Mount Sinai Hospital

Background Non–vitamin K oral anticoagulants are recommended over vitamin K antagonists in patients with nonvalvular atrial fibrillation (AF). However, the risk of gastrointestinal bleeding may be higher with non–vitamin K oral anticoagulants versus vitamin K antagonists. Patients after successful transcatheter aortic valve replacement (TAVR) who are elderly and frail have worse outcomes with major gastrointestinal bleeding (MGIB), including death. This study evaluated incidence, predictors, and impact of MGIB among patients with AF after successful TAVR. Methods This on‐treatment analysis of ENVISAGE‐TAVI AF (Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation) included patients who received ≥1 dose of the study drug. Demographic, clinical, and procedural characteristics were compared between patients with versus without an MGIB event. Cox multivariable regression analysis identified predictors of MGIB. Results Of 1377 patients in this analysis, 83 (6.0%) experienced MGIB, with 56 (67.5%) of these patients receiving edoxaban. Patients with versus without MGIB were more likely to have undergone percutaneous coronary intervention ≤30 days before TAVR (9.6% versus 4.2%; P =0.03), a higher ejection fraction (mean±SD, 58.0±10.4 versus 55.3±11.5; P =0.04), and carotid artery disease (13.3% versus 6.6%; P =0.04). Edoxaban without dose adjustment versus vitamin K antagonist use ( P =0.003), smoking ( P =0.01), low hemoglobin levels ( P <0.0001), and percutaneous coronary intervention ≤30 days before TAVR ( P =0.01) emerged as predictors of MGIB. Conclusions In this ENVISAGE‐TAVI AF subanalysis, MGIB occurred in 6.0% of patients with prevalent or incident AF undergoing TAVR, and those receiving edoxaban versus vitamin K antagonists had a higher risk of MGIB. A priori identification of risk factors for MGIB may help optimize outcomes for patients with AF undergoing TAVR. Registration URL: https://www.clinicaltrials.gov ; unique identifier: NCT02943785.

Psoriasis is a chronic immune-mediated inflammatory disease characterized by significant variability in clinical presentation and associated comorbidities. We aimed to describe the baseline demographic and clinical characteristics of patients with psoriasis enrolled in the Psoriasis Registry in Saudi Arabia (PSORSA). This multicenter cohort study included patients with moderate-to-severe psoriasis from 40 hospitals in Saudi Arabia. Baseline demographics, clinical, and comorbidity data were collected and analyzed. Follow-up assessments were conducted every three months for one year. In total, 482 patients were enrolled. The mean age at diagnosis was 32.2 years, with a median disease duration of 848 days and a mean body mass index of 27.32 kg/m2. Male patients comprised 51.8% of the cohort, and 96.5% were Saudi nationals. A positive family history of psoriasis was reported in 17.2% of the participants. A total of 83 patients (17.2%) were documented to have comorbidities. Among these 83 patients, 47 (56.6%) had psoriatic arthritis, 20 (24.1%) had diabetes, and 14 (16.9%) had hypertension. Plaque psoriasis was the most common subtype (94.2%), and the most affected body regions were the upper and lower extremities (88.1% and 85.5%, respectively), followed by the scalp and trunk (75.7% each). The mean PASI score at baseline was 25 ± 13.3, which decreased to 0.32 ± 0.94 by week > 52. Conventional systemic therapies were prescribed to 22.6% of the patients, with methotrexate being the most common agent (18%). Biologic therapies were prescribed to 28.9% of the patients, with adalimumab being the most commonly used (21%). In addition, 12.7% of the cohort received phototherapy. Adverse events occurred in 2.1% of the patients, with cyclosporine contributing to 25% of the reported events. The PSORSA registry provides valuable insights into the demographics, clinical characteristics, and treatment patterns of patients with psoriasis in Saudi Arabia. These findings emphasize the need for real-world data to guide regional psoriasis management strategies.

Aims Endometriosis frequently affects reproductive aged females and is associated with increased cardiovascular disease risk. The aims of this study were (i) to confirm the relationship between cardiovascular disease and endometriosis and (ii) to test whether aspirin modified the effect of endometriosis on cardiovascular disease risk. Methods and results A longitudinal cohort study was conducted using data from the California Teachers Study from enrolment (1995–1996) through the current administrative end follow-up (31 December 2020). Primary outcome was any incident major adverse cardiovascular event (MACE) defined using validated ICD-9/ICD-10 codes for stroke, myocardial infarction, and coronary heart disease. Inverse probability (IP) weights were used to estimate the causal effect of self-reported endometriosis on cardiovascular events. Of the included 120 435 participants, 13 754 (11.4%) reported history of endometriosis. There were 2159 admissions for MACE in the endometriosis group vs. 16 632 in the non-endometriosis group. After controlling for demographics and vascular comorbidities, risk of MACE was higher in the endometriosis group than in the non-endometriosis group [IP-weighted hazard ratio (HR) 1.10, confidence interval (CI) 1.04–1.15], particularly in participants < 40 years of age (IP-weighted HR 1.48, CI 1.08–2.02). Aspirin use did not modify the effect of endometriosis on MACE (P interaction = 0.467). Among participants taking aspirin, the adjusted HR for endometriosis was 1.07 (95% CI, 0.96–1.19) whereas among participants not taking aspirin, adjusted HR was 1.10 (95% CI, 1.04–1.17). Conclusion In a large American cohort, endometriosis was associated with increased risk of adverse cardiovascular events, especially in younger participants. Aspirin did not modify this risk. Research to determine how to best reduce cardiovascular risk in endometriosis is warranted.

Non-coronary artery systemic arterial aneurysms (SAAs) are rare and an under-reported sequelae of Kawasaki disease (KD). We hypothesize that practices regarding SAA screening and management vary widely among experts and published literature. A survey was sent to members of the International KD Registry regarding their experiences and practices with SAAs in KD patients. For comparison, a systematic scoping review was conducted using PRISMA methodology, from which 25 reports with 83 patients were included. Results from each were compared. Surveys were completed by 48 (56%) of 86 IKDR investigators; 35 (73%) respondents had > 10 years of experience caring for KD patients. However, 33% of respondents had not cared for a patient with SAA. Features prompting assessment for SAA included demographics, presence and degree of coronary artery (CA) involvement, and clinical features, including prolonged/persistent fever, progressing/persistent elevation of inflammatory markers, and resistance to standard treatment. Features prompting screening were somewhat concordant with the characteristics of patients with SAA identified in the scoping review. From the survey, the initial preferred assessment included computed tomographic angiography (48%), ultrasound (29%), and magnetic resonance imaging (24%). In contrast, assessment of patients with SAA from the scoping review commonly used multiple imaging modalities. SAA often regressed, but associated complications included thrombosis, calcification, stenosis, occlusion, and collateral formation. While SAA is a known but rare complication of acute KD, there remains a gap in evidence regarding which patients are at risk, best practices for screening and management, and outcomes. Prospective cohort studies are needed.

Advances in cancer care have led to a growing number of cancer survivors globally. As cancer increasingly affects women and people of reproductive age, more individuals will be experiencing pregnancy after completing cancer treatment. This Best Practice Advice manuscript describes the epidemiology of pregnancy after cancer, recommended clinical evaluation before pregnancy, key components of pregnancy care for cancer survivors, considerations for delivery planning and postpartum care, and suggested steps for future health and prevention.

Background The majority of esophageal and gastric cancers are diagnosed at an advanced stage with poor overall survival (OS). Whether the pre‐diagnostic interval from symptom onset has any impact on OS is unclear. We investigated this question in the peri‐COVID19 pandemic era. Methods We retrospectively analyzed a cohort of 308 patients with esophageal, gastroesophageal junction, or gastric carcinoma treated with curative intent at the Princess Margaret Cancer Centre from January 2017 to December 2021. Clinical details pertaining to the initial presentation were determined through a retrospective chart review. Cox proportional hazards regression models were used to assess the association between pre‐diagnostic intervals and OS, adjusting for baseline patient characteristics. Results The median interval from symptom onset to diagnosis was 98 days (IQR 47–169 days). Using a cox proportional hazard model, prolonged pre‐diagnostic interval was not associated with worse OS (HR 1.00, p = 0.62). Comparing patients diagnosed before and during the COVID19 pandemic, there was a notable increase in diagnostic delay with median pre‐diagnostic interval increasing from 92 to 126 days (p = 0.007). Median age at time of diagnosis was 69.6 during the pandemic vs. 64.7 before the pandemic. Linear regression showed squamous cell histology was significantly associated with increasing time to initial diagnosis (p = 0.04), but this did not hold true in a multivariable model. Looking at other delay metrics, there were no changes in time interval from diagnosis to treatment during versus before the pandemic (median = 1.7 weeks for both), and there was no change in time from diagnosis to resection in those patients who underwent surgery. Conclusion The COVID19 pandemic caused significant diagnostic delay for patients presenting with curative gastroesophageal and gastric cancer. The lack of correlation of pre‐diagnostic interval with OS may reflect underlying tumor biology as the driving force that determines prognosis.

Introduction Little information is available on the surgical treatment options for patients with Airway Obstruction (AO) and early-stage non-small cell lung cancer (NSCLC) followed in lung cancer screening programs (LCS). This study aims to compare the potential impact of anatomical sub lobar resections vs. lobectomies in these patients. Methods This is a retrospective analysis of participants who underwent surgical resections within a Lung Cancer Screening Program, including those with AO (post bronchodilator FEV1/FVC < 0.70). The short-term survival, locoregional recurrence, perioperative complications, and difference between pre and postoperative pulmonary function tests were compared between the surgical groups in those with AO. Results Anatomical sub lobar resections or lobectomies for Stages IA and IB NSCLC were performed in 133 patients. Out of these, 57 had AO. Anatomical sub lobar resections were non-inferior to lobectomies for short-term survival in patients with AO (3-year survival rate: 95.8% vs. 97%, p = 0.83). In these patients, sub lobar resections had a higher recurrence rate (12.5% vs 0%, p < 0.01). No significant differences were found in postoperative complications between surgical techniques (sub lobar 33% vs lobectomy 24%, p = 0.44). Lastly, no significant difference was found on the change between pre and postoperative FEV1 and DLCO (p = 0.96 and 0.79 for FEV1 and DLCO, respectively). Conclusions The present retrospective analysis suggests that sub lobar resection might be the best surgical option for treating early-stage NSCLC in patients with AO, where lung function preservation techniques are desired, but requires closer follow up to detect recurrence. Further studies in larger samples should confirm our findings.

Early identification of kidney disease can protect kidney health, prevent kidney disease progression and related complications, reduce cardiovascular disease risk, and decrease mortality. We must ask “ Are your kidneys ok ?” using serum creatinine to estimate kidney function and urine albumin to assess for kidney and endothelial damage. Evaluation for causes and risk factors for chronic kidney disease (CKD) includes testing for diabetes and measurement of blood pressure and body mass index (BMI). This World Kidney Day, we assert that case-finding in high-risk populations, or even population-level screening, can decrease the burden of kidney disease globally. Early-stage CKD is asymptomatic and simple to test for and recent paradigm-shifting CKD treatments such as sodium glucose co-transporter-2 inhibitors dramatically improve outcomes and favor the cost-benefit analysis for screening or case-finding programs. Despite this, numerous barriers exist, including resource allocation, healthcare funding, healthcare infrastructure, and healthcare-professional and population awareness of kidney disease. Coordinated efforts by major kidney non-governmental organizations to prioritize the kidney health agenda for governments and aligning early detection efforts with other current programs will maximize efficiencies.

The novel HLA‐A*26:254 allele (HLA‐A*26:01P) was identified from a healthy mestizo from Ecuador.

This study assessed the effect of intravenous (IV) milrinone as first-line therapy for cerebral vasospasm (CVS) or delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH). A retrospective study was performed on consecutive patients with aSAH from 2017 to 2022. We assessed the association of IV milrinone treatment with outcomes graded with modified Rankin Scale score at 6 months. We compared the use of alternative therapies for CVS or DCI between patients who received IV milrinone and those who did not. All statistical analyses were performed using STATA 18.0 (StataCorp, College Station, TX). Of 336 patients, 130 (39%) developed CVS or DCI. Seventy-three patients received IV milrinone and 57 patients did not. Among symptomatic patients, 59% showed improvement in symptoms after milrinone was started. Twenty percent of patients in the milrinone group required vasopressor therapy, whereas 84% of patients were treated with vasopressors in the nonmilrinone group (p < 0.01). Thirty one percent of patients receiving milrinone and 56% of patients in the non-milrinone group received endovascular therapy (p = 0.02). Univariate analysis showed milrinone was likely associated with good outcome (odds ratio [OR] 2.12 [95% confidence interval [CI] 0.97–4.63]; p = 0.06). Propensity score matching analysis confirmed an association between milrinone and good outcome (coefficient 0.30, standard error 0.13 [95% confidence interval [CI] 0.05–0.55]; p = 0.02). Our study showed several potential benefits of early IV milrinone therapy for patients with aSAH with CVS or DCI. Patients who received IV milrinone had better outcome and required vasopressor or endovascular therapy less often. Limitations of the study included several protocol deviations, incomplete documentation of drug effect, and inconsistent assessment of CVS resolution. Early IV milrinone improved outcomes and reduced the use of other therapies to treat CVS and DCI. These results need confirmation in a large clinical trial with stratification of patients by clinical severity, indication, and optimized protocols.

Background Due to high prevalence of Kaposi Sarcoma (KS)-Associated Herpesvirus (KSHV) among people with HIV, KSHV-associated disease (KAD) may be increased after kidney transplantation from donors with HIV (HIV D+) to recipients with HIV (HIV R+). Methods Anti-KSHV antibodies were measured in HIV R+ and donors with and without HIV (HIV D-) using a 30-antigen multiplex assay within three multicenter kidney transplantation studies. KSHV seropositivity was defined as reactivity to conventional KSHV antigens (≥1 ORF73 or K8.1); reactivity to expanded 5-antigen and 30-antigen panels were also reported. Risk factors were identified using modified Poisson regression. Recipients were monitored for post-transplant anti-KSHV antibody changes and KAD. Results KSHV seroprevalence was 40.6% (143/352) among HIV R+, 25.2% (33/131) among HIV D+, and 7.5% (4/53) among HIV D-. In the multivariable model, only men who have sex with men (MSM) was associated with KSHV seropositivity: relative risk 1.51 (95% confidence interval [CI] 1.07-2.14) in recipients and 2.39 (95%CI 1.03-5.53) in donors. Among 418 HIV R+ (215 HIV D+/R+, 203 HIV D-/R+), there were 5 KAD cases (incidence 0.63 cases/100 person-years, 95%CI 0.26-1.52): 3 skin-only KS, 1 multicentric Castleman disease, 1 allograft KS. The allograft KS occurred in a female HIV D+/R+ and was likely donor-derived. Remaining KAD cases occurred in male HIV D-/R+ and were likely recipient KSHV reactivation or acquisition. Conclusions In the United States, KSHV seroprevalence in donors and recipients with HIV was high, particularly among MSM. Reassuringly, KSHV-associated disease was rare, and primarily attributed to recipient rather than donor-derived KSHV.

Background: Although spine surgery has a high number of patented technologies, there has been little prior application of bibliometric analyses to effectively evaluate the technological literature in the cervical spine field. The aim of this review is to summarize and identify current patent trends in technologies for the stabilization and surgical management of cervical spine pathologies. Methods: Multiple databases were systematically queried using Lens.org to identify technology patents designed to stabilize or surgically manage cervical spine injury or disease. The patents were then ordered by forward citation count, and the top 50 unique patents were included and organized into five categories: fusion/stabilization/fixation devices, external brace/supporter devices, arthroplasty implants, surgical instruments, and spacer/expansion devices. Subsequent assessments included patent priority year, publication year, priority region, legal status, and rank. Results: The search results on March 11, 2024, yielded 440 patents published between 1973 and 2014. Of the top 50 most-cited patents, fusion/stabilization/fixation devices were the most common (27), followed by external brace/support devices (18). Patents for fusion/stabilization/fixation devices were more recent, peaking in 2001. The most common patents in the first to third quintiles were for fusion/stabilization/fixation devices. Conclusions: Most patents before 1995 were for cervical brace and supporter devices. Since the turn of the 21st century, patented surgical fusion/fixation/stabilization devices have markedly increased. Further analysis of trends in cervical spine device technology can assist in guiding future innovation efforts.

Objective Electronic health records (EHRs) are increasingly used to conduct research and evaluate epilepsy quality of care. We examined the accuracy of International Classification of Diseases, 9th and 10th Revision, Clinical Modification (ICD‐9‐CM, ICD‐10‐CM)‐ and antiseizure medicine (ASM)‐based algorithms for adult epilepsy. Methods Data from a diverse New York multicenter EHR were queried to identify encounters between January 1, 2012 and September 20, 2018 coded with an epilepsy/seizure ICD‐CM code or an ASM. Eight hundred adults were randomly selected (350 with epilepsy‐related codes, 150 with an ASM, and 300 with drug‐resistant epilepsy codes). With chart review defined as the reference standard, sensitivity (Sn), specificity (Sp), negative predictive value (NPV), positive predictive value (PPV), and Youden index (YI) were calculated to evaluate various ICD‐9‐CM‐, ICD‐10‐CM‐, ± ASM‐based algorithms' accuracy in predicting epilepsy. Results Ninety‐four algorithms were tested. A total of 435 (54.4%) patients had definite epilepsy. Estimates ranged as follows: YI = .18–.68, Sn = .59–.95, Sp = .52–.97, PPV = .67–.92, and NPV = .51–.93. The best algorithms were as follows. Highest YI for ICD‐9‐CM was single encounter with 345 (except 345.2 or 345.3) or 345.2, 345.3, or 780.3 with an ASM (Sn = .95, Sp = .73, PPV = .81, NPV = .92, YI = .68). Highest Y1 for ICD‐10‐CM was one encounter with G40 in primary diagnostic position or ≥2 encounters with G40 in any diagnostic position (Sn = .82, Sp = .85, PPV = .87, NPV = .80, YI = .67). Highest sensitivity was any encounter with ICD‐9‐CM 345 or 780.39 or ICD‐10‐CM G40, G41, or R56.9 (Sn = .96, Sp = .57, PPV = .73, NPV = .93, YI = .53). Highest specificity was ≥1 hospitalization with ICD‐9‐CM 345.x (except 345.2 and 345.3) or ICD‐10‐CM G40.x (Sn = .21, Sp = .97, PPV = .89, NPV = .51, YI = .18). Significance We identified ICD‐9/10‐CM‐based case definitions (with and without ASM) that were sensitive and specific for epilepsy. Ultimately, extensive algorithms are provided to help inform case definition selection according to future study aims.

This dataset, Collab-CXR, provides a unique resource to study human-AI collaboration in chest X-ray interpretation. We present experimentally generated data from 227 professional radiologists who assessed 324 historical cases under varying information conditions: with and without AI assistance, and with and without clinical history. Using a custom-designed interface, we collected probabilistic assessments for 104 thoracic pathologies using a comprehensive hierarchical reporting structure. This dataset is the largest known comparison of human-AI collaborative performance to either AI or humans alone in radiology, offering assessments across an extensive range of pathologies with rich metadata on radiologist characteristics and decision-making processes. Multiple experimental designs enable both within-subject and between-subject analyses. Researchers can leverage this dataset to investigate how radiologists incorporate AI assistance, factors influencing collaborative effectiveness, and impacts on diagnostic accuracy, speed, and confidence across different cases and pathologies. By enabling rigorous study of human-AI integration in clinical workflows, this dataset can inform AI tool development, implementation strategies, and ultimately improve patient care through optimized collaboration in medical imaging.

Introduction The objective of the Chinese Neonatal Follow-Up Network (CHNFUN) is to establish a standardised follow-up protocol for the assessment of high-risk preterm infants, and collaborative research aimed at improving early intervention and neurodevelopmental outcomes for preterm infants with gestational age less than 32 weeks in China. The CHNFUN is the first national neonatal follow-up network and has the largest geographically representative cohort from neonatal intensive care units (NICUs) in China. Methods and analysis A survey of neonatal follow-up clinics participating in CHNFUN was used to inform the development of a standardised protocol for the assessment of high-risk preterm infants in China. Training in the use of assessment tools and data collection was provided to all participating centres. Individual-level neurodevelopmental outcomes data from participating neonatal follow-up clinics will be collected at corrected age, 40 weeks, 3–4 months, 12 months, 18–24 months, 3 years and 6 years of age, using a unique database developed by the CHNFUN and linked to NICU outcomes data in the CHNN Database. Data will be prospectively collected on an ongoing basis from all surviving infants born at <32 weeks’ gestation or <1500 g birth weight and discharged from 34 participating NICUs from 1 June 2023. Infant neurodevelopmental outcomes and interinstitutional variations in outcomes will be examined and used to inform quality improvement measures aimed at improving outcomes, development and evaluation of early intervention programmes and other collaborative research, including clinical trials. Ethics and dissemination This study was approved by the ethics review board of Children’s Hospital of Fudan University (#CHFU 2022-112), which was recognised by all participating hospitals. Waiver of consent was granted at all sites. Only non-identifiable patient-level data will be transmitted, and only aggregate data will be reported in CHNFUN reports and publications.

As patients increase in age and medical complexity, coronary artery calcification is frequently encountered and its presence portends worse outcomes following percutaneous coronary intervention (PCI) - negatively impacting procedural success and long-term outcomes. This review paper explores available imaging techniques and calcium modification technique that can identify, characterize and modify these lesions to facilitate stent implantation. The data supporting these techniques are explored and an algorithm for decision-making during lesion modification is presented. Current barriers and future directions are additionally discussed.