New Concepts in Endometrial Ablation

Howard T. Sharp MDJon M Huntsman Presidential Endowed Chair

Professor and Vice Chair for Clinical AffairsDepartment of Obstetrics and Gynecology

University of Utah Health

Objectives

• Discuss impact of AUB• To review new devices for endometrial ablation• Discuss risks associated with EA

Impact of Heavy Menstrual Bleeding

• “Women who have a heavier flow are 72% as likely to be working as are women who have a lighter or normal flow.”

• “…work loss from increased blood flow is estimated to be $1692 annually per woman…”

Obstet Gynecol 2002;100:683-7

Impact of Heavy Menstrual BleedingFrick et al, Women’s Health Issues 2009;19:70-8

• Leisure activity was limited moderately in 82% of women with HMB.

• Annual cost of HMB (pharmaceuticals, pads / tampons, missed work, home management was estimated as $2,625.

• In the U.S. the estimated annual total economic impact is 37+ billion in 2007 dollars.

Endometrial Ablation• YAG Laser Ablation• Endometrial Resection• Rollerball Ablation• Thermal Balloon Ablation• Cryoablation Ablation• Circulated Hot Fluid Ablation• Microwave Ablation• Radiofrequency Ablation

Why Global Ablation?

Endometrial Ablation

• YAG Laser Ablation• Endometrial Resection• Rollerball Ablation• Thermal Balloon Ablation• Cryoablation Ablation• Circulated Hot Fluid Ablation• Microwave Ablation• Radiofrequency Ablation

Market Share

• Global EA Market - $985 M in 2017• Over 500,000 cases in 2018

• Radiofrequency Ablation 55%

Market Share

Amenorrhea / Success RatesFDA Data at 12 monthsAll Randomized TrialsMethod Amenorrhea Pt Satisfaction

ThermaChoice 13.2% (32.6%) 85%Her Option 22.2% 86%HTA 35.3% N/ANovaSure 36.0% 92%Microwave 55.5% 89%

Note: RB amenorrhea rates range 27.2% - 47.1%

(5 year hysterectomy rate = 15-30%)

What is the chance she will get a hysterectomy within 5 years?Method Rate Source• TCRE 25% Cooper, BJOG 2005• MEA 16% Cooper, BJOG 2005• RF 25% Longinotti, Obstet Gynecol 2008• Balloon 15% Longinotti, Obstet Gynecol 2008• HTA 22% Longinotti, Obstet Gynecol 2008• Overall 23% Longinotti, Obstet Gynecol 2008• Overall 29% Dickersin, Obstet Gynecol 2007

Who Fails?(El-Nashar, Obstet Gynecol 2009)

RF compared to Balloon

• Age < 45 (aHR 2.6)• Parity > 5 (aHR 6.0)• Prior BTL (aHR 2.2)• Dysmenorrhea (aHR 3.7)• Balloon (aHR 1.5)

New Devices

• Argon-bipolar ablation (Minerva)• Low-pressure vapor ablation (Aegea)• Glycerine-filled balloon (Lina Librata)• Cryotherapy (Cerene)

Combined Thermal-RF Ablation (Minerva)• FDA approved 2015• Heat applied by circulating ionized gas in silicon

membrane heated by RF energy• 40 watts (compared to 180 watts)

Minerva RBAmenorrhea 71.6% 49% (12 months)(Laberge et al. JMIG 2017)

Minerva

MAUDE 12 month review only

Bowel injury Hematometra EndometritisMirerva 12 1 3

AEGEA (Mara) Vapor Ablation

• FDA approved 2017• Delivers vapor for 120 seconds• Cervix may not need dilatation (5.8 mm)• Does not touch fundus

MaraSuccess 78.7% (PBLAC score < 75)Amenorrhea 19.4Satisfaction 91% (Levie, et al. JMIG 2019)

Mara Vapor Ablation

Cerene Cryotherapy Ablation

• Better designed for in-office use• Liquide to gas phase change of Nitrous Oxide• Polyurethane liner• 2.5 minute treatment

• PBLAC score <75 at 12 months = 71%• Satisfaction rate = 89%• Amenorrhea rate = 10%• 98.7% of uterine cavities accessible at the 12 months

Cerene Cryoablation

Lina Librata

• Disposable cordless thermal balloon• 2 minute treatment• 5.4 mm catheter

MAUDE Database

Endometrial AblationGurtcheff SE, Sharp HT, Obstet Gynecol 2003

MAUDE DBComplications: 85

Thermal bowel injury: 8Emergent lap: 12

Death: 1

WORLD LITERATUREHemorrhage: 2

PID: 1Endometritis: 20Vaginal burns: 2

Hierarchy of Study Design

Descriptive Studies

COHORTTROHOC

RCT

Hierarchy of Study Design

Descriptive Studies

COHORTTROHOC

RCT

MAUDE

What A Year taught us

Transmural bowel burnsU/S thickness measure

Bowel burns

Vaginal burnsSkin burns (tubing)Insulation stabilizer

Bowel burnsPropeller

New Material

Ureteral burn

New Technology

“Don’t be the first or the last to embrace new technology”

- James R. Scott MD

Postmenopausal Bleeding After Ablation• Endometrial ablation and ultrasound are not accurate to

exclude endometrial hyperplasia / cancer after EA.• Pain / bleeding are common symptoms of endometrial

cancer• Hysterectomy is the only definitive way to exclude

endometrial cancer.• We are just getting to the decade of endometrial cancer

for women who have had ablations (average age 65).• 1997 is the year the Thermal Balloon was introduced.

Pregnancy After Ablation

• Systematic review• 274 pregnancies• 80% of pregnancies were not associated with any

contraception.• Takeaway: Remember to counsel about contraception

(Kohn et al, BJOG 2017

52 mg LNG-IUDSimilar efficacy as EA(Spencer AJOG 2017)

Favorable for efficacy and cost-effectiveness compared to EA and hysterectomy(Ont Health Technol Assess Ser 2016)

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Conclusions

• AUB is a significant problem for many women in terms of cost and lifestyle impact.

• All EA methods have limitations and risks• Counseling about risks / benefits is important