I have no disclosures. Lori Strachowski, MD Clinical Professor of - PowerPoint PPT Presentation

6/6/2014 Sonographic Criteria for Nonviable Pregnancy in the 1st Trimester I have no disclosures. Lori Strachowski, MD Clinical Professor of Radiology, UCSF Chief of Ultrasound, SFGH The Article Lecture Goals • Detailed overview of update on diagnostic criteria for nonviable pregnancy early in the first trimester – Panelists – Issue – Objective – Plan – Recommended criteria – Reasoning N Engl J Med October 2013;369:1443-51 1

6/6/2014 The Panelists The Rads • Society of Radiologists in Ultrasound (SRU) Multispecialty Panel on Early First Trimester Miscarriage and Exclusion of a • Peter M. Doubilet, M.D., Ph.D., Brigham and Women’s and Viable Intrauterine Pregnancy Harvard Medical School* • Carol B. Benson, M.D., Brigham and Women’s/Harvard* • 3 Specialties: • Beryl R. Benacerraf, M.D., Brigham and Women’s/Harvard – Radiologists (7) • Douglas L. Brown, M.D., Mayo Clinic, Rochester – Obstetrician-Gynecologists (5) • Roy A. Filly, M.D., UCSF – Emergency Medicine (3) • Edward A. Lyons, M.D., Univ of Manitoba, Winnipeg, MB • Dolores H. Pretorius, M.D., UCSD * primary authors The OB/Gyn’s The ER Docs • Tom Bourne, M.B., B.S., Ph.D., Imperial College, London* • Michael Blaivas, M.D., University of South Carolina* • Steven R. Goldstein, M.D., NYU School of Medicine • J. Christian Fox, M.D., University of California, Irvine • Ilan E. Timor-Tritsch, M.D., NYU School of Medicine • John L. Kendall, M.D., Denver Health Medical Center • Kurt T. Barnhart, M.D., M.S.C.E., University of Pennsylvania • Misty Blanchette Porter, M.D., Dartmouth * primary authors * primary authors 2

6/6/2014 The Issue Pain +/- Bleeding in Early Pregnancy Misuse and misinterpretation of US and β-hCG Methotrexate inadvertently administered Miscarriage and malformations MALPRACTICE _ _ _ _ _ _ _ _ _ _ _ www.facebook.com Medical Liability Action Inadvertent Tx of IUPs with MTX • 2009 Survey on Professional Liability conducted by ACOG • 3 diagnostic error patterns – 90.5%: ≥ 1 professional liability claim – Avg: 2.69 claims per obstetrician - gynecologist – Perception and interpretation of findings on US • 62% - OB care • 38% - Gyne care – Improper correlation of β-hCG levels and US findings – Delayed dx of breast cancer – Inadvertent Tx of IUPs with MTX – Treatment based on a single hCG level without a definitive US diagnosis of ectopic pregnancy Obstetrics and Gynecology 2010 ;116:8-15 Obstetrics and Gynecology 2010 ;116:8-15 3

6/6/2014 US Error Types The Objective • Perception: – Finding seen in retrospect but initially missed • i.e. an early intrauterine gestational sac or yolk sac • Interpretation: First, DO NO HARM – Findings perceived but incorrectly diagnosed • i.e. CL of pregnancy interpreted as an EP or an early GS or the least possible as a pseudo-sac • Confounding factors for both: – Poor quality images, noncritical image evaluation, incomplete clinical info Obstetrics and Gynecology 2010 ;116:8-15 The Plan The Diagnostic Tests: hCG • Set quality standards for diagnostic tests • Human chorionic gonadotropin – Serum measured with use of WHO 3rd or 4th International • Standardize terminology Standard • Establish diagnostic criteria – Positive serum pregnancy test – Widely applicable and reproducible is defined by > 5 mIU/ml – Minimize risk • Based (in part) on downstream consequences of false positive and false negative results NOTE: low levels of hCG can occur in health non-pregnant patients. 4

6/6/2014 The Diagnostic Tests: US The Terminology • Minimum quality criteria: • Viable – TVS of uterus and adnexa – TAS for FF and mass high in the pelvis – Oversight by an appropriately trained physician – Performed by providers and interpreted by physicians, all • Nonviable of whom meet at least minimum training or certification standards – Scanning equipment permitting adequate visualization of structures early in the first trimester Definition: Viable (vī-ə-bəl) Definition: Viable (vī-ə-bəl) 1: capable of living; especially : having attained such form and 1: capable of living; especially : having attained such form and development as to be normally capable of surviving outside the development as to be normally capable of surviving outside the mother's womb <a viable fetus> mother's womb <a viable fetus> www.Merriam-Webster.com www.Merriam-Webster.com 5

6/6/2014 Definition: Viable (vī-ə-bəl) Definition: Viable (vī-ə-bəl) 1: capable of living; especially : having attained such form and 1: capable of living; especially : having attained such form and development as to be normally capable of surviving outside the development as to be normally capable of surviving outside the mother's womb <a viable fetus> mother's womb <a viable fetus> 2: capable of growing or developing < viable seeds> < viable eggs> 2: capable of growing or developing < viable seeds> < viable eggs> 3 a : capable of working, functioning, or developing adequately 3 a : capable of working, functioning, or developing adequately < viable alternatives> < viable alternatives> b : capable of existence and development as an independent unit b : capable of existence and development as an independent unit <the colony is now a viable state> <the colony is now a viable state> c (1) : having a reasonable chance of succeeding <a viable c (1) : having a reasonable chance of succeeding <a viable candidate> (2) : financially sustainable <a viable enterprise> candidate> (2) : financially sustainable <a viable enterprise> www.Merriam-Webster.com www.Merriam-Webster.com The Terminology The Differential • Viable: – A pregnancy is viable if it can potentially result in a liveborn baby. Currently Ectopic Failed/ • Nonviable: Viable pregnancy Failing – A pregnancy is nonviable if it cannot possibly result in a IUP IUP liveborn baby. • Ectopic pregnancies and failed intrauterine pregnancies are nonviable. Expectant MUA MUA, MTX, management +/- surgery 6

6/6/2014 Currently Viable IUP The Differential Currently Ectopic Failed/ Viable pregnancy Failing IUP IUP Expectant MUA MUA, MTX, management surgery Ectopic Pregnancy The Differential Ov Currently Ectopic Failed/ Viable pregnancy Failing IUP IUP Expectant MUA MUA, MTX, management surgery 7

6/6/2014 Spontaneous AB in Progress The Differential Cervix Currently Ectopic Failed/ Viable pregnancy Failing IUP IUP Expectant MUA MUA, MTX, management surgery FP + FN Consequences It ain’t always that easy! FN: Failure FP Currently Ectopic Failed/ Viable pregnancy Failing IUP IUP Expectant Short delay in dx MUA MUA, MTX, management surgery 8

6/6/2014 FP + FN Consequences FP + FN Consequences FN: EP FN: EP FN: Failure Currently Ectopic Currently Ectopic Failed/ Failed/ Viable pregnancy Viable pregnancy Failing Failing IUP IUP IUP IUP Expectant Expectant Short delay in dx Short delay in dx MUA MUA, MTX, MUA MUA, MTX, management management Likely non-life- Likely non-life- surgery surgery threatening! threatening! FP + FN Consequences To “DO NO HARM” 1. Criteria for non-viability require FN: Viable IUP FN: Viable IUP – 100% Specificity or as close as possible FP FP – 100% PPV Currently Ectopic Failed/ 2. Need more buckets! Viable pregnancy Failing IUP IUP Expectant Short delay in dx MUA MUA, MTX, management Likely non-life- surgery threatening! 9

6/6/2014 The Expanded Differential The Terminology • Intrauterine pregnancy of uncertain viability: – If transvaginal ultrasonography shows an intrauterine gestational sac with no embryonic heartbeat and no findings of definite pregnancy failure. Currently Ectopic Failed/ Viable Pregnancy pregnancy Failing • Pregnancy of unknown location: IUP of IUP of IUP – Positive pregnancy test and no intrauterine or ectopic Uncertain Unknown Viability pregnancy is seen on transvaginal US. Location MUA, MTX, Expectant MUA Is there a chance of a viable pregnancy? +/- surgery management The Expanded Differential The Expanded Differential Failure IUP Viable EP IUP Currently Ectopic Currently Ectopic Failed/ Failed/ Viable pregnancy Viable pregnancy Pregnancy Pregnancy Failing Failing IUP of IUP of IUP IUP of of IUP IUP Uncertain Uncertain Unknown Unknown Viability Viability Location Location MUA, MTX, MUA, MTX, Expectant MUA Expectant MUA +/- surgery +/- surgery Short delay in dx management management Expectant Expectant Expectant Short delay in dx Expectant Likely non-life- management management management management threatening 10

6/6/2014 The Expanded Differential Literature on Nonviable IUP Criteria • Serum beta level Specific criteria and management algorithms – Largely unreliable given range of normal • US findings Failed/ – Size-based criteria Pregnancy Failing IUP of • Embryo without heart motion of IUP Uncertain • GS without an embryo Unknown Viability Location – Time-based criteria • Appearance of interval findings US of Early Pregnancy Let’s review normal. • In order of appearance: – Intradecidual sign Gestational sac – Double decidual sac sign – Yolk sac – Embryo (+ heart motion) – Amnion v v 11