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Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).

To evaluate the accuracy of third trimester ultrasound in predicting birthweight in patients with inflammatory bowel disease (IBD) using the gestation-adjusted projection (GAP) method.Retrospective cohort study including pregnant patients with IBD who had third trimester ultrasounds and delivered at a single institution from 2012 to 2017. Controls included pregnant patients without IBD seen during the study period with third trimester ultrasounds. Correlation plots of GAP birthweight and actual birthweight (AB) were created for IBD-positive cases, IBD-negative controls, and IBD-positive cases with and without prior abdominal surgery. GAP predicted birthweight error was calculated for cases and controls. Univariable linear regression models estimated the association between predicted birthweight and AB. Multivariable linear regression models estimated the association between GAP birthweight and AB adjusting for age, BMI, race, and IBD status.320 patients were included (172 cases and 148 controls). Cases were more likely to be older (p 0.001), white (p 0.001), and have a lower BMI (p = 0.001). Correlation plots of GAP birthweight and AB showed linear correlations in cases (Spearman ρ = 0.81), controls (ρ = 0.74), cases with (p = 0.78) and without prior surgery (ρ = 0.83). GAP birthweight was significantly associated with AB in controls and cases in univariable linear regression models (β = 0.85, standard error = 0.04, p 0.001; β = 0.90, standard error = 0.06, p 0.001, respectively). No significant difference was found between the parameter estimates of the two models (p = 0.47). GAP birthweight remained significantly associated with AB in a multivariable linear regression model (β = 0.86, standard error = 0.03, p 0.001). There were no significant differences between GAP predicted birthweight error between controls and cases (APE 11% vs 10% respectively, p = 0.56) and between cases without and with prior surgery (APE 10% vs 11%, p = 0.7).The accuracy of fetal biometry in the third trimester for predicting actual birthweight was equivalent between patients with and without IBD and those with prior abdominal surgery.

Purpose: Patients with erythropoietic protoporphyria (EPP), a severe painful photodermatosis, experience prodromal sensations when exposed to sunlight, which are the “warning signals” to exit the sun, as prolonged exposure causes an excruciatingly painful phototoxic attack. The unique prodromal cutaneous sensations are reversible and differ from the severe burning pain attack lasting 2–7 days. Previously, afamelanotide treatment was studied using time to pain or time outside as primary outcome measures. Since patients have an ingrained fear of sunlight, these measures did not capture the full treatment effect. We retrospectively characterized and evaluated time to prodrome (TTP) as a safer, patient-reported outcome (PRO) measure in afamelanotide-treated patients. Methods: Structured interviews recorded TTP before and during afamelanotide treatment in retrospective US and Dutch cohort studies. Results: Thirty-one US and 58 Dutch EPP patients participated. Before afamelanotide treatment, 54.8% US and 39.7% Dutch patients reported TTP onset

Poor attendance at the 6-week postpartum (PP) visit has been well reported. Attendance at this visit is crucial to identify women who have persistent diabetes mellitus (DM) following pregnancies affected by gestational DM (GDM). The medical home model has eliminated barriers to care in various other settings. This study sought to improve PP attendance among women with GDM by jointly scheduling PP visits and the 2-month well infant visits. All patients with a diagnosis of GDM who received care at a New York City-based publicly insured hospital clinic and delivered between October 2017 and June 2019 were eligible. Data were obtained via chart review. The primary outcome was attendance at the PP visit compared with previously published historical controls. Secondary outcomes were rates of PP glucose screening and well infant attendance. Of the 74 patients enrolled, 41.9% were Hispanic and 17.6% were Black, mean age was 31.6 years, and 58.1% delivered vaginally. Attendance at the 6-week PP visit was 68.9%, and attendance at the infant visit was 55.1%. PP glucose testing was ordered for 76.5% of attendees at the PP visit, and of those ordered, 43.6% of attendees completed testing. All patients had joint visits requested, though only 70.3% of visits were scheduled jointly. Among those who were jointly scheduled, 71.2% of women attended, 57.7% of infants attended, and 7.7% of pairs attended on the same day. The PP visit attendance rate was not significantly different than the prior attendance rate ( This study was unable to improve PP visit attendance among women with GDM by jointly scheduling the 6-week PP visit and the 2-month well-infant visit. Future research could be directed toward a shared space where both women and children can be seen to attempt to increase PP visit attendance and monitoring for women with GDM.· Attendance at the PP visit is poor, and without a visit, women with pregnancies affected by gestational diabetes remain unscreened for PP dysglycemia.. · Jointly scheduling women and their infants to eliminate barriers to care studied by this group, however, were unable to improve attendance.. · Innovative strategies are needed to improve PP attendance among women with pregnancies affected by GDM..

To determine if the use of magnetic resonance imaging (MRI) changes the diagnosis of placenta accreta spectrum (PAS) made on prenatal ultrasound (US) leading to an improvement in clinical outcomes.This was a retrospective chart review of all patients with evidence of PAS on US from 2012 to 2018 in one tertiary care medical center with subsequent use of MRI of the uterus to confirm diagnosis. The type of PAS classified by imaging was compared between US and MRI, with a final diagnosis made using histology. Outcomes that were analyzed included the following: 1) MRI correctly changed diagnosis, 2) MRI incorrectly downgraded diagnosis, 3) MRI incorrectly upgraded diagnosis, and 4) MRI did not change diagnosis. AForty-one patients received an MRI to validate the diagnosis of PAS after ultrasound and are included in the analysis. MRI changed the diagnosis in 36.6% (15/41) patients, correctly changing the diagnosis in 22% (9/41) and incorrectly upgrading the diagnosis in 14.6% (6/41). Patients whose diagnosis was upgraded by MRI (either correctly or incorrectly) were more likely to deliver earlier compared to those who were either downgraded or had no change in their diagnosis [33. 2 ± 3. 5 weeks vs 35. 2 ± 2. 9 weeks,The use of MRI incorrectly changed the diagnosis as much as it correctly changed the diagnosis of PAS after US. MRI should not be used routinely as a clinical adjunct to ultrasound in the diagnosis of placenta accreta spectrum.

Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).

BACKGROUND AND AIMS The risk for hepatocellular carcinoma (HCC) is increased in acute hepatic porphyrias (AHP). The aim of this study was to explore the clinicopathologic characteristics, outcomes, and frequency of HCC in patients with AHP in the United States. APPROACH AND RESULTS This cross-sectional analysis evaluated patients with HCC in a multicenter, longitudinal study of AHP. Among 327 patients with AHP, 5 (1.5%) were diagnosed with HCC. Of the 5 HCC cases, 4 had acute intermittent porphyria and 1 had variegate porphyria, confirmed by biochemical and/or genetic testing. All patients were white females, with a median age of 27 years (range 21-75) at diagnosis. The median age at HCC diagnosis was 69 years (range 61-74). AHP was asymptomatic in 2 patients; 2 reported sporadic attacks; and 1 reported recurrent attacks (>4 attacks/year). All patients had a single HCC lesion on liver imaging that was 1.8-6.5 centimeters in diameter. Serum alpha fetoprotein levels were below 10 ng/mL in all 4 patients with available results. Four patients underwent liver resection, and 1 was treated with radioembolization. No significant inflammation or fibrosis was found in adjacent liver tissues of 3 patients who underwent liver resection. Two patients developed recurrence of HCC at 22 and 26 months following liver resection. All patients are alive with survival times from HCC diagnosis ranging from 26-153 months. CONCLUSION In this U.S. study, 1.5% of patients with AHP had HCC. HCC in AHP occurred in the absence of cirrhosis, which contrasts with other chronic liver diseases. Patients with AHP, regardless of clinical attacks, should be screened for HCC, beginning at age 50. The pathogenesis of hepatocarcinogenesis in AHP is unknown and needs further investigation.

The placental cord insertion (PCI) to the placental margin has not been well studied as a continuous variable in relation to birth outcomes. We sought to evaluate the impact of PCI distance on outcomes associated with placental function and development of fetal growth restriction (FGR).This was a retrospective study of singleton gestations that underwent a fetal anatomy ultrasound from 2011-2013. The PCI was recorded as the distance in centimeters from the placental margin. Patients had FGR if the overall estimated fetal weight was10 % for gestational age or abdominal circumference5 % in the third trimester. Delivery, obstetric, and neonatal outcomes were obtained via medical chart review. Logistic and linear regression models were used to assess the impact of PCI distance on maternal and neonatal delivery outcomes.Of the 1443 women who met inclusion criteria, 93.6 % delivered at term. The mean (±SD) PCI distance was 4.4 ± 1.4 cm. There was no association between PCI and cesarean delivery, peripartum hemorrhage (PPH), pre-eclampsia, 5-min Apgar, or intrauterine fetal demise. PCI distance was statistically significantly shorter in patients requiring neonatal intensive care unit (NICU) admission (4.1 ± 1.5 cm vs. 4.4 ± 1.4 cm, p = 0.02) and was associated with lower birthweight (p = 0.01), though this association was no longer seen when corrected for gestational age. There were 3.5 % of patients who developed FGR; PCI distances from the placental edge were not significantly different for patients who developed FGR compared to those who did not (4.2 ± 1.4 cm vs. 4.5 ± 1.4 cm, p = 0.18). Furthermore, a receiver operating characteristic (ROC) curve for PCI had poor sensitivity (area under the curve [AUC] 0.57, 95 % CI 0.49-0.65).PCI distance at the time of fetal anatomic survey is significantly associated with NICU admission, though does not appear to impact rates of preterm birth, pre-eclampsia, PPH or cesarean delivery. PCI distance in singleton gestations does not appear to be predictive of FGR.

Sacral neuromodulator (SNM) explantation is associated with higher cost and significant morbidity. The objectives were to investigate the incidence, reasons, and predictors of SNM explantation at our institution and evaluate whether combined versus staged procedures are associated with increased SNM explantation rates. A retrospective chart review of subjects with SNM implantation between Jan 2012 and Dec 2017 was performed. Explantation-free survival was estimated using the Kaplan-Meier method, and associations of demographic and clinical characteristics with time to explantation were assessed using Cox regression. One hundred three subjects were included in the final analysis. Of which, 39 underwent staged procedures and 64 received combined procedures. General surgeons implanted most SNMs (102/103) primarily for fecal incontinence (90.3%). The median follow-up time was 9.5 months (IQR 4.3, 30.0). Twelve subjects (11.7%) underwent explantation with an incidence rate of 0.006 per person-month (95% CI 0.003, 0.011). The mean time to explantation was 25 months (SD ± 16.9 months). The most common reason for explantation was loss of efficacy (58.3%). In univariable analyses, only age (HR 0.97(95%CI 0.93–1.00); p = .04) was significantly associated with explantation. Subjects that underwent staged procedures were more likely to undergo explantation at any given time compared with subjects that underwent combined procedures, however, it was not statistically significant (HR 2.91(95%CI 0.87–9.71); p = .08). Over a 6-year period, the incidence of SNM explantation was 0.006 per person-month at our institution. The most common reason for SNM explantation was loss of efficacy. Older subjects were more likely to get explantation. Compared to subjects who had a staged procedure, those who had a combined procedure did not have a significantly different rate of explantation in our population. Further prospective studies are warranted.

Objectives The primary objective was to measure IUD-fundus and IUD-myometrium distances by ultrasound of IUDs placed during cesarean section over the first year of use. The secondary objective was to determine if these distances are associated with risk of expulsion or removal for side effects. Study design In this prospective observational study, we performed ultrasounds at six - ten weeks, three months and one year postpartum to measure the distance from the top of the device to the fundal serosa (IUD-fundus) and upper margin of the endometrial cavity (IUD-myometrium). We also assessed IUD expulsion or discontinuation for side effects at each visit. Results We enrolled 93 women who had copper (n = 77) or levonorgestrel (n = 16) IUDs placed at time of cesarean section. Two patients had complete expulsion, six had partial expulsion and nine requested removal for symptoms. Overall, median IUD-fundus measurements were 2.13 cm (IQR 1.87–2.55) at 6–10 weeks, 1.87 cm (IQR 1.53–2.23) at 3-months and 2.02 cm (IQR 1.67–2.40) at 1-year. Among copper IUD users, distances at six weeks and three months were similar in women who did or did not have expulsion or removal at one year however small numbers limit our ability to assess this relationship. Conclusion We describe the location on ultrasound of IUDs placed at the time of Cesarean section over the first year. We found similar IUD locations at six weeks and three months for participants who did or did not experience expulsion or removal by one year. Implications Position of intrauterine devices placed during cesarean section was similar for those who did or did not have expulsion or removal for symptoms in the first year after placement. These data may help in the design of future studies to determine if ultrasound measurement of IUDs predicts IUD complications.

Background Epiaortic ultrasound detects and localizes ascending aortic atherosclerosis. In this analysis we investigated the association between epiaortic ultrasound-based atheroma grade during surgical aortic valve replacement (SAVR) and perioperative adverse outcomes. Methods SAVR patients in a randomized trial of 2 embolic protection devices underwent a protocol-defined 5-view epiaortic ultrasound read at a core laboratory. Aortic atherosclerosis was quantified with the Katz atheroma grade, and patients were categorized as mild (grade I-II) or moderate/severe (grade III-V). Multivariable logistic regression was used to estimate associations between atheroma grade and adverse outcomes, including death, clinically apparent stroke, cerebral infarction on diffusion-weighted magnetic resonance imaging, delirium, and acute kidney injury (AKI) by 7 and 30 days. Results Precannulation epiaortic ultrasound data were available for 326 of 383 randomized patients (85.1%). Of these, 106 (32.5%) had moderate/severe Katz atheroma grade at any segment of the ascending aorta. Although differences in the composite of death, stroke, or cerebral infarction on diffusion-weighted magnetic resonance imaging by 7 days were not statistically significant, moderate/severe atheroma grade was associated with a greater risk of AKI by 7 days (adjusted odds ratio, 2.63; 95% confidence interval, 1.24-5.58; P = .01). At 30 days, patients with moderate/severe atheroma grade had a greater risk of death, stroke, or AKI (adjusted odds ratio, 1.97; 95% confidence interval, 1.04-3.71; P = .04). Conclusions Moderate/severe aortic atherosclerosis was associated with an increased risk of adverse events after SAVR. Epiaortic ultrasound may serve as a useful adjunct for identifying patients who may benefit from strategies to reduce atheroembolic complications during SAVR.

Since liver tests are not routinely checked in pregnancy, the prevalence of abnormal liver tests and liver-related abnormalities in pregnancy in a US-based population is not known. We sought to determine the prevalence of abnormal alanine aminotransferase (ALT) among pregnant Individuals who present to labor and delivery for evaluation and to evaluate prevalence of underlying diagnosed liver conditions. Prospective study evaluating liver tests in consecutive samples obtained on the labor and delivery unit. Patient characteristics were compared between those with and without abnormal ALT and those with and without abnormal ALT without a liver-related diagnosis made in clinical practice, using t tests for continuous measures and χ2 or Fisher's exact tests as appropriate for categorical measures. Logistic regression was utilized to identify factors associated with abnormal ALT in this subcohort to determine predictors of abnormal ALT in those without a known liver-related diagnosis. We collected 1024 laboratory specimens from 996 patients. Of these patients, 131 of 996 (13.2%) had elevated ALT ≥25 IU/L; 20 (2%) had ALT ≥50, 6 (0.6%) had ALT ≥125 and 3 (0.3%) had ALT ≥250. 61/131 (46.6%) of patients with ALT ≥25 IU/L had not had LTs checked during routine pregnancy care. 20 (15%) of individuals with abnormal LT had preeclampsia; 5 (4%) had cholestasis of pregnancy; 1 (0.8%) had hepatitis C; there were no other chronic liver diseases diagnosed. There were no significant demographic or clinical differences between those with and without ALT ≥25, whether liver disease diagnosis was made or not. We identified an over 10% prevalence of abnormal LTs in consecutive pregnant individuals who presented to LD, most of whom did not have a liver-related condition diagnosed in clinical practice. Among those with liver-related diagnoses, PE and ICP were the most common among individuals with ALT≥25 IU/mL, with chronic liver disease rarely diagnosed. Further evaluation of the role of ALT testing as part of routine prenatal care is needed, particularly in establishing a baseline prevalence of liver test abnormalities in pregnancy and independent association with pregnancy outcomes.

Author(s): Naik, Hetanshi; Overbey, Jessica R; Desnick, Robert J; Anderson, Karl E; Bissell, D Montgomery; Bloomer, Joseph; Bonkovsky, Herbert L; Phillips, John D; Wang, Bruce; Singal, Ashwani; Balwani, Manisha | Abstract: BackgroundErythropoietic protoporphyria (EPP) and X-linked Protoporphyria (XLP) are rare photodermatoses presenting with severe phototoxicity. Although anecdotally, providers who treat EPP patients acknowledge their life-altering effects, tools that fully capture their impact on quality of life (QoL) are lacking.MethodsAdult patients with EPP/XLP were given four validated QoL tools: the Patient Reported Outcomes Measurement Information System 57 (PROMIS-57), the Hospital Anxiety and Depression Scale (HADS), the Illness Perception Questionnaire Revised (IPQR), and an EPP-Specific tool. All patients received the PROMIS-57 while the HADS, IPQR, and EPP-Specific tools were introduced at a later date. Associations between responses and clinical phenotypes were explored.ResultsTwo hundred and two patients were included; 193 completed PROMIS-57, 104 completed IPQR, 103 completed HADS, and 107 completed the EPP-Specific tool. The IPQR showed that patients strongly believed EPP/XLP had a negative impact on their lives. Mean scores in anxiety and depression domains of both HADS and PROMIS-57 were normal; however, anxiety scores from HADS were borderline/abnormal in 20% of patients. The EPP-Specific tool revealed a decreased QoL in most patients. The PROMIS-57 showed that 21.8% of patients have clinically significant pain interference. Several tool domains correlated with measures of disease severity, most being from the PROMIS-57.ConclusionsImpaired QoL is an important consequence of EPP/XLP. PROMIS-57 was most sensitive in evaluating impaired QoL in EPP/XLP. Further research is needed to compare the effectiveness of it for assessing response to treatment.

Objectives This study investigated sex-based differences in outcomes after mitral valve (MV) surgery for severe ischemic mitral regurgitation (SIMR). Background Whether differences in outcomes exist between men and women after surgery for SIMR remains unknown. Methods Patients enrolled in a randomized trial comparing MV replacement versus MV repair for SIMR were included and followed for 2 years. Endpoints for this analysis included all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI) from baseline through 2 years. Results Of 251 patients enrolled in the trial, 96 (38.2%) were women. Compared with men, women had smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios. At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02). Women also reported worse QOL and functional status at 2 years. There were no significant differences in the percentage of change over 2 years in LVESVI between women and men (adjβ: −10.4; 95% CI: −23.4 to 2.6; p = 0.12). Conclusions Women with SIMR displayed different echocardiographic features and experienced higher mortality and worse QOL after MV surgery than men. There were no significant differences in the degree of reverse LV remodeling between sexes. (Comparing the Effectiveness of Repairing Versus Replacing the Heart9s Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation]; NCT00807040)

Does the composite morphology score or a particular developmental component (expansion stage, inner cell mass [ICM] or trophectoderm [TE]) of euploid blastocysts undergoing single frozen embryo transfer (FET) impact ongoing pregnancy/live birth (OP/LB) rates?Retrospective cohort study including a total of 2236 embryos from 1629 patients who underwent single euploid FET between 2012 and 2017.Embryos with an ICM grade of A compared with C had a higher OP/LB rate (55.6% versus 32.3%, P 0.001). Blastocysts with a TE grade of A or B compared with C had a higher likelihood of OP/LB (A versus C: odds ratio [OR] 1.6, 99% confidence interval [CI] 1.1-2.3, B versus C: OR 1.5, 99% CI 1.1-2.1), and blastocysts with a developmental stage of 4 or 5 compared with 6 had higher odds of OP/LB (4 versus 6: OR 1.6, 99% CI 1.2-2.2, 5 versus 6: OR 1.6, 99% CI 1.2-2.3).Among euploid embryos, ICM morphology is the best predictor of sustained implantation; however, a composite score may provide additional guidance. While there is a known benefit in genomic screening prior to embryo selection, morphology provides individualized, prognostic information about implantation potential.

Rates of hepatitis C virus (HCV) among women of childbearing age have increased as a result of the opioid epidemic, especially in the nonurban white population. Recently updated US Preventative Services Task Force and Centers for Disease Control and Prevention guidance have recommended universal HCV screening during pregnancy, but obstetrics societies have not yet endorsed this recommendation. We evaluated the seroprevalence of HCV among pregnant women in an inner-city population, compared rates with other sexually transmitted infections (STIs) screened for during pregnancy, and evaluated factors associated with HCV positivity.We performed a prospective seroprevalence study of consecutive labor and delivery admissions (both antepartum complications and delivery admissions) by testing serum samples for HCV antibody over 9 months at 2 major hospital settings in New York City.Fifty-six of 7373 (0.75%; 95% confidence interval [CI], 0.57-0.98) patients screened positive for HCV, with 28 of 4013 (0.70%; 95% CI, 0.46%-1.01%) and 28 of 3413 (0.82%; 95% CI, 0.55%-1.18%) at each hospital. Forty-one percent of HCV-positive patients had any reported HCV risk factors. Hepatitis C virus-positive patients were less likely to have private insurance and more likely to have a history of cannabis, cocaine, and injection drug use (We found a higher than expected HCV seroprevalence among pregnant women and higher than most other STIs routinely screened for in pregnancy. Most patients had no risk factors. These findings support universal screening for hepatitis C during pregnancy.

Multifetal pregnancy reduction is a technique used to reduce the fetal number to mitigate the risks of adverse outcomes associated with multiple gestations. Monochorionic diamniotic twin pregnancies are subject to unique complications, contributing to adverse pregnancy outcomes. Thus, patients have an option to electively reduce 1 fetus to improve outcomes.This study aimed to compare outcomes of elective reduction of monochorionic diamniotic twins by radiofrequency ablation to planned ongoing monochorionic diamniotic twins.We performed a retrospective review of 315 monochorionic diamniotic twin gestations that underwent first-trimester ultrasound within 1 institution. Planned electively reduced twins were compared with ongoing monochorionic diamniotic twins. All reductions were performed via radiofrequency ablation of the cord insertion site into the fetal abdomen. The primary outcome was preterm birth at36 weeks' gestation. Secondary outcomes included gestational age at delivery; preterm birth at less than 37-, 34-, 32-, and 28-weeks' gestation; unintended loss; and adverse perinatal outcomes.Among 315 monochorionic diamniotic pregnancies, 14 (4.4%) underwent elective multifetal pregnancy reduction, and 301 (95.6%) were planned ongoing twins. The mean gestational age of radiofrequency ablation in the elective multifetal pregnancy reduction group was 15.1±0.68 weeks. Patients who underwent elective multifetal pregnancy reduction had significantly higher maternal age (P.01) and were more likely to be Asian (P.01). Moreover, they were more likely to have undergone in vitro fertilization (P=.03) and chorionic villus sampling (P.01). There was a significantly higher rate of term deliveries in the elective radiofrequency ablation group compared with ongoing twins (gestational age, 38 weeks [interquartile range, 36.1-39.1] vs 35.9 weeks [interquartile range, 34.0-36.9]; P.01). Patients with ongoing pregnancies had a trend of increased rate of preterm birth at36 weeks' gestation (odds ratio, 3.4; 95% confidence interval, 1.0-12.0; P=.06), a significantly increased risk of preterm birth at37 weeks' gestation (odds ratio, 8.0; 95% confidence interval, 2.4-26.4; P.01), and no difference at less than 34-, 32-, or 28- weeks' gestation. All patients who underwent elective radiofrequency ablation had successful pregnancies with no pregnancy losses or terminations. Of ongoing gestations, 36 required procedures, including 16 (5.3%) medically indicated radiofrequency ablation, 14 (4.6%) laser ablation, and 6 (1.9%) amnioreductions. Furthermore, 22 patients (7.3%) with planned ongoing twins had total pregnancy loss at24 weeks' gestation. Notably, 12 patients (4.0%) had unintended loss of 1 fetus before 24 weeks' gestation in the ongoing pregnancy cohort, and 12 patients (4.0%) had unintended loss of both fetuses before 24 weeks' gestation. Moreover, 5 patients (1.7%) in the ongoing pregnancy group had intrauterine fetal demise at24 weeks' gestation and 10 patients (3.3%) electively terminated both fetuses. There was no significant difference in loss rates between the 2 groups.In this study of monochorionic diamniotic twins, patients who elected to undergo multifetal pregnancy reduction had significantly lower rates of preterm birth at37 weeks and a lower trend of preterm birth at36 weeks' gestation without an increased risk of pregnancy loss. Median gestational age at delivery was significantly higher in the elective multifetal pregnancy reduction group (38 weeks) than in the ongoing pregnancy group (35.9 weeks). Further research is needed to clarify if multifetal pregnancy reduction improves long-term outcomes.

In March 2020, as community spread of severe acute respiratory syndrome coronavirus 2 became increasingly prevalent, pregnant women seemed to be equally susceptible to developing coronavirus disease 2019. Although the disease course usually appears mild, severe and critical cases of coronavirus disease 2019 seem to lead to substantial morbidity, including intensive care unit admission with prolonged hospital stay, intubation, mechanical ventilation, and even death. Although there are recent reports regarding the impact of coronavirus disease 2019 on pregnancy, there is a lack of information regarding the severity of coronavirus disease 2019 in pregnant vs nonpregnant women.We aimed to describe the outcomes of severe and critical cases of coronavirus disease 2019 in pregnant vs nonpregnant, reproductive-aged women.This is a multicenter, retrospective, case-control study of women with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection hospitalized with severe or critical coronavirus disease 2019 in 4 academic medical centers in New York City and 1 in Philadelphia between March 12, 2020, and May 5, 2020. The cases consisted of pregnant women admitted specifically for severe or critical coronavirus disease 2019 and not for obstetrical indications. The controls consisted of reproductive-aged, nonpregnant women admitted for severe or critical coronavirus disease 2019. The primary outcome was a composite morbidity that includes the following: death, a need for intubation, extracorporeal membrane oxygenation, noninvasive positive pressure ventilation, or a need for high-flow nasal cannula OA total of 38 pregnant women with severe acute respiratory syndrome coronavirus 2 polymerase chain reaction-confirmed infections were admitted to 5 institutions specifically for coronavirus disease 2019, 29 (76.3%) meeting the criteria for severe disease status and 9 (23.7%) meeting the criteria for critical disease status. The mean age and body mass index were markedly higher in the nonpregnant control group. The nonpregnant cohort also had an increased frequency of preexisting medical comorbidities, including diabetes, hypertension, and coronary artery disease. The pregnant women were more likely to experience the primary outcome when compared with the nonpregnant control group (34.2% vs 14.9%; P=.03; adjusted odds ratio, 4.6; 95% confidence interval, 1.2-18.2). The pregnant patients experienced higher rates of intensive care unit admission (39.5% vs 17.0%; P.01; adjusted odds ratio, 5.2; 95% confidence interval, 1.5-17.5). Among the pregnant women who underwent delivery, 72.7% occurred through cesarean delivery and the mean gestational age at delivery was 33.8±5.5 weeks in patients with severe disease status and 35±3.5 weeks in patients with critical coronavirus disease 2019 status.Pregnant women with severe and critical coronavirus disease 2019 are at an increased risk for certain morbidities when compared with nonpregnant controls. Despite the higher comorbidities of diabetes and hypertension in the nonpregnant controls, the pregnant cases were at an increased risk for composite morbidity, intubation, mechanical ventilation, and intensive care unit admission. These findings suggest that pregnancy may be associated with a worse outcome in women with severe and critical cases of coronavirus disease 2019. Our study suggests that similar to other viral infections such as severe acute respiratory syndrome coronavirus and Middle East respiratory syndrome coronavirus, pregnant women may be at risk for greater morbidity and disease severity.

Objectives: We studied uterine cancer patients who presented to the two public hospitals in Queens, New York from 2006 to 2015 with the purpose of examining the relationship between nativity (birthplace) and survival. Methods: A retrospective review of tumor registries was used to identify patients diagnosed with uterine cancer between January 1, 2006 and December 31, 2015. Using electronic medical records, data from 260 patients were available for this analysis. Results: The majority of patients were born outside the United States (US) (76.2% versus 23.8%). The majority of US-born patients were BlackBlack (67.7%). Ninety-five patients (36.5%) were born in the Caribbean Islands, 59 in Latin America (22.7%) and 44 in Asia/South Asia (16.9%). Most patients presented with stage I/II disease (69.7%) and stage did not vary significantly by nativity. Endometrioid/mucinous histology (67.8%) was the most common followed by serous/clear cell (17.7%) and uterine sarcomas (11.4%) with no significant difference in histology among nativity groups. Kaplan-Meier estimated survival curves stratified by birthplace demonstrated significant differences in survival distributions among the groups using the log-rank test (P Download : Download high-res image (120KB) Download : Download full-size image Conclusions: A Latin American health paradox was defined for foreign-born Latino patients presenting to the two Public Hospitals of Queens, New York as patients born in Latin America were less likely to die at any given time compared to those born in the United States.

Background Rates of hepatitis C virus (HCV) among women of childbearing age have increased as a result of the opioid epidemic, especially in the nonurban white population. Recently updated US Preventative Services Task Force and Centers for Disease Control and Prevention guidance have recommended universal HCV screening during pregnancy, but obstetrics societies have not yet endorsed this recommendation. We evaluated the seroprevalence of HCV among pregnant women in an inner-city population, compared rates with other sexually transmitted infections (STIs) screened for during pregnancy, and evaluated factors associated with HCV positivity. Methods We performed a prospective seroprevalence study of consecutive labor and delivery admissions (both antepartum complications and delivery admissions) by testing serum samples for HCV antibody over 9 months at 2 major hospital settings in New York City. Results Fifty-six of 7373 (0.75%; 95% confidence interval [CI], 0.57–0.98) patients screened positive for HCV, with 28 of 4013 (0.70%; 95% CI, 0.46%–1.01%) and 28 of 3413 (0.82%; 95% CI, 0.55%–1.18%) at each hospital. Forty-one percent of HCV-positive patients had any reported HCV risk factors. Hepatitis C virus-positive patients were less likely to have private insurance and more likely to have a history of cannabis, cocaine, and injection drug use (P, A higher than expected seroprevalence of hepatitis C was found among pregnant women, many without known risk factors, in a prospective study of consecutive labor and delivery admissions.

Background Chest radiography (CXR) often is performed in the acute setting to help understand the extent of respiratory disease in patients with COVID-19, but a clearly defined role for negative chest radiograph results in assessing patients has not been described. Research Question Is portable CXR an effective exclusionary test for future adverse clinical outcomes in patients suspected of having COVID-19? Study Design and Methods Charts of consecutive patients suspected of having COVID-19 at five EDs in New York City between March 19, 2020, and April 23, 2020, were reviewed. Patients were categorized based on absence of findings on initial CXR. The primary outcomes were hospital admission, mechanical ventilation, ARDS, and mortality. Results Three thousand two hundred forty-five adult patients, 474 (14.6%) with negative initial CXR results, were reviewed. Among all patients, negative initial CXR results were associated with a low probability of future adverse clinical outcomes, with negative likelihood ratios of 0.27 (95% CI, 0.23-0.31) for hospital admission, 0.24 (95% CI, 0.16-0.37) for mechanical ventilation, 0.19 (95% CI, 0.09-0.40) for ARDS, and 0.38 (95% CI, 0.29-0.51) for mortality. Among the subset of 955 patients younger than 65 years and with a duration of symptoms of at least 5 days, no patients with negative CXR results died, and the negative likelihood ratios were 0.17 (95% CI, 0.12-0.25) for hospital admission, 0.09 (95% CI, 0.02-0.36) for mechanical ventilation, and 0.09 (95% CI, 0.01-0.64) for ARDS. Interpretation Initial CXR in adult patients suspected of having COVID-19 is a strong exclusionary test for hospital admission, mechanical ventilation, ARDS, and mortality. The value of CXR as an exclusionary test for adverse clinical outcomes is highest among young adults, patients with few comorbidities, and those with a prolonged duration of symptoms.

Objective This study aimed to estimate the prevalence of measles immunity in a cohort of pregnant women in New York City and determine if there is a positive correlation of measles immunity with patient demographics, rubella immunity, number of measles, mumps, and rubella vaccine (MMR) doses received, and age at last vaccination. Study Design This is a cross-sectional study of pregnant patients seen at a single institution from January 2019 to May 2019. Patients were classified as measles and rubella immune or nonimmune using commercial immunoglobulin G (IgG) tests. Patient characteristics were compared using t-tests, Chi-square tests, or Fisher's exact tests as appropriate. The association of age at last vaccination with immunity status was assessed using multivariable logistic regression adjusted for age at presentation. The utility of rubella IgG for distinguishing measles immunity was assessed using receiver operating characteristic curve analysis. Results Serologic immunity for measles and rubella was obtained for 1,366 patients. Of these, 1,047 (77%) were measles immune and 1,291 (95%) were rubella immune. Patients born after 1989 were less likely to be immune to measles, while multiparity and private insurance were associated with increased measles immunity. Documentation of MMR vaccination was available for 140 (10%) patients. Of these, 44 (31%) were serologically nonimmune to measles and 9 (6.4%) were nonimmune to rubella. In patients known to have received one dose of MMR, 62% (24/39) were immune to measles with an improvement to 72% (69/96) among those who received two or more doses. Age at last vaccination was not associated with measles immunity. Rubella IgG level was a poor predictor of positive measles titer (area under the curve = 0.59). Conclusion Approximately one of every four pregnant patients is serologically measles nonimmune, even among women with documented MMR vaccination or documented rubella immunity. These findings raise concerns that relying on vaccination history or rubella immune status may not be sufficient to assure protection from infection with measles. If further suggests that measles serology should be added to routine prenatal laboratory testing to identify nonimmune patients that may benefit from postpartum vaccination. Key Points

BackgroundIn A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up.MethodsARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion. Patients were randomly assigned (1:1) by a web-based data collection system, stratified by clinical centre in a random permuted block design with block sizes of two, four, and six, to medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number). Although patients and investigators at a given centre were not masked to treatment assignment, investigators at other centres and those in the clinical coordinating centre were not informed of assignment or outcomes at any of the centres. The primary outcome was time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care, and monitored by an independent committee using an adaptive approach with interim analyses. Enrolment began on April 4, 2007, and was halted on April 15, 2013, after which follow-up continued until July 15, 2015. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00389181.FindingsOf 1740 patients screened, 226 were randomly assigned to medical management alone (n=110) or medical management plus interventional therapy (n=116). During a mean follow-up of 50·4 months (SD 22·9), the incidence of death or symptomatic stroke was lower with medical management alone (15 of 110, 3·39 per 100 patient-years) than with medical management with interventional therapy (41 of 116, 12·32 per 100 patient-years; hazard ratio 0·31, 95% CI 0·17 to 0·56). Two patients in the medical management group and four in the interventional therapy group (two attributed to intervention) died during follow-up. Adverse events were observed less often in patients allocated to medical management compared with interventional therapy (283 vs 369; 58·97 vs 78·73 per 100 patient-years; risk difference −19·76, 95% CI −30·33 to −9·19).InterpretationAfter extended follow-up, ARUBA showed that medical management alone remained superior to interventional therapy for the prevention of death or symptomatic stroke in patients with an unruptured brain arteriovenous malformation. The data concerning the disparity in outcomes should affect standard specialist practice and the information presented to patients. The even longer-term risks and differences between the two therapeutic approaches remains uncertain.FundingNational Institute of Neurological Disorders and Stroke for the randomisation phase and Vital Projects Fund for the follow-up phase.

Recently, a novel coronavirus, precisely severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), that causes the disease novel coronavirus disease 2019 (COVID-19) has been declared a worldwide pandemic. Over a million cases have been confirmed in the United States. As of May 5, 2020, New York State has had over 300,000 cases and 24,000 deaths with more than half of the cases and deaths occurring in New York City (NYC). Little is known, however, of how this virus impacts pregnancy. Given this lack of data and the risk for severe disease in this relatively immunocompromised population, further understanding of the obstetrical management of COVID-19, as well as hospital level preparation for its control, is crucial. Guidance has come from expert opinion, professional societies and public health agencies, but to date, there is no report on how obstetrical practices have adapted these recommendations to their local situations. We therefore developed an internet-based survey to elucidate the practices put into place to guide the care of obstetrical patients during the COVID-19 pandemic. We surveyed obstetrical leaders in four academic medical centers in NYC who were implementing and testing protocols at the height of the pandemic. We found that all sites made changes to their practices, and that there appeared to be agreement with screening and testing for COVID-19, as well as labor and delivery protocols, for SARS-CoV-2-positive patients. We found less consensus with respect to inpatient antepartum fetal surveillance. We hope that this experience is useful to other centers as they formulate their plans to face this pandemic. KEY POINTS: · Practices changed to accommodate public health needs.. · Most practices are screened for novel COVID-19 on admission.. · Fetal testing in COVID-19 patients varied..

PurposeAcute intermittent porphyria (AIP) is a rare inborn error of heme biosynthesis characterized by life-threatening acute attacks. Few studies have assessed quality of life (QoL) in AIP and those that have had small sample sizes and used tools that may not have captured important domains.MethodsBaseline data from the Porphyrias Consortium's Longitudinal Study were obtained for 259 patients, including detailed disease and medical history data, and the following Patient-Reported Outcomes Measurement Information System (PROMIS) scales: anxiety, depression, pain interference, fatigue, sleep disturbance, physical function, and satisfaction with social roles. Relationships between PROMIS scores and clinical and biochemical AIP features were explored.ResultsPROMIS scores were significantly worse than the general population across all domains, except depression. Each domain discriminated well between asymptomatic and symptomatic patients with symptomatic patients having worse scores. Many important clinical variables like symptom frequency were significantly associated with domain scores in univariate analyses, showing responsiveness of the scales, specifically pain interference and fatigue. However, most regression models only explained ~20% of the variability observed in domain scores.ConclusionPain interference and fatigue were the most responsive scales in measuring QoL in this AIP cohort. Future studies should assess whether these scales capture longitudinal disease progression and treatment response.

Objective To evaluate the rate of coronavirus disease 2019 (COVID-19) infection with the use of universal testing in our obstetric population presenting for scheduled deliveries, as well as the concordance or discordance rate among their support persons during the initial 2-week period of testing. Additionally, we assessed the utility of a screening tool in predicting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing results in our cohort. Methods This was an observational study in which all women who were scheduled for a planned delivery within the Mount Sinai Health system from April 4 to April 15, 2020, were contacted and provided with an appointment for themselves as well as their support persons to undergo COVID-19 testing 1 day before their scheduled delivery. Both the patients and the support persons were administered a standardized screen specific for COVID-19 infection by telephone interview. Those support persons who screened positive were not permitted to attend the birth. All patients and screen-negative support persons underwent SARS-CoV-2 testing. Results During the study period, 155 patients and 146 support persons underwent SARS-CoV-2 testing. The prevalence of asymptomatic COVID-19 infection was 15.5% (CI 9.8-21.2%) and 9.6% (CI 4.8-14.4%) among patients and support persons, respectively. The rate of discordance among tested pairs was 7.5%. Among patients with COVID-19 infection, 58% of their support persons also had infection; in patients without infection, fewer than 3.0% of their support persons had infection. Conclusion We found that more than 15% of asymptomatic maternity patients tested positive for SARS-CoV-2 infection despite having screened negative with the use of a telephone screening tool. Additionally, 58% of their asymptomatic, screen-negative support persons also tested positive for SARS-CoV-2 infection. Alternatively, testing of the support persons of women who had tested negative for COVID-19 infection had a low yield for positive results. This has important implications for obstetric and newborn care practices as well as for health care professionals.

It is unknown how variations in surgical entry time in primary cesarean delivery (CD) may affect operative outcomes and maternal morbidity.Determine whether performing a primary CD in labor emergently ("stat") is associated with adverse maternal outcomes.Retrospective cohort study of patients who underwent primary CD at The Mount Sinai Hospital during the years of 2011-2016. Women with a singleton pregnancy and without a prior uterine scar attempting a trial of labor were included. An emergent CD was defined as a skin-to-uterine incision (I-U) time of ≤3 minutes. Subjects were dichotomized into those with an I-U time of ≤3 minutes or ≥5 minutes.1722 patients underwent primary CD and met eligibility criteria. 72 patients with an I-U time of 4 minutes were removed from the analysis. 196 patients (11.9%) had an I-U time ≤3 minutes and 1454 patients (88.1%) had an I-U time ≥5 minutes. There were no differences in any outcomes between groups. The likelihood of transfusion, hysterectomy, or admission to the intensive care unit (ICU) was 1.5% in the emergent group and 1.0% in the control group (p = .334). Postpartum length of stay was also similar between the groups (3.3 versus 3.2 days, p = .259). When 384 patients with I-U times10 minutes were excluded, surgical outcomes remained similar between groups. Among the subgroup of patients who reached the second stage of labor, surgical outcomes were also similar between groups.Emergent primary CD is not associated with increased maternal morbidity.

To determine the frequency and risk factors for non-home discharge (NHD) and its association with clinical outcomes and quality of life (QOL) at 1 year following cardiac surgery in patients with ischemic mitral regurgitation (IMR).Discharge disposition was evaluated in 552 patients enrolled in trials of severe or moderate IMR. Patient and in-hospital factors associated with NHD were identified using logistic regression. Subsequently, association of NHD with 1-year mortality, serious adverse events (SAEs), and QOL was assessed.NHD was observed in 30% (154/522) with 25% (n = 71/289) in moderate and 36% (n = 83/233) in patients with severe IMR (unadjusted P = .006), a difference not significant after including age (5-year change: adjusted odds ratio [adjOR], 1.52; 95% confidence interval [CI], 1.35-1.72; P .001), diabetes (adjOR, 1.94; 95% CI, 1.27-2.94; P = .002), and previous heart failure (adjOR, 1.64; 95% CI, 1.06-2.52; P = .03). Odds of NHD were increased for patients with postoperative SAEs (adjOR, 1.85; 95% CI, 1.19-2.86; P = .01) but not based on type of cardiac surgery. Greater rates of death and SAEs were observed in NHD patients at 1 year: adjusted hazard ratio, 4.29 (95% CI, 2.14-8.59; P .001) and adjusted rate ratio, 1.45 (95% CI, 1.03-2.02; P = .03), respectively. QOL did not differ significantly between groups.NHD is common following surgery for IMR, influenced by older age, diabetes, previous heart failure, and postoperative SAEs. These patients may be at greater risk of death and subsequent SAEs after discharge. Discussion of NHD with patients may have important implications for decision-making and guiding expectations following cardiac surgery.

Background High-volume and fellowship-trained surgeons have superior outcomes. However, in gynecology, a large proportion of cases are performed by low-volume surgeons. Simulation has been shown to be useful in assessing surgical skill and may be a useful tool in hospital credentialing and maintenance of privileges. Objective To determine the correlation between a surgical case volume and fellowship training with performance on simulated procedural tasks. Study Design A total of 108 obstetricians and gynecologists with laparoscopic privileges at 2 academic institutions completed a pre-test survey and performed 3 tasks on the LapSim laparoscopic virtual reality simulator. The pre-test survey inquired about the monthly laparoscopic case volume and prior training. Simulations included a basic skills task (peg transfer) followed by a procedural task (salpingectomy) of 2 difficulty levels (low and moderate). Spearman correlation and Wilcoxon tests were used to determine correlations between the survey responses and performance metrics. Results Participants included 67 generalists (62%) and 41 fellowship-trained specialists (38%). There was an observed weak correlation among surgical volume (more than 6 cases per month), time to completion, and the amount of blood loss when performing the low-difficulty level salpingectomy (r=−0.32, P=.0007 and r=−0.29, P=.002, respectively). The economy of movement (instrument path length) was correlated to high surgical volume (r=−0.35, P=.0002). Compared with generalists, surgeons with fellowship training performed tasks faster (410.8 seconds [interquartile range, 309.7–595.2]) vs 530.2 seconds (interquartile range, 406.2–605.0; P=.0009), more efficiently at 6.1 m (interquartile range, 4.8–7.3) vs 8.1 m (interquartile range, 5.8–10.7; P=.0003), and with less blood loss at 21.7 mL (interquartile range, 11.8–37.7) vs 42.9 mL (interquartile range, 18.1–70.6; P=.002). Regarding the case volume and fellowship background, there was no difference in ovarian diathermy damage. In addition, there was no difference among most performance parameters for the peg transfer task and the moderate-difficulty salpingectomy procedure. Conclusion Surgical experience obtained through higher case volume and fellowship training correlate with higher performance scores during simulated procedural tasks. In a previous study, we found a similar correlation with simulated basic skills tasks. The current study is a continuation of an ongoing quality initiative to establish a summative assessment of laparoscopic surgical skills using virtual reality simulator for the maintenance of credentials among obstetrical and gynecologic surgeons. Future studies will compare the performance metrics from laparoscopic procedures performed on virtual reality simulator with the performance in the operating room and clinical outcomes.

Objective The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. Methods We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. Results In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; −0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [−3866 to 56,826]) and quality-adjusted life years showed no difference (−0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. Conclusions: The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.

OBJECTIVE: The alpha 2C adrenoreceptor deletion 322–325 (ADRA2C del 322–325) polymorphism has been associated with autonomic activity and thermoregulation, which are implicated in the vasomotor symptom (VMS) mechanism. The ADRA2C del (322–325) has higher prevalence in African American women, a group known to experience more frequent and bothersome VMS. We assessed whether the ADRA2C del (322–325) genotype is associated with increased frequency of VMS in African American women. METHODS: DNA samples from African American (N=400) women participating in the Study of Women’s Health Across the Nation (SWAN) were genotyped for the ADRA2C del (322–325) polymorphism. Longitudinal data on VMS was obtained from the SWAN Repository. The relation of ADRA2C del (322–325) genotypes, [deletion/deletion (D/D); insertion/deletion (I/D); insertion/insertion (I/I)] with VMS over the menopause transition for up to 12 years of follow up was examined using generalized estimating equations. Primary models considered the outcome of frequent VMS (6 or more days in the prior two weeks versus VMS

Background The incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared with MVS alone. Objectives This study identified risk factors and outcomes associated with PPM implantation in a randomized trial that evaluated ablation for AF in patients who underwent MVS. Methods A total of 243 patients with AF and without previous PPM placement were randomly assigned to MVS alone (n = 117) or MVS + ablation (n = 126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI) (n = 62) or the biatrial maze procedure (n = 64). Using competing risk models, this study examined the association among PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions, and 1-year mortality. Results Thirty-five patients received a PPM within the first year (14.4%), 29 (83%) underwent implantation during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS + PVI, and 25% in MVS + biatrial maze. The indications for PPM were similar among patients who underwent MVS with and without ablation. Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients who received PPMs, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.61 to 1.08; p = 0.14). PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50). The need for PPM was associated with a higher risk of 1-year mortality (HR: 3.21; 95% CI: 1.01 to 10.17; p = 0.05) after adjustment for randomization assignment, age, and NYHA functional class. Conclusions AF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing. PPM implantation following MVS was associated with a significant increase in 1-year mortality. (Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; NCT00903370)

Background: In ischemic mitral regurgitation (IMR), ring annuloplasty is associated with a significant rate of recurrent MR. Ring size is based on intertrigonal distance without consideration of left ventricular (LV) size. However, LV size is an important determinant of mitral valve (MV) leaflet tethering before and after repair. We aimed to determine whether LV-MV ring mismatch (mismatch of LV size relative to ring size) is associated with recurrent MR in patients with IMR after restrictive ring annuloplasty. Methods: Patients with moderate or severe IMR from the 2 Cardiothoracic Surgical Trials Network IMR trials who received MV repair were examined at 1 year after surgery. Baseline LV size was assessed by LV end-diastolic dimension and LV end-systolic dimension (LVESd). LV-MV ring mismatch was calculated as the ratio of LV to ring size (LV end-diastolic dimension/ring size and LVESd/ring size). Results: At 1 year after ring annuloplasty, 45 of 214 patients with MV repair (21%) had moderate or greater MR. In univariable logistic regression analysis, larger LVESd ( P =0.02) and LVESd/ring size ( P =0.007) were associated with recurrent MR. In multivariable models adjusted for age, sex, baseline LV ejection fraction, and severe IMR, only LVESd/ring size (odd ratio per 0.5 increase, 2.20; 95% confidence interval, 1.05–4.62; P =0.038) remained significantly associated with 1-year MR recurrence. Conclusions: LV-MV ring size mismatch is associated with increased risk of MR recurrence. This finding may be helpful in guiding choice of ring size to prevent recurrent MR in patients undergoing MV repair and in identifying patients who may benefit from MV repair with additional subvalvular intervention or MV replacement rather than repair alone. Clinical Trial Registration: URL: http://clinicaltrials.gov . Unique identifiers: NCT00806988 and NCT00807040.

Background Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non–left anterior descending vessels. HCR is increasingly used to treat multivessel coronary artery disease that includes stenoses in the proximal left anterior descending artery and at least 1 other vessel, but its effectiveness has not been rigorously evaluated. Objectives This National Institutes of Health–funded, multicenter, observational study was conducted to explore the characteristics and outcomes of patients undergoing clinically indicated HCR and multivessel PCI for hybrid-eligible coronary artery disease, to inform the design of a confirmatory comparative effectiveness trial. Methods Over 18 months, 200 HCR and 98 multivessel PCI patients were enrolled at 11 sites. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) (i.e., death, stroke, myocardial infarction, repeat revascularization) within 12 months post-intervention. Cox proportional hazards models were used to model time to first MACCE event. Propensity scores were used to balance the groups. Results Mean age was 64.2 ± 11.5 years, 25.5% of patients were female, 38.6% were diabetic, and 4.7% had previous stroke. Thirty-eight percent had 3-vessel coronary artery disease, and the mean SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 19.7 ± 9.6. Adjusted for baseline risk, MACCE rates were similar between groups within 12 months post-intervention (hazard ratio [HR]: 1.063; p = 0.80) and during a median 17.6 months of follow-up (HR: 0.868; p = 0.53). Conclusions These observational data from this first multicenter study of HCR suggest that there is no significant difference in MACCE rates over 12 months between patients treated with multivessel PCI or HCR, an emerging modality. A randomized trial with long-term outcomes is needed to definitively compare the effectiveness of these 2 revascularization strategies. (Hybrid Revascularization Observational Study; NCT01121263 )