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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

Global Endometrial Ablation

Robert D. Auerbach, M.D. FACOG

Senior Vice President & Chief Medical Officer

CooperSurgical, Inc.

the endometrium
The Endometrium

Endometrium

endometrial ablation therapy goals
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

the menstrual cycle and beyond
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
pbac pictorial bleeding assessment chart
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
etiology things to consider
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?
the workup
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
the workup1
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
the workup2
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
menorrhagia rx should be individualized
Menorrhagia: Rx Should Be Individualized

Etiology:

  • Anatomic
    • Submucosal fibroids
    • Endometrial polyps
    • Adenomyosis
  • Functional
    • Bleeding diatheses
    • Anovulation
menorrhagia rx
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
menorrhagia without organic pathology is the primary indication for endometrial ablation
Menorrhagia without organic pathology is the primary indication for endometrial ablation
continuing on with the procedure
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
endometrial thinning
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

cervical priming her option probe is 5 5 mm
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)
endometrial ablation

Endometrial Ablation

The Technologies

standard versus global endometrial ablation
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
standard versus global endometrial ablation1
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
slide22

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.

global endometrial ablation devices
Page 23Global Endometrial Ablation: Devices
  • NovaSure®
    • RF heat
  • HTA®
    • Circulating hot saline
  • Thermachoice®
    • Heated fluid-filled balloon
  • MEA™
    • Microwave heat
  • Her Option®
    • Cryotherapy/Freezing
thermachoice
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
novasure
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
slide26
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
slide27
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
her option a twist on cryotherapy
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
device comparisons thermal technology

Device ComparisonsThermal Technology

Devices available in the US

heat injury and scarring
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

her option and cryobiology
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

why is it important
Why is it important?

Normal Menstrual Flow

why is it important1
Why is it important?

Tubal Ligation

Normal Menstrual Flow

why is it important2
Why is it important?

Tubal Ligation

hematosalpinx

hematosalpinx

Occluded Uterine Cavity

why is it important3
Why is it important?

Desired post GEA

uterine cavity remains open

Tubal Ligation

Normal Menstrual Flow or Less

other issues regarding cavity integrity
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
cryoablation may cause less scarring
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.

lahey clinic study
Lahey Clinic Study

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

lahey clinic study1
Lahey Clinic Study

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

procedure discomfort every patient is unique
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
procedure discomfort pain medications con t
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)
global endometrial ablation and pain
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
paracervical and intracervical block deep cervical block
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
paracervical and intracervical block deep cervical block1
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

slide49

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
pain associated with global endometrial ablation procedures
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
visual analogue scores vas of pain
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
visual analogue scores vas of pain1
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
fda and global endometrial ablation devices
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
why not amenorrhea as a measuring stick
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
why not amenorrhea as a measuring stick1
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

hidden menstruation and pain clinical evidence
“Hidden” Menstruation and Pain: Clinical Evidence

Devices – NovaSure, thermal balloon

hidden menstruation and pain clinical evidence1
“Hidden” Menstruation and Pain: Clinical Evidence

Devices – NovaSure, thermal balloon

improvements in pain associated with aub
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

Example – Her Option data

improvements in mood associated with aub
Improvements in Mood Associated with AUB

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

endometrial ablation and transcervical sterilization1
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
acog s position
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.”
confirming occlusion ultrasound
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
hsg fda standard for confirming bilateral tubal occlusion
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.”
complications
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
reimbursement for global endometrial ablation in an office setting
Reimbursement for Global Endometrial Ablation in anOffice 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
endometrial ablation therapy goals1
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

  • Key tool:
  • ACOG Practie Bulletin Clinical Management, Guidelines for Obstetrician-Gynecologists; Number 81, May 2007
  • Part Number: 21200030
slide76
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.

considerations for performing global endometrial ablation in the office
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
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