Classification and treatment of vaginal strictures at the donor-recipient anastomosis after uterus transplant.

OBJECTIVE: To describe the incidence and management of vaginal stricture after uterus transplantation (UTx) in the US, to propose a grading system to classify stricture severity, and to identify risk factors for stricture formation. DESIGN: Prospective cohort study. SETTING: University Hospital. PATIENTS: Recipients undergoing UTx from 2016-2023 at Baylor University Medical Center in Dallas, Cleveland Clinic, the University of Pennsylvania, and the University of Alabama at Birmingham were monitored postoperatively with regular pelvic examinations. Stricture was defined as vaginal narrowing of <3 cm in patients with graft survival of at least 7 days. INTERVENTION: Demographic and surgery characteristics. MAIN OUTCOME MEASURES: Stricture development and severity (grade 1 for diameter 2-<3 cm, grade 2 for 1-<2 cm, or grade 3 for <1 cm). RESULTS: Of the 45 UTx from 2016-2023 (16 deceased donors and 29 living donors), 3 were excluded from the analysis because of graft loss within 7 days. Of the 42 remaining recipients, 39 (92.9%) had Mayer-Rokitansky-Küster-Hauser syndrome and 3 (7.1%) had a prior hysterectomy. Twenty-eight (66.7%) UTx recipients developed postoperative vaginal strictures with a median time to stricture of 33 days (interquartile range 19-53 days). Most strictures were of moderate severity, with 4 (14.3%) strictures categorized as grade 1, 19 (67.9%) as grade 2, and 5 (17.9%) as grade 3. History of Mayer-Rokitansky-Küster-Hauser syndrome and preoperative recipient vaginal length were significant risk factors for stricture, after adjustment for donor and recipient age and body mass index, anastomosis technique, total ischemia time, center, and year. Patients with longer preoperative vaginal length had a lower risk of stricture (hazard ratio 0.45, 0.29-0.70). The severity grading of the stricture was associated with the effectiveness of a nonoperative treatment approach (grade 1 vs. grade 3). No patients with grade 3 strictures improved with self-dilation alone; all required surgical repair and/or dilation under anesthesia. Conversely, for grade 1 or 2 strictures, self-dilation alone was successful in 47.8% (11/23), and no grade 1 strictures required surgical repair. CONCLUSIONS: Vaginal stricture is a common postoperative complication after UTx, affecting >65% of recipients. Short preoperative vaginal length and history of müllerian agenesis in the recipient are significant risk factors. Vaginal self-dilation was effective for some mild to moderate strictures, although dilation under anesthesia or surgical repair was required in most cases. CLINICAL TRIAL REGISTRATION NUMBERS: Dallas UtErus Transplant Study (DUETS) at Baylor University Medical Center (NCT02656550), Uterine transplantation for the treatment of uterine factor infertility at the Cleveland Clinic (NCT02573415), The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial (UNTIL) (NCT03307356).

Advanced wireless monitoring for children in the cardiac perioperative setting.

INTRODUCTION: More than 40,000 children undergo surgical interventions annually for the treatment of congenital heart defects. Intraoperative and postoperative vital sign monitoring is a cornerstone of pediatric care. METHODS: A single-arm prospective observational study was performed. Pediatric patients undergoing a procedure with a planned admission to the Cardiac Intensive Care Unit at Lurie Children's Hospital (Chicago, IL) were eligible for enrollment. Participant vital signs were monitored using standard equipment and an FDA-cleared experimental device (ANNE® ) consisting of a wireless patch positioned at the suprasternal notch and index finger or foot. The primary goal of the study was to assess real-world feasibility of wireless sensors in pediatric patients with congenital cardiac defects. RESULTS: A total of 13 patients were enrolled, ranging in age from 4 months to 16 years with a median age of 4 years. Overall, 54% (n = 7) were female and the most common anomaly in the cohort was an atrial septal defect (n = 6). The mean admission length was 3 days (range 2-6), resulting in more than 1000 h of vital sign monitoring (⟩60,000 data points). Bland-Altman plots were generated for heart rate and respiratory rate to assess beat-to-beast differences between the standard equipment and the experimental sensors. CONCLUSIONS: Novel, wireless, flexible sensors demonstrated comparable performance to standard monitoring equipment in a cohort of pediatric patients with congenital cardiac heart defects undergoing surgery.

Neighborhood disadvantage is associated with decreased ovarian reserve in women with overweight and obesity.

OBJECTIVE(S): To evaluate the association between neighborhood disadvantage and ovarian reserve stratified by body mass index (BMI). DESIGN: Cross-sectional cohort study. SETTING: Single academic medical center. PATIENT(S): A total of 193 healthy reproductive-age women with regular menstrual cycles in the St. Louis, Missouri metropolitan area. INTERVENTION(S): Residence in a disadvantaged neighborhood. MAIN OUTCOME MEASURE(S): Ovarian reserve as assessed by ovarian antral follicle count (AFC) and serum anti-Müllerian hormone (AMH) concentration. RESULT(S): Women (n = 193) ranged from 20 to 44 years. The majority had overweight or obesity (59%, n = 117) with mean BMI of 28±7 kg/m2. Forty-eight women lived in the most disadvantaged neighborhood quartile, of which 75% had overweight or obesity, compared with 54% of the 145 women living in the 3 less disadvantaged neighborhood quartiles. When controlling for age, race, and smoking status, women with overweight or obesity living in the most disadvantaged neighborhoods had significantly lower AMH compared with those living in the less disadvantaged neighborhoods. Antral follicle count did not differ among women with overweight or obesity by neighborhood of residence. Neighborhood disadvantage was not associated with ovarian reserve by AFC or AMH in women with normal weight or underweight status. CONCLUSION(S): Living in a socioeconomically deprived area is associated with lower markers of ovarian reserve among women with an elevated BMI.

Assessment of Blue Light Phototherapy for Grover Disease: A Nonrandomized Controlled Trial.

This nonrandomized clinical trial assesses treatment of patients diagnosed with Grover disease with blue light phytotherapy for several weeks.

Pregnancy outcomes in infertility patients diagnosed with sleep disordered breathing with wireless wearable sensors.

OBJECTIVE: To study the feasibility of home-based assessment of sleep disordered breathing (SDB) on early pregnancy success after in vitro fertilization with novel wearable sensors. DESIGN: Prospective observational study. SETTING: Patients 18 to 45 years old undergoing autologous IVF at an academic infertility center. PATIENTS: 30 women (24-44 years old) INTERVENTION: Participants provided medical history, completed sleep surveys, and a single night of home sleep monitoring prior to IVF with a novel, FDA-cleared wireless sensor system (ANNE® Sleep, Sibel Health), to collect continuous measurements of heart rate, respiratory rate, pulse oxygenation, respiratory effort/snoring, peripheral arterial tonometry, pulse arrival time, and pulse transit time, an accepted surrogate of continuous blood pressure generated by pulse arrival time and pulse transit time. Sleep nights were reviewed to derive the apnea hypopnea index (AHI), defined as the average number of apnea or hypopnea events per hour. An AHI of greater than or equal to 5 events/hour was considered abnormal. MAIN OUTCOME MEASURE: Rate of clinical pregnancy (defined as intrauterine gestational sac with a yolk sac) after IVF. Logistic regression models were used to estimate the unadjusted and adjusted odds ratio. RESULTS: The overall rate of sleep disordered breathing of any severity was 57%. Participants with SDB had a mean AHI of 13.4 compared to 2.7 events/hr (p<0.01), were younger, and more likely to have polycystic ovary syndrome. Of the 29 patients undergoing an embryo transfer, clinical pregnancy and livebirth occurred in 35% of women with SDB compared to 58% without SDB (p = 0.22). After adjusting for age, SDB reduced pregnancy rates but was not statistically significant (aOR 0.23, 95% CI: 0.04-1.5, p = 0.12). Though polycystic ovary syndrome was associated with higher rates of SDB it was not independently associated with lower pregnancy rates. CONCLUSION: Screening for sleep disordered breathing using home-based wireless, wearable sensors was well accepted and easily performed by infertile patients in this cohort. Sleep disordered breathing of any severity was associated with an 77% (95% CI: 0.08-1.8) lower likelihood of clinical pregnancy and live birth independent of underlying diagnosis. Future larger studies will be needed to understand the role of sleep disordered breathing and IVF outcomes.

Racial disparities in frozen embryo transfer success.

PURPOSE: To compare pregnancy and birth outcomes after frozen embryo transfers (FETs) among White, Black, and Asian women and evaluate the effect of patient, protocol, and cycle characteristics on success. METHODS: A retrospective chart review identified women who underwent an autologous FET at an academic fertility center between January 2013 and March 2020. RESULTS: White, Black, and Asian women completed 1,181 (71.7%), 230 (14.0%), and 235 (14.3%) cycles, respectively. Black women were significantly less likely to achieve a positive hCG level (AOR 0.66, 95% CI 0.49-0.90), clinical pregnancy (AOR 0.71, 95% CI 0.53-0.97), and live birth (AOR 0.65, 95% CI 0.47-0.89) compared to White women after adjusting for possible confounders. There were no differences in the aforementioned outcomes when looking at cycles completed by Asian versus White women. When comparing outcomes by endometrial preparation protocol, significant differences were seen amongst the three groups for live birth rates following natural cycle FETs (52.36%, 25.81%, and 44.19% for White, Black, and Asian women, respectively, p = 0.02), a difference not appreciated after programmed FETs. CONCLUSION: Black race is associated with significantly worse pregnancy and live birth rates following FET when compared to White race. Additionally, significant differences in live birth rates among White, Black, and Asian women exist following natural cycle FET versus programmed FET. These disparities in success are not only important for patient counseling, but also when determining management strategies to improve fertility rates among minority women.

A Call for Fertility Preservation Coverage for Breast Cancer Patients: The Cost of Consistency.

In 1998, the passage of the Women's Health and Cancer Rights Act required insurance health plans nationwide covering breast cancer treatments to also reimburse for subsequent breast reconstructive surgery and prostheses. In response to low utilization of breast reconstructive services, particularly among racial minorities, plastic surgery interest groups successfully advocated for the passage of the Breast Cancer Patient Education Act, which provides a timely opportunity to reconsider patient accessibility to other equally important quality of life issues for cancer survivors. Currently, the potential threat of infertility as a consequence of cancer therapy does not meet preexisting definitions of infertility, making preemptive fertility preservation elective. Ultimately, cost remains the largest barrier to the pursuit of fertility preservation. In this Commentary, we estimate the potential additive cost of providing fertility preservation coverage for approximately 19 000 eligible women of reproductive age diagnosed with breast cancer based on previously published prevalence and cost data. We determine an upper limit of yearly cost of $126.6 million US dollars assuming 100% participation. Legislation providing mandatory insurance coverage of breast reconstruction surgeries in all 50 states following cancer treatment represents a powerful policy commitment to address existing health disparities in reproductive health services and ensures comprehensive cancer survivorship care. Extending coverage for fertility preservation in the setting of fertility-threatening treatment offers a consistent stance for insurance coverage of iatrogenic sequelae of cancer therapy at a fraction of the cost of breast reconstruction.

Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.

In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

Oncofertility considerations in adolescents and young adults given a diagnosis of melanoma: Fertility risk of Food and Drug Administration-approved systemic therapies.

BACKGROUND: Melanoma is the most common cancer diagnosed for patients ages 25 to 29 years, the group with the highest birth rates in the United States. Oncofertility is a new field addressing the reproductive needs of patients with cancer facing fertility-threatening treatments. OBJECTIVE: We sought to assess gender-specific fertility risk for Food and Drug Administration (FDA)-approved melanoma therapies with a new risk category system. METHODS: We conducted a retrospective review of FDA, European Union, and Health Canada regulatory filings, along with previously published reports to grade fertility risk of systemic melanoma therapies. The proposed fertility risk category system is analogous to the FDA's A/B/C/D/X/N pregnancy-risk categories. RESULTS: For female patients, 58% of treatments represent a fertility risk (Category C and D), 33% have unknown risk (Category N), and 1 therapy (vemurafenib) did not show animal ovarian toxicity (Category B). For male patients, 33% represented a fertility risk (Category C and D), 50% of treatments had unknown risk (Category N), and 17% did not show animal testicular toxicity (Category B). LIMITATIONS: Data on fertility risk for melanoma therapies approved after 2009 are limited to preclinical animal studies. CONCLUSION: Dermatologists have an opportunity to discuss fertility preservation, make appropriate referrals, and steward registries on reproductive outcomes for patients with melanoma.