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Background: Preterm birth survivors are at risk for short- and long-term respiratory morbidity. This includes increased rates of chronic obstructive pulmonary disease and infectious morbidity. Previous studies showed increased utilization of healthcare services throughout early childhood. However, only a few large-scale studies showed the effect on respiratory morbidity throughout the full spectrum of gestational age at birth. The aim of this study was to show the healthcare burden associated with prematurity, in a large nationwide cohort., Study Design: Data regarding gestational age at birth, month and year of birth, and infant sex were gathered for all 1,762,149 infants born in Israel between January 1, 2010, and December 31, 2019. Rates of hospitalization, length of hospitalization, and emergency department visits were calculated per 1000 live births and stratified by gestational age. Poisson regression was constructed to adjust for infant sex, year and month of birth., Results: Preterm birth occurred in 6.43 % of deliveries (n = 109,405). A negative association was found between gestational age at birth and respiratory morbidity. As gestational age at birth advances, rates of respiratory hospitalization decrease, and length of hospitalization shortens. This association continues even after full term is reached., Conclusion: The short- and long-term effect of preterm birth poses a significant burden on healthcare systems globally, not only at birth or in infancy, but well into early childhood. These results are a call for action to stakeholders and professional organizations to increase efforts in preventing and treating preterm and early term labor., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Fenestrating a Fontan baffle has been associated with improved perioperative outcomes in patients with univentricular hearts. However, longer-term potential adverse effects remain debated. We sought to assess the impact of a fenestrated Fontan baffle on adverse cardiovascular events including all-cause mortality, cardiac transplantation, atrial arrhythmias, and thromboemboli., Methods: A multicentre North American retrospective cohort study was conducted on patients with total cavopulmonary connection Fontan baffle, with and without fenestration. All components of the composite outcome were independently adjudicated. Potential static and time-varying confounders were taken into consideration, along with competing risks., Results: A total of 407 patients were followed for 10.4 (7.1-14.4) years; 70.0% had fenestration of their Fontan baffle. The fenestration spontaneously closed or was deliberately sealed in 79.9% of patients a median of 2.0 years after Fontan completion. In multivariable analysis in which a persistent fenestration was modelled as a time-dependent variable, an open fenestration did not confer a higher risk of the composite outcome (hazard ratio, 1.18; 95% confidence interval, 0.71-1.97; P = 0.521). In secondary analyses, an open fenestration was not significantly associated with components of the primary outcome: that is, mortality or transplantation, atrial arrhythmias, or thromboemboli. However, sensitivity analyses to assess the possible range of error resulting from imprecise dates for spontaneous fenestration closures could not rule out significant associations between an open fenestration and atrial arrhythmias or thromboemboli., Conclusions: In this multicentre study, no significant association was identified between an open fenestration in the Fontan baffle and major adverse cardiovascular events., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

There are high rates of posttraumatic stress disorder (PTSD) among treatment-seeking veterans with substance use disorders (SUD). While addiction programs traditionally do not address PTSD, there is evidence that trauma treatments for individuals with this comorbidity have improved PTSD and SUD outcomes. Written exposure therapy (WET), a five-session evidence-based psychotherapy (EBP) for PTSD, has high patient satisfaction, and lower dropout compared to other EBPs for PTSD. WET may be ideally suited for clinical settings that may not have the trauma expertise found in PTSD specialty clinics, given it requires less training time, treatment sessions, preparation time, and therapist involvement than existing EBPs, and no homework assignments. This paper describes the design, methodology, and protocol of a randomized clinical trial to evaluate whether treatment as usual (TAU) plus WET (n = 51) is superior to TAU plus a neutral topic writing condition (n = 51) on both PTSD and addiction outcomes for veterans in SUD treatment. The primary hypothesis is that participants assigned to TAU+WET, compared to those in TAU+ neutral topic writing, will report reduced symptoms of PTSD. The secondary hypothesis is that veterans receiving WET will have greater decreases in number of days of substance use compared to TAU+ neutral topic controls at follow-up. Assessments will take place at baseline, post-treatment, 8-week, and 12-week follow-up. Exploratory aims will examine the association between heart rate variability and treatment outcomes. If results prove promising, they will support WET as an effective brief, easy to disseminate, adjunct to current SUD treatment for veterans with comorbid PTSD. Trial registration: ClinicalTrials.gov ID NCT05327504., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Meshberg-Cohen, Dr. Cook, and Ms. Bin-Mahfouz have no potential conflicts of interest or disclosures to report. Dr. Ismene Petrakis has received in kind (medications) support for research studies from Alkermes and BioXcel Therapeutics. Dr. Petrakis is co-Editor for Journal of Addiction Medicine (JAM). Dr. Petrakis has received textbook royalties from MacGraw/Hill. Dr. Ismene Petrakis also reports Patents and Inventions: (1) Arias A, Petrakis I, Krystal JH. – Composition and methods to treat addiction. Provisional Use Patent Application no.61/973/961. April 2, 2014. Filed by Yale University Office of Cooperative Research. (2) Gihyun, Yoon, Petrakis I, Krystal JH – Compounds, Compositions and Methods for Treating or Preventing Depression and Other Diseases. U. S. Provisional Patent Application No. 62/444,552, filed on January10, 2017 by Yale University Office of Cooperative Research OCR 7088 US01., (Published by Elsevier Inc.)

Background: Transcatheter pulmonary valve implantation (TPVI) is effective for treating right ventricle outflow tract (RVOT) dysfunction. Factors associated with long-term valve durability remain to be investigated., Methods: Consecutive patients successfully treated by TPVI with Melody valves (n = 32) and SAPIEN valves (n = 182) between 2008 and 2020 at a single tertiary centre were included prospectively and monitored., Results: The 214 patients had a median age of 28 years (range, 10-81). The RVOT was a patched native pulmonary artery in 96 (44.8%) patients. Median follow-up was 2.8 years (range, 3 months-11.4 years). Secondary pulmonary valve replacement (sPVR) was performed in 23 cases (10.7%), due to stenosis (n = 22, 95.7%) or severe regurgitation (n = 1, 4.3%), yielding an incidence of 7.6/100 patient-years with melody valves and 1.3/100 patient-years with SAPIEN valves (P = 0.06). The 5- and 10-year sPVR-freedom rates were 78.1% and 50.4% with Melody vs. 94.3% and 82.2% with SAPIEN, respectively (P = 0.06). The incidence of infective endocarditis (IE) was 5.5/100 patient-years with Melody and 0.2/100 patient-years with SAPIEN (P < 0.0001). Factors associated with sPVR by univariate analysis were RV obstruction before TPVI (P = 0.04), transpulmonary maximal velocity > 2.7 m/s after TPVI (p = 0.0005), valve diameter ≤ 22 mm (P < 0.003), IE (P < 0.0001), and age < 25 years at TPVI (P = 0.04). By multivariate analysis adjusted for IE occurrence, transpulmonary maximal velocity remained associated with sPVR., Conclusions: TPVI is effective for treating RVOT dysfunction. Incidence of sPVR is higher in patients with residual RV obstruction or IE. IE add a substantial risk of TPVI graft failure and is mainly linked to the Melody valve., Social Media Abstract: Transcatheter pulmonary valve implantation is effective for treating right ventricular outflow tract dysfunction in patients with congenital heart diseases. Incidence of secondary valve replacement is higher in patients with residual obstruction or infective endocarditis., Competing Interests: Declaration of Competing Interest Sebastien Hascoët has received proctoring and consultant fees from Abbott. None of the other authors has any conflicts of interest to disclose., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Post-COVID-19 vaccine boosting is a potent tool in the ongoing pandemic. Relevant data regarding this approach during pregnancy are lacking, which affects vaccination policy guidance, public acceptance, and vaccine uptake during pregnancy. We aimed to investigate the dynamics of anti-SARS-CoV-2 antibody levels following SARS-CoV-2 infection during pregnancy and to characterize the effect of a single postinfection vaccine booster dose on the anti-SARS-CoV-2 antibody levels in parturients in comparison with the levels in naïve vaccinated and convalescent, nonboosted parturients., Study Design: Serum samples prospectively collected from parturients and umbilical cords at delivery at our university-affiliated urban medical center in Jerusalem, Israel, from May to October 2021, were selected and analyzed in a case-control manner. Study groups comprised the following participants: a consecutive sample of parturients with a polymerase chain reaction-confirmed history of COVID-19 during any stage of pregnancy; and comparison groups selected according to time of exposure comprising (1) convalescent, nonboosted parturients with polymerase chain reaction-confirmed COVID-19; (2) convalescent parturients with polymerase chain reaction-confirmed COVID-19 who received a single booster dose of the BNT162b2 messenger RNA vaccine; and (3) infection-naïve, fully vaccinated parturients who received 2 doses of the BNT162b2 messenger RNA vaccine. Outcomes that were determined included maternal and umbilical cord blood anti-SARS-CoV-2 antibody levels detected at delivery, the reported side effects, and pregnancy outcomes., Results: A total of 228 parturients aged 18 to 45 years were included. Of those, samples from 64 were studied to characterize the titer dynamics following COVID-19 at all stages of pregnancy. The boosting effect was determined by comparing (1) convalescent (n=54), (2) boosted convalescent (n=60), and (3) naïve, fully vaccinated (n=114) parturients. Anti-SARS-CoV-2 antibody levels detected on delivery showed a gradual and significant decline over time from infection to delivery (r=0.4371; P=.0003). Of the gravidae infected during the first trimester, 34.6% (9/26) tested negative at delivery, compared with 9.1% (3/33) of those infected during the second trimester (P=.023). Significantly higher anti-SARS-CoV-2 antibody levels were observed among boosted convalescent than among nonboosted convalescent (17.6-fold; P<.001) and naïve vaccinated parturients (3.2-fold; P<.001). Similar patterns were observed in umbilical cord blood. Side effects in convalescent gravidae resembled those in previous reports of mild symptoms following COVID-19 vaccination during pregnancy., Conclusion: Postinfection maternal humoral immunity wanes during pregnancy, leading to low or undetectable protective titers for a marked proportion of patients. A single boosting dose of the BNT162b2 messenger RNA vaccine induced a robust increase in protective titers for both the mother and newborn with moderate reported side effects., (Copyright © 2022. Published by Elsevier Inc.)

Maternal tolerance of the semiallogenic fetus necessitates conciliation of competing interests. Viviparity evolved with a placenta to mediate the needs of the fetus and maternal adaptation to the demands of pregnancy and to ensure optimal survival for both entities. The maternal-fetal interface is imagined as a 2-dimensional porous barrier between the mother and fetus, when in fact it is an intricate multidimensional array of tissues and resident and circulating factors at play, encompassing the developing fetus, the growing placenta, the changing decidua, and the dynamic maternal cardiovascular system. Pregnancy triggers dramatic changes to maternal hemodynamics to meet the growing demands of the developing fetus. Nearly a century of extensive research into the development and function of the placenta has revealed the role of placental dysfunction in the great obstetrical syndromes, among them preeclampsia. Recently, a debate has arisen questioning the primacy of the placenta in the etiology of preeclampsia, asserting that the maternal cardiovascular system is the instigator of the disorder. It was the clinical observation of the high rate of preeclampsia in hydatidiform mole that initiated the focus on the placenta in the etiology of the disease. Over many years of research, shallow trophoblast invasion with deficient remodeling of the maternal spiral arteries into vessels of higher capacitance and lower resistance has been recognized as hallmarks of the preeclamptic milieu. The lack of the normal decrease in uterine artery resistance is likewise predictive of preeclampsia. In abdominal pregnancies, however, an extrauterine pregnancy develops without remodeling of the spiral arteries, yet there is reduced resistance in the uterine arteries and distant vessels, such as the maternal ophthalmic arteries. Proponents of the maternal cardiovascular model of preeclampsia point to the observed maternal hemodynamic adaptations to pregnancy and maladaptation in gestational hypertension and preeclampsia and how the latter resembles the changes associated with cardiac disease states. Recognition of the importance of the angiogenic-antiangiogenic balance between placental-derived growth factor and its receptor soluble fms-like tyrosine kinase-1 and disturbance in this balance by an excess of a circulating isoform, soluble fms-like tyrosine kinase-1, which competes for and disrupts the proangiogenic receptor binding of the vascular endothelial growth factor and placental-derived growth factor, opened new avenues of research into the pathways to normal adaptation of the maternal cardiovascular and other systems to pregnancy and maladaptation in preeclampsia. The significance of the "placenta vs heart" debate goes beyond the academic: understanding the mutuality of placental and maternal cardiac etiologies of preeclampsia has far-reaching clinical implications for designing prevention strategies, such as aspirin therapy, prediction and surveillance through maternal hemodynamic studies or serum placental-derived growth factor and soluble fms-like tyrosine kinase-1 testing, and possible treatments to attenuate the effects of insipient preeclampsia on women and their fetuses, such as RNAi therapy to counteract excess soluble fms-like tyrosine kinase-1 produced by the placenta. In this review, we will present an integrated model of the maternal-placental-fetal array that delineates the commensality among the constituent parts, showing how a disruption in any component or nexus may lead to the multifaceted syndrome of preeclampsia., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Failure to progress is one of the leading indications for cesarean delivery in trials of labor in twin gestations. However, assessment of labor progression in twin labors is managed according to singleton labor curves., Objective: This study aimed to establish a partogram for twin deliveries that reflects normal and abnormal labor progression and customized labor curves for different subgroups of twin labors., Study Design: This was a multicenter, retrospective cohort analysis of twin deliveries that were recorded in 3 tertiary medical centers between 2003 and 2017. Eligible parturients were those with twin gestations at ≥34 weeks' gestation with cephalic presentation of the presenting twin and ≥2 cervical examinations during labor. Exclusion criteria were elective cesarean delivery without a trial of labor, major fetal anomalies, and fetal demise. The study group comprised twin gestations, whereas singleton gestations comprised the control group. Statistical analysis was performed using Python 3.7.3 and SPSS, version 27. Categorical variables were analyzed using chi-square tests. Student t test and Mann-Whitney U test were applied to analyze the differences in continuous variables, as appropriate., Results: A total of 1375 twin deliveries and 142,659 singleton deliveries met the inclusion criteria. Duration of the active phase of labor was significantly longer in twin labors than in singleton labors in both nulliparous and multiparous parturients; the 95th percentile duration was 2 hours longer in nulliparous twin labors and >3.5 hours longer in multiparous twin labors than in singleton labors. The cervical dilation progression rate was significantly slower in twin deliveries than in singleton deliveries with a mean rate in twin deliveries of 1.89 cm/h (95th percentile, 0.51 cm/h) and a mean rate of 2.48 cm/h (95th percentile, 0.73 cm/h) in singleton deliveries (P<.001). In addition, epidural use further slowed labor progression in twin deliveries. The second stage of labor was also markedly longer in twin deliveries, both in nulliparous and multiparous women (95th percentile, 3.04 vs 2.83 hours, P=.002)., Conclusion: Twin labors are characterized by a slower progression of the active phase and second stage of labor compared with singleton labors in nulliparous and multiparous parturients. Epidural analgesia further slows labor progression in twin labors. Implementation of these findings in clinical management might lower cesarean delivery rates among cases with protracted labor in twin gestations., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Study Objective: Develop a model for predicting adverse outcomes at the time of laparoscopic hysterectomy (LH) for benign indications., Design: Retrospective cohort study., Setting: Large academic center., Patients: All patients undergoing LH for benign indications at our institution between 2009 and 2017., Interventions: LH (including robot-assisted and laparoscopically assisted vaginal hysterectomy) was performed per standard technique. Data about the patient, surgeon, perioperative adverse outcomes (intraoperative complications, readmission, reoperation, operative time >4 hours, and postoperative medical complications or length of stay >2 days), and uterine weight were collected retrospectively. Pathologic uterine weight was used as a surrogate for predicted preoperative uterine weight. The sample was randomly split, using a random sequence generator, into 2 cohorts, one for deriving the model and the other to validate the model., Measurements and Main Results: A total of 3441 patients were included. The rate of composite adverse outcomes was 14.1%. The final logistic regression risk-prediction model identified 6 variables predictive of an adverse outcome at the time of LH: race, history of laparotomy, history of laparoscopy, predicted preoperative uterine weight, body mass index, and surgeon annual case volume. Specifically included were race (97% increased odds of an adverse outcome for black women [95% confidence interval (CI), 34%-110%] and 34% increased odds of an adverse outcome for women of other races [95% CI, -11% to 104%] when compared with white women), history of laparotomy (69% increased odds of an adverse outcome [95% CI, 26%-128%]), history of laparoscopy (65% increased odds of an adverse outcome [95% CI, 21%-124%]), and predicted preoperative uterine weight (2.9% increased odds of an adverse outcome for each 100-g increase in predicted weight [95% CI, 2%-4%]). Body mass index and surgeon annual case volume also had a statistically significant nonlinear relationship with the risk of an adverse outcome. The c-statistic values for the derivation and validation cohorts were 0.74 and 0.72, respectively. The model is best calibrated for patients at lower risk (<20%)., Conclusion: The LH risk-prediction model is a potentially powerful tool for predicting adverse outcomes in patients planning hysterectomy., (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)

Patients with end-stage pulmonary arterial hypertension due to congenital heart disease have limited access to heart-lung transplantation or double-lung transplantation. We aimed to assess the effects of a high-priority allocation program established in France in 2007. We conducted a retrospective study to compare waitlist and posttransplantation outcomes before versus after implementation of the high-priority allocation program. We included 67 consecutive patients (mean age at listing, 33.2 ± 10.5 years) with pulmonary arterial hypertension due to congenital heart disease listed for heart-lung transplantation or double-lung transplantation from 1997 to 2016. At one month, the incidences of transplantation and death before transplantation were 3.5% and 24.6% in 1997-2006, 4.8% and 4.9% for patients on the regular list in 2007-2016, and 41.2% and 7.4% for patients listed under the high-priority allocation program (p < .001 and p = .0001, respectively). Overall survival was higher in patients listed in 2007-2016 (84.2% and 61.2% at 1 and 10 years vs. 36.8% and 22.1%, p = .0001). Increased incidence of transplantation, decreased waiting list mortality, and improved early and long-term outcomes were observed in patients with pulmonary arterial hypertension due to congenital heart disease listed for transplantation in the recent era, characterized by implementation of a high-priority allocation program., (© 2021 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Objective: This review seeks to establish the incidence of adverse outcomes associated with minimally invasive tissue extraction at the time of surgical procedures for myomas., Data Sources: Articles published in the following databases without date restrictions: PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews and Trials. Search was conducted on March 25, 2020., Methods of Study Selection: Included studies evaluated minimally invasive surgical procedures for uterine myomas involving morcellation. This review did not consider studies of nonuterine tissue morcellation, studies involving uterine procedures other than hysterectomy or myomectomy, studies involving morcellation of known malignancies, nor studies concerning hysteroscopic myomectomy. A total of 695 studies were reviewed, with 185 studies included for analysis., Tabulation, Integration, and Results: The following variables were extracted: patient demographics, study type, morcellation technique, and adverse outcome category. Adverse outcomes included prolonged operative time, morcellation time, blood loss, direct injury from a morcellator, dissemination of tissue (benign or malignant), and disruption of the pathologic specimen., Conclusion: Complications related to morcellation are rare; however, there is a great need for higher quality studies to evaluate associated adverse outcomes., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: Heart failure (HF) is the leading cause of death in adult patients with congenital heart disease (ACHD). No risk prediction model exists for HF hospitalization (HFH) for ACHD patients. We aimed to develop a clinically relevant one-year risk prediction system to identify ACHD patients at high risk for HFH., Methods: Data source was the Quebec CHD Database. A retrospective cohort including all ACHD patients aged 18-64 (1995-2010) was constructed for assessing the cumulative risk of HFH adjusting for competing risk of death. To identify one-year predictors of incident HFH, multivariable logistic regressions were employed to a nested case-control sample of all ACHD patients aged 18-64 in 2009. The final model was used to create a risk score system based on adjusted odds ratios., Results: The cohort included 29,991 ACHD patients followed for 648,457 person-years. The cumulative HFH risk by age 65 was 12.58%. The case-control sample comprised 26,420 subjects, of whom 189 had HFHs. Significant one-year predictors were age ≥ 50, male sex, CHD lesion severity, recent 12-month HFH history, pulmonary arterial hypertension, chronic kidney disease, coronary artery disease, systemic arterial hypertension, and diabetes mellitus. The created risk score ranged from 0 to 19. The corresponding HFH risk rose rapidly beyond a score of 8. The risk scoring system demonstrated excellent prediction performance., Conclusions: One eighth of ACHD population experienced HFH before age 65. Age, sex, CHD lesion severity, recent 12-month HFH history, and comorbidities constructed a risk prediction model that successfully identified patients at high risk for HFH., Competing Interests: Declaration of Competing Interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome is a rare primary immunodeficiency caused by gain-of-function mutations in the CXCR4 gene. We report the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mavorixafor from a phase 2 open-label dose-escalation and extension study in 8 adult patients with genetically confirmed WHIM syndrome. Mavorixafor is an oral small molecule selective antagonist of the CXCR4 receptor that increases mobilization and trafficking of white blood cells from the bone marrow. Patients received escalating doses of mavorixafor, up to 400 mg once daily. Five patients continued on the extension study for up to 28.6 months. Mavorixafor was well tolerated with no treatment-related serious adverse events. At a median follow-up of 16.5 months, we observed dose-dependent increases in absolute neutrophil count (ANC) and absolute lymphocyte count (ALC). At doses ≥300 mg/d, ANC was maintained at >500 cells per microliter for a median of 12.6 hours, and ALC was maintained at >1000 cells per microliter for up to 16.9 hours. Continued follow-up on the extension study resulted in a yearly infection rate that decreased from 4.63 events (95% confidence interval, 3.3-6.3) in the 12 months prior to the trial to 2.27 events (95% confidence interval, 1.4-3.5) for patients on effective doses. We observed an average 75% reduction in the number of cutaneous warts. This study demonstrates that mavorixafor, 400 mg once daily, mobilizes neutrophil and lymphocytes in adult patients with WHIM syndrome and provides preliminary evidence of clinical benefit for patients on long-term therapy. The trial was registered at www.clinicaltrials.gov as #NCT03005327., (© 2020 by The American Society of Hematology.)

Background: Cardiac magnetic resonance (CMR) imaging with velocity encoding along all three directions of flow, known as 4DFlow CMR, provides both anatomical and functional information. Few data are available on the usefulness of 4DFlow CMR in everyday practice. Here, our objective was to investigate the usefulness of 4DFlow CMR for assessing congenital heart disease (CHD) in everyday practice., Methods: From 2017 to 2019, consecutive patients who underwent 4DFlow CMR were included prospectively at a single high-volume centre. The parameters recommended by an expert's consensus statement for each diagnosis (congenital valvulopathy, septal defect, complex CHD, tetralogy of Fallot, aortic abnormalities) were assessed by two blinded experienced readers. 4DFlow CMRs that provided all recommended parameters were considered successful. Inter-observer and intra-observer agreement were investigated., Results: We included 187 adults and 60 children covering broad ranges of weight (4.5-142 kg) and age (0.1-67 years). 4DFlow CMR was always the second-line imaging modality, after inconclusive echocardiography, and was successful in 231/247 (91%) patients, with no significant difference between children and adults (54/60, 90%; and 177/187, 95%; respectively; p = .13). Longer time using 4DFlow CMR at our centre was associated with success; in children, older age was also associated with exam success. There was an about 12-month learning curve in children. The success rate was lowest in neonates. Inter-observer and intra-observer agreement were substantial., Conclusion: Our results suggest that 4DFlow CMR usually provides a comprehensive assessment of CHD in adults and children. A learning curve exists for children and the investigation remains challenging in neonates., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: To determine if two encounter conversation aids for early-stage breast cancer surgery increased observed and patient-reported shared decision making (SDM) compared with usual care and if observed and patient-reported SDM were associated., Methods: Surgeons in a cluster randomized trial at four cancer centers were randomized to use an Option Grid, Picture Option Grid, or usual care. We used bivariate statistics, linear regression, and multilevel models to evaluate the influence of trial arm, patient socioeconomic status and health literacy on observed SDM (via OPTION-5) and patient-reported SDM (via collaboRATE)., Results: From 311 recordings, OPTION-5 scores were 73/100 for Option Grid (n = 40), 56.3/100 for Picture Option Grid (n = 144), and 41.0/100 for usual care (n = 127; p < 0.0001). Top collaboRATE scores were 81.6 % for Option Grid, 80.0 % for Picture Option Grid, and 56.4 % for usual care (p < 0.001). Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis. Patients of lower socioeconomic status had lower OPTION-5 scores before accounting for clustering., Conclusions: Both conversation aids led to meaningfully higher observed and patient-reported SDM. Observed and patient-reported SDM were not strongly correlated., Practice Implications: Healthcare providers could implement these conversation aids in real-world settings., Competing Interests: Declaration of Competing Interest GE has edited and published books that provide royalties on sales by the publishers: the books include Shared Decision Making (Oxford University Press) and Groups (Radcliffe Press). He owns copyright in measures of shared decision making and care integration, namely collaboRATE, integRATE (measure of care integration, consideRATE (patient experience of care in serious illness), coopeRATE (measure of goal setting), toleRATE (clinician attitude to shared decision making, Observer OPTION-5 and Observer OPTION-12 (observer measures of shared decision making). He has in the past provided consultancy for organizations, including: 1) Emmi Solutions LLC who developed patient decision support tools; 2) National Quality Forum on the certification of decision support tools; 3) Washington State Health Department on the certification of decision support tools; 4) SciMentum LLC, Amsterdam (workshops for shared decision making). He is the Founder and Director of &think LLC which owns the registered trademark for Option Grids™ patient decision aids; Founder and Director of SHARPNETWORK LLC, a provider of training for shared decision making. He provides advice in the domain of shared decision making and patient decision aids to: 1) Access Community Health Network, Chicago (Adviser to Federally Qualified Medical Centers); 2) EBSCO Health for Option Grids ™ patient decision aids (Consultant); 3) Bind On Demand Health Insurance (Consultant), 4) PatientWisdom Inc (Adviser); 5) abridge AI Inc (Chief Clinical Research Scientist). M-A D helped develop the Option Grid patient decision aids, which are licensed to EBSCO Health. She receives consulting income from EBSCO Health, and may receive royalties in the future. M-A D is a consultant for ACCESS Community Health Network. CHS holds copyright in The consideRATE Suite of tools. No other competing interests declared., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Study Objective: To review pregnancy outcomes after laparoscopic myomectomy with the use of barbed suture., Design: Retrospective cohort study and follow-up survey., Setting: Single, large academic medical center., Patients: Patients who underwent laparoscopic myomectomy with the use of barbed suture for myometrial closure between 2008 and 2016., Intervention: Laparoscopic myomectomy and a follow-up survey regarding pregnancy outcome., Measurements and Main Results: A total of 486 patients met inclusion criteria and underwent a laparoscopic myomectomy between 2008 and 2016. Of the 428 with viable contact information, 240 agreed to participate (56%). Of those who responded to the survey, 101 (42%) attempted to get pregnant, and there were 4 unplanned pregnancies. There were 110 pregnancies among 76 survey respondents. In total, of the women attempting a postoperative pregnancy, 71% had at least 1 pregnancy. Comparing the women who did and did not conceive postoperatively, the group who got pregnant was on average younger, 33.8 ± 4.5 years vs 37.5 ± 6.5 years (p = .001); had fewer myomas removed, median = 2 (range 1-9) vs median = 2 (range 1-16) myomas (p = .038); and had a longer follow-up period, 30 months ( vs 30 (11-93 months) ± 20 (p <.001). The mean time to first postoperative pregnancy was 18.0 months (range 2-72 months). Of the 110 reported postoperative pregnancies, there were 60 live births (55%), 90% by means of cesarean section. The mean gestational age at birth was 37.8 weeks. In the cohort, there were 8 preterm births, 3 cases of abnormal placentation, 2 cases of fetal growth restriction, 3 cases of hypertensive disorders of pregnancy, and 2 cases of myoma degeneration requiring hospitalization for pain control. There were no uterine ruptures reported., Conclusion: According to our findings, pregnancy outcomes after laparoscopic myomectomy with barbed suture are comparable with available literature on pregnancy outcomes with conventional smooth suture., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Objective: Assess the effect of pictorial health information on patients' and consumers' health behaviors and outcomes, evaluate these effects in lower health literacy populations, and examine the attributes of the interventions., Methods: We included randomized controlled trials (RCTs) that assessed the effect of pictorial health information on patient and consumer health behaviors and outcomes. We conducted a meta-analysis of RCTs that assessed knowledge/understanding, recall, or adherence, and a subgroup analysis of those outcomes on lower health literacy populations. We narratively reviewed characteristics of pictorial health interventions that significantly improved outcomes for lower health literacy populations., Results: From 4160 records, we included 54 RCTs (42 in meta-analysis). Pictorial health information moderately improved knowledge/understanding and recall overall, but largely increased knowledge/understanding for lower health literacy populations (n = 13), all with substantial heterogeneity. Icons with few words may be most helpful in conveying health information., Conclusion: Our results support including pictures in health communication to improve patient knowledge. Our results should be interpreted with caution considering the significant heterogeneity of the meta-analysis outcomes., Practice Implications: Future research should assess which types and characteristics of pictures that best convey health information and are most useful and the implementation and sustainability in healthcare contexts., Systematic Review Registration: PROSPERO CRD42018084743., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Although laparoscopic hysterectomy is well established as a favorable mode of hysterectomy owing to decreased perioperative complications, there is still room for improvement in quality of care. Previous studies have described laparoscopic hysterectomy risk, but there is currently no tool for predicting risk of complication at the time of laparoscopic hysterectomy., Objective: This study aimed to create a prediction model for complications at the time of laparoscopic hysterectomy for benign conditions., Study Design: This is a retrospective cohort study that included patients who underwent laparoscopic hysterectomy for benign indications between 2014 and 2017 in US hospitals contributing to the American College of Surgeons - National Surgical Quality Improvement Program database. Data about patient baseline characteristics, perioperative complications (intraoperative complications, readmission, reoperation, need for transfusion, operative time greater than 4 hours, or postoperative medical complication), and uterine weight at the time of pathologic examination were collected retrospectively. Postoperative uterine weight was used as a proxy for preoperative uterine weight estimate. The sample was randomly divided into 2 patient populations, one for deriving the model and the other to validate the model., Results: A total of 33,123 women met the inclusion criteria. The rate of composite complication was 14.1%. Complication rates were similar in the derivation and validation cohorts (14.1% [2306 of 14,051] vs 13.9% [2289 of 14,107], P=.7207). The logistic regression risk prediction tool for hysterectomy complication identified 7 variables predictive of complication: history of laparotomy (21% increased odds of complication), age (2% increased odds of complication per year of life), body mass index (0.2% increased odds of complication per each unit increase in body mass index), parity (7% increased odds of complication per delivery), race (when compared with white women, black women had 34% increased odds and women of other races had 18% increased odds of complication), and American Society of Anesthesiologists score (when compared with American Society of Anesthesiologists 1, American Society of Anesthesiologists 2 had 31% increased odds, American Society of Anesthesiologists 3 had 62% increased odds, and American Society of Anesthesiologists 4 had 172% increased odds of complication). Predicted preoperative uterine weight also had a statistically significant nonlinear relationship with odds of complication. The c-statistics for the derivation and validation cohorts were 0.62 and 0.62, respectively. The model is well calibrated for women at all levels of risk., Conclusion: The laparoscopic hysterectomy complication predictor model is a tool for predicting complications in patients planning to undergo hysterectomy., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The process of childbirth is one of the most crucial events in the future health and development of the offspring. The vulnerability of parturients and fetuses during the delivery process led to the development of intrapartum monitoring methods and to the emergence of alternative methods of delivery. However, current monitoring methods fail to accurately discriminate between cases in which intervention is unnecessary, partly contributing to the high rates of cesarean deliveries worldwide. Machine learning methods are applied in various medical fields to create personalized prediction models. These methods are used to analyze abundant, complex data with intricate associations to aid in decision making. Initial attempts to predict vaginal delivery vs cesarean deliveries using machine learning tools did not utilize the vast amount of data recorded during labor. The data recorded during labor represent the dynamic process of labor and therefore may be invaluable for dynamic prediction of vaginal delivery., Objective: We aimed to create a personalized machine learning-based prediction model to predict successful vaginal deliveries using real-time data acquired during the first stage of labor., Study Design: Electronic medical records of labor occurring during a 12-year period in a tertiary referral center were explored and labeled. Four different models were created using input from multiple maternal and fetal parameters. Initial risk assessments for vaginal delivery were calculated using data available at the time of admission to the delivery unit, followed by models incorporating cervical examination data and fetal heart rate data, and finally, a model that integrates additional data available during the first stage of labor was created., Results: A total of 94,480 cases in which a trial of labor was attempted were identified. Based on approximately 180 million data points from the first stage of labor, machine learning models were developed to predict successful vaginal deliveries. A model using data available at the time of admission to the delivery unit yielded an area under the curve of 0.817 (95% confidence interval, 0.811-0.823). Models that used real-time data increased prediction accuracy. A model that includes real-time cervical examination data had an initial area under the curve of 0.819 (95% confidence interval, 0.813-0.825) at first examination, which increased to an area under the curve of 0.917 (95% confidence interval, 0.913-0.921) by the end of the first stage. Adding the real-time fetal heart monitor data provided an area under the curve of 0.824 (95% confidence interval, 0.818-0.830) at first examination, which increased to an area under the curve of 0.928 (95% confidence interval, 0.924-0.932) by the end of the first stage. Finally, adding additional real-time data increased the area under the curve initially to 0.833 (95% confidence interval, 0.827-0.838) at the first cervical examination and up to 0.932 (95% confidence interval, 0.928-0.935) by the end of the first stage., Conclusion: Real-time data acquired throughout the process of labor significantly increased the prediction accuracy for vaginal delivery using machine learning models. These models enable translation and quantification of the data gathered in the delivery unit into a clinical tool that yields a reliable personalized risk score and helps avoid unnecessary interventions., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Efforts to reduce cesarean delivery rates to 12-15% have been undertaken worldwide. Special focus has been directed towards parturients who undergo a trial of labor after cesarean delivery to reduce the burden of repeated cesarean deliveries. Complication rates are lowest when a vaginal birth is achieved and highest when an unplanned cesarean delivery is performed, which emphasizes the need to assess, in advance, the likelihood of a successful vaginal birth after cesarean delivery. Vaginal birth after cesarean delivery calculators have been developed in different populations; however, some limitations to their implementation into clinical practice have been described. Machine-learning methods enable investigation of large-scale datasets with input combinations that traditional statistical analysis tools have difficulty processing., Objective: The aim of this study was to evaluate the feasibility of using machine-learning methods to predict a successful vaginal birth after cesarean delivery., Study Design: The electronic medical records of singleton, term labors during a 12-year period in a tertiary referral center were analyzed. With the use of gradient boosting, models that incorporated multiple maternal and fetal features were created to predict successful vaginal birth in parturients who undergo a trial of labor after cesarean delivery. One model was created to provide a personalized risk score for vaginal birth after cesarean delivery with the use of features that are available as early as the first antenatal visit; a second model was created that reassesses this score after features are added that are available only in proximity to delivery., Results: A cohort of 9888 parturients with 1 previous cesarean delivery was identified, of which 75.6% of parturients (n=7473) attempted a trial of labor, with a success rate of 88%. A machine-learning-based model to predict when vaginal delivery would be successful was developed. When features that are available at the first antenatal visit are used, the model showed a receiver operating characteristic curve with area under the curve of 0.745 (95% confidence interval, 0.728-0.762) that increased to 0.793 (95% confidence interval, 0.778-0.808) when features that are available in proximity to the delivery process were added. Additionally, for the later model, a risk stratification tool was built to allocate parturients into low-, medium-, and high-risk groups for failed trial of labor after cesarean delivery. The low- and medium-risk groups (42.4% and 25.6% of parturients, respectively) showed a success rate of 97.3% and 90.9%, respectively. The high-risk group (32.1%) had a vaginal delivery success rate of 73.3%. Application of the model to a cohort of parturients who elected a repeat cesarean delivery (n=2145) demonstrated that 31% of these parturients would have been allocated to the low- and medium-risk groups had a trial of labor been attempted., Conclusion: Trial of labor after cesarean delivery is safe for most parturients. Success rates are high, even in a population with high rates of trial of labor after cesarean delivery. Application of a machine-learning algorithm to assign a personalized risk score for a successful vaginal birth after cesarean delivery may help in decision-making and contribute to a reduction in cesarean delivery rates. Parturient allocation to risk groups may help delivery process management., (Copyright © 2020 Elsevier Inc. All rights reserved.)

As life expectancy in patients with congenital heart disease (CHD) has improved, the risk for developing noncardiac morbidities is increasing in adult patients with CHD (ACHD). Among these noncardiac complications, malignancies significantly contribute to the disease burden of ACHD patients. Epidemiologic studies of cancer risk in CHD patients are challenging because they require large numbers of patients, extended follow-up, detailed and validated clinical data, and appropriate reference populations. However, several observational studies suggest that cancer risks are significantly elevated in patients with CHD compared with the general population. CHD and cancer share genetic and environmental risk factors. An association with exposure to low-dose ionizing radiation secondary to medical therapeutic or diagnostic procedures has been reported. Patients with Down syndrome, as well as, to a lesser extent, deletion of 22q11.2 and renin-angiotensin system pathologies, may manifest both CHD and a predisposition to cancer. Such observations suggest that carcinogenesis and CHD may share a common basis in some cases. Finally, specific conditions, such as Fontan circulation and cyanotic CHD, may lead to multisystem consequences and subsequently to cancer. Nonetheless, there is currently no clear consensus regarding appropriate screening for cancer and surveillance modalities in CHD patients. Physicians caring for patients with CHD should be aware of this potential predisposition and meet screening recommendations for the general population fastidiously. An interdisciplinary and global approach is required to bridge the knowledge gap in this field., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objective: The primary objective is to assess psychomotor aptitude of medical students interested in pursuing a procedural career. Secondary objectives include exploring the relationship between actual and perceived aptitude, and identifying predictors of superior aptitude., Design: This is a cross-sectional, multisite study in which participants completed a paper survey, four visuospatial aptitude assessments, and a laparoscopic simulation modeled after the Fundamentals of Laparoscopic Surgery (FLS) peg transfer test (used as a proxy for psychomotor aptitude)., Setting: Johns Hopkins University School of Medicine and Mayo Clinic School of Medicine., Participants: All second-year medical students who had not yet initiated clinical rotations were eligible. Sixty-four students participated., Results: Students interested in a procedural career exhibited superior psychomotor aptitude (faster FLS task completion time), and a majority of these students correctly identified themselves as having above-average aptitude compared with peers. However, over one quarter of all students, regardless of career interest, incorrectly over- or under-rated their psychomotor aptitude. Upon completing their preclinical curriculum, a minority of students felt prepared to participate or assist in their surgical clinical rotations., Conclusions: Prior to embarking on their clinical rotations, over one quarter of medical students lack awareness of their psychomotor aptitude and many do not feel prepared to participate in the next phase of their training. Early aptitude testing and introduction to laparoscopic training may assist in career selection, preparedness, and success., (Copyright © 2019 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Study Objective: To describe the perioperative outcomes of various modes of myomectomy (abdominal [AM], laparoscopic [LM], or robotic [RM]) in cases of extreme myoma burden., Design: Retrospective cohort study (Canadian Task Force classification II-2)., Setting: A tertiary academic center in Boston, Massachusetts., Patients: All women who underwent an AM, LM, or RM for extreme myoma burden, defined as representing the upper quartile for specimen weight (≥434.6 g) or myoma count (≥7 myomas), between 2009 and 2016., Interventions: Baseline demographics and perioperative outcomes were collected from review of medical records, including estimated blood loss, operative time, length of stay, and complications. Univariate linear and logistic regression analyses were conducted., Measurements and Main Results: During the study period 659 women underwent myomectomy for extreme myoma burden; 47.2% of cases were AM, 28.1% LM, and 24.7% RM. Overall myoma burden differed across the 3 routes and was greatest in the AM group (mean weight: 696.2 ± 784.5 g for AM vs 586.6 ± 426.1 g for LM and 586.6 ± 426.1 g for RM; mean number: 16.8 ± 15.0 for AM vs 7.2 ± 7.0 for LM and 6.7 ± 4.7 for RM; p <.001 for both). The 3 routes differed in operative time and length of stay, with RM having the longest operative time (mean, 239.7 minutes; p <.001) and AM the longest length of stay (mean, 2.2 ± .9 days; p <.001). Other perioperative outcomes were similar across the surgical approaches. Increasing myoma burden was associated with an increased risk of perioperative complications for all surgical approaches, with a threshold of 13 myomas associated with an almost 2-fold higher risk of perioperative complications (odds ratio, 1.77; 95% confidence interval, 1.17-2.70; p = .009). Cumulative incidence of perioperative complications with increasing specimen weight was greater in the RM cases as compared with AM (p = .002) or LM (p = .020), whereas the cumulative incidence of perioperative complications with increasing myoma count was lowest with AM compared with LM (p <.001) or RM (p <.001)., Conclusion: Myomectomy for extreme myomas is feasible using an abdominal, laparoscopic, or robotic approach. Increased myoma burden is associated with an increased risk of perioperative complications. A threshold of 13 myomas was associated with an almost 2-fold higher risk of perioperative complications for all modes. Perioperative complication outcomes were more favorable in AM or LM over RM with increased myoma weight and AM over LM or RM with increased myoma number., (Copyright © 2018 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To compare symptom persistence in women with adenomyosis based on retention or removal of the cervix at the time of hysterectomy., Design: Retrospective cohort study and follow-up survey (Canadian Task Force classification xx)., Setting: Tertiary care academic hospital in Boston, Massachusetts., Patients: Women (n = 1580) who underwent laparoscopic hysterectomy for benign indications between 2008 and 2012 at Brigham and Women's Faulkner Hospital and Brigham and Women's Hospital., Intervention: Retrospective chart review and follow-up survey., Measurements and Main Results: Among the 1580 women contacted, 762 (48%) responded to the postoperative symptom resolution survey. Of these 762 women, 623 agreed to participate in the study. Menopausal women or those who had undergone bilateral salpingo-oophorectomy were excluded. Adenomyosis was identified on histopathologic evaluation of the uterus in 171 of the remaining 443 women (39%). Compared with women without adenomyosis, those with adenomyosis were older on average (mean age, 46.6 ± 6.8 years vs 45.0 ± 5.5 years; p = .009) and more likely to report that abnormal bleeding and pain led to their hysterectomy (87.7% vs 79.8%; p = .03 and 64.9% vs 51.4%; p = .009, respectively). The rates of total and supracervical hysterectomies were similar in the 2 groups. Following surgery, women with adenomyosis were less likely than those without adenomyosis to report persistent pain (adjusted odds ratio [aOR], 0.43; 95% confidence interval [CI], 0.20-0.93; p = .03). Persistent bleeding was similar in the 2 groups (aOR, 0.97; 95% CI, 0.49-1.93; p = .94). Among women with adenomyosis, multivariable logistic regression showed no difference in persistence of symptoms with cervical removal or retention at the time of hysterectomy., Conclusion: Compared with women without adenomyosis, those with histopathologically proven adenomyosis were less likely to report persistent pain following hysterectomy. Retention of the cervix does not appear to increase the risk of symptom persistence or postprocedure patient satisfaction., (Copyright © 2018 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: Advances in congenital heart disease (CHD) have transferred the mortality from childhood to adulthood. Exercise capacity in young patients with CHD remains lower than in the general population, resulting in deconditioning and impaired quality of life. Evidence based-medicine in cardiac rehabilitation in this age group with CHD remains limited. We present the QUALI-REHAB study rationale, design and methods., Methods: The QUALI-REHAB trial is a nationwide, multicentre, randomised, controlled study, aiming to assess the impact of a combined centre and home-based cardiac rehabilitation program on the quality of life of adolescents and young adults (13 to 25 years old) with CHD. Patients with a maximum oxygen uptake (VO2 max ) < 80% and/or a ventilatory anaerobic threshold (VAT) < 55% of predicted VO2 max , will be eligible. Patients will be randomised into 2 groups (12-week cardiac rehabilitation program vs. controls). The primary outcome is the change in the PedsQL quality of life score between baseline and 12-month follow-up. A total of 130 patients are required to observe a significant increase of 7 ± 13.5 points in the PedsQL, with a power of 80% and an alpha risk of 5%. The secondary outcomes are: VO2 max , VAT, stroke volume, clinical outcomes, physical and psychological status, safety and acceptability., Conclusion: After focusing on the survival in CHD, current research is opening on secondary prevention and patient-related outcomes. The QUALI-REHAB trial intends to assess if a combined centre and home-based rehabilitation program, could improve the quality of life and the exercise capacity in youth with CHD., Trial Registration: Clinicaltrials.gov (NCT03690518)., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Study Objective: To compare the number of days required to return to daily activities after laparoscopic hysterectomy with 2 tissue extraction methods: manual morcellation via colpotomy or minilaparotomy. Secondary outcomes were additional measures of patient recovery, perioperative outcomes, containment bag integrity, and tissue spillage., Design: Multicenter prospective cohort study and follow-up survey (Canadian Task Force classification II-2)., Setting: Two tertiary care academic centers in northeastern United States., Patients: Seventy women undergoing laparoscopic hysterectomy with anticipated need for manual morcellation., Interventions: Tissue extraction by either contained minilaparotomy or contained vaginal extraction method, along with patient-completed recovery diary., Measurements and Main Results: Recovery diaries were returned by 85.3% of participants. There were no significant differences found in terms of average pain at 1, 2, or 3 weeks after surgery or in time to return to normal activities. Patients in both groups used narcotic pain medication for an average of 3 days. After adjusting for patient body mass index, history of prior surgery, uterine weight, and surgeon, there were no differences found for blood loss, operative time, length of stay, or incidence of any intra- or postoperative complication between groups. All patients had benign findings on final pathology. More cases in the vaginal contained extraction group were noted to have bag leakage on postprocedure testing (13 [40.6%] vs 3 [8.3%] tears in vaginal and minilaparotomy groups, respectively; p = .003)., Conclusion: Regarding route of tissue extraction, contained minilaparotomy and contained vaginal extraction methods are associated with similar patient outcomes and recovery characteristics., (Copyright © 2018 AAGL. Published by Elsevier Inc. All rights reserved.)

Sterilization is the most common form of contraception used worldwide and is highly effective in preventing unintended pregnancy. Each of the available sterilization methods has unique advantages and disadvantages that influence the choice of approach for each individual patient. Salpingectomy for sterilization has become more popular in recent years, with mounting evidence suggesting a protective effect against ovarian cancers originating in the fallopian tube. At the same time, Essure hysteroscopic sterilization has come under scrutiny because of increasing reports of possible adverse effects associated with its use. Here we review clinical updates in sterilization techniques, with a focus on salpingectomy and Essure hysteroscopic sterilization., (Copyright © 2017 American Association of Gynecologic Laparoscopists. All rights reserved.)

Objective: The Patient-Centered Outcomes Research Institute (PCORI) uses a unique approach to Merit Review that includes patients and stakeholders as reviewers with scientists, and includes unique review criteria (patient-centeredness and active engagement of end users in the research). This study assessed the extent to which different reviewer types influence review scores and funding outcomes, the emphasis placed on technical merit compared to other criteria by a multistakeholder panel, and the impact of the in-person discussion on agreement among different reviewer types., Methods: Cross-sectional analysis of administrative data from PCORI online and in-person Merit Review (N = 1312 applications from the five funding cycles from November 2013 to August 2015). Linear and logistic regression models were used to analyze the data., Results: For all reviewer types, final review scores were associated with at least one review criterion score from each of the three reviewer types. The strongest predictor of final overall scores for all reviewer types was scientists' prediscussion ratings of technical merit. All reviewers' prediscussion ratings of the potential to improve health care and outcomes, and scientists' ratings of technical merit and patient-centeredness, were associated with funding success. For each reviewer type, overall impact scores from the online scoring were changed on at least half of the applications at the in-person panel discussion. Score agreement across reviewer types was greater after panel discussion., Conclusions: Scientist, patient, and stakeholder views all contribute to PCORI Merit Review of applications for research funding. Technical merit is critical to funding success but patient and stakeholder ratings of other criteria also influence application disposition., (Copyright © 2018 ISPOR --The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objective: To determine whether visuospatial perception (VSP) testing is correlated to simulated or intraoperative surgical performance as rated by the American College of Graduate Medical Education (ACGME) milestones., Design: (Canadian Task Force classification II-2)., Setting: Two academic training institutions., Participants: Forty-one residents, including 19 from Brigham and Women's Hospital and 22 from the Mayo Clinic, from 3 different specialties: obstetrics and gynecology, general surgery, and urology., Intervention: Participants underwent 3 different tests: visuospatial perception testing (VSP), Fundamentals of Laparoscopic Surgery (FLS) peg transfer, and da Vinci robotic simulation peg transfer. Surgical grading from the ACGME milestones tool was obtained for each participant. Demographic and background information was also collected, including specialty, year of training, previous experience with simulated skills, and surgical interest. Standard statistical analyses were performed using Student's t test, and correlations were determined using adjusted linear regression models., Measurements and Main Results: In univariate analysis, Brigham and Women's Hospital and Mayo Clinic training programs differed in times and overall scores for both the FLS peg transfer and da Vinci robotic simulation peg transfer tests (p < .05 for all). In addition, type of residency training affected time and overall score on the robotic peg transfer test. Familiarity with tasks correlated with higher score and faster task completion (p = .05 for all except VSP score). There were no differences in VSP scores by program, specialty, or year of training. In adjusted linear regression modeling, VSP testing was correlated only to robotic peg transfer skills (average time, p = .006; overall score, p = .001). Milestones did not correlate to either VSP or surgical simulation testing., Conclusion: VSP score was correlated with robotic simulation skills, but not with FLS skills or ACGME milestones. This suggests that the ability of VSP score to predict competence differs between tasks. Therefore, further investigation of aptitude testing is needed, especially before its integration as an entry examination into a surgical subspecialty., (Copyright © 2018 American Association of Gynecologic Laparoscopists. Published by Elsevier Inc. All rights reserved.)

Study Objective: To compare outcomes following umbilical minilaparotomy and suprapubic minilaparotomy for tissue extraction., Design Classification: Retrospective cohort study (Canadian Task Force classification II-2)., Setting: Two large academic medical centers., Patients: Women who underwent a minilaparotomy for tissue extraction following a laparoscopic hysterectomy or myomectomy between 2014 and 2016., Interventions: Umbilical or suprapubic minilaparotomy for tissue extraction., Measurements and Main Results: A total of 374 women underwent laparoscopic hysterectomy or myomectomy with minilaparotomy, including 289 (77.3%) with an umbilical minilaparotomy and 85 (22.7%) with a suprapubic minilaparotomy. The 2 groups were similar in terms of age, body mass index, parity, surgical history, procedure type, surgical approach, and surgical indication. The size of the minilaparotomy incision and the specimen weight were significantly smaller in the umbilical minilaparotomy group (mean, 3.3 ± 0.8 cm vs 4.2 ± 0.6 cm [p < .001] and 472.6 ± 357.1 g vs 683.0 ± 475.7 g [p < .001], respectively). Two women in the suprapubic minilaparotomy group sustained a bladder injury during creation of the incision. There were no other complications related to the minilaparotomy in either group. Postoperative outcomes related to the minilaparotomy incision were compiled using the medical record and a follow-up survey. Of the 374 women in this cohort, 163 responded to a detailed survey about their minilaparotomy incision (response rate, 43.5%). With regard to the minilaparotomy, 52.7% of women reported incisional symptoms; 25.9% had increased pain at the incision, 8.3% had an incisional infection, and 2.7% reported an incisional hernia. There was no significant between-group difference in incisional outcomes; however nearly 3 times as many women in the umbilical minilaparotomy group reported concerns about incisional hernia (3.1% vs 1.2%; p = .833). These findings were maintained in a multivariable logistic regression analysis. No patient or procedure characteristics were significantly associated with the development of hernia., Conclusion: There were no significant difference in incisional symptoms, pain, or infection following umbilical minilaparotomy vs a suprapubic minilaparotomy for tissue extraction. Although not statistically significant, the rate of incisional hernia was higher at the umbilical site compared with the suprapubic site., (Copyright © 2018 American Association of Gynecologic Laparoscopists. Published by Elsevier Inc. All rights reserved.)

Eukaryotic cells are organized into membrane-bound organelles. These organelles communicate with one another through vesicular trafficking pathways and membrane contact sites (MCSs). MCSs are sites of close apposition between two or more organelles that play diverse roles in the exchange of metabolites, lipids and proteins. Organelle interactions at MCSs also are important for organelle division and biogenesis. For example, the division of several organelles, including mitochondria and endosomes, seem to be regulated by contacts with the endoplasmic reticulum (ER). Moreover, the biogenesis of autophagosomes and peroxisomes involves contributions from the ER and multiple other cellular compartments. Thus, organelle-organelle interactions allow cells to alter the shape and activities of their membrane-bound compartments, allowing them to cope with different developmental and environmental conditions., (Copyright © 2018. Published by Elsevier Ltd.)

Background: Persistently high rates of cesarean deliveries are cause for concern for physicians, patients, and health systems. Prelabor assessment might be refined by identifying factors that help predict an individual patient's risk of cesarean delivery. Such factors may contribute to patient safety and satisfaction as well as health system planning and resource allocation. In an earlier study, neonatal head circumference was shown to be more strongly associated with delivery mode and other outcome measures than neonatal birthweight., Objective: In the present study we aimed to evaluate the association of sonographically measured fetal head circumference measured within 1 week of delivery with delivery mode., Study Design: This was a multicenter electronic medical record-based study of birth outcomes of primiparous women with term (37-42 weeks) singleton fetuses presenting for ultrasound with fetal biometry within 1 week of delivery. Fetal head circumference and estimated fetal weight were correlated with maternal background, obstetric, and neonatal outcome parameters. Elective cesarean deliveries were excluded. Multinomial regression analysis provided adjusted odds ratios for instrumental delivery and unplanned cesarean delivery when the fetal head circumference was ≥35 cm or estimated fetal weight ≥3900 g, while controlling for possible confounders., Results: In all, 11,500 cases were collected; 906 elective cesarean deliveries were excluded. A fetal head circumference ≥35 cm increased the risk for unplanned cesarean delivery: 174 fetuses with fetal head circumference ≥35 cm (32%) were delivered by cesarean, vs 1712 (17%) when fetal head circumference <35 cm (odds ratio, 2.49; 95% confidence interval, 2.04-3.03). A fetal head circumference ≥35 cm increased the risk of instrumental delivery (odds ratio, 1.48; 95% confidence interval, 1.16-1.88), while estimated fetal weight ≥3900 g tended to reduce it (nonsignificant). Multinomial regression analysis showed that fetal head circumference ≥35 cm increased the risk of unplanned cesarean delivery by an adjusted odds ratio of 1.75 (95% confidence interval, 1.4-2.18) controlling for gestational age, fetal gender, and epidural anesthesia. The rate of prolonged second stage of labor was significantly increased when either the fetal head circumference was ≥35 cm or the estimated fetal weight ≥3900 g, from 22.7% in the total cohort to 31.0%. A fetal head circumference ≥35 cm was associated with a higher rate of 5-minute Apgar score ≤7: 9 (1.7%) vs 63 (0.6%) of infants with fetal head circumference <35 cm (P = .01). The rate among fetuses with an estimated fetal weight ≥3900 g was not significantly increased. The rate of admission to the neonatal intensive care unit did not differ among the groups., Conclusion: Sonographic fetal head circumference ≥35 cm, measured within 1 week of delivery, is an independent risk factor for unplanned cesarean delivery but not instrumental delivery. Both fetal head circumference ≥35 cm and estimated fetal weight ≥3900 g significantly increased the risk of a prolonged second stage of labor. Fetal head circumference measurement in the last days before delivery may be an important adjunct to estimated fetal weight in labor management., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Morcellation allows minimally invasive approaches to surgery even in the presence of large uteri or myomas. Recent restrictions in the use of power morcellation, as well as concerns regarding the potential for morcellation to disseminate malignant tissue, have initiated investigation and innovation to find safer methods. This review examines current techniques for tissue extraction during uterine surgery, with a focus on contained power morcellation and contained manual morcellation via mini-laparotomy or colpotomy. Videos are included to demonstrate these methods., (Copyright © 2017 American Association of Gynecologic Laparoscopists. Published by Elsevier Inc. All rights reserved.)

The combination of a thorough physical examination and imaging with either magnetic resonance imaging (MRI) or pelvic ultrasound are important in the preoperative planning for deep infiltrating endometriosis (DIE). A 2-dimensional (2D) rendering of the pathology by imaging does not always accurately represent intraoperative findings. The detailed topographical relationship and extent of surrounding tissue invasion can be better appreciated by 3-dimensional (3D) modeling. A 49-year-old patient with history of endometriosis and persistent pain underwent preoperative MRI that showed features consistent with DIE endometriosis. Surgery was performed, and the findings were documented. A 3D printed model of the DIE was generated from the MRI and retrospectively compared with intraoperative findings. The 3D model demonstrated both the laterality and spatial relationship of the endometriotic nodule to the posterior uterine wall and rectum. Three-dimensional printing of DIE may be a beneficial adjunct to 2D imaging and can identify further structural relationships to support surgical planning., (Copyright © 2017 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To evaluate perioperative outcomes and symptom resolution in women undergoing removal of the Essure device for device-attributed symptoms., Design: Retrospective case series and follow-up patient survey (Canadian Task Force classification III)., Setting: Large academic medical center., Patients: Fifty-two women who underwent laparoscopic or hysteroscopic Essure removal between 2012 and 2016., Interventions: Women underwent one of four procedures: laparoscopic hysterectomy (LH) and bilateral salpingectomy (BS), laparoscopic BS and cornuectomy, laparoscopic Essure removal and BS, or hysteroscopic Essure removal and laparoscopic BS., Measurements and Main Results: Fifty-two women who underwent Essure removal were asked to complete a survey regarding symptom resolution and quality of life following the procedure. Thirty-two women (61.5%) responded to the survey. Seventy-five percent (24/32) reported almost total or total improvement in quality of life, 56.3% (18/32) for sex life, 53.1% (17/32) for pelvic pain, and 65.6% (21/32) for daily activities. The majority of women reported some degree of improvement in all four domains queried (87.5%, 28/32). When asked about their symptoms in general, 31.3% (10/32) of women reported ongoing or worse symptoms after Essure removal. All procedures took approximately one hour (mean 65 min, SD 33 min), were associated with minimal blood loss (mean 31 mL, SD 17), and had no perioperative complications., Conclusion: Essure removal is a procedure that may be effective for treating most women with symptoms attributed to the device. Patients should be counseled that some symptoms may persist or even worsen following surgery., (Copyright © 2017 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To compare perioperative outcomes associated with the use of 3 techniques for tissue removal at the time of laparoscopic hysterectomy and myomectomy., Design: A retrospective cohort study (Canadian Task Force classification II-2)., Setting: An academic hospital in Boston, MA., Patients: Women who underwent a laparoscopic or robot-assisted laparoscopic hysterectomy or myomectomy involving tissue morcellation in 2014., Interventions: One of 3 morcellation techniques: electronic power morcellation (PM), manual vaginal morcellation via the vagina (VM), or manual morcellation via minilaparotomy (ML)., Measurements and Main Results: Of the 297 cases included in this study (137 myomectomies, 62 total laparoscopic hysterectomies, and 98 laparoscopic supracervical hysterectomies), 96% of the cases were performed by fellowship-trained surgeons using conventional laparoscopy. Containment bags were used at the time of tissue extraction in 77% of the cases. Baseline characteristics and perioperative outcomes were similar in all groups. In hysterectomy cases, the average specimen size was largest in the ML group (591 ± 419 g in the ML group compared with 368 ± 293 g in the PM group and 449 ± 175 g in the VM group, p = .0009). After multivariate regression, no significant difference was found in blood loss, length of stay, or complications. The operative time was shorter in the PM group compared with the ML group by 16 minutes (mean = 140 minutes [95% confidence interval, 130-149 minutes] compared with 156 [95% confidence interval, 146-167], p = .02); this association remained significant once additionally adjusting for the use or nonuse of containment bags (p = .05)., Conclusion: We did not detect a significant difference between the 3 morcellation techniques when comparing the perioperative complications although the longest operative times were noted for the minilaparotomy approach. All 3 morcellation techniques represent viable options for tissue extraction at the time of minimally invasive surgery., (Copyright © 2017 AAGL. Published by Elsevier Inc. All rights reserved.)

Study Objective: To determine if racial differences exist in receipt of minimally invasive hysterectomy (defined as total vaginal hysterectomy [TVH] and total laparoscopic hysterectomy [TLH]) compared with an open approach (total abdominal hysterectomy [TAH]) within a universally insured patient population., Design: Retrospective data analysis (Canadian Task Force classification II-2)., Setting: The 2006-2010 national TRICARE (universal insurance coverage to US Armed Services members and their dependents) longitudinal claims data., Patients: Women aged 18 years and above who underwent hysterectomy stratified into 4 racial groups: white, African American, Asian, and "other.", Intervention: Receipt of hysterectomy (TAH, TVH, or TLH)., Measurements and Main Results: We used risk-adjusted multinomial logistic regression models to determine the relative risk ratios of receipt of TVH and TLH compared with TAH in each racial group compared with referent category of white patients for benign conditions. Among 33 015 patients identified, 60.82% (n = 20 079) were white, 26.11% (n = 8621) African American, 4.63% (n = 1529) Asian, and 8.44% (n = 2786) other. Most hysterectomies (83.9%) were for benign indications. Nearly 42% of hysterectomies (n = 13 917) were TAH, 27% (n = 8937) were TVH, and 30% (n = 10 161) were TLH. Overall, 36.37% of white patients received TAH compared with 53.40% of African American patients and 51.01% of Asian patients (p < .001). On multinomial logistic regression analyses, African American patients were significantly less likely than white patients to receive TVH (relative risk ratio [RRR], .63; 95% confidence interval [CI], .58-.69) or TLH (RRR, .65; 95% CI, .60-.71) compared with TAH. Similarly, Asian patients were less likely than white patients to receive TVH (RRR, .71; 95% CI, .60-.84) or TLH (RRR, .69; 95% CI, .58-.83) compared with TAH. Analyses by benign indications for surgery showed similar trends., Conclusion: We demonstrate that racial minority patients are less likely to receive a minimally invasive surgical approach compared with an open abdominal approach despite universal insurance coverage. Further work is warranted to better understand factors other than insurance access that may contribute to racial differences in surgical approach to hysterectomies., (Copyright © 2017 AAGL. All rights reserved.)

For decades, it has been speculated that specific loci on eukaryotic chromosomes are inherently susceptible to breakage. The advent of high-throughput genomic technologies has now paved the way to their identification. A wealth of data suggests that transcriptionally active loci are particularly fragile and that a specific DNA damage response is activated and dedicated to their repair. Here, we review current understanding of the crosstalk between transcription and double-strand break repair, from the reasons underlying the intrinsic fragility of genes to the mechanisms that restore the integrity of damaged transcription units., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Cystoscopy can be used to diagnose urologic injuries at the time of gynecologic surgery. Current cystoscopy setup involves removing the indwelling catheter placed for the procedure and assembling a multicomponent cystoscope. The objective of this study was to evaluate and report on our initial experience with CystoSure (Emmy Medical, Holliston, MA), a new Food and Drug Administration-approved device designed to facilitate perioperative diagnostic cystoscopy. The CystoSure catheter is an 18F quad-port silicone transurethral catheter with a central sealed port for the cystoscope and a side port that allows for bladder filling. A retrospective chart review was performed of women who underwent benign laparoscopic or robotic gynecologic surgery with cystoscopy at Brigham and Women's Faulkner Hospital, Boston, MA, from May 1, 2015, to August 31, 2015. Thirty women underwent cystoscopy during the study period. The CystoSure catheter is placed at the beginning of the procedure. Total laparoscopic hysterectomy was the most common procedure, representing 90% of cases (27/30). Using the CystoSure system, full bladder survey and bilateral ureteral jets were easily evaluated in 87% (26/30) of the patients. Of the 26 cystoscopies performed successfully, 1 intravesical suture was diagnosed and addressed. In the remaining 4 patients, the 18F CystoSure catheter was too large for the urethral orifice, and a 16F catheter was used for the case. The CystoSure device allows for minimal setup and efficient performance of diagnostic cystoscopy postgynecologic surgery., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Objectives: To report the surgical outcomes of laparoscopic myomectomy (LM) and abdominal myomectomy (AM) at a high-volume tertiary care hospital, to evaluate the risk of conversion during LM, and to analyze the associated risk factors., Design: Retrospective cohort study (Canadian Task Force classification II)., Patients: All patients who underwent LM and AM in a tertiary academic center in Boston, Massachusetts between 2009 and 2012., Intervention: Medical records were reviewed for baseline characteristics and perioperative outcomes. Robot-assisted laparoscopy was considered a subtype of LM., Results: A total of 966 patients underwent myomectomy during the study period, including 731 LM cases (75.67%) and 235 AM cases (24.33%). Compared with patients undergoing LM, those undergoing AM had more myomas removed and heavier specimens (mean number of myomas, 12.60 vs 3.54, p ≤ .001; mean weight, 592.75 g vs 263.4 g, p ≤ .001). Conversion was necessary in 8 LM cases (1.09%). All conversions were reactive in nature and were associated with greater blood loss (mean, 1381.25 vs 167.95 mL; p ≤ .001) and longer hospital stay (mean, 3.13 vs 0.55 days; p ≤ .001) compared with cases without conversion. Factors associated with conversion included both the number and the weight of myomas removed (mean number, 9.75 vs 3.48, p = .003; mean weight, 667.9 vs 259.25 g, p = .015), especially with myomas weighing >500 g (odds ratio = 8.551; p = .005)., Conclusion: The risk of conversion for LM was low (1.09%) in this cohort, and was associated both with the number and the weight of myomas removed. LM is a feasible approach for surgical management of myomas in the majority of cases; however, when myomas are expected to weigh >500 g, it may be prudent to consider referring those cases to specialized centers with highly experienced teams., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: Safe tissue removal is a challenge for minimally invasive procedures such as myomectomy, supracervical hysterectomy, or total hysterectomy of a large uterine specimen. There is concern regarding disruption or dissemination of tissue during this process, which may be of particular significance in cases of undetected malignancy. Contained tissue extraction techniques have been developed in an effort to mitigate morcellation-related risks., Objective: The objective of the study was to quantify perioperative outcomes of contained tissue extraction using power morcellation, specifically evaluating parameters of tissue or fluid leakage from within the containment system., Study Design: This was a study including a multicenter prospective cohort of adult women who underwent minimally invasive hysterectomy or myomectomy using a contained power morcellation technique. Blue dye was applied to the tissue specimen prior to removal to help identify cases of fluid or tissue leakage from within the containment system., Results: A total of 76 patients successfully underwent the contained power morcellation protocol. Mean time for the contained morcellation procedure was 30.2 minutes (±22.4). The mean hysterectomy specimen weight was 480.1 g (±359.1), and mean myomectomy specimen weight was 239.1 g (±229.7). The vast majority of patients (73.7%) were discharged home the same day of surgery. Final pathological diagnosis was benign in all cases. Spillage of dye or tissue was noted in 7 cases (9.2%), although containment bags were intact in each of these instances., Conclusion: Findings are consistent with prior work demonstrating the feasibility of contained tissue extraction; however, further refinement of this technique is warranted., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: Fetal size impacts on perinatal outcomes. We queried whether the fetal head, as the fetal part interfacing with the birth canal, might impact on obstetric outcomes more than birthweight (BW). We examined associations between neonatal head circumference (HC) and delivery mode and risk of perinatal complications as compared to high BW., Study Design: This was an electronic medical records-based study of term singleton births (37-42 weeks' gestation) from January 2010 through December 2012 (N = 24,780, 6343 primiparae). We assessed risks of unplanned cesarean or instrumental delivery and maternal and fetal complications in cases with HC or BW ≥95th centile (large HC, high BW) vs those with parameters <95th centile (normal). Newborns were stratified into 4 subgroups: normal HC/normal BW (reference, n = 22,548, primiparae 5862); normal HC/high BW (n = 817, P = 213); large HC/normal BW (n = 878, P = 265); and large HC/high BW (n = 537, P = 103). Multinomial multivariable regression provided adjusted odds ratio (aOR) while controlling for potential confounders., Results: Infants with HC ≥95th centile (n = 1415) were delivered vaginally in 62% of cases, unplanned cesarean delivery 16%, and instrumental delivery 11.2%; 78.4% of infants with HC <95th centile were delivered vaginally, 7.8% unplanned cesarean, and 6.7% instrumental delivery. Odds ratio (OR) for unplanned cesarean was 2.58 (95% confidence interval [CI], 2.22-3.01) and for instrumental delivery OR was 2.13 (95% CI, 1.78-2.54). In contrast, in those with BW ≥95th centile (n = 1354) 80.3% delivered vaginally, 10.2% by unplanned cesarean (OR, 1.2; 95% CI, 1.01-1.44), and 3.4% instrumental delivery (OR, 0.46; 95% CI, 0.34-0.62) compared to infants with BW <95th centile: spontaneous vaginal delivery, 77.3%, unplanned cesarean 8.2%, instrumental 7.1%. Multinomial regression with normal HC/normal BW as reference group showed large HC/normal BW infants were more likely to be delivered by unplanned cesarean (aOR, 3.08; 95% CI, 2.52-3.75) and instrumental delivery (aOR, 3.03; 95% CI, 2.46-3.75). Associations were strengthened in primiparae. Normal HC/high BW was not associated with unplanned cesarean (aOR, 1.18; 95% CI, 0.91-1.54), while large HC/high BW was (aOR, 1.93; 95% CI, 1.47-2.52). Analysis of unplanned cesarean indications showed large HC infants had more failure to progress (27.7% vs 14.1%, P < .001), while smaller HC infants had more fetal distress (23.4% vs 16.9%, P < .05)., Conclusion: A large HC is more strongly associated with unplanned cesarean and instrumental delivery than high BW. Prospective studies are needed to test fetal HC as a predictive parameter for prelabor counseling of women with "big babies.", (Copyright © 2015 Elsevier Inc. All rights reserved.)