Transcript Endometrial Ablation - Center for Women's Health

Endometrial Ablation
for
Heavy bleeding
“A new treatment for an old problem”
Abnormal
Uterine
Bleeding:
Scope and Impact
Widespread Impact
In the United States,
AUB affects more than
40 of every 100 women
between the ages of 35
and 55
A Common Condition
Abnormal Uterine Bleeding
Affects 7.5 Million American Women
When asked:
Does heavy menstrual bleeding
disrupt your life?
20%
80%
Warner P. British Med J. 2001;323:24
1 woman in 5
says
“Yes”
Heavy Bleeding Disrupts Lives
“How often does your period cause you to miss
the following activities?”
60%
Sometimes
50%
Many times
40%
30%
20%
10%
0%
Sex
Work
Party/Fun
Event
Athletic Event Time with
Friends/Family
National Women's Health Resource Center. National survey of 653 women, 35-49 with
reported heavy periods and intact uterus; conducted Sept 29-Oct 12, 2005.
Other Symptoms
Accompany Bleeding
“Do you have the following problems often,
sometimes, rarely, never?” Often
Often/
(%)
Sometimes (%)
Fatigue or tiredness
45
85
Depression or moodiness
38
77
Really bad cramps
34
76
Headaches
32
69
Low blood count or anemia
13
38
Nausea
5
29
Other severe symptoms
9
30
National Women's Health Resource Center. National survey of 653 women, 35-49 with
reported heavy periods and intact uterus; conducted Sept 29-Oct 12, 2005.
Many Women Suffer in Silence
>5 Million
Silent Sufferers
2 Million Diagnosed,
Receiving Therapy
Silent Sufferers
 Don’t recognize heavy bleeding as a problem
 Fertility concerns
 Past therapy ineffective
 Unaware of alternatives
 Problem not diagnosed
Few Women Mention Abnormal
Uterine Bleeding
Have you discussed this problem
with your doctor?
No
71%
Data on file. BioVid; January 2005
Yes
29%
Assess Abnormal Uterine Bleeding
With Four Questions
 How are your periods?
 How many days do they last?
 Do you think they are heavy?
 Do your periods bother you or disrupt your life?
Answers to these questions provide an
excellent gauge of how a woman perceives
her menstrual bleeding
Diagnostic Techniques in AUB
 Careful history and PE *
 Laboratory work-up *
 Endometrial biopsy *
 Transvaginal ultrasonography (TVS) *
 Hysteroscopy
 Saline infusion sonography (SIS) *
 Magnetic resonance imaging (MRI)
Etiologies of
Abnormal Uterine Bleeding
 Organic causes
– Reproductive tract
lesions
– Systemic disease
 Iatrogenic causes
– Hormones
– Nonhormonal drugs
– Foreign bodies
Mishell D in Comprehensive Gynecology 4th Edition 2003
 Dysfunctional causes
– Anovulatory
– Ovulatory
Current Management of AUB
(Among Women 35-55)
No Treatment
“Silent Sufferers”
Medical Management
< 2 MM
 Hormonal
 NSAIDs
< 1MM
Surgical Intervention
 D&C
 Hysterectomy
 Endometrial Ablation
Cytyc Corporation, 2005, Data on file.
5 MM
Perspective on Management
Historically, Two Predominant Modalities:


Medical management for women wanting to
preserve their fertility
Hysterectomy for women not concerned about
fertility
Newer Treatment Modalities Have Expanded
The Options:
 Drug-eluting IUDs
 Endometrial ablation
Medical Management
<2 MM
Options Include
 Dual-hormone contraceptives
 Progestins
 Levonorgestrel-releasing IUD
 NSAIDs
 Antifibrinolytics
Identifying
Candidates
for
Endometrial
Ablation
Endometrial Ablation History
 Skill dependent: <10% gynecologists
able to perform
 General anesthesia/O.R. setting
 Risk of fluid overload and electrolyte
disturbances
1976 Laser
1987 Desiccation
 Risk of thermal or mechanical
perforation of the uterus or adjacent
organs
1990s Vaporization
 Risk of hemorrhage
1983 Resection
Late 1990s
Global Endometrial Ablation
Ablation vs. Hormone Therapy
Advantages of Ablation
 More immediate relief from problem bleeding
 Fewer contraindications
 No additional medications to monitor or
remember
 No drug interactions
 If failure, other options remain for medical or
surgical intervention
Ablation vs. Hysterectomy
Advantages of Ablation
 Fewer contraindications
 Option for local anesthesia, or conscious
sedation
 Minimal morbidity
 Outpatient or office-based procedure
 Diminished potential for post-op complications
 If failure, other options remain for medical or
surgical intervention
Impact of Endometrial Ablation
Rate of Operations (000s)
Reduction in Hysterectomy Rates
4.2
4
3.8
3.6
3.4
3.2
3
1994
1995
1996
1997
Jacobson GF et al. Obstet Gynecol. 2006;107:1278
1998
1999
2000
2001
2002
2003
NovaSure® Contraindications*
 Pregnant or the desire to be pregnant in the future
 Known or suspected endometrial carcinoma or pre-malignancy
 Any anatomic condition that could lead to weakening of the
myometrium:
– Classical C-section
– Transmural myomectomy
 Uterine cavity length < 4 cm
 Uterine cavity width < 2.5 cm as determined by the Disposable
Device Width Dial
 Active pelvic inflammatory disease
 Genital or urinary tract infection
 IUD currently in place
*For complete descriptions of contraindications refer to the NovaSure® Instructions for Use
NovaSure® Success Rates
Success
100%
98%
97%
Amenorrhea
91%
80%
60%
41%
47%
44%
40%
20%
0%
1 Year
2 Years
3 Years
Fulop I. 2nd World Congress on Controversies in Obstetrics, Gynecology & Infertility.
September 6-9, 2001.
NovaSure® Avoids Additional Intervention
Long-term avoidance of hysterectomy
100%
97%
94%
92%
80%
60%
40%
Pivotal trial, 3 years
Gallinat, 5 Years
NovaSure® Instructions for Use
Gallinat A. J Reprod Med. 2007;52:467.
Fulop T et al. J Minim Invasiv Gynecol. 2007;14:85
Fulop, 7 Years
NovaSure® Improves Quality of Life
“During your last menstrual cycle did you
experience … ?”
Pre-treatment
100%
12-months follow-up
84%
80%
75%
66%
60%
57%
40%
20%
24%
16%
24%
10%
0%
Lack of
confidence
NovaSure® Instructions for Use
Less or no
enegry
Difficulty w/
work/activities
Anxiety
Many Women May Prefer In-Office
Scheduling
 Increased patient acceptance of in-office
procedures
 Preference for office vs. hospital setting
– More comfortable for some
– Perceived as more “confidential”
– Charges may be limited to office co-payment
 Ease of access and scheduling
Given Options,
Women Prefer Ablation
% Ranking as
Top Choice
% Ranking as
Bottom Choice
Endometrial
Ablation
Hormone
Therapy
Hysterectomy
49%
37%
15%
8%
23%
69%
Data (rounded to the nearest whole number) on file. BioVid; January 2005
NovaSure® Procedure
Uterine Cavity, Hysteroscopic View,
After 85-Second Treatment
Before
After
Endometrium completely removed, leaving
only myometrium