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Hysteroscopic Morcellator

Hysteroscopic Morcellator. Amy Garcia, MD Director, Center for Women’s Surgery Assistant Professor, University of New Mexico Department of Obstetrics and Gynecology Division of Urogynecology Albuquerque, New Mexico. Disclosure. Consultant: Conceptus, Inc Minerva Surgical

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Hysteroscopic Morcellator

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  1. Hysteroscopic Morcellator Amy Garcia, MD Director, Center for Women’s Surgery Assistant Professor, University of New Mexico Department of Obstetrics and Gynecology Division of Urogynecology Albuquerque, New Mexico

  2. Disclosure • Consultant: • Conceptus, Inc • Minerva Surgical • Ethicon Women’s Health and Urology • Speaker: • Conceptus, Inc • Ethicon Endo-Surgery

  3. Clinical Indications for Hysteroscopic Myomectomy Infertility • Molecular Causal Relationship • Rackow BW, Taylor HS • Submucosal uterine leiomyomas have a global effect on molecular determinants of endometrial receptivity. Fertil Steril. 2010;93(6):2027-2034 • Improved Fertility After Myomectomy • Pritts EA, Parker WH, Olive DL • Fibroids and Infertility: An updated systematic review of the evidence. Fertil Steril. 2009;91(4):1215-1223

  4. Clinical Indications for Hysteroscopic Myomectomy Infertility • Improved Pregnancy Rates • Shokeir T, etal. • Submucosal myomas and their implications in the pregnancy rates of patients with otherwise unexplained primary infertility undergoing hysteroscopic myomectomy: a randomized matched control study. Fertil Steril. 2010;94(2):724-729 • 215 women infertility longer than 12 months • Fibroids classified by US with ESGE classification • Results • Myomectomy patients twice as likely as control to become pregnant (RR = 2.1; 95% CI = 1.59-2.9) • Women with type 0 and type 1 myomas removed had significantly higher pregnancy rates than control (p < .001) • No statistically significant difference in the type ll groups

  5. Clinical Indications for Hysteroscopic Myomectomy Abnormal Uterine Bleeding • Genetic – Molecular Level • Stewart EA, Nowak RA • Myoma-related bleeding: a classic hypothesis updated for the molecular era. Human Repro Update 1996;2:295-306 • Laughlin SK, Stewart EA • Uterine Leiomyomas. Individualizing the Approach to a Heterogeneous Condition. Obstet Gynecol 2011;117:396-403 • Improved Bleeding after Myomectomy • Loffer FD • Improving results of hysteroscopic submucosal myomecomy for menorrhagia by concomitant endometrial ablation. J Minim Invasive Gynecol 2005;12:254-260 • Emanuel MH • Long-term results of hysteroscopic myomectomy for abnormal uterine bleeding. Obstet Gynecol 1999;93:743-748

  6. Pre-operative Assessment of Submucosal Myomas is Essential!

  7. Submucosal FibroidsPreoperative Evaluation European Society for Gynaecological Endoscopy (ESGE) • Percent Intramural Extension • Type 0 None • Type I < 50% • Type II > 50% Wamsteker K,et al. Transcervical hysteroscopic resection of submucous fibroids for abnormal uterine bleeding: results regarding the degree of intramural extension. Obstet Gynecol 1993;82:736-740.

  8. Hysteroscopic Myomectomy Wamsteker K, 1993

  9. Submucosal FibroidsPreoperative Evaluation Wamsteker K, 1993 • Type II Hysteroscopic Myomectomy • Increased risk of: • Excessive fluid absorption • Electrolyte abnormalities with non-electrolyte media • Excessive bleeding • Incomplete resection • Need for additional procedure • Increased operative time Even with expert hysteroscopic surgeons

  10. Submucosal FibroidsPreoperative Evaluation New Classification Lasmar RB,et al. Submucous myomas: A new presurgical classification to evaluate the viability of hysteroscopic surgical treatment—Preliminary report. J Minim Invasive Gynecol 2005;12:308-311.

  11. Size, Topography, Extension of Base, Penetration, Lateral Wall (STEPW) Lasmar, 2005, 2011

  12. Submucosal FibroidsPreoperative Evaluation New Classification Lasmar, 2005 • STEPW • 57 myomectomies compared to ESGE • STEPW more accurately predicted differences between groups I and II with respect to: • completed procedures • fluid deficit • operative time

  13. Fertil Steril. 2011;95:2073-2077 Lasmar RB, Xinmei Z, Indman PD, et al. • 465 myomas comparing STEPW and ESGE • Complete removal in 432 (92.9%) incomplete in 33 (7.1%) • ALL 320 myomas with score </4 removed (100%) • 112/145 myomas with score >/4 removed (77.2%) • ALL 33 cases of incomplete removal had score >/4 (100%) • 85/86 Type 0 removed (98.9%) • 278/298 Type 1 removed (93.3%) • 69/81 Type 2 removed (85.2%)

  14. ESGE Better predicted incomplete resection of fibroids

  15. ESGE Classification of Fibroids 0.4 cm Type 1 1.5 cm Type 0 2.5 cm Type 1 1.5 cm Type 2

  16. Size, Topography, Extension of Base, Penetration, Lateral Wall (STEPW) 0.4 cm Type 1 0 + 1 + 0 + 1 + 0 = 2 1.5 cm Type 0 0 + 1 + 0 + 0 + 1 = 2 2.5 cm Type 1 1 + 0 + 1 + 1 + 1 = 4 1.5 cm Type 2 0 + 0 + 0 + 2 + 1 = 3 Lasmar, 2005,2011

  17. STEPW Lasmar, 2005,2011 Prediction of complete removal 100%

  18. Hysteroscopic ResectionSurgical Training • Miller CE • Training in minimally Invasive surgery—you say you want a revolution. J Minim Invasive Gynecol. 2009;16(2):113–120. • The Typical ObGyn resident graduating between 2002 and 2007 had performed a median of only 40 operative hysteroscopic procedures 10 Operative Hysteroscopic Procedures per year!

  19. Resectoscopy • Requires Skilled Surgeon • Risk of: • Fluid overload (non-electrolyte fluid) • Multiple instrumentations of the uterus • Uterine perforation, air embolus, false passageway • Injury related to electrical energy source • Generates Visually Obscuring Tissue Pieces

  20. Clinical Indications for Hysteroscopic Polypectomy • AUB • Nathani F, Clark TJ. • Uterine polypectomy in the management of abnormal uterine bleeding: A systematic review. J Minim Invasive Gynecol 2006;13:260-268. • Infertility • Rackow etal. • Endometrial polyps affect uterine receptivity. Fertil Steril 2011 (In-Press). • Afifi etal. • Management of endometrial polyps in subfertile women: a systematic review. Eur J Obstet Gynecol Reprod Biol 2010;151:117-121.

  21. Hysteroscopic Morcellator

  22. Hysteroscopic MorcellatorsTRUCLEAR 8.0 – Smith & NephewFDA Approved 2005 • Dedicated Fluid Management • Tissue Removed with Suction • Offset Lens Hysteroscope • Outer Blade 4.0 mm OD • Scope 8 mm, 0° • Hysteroscopic Sheath 9 mm OD • Tissue Trap • Reusable Hand-piece

  23. Hysteroscopic MorcellatorsTRUCLEAR 8.0 – Smith & Nephew • Reusable Hand-Piece • Rotary Morcellator • Polyps • Oscillates back and forth • Serrated • 7 mm cutting window • Reciprocating Morcellator • Myomas • Rotates and reciprocates • 10 mm cutting window • 357 bites per minute at 2,500 rpm

  24. Fluid Management • Smith and Nephew • Fluid Management System

  25. Hysteroscopic MorcellatorsTRUCLEAR 5.0 – Smith & NephewPending 510(K) FDA Approval • Offset Lens Hysteroscope • Outer Blade TRUCLEAR INCISOR PLUSTM • 2.9 mm OD • Scope 5.0 mm, 0° • Hysteroscopic Sheath 5.6 mm OD

  26. Decreased Operative Time Polyps 2/3 Type I/II Myomas 1/2

  27. Operating time (minutes) Volume of intrauterine lesion cm3

  28. Gynecol Surg (2011) 8:193 -196 • Retrospective Experience Report • 315 women 2006 - 2009 • Polyps – Rotary Blade S & N • Total 278 • Mean 7.3 minutes operative time • Mean diameter 2.4 cm, fluid deficit 40 mL (0-300) • Myomas Type I and II – Reciprocating Blade • Mean 18.2 minutes operative time • Total = 37 (Type 0 = 23, Type 1 = 11, Type 2 = 3) • Mean diameter 2 cm, fluid deficit 440 mL (100-890)

  29. Hysteroscopic MorcellatorsMyoSure – HologicFDA Approved 2009 • Standard Set-up Fluid/Suction • Tissue Removed with Suction • Offset Lens Hysteroscope • Outer Blade 3 mm OD • 7 mm cutting window • Inner Rotating-Oscillating Blade 2 mm • Hysteroscopic Sheath 6.25 mm OD • Tissue Trap • Removes 1.5 gm/min of tissue • Single-Use Device

  30. 11 Women • Polyps Mean Operating Time • 37 seconds (100%) • Myomas Mean Operating Time • Type 0 2 minutes 19 seconds (100%) • Type1 9 minutes 10 seconds (100%) • Type 2 11 minutes 49 seconds (50%) J of Medicine 2009;2:163-166.

  31. Hysteroscopic MorcellatorsAdvantages • Operate in Saline • Decreased risk of fluid overload • Mechanical • No thermal injury • Remove Tissue Pieces • Clear visual field • Decreases risks of multiple instrument placement • Uterine perforation, false passageway and air embolus • Are Easy to Use • Facilitate Removal Type 0 and I Myomas • Decreased operative time and Fluid deficit • Small Diameter Can Be Used in the Office

  32. Hysteroscopic MorcellatorsAdvantages • Operate in Saline • Decreased risk of fluid overload • Mechanical • No thermal injury • Remove Tissue Pieces • Clear visual field • Decreases risks of multiple instrument placement • Uterine perforation, false passageway and air embolus • Are Easy to Use • Facilitate Removal Type 0 and I Myomas • Decreased operative time and Fluid deficit • Small Diameter Can Be Used in the Office

  33. Fluid Use • Miller -- MyoSure • Type 0 • 3,400 (1,500 – 5,300) • Deficit 205 (200-210) • Type 1 Myoma • 11,153 (4,670 – 24,000) • Deficit 1,300 (500-1,900) • Emanuel -- TRUCLEAR • Total not recorded • Deficit ALL Myomas • 714 (0-3,000) • Van Dongen --TRUCLEAR • All Procedures • 3,413 (2,209-4,617) • Deficit All Procedures • 409 (229-589) • Wibeke -- TRUCLEAR • Total not recorded • Deficit ALL Myomas • 400 (100 – 890) Operative Hysteroscopy of Myomas (resectoscopy or morcellator) = Fluid Management System

  34. Hysteroscopic MorcellatorsDisadvantages • No electrosurgery for hemostasis • Type 2 myomas are difficult • Fundal pathology is difficult • Potential for significant fluid use • Cost of fluid management system • Currently no reimbursement for office use

  35. Reimbursement No Global 2011 Myosure Device Cost $1,300 With E/M Visit Modifier 25 Document HS Separately

  36. Reimbursement No Global 2011

  37. Hysteroscopic MorcellatorsSummary More women will have the opportunity for uterine preserving surgery with the removal of Type 0 and 1 myomas with safer instruments, that require less surgical skill. Removal of polyps is easier.

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