Large for Gestational Age and Adverse Outcomes: Stratified By Diabetes Status.

OBJECTIVE: To examine the association of adverse outcomes among parturients with large for gestational age (LGA; birth weight ≥ 90th) newborns, stratified by diabetes status. Additionally, we described the temporal trends of adverse outcomes among LGA neonates. STUDY DESIGN: This retrospective cohort study used the U.S. Vital Statistics dataset between 2014 and 2020. The inclusion criteria were singleton, nonanomalous LGA live births who labored and delivered at 24 to 41 weeks with known diabetes status. The coprimary outcomes were composite neonatal adverse outcomes of the following: Apgar score < 5 at 5 minutes, assisted ventilation > 6 hours, seizure, or neonatal or infant mortality, and maternal adverse outcomes of the following: maternal transfusion, ruptured uterus, unplanned hysterectomy, admission to intensive care unit, or unplanned procedure. Multivariable Poisson regression models were used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI). Average annual percent change (AAPC) was calculated to assess changes in rates of LGA and morbidity over time. RESULTS: Of 27 million births in 7 years, 1,843,467 (6.8%) met the inclusion criteria. While 1,656,888 (89.9%) did not have diabetes, 186,579 (10.1%) were with diabetes. Composite neonatal adverse outcomes (aRR = 1.48, 95% CI = 1.43, 1.52) and composite maternal adverse outcomes (aRR = 1.37, 95% CI = 1.36, 1.38) were significantly higher among individuals with diabetes, compared with those without diabetes. From 2014 to 2020, the LGA rate was stable among people without diabetes. However, there was a downward trend of LGA in people with diabetes (AAPC = - 2.4, 95% CI = - 3.5, -1.4). CONCLUSION: In pregnancies with LGA newborns, composite neonatal and maternal morbidities were higher in those with diabetes, compared with those without diabetes. KEY POINTS: · Large for gestational age stratified by diabetes status.. · Composite neonatal and maternal adverse outcomes are worse among individuals with diabetes as compared to those without.. · During 2014 to 2020, the trend of LGA in individuals without diabetes increased..

Sexual and Reproductive Health Care Visits as a Venue for Preexposure Prophylaxis Service Delivery Among Women in the United States: Results From a Nationally Representative Survey.

BACKGROUND: Preexposure prophylaxis (PrEP) for HIV is disproportionately underprescribed to women. Centers for Disease Control and Prevention guidelines identify a group of women at risk of HIV acquisition who should be offered PrEP, but opportunities remain to improve patient awareness of and provider counseling about PrEP and to expand service delivery of PrEP. METHODS: Using nationally representative data from the 2017-2019 National Survey of Family Growth, we compared women with (n = 689) and without (n = 5,452) Centers for Disease Control and Prevention indications for PrEP on measures of PrEP awareness, counseling by a provider, and interaction with the health care system. RESULTS: Women with PrEP indications were no more likely to report awareness of PrEP (odds ratio [OR], 1.03; 95% confidence interval [CI], 0.82-1.29) or PrEP counseling by a provider (OR, 1.32; 95% CI, 0.77-2.27), compared with those without PrEP indications. However, women with PrEP indications were more likely than those without to report a birth control visit (OR, 1.82; 95% CI, 1.39-2.38) or an abortion within the last 12 months (OR, 5.93; 95% CI, 1.48-23.73), and to currently use prescription contraception (OR, 1.45; 95% CI, 1.19-1.78). A majority of both groups reported accessing prenatal care within the last 12 months. CONCLUSIONS: There remains a gap in PrEP awareness and counseling among women at highest risk for HIV acquisition. Sexual and reproductive health visits represent a logical and feasible venue for PrEP provision. Obstetrician-gynecologists and other family planning providers may be able to aid in service delivery innovations by providing PrEP alongside other sexual and reproductive health care.

Reduction of anti-A and anti-B isoagglutinin titers of group O whole blood units employing an ABO antibody immune adsorption column.

BACKGROUND: Massive hemorrhage is a leading cause of death from trauma. There is growing interest in group O whole blood transfusions to mitigate coagulopathy and hemorrhagic shock. Insufficient availability of low-titer group O whole blood is a barrier to routine use. We tested the efficacy of the Glycosorb® ABO immunoadsorption column to reduce anti-A/B titers in group O whole blood. METHODS: Six group O whole blood units were collected from healthy volunteers, and centrifuged to separate platelet poor plasma. Platelet-poor plasma was filtered through a Glycosorb® ABO antibody immunoabsorption column, then reconstituted to prepare post-filtration whole blood. Anti-A/B titers, CBC, free hemoglobin, and thromboelastography (TEG) assays were performed on pre-and post-filtration whole blood. RESULTS: Mean( ± SEM) anti-A (224 ± 65 pre vs 13 ± 4 post) and anti-B (138 ± 38 pre vs 11 ± 4 post) titers were significantly reduced (p = 0.004) in post-filtration whole blood. No significant changes were detected in CBC, free hemoglobin, and TEG parameters on day 0. Free hemoglobin increased throughout storage (48 mg/dl ± 24 Day 0 vs 73 ± 35 Day 7 vs 96 ± 44 Day 14; p = 0.14). CONCLUSIONS: The Glycosorb® ABO column can significantly reduce anti-A/B isoagglutinin titers of group O whole blood units. Glycosorb® ABO could be employed to provide whole blood with lower risk of hemolysis and other consequences of infusing ABO incompatible plasma. Preparation of group O whole blood with substantially reduced anti-A/B would also increase the supply of low-titer group O whole blood for transfusion.

Factors associated with exclusive formula feeding among individuals with low-risk pregnancies in the United States.

BACKGROUND: Better understanding of the factors associated with formula feeding during the hospital stay can help in identifying potential lactation problems and promote early intervention. Our aim was to ascertain factors associated with exclusive formula feeding in newborns of low-risk pregnancies. METHODS: A population-based, retrospective study using the United States vital statistics datasets (2014-2018) evaluating low-risk pregnancies with a nonanomalous singleton delivery from 37 to 41 weeks. People with hypertensive disorders, or diabetes, were excluded. Primary outcome was newborn feeding (breast vs exclusive formula feeding) during hospital stay. Adjusted relative risks (aRRs) with 95% confidence intervals (CI) were calculated. RESULTS: Of the 19 623 195 live births during the study period, 11 605 242 (59.1%) met inclusion criteria and among them, 1 929 526 (16.6%) were formula fed. Factors associated with formula feeding included: age < 20 years (aRR 1.31 [95% CI 1.31-1.32]), non-Hispanic Black (1.42, 1.41-1.42), high school education (1.69, 1.69-1.70) or less than high school education (1.94, 1.93, 1.95), Medicaid insurance (1.52, 1.51, 1.52), body mass index (BMI) < 18.5 (1.10, 1.09-1.10), BMI 25-29.9 (1.09, 1.09-1.09), BMI 30-34.9 (1.19, 1.19-1.20), BMI 35-39.9 (1.31, 1.30-1.31), BMI ≥ 40 (1.43, 1.42-1.44), multiparity (1.29, 1.29-1.30), lack of prenatal care (1.49, 1.48-1.50), smoking (1.75, 1.74-1.75), and gestational age (ranged from 37 weeks [1.44, 1.43-1.45] to 40 weeks [1.11, 1.11-1.12]). CONCLUSIONS: Using a large cohort of low-risk pregnancies, we identified several modifiable factors associated with newborn feeding (eg, prepregnancy BMI, access to prenatal care, and smoking cessation). Improving the breast feeding initiation rate should be a priority in our current practice to ensure equitable care for all neonates.

Racial and Ethnic Disparities among Pregnancies with Chronic Hypertension and Adverse Outcomes.

OBJECTIVE: We aimed to ascertain whether the risk of adverse pregnancy outcomes in the United States among individuals with chronic hypertension differed by maternal race and ethnicity and to assess the temporal trend. STUDY DESIGN: Population-based retrospective study using the U.S. Vital Statistics datasets evaluated pregnancies with chronic hypertension, singleton live births that delivered at 24 to 41 weeks. The coprimary outcomes were a composite maternal adverse outcome (preeclampsia, primary cesarean delivery, intensive care unit admission, blood transfusion, uterine rupture, or unplanned hysterectomy) and a composite neonatal adverse outcome (preterm birth, small for gestational age, Apgar's score <5 at 5 minutes, assisted ventilation> 6 hours, seizure, or death). Multivariable Poisson regression models were used to estimate adjusted relative risks (aRRs) and 95% confidence intervals (CIs). RESULTS: Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased from 1.6 to 2.2%. After multivariable adjustment, an increased risk for the composite maternal adverse outcome was found in Black (aRR = 1.10, 95% CI = 1.09-1.11), Hispanic (aRR = 1.04, 95% CI = 1.02-1.05), and Asian/Pacific Islander (aRR = 1.07, 95% CI = 1.05-1.10), compared with White individuals. Compared with White individuals, the risk of the composite neonatal adverse outcome was higher in Black (aRR = 1.39, 95% CI = 1.37-1.41), Hispanic (aRR = 1.15, 95% CI = 1.13-1.16), Asian/Pacific Islander (aRR = 1.34, 95% CI = 1.31-1.37), and American Indian (aRR = 1.12, 95% CI = 1.07-1.17). The racial and ethnic disparity remained unchanged during the study period. CONCLUSION: We found a racial and ethnic disparity with maternal and neonatal adverse outcomes in pregnancies with chronic hypertension that remained unchanged throughout the study period. KEY POINTS: · Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased.. · Among people with chronic hypertension, there are racial and ethnic disparities in adverse outcomes.. · Black, Hispanic, and Asian/Pacific Islander have a higher risk of the adverse neonatal outcomes..

The association between trial of labor after cesarean in obese patients and adverse maternal outcomes.

PURPOSE: We hypothesized that among obese patients with a history of cesarean birth, a TOLAC is associated with decreased composite maternal adverse outcomes (CMAO) compared to planned repeat low transverse cesarean section (RLTCS). METHODS: In this population-based cross-sectional study using the National Birth Certificate database from 2016 to 2020, we compared obese patients who attempted TOLAC at term (≥ 37 weeks estimated gestational age) to planned RLTCS. The primary outcome was a CMAO, defined as delivery complications, including intensive care unit (ICU) admission, uterine rupture, unplanned hysterectomy, or maternal blood transfusion. RESULTS: Overall, 794,278 patients met inclusion criteria for the study; 126,809 underwent a TOLAC, and 667,469 had a planned RLTCS. The overall CMAO was significantly higher for patients undergoing TOLAC (9.0 per 1000 live births) compared to RLTCS (5.3 per 1000 live births; aRR 1.64, 95% CI 1.53-1.75). CONCLUSION: This data demonstrate that in obese patients with prior cesarean birth, a trial of labor is associated with increased maternal morbidity when compared to a planned repeat cesarean birth.

Time from apheresis platelet donation to cold storage: Evaluation of platelet quality and bacterial growth.

BACKGROUND: Cold storage reduces posttransfusion survival of platelets; however, it can improve platelet activation, lower risk of bacterial contamination, and extend shelf-life compared to room temperature (RT) storage. To facilitate large-scale availability, manufacturing process optimization is needed, including understanding the impact of variables on platelet potency and safety. Short time requirements from collection to storage is challenging for large blood centers to complete resuspension and qualify platelets for production. This study evaluated the impact of time from platelet component collection to cold storage on in vitro properties and bacterial growth. STUDY DESIGN AND METHODS: Double-apheresis platelet components were collected from healthy donors, suspended in 65% PAS-III/35% plasma, and split into 2 equal units. One unit was placed into cold storage within 2 h and the other unit after 8 h. Eight matched pairs were evaluated for 12 in vitro parameters. Twenty-four matched pairs were evaluated with 8 bacterial strains tested in triplicate. Samples were tested throughout 21 days of storage. RESULTS: In vitro properties were not different between 2 and 8 h units, and trends throughout storage were similar between arms. Time to cold storage did not significantly impact bacterial growth, with <1 log10 difference at all timepoints between units. DISCUSSION: Our studies showed that extending time to cold storage from 2 to 8 h from collection did not significantly increase the bacterial growth, and the platelet component quality and function is maintained. The ability to extend the time required from collection to storage will improve blood center logistics to feasibly produce CSPs.

Association Between Low-Dose Aspirin and Development of Gestational Diabetes: A Systematic Review and Meta-Analysis.

OBJECTIVE: To evaluate the association between the use of low-dose aspirin for preeclampsia prophylaxis and risks of gestational diabetes (primary outcome), neonatal hypoglycemia, macrosomia, large for gestational age, birth trauma, and shoulder dystocia (secondary outcomes). DATA SOURCES: We searched Ovid MEDLINE, Embase, CINAHL, and Cochrane/CENTRAL for studies published between January 1, 1989, and April 24, 2021. STUDY SELECTION: Randomized controlled trials (RCTs) or cohort studies of any size conducted in any setting were included. DATA EXTRACTION AND SYNTHESIS: We assessed risk of bias using the Cochrane Risk of Bias tool 2.0 (for RCTs) and the Newcastle-Ottawa Scale (for cohort studies). We meta-analyzed relative risks (RRs) using random-effects models. CONCLUSIONS: Our search retrieved 4441 records, of which 9 studies (6 RCTs with 1932 patients and 3 cohort studies with 313 837 patients) met inclusion criteria. We rated only 4 of the 6 RCTs and 1 of the 3 cohort studies at low risk of bias. Low-dose aspirin in pregnancy for preeclampsia prophylaxis was not associated with a greater risk of gestational diabetes (RR 1.18; 95% confidence interval 0.80-1.74). No studies reported data for the secondary outcomes. In summary, the use of low-dose aspirin does not appear associated with risk of gestational diabetes. The poor quality and small number of studies limit the interpretation of these results.

Maternal Education Level Among People with Diabetes and Associated Adverse Outcomes.

OBJECTIVE: The aim of the study is to determine the relation between education and adverse outcomes in individuals with pregestational or gestational diabetes. STUDY DESIGN: This population-based cohort study, using the U.S. vital statistics datasets, evaluated individuals with pregestational or gestational diabetes who delivered between 2016 and 2019. The primary outcome was composite neonatal adverse outcome including any of the following: large for gestational age (LGA), Apgar's score 6 hours, neonatal seizure, or neonatal death. The secondary outcome was composite maternal adverse outcomes including any of the following: admission to intensive care unit, transfusion, uterine rupture, or unplanned hysterectomy. Multivariable analysis was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CIs). RESULTS: Of 15,390,962 live births in the United States, 858,934 (5.6%) were eligible for this analysis. Compared with individuals with a college education and above, the risk of composite neonatal adverse outcome was higher in individuals with some college (aRR = 1.08, 95% CI = 1.07-1.09), high school (aRR = 1.06, 95% CI = 1.04-1.07), and less than high school (aRR = 1.05, 95% CI = 1.03-1.07) education. The components of composite neonatal adverse outcome that differed significantly between the groups were LGA, Apgar's score 6 hours. Infant death differed when stratified by education level. An increased risk of composite maternal adverse outcome was also found with a lower level of education. CONCLUSION: Among individuals with diabetes, lower education was associated with a modestly higher risk of adverse neonatal and maternal outcomes. KEY POINTS: · Education levels were associated with adverse outcomes among individuals with diabetes.. · Lower education is associated with multiple neonatal complications, including infant death.. · Individuals with varying levels of education are at higher risk for adverse maternal outcomes..

Labor Induction at 39 Weeks Compared with Expectant Management in Low-Risk Parous Women.

OBJECTIVE: Our objective was to compare outcomes among low-risk parous women who underwent elective labor induction at 39 weeks versus expectant management. STUDY DESIGN: This is a secondary analysis of an observational cohort of 115,502 mother-infant dyads who delivered at 25 hospitals between 2008 and 2011. The inclusion criteria for this analysis were low-risk parous women with nonanomalous singletons with at least one prior vaginal delivery after 20 weeks, who delivered at ≥390/7 weeks. Women who electively induced between 390/7 and 396/7 weeks were compared with women who expectantly managed ≥390/7 weeks. The primary outcome for this analysis was cesarean delivery. Secondary outcomes were composites of maternal adverse outcome and neonatal adverse outcome. Multivariable logistic regression was used to estimate adjusted odds ratios (aOR). RESULTS: Of 20,822 women who met inclusion criteria, 2,648 (12.7%) were electively induced at 39 weeks. Cesarean delivery was lower among women who underwent elective induction at 39 weeks than those who did not (2.4 vs. 4.6%, adjusted odds ratio [aOR]: 0.70, 95% confidence interval [CI]: 0.53-0.92). The frequency of the composite maternal adverse outcome was significantly lower for the elective induction cohort as well (1.6 vs. 3.1%, aOR: 0.66, 95% CI: 0.47-0.93). The composite neonatal adverse outcome was not significantly different between the two groups (0.3 vs. 0.6%; aOR: 0.60, 95% CI: 0.29-1.23). CONCLUSION: In low-risk parous women, elective induction of labor at 39 weeks was associated with decreased odds of cesarean delivery and maternal morbidity, without an increase in neonatal adverse outcomes. KEY POINTS: · 39-week elective induction is associated with decreased cesarean delivery in low-risk parous women.. · Compared with expectant management, maternal adverse outcomes were lower with elective induction.. · Neonatal adverse outcomes are unchanged between elective and expectant management groups..

Fatal sepsis associated with a storage container leak permitting platelet contamination with environmental bacteria after pathogen reduction.

BACKGROUND: Pathogen reduction technology and enhanced bacterial culture screening promise to significantly reduce the risk of transfusion-associated septic reactions due to contaminated platelets. Recent reports suggest that these interventions lack efficacy for post-collection and processing contamination with environmental organisms if the storage bag integrity is compromised. CASE REPORT: We report a fatal septic transfusion reaction in a 63-year-old patient with chronic kidney and liver disease who received a pathogen reduced platelet transfusion in anticipation of surgery. METHODS: The residual platelet concentrate was cultured, with the detected microorganisms undergoing 16S genotype sequencing. Separate pathogen reduction studies were performed on the recovered bacteria, including assessment for amotosalen photoproducts. The storage container was subjected to pressure testing and microscopic examination. Environmental culture screening was performed at the hospital. RESULTS: Gram negative rods were detected in the platelet unit and cultures of both platelet component and the patient's blood grew Acinetobacter baumannii complex, Leclercia adecarboxylata and Staphylococcus saprophyticus. These strains were effectively inactivated with >7.2, 7.7, and >7.1 log10 kill, respectively. The platelet storage container revealed a leak visible only on pressure testing. Hospital environmental cultures were negative and the contamination source is unknown. A. baumannii complex and S. saprophyticus 16S genotyping sequences were identical to those implicated in a previously reported septic reaction. CONCLUSION: Findings are compatible with post-processing environmental contamination of a pathogen reduced platelet concentrate via a non-visible, acquired storage container leak. Efforts are warranted to actively prevent damage to, and detect defects in, platelet storage containers, and to store and transport components in clean environments.

Interventions to decrease complications after shoulder dystocia: a systematic review and Bayesian meta-analysis.

OBJECTIVE: This study aimed to evaluate the outcomes associated with the implementation of simulation exercises to reduce the sequela of shoulder dystocia. DATA SOURCES: Electronic databases (Ovid MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature database, and Scopus) were initially queried in June 2020 and updated in November 2020. The following 3 concepts were introduced and refined using the controlled vocabulary of the database: vaginal birth, shoulder dystocia, and simulation training. There were no limitations to the year of publication as part of the search strategy. STUDY ELIGIBILITY CRITERIA: We included all studies that reported on the frequency of shoulder dystocia and the associated complications before and after the implementation of interventional exercises to improve outcomes. METHODS: Two authors independently assessed the abstracts and full-text articles of all studies for eligibility and evaluated the quality of the included studies using the Newcastle-Ottawa Scale. Any inconsistencies related to study evaluation or data extraction were resolved by a third author. The coprimary outcomes of this systematic review and meta-analysis were neonatal brachial plexus palsy diagnosed following deliveries complicated by shoulder dystocia and persistence of brachial palsy at 12 months or later. The secondary outcomes were the frequency of shoulder dystocia and cesarean delivery. Study effects were combined using a Bayesian meta-analysis and were reported as risk ratios and 95% credible intervals (Crs). RESULTS: Of the 372 articles reviewed, 16 publications, which included 428,552 deliveries with 217,713 (50.8%) deliveries during the preintervention and 210,839 (49.2%) deliveries during the postinterventional period, were included in the meta-analysis. The incidence of neonatal brachial plexus palsy after shoulder dystocia decreased from 12.1% to 5.7% (risk ratio, 0.37; 95% Cr, 0.26-0.57; probability of reduction 100%). The overall proportion of neonatal brachial plexus palsy decreased, but with less precision, from 0.3% to 0.1% (risk ratio, 0.53; 95% Cr, 0.21-1.26; probability of reduction 94%). Two studies followed newborns with brachial plexus palsy for at least 12 months. One study that reported on persistent neonatal brachial plexus palsy at 12 months among 1148 shoulder dystocia cases noted a reduction in persistent neonatal brachial plexus palsy from 1.9% to 0.2% of shoulder dystocia cases (risk ratio, 0.13; 95% confidence interval, 0.04-0.49). In contrast, the study that reported on persistent neonatal brachial plexus palsy at 12 months for all deliveries noted that it did not change significantly, namely from 0.3 to 0.2 per 1000 births (risk ratio, 0.77; 95% confidence interval, 0.31-1.90). Following the implementation of shoulder dystocia interventional exercises, the diagnosis of shoulder dystocia increased significantly from 1.2% to 1.7% of vaginal deliveries (risk ratio, 1.39; 95% Cr, 1.19-1.65; probability of increase 100%). Compared with the preimplementation period, the cesarean delivery rate increased postimplementation from 21.2% to 25.9% (risk ratio, 1.22; 95% Cr, 0.93-1.59; probability of increase 93%). We created an online tool (https://ccrebm-bell.shinyapps.io/sdmeta/) that permits calculation of the absolute risk reduction and absolute risk increase attributable to the intervention vis-à-vis the incidence of shoulder dystocia, neonatal brachial plexus palsy, and cesarean deliveries. CONCLUSION: Introduction of shoulder dystocia interventional exercises decreased the rate of neonatal brachial plexus palsy per shoulder dystocia case; the data on persistence of neonatal brachial plexus palsy beyond 12 months is limited and contradictory. Implementation of the interventions was associated with an increase in the diagnosis of shoulder dystocia and rate of cesarean deliveries.

Establishment of transfusion-relevant bacteria reference strains for red blood cells.

BACKGROUND AND OBJECTIVES: Red blood cell concentrates (RBCC) are susceptible to bacterial contamination despite cold storage. A reliable evaluation of strategies to minimize the risk of RBCC-associated bacterial transmission requires the use of suitable reference bacteria. Already existing Transfusion-Relevant Bacteria Reference Strains (TRBRS) for platelet concentrates fail to grow in RBCC. Consequently, the ISBT TTID, Working Party, Bacterial Subgroup, conducted an international study on TRBRS for RBCC. MATERIALS AND METHODS: Six bacterial strains (Listeria monocytogenes PEI-A-199, Serratia liquefaciens PEI-A-184, Serratia marcescens PEI-B-P-56, Pseudomonas fluorescens PEI-B-P-77, Yersinia enterocolitica PEI-A-105, Yersinia enterocolitica PEI-A-176) were distributed to 15 laboratories worldwide for enumeration, identification, and determination of growth kinetics in RBCC at days 7, 14, 21, 28, 35 and 42 of storage after low-count spiking (10-25 CFU/RBCC). RESULTS: Bacterial proliferation in RBCC was obtained for most strains, except for S. marcescens, which grew only at 4 of 15 laboratories. S. liquefaciens, S. marcescens, P. fluorescens and the two Y. enterocolitica strains reached the stationary phase between days 14 and 21 of RBCC storage with a bacterial concentration of approximately 109  CFU/ml. L. monocytogenes displayed slower growth kinetics reaching 106 -107  CFU/ml after 42 days. CONCLUSION: The results illustrate the importance of conducting comprehensive studies to establish well-characterized reference strains, which can be a tool to assess strategies and methods used to ameliorate blood safety. The WHO Expert Committee on Biological Standardization adopted the five successful strains as official RBCC reference strains. Our study also highlights the relevance of visual inspection to interdict contaminated RBC units.

Digitally Fabricated Removable Complete Denture Clinical Workflows using Additive Manufacturing Techniques.

The use of computer aided design and computer aided manufacturing in the fabrication of complete removable dentures has demonstrated that the prostheses produced are superior in many ways to removable dentures produced using analog techniques. A variety of clinical workflows that take advantage of digital technology have been shown to shorten the number of appointments required to produce high quality prostheses. This paper presents an overview of additive manufacturing in contemporary removable complete denture workflows and describes effective three appointment clinical techniques using additive manufacturing to produce a clinical trial denture and definitive prosthesis.

CAD/CAM Complete Denture Systems and Physical Properties: A Review of the Literature.

PURPOSE: CAD/CAM complete dentures have increased in popularity and a wide variety of systems are currently available. These prostheses present many advantages for clinicians, technicians and patients. Subtractive manufacturing is used by most of the available systems while a few manufacturers use an additive manufacturing technique. This article describes the currently available systems and materials available for the fabrication of CAD/CAM complete dentures and reviews the literature relative to their physical properties. METHODS: A comprehensive review of the literature was completed to enumerate the currently available techniques to fabricate CAD/CAM complete dentures and discuss their physical properties. A search of English language peer-reviewed literature was undertaken using MEDLINE and PubMed on research articles published between 2000 and 2019. A hand search of relevant dental journals was also completed. RESULTS: The literature indicates the physical properties of CAD/CAM milled poly(methylmethacrylate) or PMMA as it is commonly described is superior to conventionally processed PMMA for the fabrication of complete dentures. CONCLUSION: The incorporation of CAD/CAM technology into complete denture design and fabrication streamlines the clinical and laboratory processes and provides improved physical properties that enhance denture quality.

Preliminary characterization of the properties of cold-stored apheresis platelets suspended in PAS-III with and without an 8-hour room temperature hold.

BACKGROUND: Use of extended cold storage of platelets promises to increase PLT availability and the bacterial safety of bleeding patients. No information is currently available on the preservation of apheresis PLT in vitro quality parameters when PLTs are held at room temperature early in the storage period prior to transfer to cold storage. STUDY DESIGN AND METHODS: Double units of platelets suspended in 35% plasma/65% PAS-III were collected from normal consenting research donors and rested at room temperature for 1-2 hours. One of the units was then stored at 1-6°C while the other unit was placed on an agitator at 20-24°C. Eight hours after collection, the unit stored at room temperature was transferred to 1-6°C storage without agitation. Units were sampled for an array of PLT in vitro parameters on Days 1, 7, 14, and 21. RESULTS: As expected, PLTs held for 8 hours at 20-24°C prior to 1-6°C storage had greater lactate levels and reduced glucose levels and pH compared to PLTs subjected to a 1-2-hour room temperature hold prior to cold storage (P < .05). Unexpectedly, platelets held for 8 hours at room temperature had less aggregation response to collagen, ADP, and TRAP compared to PLTs held 1-2 hours at room temperature prior to cold storage (P < .05, n = 8). CONCLUSION: Decline of aggregation response should be considered when evaluating longer than necessary room temperature holds prior to cold storage of platelets.

Validation of a SCID mouse model for transfusion by concurrent comparison of circulation kinetics of human platelets, stored under various temperature conditions, between human volunteers and mice.

BACKGROUND: Initial evaluation of new platelet (PLT) products for transfusion includes a clinical study to determine in vivo recovery and survival of autologous radiolabeled PLTs in healthy volunteers. These studies are expensive and do not always produce the desired results. A validated animal model of human PLTs in vivo survival and recovery used pre-clinically could reduce the risk of failing to advance product development. STUDY DESIGN AND METHODS: An immunodeficient (SCID) mouse model to evaluate recovery of human PLTs was compared to a radiolabeling study in human volunteers. Autologous apheresis PLTs stored for 7 days at room temperature (RT), thermo-cycled (TC), and cold temperature (CT) were radiolabeled and infused into healthy humans (n = 16). The same PLTs, non-radiolabeled, were also infused into mice (n = 160) on the same day. Blood samples from humans and mice were collected to generate clearance curves of PLTs in circulation. Flow cytometry was used to detect human PLTs in mouse blood. RESULTS: Human and mouse PLTs were cleared with one phase exponential clearance. Relative differences for initial recovery and AUC, expressed as ratio of test and control PLTs, were similar in humans and mice. The initial recovery ratio of TC/RT was 0.73 ± 0.07 in humans and 0.67 ± 0.14 in mice. The ratio for CT/TC was 0.53 ± 0.06 in humans and 0.75 ± 0.18 in mice. CONCLUSION: The SCID mouse model can provide information on relative differences of initial in vivo recovery and AUC between control and alternatively stored/processed human PLTs that is predictive of performance in healthy human volunteers.

Sepsis from an apheresis platelet contaminated with Acinetobacter calcoaceticus/baumannii complex bacteria and Staphylococcus saprophyticus after pathogen reduction.

BACKGROUND: Strategies to reduce platelet (PLT) bacterial contamination include donor screening, skin disinfection, sample diversion, bacterial culture, pathogen reduction (PR), and day-of-transfusion tests. We report bacterial sepsis following a pathogen-reduced PLT transfusion. CASE REPORT: An adult male with relapsed acute lymphoblastic leukemia was successfully treated for central catheter-associated Staphylococcus aureus bacteremia. A peripherally inserted central catheter (PICC) was placed. Chills, rigors, and flushing developed immediately after PICC-infused pathogen-reduced PLTs, progressing to septic shock requiring intensive care management. METHODS: PICC and peripheral blood (PB), transfused bag saline flushes (TBFs), environmental samples, and the pathogen-reduced untransfused co-component (CC) were cultured. Plasma metagenomic and bacterial isolate whole-genome sequencing; PLT mitochondrial DNA (mtDNA) testing of untransfused CC and TBF; CC testing for amotosalen (S-59)/S-59 photoproducts; isolate PR studies (INTERCEPT); and TBF polymerase chain reaction for recipient Y-chromosome DNA were performed. RESULTS: PB and PICC cultures grew Acinetobacter calcoaceticus/baumannii complex (ACBC). TBF was gram-positive; mass spectrometry identified ACBC and Staphylococcus saprophyticus (SS). CC Gram stain and cultures were negative. Environmental cultures, some done after decontamination, were ACBC/SS negative. Posttransfusion patient plasma and TBF ACBC sequences were genetically identical. No Y-chromosome signal was detected in TBF. S-59 photoproducts and evidence of mtDNA amplification inhibition were found in the CC. Spiking PR studies showed >5.9-log inactivation for both isolates. Donor skin cultures for Acinetobacter were negative. CONCLUSION: CC sterility, PR studies, residual S-59 photoproducts, and mtDNA amplification inhibition suggest successful PR. Unidentified environmental sources and inherent or acquired bag defects may have contributed to postmanufacturing pathogen-reduced PLT contamination.

The Influence of Academic Hospitalists on Labor and Delivery Outcomes.

BACKGROUND: Our goal was to examine differences in maternal and neonatal outcomes following the transition from a private practice to an academic model at a community hospital. METHODS: This is a retrospective cohort study of a high-volume community hospital labor and delivery unit. A private practice hospitalist group was replaced with academic hospitalists. Maternal and neonatal outcomes for patients cared for by these groups were compared. The primary outcome was a composite of maternal morbidity that included blood transfusion, anal sphincter injuries, dilation and curettage, hysterectomy, chorioamnionitis, endometritis, wound infection, intensive care unit admission, and readmission. The secondary outcomes were cesarean delivery rate and a composite of neonatal morbidity that included Apgar score ≤3 at 5 min, shoulder dystocia, birth trauma, seizure, sepsis, necrotizing enterocolitis, intraventricular hemorrhage, or mechanical ventilation. RESULTS: 245 patients were delivered by private physicians and 447 by academic physicians over the study period. No difference in the composite maternal morbidity between private and academic hospitalist groups was identified (21 vs. 25%; aOR 1.37, 95% CI: 0.36-5.21). The academic hospitalist group had a higher cesarean delivery rate compared to the private group (25 vs. 18%; aOR 2.03, 95% CI: 1.17-3.53). There was no difference in a composite neonatal morbidity (9 vs. 8%; aOR 0.92, 95% CI: 0.052-1.63). CONCLUSION: Women cared for by academic hospitalists were more likely to have a cesarean delivery, but there was no difference in maternal or neonatal morbidity in patients delivered by private or academic hospitalists.

Sodium citrate contributes to the platelet storage lesion.

BACKGROUND: Sodium citrate has become the preferred anticoagulant used for apheresis collection and has been included in commercial platelet additive solutions (PASs) since PAS-II. It was suggested that citrate be included in PASs to prevent spontaneous aggregation. Reports in cell lines and cord blood have demonstrated that concentrations of citrate present in PAS formulations (10 mM) cause apoptosis. We evaluated whether the removal of citrate from PAS-III could improve platelet storage. STUDY DESIGN AND METHODS: Study 1 evaluated the effects of a citrate dose response on the storage of platelets in 65% PAS containing sodium chloride, sodium acetate, and phosphate. Study 2 compared the cell quality and function of platelets stored in 65% citrate-free PAS-III or PAS-III containing 10 mM of citrate. Measurements included cell count, blood gases, flow cytometry analysis of surface activation markers, and aggregation. RESULTS: Study 1 identified that inclusion of citrate in PAS resulted in a dose-dependent increase in glucose utilization, lactate formation, P-selectin expression, phosphatidylserine (PS) exposure, and reactive oxygen species (ROS) formation. Study 2 showed similar results in which platelets stored in citrate-free PAS-III benefited through better maintenance of glucose utilization with less lactate production, P-selectin expression, PS exposure, and ROS formation compared to citrate-containing PAS-III. Platelets stored in citrate-free PAS-III had aggregation responses that were at least 10% greater than those platelets stored in PAS-III. CONCLUSION: Storage of apheresis platelets in citrate-free PAS-III improved multiple storage parameters including glucose utilization, lactate production, P-selection expression, PS exposure, and ROS formation and resulted in a modest increase in aggregation.