Nothing to disclose. Lori Strachowski, MD Clinical Professor of - PowerPoint PPT Presentation

10/22/2014 New Recommendations for Diagnosing Failed Intrauterine Pregnancy Nothing to disclose. Lori Strachowski, MD Clinical Professor of Radiology, UCSF Chief of Ultrasound, SFGH lori.strachowski@ucsf.edu 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

10/22/2014 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

10/22/2014 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

10/22/2014 US Error Types The Objective • Perception: – Finding seen in retrospect but initially missed • i.e. an early intrauterine GS or YS • Interpretation: First, DO NO HARM – Findings perceived but incorrectly diagnosed • i.e. CL interpreted as EP or early GS as a pseudo-sac “or the least possible” • Confounding factors: – 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 on consequences of false positive and negative results NOTE: low levels of hCG can occur in health non-pregnant patients. 4

10/22/2014 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

10/22/2014 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. • Examples: ectopic pregnancies and failed intrauterine pregnancies Expectant MUA MUA +/- MTX Manual uterine management +/or surgery aspiration 6

10/22/2014 Currently Viable IUP The Differential Currently Ectopic Failed/ Viable pregnancy Failing IUP IUP Expectant MUA MUA +/- MTX management +/or surgery Ectopic Pregnancy The Differential Ov Currently Ectopic Failed/ Viable pregnancy Failing IUP IUP Expectant MUA MUA +/- MTX management +/or surgery 7

10/22/2014 Spontaneous AB in Progress The Differential Cervix Currently Ectopic Failed/ Viable pregnancy Failing IUP IUP Expectant MUA MUA +/- MTX management +/or surgery What is the best diagnosis for this It ain’t always that easy! 1 st trimester pregnancy? A. Currently viable IUP B. Failed/failing IUP C. Ectopic Pregnancy D. I don’t like any of these answers 71% 20% 7% 1% A. B. C. D. 8

10/22/2014 FP + FN Consequences FP + FN Consequences FP: Viable IUP FN: EP FN: Failure Currently Ectopic Currently Ectopic Failed/ Failed/ Viable pregnancy Viable pregnancy Failing Failing IUP IUP IUP IUP Short delay in dx Short delay in dx MUA MUA +/- MTX MUA MUA +/- MTX Expectant Expectant +/or surgery +/or surgery Likely non-life- management management threatening! FP + FN Consequences FP + FN Consequences FN: Viable IUP FN: Viable IUP FN: EP FN: Failure FP: Failure FP: EP Currently Ectopic Currently Ectopic Failed/ Failed/ Viable pregnancy Viable pregnancy Failing Failing IUP IUP IUP IUP Short delay in dx Short delay in dx MUA MUA +/- MTX MUA MUA +/- MTX Expectant Expectant +/or surgery +/or surgery Likely non-life- Likely non-life- management management threatening! threatening! 9

10/22/2014 To “DO NO HARM” The Expanded Differential 1. Criteria for non-viability require – 100% Specificity “or as close as possible” – 100% PPV Currently Ectopic Failed/ 2. Need more buckets!!! Viable pregnancy Pregnancy Failing IUP of IUP of IUP Uncertain Unknown Viability Location Expectant MUA MUA +/- MTX management +/or surgery The Expanded Differential The Terminology • Intrauterine pregnancy of uncertain viability: – 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 IUP of • Pregnancy of unknown location: IUP of IUP Uncertain – Positive pregnancy test and no intrauterine or ectopic Unknown Viability pregnancy on transvaginal US. Location Expectant MUA MUA +/- MTX management +/or surgery Expectant Expectant management management 10

10/22/2014 The Pivotal Question The Expanded Differential Failure Failure EP Viable EP Viable IUP IUP Currently Ectopic Failed/ Is there a chance of a viable pregnancy? Viable pregnancy Pregnancy Failing IUP of IUP of IUP Uncertain Unknown Viability Location Expectant MUA MUA +/- MTX management +/or surgery Short delay in dx Expectant Short delay in dx Expectant management management Likely non-life Likely non-life threatening threatening The Expanded Differential The Expanded Differential Specific criteria and management algorithms Currently Ectopic Failed/ Failed/ Viable pregnancy Pregnancy Pregnancy Failing Failing IUP of IUP of IUP of of IUP IUP Uncertain Uncertain Unknown Unknown Viability Viability Location Location Expectant MUA MUA +/- MTX management +/or surgery Expectant Expectant management management 11