External Validation of a Prediction Model Assessing Risk of Delivery in Fetuses with Growth Restriction after Diagnosis of Abnormal Umbilical Artery Doppler.

OBJECTIVE: We have previously described a model using maternal, antenatal, and ultrasonographic characteristics to assess the risk of delivery within 7 days following diagnosis of abnormal umbilical artery Doppler (UAD) in pregnancies affected by fetal growth restriction (FGR). Therefore, we sought to validate this model in an independent cohort. STUDY DESIGN: Retrospective, single referral center study of liveborn singleton pregnancies from 2016 to 2019 complicated by FGR and abnormal UAD (systolic/diastolic ratio ≥95th percentile for gestational age [GA]). Prediction probabilities were calculated by applying the original model (Model 1) to the current cohort (Brigham and Women's Hospital [BWH] cohort). The variables of this model include GA at first abnormal UAD, severity of first abnormal UAD, oligohydramnios, preeclampsia, and prepregnancy body mass index. Model fit was assessed with area under the curve (AUC). Two alternative models (Models 2 and 3) were created to identify a model with better predictive characteristics than Model 1. The receiver operating characteristics curves were compared using the DeLong test. RESULTS: A total of 306 patients were assessed for eligibility, 223 of whom were included in the BWH cohort. Median GA at eligibility was 31.3 weeks, and median interval from eligibility to delivery was 17 days (interquartile range: 3.5-33.5). Eighty-two (37%) patients delivered within 7 days of eligibility. Applying Model 1 to the BWH cohort resulted in an AUC of 0.865. Using the previously determined probability cutoff of 0.493, the model was 62% sensitive and 90% specific in predicting the primary outcome in this independent cohort. Models 2 and 3 did not perform better than Model 1 (p = 0.459). CONCLUSION: A previously described prediction model to predict risk of delivery in patients with FGR and abnormal UAD performed well in an independent cohort. With high specificity, this model could assist in identifying low-risk patients and improve antenatal corticosteroid timing. KEY POINTS: · Risk of delivery in 7 days can be predicted.. · Risk of delivery can inform corticosteroid timing.. · An externally validated clinical aid can be developed..

Overcoming roadblocks in clinical innovation via high fidelity simulation: use of a phantom simulator to achieve FDA and IRB approval of a clinical trial of fetal embolization of vein of Galen malformations.

BACKGROUND: Vein of Galen malformation (VOGM) is a rare, life-threatening vascular malformation in neonates and is treated with embolization. However, even at the most experienced centers, patients face high mortality and morbidity. In utero treatment options have been limited by lack of animal models or simulations. OBJECTIVE: To create a novel ultrasound phantom simulator for a preclinical feasibility study of in utero fetal intervention for VOGM. METHODS: Novel phantoms were designed and built in two configurations of spherical and windsock shape from cryogel material to mimic the salient vasculature of the fetal VOGM, based on real-patient fetal MR imaging dimensions. Critical anatomy was realistically mimicked within this model and transtorcular ultrasound-guided coil deployment was simulated. Each phantom model was assessed before and after treatment to evaluate coil mass deposition within the target. RESULTS: The two phantoms underwent pretreatment T2-weighted MR imaging assessment, ultrasound-guided embolization, post-treatment MR and fluoroscopic imaging, and visual inspection of the sliced phantoms for target embolization verification. Postoperative MR scans confirmed realistic compact deposition of the coil masses within the central cavity. Phantom embolization results were submitted as part of the institutional review board and US Food and Drug Administration investigative device exemption approval for a first-in-humans clinical trial of fetal intervention for VOGM. CONCLUSIONS: A phantom simulator for fetal intervention of VOGM produces lifelike results during trial interventions, removing obstacles to feasibility and safety evaluations, typically precluded by non-availability of appropriate animal models. The study provides a proof of concept for potentially wider applications of medical simulation to enable novel procedural advancements in neurointerventions.

Interreader Agreement and Intermodality Concordance of O-RADS US and MRI for Assessing Large, Complex Ovarian-Adnexal Cysts.

Purpose To assess interreader agreement of the Ovarian-Adnexal Reporting and Data System (O-RADS) and intermodality concordance between US and MRI for characterizing complex adnexal cysts measuring 5 cm or larger. Materials and Methods This retrospective study included 58 "complex cysts" measuring at least 5 cm in size observed at both US and MRI in 54 women (median age, 37 years ± 12 [SD]; seven postmenopausal women) between July 2017 and June 2020, identified from an electronic US database. A separate set of two blinded radiologists independently reviewed the US or MR images to assign the O-RADS category, and an adjudicator resolved discrepancies (a total of six readers). Lesion outcome (49 benign, eight malignant, one lost to follow-up) was recorded. Interreader agreement of O-RADS US and O-RADS MRI and concordance between US and MRI were analyzed. Results Interreader agreement was fair for US (κ = 0.31), moderate for MRI (κ = 0.43), and moderate between US and MRI (κ = 0.58). A significant positive correlation was found between O-RADS US and MRI (τ = 0.72, P < .001). The O-RADS 4 threshold yielded the highest accuracy for both US and MRI (area under the receiver operating characteristic curve = 0.92 and 0.995, respectively). Considering O-RADS US 4 or 5 as potentially malignant and 1-3 as benign, eight lesions that were assessed as potentially malignant at US were correctly downgraded to benign by using findings at MRI. Using findings at MRI, one malignant lesion that was assessed as benign at US was upgraded to potentially malignant. Conclusion O-RADS US and MRI had excellent performance and positive correlation, but significant interobserver variability remains. Keywords: Ovary, MR Imaging, Ultrasonography © RSNA, 2022 See also the commentary by Baumgarten in this issue.

Hemodynamic and anatomic changes after fetal aortic valvuloplasty are associated with procedural success and postnatal biventricular circulation.

BACKGROUND: There are minimal data characterizing the trajectory of left heart growth and hemodynamics following fetal aortic valvuloplasty (FAV). METHODS: This retrospective study included patients who underwent FAV between 2000 and 2019, with echocardiograms performed pre-FAV, immediately post-FAV, and in late gestation. RESULTS: Of 118 fetuses undergoing FAV, 106 (90%) underwent technically successful FAV, of which 55 (52%) had biventricular circulation. Technically successful FAV was associated with improved aortic valve growth (p < 0.001), sustained antegrade aortic arch (AoA) flow (p = 0.02), improved mitral valve (MV) inflow pattern (p = 0.002), and favorable patent foramen ovale (PFO) flow pattern (p = 0.004) from pre-FAV to late gestation. Compared to patients with univentricular outcome, patients with biventricular outcome had less decrement in size of the left ventricle (LV) (p < 0.001) and aortic valve (p = 0.005), as well as more physiologic PFO flow (p < 0.001) and antegrade AoA flow (p < 0.001) from pre-FAV to late gestation. In multivariable analysis, echocardiographic predictors of biventricular outcome were less decline in LV end diastolic dimension (p < 0.001), improved PFO flow (p = 0.004), and sustained antegrade AoA flow (p = 0.002) from pre-FAV to late gestation. CONCLUSION: Stabilization of left heart growth and improved hemodynamics following successful FAV through late gestation are associated with postnatal biventricular circulation.

O-RADS Ultrasound Version 1: A Scenario-Based Review of Implementation Challenges.

The Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound (US) risk stratification and management system was first published by the American College of Radiology in 2020. It provides standardized terminology for evaluation of ovarian and adnexal masses, aids risk stratification, and provides management guidelines for different categories of lesions. This system has been validated by subsequent research and found to be a useful diagnostic and management tool. However, as noted in the system's governing concepts, in some clinical scenarios, such as patients with acute symptoms or with a history of ovarian malignancy, O-RADS US does not apply, or the system's standard management may be adjusted. Additional scenarios, such as an adnexal mass in pregnancy, present challenges in the application of O-RADS US to assist diagnosis and management. The purpose of this article is to highlight 10 clinical scenarios in which O-RADS US version 1 may not apply, may be difficult to apply, or may require modified management. Additional scenarios in which O-RADS US can be appropriately applied are also described.

Percutaneous transuterine fetal cerebral embolisation to treat vein of Galen malformations at risk of urgent neonatal decompensation: study protocol for a clinical trial of safety and feasibility.

INTRODUCTION: Although endovascular techniques have improved outcomes in vein of Galen malformations (VOGM), there is still a high rate of morbidity and mortality, particularly among cases with decompensation in the neonatal period. The dimension of the draining venous sinus on fetal imaging correlates with the risk of neonatal decompensation. In fetuses within this high-risk group who do not have end-organ injury, there is a theoretical therapeutic opportunity to reduce the arteriovenous shunt before the normal physiological changes of birth precipitate decompensation. This study investigates the safety and potential benefit of treating a VOGM in utero, which has not been previously studied. METHODS AND ANALYSIS: This study aims to enroll 20 subjects: pregnant women with a fetus harbouring a high-risk VOGM (defined on MRI by a narrowest medial-lateral width greater than 8 mm in the draining venous sinus). Unfortunately, the subset of fetuses with in utero end-organ injury is ineligible, because the late stage of pathology is not amenable to recovery from a cerebrovascular intervention, likely not even in utero. This study aims to alter the physiology before such developments accrue.At or after 23 weeks of gestation, a transuterine transposterior fontanelle needle puncture to the torcular allows ultrasound-guided deployment of coils to embolise the draining venous malformation.This study has 97.5% power to detect major safety events at 30% or greater, and 80% power to detect a reduction in the rate of neonatal intervention from 80% to 30%. In the staged study design, an interval evaluation after 11 patients invokes study termination if safety events occur above the allowed threshold. ETHICS AND DISSEMINATION: The institutional review boards at Mass General Brigham and Boston Children's Hospital (BCH) reviewed and approved this protocol. The BCH Department of Radiology and a patient family philanthropic donation fund this study. The trial results will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: NCT04434729.

Thyroid Nodule Shape Independently Predicts Risk of Malignancy.

CONTEXT: Predictive models of thyroid nodule cancer risk are presently based upon nodule composition, echogenicity, margins, and the presence of microcalcifications. Nodule shape has shown promise to be an additive factor helping determine the need for nodule biopsy. OBJECTIVE: We sought to determine if calculation of a nodule's spherical shape independently associates with cancer risk. METHODS: This prospective cohort study, conducted at a single large academic healthcare system in the United States, included patients with 1 or 2 clinically relevant thyroid nodules (predominantly solid and over 1 cm) presenting for diagnostic evaluation. Thyroid ultrasound, cytological evaluation with fine-needle biopsy, and/or histopathological examination on occasion of thyroid surgery were performed. We calculated the nodule's long to short ratio (spherical shape), and its association with tissue proven benign or malignant endpoints. RESULTS: The long to short nodule ratio was significantly lower in malignant compared to benign nodules indicating greater risk of malignancy in more spherical nodules (1.63 ±â€…0.38 for malignant nodules vs 1.74 ±â€…0.47 for benign, P < 0.0001). The risk of malignancy continually increased as the long to short ratio approached a purely spherical ratio of 1.0 (ratio > 2.00, 14.6% cancer; ratio 1.51-2.00, 19.7%; ratio 1.00-1.50, 25.5%, P < 0.0001). In multiple regression analysis, younger age, male sex, and nodule's spherical shape were each independently associated with cancer risk. CONCLUSION: The more a thyroid nodule is spherically shaped, as indicated by a long to short ratio approaching 1.0, the greater its risk of malignancy. This was independent of age, sex, and nodule size. Incorporating a nodule's sphericity in the risk stratification systems may improve individualized clinical decision making.

Fourfold Improved Odds of a Good First Trimester Outcome Once a Yolk Sac Is Seen in Early Pregnancy.

OBJECTIVES: To compare first trimester prognosis when an early pregnancy sonogram demonstrates a gestational sac with yolk sac versus gestational sac without yolk sac. METHODS: Our study comprised 823 transvaginal sonograms without identifiable embryo performed at least 35 days from last menstrual period (LMP), in which mean sac diameter was <16 mm and first trimester outcome (live or early pregnancy loss) was known. We recorded the presence or absence of yolk sac, first trimester outcome, and several clinical features: maternal age, time since LMP, and presence or absence of vaginal bleeding. We compared the likelihood of a successful first trimester outcome in cases with a visible yolk sac to those without a yolk sac. RESULTS: At the end of the first trimester, 113 of 270 (41.9%) cases without a yolk sac and 414 of 553 (74.9%) with a yolk sac were live (P < .000001, chi-square). This corresponds to an odds ratio of 4.14 for the presence of yolk sac, a result confirmed by logistic regression. Advanced maternal age, ≥42 days since LMP, and vaginal bleeding all carried an increased risk of loss (P < .000001, chi-square). Outcome was better with a visualized yolk sac than without a yolk sac, regardless of number of risk factors (P < .001, chi-square). CONCLUSIONS: The odds of successful first trimester outcome are 4-fold higher when a yolk sac is seen on an early pregnancy sonogram than when no yolk sac is seen. For any level of risk, based on maternal age, vaginal bleeding, and time since LMP, outcome is significantly better when a yolk sac is seen.

Prenatal Imaging Diagnosis of Suprarenal Lesions.

INTRODUCTION: Prenatal suprarenal lesions represent diverse pathologies. This study investigated prenatal imaging features and regression patterns associated with specific lesion diagnoses. METHODS: This is a multicenter retrospective review of fetuses with prenatally diagnosed suprarenal lesions between 2001 and 2019. Prenatal ultrasound and MRI characteristics, postnatal imaging, and clinical course were reviewed. Prenatal imaging findings were compared by the most common diagnoses and regression patterns. RESULTS: Forty-four fetuses were prenatally diagnosed with suprarenal lesions. Diagnoses included pulmonary sequestration (n = 12; 27.3%), adrenal hemorrhage (n = 12; 27.3%), upper quadrant cyst (including 2 duplication cysts, 1 splenic cyst, and 3 indeterminate cysts), neuroblastoma (n = 4), adrenal hyperplasia (n = 3), bilateral adrenal calcifications (n = 1), and indeterminate lesions (n = 6). Sequestrations were uniformly left-sided (100 vs. 50%; p = 0.014) and diagnosed earlier in gestation than adrenal hemorrhages (p = 0.025). Sequestrations were also significantly more likely to have a prenatal feeding vessel (p = 0.005), low T1 MRI signal (p = 0.015), and no MRI blood products (p = 0.018) compared to adrenal hemorrhages. When comparing all 44 patients, a prenatal feeding vessel and low T1 signal on prenatal MRI were significantly associated with lesion persistence (p = 0.003; p = 0.044). DISCUSSION/CONCLUSION: Imaging findings on prenatal ultrasound and MRI aid in the diagnosis of suprarenal lesions, including differentiating pulmonary sequestrations and adrenal hemorrhages.

Role of Sonographic Characteristics of Thyroid Bed Lesions Identified Following Thyroidectomy in the Diagnosis or Exclusion of Recurrent Cancer.

Background US of the thyroid bed in patients with thyroid cancer often depicts small lesions, but it is unclear whether US characteristics of lesions can help predict cancer recurrence. Purpose To determine whether size or US features of lesions in the thyroid bed after thyroidectomy in conjunction with clinical features can help predict thyroid cancer recurrence. Materials and Methods With use of a US reporting database, all patients imaged between July 2006 and June 2016 with an indication of post-thyroidectomy follow-up were retrospectively identified. Recorded data included patient demographic characteristics; date of thyroidectomy; thyroid cancer type; presence, size, and US characteristics of thyroid bed lesions; and results of fine-needle aspiration (FNA). Images were reviewed for lesions that underwent FNA. The Fisher exact test was used for analysis. Results A total of 1885 patients (mean age ± standard deviation, 48 years ± 15; 1493 female patients) underwent 5732 US examinations. Most patients (1541 of 1885 [82%]) had papillary cancer. Overall, 3163 thyroid bed lesions were reported in 5732 US examinations (40.4%). More than half of these lesions (1860 of 3163 [58.8%]) had a maximum measurement of 6 mm or greater. FNA was performed in 144 of the 3163 lesions (4.6%), of which 61 (42.4%) were malignant, 33 (22.9%) were benign, and 50 (34.7%) were nondiagnostic. Five nondiagnostic lesions eventually proved malignant. Only the presence of punctate echogenicities in the lesion (28 of 61 malignant lesions [45.9%]; three of 33 benign lesions [9%]; 12 of 50 nondiagnostic lesions [24%]; P < .001) or the history of positive lymph nodes at thyroidectomy (44 of 61 malignant lesions [72.1%]; 10 of 33 benign lesions [30%]; 19 of 50 nondiagnostic lesions [38%]; P < .001) were associated with malignancy. Of 3019 thyroid bed lesions that did not undergo FNA, three were malignant and 2248 showed no growth at follow-up US ranging from 6 months to 10 years and are presumed benign. Of the 1303 lesions smaller than 6 mm, only two (0.2%) were malignant. Conclusion Small lesions are commonly found in the thyroid bed after thyroidectomy, and most are likely to be benign. Lesions smaller than 6 mm with no punctate echogenicities had a minimal risk for malignancy. © RSNA, 2021 See also the editorial by Grant and Malhi in this issue.

Late gestation predictors of a postnatal biventricular circulation after fetal aortic valvuloplasty.

OBJECTIVES: Fetal aortic valvuloplasty (FAV) for severe aortic stenosis (AS) has shown promise in averting progression to hypoplastic left heart syndrome. After FAV, predicting which fetuses will achieve a biventricular (BiV) circulation after birth remains challenging. Identifying predictors of postnatal circulation on late gestation echocardiography will improve parental counseling. METHODS: Liveborn patients who underwent FAV and had late gestation echocardiography available were included (2000-2017, n = 96). Multivariable logistic regression and classification and regression tree analysis were utilized to identify independent predictors of BiV circulation. RESULTS: Among 96 fetuses, 50 (52.1%) had BiV circulation at the time of neonatal discharge. In multivariable analysis, independent predictors of biventricular circulation included left ventricular (LV) long axis z-score (OR 3.2, 95% CI 1.8-5.7, p < 0.001), LV ejection fraction (OR 1.3, 95% CI 1.0-1.8, p = 0.023), anterograde aortic arch flow (OR 5.0, 95% CI 1.2-20.4, p = 0.024), and bidirectional or right-to-left foramen ovale flow (OR 4.6, 95% CI 1.4-15.8, p = 0.015). CONCLUSION: Several anatomic and physiologic parameters in late gestation were found to be independent predictors of BiV circulation after FAV. Identifying these predictors adds to our understanding of LV growth and hemodynamics after FAV and may improve parental counseling.

Sonographic characteristics and follow-up of pancreatic cysts.

OBJECTIVES: To assess sonographic characteristics and outcome of patients with pancreatic cystic lesions seen by ultrasound. METHODS: From our ultrasound electronic reporting database we identified all patients in which "pancreatic cyst" or "pancreatic cysts" were reported from 1995 to 2018. In patients with more than one sonogram, the first was used for our study. For each case, we recorded sonographic characteristics, maximal diameter, cyst location, and results of follow-up ultrasound, CT or magnetic resonance imaging, as well as patient sex, age, relative clinical history, and endoscopic ultrasound (EUS) or surgical findings when available. RESULTS: Our study included 177 patients of whom 121 were female (68.4%). Mean age at diagnosis was 65 (±16, SD, range 22-99). Ultrasound was the initial diagnostic test in 122 (68.9%). Mean diameter of the index cyst was 13.7 mm (±11.5 mm, SD, range 2-91 mm). Among 177 index cysts, 155 were simple and 22 complex. Three complex cysts were surgically resected, yielding a primary pancreatic malignancy, a metastasis, and an epithelial-lined cyst. One simple cyst was resected, yielding a benign intraductal papillary mucinous neoplasm. Seventeen patients underwent EUS showing six mucinous cysts and 11 nonmucinous cysts. One hundred-eighteen patients had follow-up imaging for a mean time of 5.6 years (±3.8, range 0.25-21 years). One patient was presumed to have primary pancreatic cancer. The overall rate for primary pancreatic malignancy was 1.7% (2/118). CONCLUSIONS: Cystic pancreatic lesions seen on ultrasound are most often benign, with a low risk of pancreatic malignancy. Ultrasound is an excellent method to follow-up these cysts.

Clinical Significance of Renal Allograft Urothelial Thickening Identified by Ultrasound.

OBJECTIVES: To assess the etiology and clinical implications of ultrasound (US)-diagnosed urothelial thickening (UT) in renal transplants. METHODS: Patients with renal transplants who had UT diagnosed by US from January 2000 to December 2018 were retrospectively identified and compared to patients with transplants without UT scanned during the study period. Medical records were reviewed for demographics, US findings, pathologic results, laboratory values, and clinical outcomes and compared between groups by Fisher exact and t tests. RESULTS: A total of 143 patients with UT and 128 controls comprised our cohorts. The patient age in the UT group versus controls (mean ± SD, 50.2 ± 16.5 versus 51.2 ± 15.3 years) and the time since transplant (2.9 ± 4.2 versus 2.4 ± 5.8 years) were similar. Patients with UT were more likely to be female than controls (76 of 143 [53.1%] versus 53 of 128 [41.4%]; P = .07), but the difference was not statistically significant, and patients with UT were more likely to have indwelling stents (31 of 143 [21.7%] versus 9 of 128 [7.0%]; P = .001) and hydronephrosis (25 of 143 [17.4%] versus 11 of 128 [8.6%]; P = .03). At biopsy, rejection and vascular sclerosis were more likely in patients with UT compared to controls (24 of 25 [49.0%] versus 11 of 43 [25.6%]; P = .031; 42 of 49 [85.7%] versus 22 of 43 [51.2%]; P = .0005, respectively), whereas acute tubular necrosis was similar. The sensitivity (50.0%) and specificity (74.4%) of UT for rejection were low. CONCLUSIONS: Urothelial thickening correlates with US findings of urinary obstruction and indwelling stents, suggesting a possible mechanical component to UT's etiology. Although transplant rejection and vascular sclerosis were more frequent at biopsy in the UT group than controls, UT had low sensitivity and specificity for rejection.

First-Trimester Prognosis When an Early Gestational Sac is Seen on Ultrasound Imaging: Logistic Regression Prediction Model.

OBJECTIVES: To determine the factors that jointly and independently affect first-trimester outcome of very early intrauterine pregnancies (those whose sonogram shows a gestational sac with no identifiable yolk sac or embryo) and develop a mathematical model and Web-based calculator that computes prognosis based on these factors. METHODS: Our study population included 590 very early pregnancies scanned between January 1, 2012, and June 30, 2018, with known outcomes (live or spontaneous loss) at 14 weeks. We recorded patient age, mean sac diameter (MSD), human chorionic gonadotropin (hCG) rise, and presence/absence of: vaginal bleeding, history of infertility, prior miscarriage, and pregnancy via assisted reproductive technology. We assessed the correlation between each of these factors and outcome and performed stepwise logistic regression to determine the subset that independently correlated with outcome. RESULTS: Patient age, MSD, hCG rise, vaginal bleeding, history of infertility, and assisted reproductive technology pregnancy were significantly correlated with outcome (P < .05, t test for age and MSD, χ2 for the others). Stepwise logistic regression identified age, MSD, hCG rise, and vaginal bleeding as the subset of factors that independently predicted outcome. The regression model's area under the receiver operating characteristic curve was 0.823. We incorporated the regression model into a Web-based calculator (https://tinyurl.com/Prognosis-PD) that predicts the outcome of an early intrauterine pregnancy based on these 4 key variables. CONCLUSIONS: The prognosis of very early intrauterine pregnancies is related to several clinical, biochemical, and sonographic factors. The factors that independently correlate with first-trimester outcome are patient age, MSD, hCG rise, and vaginal bleeding. The logistic regression model predicts outcome based on these variables.

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome: A Decision Analysis.

BACKGROUND: Fetal aortic valvuloplasty (FAV) may prevent progression of midgestation aortic stenosis to hypoplastic left heart syndrome. However, FAV has well-established risks, and its survival benefit remains unknown. Our primary aim was to determine whether FAV for midgestation aortic stenosis increases survival from fetal diagnosis to age 6 years. METHODS AND RESULTS: We performed a retrospective analysis of 143 fetuses who underwent FAV from 2000 to 2017 and a secondary analysis of the Pediatric Heart Network Single Ventricle Reconstruction trial. Using these results, we developed a decision model to estimate probability of transplant-free survival from fetal diagnosis to age 6 years and postnatal restricted mean transplant-free survival time. FAV was technically successful in 84% of 143 fetuses with fetal demise in 8%. Biventricular circulation was achieved in 50% of 111 live-born infants with successful FAV but in only 16% of the 19 patients with unsuccessful FAV. The model projected overlapping probabilities of transplant-free survival to age 6 years at 75% (95% CI, 67%-82%) with FAV versus 72% (95% CI, 61%-82%) with expectant fetal management, resulting in a restricted mean transplant-free survival time benefit of 1.2 months. When limiting analyses to the improved FAV experience since 2009 to reflect current practice, (probability of technical success [94%], fetal demise [4%], and biventricular circulation [66%]), the model projected that FAV increased the probability of survival to age 6 years to 82% (95% CI, 73%-89%). Expectant management is favored if risk of fetal demise exceeded 12% or probability of biventricular circulation fell below 26%, but FAV remained favored over plausible recent range of technical success. CONCLUSIONS: Our model suggests that FAV provides a modest, medium-term survival benefit over expectant fetal management. Appropriate patient selection and low risk of fetal demise with FAV are critical factors for obtaining a survival benefit.

"Pseudogestational Sac" and Other 1980s-Era Concepts in Early First-Trimester Ultrasound: Are They Still Relevant Today?

OBJECTIVES: To determine whether an intrauterine round or oval fluid collection ("saclike structure") can prove to be either an intrauterine pregnancy or intrauterine fluid in conjunction with an ectopic pregnancy (sometimes termed "pseudogestational sac") and whether ultrasound features, including the presence or absence of an echogenic rim, "double sac sign" (DSS), or "intradecidual sign" (IDS), are helpful for establishing the diagnosis or predicting the prognosis. METHODS: We identified all sonograms obtained from women with positive serum human chorionic gonadotropin results at our institution between January 1, 2012, and June 30, 2018, meeting the following criteria: presence of an intrauterine saclike structure without a yolk sac or embryo; no extraovarian adnexal mass; and follow-up information identifying the location of the pregnancy as intrauterine or ectopic. Study authors reviewed sonograms in all cases and recorded the following information: presence or absence of each of an echogenic rim around the collection, a DSS, and an IDS, as well as the mean sac diameter. The indications for the initial ultrasound examinations were recorded. RESULTS: A total of 649 sonograms met the inclusion criteria. Of these, 598 fluid collections showed an echogenic rim, 182 a DSS, and 347 an IDS (findings not mutually exclusive). In all 649 cases, a subsequent sonogram or other clinical follow-up confirmed that the patient had an intrauterine pregnancy. That is, none of the fluid collections proved to be a pseudogestational sac. In total, 41.2% were live at the end of the first trimester, and 58.8% miscarried. The prognosis was better in cases with, compared to without, an IDS (P = .01, χ2 ), but no ultrasound feature was clinically useful for ruling in or excluding a good prognosis. CONCLUSIONS: In a woman with positive human chorionic gonadotropin results and no extraovarian adnexal mass, the ultrasound finding of an intrauterine saclike structure is virtually certain to be a gestational sac. Ultrasound features of the structure are of no diagnostic or clinically useful prognostic value. Concepts introduced 30 to 40 years ago when ultrasound equipment had far lower resolution than currently, including a DDS, an IDS, and a pseudogestational sac, have no role today in assessing early pregnancy.

Interobserver Reliability of the Antenatal Consensus Classification System for Urinary Tract Dilatation.

OBJECTIVES: The consensus classification system for urinary tract dilatation (UTD) was designed to be more objective and reproducible than previously used systems. We sought to evaluate interobserver reliability of UTD components and overall scores in a prenatal population undergoing third-trimester ultrasound examinations. METHODS: We retrospectively identified patients who underwent antenatal ultrasound examinations for UTD between 28 and 40 weeks' gestation. All images from individual studies of 300 fetuses were reviewed independently by 5 experienced sonologists (1 maternal-fetal medicine specialist and 4 radiologists). Urinary tract dilatation scores (normal, A1, or A2/3) and Society for Fetal Urology (SFU) scores were assigned. Interobserver agreement between raters was evaluated with the Fleiss κ statistic. RESULTS: Overall interobserver agreement for the antenatal UTD risk score showed substantial agreement among all 5 readers (κ = 0.657 [95% confidence interval, 0.632, 0.683]; P < .001). All 5 readers applied the same UTD risk score in 53.7% of cases. Some variability in the antenatal UTD score and individual elements was observed. At least 2 UTD risk scores were assigned to a specific individual patient in 46.3% of cases (139 of 300), and all 3 UTD risk scores were assigned to a specific individual patient in 1.7% of cases (5 of 300). In 18.0% of cases (54 of 300), at least 2 readers assigned a UTD score different from that assigned by the other readers. Agreement was lowest for parenchymal appearance (κ = 0.225). Agreement for the SFU system was fair (κ = 0.368; P < .001). CONCLUSIONS: Interobserver agreement for the antenatal UTD grading system was substantial. Compared to the SFU system, the antenatal UTD system showed better agreement among readers.