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Gyn 2012 Practice Guidelines Update
Robert J Kahler, MD FACOG Genesis OBGYN
3 common issues Gyn Ultrasound
Incidental Gyn Ultrasound findings Ovarian cysts
Thick endometrial echo
Postmenopausal bleeding
Pap smear routines
New OC hormone free intervals
Incidental ultrasound findings
SRU: Society of Radiologists in Ultrasound
2010 Consensus Conference Statement on Asymptomatic Adnexal Masses
Guideline use should avoid patient (and provider) anxiety and limit the need for f/u exams for benign physiologic and clinically inconsequential adnexal cysts
Levine D, et al Management of Asymptomatic Ovarian and Other Adnexal Cysts Imaged at US. Ultrasound Quarterly 2010;26:121-131
Normal Ovaries “make cysts for a living”
“Simple” Ovarian cyst
Unilocular
Anechoic No echogenic material within
Thin capsule No solid element
No Doppler flow (Blood flow)
Less than 7 cm
“Complex” Ovarian cyst
Echogenic material within mass
Septations
Thickened capsule
Solid elements
Doppler flow
Size > 7-10cm
Complex ovarian cyst
Ovarian Cancer “Pay attention to the donut, not the hole”
“Simple” Ovarian cyst (SRU)
Virtually never malignant
Premenopausal simple or hemorrhagic <3cm need no reporting or f/u 3-5cm should be described as almost cert benign, no f/u 5-7cm simple, almost cert benign, annual f/u recommended >5cm hemorrhagic, benign, f/u sono 6-12 weeks
Postmenopausal <= 1cm, clinically inconsequential, need no reporting (~20%) 1-7cm, benign, recommend annual sono f/u once stable
CA125 helps triage
>7cm simple recommend further eval
Question
Your 63 mother-in-law tells you a 4cm ovarian cyst was found by ultrasound f/u of an MRI of her back. She has no gyn complaints. It is described as unilocular, anechoic, thin walled, and with no doppler flow. The other ovary is unremarkable and there is no free fluid. She asks your advice. You tell her:
1. Obtain a CA125 and, if normal, repeat sono in 2 months. If stable, observe by ultrasound
2. You’ll get her in to your Gyn Oncologist colleague.
3. Her Gyn should take it out.
Summary: Incidental simple ovarian cysts
3-7cm premenopausal <3cm consider functional, <5cm benign and don’t follow
1-7cm postmenopausal < 1cm clinically inconsequential
Unilocular, anechoic, thin walled w/o solid element, no doppler
Very low malignant potential
Observe until stable (ie q2mo, then 4mo, then 6mo) then annually
Endometrium
Postmenopausal Bleeding
Endometrial cancer until proven otherwise
H&P may find vulvar, vaginal, or cervical pathology Issues of hormone therapy Higher risk with obesity, DM, HTN
Transvaginal ultrasound (TVUS)
Endometrial biopsy (EMBx)
Saline Infusion Sonography (SIS)
Hysteroscopy, hysterectomy
Ultrasound as initial w/u of Postmenopausal Bleeding
Transvaginal Ultrasound has an extremely high negative predictive value (> 99.4%) and can be used to exclude endometrial pathology The endometrial echo must be reliably seen Measures <=4mm
Risk 1:917 Use clinical judgment
Persistent bleeding Risk factors, ie obesity
ACOG Committee Opinion #440 8/09 (Reaffirmed 2011)
AUB Algorithm
Perimenopausal AUB
TVUS
SIS
EMBx Hysteroscopy
Reliable and thin
<= 4mm
<= 2mm each Global >2mm each
Not reliable +/or not thin
Focal or unsatisfactory
Goldstein SR AJOG 1997;177:102-8
DUB
Saline infusion sonography
AUB Algorithm
Perimenopausal AUB
TVUS (433pts)
SIS
EMBx 2.3%
Hysteroscopy 16%
Reliable and thin
<= 4mm 65%
<= 2mm each 16%
Global >2mm each
29% unreliable 71% >5mm
Focal or unsatisfactory
13.4% polyp 5.3% myoma 3.5% EH
Goldstein SR AJOG 1997;177:102-8
DUB 79%
Post Menopausal Bleeding Algorithm
PMB
TVUS
Observe
EMBx
Gyn Onc
SIS
Refer to Gyn for further evaluation
Reliable and thin
<= 2mm each Cancer
<=4mm
Anything else
Anything else
Gyn
“Thickened endometrial echo” as an incidental imaging finding
Hysteroscopy for 82 asymptomatic PM thick EM1
67 (82%) inactive polyps, 7 myoma, 6 atrophy, no Ca or complex hyperplasia. (3.6% complication rate)
Asymptomatic polyps common, up to 17%2
< 4/1,000 Ca in 1152 asx PM polyps by SIS (1% complix rate)3
Cancer dx w/in 8 weeks of bleeding did not change prognosis4
1 Lev-Sagie A et al BJOG 2005;112:379-382
2 Berliere et al Euro J Ca 2000;36:S35-6
3 Ferrazzi E et al AJOG 2009,200: 235
4 Gerber et al EurJCa 2001;57:64-71
Summary: Endometrial ultrasound
Post menopausal bleeding Adequately visualized <= 4mm has a very high negative
predictive value and reliably excludes pathology >4mm work up with SIS, EMBx Hysteroscopy for inadequate eval, hyperplasia, focal
lesions
An incidental (no bleeding) “thick” endometrial echo is common, possibly up to 10-17% not a good predictor of endometrial pathology Automatic endometrial sampling may not be justified
may lead to unintended problems
Clinical judgment is important in high risk
Pap Smear routines
ASCCP.org American Society for Colposcopy and Cervical Pathology
2012 algorithms for pap smear and HRHPV frequency Saslow D. ACS, ASCCP, ASCP Screening Guidelines for the
Prevention and Early Detection of Cervical Cancer. J Lower Genital Tract Disease 2012
Algorithms for recommended f/u of abnormal paps
Algorithms for recommended f/u of abnormal colpo biopsy
ACS, ASCCP, ASCP Screening Guidelines 2012
ACOG.org Chelmow D, et al. The Evolution of Cervical Screening
and the Specialty of OBGYN. OG 2012;119:695-9
American Cancer Society http://Caonline.AmCancerSoc.org March 14 2012
US Prev Serv Task Force
Pap background George Papanicolau 1883-1962
Cervical cytology evaluation (manual, automated)
A routine for over 60 years (pub. 1943) 50% reduction in Cx Ca 1975-2006 (15 to 6.5/100K)
Potential errors (in a 36 mo Kaiser study*) Sampling
Patient (56% w/ Ca never screened) Good technique
Liquid based filters out contaminates Interpretation (32%)
Inconsistency among cytologists (>50%) Follow up (13%)
Where we come in
Retrospective of Cx Ca at Kaiser. Leyden MA JNCI 2005;97
High Risk Human Papilloma Virus DNA testing (HRHPV)
Cervix cancer: 1st human cancer identified to have a single necessary cause Found in 99.7% of cervix cancers 13 HPV types considered high risk, types 16 and 18 account for 70% Downside: almost everyone has HPV at some time Upside: >90% clear it within 1-2 years Viral persistence and the development of high grade dysplasia are key
Accurate detection by PCR from a cervical sample >20% in under 25yo, <10% over 30yo Higher detection with more, and more recent sex partners
High negative predictive value when “not detected” Risk of cancer < 1/1,000
High Risk Human Papilloma Virus DNA testing (HRHPV)
Add later as “reflex” for an abnormality on pap
With pap to decrease the pap frequency
F/u previous abnormal cytology or histology
As primary sample with reflex pap if detected Not considered standard
Reported as positive/negative or detected/not detected
Some labs reflex HRHPV+ to 16 and/or 18 detection
Pap results - Squamous NIL: No intraepithelial lesion
Satisfactory or unsatisfactory for evaluation Endocervical cells present or absent (?atrophy)
LSIL: Low grade squamous intraepithelial lesion HPV effect, mild dysplasia, CIN1
HSIL: High grade squamous intraepithelial lesion CIN2/3, moderate or severe dysplasia, CIS
ASC- : Atypical squamous cells- ASC-US: uncertain significance (85%) ASC-H: cannot rule out High grade SIL
Similarity between metaplastic and high grade cells 27% >=CIN2, 17% >=CIN3
Squamous cell carcinoma
Pap results - Glandular
AGC: Atypical glandular cells Cervical, endometrial
AIS: Adenocarcinoma in situ
Adenocarcinoma
Pap choices
Pap alone Slide or liquid based
Pap with reflex HRHPV for ASC-US No advantage for reflex with dysplasia or AGC No benefit of low grade HPV testing
Pap and HRHPV “co-testing”
With or without GC/chlamydia testing
New* screening pap guidelines (assuming prior paps normal, immunocompetent, no DES)
< age 21, no pap
Age 21-29 (with or without vaccination) Pap with reflex HRHPV for ASCUS every 3* years
Age 30-65 Pap and HRHPV cotesting every 5* years “preferred” Pap alone every 3 years “acceptable”
> 65yo or after hyst with cervix removed No pap if no CIN2+ in previous 20 years Once stopped, do not resume*
Little evidence supporting annual screening of any type*
Recommended Pap frequency
Under age 21 Don’t start regardless of sexual debut 0.1% of Cx Ca -- 1-2/Million
Incidence hasn’t changed in over 40 years
0.7% of paps HSIL, 75% CIN2 regressed in 3 yrs Potential adverse effects of f/u leads to net harm
Anxiety, stigma of STD, discomfort, potential preterm delivery
STD testing
Recommended Pap frequency
Age 21-29 (previously normal pap) Pap with HRHPV reflex if ASC-US every 3 yrs
Predicted risk CA w/ 3,2,1 yr intervals is 5,5,3/100,000 with 760, 1,080, 2,000 colpos per 1,000
HRHPV is common—don’t use it as a screening test Treat ASCUS/HRHPV negative as NIL and continue screen Colposcopy for ASCUS/HRHPV+ or greater Not enough evidence to support longer interval
with history of normal paps or vaccination (<32% vaccinated, pre-existing HRHPV)
GC/chlamydia
Recommended Pap frequency Age 30-65
Pap and HRHPV cotesting every 5 years “preferred” 0.61% lifetime cancer risk vs 0.39% w/ 3 yr interval
Fewer colpos and other intervention
Increased AdenoCa and AIS detection vs pap HPV more sensitive and reproducible than pap
Pap every 3 years “acceptable” 0.69% lifetime cancer risk
Except HIV+, immune suppression, DES exposed, prior CIN2/3
Recommended Pap frequency Over age 65 No further paps
With >= 3 consecutive NIL paps and no CIN2+ in the last 20 yrs
Continued screening until age 90 would Prevent 1.6 cancers and 0.5 deaths / 1,000
Add 127 colpos and 58 false positives / 1,000
Do not restart for any reason once stopped
Recommended Pap frequency After hysterectomy (no cervix)
No pap unless history CIN2/3 or cancer in previous 20 years
Evidence of negative prior screening not required
1.8% abnormal pap 1/1,000 VaIN on biopsy, no cancer
Primary vaginal cancer 7/million Don’t resume once stopped for any reason
including new sexual partner
F/u abnormal pap ASC-US pap with HRHPV not detected, treat as NIL and cont
screening
12 month Pap AND HRHPV cotesting Pap NIL but HRHPV detected (6% risk CIN2+)
NIL, HRHPV+ but type 16, 18 not detected
Lack of endocervical cells
Colposcopy ASC-US with reflex HRHPV positive NIL, HRHPV+ and type 16 or 18 are detected LSIL (except <21yo: rpt pap 12 mo) HSIL, ASC-H, AGC, AIS
Routine screening continued 20 years with hx CIN2/3, Cancer Continue after hysterectomy, age 65
Pap frequency POBASCAM trial (Netherlands)
40K women ages 29-56 in cervix screening program 20K with pap alone, 20K with pap + HRHPV
16,750 in each group followed up at 5 years after appropriate Rx
RR of disease in 5 years >= CIN3 was 0.73 (CI 0.55-0.96) (0.45% vs 0.62%) Cancer was 0.29 (CI 0.1-0.87) (4 vs 14 of 19,500)
Adding HRHPV to pap lead to earlier detection and Rx
POBASCAM RCT final results. Rijkaart DC Lancet Oncology. 2012;13:78-88
Question
A 35yo healthy monogamous G3P3 has had normal annual pap smears since she was 18 at your office but missed last year. Do you
1. Remind her of the necessity of annual paps and obtain one?
2. Obtain pap and HRHPV and if normal counsel a 5 year interval?
3. Suggest she could wait another year prior to repeating pap, discussing the potential addition of HRHPV then?
Summary routine pap
Don’t start until age 21
Ages 21-29 pap w/ reflex HRHPV for ASC-US q 3 years
Ages 30-65 Pap and HRHPV q 5 years preferred Pap w/ reflex HRHPV for ASC-US q 3 years acceptable
Stop after age 65 with known nml pap history
No pap after hysterectomy w/o cancer or CIN 2/3
Reconsidering monthly menses
Monthly menses is a fairly modern concept. Now 12M OC users
My 7th Great-grandmother in the late 1600s New England had 16 children, 12 survived. With pregnancy and nursing, she would have few unsuccessful ovulations leading to menses
The ovary (unlike thyroid, etc) is accustomed to suppression Every other month, during pregnancy, lactation
No menses in children, lactation, or menopause Depo Provera (DMPA), Mirena do not provide “menses”
Original high dose OC designed with 21 active pills and a week break.
Benefits of new formulations
Retain excellent contraception with lower doses All OCs reduce risk of endometrial and ovarian cancer No consistent effect on breast cancer risk Non-contraceptive benefits on acne, dysmenorrhea, etc
Lighter, less uncomfortable menses, PMS, mastalgia Reduce menstrual migraine (beware aura) Fewer functional cysts leading to pain, tests, surgery
Amenorrhea for lifestyle considerations
Less unintended bleeding
New OC: Hormone Free Intervals Old and new pills in new packaging, lower doses
3 months of active pills followed by a withdrawal bleed Seasonique and LoSeasonique
28 active pills per pack with no break Lybrel (or any monophasic off label) Extended Nuvaring use
½ dose EE in HFI Mircette, LoSeasonique
HFI to 4 or 2 days (FSH by rises CD4) Loestrin24, Lo Loestrin, Yaz, Natazia
Risks
Unscheduled bleeding Tends to improve over time
Confusion Don’t wait for withdrawal bleed to start new pack
Cost if manipulating standard 21/7 pill pack (off label) for extended or continuous use
ACOG Practice Bulletin #110, Jan 2010
Micks E, Jensen JT. OC… latest formulations. Contemporary OBGYN Feb 2012
Question
A 23 yo healthy G0 is new to your office and has been using a generic monophasic 20mcg OC. She’s looking for alternatives because she doesn’t like to have menses but other pills have been expensive or caused adverse effects. Do you
1. Refer her to Gyn
2. Use her OC without interval (will need 16 packs per year)
3. Discuss Mirena, DMPA, and Implanon
4. Suggest monthly withdrawal bleeding is most normal
5. 2 and 3
Summary
New lower dose OC formulations and packaging can be used to reduce symptoms and reduce or eliminate bleeding
Pap/HRHPV co-testing has a high negative predictive value and can extend pap frequency to 5 yrs when over age 30
A reliable <= 4mm endometrial echo by TVUS has a high negative predictive value in the w/u of PMB
An incidentally found (no bleeding) thick endometrial echo is poorly predictive of endometrial pathology
A simple ovarian cyst has a high negative predictive value for ovarian cancer