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  1. 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. 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. 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. 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. 5
  6. 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. 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. 8. NICE (Jan 2007) HMB 8
  9. 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. 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. 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. 12. Fibroids >3cm size Fertility preserved Contraceptive Fertility is potentially retained 12
  13. 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. 14. Abdominal Myomectomy 14
  15. 15. Value of adhesion prevention ? 15
  16. 16. Hysteroscopic Myomectomy Versapoint®Resectoscope 16
  17. 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. 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. 19. 3.5mm diameter disposable outer sheath 19
  20. 20. Video clip Outpatient fibroid resection 20
  21. 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. 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. 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 ( 23
  24. 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. 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. 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 ( 26
  27. 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. 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. 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. 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. 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 31