1. Rajesh Varma MA PhD MRCOG
Consultant Obstetrician and Gynaecologist
Guy’s and St.Thomas’ NHS Foundation Trust
1415-1515: Tue 25th
November 2008
Hot Topics in Clinical Practice
Postgraduate Centre, Gassiot House, St.Thomas’ Hospital 1

2. Fibroids
Benign, but have 0.2% risk of malignant transformation
Occur in 10% of HMB
Recurrence risk after myomectomy (10% at 5 years)
May undergo degeneration (hyaline, fatty, Red during pregnancy)
May become acutely painful (torsion, haemorrhage, sepsis, degeneration)
2

3. Wamsteker K et al. Transcervical
hysteroscopic resection of submucous
fibroids for abnormal uterine bleeding:
results regarding the degree of
intramural extension. Obstet Gynecol
1993; 82(5):736-740.
3

4. Do all women with fibroids
need treatment?
1. Asymptomatic
2. Abnormal Uterine Bleeding (AUB)
Menorrhagia, anaemia
Pelvic pressure effects (renal tract-ureter, bladder)
Pelvic Pain
3. Improve fertility (reduce risk of miscarriage)
4

5. 5

6. Myomectomy and AUB
Removal of the intracavity component of the submucous
fibroid improves AUB (70-80% improvement)
(Level II evidence)
Parker WH. Uterine myomas: management. Fertil Steril. 2007 Aug;88(2):255-71. 2007 Jul 20.
Varma R et al. Hysteroscopic myomectomy for menorrhagia using Versascope™ bipolar
system: efficacy and prognostic factors at a minimum of one year follow up. In Press 2008,
EJOG.
Paradox:
Post operative adhesions may cause pain and infertility
6

7. Klatsky PC et al. Fibroids and reproductive outcomes: a systematic literature review from
conception to delivery. Am J Obstet Gynecol. 2008 Apr;198(4):357-66.
ASRM. Myomas and reproductive function. Fertility and Sterility, Volume 90, Issue 5, Supplement
1, November 2008, Pages S125-S130
Pritts EA et al. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril.
2008 Mar 11
Removal of the intracavity component of the submucous
fibroid improves fertility (RR 1.72; 95% CI 1.13-2.58)
Subserosal fibroids do not affect fertility outcome
Intramural fibroids appear to decrease fertility, but the results of
therapy are unclear.
(Level II evidence)
Myomectomy and Fertility
7

8. NICE (Jan 2007)
HMB
8

9. MEDICAL THERAPIES
FIBROID SIZE AUB FERTILITY
NSAIDs No effect fibroid
size
Decrease 30% No effect
COC No data Decrease 20-30% Contraceptive
GNRHa *
(3m-6m)
Decrease 30%
Decrease uterine
volume by 35%
Decrease >80% Contraceptive
Progestins
LARC
LNG-IUS
Mirena
(uterine
cavity<12cm)
Decrease 30%
Decrease uterine
volume by 35%
Decrease>60%
Breakthrough
bleeding
systemic side
effects
Contraceptive
9

10. GnRHa
Side effects
Experienced by 95%
Hot flushes; vaginal dryness; frontal headaches
10% women stop treatment due to side effects
Osteopenia: >6m use
Prevented with add-back (tibilone, raloxifene)
Suitable women?
1. 3-4 m prior to myomectomy (hysteroscopic, abdominal) or
hysterectomy (anaemia, transfusion, avoid midline entry)
(concern: recurrence of small myomas & surgical dissection)
2. Late perimenopause as “short-term” treatment (+/- add-back)
10

11. NEW MEDICAL THERAPIES (UNDER TRIAL)
FIBROID SIZE AUB FERTILITY
GnRH antagonist
Ganirelix
(sc daily/6m)
Decrease 30-40% Decrease Contraceptive
Mifepristone
(5mg daily/6m)
Decrease 40%
Decrease uterine
size 40%
Decrease
(risk of endometrial
hyperplasia)
Contraceptive
SPRM
Asoprisnil
(10mg daily/6m)
Decrease Decrease Contraceptive
Aromatase
Inhibitors
Decrease Decrease Contraceptive
11

12. Fibroids >3cm size
Fertility preserved
Contraceptive
Fertility is
potentially
retained
12

13. Abdominal Myomectomy
>80% improvement in AUB
Very low conversion rate to hysterectomy
Comparable risk to hysterectomy (organ damage,
transfusion)
Correct pre-operative anaemia (EPO, GnRHa)
Tourniquet
Transverse uterine incisions (parallel to arcuate vessels)
Anti-adhesion : limit number of uterine incisions, anti-
adhesion barrier, drainage
Re-treatment rates after myomectomy over 5-10 years
(symptom +/-fibroid recurrence):
10% single myomectomy vs. 25% multiple myomectomy
13

14. Abdominal Myomectomy
14

15. Value of adhesion
prevention ?
15

16. Hysteroscopic Myomectomy
Versapoint®Resectoscope
16

17. Hysteroscopic myomectomy
Fibroid size Intracavity fibroid 90-100%
AUB Decrease >80%
Fertility Increase 40-60%
Secondary treatment (2yr 10%; 5yr 30%)
Complication rate 1-2%
Uterine perforation
Sepsis; intrauterine adhesions
Haemorrhage
Hyponatraemic fluid overload
Additional treatment May be combined with endometrial
resection or ablation-improved
effect on AUB
17

18. Hysteroscopic myomectomy:
New developments
Use of pre-operative GnRHa 3-4m
Improved video instrumentation
Bipolar resectoscopes: virtually eliminates risk of
hyponatraeimc fluid overload syndrome
Outpatient microhysteroscopy and Versapoint®-
concept of One Stop See-and-Treat gynaecology clinic18

19. 3.5mm diameter disposable outer sheath 19

20. Video clip Outpatient fibroid
resection
20

21. New Interventional Technologies
Treatment in women with fibroid-related symptoms
and not desiring future fertility
Uterine artery embolization (UAE)
Magnetic resonance image-guided transcutaneous
focused ultrasound for uterine fibroids (MRgFUS)
Magnetic resonance (MR) image-guided percutaneous
laser ablation of uterine fibroids
Laparoscopic or transvaginal uterine artery occlusion
Laparoscopic cryomyolysis
21

22. Aims: New Interventional Technologies
Improvement in AUB, fertility and & QoL
Avoid risks of major surgery (e.g. quicker recovery)
Safety (lower complication rate)
Sustained benefit (low re-treatment rate)
Cost-effective
Insufficient evidence:
RCTs with long term data are lacking22

23. NICE (Oct 2004)
Audit and review clinical
outcomes of all
patients having UAE.
Data should be
submitted to the British
Society of Interventional
Radiology registry
(www.bsir.org).
23

24. •Both uterine arteries are blocked by Interven. Radiol.
•Contraindications :active genitourinary infection,
genital tract malignancy
•Relative contraindications:submucous myomas
(check hysteroscopy prior to UAE), pedunculated
myomas, recent GnRHa, previous UAE,
postmenopausal status
Uterine artery embolisation (UAE)
24

25. UAE
Fibroid size Reduced 30-50%
AUB Improved (>80% satisfaction)- sustained over 5yr
Fertility Reported case series: obstetric outcome uncertain
Secondary
treatment
20-30% within 5yr
Complication
rate
1-2w recovery back to work
10-15% persistent vaginal discharge
5% Post embolization syndrome (pain, fever, nausea,
vomiting)
10-15% risk premature ovarian failure (especially>45y)
20% intra-abdominal adhesions
<1% uterine necrosis/sepsis; death 1/10,000
•Gupta, JK et al. Uterine artery embolization for symptomatic uterine fibroids. Cochrane 2008.
•G. Tropeano et al.Non-surgical management of uterine fibroids. Hum Reprod Update 2008;14(3):
259 – 274.
•Agdi et al. Intraabdominal adhesions after uterine artery embolization. AJOG, Volume 199, Issue 5,
November 2008, Pages 482.e1-482.e3 25

26. NICE (Sept 2007)
Audit and review clinical
outcomes of all
patients having MRgFUS.
Data should be
submitted to the British
Society of Interventional
Radiology registry
(www.bsir.org).
26

27. Hindley, J. et al. Am. J. Roentgenol. 2004;183:1713-1719
Woman lying on ExAblate 2000 (InSightec) focused ultrasound
system ready to be placed into MRI unit
MRI-guided focused ultrasound
(MRgFUS)
27

28. MRgFUS: outline of procedure
Clear pathwayfrom the anterior abdominal wall to the
fibroid without passingthrough the bladder or the bowel
Shaved anteriorabdomen
A urinary catheter is inserted
Unsuitable for very large uteri (>24w) or fibroids (>10cm)
IV analgesia and conscious sedation
Maximumtreatment time of 3 hr ; recovery 1-2 days
Thermal ablation of selected fibroid
Real time MR Thermometry (aiming >55 degrees C)
Gadolinium-enhanced MRI performed immediately after
treatment 28

29. Hindley, J. et al.
Am. J. Roentgenol. 2004;183:1713-19
AFTER MRgFUS:
Non-Perfused Volume (NPV) ratio
calculated from the gadolinium-enhanced MRI
performed immediately after treatment
BEFORE
29

30. MRgFUS
Fibroid size 20% at 2yr
AUB 60-70%
Higher NPV corresponds to
greater fibroid size reduction and symptom relief at 12-month
Fertility Reported-mainly for single fibroid ablations
Secondary treatment ? 30%
Complication rate 10% (pain, vaginal discharge)
•E. A. Stewart et al. Sustained Relief of Leiomyoma Symptoms by Using Focused Ultrasound
Surgery. Obstet. Gynecol., August 1, 2007; 110(2): 279 - 287.
•Z. M. Lenard et al. Uterine Leiomyomas: MR Imaging-guided Focused Ultrasound Surgery--
Imaging Predictors of Success. Radiology, Oct 1, 2008; 249(1): 187 – 194
•Rabinovici J et al. Pregnancy outcome after magnetic resonance–guided focused ultrasound
surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertility &Sterility, In Press, 200830

31. Conclusions
Multiple treatment options exist
Advances in hysteroscopy
New interventional technologies show early promise
However,
• Several unanswered questions
• Urgent need for further research
• Need for increased consumer input
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