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Global Endometrial Ablation

Global Endometrial Ablation. Robert D. Auerbach, M.D. FACOG Senior Vice President & Chief Medical Officer CooperSurgical, Inc. The Endometrium. Endometrium. Endometrial Ablation Therapy Goals. Endometrial ablation is

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Global Endometrial Ablation

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  1. Global Endometrial Ablation Robert D. Auerbach, M.D. FACOG Senior Vice President & Chief Medical Officer CooperSurgical, Inc.

  2. The Endometrium Endometrium

  3. Endometrial Ablation Therapy Goals Endometrial ablation is Indicated for the treatment of menorrhagia or patient-perceived heavy menstrual bleeding Premenopausal women with normal endometrial cavities No desire for future fertility Patients who choose endometrial ablation should be willing to accept normalization of menstrual flow, not necessarily amenorrhea, as an outcome.* * ACOG Practice Bulletin Clinical Management, Guidelines for Obstetrician-Gynecologists; Number 81, May 2007

  4. The Menstrual Cycle… and Beyond • Normal menses • Menarche: 12 yo • Menopause: 51 yo • 35-40 ml/cycle • Abnormalities • Menorrhagia: an abnormally heavy and prolonged menstrual period bleeding at regular intervals • Metrorrhagia: uterine bleeding at irregular intervals • Meno-metrorrhagia: irregular heavy and prolonged uterine bleeding • Polymenorrhea: menstrual cycles more frequent than 21 days

  5. Menorrhagia

  6. PBAC (Pictorial Bleeding Assessment Chart) • PBAC - Menorrhagia • Simple non-laboratory method for semi-objective diagnosis • Sensitivity: 86% (doesn’t miss the Dx) • Specificity: 89% (doesn’t overcall the Dx) • FDA studies • Menorrhagia: PBAC>150 • Normal menses: PBAC≤75

  7. Etiology: Things to Consider • AUB can be caused by a wide variety of local and systemic diseases. • Most cases are related to pregnancy, structural uterine pathology (e.g., fibroids, polyps), anovulation, a disorder of clotting, or neoplasia. • Questions to ask: • What is the woman's age? • Is she sexually active? Could she be pregnant? • What is her normal menstrual cycle like? Are there symptoms of ovulation? • What is the nature of the abnormal bleeding (frequency, duration, volume, relationship to activities such as coitus)? • Are there any associated symptoms? • Does she have a systemic illness or take any medications? • History of a bleeding disorder?

  8. AUB: Making a Diagnosis

  9. AUB: Making a Diagnosis

  10. The Workup • History and Physical Exam • Laboratory Studies • HCG to rule-out pregnancy and rare conditions (molar disease) • Blood count to assess for anemia • Other blood studies based on history (i.e., coagulation profile, thyroid etc.) • Hysteroscopy (alternative SIS) • Direct visualization of the endometrial cavity • Requires anesthesia • Allows for targeted biopsy

  11. The Workup • Ultrasound and SIS (alternative hysteroscopy) • Sterile saline is instilled into the endometrial cavity and a transvaginal ultrasound examination is performed • Allows for careful architectural evaluation can detect small lesions which may be missed or poorly defined by transvaginal sonography

  12. The Workup • Endometrial biopsy • After pregnancy has been excluded • Endometrial biopsy should be performed in all women >35 to rule out endometrial cancer or a premalignant lesion (endometrial hyperplasia) • Endometrial biopsy in women between the ages of 18 and 35 who have risk factors for endometrial cancer: family or personal history of ovarian, breast, colon or endometrial cancer; PCO, obesity, diabetes

  13. Menorrhagia: Rx Should Be Individualized Etiology: • Anatomic • Submucosal fibroids • Endometrial polyps • Adenomyosis • Functional • Bleeding diatheses • Anovulation

  14. Menorrhagia Rx • Menorrhagia unrelated to malignancy - variety of therapeutic options: • Watchful waiting • Medical therapy • Oral hormonal therapy (OCP, E2/P, P) • Injection (Depo-Provera) • IUD (Mirena) • Surgical therapy • Endometrial resection/ablation • 1st generation • 2nd generation • Hysterectomy

  15. Menorrhagia without organic pathology is the primary indication for endometrial ablation

  16. Continuing on with the Procedure… • H&P • Lab studies • SIS or hysteroscopy • Endometrial bx • Patient counseling • Informed consent • Schedule procedure • Items to consider • Cycle timing • Endometrial thinning • Cervical priming • Pre-op antibiotics • Not routine • Certain cases would be indicated such as h/o PID

  17. Endometrial Thinning • Endometrial thinning • Benefit: reduction in lining thickness with closer exposure to basal layer • Recommended for all Global Endometrial Ablation – not required for NovaSure • Methods • Cycle timing • GnRH (Lupron – 3.75mg one month prior to procedure) • Uterine curettage immediately prior to procedure Proliferative Endometrium Atrophic Endometrium

  18. Cervical Priming: Her Option Probe is 5.5 mm • Cervical dilation can be painful • 6 mm or less diameter may not require dilation (Thermachoice and Her Option) • 8 mm or greater diameter will require dilation (HTA, NovaSure, MEA) • Physician will determine need for dilation during the workup of AUB during the examination and endometrial biopsy. Options include: • Hygroscopic dilation - Laminaria • Paracervical block followed by manual cervical dilation • Pharmaceutical • Prostaglandins such as Cytotec are most common • The optimal Cytotec dose has not been established (most studies used 200-400 mcg)

  19. Endometrial Ablation The Technologies

  20. Standard versus Global Endometrial Ablation • Rollerball Standard Endometrial Ablation (RB) • Utilizes operative hysteroscope and energy source • Considered the “Gold Standard” and used as the comparator in FDA approvals • All Global Endometrial Ablation must be approved in the US via a PMA that requires substantial scientific investigation

  21. Standard Versus Global Endometrial Ablation Global Endometrial Ablation • Do not require an operative hysteroscope – heating and freezing • Goal is to simplify the procedure and increase adoption rates

  22. Standard Versus Global Endometrial Ablation • Rollerball and global techniques (GEA) have similar success rates – used in PMA process • Global methodologies tended to take less time and are more readily performed • Patients undergoing global techniques had a lower incidence of complications Lethaby, A, Hickey, M, Garry, R, Lethaby, A. Endometrial destruction techniques for heavy menstrual bleeding. Cochrane Database Syst Rev 2005; :CD001501.

  23. Page 23 Global Endometrial Ablation: Devices • NovaSure® • RF heat • HTA® • Circulating hot saline • Thermachoice® • Heated fluid-filled balloon • MEA™ • Microwave heat • Her Option® • Cryotherapy/Freezing

  24. Thermachoice • Hot liquid silicone balloon • 5 mm probe • Balloon is inflated with 5% dextrose in water • Pressure of 160-180 mmHg • Heated to approximately 87 degrees Celsius for 8 minutes • Circulating device within the balloon that provides more even distribution of the hot water

  25. NovaSure • 3-D bipolar mesh • 8 mm probe • Suction is applied to the endometrial cavity and up to 180 watts of bipolar power applied • System will shut down with complete desiccation or after a total treatment time of 2 minutes

  26. HTA • 8 mm hysteroscope sheath is inserted into the uterus • Ablation under direct vision • Uterine cavity is distended by heated saline • Treatment phase lasts for 10 minutes • Total time approximately 17 minutes

  27. MEA™ • 9.2 GHz, 30 watt microwave system • 8 mm probe • Produce a tissue temp of 75-85 degrees Celsius at a depth of 6 mm • Treat the entire cavity - surgeon moves the probe from cornu to cornu and across the lower uterine segment

  28. Her Option: A Twist on Cryotherapy • Cryoprobe - 5.5 mm • Elliptical ice ball approximately 3.5 by 5 cm forms around the probe • At the edge of the ice ball the temperature is not destructive • Number of ice balls that must be created is dependent upon the size of the cavity • Procedure takes 10 to 20 minutes

  29. Device ComparisonsThermal Technology Devices available in the US

  30. Heat Injury and Scarring Pathology of Heat • Intense areas of necrosis with acute and chronic inflammatory cells • Foreign body giant cells common • Fibroblasts proliferate • Scarring develops Post-NovaSure Post-Thermachoice

  31. Her Option and Cryobiology Three mechanisms of cell death Intracellular ice formation Dehydration Ischemia Potential benefits of cold Cold has a natural analgesic affect, reducing pain Post-op tissue may have less scarring Less risk of adhesion in cavity May not mask future pathologies

  32. Uterine Cavity Integrity

  33. Why is it important? Normal Menstrual Flow

  34. Why is it important? Tubal Ligation Normal Menstrual Flow

  35. Why is it important? Tubal Ligation hematosalpinx hematosalpinx Occluded Uterine Cavity

  36. Why is it important? Desired post GEA uterine cavity remains open Tubal Ligation Normal Menstrual Flow or Less

  37. Cavity Integrity: Hematometra

  38. Other Issues Regarding Cavity Integrity • Advantages of an open uterine cavity • Ability to investigate later pathology • Endometrial biopsy • Hysteroscopy • Ability to perform hysteroscopic procedures • Trans-cervical sterilization • Reduction in pain-associated failures of GEA

  39. Inability to Perform Endo Bx or SIS: from the Literature Devices – NovaSure, thermal balloon

  40. Cryoablation May Cause Less Scarring • Lahey Clinic study • Subjects: 112 women with menometrorrhagia • Amount and duration of bleeding recorded • All underwent pretreatment hysteroscopy and endometrial sampling • Contour and depth of cavity noted • Her Option procedure performed • Following Cryoablation patients were evaluated at one, three, six and 12 months • Hysteroscopy was carried out between three and 12 months post-op Duane Townsend, MD, FACOG, Innovative Technologies in Operative Gynecology For the 21st Century.

  41. Lahey Clinic Study Duane Townsend, MD, FACOG, Innovative Technologies in Operative Gynecology For the 21st Century.

  42. Lahey Clinic Study Duane Townsend, MD, FACOG, Innovative Technologies in Operative Gynecology For the 21st Century.

  43. Pain Associated with Global Endometrial Ablation

  44. Procedure Discomfort: Every Patient is Unique • Physician will individualize pain management strategy • Anxiety • Anxiolytic medication is used to treat the symptoms of anxiety • Common medications: Valium, Xanax, Ativan • Pain • Local Anesthetics • Block pain fibers • Common medications: Lidocaine, Bupivacaine, Mepivacaine

  45. Procedure Discomfort: Pain Medications (cont.) • Analgesic known as “painkillers” • Non-narcotic: NSAID • Non-addicting, anti-inflammatory, anti-pyretic • Common medications: Toradol, Ibuprophin, Naproxen • Narcotic: Opioid • Effects of opioids are due to decreased perception of pain, decreased reaction to pain as well as increased pain tolerance • Sedation and respiratory depression are side-effects • Common medications: Percocet (acetaminophen and oxycodone), Vicodin (acetaminophen and hydrocodone)

  46. Global Endometrial Ablation and Pain Important for patient and staff • Cervical dilation • sacral plexus • Uterine distension • thoracic plexus • Tissue destruction • thoracic plexus • Time to perform procedure • Combined sacral and thoracic plexus plus anxiety • Vasovagal • Syncope may occur in women who have pain during the gynecological procedure

  47. Paracervical and Intracervical Block (deep cervical block) • Para and Intracervical infiltration of a local anesthetic interrupts the visceral sensory fibers of: • lower uterus • cervix • upper vagina • Procedure • Equipment • Sterile gloves • Local anesthetic • Syringe with appropriate needle • Prepare cervix with antiseptic

  48. Paracervical and Intracervical Block (deep cervical block) • Procedure (cont.) • Injections at 10 mm deep at 2, 4, 8 and 10 positions • lateral cervical margin (paracervical) • mid-stroma (intracervical) • 1% Lidocaine (10 to 20 ml) commonly used • Two randomized trials that compared the analgesic effects of paracervical and intracervical block - no statistically significant differences between the two blocks in pain levels • Onset within 5 minutes and peak plasma levels 10-15 minutes Risk - seizure activity related to inadvertent intravascular injection

  49. Global Endometrial Ablation and Pain Important for patient and staff • Cervical dilation • Paracervical block • Uterine distension • Significant: narcotic • Minimal: NSAID • Tissue destruction • Significant: narcotic • Minimal: NSAID • Time to perform procedure • Anxiolytic, paracervical block, analygesic

  50. Pain Associated with Global Endometrial Ablation Procedures • Cervical dilation • Minimal dilation (if any) required: Her Option, Thermachoice • Dilation required: NovaSure, HTA, MEA • Uterine distension • Minimal cavity distention: Her Option, MEA • Mechanism requires distention: Thermachoice, NovaSure, HTA • Tissue destruction • Freezing-based treatment: Her Option • Heat-based treatment: NovaSure, Thermachoice, HTA, MEA • Time to perform procedure • Shortest: NovaSure, MEA • Intermediate: Thermachoice • Longest: HTA, Her Option

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