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Global Endometrial Ablation

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Presentation on theme: "Global Endometrial Ablation"— Presentation transcript:

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.* Highlight that it is critical the rep needs to uncover where the physician is related to amenorrhea as a goal and will need to get them to agree with the bulletin before they move forward with selling our efficacy story * ACOG Practice Bulletin Clinical Management, Guidelines for Obstetrician-Gynecologists; Number 81, May 2007 3

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 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
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; :CD

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

24 Thermachoice Hot liquid silicone balloon
5 mm probe Balloon is inflated with 5% dextrose in water Pressure of 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 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 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 Comparisons Thermal 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 uterine cavity remains open
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 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 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 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

51 Visual Analogue Scores (VAS) of Pain
One of the most important aspects of performing a Global Endometrial Ablation procedure in the office is patient comfort Patients that easily tolerate procedures such as endometrial or colposcopic-directed biopsy are usually excellent office candidates Patients many times are motivated to have a procedure performed in a familiar setting VAS is a measurement instrument for subjective characteristics

52 Visual Analogue Scores (VAS) of Pain
VAS Studies: Thermachoice: VAS scores of 2.6 (intraoperative) to 6.0 (post-operative); subjects used a fentanyl (narcotic) patch Hector O. Chapa et al. In-Office Thermachoice III Ablation: A Comparison of Two Anesthetic Techniques. Gynecol Obstet Invest 2010;69:140–144 HTA: VAS score of 6.4 Martin Farrugia. Hysteroscopic endometrial ablation using the Hydro ThermAblator in an outpatient hysteroscopy clinic: Feasibility and acceptability. Journal of Minimally Invasive Gynecology (2006) 13, 178–182 NovaSure: VAS 2 to 3 range with intravenous narcotic sedation P. Y. Labergeet al. Assessment and Comparison of Intraoperative and Postoperative Pain Associated with NovaSure and ThermaChoice Endometrial Ablation Systems. May 2003, Vol. 10, No. 2 The Journal of the American Association of Gynecologic Laparoscopists Her Option: VAS pain scores of 1.1 without narcotic sedation Herbst SJ, Roy KH, Manjon JM, Lukes AS, Bruno R. An Extended Treatment Regimen Using the Her Option Office Cryoablation Therapy for AUB is Well-Tolerated. AAGL 2007

53 Outcomes

54 ACOG Practice Bulletin

55 ACOG Practice Bulletin

56 FDA and Global Endometrial Ablation Devices
FDA decided on PBAC score comparison between Global Endometrial Ablation devices and first generation endometrial treatment as the basis of approval Criteria for enrollment Menorrhagia defined as PBAC >150 Endometrial ablation success defined as PBAC <75 All approved GEA devices were found to be equal to first generation endometrial ablation for the treatment of menorrhagia

57 Why not amenorrhea as a measuring stick?
Some studies have a stricter interpretation of amenorrhea than others; this dramatically affects Global Endometrial Ablation amenorrhea outcomes Rare controlled comparisons in the literature Unless two devices are compared head/head in a randomized controlled trial (RCT), it is impossible to reliably compare amenorrhea rates Most published studies that present amenorrhea rates are single-arm (no comparison group) case series Wide swings in amenorrhea rates as compared to RCT data Bias introduced into results Population bias Provider bias

58 Why not amenorrhea as a measuring stick?
“Hidden” menstruation: Heat-ablation technologies cause an Asherman-like syndrome with obliteration of the endometrial cavity Hormone levels are unaffected by endometrial ablation “Trapped” areas of functional endometrial tissue can result in a hematometra or post ablation tubal syndrome (PATS) leading to cyclic pain - 10% with heat based procedures Hysterectomy rates in patients utilizing heat technology are reported as: Up to 8% NovaSure Up to 13% Thermachoice Up to 9% HTA Cryoablation affects the endometrium via intracellular ice formation, dehydration and ischemia to cause ablation Cavity remaining patent and without significant scarring - Lahey clinic study 0f 112 patients with intact cavity* Hysterectomy rate: up to 8% * Duane Townsend, MD, FACOG, Innovative Technologies in Operative Gynecology For the 21st Century

59 “Hidden” Menstruation and Pain: Clinical Evidence
Devices – NovaSure, thermal balloon

60 “Hidden” Menstruation and Pain: Clinical Evidence
Devices – NovaSure, thermal balloon

61 Other Benefits

62 Improvements in Pain Associated with AUB
87% of patients experienced moderate to severe pain at baseline 85% of patients reported mild to no pain at 12 months 87% of patients experienced moderate to severe pain at baseline 85% of patients reported mild to no pain at 12 months Example – Her Option data 62

63 Improvements in Mood Associated with AUB
93% of patients reported mood sometimes to often at baseline 90% of patients never or rarely had “mood” at 12 months 93% of patients reported mood complaints sometimes to often at baseline 90% of patients never or rarely had mood complaints at 12 months Example – Her Option data 63

64 Endometrial Ablation and Transcervical Sterilization

65 Endometrial Ablation and Transcervical Sterilization
Hysteroscopic sterilization has become an important alternative for women deciding to undergo a permanent contraceptive procedure Gynecologists have explored combining these procedures with endometrial ablation: Thermachoice: Valle, RF. Concomitant Essure tubal sterilization and Thermachoice endometrial ablation: feasibility and safety. Fertil Steril 2006; 86:152 NovaSure: Hopkins, MR. Radiofrequency global endometrial ablation followed by hysteroscopic sterilization. J Minim Invas Gynecol 2008; 14:494 Her Option: Presthus JB. Gynecology, Minnesota Gynecology and Surgery, Edina, Minnesota. A Preliminary Study of the Safety of Her Option Office Cryoablation Therapy System in Women with Implanted Essure Contraceptive Inserts. Abstracts / Journal of Minimally Invasive Gynecology 15 (2008) S2

66 ACOG’s Position “DO NOT perform the Essure procedure concomitantly with endometrial ablation.  Ablation causes intrauterine synechiae, which can compromise (i.e., prevent) the 3-month Essure confirmation test (HSG). Women who have inadequate 3-month confirmation tests cannot rely on Essure for contraception” “Health care providers should follow the manufacturers’ instructions and not perform same-day endometrial ablation and hysteroscopic sterilization.”

67 Confirming Occlusion: Ultrasound???
Pelvic radiography or transvaginal ultrasound as an initial test for appropriate placement following Essure: 150 women underwent Essure procedures followed at 12 weeks by pelvic ultrasound, pelvic radiograph and HSG A "satisfactory" pelvic radiograph or ultrasound had high predictive values for HSG-confirmed tubal occlusion (100 and 99% respectively) Case series of approximately 6,000 Essure procedures, 4 of 10 women who became pregnant after the procedure had post-procedure confirmation of placement with ultrasound alone Veersema, S, Vleugels, MP, Timmermans, A, Brolmann, HA. Follow-up of successful bilateral placement of Essure microinserts with ultrasound. Fertil Steril 2005; 84:1733. 2. Veersema, S, Vleugels, MP, Moolenaar, LM, et al. Unintended pregnancies after Essure sterilization in the Netherlands. Fertil Steril 2008

68 HSG: FDA Standard for Confirming Bilateral Tubal Occlusion
“According to the U.S. device labeling, HSG is the only method to be used for confirmation of tubal occlusion.” “…rates of adherence with HSG, rates varied from as high as 86.4% to as low as 12.7%” Essure: “Out of the 64 pregnancies that occurred…47% appeared to result from nonadherence to use of interim contraception or return for HSG.” Adiana: “Out of the six pregnancies that occurred in the first 12 months…three were attributed by the manufacturer to improper interpretation of the HSG.”

69 Safety of Global Endometrial Ablation

70 Complications Complications do occur with Global Endometrial Ablation - the rates of adverse events are relatively rare Global Endometrial Ablation devices enhance safety in unique manner compared to standard endometrial ablation: NovaSure: checking for uterine cavity pressure Thermachoice: monitoring balloon pressure HTA: monitoring fluid loss MEA: pre-op check of myometrial thickness Her Option: cryoablation under ultrasound guidance

71 Complications: Studies

72 Reimbursement

73 Reimbursement for Global Endometrial Ablation in an Office Setting
CMS has assigned CPT codes and associated Relative Value Units (RVU) for performing endometrial ablation in the office CPT codes now reimburse for the cost of the disposable probes as well as a significant facility fee Advantage Patient: having the procedure done with local anesthesia in the familiar setting of the office environment Physician: ability to perform the procedure without having to deal with operating room schedules, wait times, delays and paperwork CPT codes 58353: Thermal ablation without hysteroscopic guidance 58563: Thermal ablation under hysteroscopic guidance 58356: Endometrial cryoablation

74 Summary

75 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 Highlight that it is critical the rep needs to uncover where the physician is related to amenorrhea as a goal and will need to get them to agree with the bulletin before they move forward with selling our efficacy story Key tool: ACOG Practie Bulletin Clinical Management, Guidelines for Obstetrician-Gynecologists; Number 81, May 2007 Part Number: 75

76 Quality of life outcomes may be the preferred outcome measure for patients undergoing treatment for DUB Example – Her Option data Satisfaction is highly correlated with significant improvement in quality of life and not necessarily reduction in menstrual blood loss.

77 Considerations for Performing Global Endometrial Ablation in the Office
Type of patient Not overly anxious Able to tolerate minor office procedures such as endometrial biopsy Motivated to NOT go to the hospital or ambulatory surgery center Procedure Comfortable for an office procedure Low risk of complications Equipment Size: compatible with standard exam rooms Easy to perform/utilize without OR-type staff Financial Adequate reimbursement for the physician Patient Co-pay

78


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