Electrosurgery and Enseal® Overview - … et. Al . Probability of Future Procedures after...

UTERINE THERAPY:

THE SCIENCE BEHIND ENDOMETRIAL ABLATION

Presented by: Robert K. Zurawin, MD

Associate Professor Director, Fellowship in Minimally Invasive Gynecologic Surgery

Baylor College of Medicine Houston, Texas

Dr. Zurawin is a paid consultant of Ethicon, Inc.

This promotional educational activity is brought to you by Ethicon, Inc. and is not certified for continuing medical education.

Discussion Points

• Why Endometrial Ablation

• Ideal Endometrial Ablation Therapy

• Mechanism of Action

• Physics of Anatomy

• Clinical Evidence

• Conclusion

Why Endometrial Ablation ?

• Minimally Invasive alternative to hysterectomy – No incisions, can be performed in office

– Most cases patients return to normal activities the next day

– Short-term complications are low

– High efficacy rates

• Minimized incidence of repeat surgery 1

– In most cases, avoidance of hysterectomy

– Reduced incidence of long term Pelvic Organ Prolapse or SUI Issues

• Patient preference2

– Most patients seek reduced bleeding vs. AMENORRHEA

– Most patients’ treatment choice is for Endometrial Ablation

• Desire to avoid hormonal therapy & hysterectomy

1 . K Cooper et al. Outcomes following hysterectomy or endometrial ablation for heavy menstrual bleeding.

A retrospective analysis of hospital episode statistics in Scotland .BJOG. 2011; 118(10); 1171-1179.

2. Data on File

Is Amenorrhea Desirable in AUB Therapy ?

• Endometrial Ablations associated with amenorrhea may cause 1:

– Hematometra – cornual or central

– Post-ablation tubal sterilization syndrome (PATSS)

– Retrograde menstruation

– Potential delay in the diagnosis of endometrial CA

• No central hematomas in their series of >1000 partial ablations 1

1. McCausland AM, McCausland VM, “Long-term complications of endometrial ablation: cause, diagnosis, treatment, and

prevention.” J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):399-406

*Other device specific events can occur with Endometrial Ablation Procedures and can be found within the

Adverse Event section of the device’s IFUC

What is Pathway to Optimal AUB Therapy?

Treatment Path Decision

May increase probability

failures

Abnormal Uterine Bleeding

Multiple Treatment Options

Patient Selection/Screening

Patient Expectations vs. Likely

Outcomes

• Eumenorrhea

• Hypomenorrhea

• Amenorrhea

• Reduced Dysmenorrhea

What & Who

Leads To

The Want

What Defines the Ideal Ablation Technology?

1. Provides maximum SAFETY

2. Offers CONTROL & PRECISION

3. Is Highly EFFECTIVE – Destroys the endometrium & blood supply – Adaptable – Reduces heavy menstrual bleeding to normal levels

or less

Goal of Endometrial Ablation?

ACTIVE ENDOMETRIUM IN-ACTIVE ENDOMETRIUM

Seal vessels that form the blood supply to the endometrium …

The HOW: Vessel Sealing Technology

Mechanism of Action

Key Elements of Vessel Sealing Technology

1. Time – Heat must be applied for the ideal amount of time to transform the

tissue.

2. Temperature – Too much heat causes charring, scarring and collateral damage

– Too little heat will not break the hydrogen bonds in collagen and elastin

3. Compression (Coaptation) – The KEY element of vessel sealing.

– Sufficient pressure is required to coapt the tissue to stop blood flow and allow for ideal thermal transfer

Active Surgical Temperatures in Tissue “Mechanics of Vessel Sealing”

Vaporization of

water desiccates

tissues

Eschar forms

when tissues

burn

Eschar

(oxidation)

Protein

Coagulation

Tissue

Desiccation

Ultrasonic Electrosurgery

50º C 100º C 150º C 400º C+

Protein

disorganizes to

form a coagulum

Harmonic_Triple_Helix.mpg

Electro_Triple_Helix.mpg

The HOW: Endometrial Ablation Technology

Mechanics of Action

Radio Frequency & Thermal Balloon

Endometrial Ablation Market Technology

RADIOFREQUENCY 1

Key features:

- Conformable bipolar mesh electrode

- Surefit cervical seal

Key Mechanics of Action :

- Electrical Impedance

Benefits:

- Consistent radio frequency distribution

- Short procedural time & High efficacy

The top two market devices provide patient benefits; however, their approach to patient benefit via tissue destruction is very different…

THERMAL BALLOON 2

Key features:

-Silicone Conforming Balloon

- Rotating Heating Impeller

Key Mechanics of Action:

- Time, Heat, Pressure (Tamponade Effect)

Benefits:

-Conforms to fit most uteri

-Minimal Dilation & High Efficacy

1. Novasure . Instructions for Use, www.Novasure.com. 2009 & 2010 Novasure Sales Aid

2. GYNECARE THERMACHOICE III. Instructions for Use, www. Ethicon360.com

1: Endometrial Destruction

Active Endometrium

RF TB


2. GYNECARE THERMACHOICE III. Instructions for Use, www. Ethicon360.com

Endometrial Destruction “How the Device Works”

Average of 50Ω Energy Burst Pattern

160-180mmHG & 87C Outward Pressure

1. Novasure . Instructions for Use, www.Novasure.com. 2009 & 2010 Novasure Sales Aid . 2011 Novasure Patient Brochure

2. GYNECARE THERMACHOICE III. Instructions for Use, www. Ethicon360.com. GYNECARE THERMACHOICE III Patient Brochure


Active Endometrium

RF TB

Avg. 50 ohms of

electricity applied to

endometrial lining

160 -180 mmHG &

87 applied to

endometrial lining

How Device Operates

2: Basal Layer Effects

Energy Burst

pattern results in

endovascular

coagulation

Outward Pressure

results in vascular

compression &

sealing of basilar

vessels


2. GYNECARE THERMACHOICE III. Instructions for Use. www. Ethicon360.com

Tissue appearance:

Eschar Effect-

Charred/Blackened

Tissue appearance:

Whitened -

Blanched How Tissue Appears 1. Novasure . Instructions for Use, www.Novasure.com. 2009 & 2010 Novasure Sales Aid


Avg. 50 ohms of

electricity applied to

endometrial lining

160 -180 mmHG &

87 C applied to

endometrial lining How Device Operates


Active Endometrium

RF TB

2: Basal Layer Effects

Energy Burst pattern

results in

endovascular

coagulation

Outward Pressure

results in vascular

compression and

sealing of basilar

vessels

Basal Layer Effects “Tissue Appearance”

Eschar Effect:

Charred/Blackened Blanching Effect:

Whitened/Blistered 1. Novasure . Instructions for Use, www.Novasure.com. 2009 & 2010 Novasure Sales Aid . 2011 Novasure Patient Brochure


Endometrium

RF TB

Denuding of the

Endometrium with

Fibrosis of the

Myometrium:

Inner Cast

Formation

Devitalization of the

Endometrium:

Blanching &

Subsequent

Fibrosis Post Operation to 6 months

Uterine wall

collapse & begin to

form scarring,

causes grainy

discharge

Uterine wall

“weeps” filling with

fluid keeping walls

separated; causes

a watery discharge 3. Chronic Repair: Regeneration



Chronic Repair: Regeneration

Formation of Inner Cast

Collapse walls, grainy discharge

Formation of Fibrosis

Separated walls, watery discharge



3. McCausland AM, McCausland VM, “Long-term complications of endometrial ablation: cause, diagnosis, treatment, and

prevention.” J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):399-406

Endometrium

RF TB

Formation of Inner

Cast Scarring

Formation of

Fibrosis

Myometrium Post Operation to 6 months

Uterine wall

collapse & begin to

form scarring,

causes grainy

discharge

Uterine wall

“weeps” filling with

fluid keeping walls

separated; causes

a watery discharge 3. Chronic Repair: Regeneration

Inactive

Endometrium

Inactive

Endometrium Future Considerations:

Biopsies, re-entry into cavity

McCausland AM, McCausland VM, “Long-term complications of endometrial ablation: cause, diagnosis, treatment, and prevention.” J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):399-406

Physics of Tissue Anatomy

RF

Energy

Burst averaged to

endpoint of 50Ω

impedance, with

different energy ranges

across bipolar array

Electrical Impedance

through tissue, takes

path of least

resistance.

Negative Cavity

Integrity Pressure Test,

prior to procedure

Tissue water content

& burn uniformity?

Consistency of energy

source?

False Positives?

Questions to think

about?



Outward Pressure &

Heat of 160-

180mmHG & 87C with

consistent heat range

during treatment

TB

Systolic Pressure

delivered to a discrete

tissue area. Heat Sink

Effect as flowing blood

cools temperature down,

compressed arteries, yet

compression allows for a

consistent deep treatment

Positive Cavity

Integrity checks

throughout procedure

Clinical Evidence

Endometrial Ablation Adverse Events

RADIO FREQUENCY THERMAL BALLOON • Post procedure cramping/pelvic pain • Post procedure cramping/pelvic pain

• Nausea & Vomiting • Nausea & Vomiting

• Endometriosis • Endometriosis

• Pregnancy • Pregnancy

• Hematometra • Hematometra

• Uterine perforation • Uterine perforation

• Vaginal Discharge and/or infection • Vaginal Discharge and/or infection

• Post ablation tubal sterilization syndrome

• Post ablation tubal sterilization syndrome

• Hysterectomy • Vesico-Uterine Fistula

• Thermal burn to adjacent tissues • Thermal burn to adjacent tissues

• Infection/sepsis • Infection/sepsis

• Complications leading to serious injury or death

• Complications leading to serious injury or death

COAD’S Theory of Thermal Based Technology Failure

1. Coad James. Hyperthermic Tissue Injury and Host Response: A Pathologist Perspective, Focusing on Hyperthermic Endometrial Ablation for Dysfunctional

Uterine Bleeding. Poster Presentation. AAGL 2009

COAD’S Theory of Thermal Based Technology Failures (cont’d)

COADS Study Conclusion:

1. Active bleeding from non-healing

thermally fixed vessels contribute

to treatment failures

2. Thermally fixed tissue chronically

resists breakdown & repair

pathways & delay cavity healing

3. Higher energy devices appear to

be associated with a partial

“etiologic switch” from

dysfunctional endometrium to

treatment-related vascular

changes as the cause of

continued bleeding

1. Coad James. Hyperthermic Tissue Injury and Host Response: A Pathologist Perspective, Focusing on Hyperthermic Endometrial Ablation for

Dysfunctional Uterine Bleeding. Poster Presentation. AAGL 2009

Probability of Future Procedures after Endometrial Ablation

• Longinotti et. Al. “Probability of Hysterectomy after Endometrial Ablation”. Obstet Gynecol 2008; 112: 1214-20

Methodology: Retrospective cohort analysis of data from Kaiser Permanente , mean age 44.2 years (+/- 6.2 years) undergoing EA from 1999-2004

Risk factors assess: age, setting of procedure,presence of leiomyomas

N= 4,046

Results (Probability of Hysterectomy)

• 1st Gen : 10%-25%; 8 yr period

• HTA: 8% -22%; 5 yr period

• RF: 8% - 25%; 5 yr period

• TB : 4% - 22%; 7 yr period

1. Longinotti et. Al . Probability of Future Procedures after Endometrial Ablation. Obstets Gynecol. 2008; 112 (6); 1214-1220

Probability of Future Procedures after Endometrial Ablation

• Carey E. et al. “Pathologic Characteristics of Hysterectomy Specimens in Women Undergoing Hysterectomy after Global Endometrial Ablation”. JMIG 2011; 18, 96-99.

Methodology: Retrospective cohort analysis of data from 1998-2005 Mayo Clinic with a mean age of 43.3 years (+/- 5.6 years) who underwent GEA with RF or TB to treat menorrhagia

N = 711

Results: 77 (10.8%) Hysterectomies after GEA

• 8 patients hysterectomy performed unrelated to GEA Failure 2

• 69 patients hysterectomy performed related to GEA Failure

• Strongest relationship found was between pain & hematometra – Cause after ablation is thought to be from preservation or regeneration of

endometrium in the setting of substantial scarring which may block the outlet and result in obstructive symptoms

1. Cary et. Al . Pathologic Characteristics of Hysterectomy Specimens in Women Undergoing Hysterectomy after Global Endometrial Ablation. Journal of Minimally Invasive

Gynecology .2011; 18, 96-99

2. Failure defined as Hysterectomy because of persistent bleeding, pain or both

Other Device Considerations

1. Understand device contraindications Interactions with conductive vs. non conductive

treatment devices

Uterine cavity sizes

2. Know and understand the clinical data

3. Consider long term treatment impact Future medical treatment, i.e. biopsies, etc

Cavity re-entry ability

Need for other surgeries

Conclusion

1. Different device integral mechanisms impact tissue healing differently TB: Pressure

RF: Bipolar Energy

2. Understand treatment success from patient perspective

3. Safety, Effectiveness & Adaptability

4. Know the science behind your devices Link to other technologies within your arsenal (Vessel Sealing)

5. Choose the device that provides optimal patient long term results: Hysterectomy avoidance

De Novo Pain avoidance

Treats the symptoms and does not create new ones

GYNECARE THERMACHOICE® III Uterine Balloon Therapy System

Essential Product Information - Physician

INDICATIONS: The GYNECARE THERMACHOICE III System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

CONTRAINDICATIONS: The device is contraindicated for use in a patient who is pregnant or who wants to become pregnant in the future (pregnancies following ablation can be dangerous for both mother and fetus); with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia; with any anatomic condition (eg, history of previous classical cesarean sections or transmural myomectomy) or pathologic condition (eg, chronic immunosuppressive therapy) that could lead to weakening of the myometrium; with active genital or urinary tract infection at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or with active pelvic inflammatory disease (PID); with an intrauterine device (IUD) currently in place.

ADVERSE EVENTS: include cramping/pelvic pain; nausea and vomiting; complications with pregnancy (Note: pregnancies following ablation can be dangerous for both mother and fetus); endometritis and risks associated with hysteroscopy; post-procedure symptoms such as pain, fever, nausea, vomiting and difficulty with defecation or micturition; hematometra; rupture of the uterus; thermal injury to adjacent tissue; heated liquid escaping into the vascular spaces and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical burn; hemorrhage; infection or sepsis; perforation; post-ablation tubal sterilization syndrome; complications leading to serious injury or death; vesico-uterine fistula formation.

WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury. The device is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following this procedure. Pregnancies following ablation can be dangerous for both mother and fetus. If uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated. Endometrial ablation is not a sterilization procedure. Patients who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. Endometrial ablation procedures using the GYNECARE THERMACHOICE III System should be performed only by medical professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and curettage (D&C), and who have adequate training and familiarity with GYNECARE THERMACHOICE III System. Endometrial ablation procedures do not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology. DO NOT perform same-day GYNECARE THERMACHOICE® III procedure and hysteroscopic tubal occlusion/sterilization. Ablation may cause intrauterine synechiae, which can compromise (ie, prevent) the 3-month confirmation test (HSG) for the tubal occlusion device. Women who have inadequate 3-month confirmation tests cannot rely on the tubal occlusion device for contraception. Bench and clinical studies have been conducted which demonstrate that the GYNECARE THERMACHOICE® III procedure can be safely and effectively performed with nickel titanium tubal micro-inserts in place. However, the GYNECARE THERMACHOICE® III procedure should only be performed after the 3-month tubal occlusion confirmation test.

PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE III System. For the complete list of Precautions associated with the use of this device, consult the GYNECARE THERMACHOICE III System instructions for use. Rx Only.

TC3-383-11-6/13

THANK YOU

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