EVALUATION OF POSTMENOPAUSAL RELEVANT DISCLOSURES BLEEDING:WHAT IS THE STANDARD OF CARE? EQUIPMENT LOAN:PHILIPS ULTRASOUND Steven R. Goldstein, CONSULTANT:COOK M.D.,FACOG,NCMP,CCD FRCOG (H) Professor of Obstetrics & Gynecology OBGYN,COOPER SURGICAL New York University School of Medicine Director of Gynecologic Ultrasound Co-Director of Bone Densitometry New York University Medical Center ENDOMETRIUM IN TRANSVAGINAL MENOPAUSE ULTRASOUND Introduced in the mid 1980’s, Becomes thin and atrophic No epithelial stimulation by estrogen the vaginal probe utilizes Atrophic mucosa prone to superficial higher frequency transducers punctate ulceration in close proximity to the Such “senile endometritis” is most structure being studied. common cause of PMB. Must be distinguished from hyperplasia or adenocarcinoma 1
SONOMICROSCOPY Vaginal sonography provides a degree of image magnification that is as if we were doing ultrasound through a low power microscope . Goldstein SR. Endovaginal Ultrasound, 2 nd ed. New York, NY: Wiley Liss;1991 TRANSVAGINAL ULTRASOUND TRANSVAGINAL ULTRASOUND In the early 1990’s, it was utilized in Consistently, the finding of a thin women with postmenopausal bleeding distinct endometrial echo < 4 to 5mm was shown to effectively to see if it could predict which exclude significant tissue in patients lacked significant tissue and postmenopausal women with could avoid D&C or endometrial biopsy and its discomfort, expense, bleeding. and risk. Goldstein SR, Nachtigall M, Snyder JR, et al. Am J Obstet Gynecol 1990;163:119-123. Granberg S, Wikland M, Karlsson B, et al. Am J Obstet Gynecol 1991;164:47-52. 2
TRANSVAGINAL U/S VALIDATION OF EARLY STUDIES AUTHOR YEAR THINNEST EM THICKEST EM IN A CASE OF ASSOCIATED CANCER WITH INACTIVE HISTOLOGY Goldstein 90 7 6 Varner 91 5 5 Granberg 91 9 15 3
Endometrial Thickness and Cancer TRANSVAGINAL U/S VALIDATION Findings in Postmenopausal Women OF EARLY STUDIES (ACOG 2009) With Bleeding (ACOG 2009) Reference Endometrial Number Number of Negative For EM < 4mm incidence of thickness* of women cancers Predictive Value malignancy 1 in 917 ≤ 4 mm Karlsson 1995 1,168 0 100% ≤ 4 mm Ferrazzi 1996 930 2 99.8% < 5 mm 4 99.6% ≤ 4 mm Gull 2000 163 1 99.4% Epstein 2001 < 5mm 97 0 100% ≤ 4 mm Gull 2003 394 0 100% IN FACT… IS ENDOMETRIAL BIOPSY STILL NECESSARY? False negative rate of TV U/S < 4mm significantly less than a negative ACOG Committee Opinion (2/09) suction piston biopsy (more on that “When transvaginal ultrasound is later) performed for patients with EM biopsy on patients with EM < postmenopausal bleeding and an 5mm: only 82% successfully EM thickness < 4mm is found EM performed, and of those only 27% sampling is not required” gave a sample adequate for diagnosis Elsandabesee D, Obstet Gynecol 2005;25:32-4 4
Endometrial Thickness and Incidence of Cancer in UPDATED DATA… Postmenopausal Women with Bleeding THUS… Expressed as a Composite of All Other Above Studies For average risk women the current standard of < or equal to 4mm as a “cut -o ff” beneath which no further evaluation is necessary is still acceptable 5
ULTRASOUND ENDOMETRIAL HOWEVER… EVALUATION For high risk women SO WHAT ELSE IS (obese,hypertensive, diabetic, ESSENTIAL? h/o PCOS, etc) OR patients who “re - bleed”, then further evaluation in spite of an initial thin ultrasound echo may be warranted GENERAL PRINCIPLES FOR TRANSVAGINAL U/S Use the highest frequency transducer that still yields adequate penetration Once EM echo well visualized use as much magnification as feasible Obtain multiple images in the Long Axis plane… midline as well as to the right and left of midline Measurements should be on a long axis view of the thickest point 6
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IMPORTANCE OF “EM NOT WELL VISUALIZED” Not all uteri lend themselves to a meaningful U/S examination (Axial uterus,marked obesity,coexisting fibroids, adenomyosis,previous surgery,etc.) Just because you can produce something that is “linear and white” DOESN’T mean you should!!! When an EM echo is not TOTALLY distinct,do NOT be afraid to indicate “EM echo not well visualized” 8
EXAMPLES OF “GOOD” EM ECHOS SEEN ORIGINATING FROM CERVICAL OS ENDOMETRIAL ABNORMALITIES ARE NOT ALWAYS GLOBAL 9
IMPORTANCE OF 3D RECONSTRUCTION Realize that any single frozen ultrasound image is a two dimensional “snapshot” e.g. a single long axis view of a seemingly normal endometrium does not rule out pathology. The entire structure must be observed and three dimensional anatomy reconstructed. 10
THE STANDARD OF CARE HAS CHANGED!!!! ACOG PRACTICE BULLETIN ON ABNORAMAL UTERINE BLEEDING ( JULY 2012) “One third of outpatient visits BUT HOW MANY to the gynecologist are for CLINICIANS ARE AUB and it accounts for more AWARE OF IT? than 70% of GYN consults in the perimenopausal and postmenopausal years ” 11
ANSWER THE HIGH NEGATIVE WHAT IS THE PROPER PREDICTIVE VALUE OF A USE OF THE THIN DISTINCT ECHO IN ENDOMETRIAL ECHO PATIENTS WITH BLEEDING CLINICALLY? ENDOMETRIAL POSTMENOPAUSAL BLEEDING CANCER NOT SO EASILY DEFINED American Cancer Society (2016): Menopause “The Final Menstrual Period” 60,050 cases, 10,470 deaths Retrospective diagnosis Vaginal bleeding will be the presenting Classic definition: “No bleeding for 12 sign in almost all months due to a depletion of ovarian follicles” Most women with PM bleeding actually bleed secondary to atrophic changes of Serum measurements of FSH and estradiol notoriously unreliable – snapshot of ovarian vagina or EM function at that time. Incidence of EM cancer in women with PMB ranges from 1-14% 12
CLINICAL REALITY Postmenopausal bleeding is Erratic function of the “endometrial cancer until proven ovaries in late otherwise” Mandates evaluation perimenopause often ACOG Practice Bulletin July 2012 makes it difficult to label mandates that endometrial assessment to exclude cancer is indicated in any bleeding as definitively woman older than 40 years who is postmenopausal suspected of having abnormal uterine bleeding THE RELIABILITY SO WHY IS THERE (AND LIABILITY) OF AN ISSUE WITH PIPELLE HAS PIPELLE? RADICALLY CHANGED 13
SUCTION PISTON BIOPSY PIPELLE SUCTION INSTRUMENTS PISTON BIOPSY Smaller, cheaper, disposable plastic 1st described by Cornier in an article in the Gray journal in 1984 catheters with an internal piston to Of next 8 papers (1988-1991) 7 dealt with generate suction EM dating as part of infertility W/U (no Marketing success of Pipelle brand longer utilized) (“Xerox, Kleenex”) One paper dealt with AMOUNT of tissue Similar efficacy but better patient obtained with Pipelle compared to Vabra acceptance when compared to Vabra Next paper (1991) was WIDELY publicized PIPELLE AND EM PIPELLE CARCINOMA Stovall (1991) • Rodriguez (1993) did prehysterectomy – 40 women with known sampling with both . Pipelle sampled carcinoma an average of 4% of EM lining (range – Pipelle prior to TAH 0-12%) vs. 41% for Vabra • Pipelle agreed with post hysterectomy – Cancer diagnosed in 39/40 diagnosis in only 84% of cases patients – “Accuracy” = 97.5% – Widely publicized 14
False Negative Rate of Blind PIPELLE ENDOMETRIAL Endometrial Sampling in SAMPLING Patients with Known Carcinoma Guido R. et al (J Reprod Med, 1995) 65 pts with known carcinoma of EM Pipelle under anesthesia prior to TAH – missed 11/65 cancers of which 3 were < 5% EM area 4 were 6-25% EM area 4 were 26-50% EM area – 5/11 had tumor in polyps that were missed Concluded “Pipelle is excellent for detecting global processes in the endometrium” The ACOG Practice Guideline #128 (7/12) states: “If transvaginal ultrasonographic The primary imaging test of the images are not adequate or further uterus for the evaluation of AUB evaluation of the cavity is is transvaginal necessary, then ultrasonography. sonohysterography (also called saline infusion sonohysterography) or hysteroscopy (preferably in the office setting) is recommended .” 15
SALINE INFUSION SONOHYSTEROGRAPHY REMEMBER FLUID GOLDSTEIN’S ENHANCES SOUND 1 ST AXIOM OF TRANSMISSION ULTRASOUND FLUID IS YOUR FRIEND 16
SONOHYSTEROGRAM FLUID INSTILLATION TO ENHANCE U/S DETAIL OF THE ENDOMETRIUM AMONG THE EASIEST TV U/S SCANS YOU WILL EVER PERFORM! TECHNICAL ASPECTS SIMPLE FOR GYNS,SLIGHTY MORE DAUNTING FOR RADIOLOGISTS 17
SONOHYSTEROGRAM: SONOHYSTEROGRAM: TECHNIQUE TECHNIQUE Remove speculum (carefully) Pelvic scan, unenhanced (baseline appearance) Insert vaginal probe Instill sterile saline (10cc syringe), Palpatory bimanual (anteverted, slowly, watch the screen retroverted) Scan from cornua to cornua Insert speculum “reload”, turn 90 o and scan from Cleanse cervix fundus to cervix Thread catheter (flush air first) 18
CONCLUSION Endometrial fluid instillation to enhance vaginal ultrasonography can reliably distinguish between patients with no anatonic abnormality (best treated expectantly) from patients with significant tissue in need of tissue sampling (done blindly for a global process and under direct vision for a focal process) 19
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