Machine Learning for the Prediction of Surgical Morbidity in Placenta Accreta Spectrum.

OBJECTIVE: We sought to create a machine learning (ML) model to identify variables that would aid in the prediction of surgical morbidity in cases of placenta accreta spectrum (PAS). STUDY DESIGN: A multicenter analysis including all cases of PAS identified by pathology specimen confirmation, across five tertiary care perinatal centers in New York City from 2013 to 2022. We developed models to predict operative morbidity using 213 variables including demographics, obstetrical information, and limited prenatal imaging findings detailing placental location. Our primary outcome was prediction of a surgical morbidity composite defined as including any of the following: blood loss (>1,500 mL), transfusion, intensive care unit admission, vasopressor use, mechanical ventilation/intubation, and organ injury. A nested, stratified, cross-validation approach was used to tune model hyperparameters and estimate generalizability. Gradient boosted tree classifier models incorporated preprocessing steps of standard scaling for numerical variables and one-hot encoding for categorical variables. Model performance was evaluated using area under the receiver operating characteristic curve (AUC), positive and negative predictive values (PPV, NPV), and F1 score. Variable importance ranking was also determined. RESULTS: Among 401 PAS cases, 326 (81%) underwent hysterectomy. Of the 401 cases of PAS, 309 (77%) had at least one event defined as surgical morbidity. Our predictive model had an AUC of 0.79 (95% confidence interval: 0.69, 0.89), PPV 0.79, NPV 0.76, and F1 score of 0.88. The variables most predictive of surgical morbidity were completion of a hysterectomy, prepregnancy body mass index (BMI), absence of a second trimester ultrasound, socioeconomic status zip code, BMI at delivery, number of prenatal visits, and delivery time of day. CONCLUSION: By identifying social and obstetrical characteristics that increase patients' risk, ML models are useful in predicting PAS-related surgical morbidity. Utilizing ML could serve as a foundation for risk and complexity stratification in cases of PAS to optimize surgical planning. KEY POINTS: · ML models are useful models are useful in predicting PAS-related surgical morbidity.. · Optimal management for PAS remains unclear.. · Utilizing ML can serve as a foundation for risk and complexity stratification in cases of PAS..

Changes to same day discharge after minimally invasive hysterectomy throughout COVID-19 pandemic.

BACKGROUND: Minimally invasive hysterectomy is a common gynecologic procedure. Numerous studies have found that a same day discharge (SDD) is safe following this procedure. Research has found that SDDs decrease resource strain, nosocomial infections, and financial burden for both the patient and healthcare system. Due to the recent COVID-19 pandemic, the safety of hospital admissions and elective surgeries was called into question. OBJECTIVE: To assess the rates of SDD among patients who underwent a minimally invasive hysterectomy before and during the COVID-19 pandemic. STUDY DESIGN: A retrospective chart review was performed from September 2018 to December 2020 on 521 patients, who met inclusion criteria. Descriptive analysis, chi-square tests of association, and multivariable logistic regression were used for analysis. RESULTS: There was a significant difference between rate of SDDs pre-COVID-19 (12.5%) versus during the COVID-19 period (28.6%) (p < 0.001). Surgical complexity was predictive of not being discharged the same day of surgery (odds ratio [OR] = 4.4, 95% confidence interval [CI] = 2.2-8.8), as was surgical completion time after 4 p.m. (OR = 5.2, 95% CI = 1.1-25.2). There was no difference in readmissions (p = 0.209) and emergency department (ED) visits (p = 0.973) between SDD and overnight stay. CONCLUSION: Rates of SDD for patients undergoing minimally invasive hysterectomy were significantly increased during the COVID-19 pandemic. SDDs are safe; the number of readmissions and ED visits did not increase among patients who were discharged on the same day.

Effectiveness of telehealth physical therapy for patients with pelvic floor disorders in a community hospital setting.

PURPOSE: To examine whether there are differences in meeting treatment goals between pelvic floor physical therapy (PFPT) patients who participated in a majority of telehealth visits versus those who participated in mostly traditional office visits at a community hospital. METHODS: Retrospective chart review was performed among patients who received PFPT from April 2019 to February 2021. Cohorts were defined as "Mostly Office Visits" (> 50% office visits) and "Mostly Telehealth" (> / = 50% telehealth visits). Primary outcome measures included demographic data, number/type of visit for each patient, number of no-show/cancelation appointments, and number of patients discharged meeting PFPT goals. Statistical significance was defined as p < 0.05. RESULTS: 234 subjects met criteria for the "Mostly Office Visit" cohort and 48 subjects met criteria for the "Mostly Telehealth" cohort. There were no significant differences observed in age (p = 0.919), BMI (p = 0.817), race/ethnicity (p = 0.170) or insurance type (p = 0.426) between cohorts. There was no significant difference in meeting PFPT goals between the "Mostly Office Visit" cohort (24.4%) and the "Mostly Telehealth" cohort (35.4%) (p = 0.113). There was no difference in the number of canceled visits per patient (mean cancelations "Office visit" 1.98; "Telehealth" 1.63; p = 0.246) and the number of no-show visits per patient (mean no-show's "Office visit" 0.23; "Telehealth" 0.31; p = 0.297) between cohorts. CONCLUSION: There was no difference in meeting discharge goals regardless of whether a patient participated in mostly telehealth visits versus mostly traditional office visits. Therefore, we can conclude that participating in mostly provider-led telehealth visits can be equally efficacious at providing competent PFPT care.

Assessing adverse event reports of hysteroscopic sterilization device removal using natural language processing.

OBJECTIVE: To develop an annotation model to apply natural language processing (NLP) to device adverse event reports and implement the model to evaluate the most frequently experienced events among women reporting a sterilization device removal. METHODS: We included adverse event reports from the Manufacturer and User Facility Device Experience database from January 2005 to June 2018 related to device removal following hysteroscopic sterilization. We used an iterative process to develop an annotation model that extracts six categories of desired information and applied the annotation model to train an NLP algorithm. We assessed the model performance using positive predictive value (PPV, also known as precision), sensitivity (also known as recall), and F1 score (a combined measure of PPV and sensitivity). Using extracted variables, we summarized the reporting source, the presence of prespecified and other patient and device events, additional sterilizations and other procedures performed, and time from implantation to removal. RESULTS: The overall F1 score was 91.5% for labeled items and 93.9% for distinct events after excluding duplicates. A total of 16 535 reports of device removal were analyzed. The most frequently reported patient and device events were abdominal/pelvic/genital pain (N = 13 166, 79.6%) and device dislocation/migration (N = 3180, 19.2%), respectively. Of those reporting an additional sterilization procedure, the majority had a hysterectomy or salpingectomy (N = 7932). One-fifth of the cases that had device removal timing specified reported a removal after 7 years following implantation (N = 2444/11 293). CONCLUSIONS: We present a roadmap to develop an annotation model for NLP to analyze device adverse event reports. The extracted information is informative and complements findings from previous research using administrative data.

A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of the AEGEA Vapor System (Aegea Medical System, Menlo Park, CA) for the treatment of heavy menstrual bleeding (HMB). DESIGN: A prospective, multicenter, single-arm, open-label, clinical trial. Follow-up assessments were conducted at 24 hours; 2 weeks; and 3, 6, and 12 months after the endometrial ablation procedure (Canadian Task Force Classification II-1). SETTING: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. PATIENTS: One hundred fifty-five premenopausal women aged 30 to 50years with HMB as determined by a pictorial blood loss assessment score ≥150. Preoperative evaluation included ultrasound, sonohysterography or hysteroscopy, and endometrial biopsy. Screening inclusion allowed treatment of up to 12-cm uterine sound lengths and nonobstructing myomata. INTERVENTIONS: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. MEASUREMENTS AND MAIN RESULTS: The primary effectiveness end point was the reduction of menstrual blood loss to a pictorial blood loss assessment score ≤75. Success was judged based on the Food and Drug Administration's objective performance criteria, derived from the success rates of the first 5 global endometrial ablation pivotal clinical trials. The secondary effectiveness end points included quality of life and patient satisfaction as assessed using the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score as well as the need for surgical or medical intervention to treat abnormal bleeding at any time within the first 12 months after treatment. All adverse events, including device- and procedure-related events, were recorded. At 12 months, the primary effectiveness end point was achieved in 78.7% of subjects exceeding the OPC (p = .0004); 90.8% of subjects were satisfied or very satisfied with the treatment. Ninety-nine percent of subjects showed improvement in quality of life scores with an average decrease in the Menorrhagia Impact Questionnaire score by 8.1, 72% had less dysmenorrhea, and 85% of women whose sex lives were affected by their menses reported improvement in their sex lives. There were no reported serious adverse device effects or any reported serious adverse events that were procedure related. CONCLUSION: The AEGEA Vapor System is a safe, effective, and minimally invasive option for performing in-office endometrial ablation under minimal anesthesia for the purpose of treating women who suffer from HMB.

Methotrexate Administration to Patients With Presumed Ectopic Pregnancy Leads to Methotrexate Exposure of Intrauterine Pregnancies.

OBJECTIVE: To report clinical experience with methotrexate (MTX) treatment for suspected but not definite ectopic pregnancy (EP). METHODS: This was a retrospective cohort study. All patients treated with MTX for presumed EP between 2000 and 2016 were included. Demographic, clinical, sonographic, and outcome data were collected and analyzed. RESULTS: A total of 820 patients were treated with MTX, 692 (84.4%) of which were lacking definitive features of EP; 155 (22.4%) failed to follow up until complete resolution and were excluded. Retrospective sonographic categorization was applied to 537 patients; of those patients, 393 (73.2%) were categorized as probable EPs, 136 (25.3%) pregnancies of unknown location (PULs), and 8 (1.5%) probable intrauterine pregnancies (IUPs). Sixteen were eventually diagnosed with IUP: 6 from the probable EPs, 9 from the PULs, and 1 from the probable IUP group. Patients with final diagnosis of IUP had higher values of ß-human chorionic gonadotropin as well as lower prevalence of adnexal mass (38% versus 74%; P = .003), higher prevalence of intracavitary fluid (44% versus 9%; P = .0004) and thicker endometrium (17.1 ± 11.8 versus 9.7 ± 5.6; P = .04). None of the sonographic parameters were able to distinguish patients with IUP. One patient of the 16 with IUP was diagnosed with a viable pregnancy, and 7 additional patients had a possible viable pregnancy. None of them elected to continue the pregnancy. CONCLUSIONS: Most patients with suspected EP who are eligible for medical treatment lack definitive sonographic features of EP. Treatment with MTX in such cases should be delayed, as clinically reasonable, to improve the diagnosis and prevent inadvertent administration of MTX to patients with a viable IUP.

Predictors of laparoscopic simulation performance among practicing obstetrician gynecologists.

BACKGROUND: While simulation training has been established as an effective method for improving laparoscopic surgical performance in surgical residents, few studies have focused on its use for attending surgeons, particularly in obstetrics and gynecology. Surgical simulation may have a role in improving and maintaining proficiency in the operating room for practicing obstetrician gynecologists. OBJECTIVE: We sought to determine if parameters of performance for validated laparoscopic virtual simulation tasks correlate with surgical volume and characteristics of practicing obstetricians and gynecologists. STUDY DESIGN: All gynecologists with laparoscopic privileges (n = 347) from 5 academic medical centers in New York City were required to complete a laparoscopic surgery simulation assessment. The physicians took a presimulation survey gathering physician self-reported characteristics and then performed 3 basic skills tasks (enforced peg transfer, lifting/grasping, and cutting) on the LapSim virtual reality laparoscopic simulator (Surgical Science Ltd, Gothenburg, Sweden). The association between simulation outcome scores (time, efficiency, and errors) and self-rated clinical skills measures (self-rated laparoscopic skill score or surgical volume category) were examined with regression models. RESULTS: The average number of laparoscopic procedures per month was a significant predictor of total time on all 3 tasks (P = .001 for peg transfer; P = .041 for lifting and grasping; P < .001 for cutting). Average monthly laparoscopic surgical volume was a significant predictor of 2 efficiency scores in peg transfer, and all 4 efficiency scores in cutting (P = .001 to P = .015). Surgical volume was a significant predictor of errors in lifting/grasping and cutting (P < .001 for both). Self-rated laparoscopic skill level was a significant predictor of total time in all 3 tasks (P < .0001 for peg transfer; P = .009 for lifting and grasping; P < .001 for cutting) and a significant predictor of nearly all efficiency scores and errors scores in all 3 tasks. CONCLUSION: In addition to total time, there was at least 1 other objective performance measure that significantly correlated with surgical volume for each of the 3 tasks. Higher-volume physicians and those with fellowship training were more confident in their laparoscopic skills. By determining simulation performance as it correlates to active physician practice, further studies may help assess skill and individualize training to maintain skill levels as case volumes fluctuate.

Pregnancy Outcomes After Direct Uterine Myoma Thermal Ablation: Review of the Literature.

The objective of this review is to describe the reproductive outcomes of women after radiofrequency volumetric thermal ablation (RFVTA) of myomas or magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU). This is a literature review of the current case reports of reproductive outcomes after direct myoma thermal ablation at multiple academic and private centers throughout the world. A literature search was performed using PubMed and Medline. All publications that included data of women who underwent radiofrequency myoma ablation or MRgHIFU of myomas and subsequently conceived were included. There were 122 pregnancies after direct uterine myoma thermal ablation, and 20 pregnancies were reported after RFVTA. Of these cases, there was 1 spontaneous abortion and 7 elective terminations. The remaining 12 pregnancies went on to have live full-term deliveries, 9 (75%) by cesarean section and 3 (25%) by vaginal delivery. There were no reports of uterine abnormalities at delivery and 1 delayed postpartum hemorrhage with expulsion of a degenerated myoma. There are 102 reported pregnancies after MRgHIFU. There were 21 spontaneous abortions and 22 elective terminations, 48 deliveries, and 11 ongoing pregnancies at the time of report. There was 1 preterm delivery at 36 weeks due to placenta previa, and the remaining deliveries were full term. The complications reported included vaginal spotting (12.5%), delayed placental separation (4%), and placenta previa (4%). There were no cases of uterine rupture. In summary, RFVTA and MRgHIFU are new minimally invasive alternatives for the treatment of myomas. Further investigation into the reproductive outcomes after these myoma therapies is crucial to determine whether these are appropriate treatment options for women with symptomatic myomas who desire future fertility.

Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database.

STUDY OBJECTIVE: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. DESIGN: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). SETTING N/A PATIENTS: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. INTERVENTIONS: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. MEASUREMENTS AND MAIN RESULTS: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n = 14), bowel damage (n = 12), hysterectomy (n = 6), and death (n = 2). Minor events included uterine perforation requiring no other treatment (n = 29), device failure (n = 25), uncomplicated fluid overload (n = 19), postoperative bleeding controlled using noninvasive measures (n = 6), and pelvic infection (n = 4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. CONCLUSIONS: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.

Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.

OBJECTIVE: To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. DESIGN: Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). SETTING: Thirteen clinical study centers in the United States, Europe, and Australia. PATIENTS: A total of 518 previously fertile women seeking permanent contraception. INTERVENTION: The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. MEASUREMENTS AND MAIN RESULTS: The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during follow-up as being "possibly" related to the procedure or the inserts. CONCLUSION: The findings from extended follow-up of this Phase III trial with Essure inserts further support the effectiveness, tolerability, and satisfaction of this nonhormonal, nonincisional option for permanent contraception.

Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.

STUDY OBJECTIVE: To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas. DESIGN: Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1). SETTING: University hospitals and private surgical centers. PATIENTS: One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL). INTERVENTIONS: Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS: One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. CONCLUSION: RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.

Complex obstetrical surgery: building a team and defining roles.

As the number of placenta accreta spectrum cases continues to rise, the gap in surgical skills in labor and delivery units becomes more apparent. Recent scholarly work has highlighted the diminishing advanced surgical skills among obstetrician-gynecologists, particularly among new graduates. Therefore, it has become a practice in many institutions to refer complex cesarean deliveries and obstetrical hysterectomies to subspecialists, specifically gynecologic oncologists. Hence, in this commentary, we propose a process through which key personnel within departments of obstetrics and gynecology are identified and their appropriate level of involvement in cases of complex obstetrical surgery is delineated. In doing so, we describe the surgical skills expected from each provider level so that the cesarean delivery complexity level can be matched with specific surgical expertise. Through this process, an obstetrician-led complex obstetrical surgery team is formed. Ultimately, the goal of this process is 2-fold; first, to return cases with higher levels of surgical complexity back to obstetricians and, second, to reduce the surgical back-up burden from gynecology subspecialists such as gynecologic oncologists.

Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial.

BACKGROUND: Although most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. Here we analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up. METHODS: Prospective, multicenter, outpatient interventional clinical trial of fibroid treatment by RFVTA in 124 premenopausal women (mean age, 42.4 ± 4.4 years) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL).Outcome measures included: subject responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months postprocedure. Continuous and categorical variables were summarized using descriptive statistics and means and percentages. Comparisons between visits were based on t-tests using repeated measures models. P-values < 0.05, adjusted for multiplicity, were statistically significant. RESULTS: One hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was -35.7 (95% CI, -40.1 to -31.4; p<.001). Change in health-related quality of life (HRQL) was 40.9 (95% CI, 36.2 to 45.6; p < .001). HRQL subscores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function) [p<.001]. Six patients underwent surgical re-intervention for fibroid-related bleeding between 12 and 24 months providing a re-intervention rate of 4.8% (6/124). CONCLUSION: Radiofrequency volumetric thermal ablation of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up.

Sensitivity of myoma imaging using laparoscopic ultrasound compared with magnetic resonance imaging and transvaginal ultrasound.

STUDY OBJECTIVE: To determine the efficacy of laparoscopic ultrasound (LUS) as compared with contrast-enhanced magnetic resonance imaging (CE-MRI) and transvaginal ultrasound (TVUS) in detection of uterine myomas. DESIGN: Retrospective study of imaging methods used in a trial of LUS-guided radiofrequency volumetric thermal ablation in women with symptomatic myomas (Canadian Task Force classification II-2). SETTING: Eleven medical university or private outpatient surgery clinics in the United States (nine sites) and Latin America (two sites). PATIENTS: One hundred thirty-five women with symptomatic myomas and objectively confirmed moderate to severe heavy menstrual bleeding. INTERVENTIONS: LUS-guided radiofrequency volumetric thermal ablation of myomas. MEASUREMENTS AND MAIN RESULTS: Preoperative TVUS scans and CE-MRIs were read at each site, and all CE-MRIs were read by a central reader. LUS-guided scans were obtained intraoperatively by each surgeon by mapping the uterus just before radiofrequency volumetric thermal ablation. The imaging methods and their yields in terms of number of myomas found per subject were as follows: TVUS, 403 myomas (mean [SD] 3 [1.8]; range, 1-8); site CE-MRI, 562 myomas (4.2 [3.8]; range, 1-18); central reader, 619 myomas (4.6 [3.7]; range, 0-20); and LUS, 818 myomas (6.1 [4.9]; range, 1-29) (p < .001). LUS was superior to TVUS, CE-MRI, and the central reader for detection of small (≤1 cm(3)) myomas. Most imaged myomas were intramural: 197 (50.9%) by TVUS, 298 (55.5%) by site CE-MRI, 290 (48.7%) by the central reader, and 386 (48.5%) by LUS. CONCLUSION: Compared with CE-MRI and TVUS, LUS demonstrates the most myomas, regardless of size or type.

Gynecology Resident Experience with Office Hysteroscopy Training.

Background: Hysteroscopy is the gold standard for evaluating intrauterine pathology. The majority of physicians currently perform hysteroscopy in the operating room. Lack of training has been cited as a barrier to performing office hysteroscopy; however, resident training in office hysteroscopy has not yet been evaluated. Methods: A prospective cross-sectional survey was performed. A validated 17 question survey tool was sent to 297 program directors of Accreditation Council for Graduate Medical Education accredited obstetrics and gynecology residency programs for distribution to their residents. The survey utilized a Likert scale to assess resident interest in learning office hysteroscopy, satisfaction in training, and perceived self-efficacy to perform office hysteroscopy independently upon graduation. Results: Two hundred and ninety-three obstetrics and gynecology residents responded. Of the respondents, 26.3% reported receiving training in office hysteroscopy. There was no statistically significant difference in training among postgraduate years or program regions. A greater proportion of male residents received training when compared to female residents (42.9% vs. 24.2%, p = 0.019). Ninety-four percent of residents reported interest in learning office hysteroscopy. Satisfaction with hysteroscopy training in the operating room versus the office was 91.1% vs. 11.3% respectively. Of the fourth-year residents, 17.4% felt they could perform office hysteroscopy independently upon graduation and 14.5% reported feeling comfortable performing the procedure. Conclusions: Residency training in office hysteroscopy is lacking and residents are unprepared to perform the procedure after graduation. Enhanced residency training in office hysteroscopy would likely improve resident comfort and ability to perform office hysteroscopy in practice.

Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids.

The purpose of this study was to assess the feasibility of use of a novel uterine fibroid treatment device hypothesized to cause fibroid infarction by increasing intra-tumoral pressure. Between August 2019 and January 2020, 21 uterine fibroids were treated in 16 symptomatic pre-menopausal black women. Pelvic magnetic resonance imaging was performed before the procedure, a day after the procedure and at 1, 3, 6, and 12 months. The subjects were also followed for clinical outcomes and quality of life up to 12 months at a single investigational site. At 3 months, the mean reduction in the fibroid volume was 36.3% (P = .002). Incremental reduction in volume peaked at the end of the follow-up, at the 12-month mark (60.4%; P = .008). There were no procedures in which the users failed to perform laparoscopic pressure suturing of fibroids with the pressure-induced fibroid ischemia device. Improvement in the quality of life was evident in the Health-Related Quality of Life total, Energy/Mood, Control, and Sexual Function domains of the Uterine Fibroid Symptom and Quality of Life questionnaire at 3 months post-procedure. Unanticipated risks were not identified. Serious adverse events were not identified. The initial clinical assessment of the pressure-induced fibroid ischemia device supports feasibility of the approach and does not reveal serious safety concerns. Trial is currently being registered retrospectively (This was a feasibility study and therefore registration was not mandatory).

Review of vasopressin use in gynecologic surgery.

Vasopressin has been used in gynecologic surgery since the 1950s. Since its initial introduction, multiple applications of vasopressin have been explored. The expansion of vasopressin usage in gynecologic surgery is being fueled in part by the increase in minimally invasive surgical techniques, in which alternative methods of temporary hemostasis are in high demand. Nevertheless, much criticism has been directed toward use of vasopressin because of reports of serious complications including cardiac arrest. These concerns have caused several countries to restrict or prohibit the use of this valuable drug. This review explores the mechanisms of vasopressin, the current literature on vasopressin use in gynecologic surgery, and evaluates the reported complications associated with vasopressin use.

Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies. Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved. Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes. Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.

Pseudoepitheliomatous hyperplasia mimicking vulvar cancer in a patient with AIDS.

BACKGROUND: Pseudoepitheliomatous hyperplasia (PEH) clinically and histologically mimics squamous cell carcinoma (SCC), specifically in patients with HIV and AIDS. CASE: A 51-year-old G3P2 with AIDS and history of vulvar cancer presented with large bilateral exophytic lesions on the vulva, grossly appearing neoplastic. Initial biopsies of the lesions were interpreted as vulvar SCC. After resolution with empiric treatment with acyclovir for possible herpes simplex virus type 2 outbreak, additional slides were reviewed, and cells with viral inclusions were identified, making the final diagnosis PEH in association with herpes simplex virus type 2 infection. CONCLUSIONS: Although PEH is infrequently encountered, PEH should be considered in the differential diagnosis of vulvar lesions. A multidisciplinary approach including the gynecologist, pathologist, and infectious disease specialists can optimize patient outcome.