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.

Assessment of American College of Radiology Thyroid Imaging Reporting and Data System (TI-RADS) for Pediatric Thyroid Nodules.

Background The American College of Radiology (ACR) Thyroid Imaging Reporting and Data System (TI-RADS) is a recognized tool for management of thyroid nodules in adults but has not been validated in pediatric patients. Purpose To assess the performance of the ACR TI-RADS criteria for guiding decisions on whether to biopsy thyroid nodules in pediatric patients in a single referral center. Materials and Methods In this retrospective study, a database of thyroid nodules in patients younger than 19 years who underwent fine-needle aspiration (FNA) biopsy between January 2004 and July 2017 was analyzed. ACR TI-RADS criteria were applied to each nodule, and an ACR TI-RADS score was created to determine how the nodule would be managed. The number of nodules that would be biopsied with FNA on the basis of ACR TI-RADS was compared with the total number of nodules biopsied with FNA in this clinic to determine if the use of ACR TI-RADS would have changed the rate of FNA (eg, decreased the number of procedures) and whether that change would have affected the timely diagnosis of cancer. Results A total of 314 patients (mean age, 14.9 years; age range, 2-18 years; 28 prepubertal patients; 286 postpubertal patients; 260 female patients) were evaluated. In these 314 patients, 404 thyroid nodules were scored, of which 19.1% (77 of 404) were malignant. Most cancers were papillary carcinoma (68 [88.3%] of 77). The use of ACR TI-RADS criteria for management of nodules in this pediatric study sample would have resulted in 17 (22.1%) of 77 cancers being missed at the patient's initial visit. Conclusion Use of the current American College of Radiology Thyroid Imaging Reporting and Data System criteria for management of pediatric thyroid nodules is inadequate because a high percentage of cancers would be missed at the initial encounter. © RSNA, 2019.

Obstetric and gynecologic ultrasound curriculum and competency assessment in residency training programs: consensus report.

Ultrasound imaging has become integral to the practice of obstetrics and gynecology. With increasing educational demands and limited hours in residency programs, dedicated time for training and achieving competency in ultrasound has diminished substantially. The American Institute of Ultrasound in Medicine assembled a multisociety task force to develop a consensus-based, standardized curriculum and competency assessment tools for obstetric and gynecologic ultrasound training in residency programs. The curriculum and competency assessment tools were developed based on existing national and international guidelines for the performance of obstetric and gynecologic ultrasound examinations and thus are intended to represent the minimum requirement for such training. By expert consensus, the curriculum was developed for each year of training, criteria for each competency assessment image were generated, the pass score was established at, or close to, 75% for each, and obtaining a set of 5 ultrasound images with pass score in each was deemed necessary for attaining each competency. Given the current lack of substantial data on competency assessment in ultrasound training, the task force expects that the criteria set forth in this document will evolve with time. The task force also encourages use of ultrasound simulation in residency training and expects that simulation will play a significant part in the curriculum and the competency assessment process. Incorporating this training curriculum and the competency assessment tools may promote consistency in training and competency assessment, thus enhancing the performance and diagnostic accuracy of ultrasound examination in obstetrics and gynecology.

Obstetric and Gynecologic Ultrasound Curriculum and Competency Assessment in Residency Training Programs: Consensus Report.

Ultrasound imaging has become integral to the practice of obstetrics and gynecology. With increasing educational demands and limited hours in residency programs, dedicated time for training and achieving competency in ultrasound has diminished substantially. The American Institute of Ultrasound in Medicine assembled a multisociety task force to develop a consensus-based, standardized curriculum and competency assessment tools for obstetric and gynecologic ultrasound training in residency programs. The curriculum and competency assessment tools were developed based on existing national and international guidelines for the performance of obstetric and gynecologic ultrasound examinations and thus are intended to represent the minimum requirement for such training. By expert consensus, the curriculum was developed for each year of training, criteria for each competency assessment image were generated, the pass score was established at, or close to, 75% for each, and obtaining a set of 5 ultrasound images with pass score in each was deemed necessary for attaining each competency. Given the current lack of substantial data on competency assessment in ultrasound training, the task force expects that the criteria set forth in this document will evolve with time. The task force also encourages use of ultrasound simulation in residency training and expects that simulation will play a significant part in the curriculum and the competency assessment process. Incorporating this training curriculum and the competency assessment tools may promote consistency in training and competency assessment, thus enhancing the performance and diagnostic accuracy of ultrasound examination in obstetrics and gynecology.

A standardized assessment of thyroid nodules in children confirms higher cancer prevalence than in adults.

CONTEXT: Thyroid cancer is the most common endocrine malignancy, but due to its rare occurrence in the pediatric population, the cancer risk of childhood thyroid nodules is incompletely defined, and optimal management of children with suspected nodules is debated. OBJECTIVE: The aim was to study the presenting features and cancer risk of sporadic childhood thyroid nodules using a standardized clinical assessment and management plan. DESIGN AND SETTING: Boston Children's Hospital and Brigham and Women's Hospital collaborated to create a multidisciplinary pediatric thyroid nodule clinic and implement a standardized assessment plan. Upon referral for a suspected nodule, serum TSH was measured and hypothyrotropinemic patients underwent (123)I scintigraphy. All others underwent thyroid ultrasonography, and if this confirmed nodule(s) ≥ 1 cm, ultrasound-guided fine-needle aspiration was performed. Medical records were retrospectively reviewed and compared to a control population of 2582 adults evaluated by identical methods. PATIENTS AND RESULTS: Of 300 consecutive children referred for the initial evaluation of suspected thyroid nodules from 1997 to 2011, 17 were diagnosed with autonomous nodules by scintigraphy. Neck ultrasonography performed in the remainder revealed that biopsy was unnecessary in over half, either by documenting only sub-centimeter nodules or showing that no nodule was present. A total of 125 children met criteria for thyroid biopsy, which was performed without complication. Their rate of cancer was 22%, significantly higher than the adult rate of 14% (P = .02). CONCLUSIONS: Neck ultrasonography and biopsy were key to the evaluation of children with suspected thyroid nodules. Although the relative cancer prevalence of sonographically confirmed nodules ≥ 1 cm is higher in pediatric patients than adults, most children referred for suspected nodules have benign conditions, and efforts to avoid unnecessary surgery in this majority are warranted.

Development of an outpatient native kidney biopsy service in low-risk patients: a multidisciplinary approach.

BACKGROUND: In the US, native kidney biopsies are usually inpatient procedures. We developed an outpatient biopsy protocol for low-risk patients and assessed its safety and efficacy. METHODS: Patients with an SBP <140 mm Hg and a BMI ≤35 who were not taking anticoagulants, ASA and NSAIDS in the preceding week were included. Biopsies were performed under ultrasound guidance using a 15-gauge needle that changed to a 14-gauge needle during the study. Patients were discharged after 5 h of observation if there were no signs of bleeding. Complications were carefully recorded. RESULTS: Between November 2008 and April 2011, 105 patients underwent outpatient renal biopsies. A 15-gauge needle was used in 43 patients (group A) while a 14-gauge needle was used in 62 (group B). A median of 25 (range 4-64) glomeruli were obtained in group A versus 39 (range 0-107) in group B (p < 0.001). Complications requiring admission for observation occurred in 7 patients (16%) in group A versus 5 patients (8%) in group B (p = 0.22). One patient in group B had bleeding requiring intervention, while all other complications were minor. Nine complications occurred during the observation period, while 3 patients presented >48 h after biopsy. The mean cost per patient for each outpatient biopsy was USD 976 versus USD 5,489 for inpatients. CONCLUSIONS: In a selected low-risk population, outpatient renal biopsy is safe with low complication rates and results in significant cost savings relative to elective inpatient biopsies. The use of a 14-gauge biopsy needle resulted in a greater yield of glomeruli without increased complications.

Assessment of left ventricular endocardial fibroelastosis in fetuses with aortic stenosis and evolving hypoplastic left heart syndrome.

Systematic evaluation of left ventricular (LV) endocardial fibroelastosis (EFE) in the fetus has not been reported. The role of EFE in the pre- and postnatal evolution of hypoplastic left heart disease, and the implications of EFE for outcomes after prenatal intervention for fetal aortic stenosis with evolving hypoplastic left heart syndrome have also not been determined. A 4-point grading system (0-3) was devised for the assessment of fetal LV echogenicity, which was presumed to be due to EFE. Two reviewers independently graded EFE on the preintervention echocardiograms of fetuses treated with in utero aortic valvuloplasty for evolving hypoplastic left heart syndrome from 2000 to 2008. Intra- and interobserver reproducibility was determined for the EFE grade and characterization of related echocardiographic features. The relations among EFE severity, other left heart anatomic and physiologic variables, and postintervention outcomes were analyzed. The assessment and grading of EFE was possible for both observers in all 74 fetuses studied. By consensus, the EFE severity was grade 1 in 31 patients, grade 2 in 32, and grade 3 in 11. Fetuses with mild (grade 1) EFE had significantly greater maximum instantaneous aortic stenosis gradients (e.g., higher LV pressures) and less globular LV geometry than patients with grade 2 or 3 EFE on preintervention echocardiogram. The severity of EFE was not associated with the size of the aortic valve or LV. From preintervention to late gestation, the time-indexed change in LV end-diastolic volume was significantly greater in fetuses with grade 1 EFE than those with more severe EFE. Incorporation of EFE severity into our previously published threshold score improved the sensitivity and positive predictive value for the postnatal biventricular outcomes. In conclusion, echocardiographic grading of EFE is possible, with reasonable intra- and interobserver reliability in midgestation fetuses with evolving hypoplastic left heart syndrome. EFE severity corresponded to some indexes of left heart size, geometry, and function and with the probability of a biventricular outcome postnatally. Additional experience and external validation of the EFE grading scoring system are necessary.

Long-term assessment of a multidisciplinary approach to thyroid nodule diagnostic evaluation.

BACKGROUND: The diagnostic evaluation of patients with thyroid nodules is imprecise. Despite the benefits of fine-needle aspiration (FNA), most patients who are referred for surgery because of abnormal cytology prove to have benign disease. Recent technologic and procedural advances suggest that this shortcoming can be mitigated, although few data confirm this benefit in unselected patients. METHODS: A total of 2587 sequential patients were evaluated by thyroid ultrasound and were offered ultrasound-guided FNA (UG-FNA) of all thyroid nodules that measured > or =1 cm during a 10-year period. Results of aspiration cytology were correlated with histologic findings. The prevalence of thyroid cancer in all patients and in those who underwent surgery was determined. Surgical risk was calculated. RESULTS: Tumors that measured > or =1 cm were present in 14% of patients: Forty-three percent of patients had tumors that measured <2 cm in greatest dimension, and 93% had American Joint Committee on Cancer stage I or II disease. The cytologic diagnoses 'positive for malignancy' and 'no malignant cells' were 97% predictive and 99.7% predictive, respectively. Repeat FNA of initial insufficient aspirates, as well as more detailed classification of inconclusive aspirates, improved preoperative assessment of cancer risk and reduced surgical intervention. Fifty-six percent of patients who were referred for surgery because of abnormal cytology had cancer compared with from 10% to 45% of patients historically. An analysis of operative complications from a subset of 296 patients demonstrated a 1% risk of permanent surgical complications. CONCLUSIONS: The current findings demonstrated the benefits of UG-FNA and of a more detailed classification of inconclusive aspirates in the preoperative risk assessment of thyroid nodules, supporting adherence to recently published guidelines.

Assessment of nondiagnostic ultrasound-guided fine needle aspirations of thyroid nodules.

Thyroid nodules are common. Evaluation of patients with thyroid nodules typically includes fine needle aspiration biopsy (FNA), an approach that has proven to be accurate for the detection of thyroid cancer. Although the majority of biopsies are adequate for a cytological diagnosis, up to 20% will be insufficient or nondiagnostic. Current opinion suggests that such aspirates should be repeated, although no systematic study has investigated the usefulness of this approach, especially when ultrasound guidance is used to direct the initial FNA. We sought to define the predictors and optimal follow-up strategy for initial nondiagnostic ultrasound-guided FNAs of thyroid nodules. Data were collected for all patients at the Brigham and Women's Hospital Thyroid Nodule Clinic between 1995-2000 who underwent ultrasound-guided FNA of a thyroid nodule. All patients with nondiagnostic cytology were advised to return for a repeat ultrasound-guided FNA. Patient age, gender, nodule size, cystic content, solitary vs. multinodular thyroid, and nodule location were documented and evaluated as possible predictors of a nondiagnostic biopsy in a multivariable model. The rate of diagnostic cytology obtained on repeat ultrasound-guided FNA was calculated. A total of 1128 patients with 1458 nodules were biopsied over a 6-yr period. A total of 1269 aspirations (950 patients) were diagnostic, and 189 (178 patients) were nondiagnostic. The cystic content of each nodule was the only significant independent predictor of nondiagnostic cytology (P < 0.001). The fraction of specimens with initial nondiagnostic cytology increased with greater cystic content (P < 0.001 for trend). A diagnostic ultrasound-guided FNA was obtained on the first repeat biopsy in 63% of nodules and was inversely related to increasing cystic content of each nodule (P = 0.03). One hundred and nineteen patients with 127 nodules returned for follow-up as advised, and malignancy was documented in 5%. Despite ultrasound-guided FNA, there remains a significant risk of initial nondiagnostic cytology, largely predicted by the cystic content of each nodule. Repeat aspiration is often successful and should be the standard approach to such nodules, given their risk of malignancy.