to IR clinic • Telephone follow-up at 3,6, and 12 months • No need for imaging unless symptomatic • Call US if there is a problem
Outcomes • 96% Technical success • Unfavorable anatomy and/or vasospasm can be challenging • >92% Improvement in bleeding symptoms • First periods usually lighter and less painful • May have some spotting for a cycle or two • >88% Reduction in mass-related Sx • Softer consistency less pelvic pressure
50% Volume reduction = 21% Diameter reduction 7.9 10 11.9 15 20 15.9 Long-term results: the geometry of shrinkage
(P<.05) Pregnancy • MYOMECTOMY vs. UFE • Prospective, randomized Study • 121 women with “reproductive plans” and IM fibroid(s) > 4 cm • Mean follow-up 2 years • 58 UFE - 26 tried to conceive • Mean age 32.4 years • 17 Pregnancies, 5 labors, 9 Ab’s • Reintervention in 19 (32.8%) • 63 Myomectomies (42 lap, 21 open) - 40 tried to conceive • Mean age 32.0 years • 33 Pregnancies, 19 labors, 6 Ab’s • Reintervention in 2 (3.2%) • Mara M et al. CVIR 2008; 31 (1): 73-85. (P<.0001)
Cost Comparison • COHORT STUDY • Hysterectomy 2836 pts • Procedure cost $7000 • Payer cost $10,044 • 14.1% had follow-up imaging • Myomectomy 704 pts • Procedure cost $7000 • Payer cost $9,652 • 37.1% had follow-up imaging • UFE 125 pts • Procedure cost $5968 • Payer Cost $10,519 • 65.6% had follow-up imaging (P < .001) • Dembek CJ et al. JVIR 2007; 18: 1207-13
Efficacy and durability • 3-year follow-up of FIBROID Registry • 2212 patients • 1278 Surveys completed (57.8%) • Symptom and quality-of-life scores both improved into “normal range” • Mean symptom scores improved by 41.41 pts (P < .001) • Mean UFS QoL scores improved by 41.77 pts (P < .001) • Secondary procedures at 3 years • Hysterectomy 9.79%; Myomectomy 2.82%, UFE 1.83% • Goodwin SC et al. JVIR 2008; 19 (1): 47-57
Long-term outcomes • Recurrence rate • Lowest among uterine-sparing alternatives • New fibroid(s) vs. incomplete result • All options remain • MRgFUS • UFE • Surgery • Medical Rx? • New Rx?
Summary • Proper selection is important • Almost everyone is a candidate • MR imaging is crucial to outcomes • Techniques are established • Agents FDA-approved for UFE • Primary responsibility by IRs is essential • Clinic evaluation, admission, and follow-up • Long-term benefit is sustained • Few complications • High patient satisfaction
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