Higher Risk Of Adverse Outcomes Research Articles

Correction of the effect of direct oral and parenteral anticoagulants in hemorrhagic stroke

Hemorrhagic stroke is associated with high risk of adverse outcome and follows intake of anticoagulants and antiplatelet agents in 25% of cases. The latest clinical guidelines of the Neurocritical Care Society for correction (reversal) of the effect of anticoagulants and antiplatelet agents in hemorrhagic stroke were published in 2016. In accordance with PRISMA recommendations, we reviewed the PubMed, eLibrary and UpToDate databases to a depth of 5 years and selected 48 articles. Direct oral anticoagulants are currently common. To reverse their effect, one can use specific antidotes (idarucizumab is recommended for dabigatran, andexanet alfa (not yet registered In Russia) for factor Xa inhibitors (rivaroxaban, apixaban)) and combination of prothrombin complex concentrate and tranexamic acid. Protamine sulfate is antidote for unfractionated and low molecular weight heparins. Protamine sulfate completely inactivates unfractionated heparin, but it is less effective against low molecular weight heparin. It is characterized by high probability of anaphylactic reactions, especially after repeated administrations. The effectiveness of andexanet alpha and activated factor VII for reversing the effect of low molecular weight heparin is being studied. Fondaparinux sodium is used for heparin-induced thrombocytopenia. Protamine sulfate is ineffective for reversing the effect of fondaparinux. One can use prothrombin complex concentrate and andexanet alpha, but their effectiveness is unclear. Ciraparantag is being studied in clinical trials. Apparently, ciraparantag is highly effective as an antidote for various anticoagulants. Early hemostatic therapy and reversal of anticoagulant effects in patients with hemorrhagic stroke significantly reduce the risk of adverse outcomes. This problem is being studied. Regular literature review with creation of updated clinical guidelines is needed.

Use of Macrogol to accelerate feeding advancement in extremely preterm infants

Introduction Delayed enteral nutrition is associated with a higher risk for adverse outcomes in extremely preterm infants. Limited evidence exists on therapeutic options to support meconium evacuation and increase gastrointestinal motility. The aim of this study was to determine the effect of macrogol on feeding tolerance and microbiome establishment in preterm infants < 27 weeks of gestation. Methods We investigated the impact of early macrogol administration in two observational cohort studies: the multi-center German-Neonatal-Network (GNN) study comparing extremely preterm infants born in Neonatal intensive care units (NICUs) using macrogol in the first week of life in >30% of their infants as compared to the remaining units, and the single center Immunoregulation-of-the-Newborn (IRoN) study including gut microbiome assessment of infants born before and after implementation of macrogol use in this NICU. Results In the GNN study cohort including 4290 infants, advancement to full enteral feedings was significantly faster in macrogol-using NICUs compared to the remaining NICUs (median/SD: 14/16.5 vs. 16/16.7days, p=0.001). Risk for short-term outcomes such as sepsis or abdominal complications was not elevated in units with regular use of macrogol. In the IRoN cohort (n=68), macrogol treated infants had a shorter time to reach full enteral feeding (median/SD: Macrogol 12/4.8, Control 16/6.6days, p=0.004). Higher Bifidobacterium longum abundance in the gut microbiome correlated with acceleration to full enteral nutrition. Conclusion Our observational data suggests that early off-label use of macrogol may support feeding advancement in highly vulnerable babies. These data provide a basis for a randomized controlled trial.

Valvular heart disease in transthyretin cardiac amyloidosis

Abstract Introduction Amyloidosis cardiomyopathy (CM) is known to be associated with valvular heart disease (VHD) and particularly with aortic stenosis (AS). However, previous studies included both immunoglobulin light-chain CM and transthyretin amyloid CM (ATTR-CM), with limited data focussing specifically on ATTR-CM. Furthermore, VHD assessment was mostly limited to isolated significant VHD, and the difference in outcome between isolated and multiple VHD is largely unknown. Aim To evaluate the prevalence and prognostic value of significant VHD in ATTR-CM patients, including the differences in outcome between isolated and multiple significant VHD, with or without AS. Methods Patients with ATTR-CM were retrospectively included in this multicentric study. Significant VHD was defined as at least moderate VHD. The study endpoint was a composite of heart failure hospitalisations and all-cause death. Results A total of 694 ATTR-CM patients (mean age 75 ±13 years, 74% male) were included, and 302 (44%) presented with significant VHD (Figure 1). These patients were older (81±9 vs. 71±13, p<0. 001), had more cardiovascular risk factors, lower left ventricular ejection fraction (50±12 vs. 54±12, p<0.001) and more pulmonary arterial hypertension (76% vs. 45%, p<0.001), as compared to patients without significant VHD. Among patients with significant VHD, only 98 patients had VHD including AS (isolated AS in 45%; multiple VHD with AS in 55%), while the majority (n=204) had VHD without AS (isolated in 64%, multiple VHD in 36%) (Figure 1). During a median follow-up of 16 (6 - 33) months, 214 (31%) patients reached the study endpoint. Univariable Cox regression analysis identified significant VHD as a predictor of worse outcomes (HR: 3.486; 95% CI: 2.627 - 4.626; p < 0.001), which remained significant in the multivariable Cox regression analysis (HR: 1.879;95%CI:1.182 - 2.987;p=0.008), after adjusting for transthyretin amyloid cardiomyopathy phenotype, disease-modifying treatment, coronary artery disease, atrial fibrillation, renal function, New York Heart Association III-IV, polyneuropathy, electrocardiographic abnormalities, left ventricular stroke volume, interventricular septum thickness, left atrial dilatation, tricuspid annular plane systolic excursion, and arterial pulmonary hypertension(Figure2). Further stratification based on the presence of significant AS, and according to isolated or multiple VHD, revealed that patients isolated significant AS (HR:2.399;95%CI 1.179 – 4.884;p=0.016), and patients with multiple VHD including significant AS, had the highest risk for adverse outcomes (HR:3.542; 95%CI: 1.809 - 6.935;p<0.001)(Figure 2). Conclusion In ATTR-CM, significant VHD is strongly associated with poor prognosis, with the highest risk for adverse events in patients with significant multiple VHD including AS. These findings underscore the importance of VHD assessment for risk stratification and possibly targeted treatment in this patient population. The distribution of significant VHD.

Evaluating the ability of fullPIERS calculator to predict adverse maternal outcomes in pre-eclampsia at Charlotte Maxeke Johannesburg Academic Hospital.

To evaluate the ability of the fullPIERS model to predict adverse maternal outcomes in patients diagnosed as early-onset pre-eclampsia at Charlotte Maxeke Johannesburg Academic Hospital, South Africa. Retrospective record review and analysis of 134 patients admitted with early-onset pre-eclampsia. Demographic data, symptoms, and investigation results relevant to the fullPIERS calculator present on admission were collected. Adverse maternal outcomes occurring before the end of 7 days from admission were recorded. Descriptive analysis was conducted, χ2 and Wilcoxon rank-sum tests were used to evaluate the association between fullPIERS parameters, score, and adverse outcomes. Performance of fullPIERS score was evaluated by positive and negative predictive values, sensitivity, specificity, and receiver operating curve analysis. The median age was 34 years (interquartile range [IQR] 28-37 years). A total of 131 deliveries were recorded at a median gestation of 31 weeks (IQR 29-33 weeks). Most deliveries (71; 54.2%) were due to fetal indications and 102 (77.9%) were by cesarean section. A total of 20 (15.1%) patients had adverse maternal outcomes. Three (2.6%) neonates were delivered with Apgar score less than 7 at 5 minutes and were all admitted to the neonatal intensive care unit. FullPIERS formula predicted adverse maternal outcomes with positive and negative predictive values of 100% and 94.9%, respectively, and sensitivity and specificity of 70% and 100%, respectively. The area under the receiver operating characteristic curve was 0.88 (95% confidence interval 0.75-0.95), which shows good discrimination. FullPIERS model is a useful adjunct in identifying patients at high risk of adverse outcomes from early-onset pre-eclampsia; this allows timely and appropriate management.

Independent risk factors for twin pregnancy adverse fetal outcomes before 28 gestational week by first trimester ultrasound screening.

The incidence of multiple pregnancies has increased worldwide recently and women with a twin pregnancy are at higher risk of adverse outcomes compared with women with a singleton pregnancy. It is important to understand the risk factors for adverse fetal outcomes in twin pregnancy in order to guide clinical management. To identify the independent risk factors, including maternal personal and family medical histories and first trimester ultrasound screening findings, for adverse fetal outcomes of twin pregnancy before 28 weeks of gestation. The data of 126 twin pregnancies in our hospital, including pregnancy outcomes, first trimester ultrasound screening findings and maternal medical history, were retrospectively collected. Twenty-nine women with adverse outcomes were included in the abnormal group and the remaining 97 women were included in the control group. Patients in the abnormal group were more likely to be monochorionic diamniotic (13/29 vs 20/97, P= 0.009), with a higher mean pulsatility index (PI, 1.57 ± 0.55 vs 1.28 ± 0.42, P = 0.003; cutoff value: 1.393) or a higher mean resistance index (0.71 ± 0.11 vs 0.65 ± 0.11, P = 0.008; cutoff value: 0.683) or early diastolic notch of bilateral uterine arteries (UtAs, 10/29 vs 15/97, P = 0.024) or with abnormal ultrasound findings (13/29 vs 2/97, P < 0.001), compared with the control group. Monochorionic diamnioticity, higher mean PI of bilateral UtAs and abnormal ultrasound findings during first trimester screening were independent risk factors for adverse fetal outcomes (P < 0.05). First trimester ultrasound screening for twin pregnancy identifies independent risk factors and is useful for the prediction of fetal outcomes.

Cardiovascular Reactivity to Mental Stress and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease.

Acute psychological stress may induce physiological changes predisposing individuals to adverse health outcomes through hemodynamic and vascular effects. We studied the association between the aggregated stress-induced changes in hemodynamic and vascular function tests with adverse cardiovascular outcomes in patients with coronary artery disease, after adjusting for sociodemographic and clinical factors. Individuals with stable coronary artery disease from 2 prospective cohort studies were studied. Hemodynamic reactivity, changes in endothelial function, and vasoconstriction during mental stress were evaluated using changes in rate-pressure product, brachial artery flow-mediated vasodilation, and peripheral arterial tonometry, respectively. A cardiovascular reactivity risk score was calculated by allotting 0 to 3 points for each quartile of increasing abnormality for each of the 3 reactivity responses and summing the quartile points from the MIPS (Mental Stress Ischemia Prognosis Study) to yield a cardiovascular reactivity risk score ranging from 0 to 9. The outcome was a composite of cardiovascular death, nonfatal myocardial infarction, and heart failure hospitalizations during follow-up. A total of 629 participants were included. After adjustment for demographic and traditional risk factors, a blunted hemodynamic response, a greater decrease in flow-mediated vasodilation, and a greater degree of peripheral vasoconstriction to mental stress were all independently associated with a higher risk of adverse outcomes in both cohorts. By adding the cardiovascular reactivity risk score, the C-statistic increased significantly by 10% (P<0.001). Among individuals with stable coronary artery disease, a risk score derived from cardiovascular reactivity to mental stress was predictive of adverse cardiovascular outcomes beyond traditional cardiovascular risk factors.

Association between triglyceride-glucose index and all-cause mortality in critically ill patients with acute myocardial infarction: analysis of the MIMIC-IV database.

Currently, the clinical evidence regarding the prognostic significance of the TyG index in acute myocardial infarction (AMI) patients remains unclear. Our research analyzed the correlation between the TyG index and the risk of mortality in patients with AMI, in order to evaluate the influence of the TyG index on the prognosis of this population. 1205 ICU patients with AMI were analyzed in this retrospective cohort analysis, and the necessary data were obtained from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. The study conducted Kaplan-Meier analysis to compare all-cause mortality rates across four groups of patients. The study included logistic regression and Cox regression analysis to examine the correlation among the TyG index and the risk of in-hospital, 28-day, and 90-day mortality. In our study, 176 (14.61%) patients experienced in-hospital deaths, 198 (16.43%) patients died within 28 days of follow-up, and 189 (23.98%) patients died within 90 days of follow-up. Logistic regression and Cox proportional hazard analyses revealed that the TyG index was an independent predictor of in-hospital, 28-day, and 90-day mortality (OR: 1.406, 95% CI 1.141-1.731, p = 0.001; HR: 1.364, 95% CI 1.118-1.665, p = 0.002; HR: 1.221, 95% CI 1.024-1.445, p = 0.026, respectively). The restricted cubic spline regression model showed that the risk of in-hospital, 28-day, and 90-day mortality increased linearly with increasing TyG index. The TyG index was significantly associated with an increased risk of mortality in AMI patients. Our findings suggested that the TyG index may be instrumental in identifying patients at high risk for adverse outcomes following AMI.

P0452 Complicated and Extra-Complicated Crohn’s Disease Course: a Prospective Inception Real-World Cohort

Abstract Background Crohn’s disease (CD) is a heterogeneous condition with a potentially complicated course. We aimed to evaluate the rates of a complicated disease course within a real-world prospective inception cohort of patients with newly diagnosed CD (ndCD). Methods A prospective, observational, longitudinal cohort study involving consecutive adults with ndCD was conducted at a tertiary referral center. Patients were managed at the discretion of their treating physician. Key outcomes were defined as ‘complicated disease course’ (any CD-related hospitalization, any CD-related surgery, steroid dependency, or ≥2 biologics) and ‘extra-complicated disease course’ (recurrent or &amp;gt;5-days hospitalization, multiple perianal procedures, CD-related intestinal resection, or ≥3 biologics) over time. The Chi-square Automatic Interaction Detector (CHAID) technique was used to identify cutoffs of clinical indices and blood count values at diagnosis associated with a complicated disease course at one year post-diagnosis. Kaplan-Meier survival analysis was used to assess complication rates over time, and multivariable Cox regression analysis was used to identify risk factors. Results A total of 192 patients with ndCD with a median age of 26 years (IQR: 21-36) were included, of whom 45.8% were female. Phenotypes included 18.8% with stricturing (B2), 9.9% with penetrating (B3), and 19.3% with perianal (P) disease. The median follow-up period was 3.9 years (IQR: 1.5-5). The cumulative rates of complicated and extra-complicated disease courses were 24.2% and 12.9% at one year, 35.9% and 18.9% at three years, and 51.3% and 26.6% at five years post-diagnosis, respectively. Patients with progressive phenotypes (B2, B3, or P) at diagnosis had a significantly elevated risk for both complicated (HR 3.362, 95% CI: 1.992-5.673) and extra-complicated disease course (HR 6.724, 95% CI: 3.36-14.418). Baseline laboratory values contributing to risk stratification included a platelet count above 370x103/uL (HR 2.64, 95% CI: 1.583-4.401 for complicated course; HR 4.105, 95% CI: 2.043-8.247 for extra-complicated course) and lymphocyte count above 1.2x103/uL (HR 1.800, 95% CI: 1.034-3.133 for extra-complicated course). Conclusion Nearly half of patients with ndCD experience a complicated disease course within five years, with progressive phenotypes at diagnosis significantly increasing the risk. Elevated platelet and lymphocyte count at diagnosis may further identify individuals at a higher risk for adverse outcomes (‘extra-complicated course’).

P0504 The Impact of Disease Activity and Medications on Pregnancy and Fetal Outcomes in Women With Inflammatory Bowel Disease: A Cohort Study From the IBD-ME Group

Abstract Background Women with Inflammatory bowel disease (IBD) and their children may face a higher risk of adverse outcomes during and after pregnancy. The primary aim was to examine the association between IBD and adverse pregnancy outcomes: preterm birth, small for gestational age, birth weight, congenital anomalies, and stillbirth. The secondary aim was to assess the impact of maternal IBD and medications used on children’s outcomes: adverse reactions to vaccinations and development of IBD in the offspring up until seven years of age. Methods We performed a multicenter retrospective study in Saudi Arabia and Kuwait. Three participating hospitals enrolled women with IBD who gave birth between 2016 and 2023. Information regarding disease characteristics, medication use, pregnancy outcomes, and long-term health outcomes of children until age fourteen was collected. Results This study analyzed data from 167 patients with a median age of 37.0 years (IQR: 33.0 to 44.0). Crohn’s disease was the most common type of IBD (51.2%), followed by ulcerative colitis (46.3%). Of note, 42.7% of the women were on mesalamine, while 25.1% of the study population were on both anti-TNF agents and Azathioprine. The most frequent pregnancy outcome was low birth weight (22.5%), and 8.2% of the offsprings were diagnosed with IBD. A history of having six or more pregnancies significantly predicted IBD in an offspring (OR = 4.02, 95% CI, 1.19 to 14.8, p &amp;lt; 0.01). In contrast, disease control before pregnancy significantly reduced the risk of adverse infant outcomes (OR = 0.10, 95% CI, 0.01 to 0.61, p &amp;lt; 0.01). None of the IBD medications predicted poor pregnancy outcomes. Conclusion Infants of women with active IBD have an increased risk of prematurity and being small for gestational age. Number of pregnancies was a significant predictor for IBD in an offspring. Controlling disease activity at conception is essential to improve both pregnancy and fetal outcomes.

Placental trophoblast aging in advanced maternal age is related to increased oxidative damage and decreased YAP.

The advanced maternal age (AMA) pregnancies escalate rapidly, which are frequently linked to higher risks of adverse outcomes. Advanced maternal age (AMA) placenta exhibited premature aging, presumably resulting in trophoblast dysfunction, inadequate placentation. However, the precise reasons and mechanisms of trophoblast aging in AMA placenta remain unclear, posing a significant limitation to provide effective guidance for prenatal healthcare in clinical settings. Notably, the organism shows heightened vulnerability to oxidative damage as it ages. YAP (Yes-associated protein) was reported to play a critical role in regulation of aging and resisting oxidative damage, yet these roles had not been elucidated in the placenta. Therefore, this study explored the relationship between trophoblast cell aging and oxidative injury and YAP in AMA pregnancy, which not only provided an insight into the mechanisms of trophoblast cell aging, but also provide valuable directions for healthcare during AMA pregnancy. In this study, human term placentas were collected from AMA and normal pregnancies for the analysis of aging, oxidative damage and YAP level. HTR8/SVneo cells were manipulated with (hydrogen peroxide) H2O2 to explore the effects of oxidative damage on trophoblast cell senescence and YAP levels. YAP expression in HTR8/SVneo cells was manipulated to investigate its role in trophoblastic senescence and oxidative damage. Compared with the control group, the AMA placenta exhibits increased aging biomarkers, which is coupled with an elevation in oxidative damage within placental trophoblast cells and a notable decline in YAP levels. Cellular experiments demonstrated that oxidative damage from H2O2 triggered trophoblast cell senescence and resulted in a reduction of YAP levels. Furthermore, employing molecular modification to silence YAP expression in these cells led to an induction of aging. Conversely, overexpressing YAP ameliorated both trophoblast cell aging and the associated DNA oxidative damage that arised from H2O2. The decline of YAP in AMA pregnancy should be responsible for the increased oxidative injury and premature placenta aging, indicating that YAP plays a significant role in combating oxidative damage and delaying aging, thereby providing a new guidance for prenatal care in AMA pregnancies. Maintaining YAP levels or implementing anti-oxidative stress interventions could potentially mitigate the incidence of complications involved AMA pregnancy.

Firearm injury survivors report extreme high risk for poor physical and mental health outcomes early after hospital discharge necessitating multidisciplinary care

BackgroundUp to 20–40% of survivors of any traumatic injury develop post-traumatic stress disorder (PTSD) or depression after injury. Firearm injury survivors may be at even higher risk for adverse outcomes....

The value of blood lactate and lactate clearance rate in evaluating the prognosis of athletes with heat illness of varying degrees after high-intensity exercise

BackgroundHeat stroke, a severe heat illness with organ damage, is a major cause of cause irreparable organ damage and higher death rates among military persons and athletes.ObjectivesTo study the changes in blood lactate (Lac) levels and lactate clearance rate (LCR) in athletes with heat illness of varying degrees after high-intensity exercise and to evaluate their prognostic value.Material and methodsIn present study, acute care unit admitted 36 heat sickness patients following high-intensity exercise from December 2019 to July 2024, with comprehensive medical records, for retrospective study. The study population consisted of two groups of high level athletes: the favourable Prognosis Group (< 7 days, 22 cases), comprising 21 males and 1 female with a mean age of 21.8 ± 2.7 years, and the bad Prognosis Group (≥ 7 days, 14cases), consisting of 14 males with a mean age of 22.6 ± 3.2 years. Lac levels were assessed at admission (0 h) and early in therapy (2 h, 6 h), and the LCR was computed. Lac and LCR values at each time point were compared between the two groups to see how they affected patient prognosis.ResultsAfter 2 and 6 h of therapy, lactate levels decreased significantly in the good prognosis group (1.2 ± 0.5 mmol/L at 2 h and 0.8 ± 0.3 mmol/L at 6 h), but remained elevated in the poor prognosis group (4.2 ± 1.2 mmol/L at 2 h and 3.5 ± 1.5 mmol/L at 6 h). Core body temperature normalized in both groups, but the good prognosis group showed a more rapid decline, with temperatures of 37.4 ± 0.6 °C at 2 h and 36.8 ± 0.4 °C at 6 h in the good prognosis group, and 38.8 ± 0.8 °C at 2 h and 38.2 ± 0.9 °C at 6 h in the poor prognosis group. Notably, a significant positive correlation existed between lactate levels and APACHE II scores at admission (P < 0.01). Furthermore, logistic regression analysis revealed that the 2-hour lactate clearance rate (LCR) (R2 = 0.83) was an independent predictor of outcomes.ConclusionsThe study suggests that athletes with elevated lactate levels after heat illness may be at higher risk of adverse outcomes. The 2-hour lactate clearance rate (LCR) appears to be a valuable prognostic indicator, with potential applications in evaluating the severity of heat illness and guiding treatment decisions. Furthermore, dynamic monitoring of lactate levels in conjunction with LCR may provide valuable insights into the clinical management and prognosis of athletes with heat-related illnesses.

Association between body mass index at birth and neonatal health outcomes in preterm infants: A retrospective analysis.

Studies on how birth body mass index (BMI) affects health outcomes in preterm infants are relatively limited. To analyze the association between BMI at birth and neonatal health outcomes in extremely low and very low birth weight preterm infants in China. Used data from the Chinese Premature Infant Informatization Platform (2022-2023). Preterm infants were categorized based on their birth BMI z-scores into three groups: low BMI group (< -2), normal BMI group (-2 to 2) and high BMI group (>2). The relationship between BMI and neonatal health outcomes was then analyzed. The final analysis included 1662 extremely low and very low birth weight preterm infants. The results indicated that low BMI was significantly associated with an increased risk of respiratory distress syndrome (RDS) (AOR 1.61, 95% CI 1.31-2.30), bronchopulmonary dysplasia (BPD) (AOR 1.34, 95% CI 1.00-1.80) and necrotizing enterocolitis (NEC) (AOR 1.57, 95% CI 1.01-2.42). High BMI was significantly associated with an increased risk of RDS (AOR 1.60, 95% CI 1.05-2.45). BMI at birth is significantly associated with the risks of RDS, BPD and NEC in ELBW and VLBW, highlighting the importance of monitoring BMI as an additional risk predictor in a population of neonates already at high risk for adverse outcomes.

Maternal and neonatal outcomes after metabolic and bariatric surgery among women with severe obesity.

Earlier evidence indicated that metabolic and bariatric surgery (MBS) may adversely affect neonatal outcomes among patients conceiving soon after MBS, but recent studies demonstrated conflicting results, especially for new surgical techniques. The aim of this study was to assess the effects of MBS types and surgery to birth interval on maternal, birth, and nonbirth outcomes in women with severe obesity. New York State's all-payer hospital discharge database (2008-2019). We identified women with severe obesity who underwent MBS (Post-MBS, n = 5001) or did not undergo MBS (No-MBS, n = 74,515), and examined maternal, neonatal, and nonbirth outcomes by MBS type and time since surgery in a propensity score-matched sample. Compared with No-MBS mothers, Post-MBS mothers had a lower incidence of stillbirths, ectopic pregnancies, and miscarriages (nonoverlapping confidence intervals). Post-MBS mothers were also significantly less likely to have pregnancy hypertension, gestational diabetes, and cesarean deliveries, but were more likely to experience vaginal bleeding during early pregnancy and deliver low birthweight newborns compared with No-MBS mothers (P < .05). Among Post-MBS mothers, deliveries within 18 months after surgery were associated with higher rate of cesarean sections and neonatal deaths compared with deliveries 18+ months after MBS (P < .05). Pregnancies after gastric bypass (RYGB) were more likely to result in cesarean deliveries compared with pregnancies after sleeve gastrectomy (P < .01). Although weight loss surgery in women with obesity may reduce the rates of adverse maternal nonbirth outcomes and pregnancy complications, neonates born to women who conceived during the first year after MBS, especially RYGB, may be at higher risk for adverse outcomes.

Coronavirus Disease 2019 (COVID-19) Real World Data Infrastructure: A Big-Data Resource for Study of the Impact of COVID-19 in Patient Populations With Immunocompromising Conditions.

We developed a United States-based real-world data resource to better understand the continued impact of the coronavirus disease 2019 (COVID-19) pandemic on immunocompromised patients, who are typically underrepresented in prospective studies and clinical trials. The COVID-19 Real World Data infrastructure (CRWDi) was created by linking and harmonizing de-identified HealthVerity medical and pharmacy claims data from 1 December 2018 to 31 December 2023, with severe acute respiratory syndrome coronavirus 2 virologic and serologic laboratory data from major commercial laboratories and Northwell Health; COVID-19 vaccination data; and, for patients with cancer, 2010 to 2021 National Cancer Institute Surveillance, Epidemiology, and End Results registry data. The CRWDi contains 4 cohorts: patients with cancer; patients with rheumatic diseases receiving pharmacotherapy; noncancer solid organ and hematopoietic stem cell transplant recipients; and people from the general population including adults and pediatric patients. The project successfully linked and harmonized longitudinal, de-identified data on 5.2 million unique patients using privacy-preserving record lineage techniques. The system was developed in early 2024 and rapidly deployed, enabling longitudinal analysis of patient healthcare over the full geography of delivery settings and exploration of novel questions for populations at high risk for adverse outcomes. The successful development of the CRWDi enables researchers to address unanswered questions that have arisen during the COVID-19 pandemic. By making the data broadly and freely available to academic researchers, this real-world data system represents an important complement to existing consortia and clinical trials that have emerged during the healthcare crisis and is readily reproducible for future purposing.

Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials.

Patients undergoing percutaneous coronary intervention in vessels with moderate-to-severe tortuosity are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation stents. We compared outcomes following percutaneous coronary intervention in vessels with moderate-to-severe tortuosity using a bioresorbable-polymer sirolimus-eluting stent (BP-SES) vs a durable-polymer everolimus-eluting stent (DP-EES). A total of 2350 patients from the BIOFLOW II, IV, and V randomized trials were stratified into 2 groups based on target-vessel tortuosity: none-to-mild and moderate-to-severe. The primary endpoints included target lesion failure (TLF)-a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (TLR)-and probable/definite stent thrombosis at 3 years. Patients with moderate-to-severe tortuosity (n=903) had more comorbidities than those with none-to-mild tortuosity (n=1447). Rates of TLF (P=.354), cardiac death (P=.690), TLR (P=.447), and stent thrombosis (P=.084) were similar between the 2 groups, whereas TV-MI occurred more frequently in the moderate-to-severe tortuosity group (P=.031). However, on multivariate analysis, moderate-to-severe tortuosity was not an independent predictor of TV-MI (adjusted HR, 1.06; 95% CI, 0.72-1.55; P=.772). Among patients with moderate-to-severe tortuosity, the use of BP-SES was associated with significantly lower rates of TLF compared with the durable-polymer everolimus-eluting stent (7.8% vs 13.4%; HR, 0.57; 95% CI, 0.37-0.87; P=.009), driven by reductions in TV-MI (5.0% vs 9.2%; HR, 0.54; 95% CI, 0.32-0.90; P=.018) and TLR (2.7% vs 6.1%; HR, 0.45; 95% CI, 0.23-0.90; P=.021). This pooled analysis of the randomized BIOFLOW trials demonstrates that patients with none-to-mild and moderate-to-severe tortuosity have comparable long-term adverse event rates. However, the use of BP-SES in patients with moderate-to-severe tortuosity may help mitigate potential ischemic risks. Clinicaltrials.gov NCT01356888, NCT01939249, NCT02389946.

Evaluating ADHD medication trial representativeness: a Swedish population-based study comparing hypothetically trial-eligible and trial-ineligible individuals.

Randomised controlled trials (RCTs) evaluating ADHD medications often use strict eligibility criteria, potentially limiting generalisability to patients in real-world clinical settings. We aimed to identify the proportion of individuals with ADHD who would be ineligible for medication RCTs and evaluate differences in treatment patterns and clinical and functional outcomes between RCT-eligible and RCT-ineligible individuals. We used multiple Swedish national registries to identify individuals with ADHD, aged at least 4 years at the age of diagnosis, initiating pharmacological treatment between Jan 1, 2007, and Dec 31, 2019, with follow-up up to Dec 31, 2020. Hypothetical RCT ineligibility was established using exclusion criteria from the international MED-ADHD dataset, including 164 RCTs of ADHD medications. Cox models evaluated differences in medication switching and discontinuation within 1 year between eligible and ineligible individuals. Quasi-Poisson models compared eligible and ineligible individuals on rates of psychiatric hospitalisations, injuries or accidents, and substance use disorder within 1 year of initiating ADHD medications. People with lived experience of ADHD were not involved in the research and writing process. Of 189 699 individuals included in the study cohort (112 153 men and boys [59%] and 77 546 women and girls [41%]; mean age 21·52 years [SD 12·83; range 4-68]) initiating ADHD medication, 53% (76 477 [74%] of 103 023 adults [aged >17 years], 12 658 [35%] of 35 681 adolescents [aged 13-17 years], and 10 643 [21%] of 50 995 children [aged <13 years]) would have been ineligible for RCT participation. Ethnicity data were not available. Ineligible individuals had a higher likelihood of treatment switching (hazard ratio 1·14, 95% CI 1·12-1·16) and a decreased likelihood of medication discontinuation (0·96, 0·94-0·98) compared with eligible individuals. Individuals ineligible for RCTs had significantly higher rates of psychiatric hospitalisations (ncidence rate ratio 9·68, 95% CI 9·57-9·78) and specialist care visits related to substance use disorder (14·78, 14·64-14·91), depression (6·00, 5·94-6·06), and anxiety (11·63, 11·56-11·69). Individuals ineligible for ADHD medication trials face higher risks of adverse outcomes. This study provides the first empirical evidence for the limited generalisability of ADHD RCTs to real-world clinical populations, by applying eligibility criteria extracted from a comprehensive dataset of RCTs to a large real-world cohort. Triangulating evidence from RCTs and real-world studies is crucial to inform rigorous evidence-based treatment guidelines. National Institute of Healthcare and Research, European Union's Horizon 2020, and Swedish Research Council.

Telemedicine in Orthopedic Oncology: An Opportunity for Cost Savings Without Compromising Clinical Outcomes.

Prior work has demonstrated that telemedicine in orthopedic surgery is cost-effective and can yield good clinical outcomes with high patient satisfaction. However, few studies have investigated the use of telemedicine in orthopedic oncology. In this study, we assessed the effect of telemedicine on (1) potential cost savings for orthopedic oncologic patients and (2) clinical outcomes as measured by unexpected in-person clinic visits and missed complications. A total of 308 patients who had 528 telemedicine visits in the orthopedic oncology clinic from May 2020 to August 2023 were identified. Demographic and clinical information, travel distance/time to clinic, complications, and instances where a telemedicine visit prompted an in-person evaluation were collected and reported with descriptive statistics. Cost savings were calculated based on travel distance and lost productivity. Patients with and without a complication or an unexpected in-person clinic visit were compared to identify risk factors for these clinical outcomes. Cost analysis demonstrated that telemedicine offers patients a potential cost savings of up to $475.2±$242.9 per visit. For 4.5% of the patients, a telehealth visit prompted an in-person evaluation. A complication was experienced by 5.5% of the patients. No complications were missed because of telemedicine. A diagnosis of a malignant tumor was associated with a higher rate of complications (P=.01) and unexpected in-person clinic visits (P=.03). Telemedicine can reduce the financial burden of treatment for orthopedic oncologic patients without negatively impacting clinical outcomes. Care should be taken when considering telehealth for patients with malignant tumors given their higher risk for adverse outcomes. [Orthopedics. 202x;4x(x):xx-xx.].

The Effect of Nirmatrelvir-Ritonavir on Short- and Long-term Adverse Outcomes From COVID-19 Among Patients With Kidney Disease: A Propensity Score-Matched Study.

Patients with kidney disease are at high risk for adverse outcomes after coronavirus disease 2019 (COVID-19) despite vaccination. Because patients with advanced chronic kidney disease (CKD) and kidney failure were excluded from registrational trials, the impact of the protease inhibitor nirmatrelvir-ritonavir in patients with kidney disease is unknown. This was a cohort study evaluating adverse outcomes in patients with kidney disease who developed COVID-19. Patients prescribed nirmatrelvir-ritonavir for COVID-19 between March 16, 2022, and November 30, 2022, were propensity score-matched to comparators diagnosed with COVID-19 between July 15, 2021, and March 15, 2022 (before the use of nirmatrelvir-ritonavir in our health care network). We determined the association between nirmatrelvir-ritonavir and short- and long-term outcomes using Fine-Gray subdistribution hazard and Cox proportional hazard models, adjusting for potential confounders. Outcomes included 30-day risk of hospitalization and 1-year risk of a major adverse cardiovascular event (MACE), CKD progression, and death. A total of 1095 nirmatrelvir-ritonavir-treated patients were matched to 584 comparators. Patients who received nirmatrelvir-ritonavir patients were less likely to be hospitalized within 30 days of diagnosis (adjusted subdistribution hazard ratio [sHR], 0.44; 95% CI, 0.26-0.73; P < .01). At 1 year, nirmatrelvir-ritonavir-treated patients had a lower risk of hospitalization for MACE (adjusted sHR, 0.49; 95% CI, 0.36-0.67; P < .01) and death (adjusted hazard ratio, 0.37; 95% CI, 0.21-0.65; P < .01). Use of nirmatrelvir-ritonavir was not associated with decreased risk of CKD progression or attenuation of estimated glomerular filtration rate decline slope in the year following infection. Nirmatrelvir-ritonavir was associated with decreased risk of hospitalization within 30 days and 1-year risk of MACE and death in patients with CKD and kidney failure.

Vertebral osteomyelitis in patients with an underlying malignancy or chronic kidney disease - who is at higher risk for adverse outcome?

Patients with vertebral osteomyelitis (VO) and comorbidities, notably chronic kidney disease (CKD), are at risk of early mortality. The aim of this study was to compare characteristics and outcomes of VO patients with an underlying malignancy (ONCO) to VO patients with CKD and VO patients without comorbidities (CONTROL). We performed a retrospective analysis of data which was prospectively collected between 2008 and 2020. Primary outcome was treatment failure defined as death and/or recurrence of VO within one year. 241 VO patients (ONCO = 56; CKD = 47; CONTROL = 138) were analysed. Treatment failure occurred in 26% of ONCO and 45% of CKD patients. Staphylococcus aureus was the most common causative pathogen in the CKD (57%) and CONTROL group (43%). ONCO patients showed a broader distribution of common VO-causing pathogens, with coagulase-negative staphylococci (CoNS) accounting for the highest proportion of causative bacteria (27%). Nevertheless, S.aureus was associated with a significantly higher risk of treatment failure in VO ONCO patients. Treatment failure in VO CKD patients was twice as high as in VO ONCO patients. However, both groups showed high treatment failure rates. CoNS should be considered when starting empirical antibiotic treatment in VO ONCO patients. Moreover, oncological patients with VO caused by S.aureus should be monitored closely.