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Coronary function testing (CFT) plays a pivotal role in the diagnosis of coronary vascular dysfunction and providing patients with tailored therapy. The Belgian registry on CFT (BELmicro registry) is a prospective, observational, multicenter registry including 14 centers in Belgium. All patients who underwent clinically indicated CFT were included in the registry. Baseline characteristics, CFT data, and clinical outcomes were collected. This analysis aimed to describe the baseline characteristics of a real-world population of patients who underwent CFT, evaluate the prevalence of coronary vascular dysfunction, and assess the safety of CFT in daily clinical practice. Between October 2021 and September 2023, 449 patients were enrolled. The mean age was 65 ± 10 years, and 47.4% of patients were men. A total of 59% of patients had hypertension, 18.7% had diabetes, 69.5% had hypercholesterolemia, and 40.1% had a smoking habit. Angina and nonobstructive coronary arteries (ANOCAs) were identified in 85.1% of the patients. Microvascular physiology assessment was performed in 95.5% of patients, vasoreactivity test in 28.5%, and both in 24.0%. coronary microvascular dysfunction was diagnosed in 23.4% of patients with ANOCA, epicardial vasospasm in 26.3%, and microvascular spasm in 14.9%. Rates of major complications were 0.7% for microvascular physiology assessment and 0% for vasoreactivity test. In conclusion, participants in the BELmicro registry represented a real-world population of patients, characterized by a high burden of cardiovascular risk factors. Coronary microvascular dysfunction and coronary vasospasm were frequent in patients with ANOCA. Performing CFT in daily clinical practice was feasible, with a low rate of complications., Competing Interests: Declaration of competing interest Dr. Segers reports financial support from Abbott Vascular and Fund for Scientific Research Flanders. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Heart transplant recipients develop cancer at two-times the rate compared to the general population. However, the incidence and mortality rates and the adjusted association between cancer and mortality remains unclear., Methods: We estimated the incidence and mortality rates and the adjusted association between developing cancer (any, skin, hematologic, and solid tumor subtypes) and the all-cause mortality rates among adult heart transplant recipients from the Scientific Registry of Transplant Recipients from October 1, 1987, until June 28, 2020., Results: Among 51,597 adult heart transplant recipients, 13,191 (25.6%) were diagnosed with de novo malignancy throughout the follow-up period. The cumulative incidence cancer at years 1, 5, 10, and 20 was 3%, 16.4%, 32.8%, and 56.6%, respectively. Among those with cancer, the cumulative mortality was 17.5%, 42.3%, 65%, and 91% at years 1, 5, 10, and 20, respectively. The incidence rate of any de novo malignancy was 38.7 cases per 1000 person-years and the mortality rate (for those with cancer) was 115.2 cases per 1000 person-years. Compared to those without cancer, those with cancer had a higher adjusted mortality association [HR: 2.14 (2.07, 2.21)]. The strongest associations were estimated for pancreatic [10.63 (8.34, 13.54)], leukemia [8.06 (4.33, 15.00)], and esophagus [6.94 (5.43, 8.87)] malignancies. The association between de novo malignancies and mortality was higher in the earlier years of follow-up., Conclusion: Compared to not developing cancer, those with de novo malignancy have a 2-fold higher mortality rate, on average. The strength of the association varies by cancer subtype and by follow-up time., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Study Design: Multicenter, prospective registry study., Objective: To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life assessments with clinical outcomes., Background: Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases., Patients and Methods: This study included 171 (out of 413) patients from the multicenter "Prospective Registration Study on Surgery for Metastatic Spinal Tumors" by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face Scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the Visual Analog Scale, and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face Scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes., Results: The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-Visual Analog Scale, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively., Conclusion: We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling., Level of Evidence: II., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Although clinical guidelines recommend self-care assessment for patients with chronic heart failure (CHF), its prognostic significance remains controversial. This study aimed to compare the prognostic significance of self-care behavior on mortality between patients with and without a history of recent hospitalization for heart failure (HF)., Methods: We analyzed consecutive 1907 CHF patients from a Japanese multicenter registry (January 2020-June 2023) using the 9-item European Heart Failure Self-care Behavior Scale (EHFScBS-9) at enrolment. Suboptimal self-care behavior was defined as a score < 70 on the EHFScBS-9. Patients were divided into recent (within 30 days post-discharge, n = 664) and no recent hospitalization for HF groups (n = 1263), respectively. The primary outcome was a composite of all-cause death and rehospitalization for HF., Results: During a median follow-up period of 427 (interquartile range 273-630) days, the primary outcome occurred in 100 patients. Patients with suboptimal self-care behavior exhibited a higher incidence of the primary outcome in the recent hospitalization for HF group (p = 0.020) but not in the no recent hospitalization for HF group (P = 0.16). Multivariable regressions showed suboptimal self-care behavior was independently associated with the primary outcome in the recent hospitalization for HF group with a significant interaction (P = 0.029)., Conclusion: In patients recently hospitalized for HF, but not in those without a recent hospitalization history for HF, suboptimal self-care behavior was associated with adverse events. This indicates the importance of self-care education for these patients., Competing Interests: Declaration of competing interest Dr. Toshiyuki Nagai is an associate editor of “International Journal of Cardiology”. Dr. Toshiyuki Nagai received a research grant from Mitsubishi Tanabe Pharma Corp. and honoraria from Kyowa Kirin Co., Ltd., Bayer Yakuhin, Ltd., Viatris Inc., and Boehringer Ingelheim Japan Co., Ltd. Dr. T.A. received a research grant from Daiichi Sankyo Co., Ltd., scholarship funds from Biotronik Japan Co., Ltd., Medtronic Japan Co., Ltd., Win International Co., Ltd., Medical System Network Co., Ltd., and Hokuyaku Takeyama Holdings, Inc. and honoraria from Daiichi Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., Boehringer Ingelheim Japan Co., Ltd., Bayer's Pharmaceuticals Co., Ltd., and Bristol-Myers Squibb Co., Ltd. The remaining authors declare no conflicts of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objectives: To determine whether adherence to hip fracture clinical care quality indicators influences mortality among people who undergo surgery after hip fracture in New South Wales, both overall and by individual indicator., Study Design: Retrospective population-based study; analysis of linked Australian and New Zealand Hip Fracture Registry (ANZHFR), hospital admissions, residential aged care, and deaths data., Setting, Participants: People aged 50 years or older with hip fractures who underwent surgery in 21 New South Wales hospitals participating in the ANZHFR, 1 January 2015 - 31 December 2018., Main Outcome Measures: Thirty-day (primary outcome), 120-day, and 365-day mortality (secondary outcomes) by clinical care indicator adherence level (low: none to three of six indicators achieved; moderate: four indicators achieved; high: five or six indicators achieved) and by individual indicator., Results: Registry data were available for 9236 hip fractures in 9058 people aged 50 years or older during 2015-2018; the mean age of patients was 82.8 years (standard deviation, 9.3 years), 5510 patients were women (69.4%). Complete data regarding adherence to clinical care indicators were available for 7951 fractures (86.1%); adherence to these indicators was high for 5135 (64.6%), moderate for 2249 (28.3%), and low for 567 fractures (7.1%). After adjustment for age, sex, comorbidity, admission year, pre-admission walking ability, and residential status, 30-day mortality risk was lower for high (adjusted relative risk [aRR], 0.40; 95% confidence interval [CI], 0.30-0.52) and moderate indicator adherence hip fractures (aRR, 0.61; 95% CI, 0.46-0.82) than for low indicator adherence hip fractures, as was 365-day mortality (high adherence: aRR, 0.59 [95% CI, 0.51-0.68]; moderate adherence: aRR, 0.74 [95% CI, 0.63-0.86]). Orthogeriatric care (365 days: aRR, 0.78; 95% CI, 0.61-0.98) and offering mobilisation by the day after surgery (365 days: aRR, 0.74; 95% CI, 0.67-0.83) were associated with lower mortality risk at each time point., Conclusions: Clinical care for two-thirds of hip fractures attained a high level of adherence to the six quality care indicators, and short and longer term mortality was lower among people who received such care than among those who received low adherence care., (© 2024 The Author(s). Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.)

Background: Persistent non-plateauing adverse event rates in patients who underwent percutaneous coronary intervention (PCI) remain a challenge. A bioadaptor is a novel implant that addresses this issue by restoring the haemodynamic modulation of the artery, allowing cyclic pulsatility, vasomotion, and adaptative remodelling, by unlocking and providing dynamic support to the artery. We aimed to assess outcomes with the device versus a contemporary drug-eluting stent (DES) in a representative PCI population., Methods: INFINITY-SWEDEHEART is a single-blind, non-inferiority, registry-based, randomised controlled study conducted in 20 hospitals in Sweden. Patients aged 18-85 years, with chronic or acute coronary syndrome ischaemic heart disease, with an indication for PCI, with up to three de novo lesions suitable for implantation with one single device per lesion, and successful pre-dilatation were identified via the Swedish Coronary Angiography and Angioplasty Registry and eligible for enrolment. Participants were randomly assigned (1:1), using block randomisation with random variation in block size and stratified by site, to either the DynamX bioadaptor (Elixir Medical, Milpitas, CA, USA) or a zotarolimus-eluting DES (Resolute Onyx and Onyx Trustar, Medtronic, Minneapolis, MN, USA). The primary endpoint was the device-oriented clinical endpoint of target lesion failure at 12 months (a composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation), assessed in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment, regardless of treatment received) who had either experienced an event up to 12 months or completed the trial up to 12 months. Non-inferiority was established if the upper limit of the two-sided 95% CI for the absolute risk difference was less than 4·2%. Powered secondary endpoints were landmark analyses from 6 months onwards for target lesion failure, target vessel failure (composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target vessel revascularisation), and target lesion failure for patients with acute coronary syndrome assessed in the ITT population). This study is registered with ClinicalTrials.gov, NCT04562805, and follow-up to 5 years is ongoing., Findings: Between Sept 30, 2020, and July 11, 2023, 2399 patients were randomly assigned to receive the bioadaptor (n=1201) or DES (n=1198; ITT population). Median age was 69·5 years (IQR 61·2-75·6), 575 (24·0%) of 2399 patients were female, and 1824 (76·0%) were male (data on race and ethnicity were not collected), and 1838 (76·6%) patients presented with acute coronary syndrome. The primary endpoint of 12-month target lesion failure occurred in 28 (2·4%) of 1189 assessable patients in the bioadaptor group versus 33 (2·8%) of 1192 assessable patients in the DES group, with a risk difference of -0·41% (95% CI -1·94 to 1·11; p non-inferiority <0·0001). In the prespecified landmark analysis from 6 months to 12 months, the Kaplan-Meier estimates of target lesion failure were 0·3% (with events in three of 1170 patients) in the bioadaptor group versus 1·7% (with events in 16 of 1176 patients) in the DES group (hazard ratio 0·19 [95% CI 0·06 to 0·65]; p=0·0079), of target vessel failure were 0·8% (events in eight of 1167) versus 2·5% (events in 23 of 1174; 0·35 [0·16 to 0·79]; p=0·011), and of target lesion failure in patients with acute coronary syndrome were 0·3% (events in two of 906) versus 1·8% (events in 12 of 895; 0·17 [0·04 to 0·74]; p=0·018). The rate of definite or probable device thrombosis, which was recorded as a safety outcome, was low and did not differ between groups (eight [0·7%] of 1201 in the bioadaptor group vs six [0·5%] of 1198 in the DES group; difference in event rates of 0·16% [95% CI -0·50 to 0·83])., Interpretation: Among patients with coronary artery disease, including those with acute coronary syndrome, treatment with the bioadaptor was non-inferior to contemporary DES, showing potential to mitigate non-plateauing device-related events and improving outcomes in patients undergoing PCI. The additional planned follow-up will help to reinforce the clinical significance of the 1-year findings., Funding: Elixir Medical., Competing Interests: Declaration of interests DE reports honoraria for advisory board or speaker fees from Amgen, AstraZeneca, Chiesi, Sanofi, Novo Nordisk, InfraredX/Nipro, and Kaminari Medical. PG reports consulting fees from Chiesi Pharma, lecture fess from Bayer Pharma, and advisory board participation for AstraZeneca. OW reports travel expenses from Abbott Medical. FB reports institutional research grants from Abbott and Boston Scientific; speaker fees from Pfizer, Abbott, Boston Scientific, and Amarin; and advisory board participation for Amarin. CH reports lecturer fees and honoraria for advisory boards from Amarin, AstraZeneca, Boehringer Ingelheim, Novo Nordisk, and Coala. PCS reports institutional grants from Abbott Vascular and SMT, consulting fees from Abbott Vascular and Microport, honoraria from SMT and Elixir, support for attending meetings from Elixir, participation in boards of the Legacy and the Proctor trials, and is a minority shareholder of the European Cardiovascular Research Center (known as CERC). CE and AA are employees of, and hold stock or stock options in, Elixir Medical. SJ and authors affiliated with the Uppsala Clinical Research Center (CH, HR, and JO) report receiving research grants for designing, conducting, and analysing the trial as an Academic Research Organization from Elixir Medical. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Sudden unexpected infant death (SUID) is a major contributor to infant death and a persistent public health issue. After an initial decline after the 1994 "Back to Sleep" campaign, SUID numbers plateaued. Currently, ∼10 infants die suddenly and unexpectedly each day in the United States. In 2019, we established a surveillance system for SUID in Cook County, Illinois, partnering our academic medical center, the Cook County Medical Examiner's Office, and child death review to create the Cook County SUID Case Registry. Our data show that, in Cook County, including the city of Chicago, ∼1 infant dies unexpectedly during sleep every week. Of these SUID, ∼25% were because of suffocation/possible suffocation. SUID peaks at 30 to 60 days old. SUID rates are 15 times higher in non-Hispanic Black infants and 3 times higher in Hispanic infants, compared with white infants. Nearly all involved 1 or more unsafe sleep factors. SUID are concentrated in community areas experiencing high hardship. Through our Community Partnership Approaches for Safe Sleep-Chicago team, we have developed collaborative prevention approaches in affected communities, allowing for conversations with families and those who support them to better understand barriers to safe sleep that they experience. These partnerships and our data allow for tailoring of informed prevention approaches to address upstream factors driving disproportionate infant mortality in historically disinvested communities, as well as optimizing the immediate risks posed by the infant sleep environment. Data from our system show the number of SUID declining modestly since our prevention work began., Competing Interests: CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest to disclose., (Copyright © 2024 by the American Academy of Pediatrics.)

Background: The prospective, single-arm, observational, phase 4 ETNA-AF Europe study collected real-world data about safety, effectiveness and therapeutic adherence in European patients with non-valvular atrial fibrillation newly prescribed with edoxaban and followed up for 4 years., Methods: Overall, 13 164 patients were included in the full-analysis set, which means that they had at least one documentation after baseline at 4 years. The current paper reports about the 3329 Italian patients out of the whole European population., Results: In the Italian cohort, median age was 76.0 (69.0-82.0) years, with 57.4% of the patients being ≥75 years old. The CHA2DS2-VASc score was >4 in 586 (18.1%) patients. At baseline, 670 (20.8%) patients were classified as frail by the investigators. Edoxaban 30 mg/day was prescribed to 1013 (31.8%) patients: these were older, with more comorbidities and a lower estimated creatinine clearance compared with those receiving 60 mg/day. All-cause mortality was 4.1%/year and there were very low yearly rates of bleeding and thromboembolic events: major bleeding, 0.9%; intracranial hemorrhage, 0.2%; ischemic stroke, 0.3%; systemic embolism, <0.1%. These events were more frequent in patients ≥75 years or in patients with renal impairment or treated with edoxaban 30 mg/day. Advancing age was not associated with an increased incidence of intracranial bleeding., Conclusions: These findings confirm the favorable long-term safety and effectiveness profile of edoxaban in non-valvular atrial fibrillation patients treated in routine clinical care in Italy.

Objectives. To investigate characteristics of data reported in US medical cannabis registries across states. Methods. Data included 2021 medical cannabis registry reports from 34 states, Puerto Rico, and the District of Columbia (hereafter, states) with active medical cannabis programs. The data from the reports were manually coded into domains and subcategories, including information related to patients (e.g., number, demographics), authorizing clinicians, sales (e.g., content, revenue), license tracking, and health and safety outcomes. Results. Among 36 states, 97% reported total patient number and 75% reported number of authorizing clinicians. Least reported subcategories included patient race/ethnicity (8%), adverse events (11%), therapeutic benefits (6%), and product recalls (6%). States that recently legalized medical cannabis (2013-2018) reported a higher number of subcategories overall, with a median of 11 versus 8 for early adopting states (1996-2012). More medical-use states reported data on authorizing clinicians compared with nonmedical adult-use states but were otherwise similar. Conclusions. Medical cannabis state registries generally reported data on consumers, clinicians, and sales rather than health and safety outcomes. More comprehensive and uniform medical cannabis public health surveillance is needed. ( Am J Public Health . 2024;114(S8):S685-S693. https://doi.org/10.2105/AJPH.2024.307728).

Background: Cancer places a high burden on society and health-care systems. Cancer research requires high-quality data, which is resource-intensive to obtain. Using administrative datasets such as cancer registries could improve the efficiency of cancer studies if data were valid and timely. We aimed to compare the validity and timeliness of diagnostic cancer data on-site during the SYMPLIFY study to that obtained from the cancer registries of England and Wales., Methods: Cancer data were collected from 5461 participants across 44 hospital sites during a prospective observational study in England and Wales, SYMPLIFY (ISRCTN10226380). Linked cancer data were obtained from Digital Health and Care Wales (DHCW), the Welsh Cancer Intelligence and Surveillance Unit (WCISU), and the English National Cancer Registration Dataset (NCRD) and Rapid Cancer Registration Dataset (RCRD), regularly between April, 2022, and September, 2023. The primary objectives of the study were to evaluate the validity (via assessment of the proportion of completed data fields and concordance with SYMPLIFY sites), and timeliness of the data in all datasets, for all cancers diagnosed within 9 months of study enrolment. Data fields investigated were cancer site via International Classification of Disease, 10th Revision (ICD-10) code; cancer morphology via International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3) morphology histology code and broad morphological grouping; overall stage; and TNM classification., Findings: For data collected between April, 2022, and September, 2023, completeness at the last data cut available for each dataset ranged from 84% to 100% for ICD-O-3 morphology, from 43% to 100% for overall stage, and from 74% to 83% for TNM stage. The concordance between SYMPLIFY data and NCRD was 96% (95% CI 92-98) for ICD-10, 60% (53-66) for ICD-O-3 morphology, 83% (78-88) for ICD-O-3 broad morphology groupings, 73% (67-78) for stage, and 51% (44-59) for TNM; and with WCISU was 89% (95% CI 81-94) for ICD-10, 63% (53-73) for ICD-O-3 morphology, 80% (70-87) for ICD-O-3 broad morphology groupings, 83% (74-90) for overall stage, and 49% (38-61) for TNM stage. Concordance between SYMPLIFY and RCRD was 95% (95% CI 92-98) for ICD-10, 67% (60-74) for ICD-O-3 morphology, 85% (79-90) for ICD-O-3 broad morphology groupings, and 73% (65-80) for overall stage; and between SYMPLIFY and DHCW was 96% (91-99) for ICD-10, 74% (64-83) for ICD-O-3 morphology, 84% (75-91) for ICD-O-3 broad morphology groupings, and 87% (74-95) for stage. The SYMPLIFY dataset reached completion at 12 months post-enrolment in November, 2022, compared with 13 months for NCRD in December, 2023. RCRD and DHCW reached completion at 13 months and 15 months post-enrolment, in December, 2022, and February, 2023, respectively., Interpretation: We report similar completeness of data fields, concordance, and timeliness between on-site and centrally collected cancer outcomes data. Our findings suggest that central registry data can help alleviate the resource burden in clinical trials and improve cancer research. Cancer registries might need additional resources to provide data for registry-based trials at scale., Funding: GRAIL Bio UK., Competing Interests: Declaration of interests BDN and MRM receive institutional research funding from GRAIL. BDN reports grants, honoraria, and consulting fees from the National Institute for Health and Care Research (NIHR), Cancer Research UK, Royal College of General Practitioners, and Multi-Cancer Early Detection Consortium. DH and DA report payment to their institution from National Health Service Wales Cancer Network for additional cancer registration officer time to expedite population-based cancer registration for this study. DH and DA report grants from Moondance Cancer Initiative. FDRN reports honoraria for occasional sessional payment for congress talks for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and Pfizer. RP reports funding from GRAIL and National Health Service England for the completion of this study, as well as grants from Medical Research Council, NIHR, and the Medical Science Division at the University of Oxford and is a statistical editor for BMJ and BMJ Medicine. HK, KNK, SH, KR, YL, and HN were all employees of GRAIL at the time of the study. HK reports a leadership position with GRAIL. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Educational attainment and income are often, but not always, associated with disease incidence. Existing research typically examines single diseases, resulting in disparate analyses with little comparability. In this study, we aimed to assess educational and income inequalities across diseases in Denmark., Methods: This register-based study included all Danish residents aged at least 30 years between Jan 1, 2013, and Dec 31, 2022, who were born after 1920, and with known educational attainment and income. We used a disease-wide approach to assess associations between education and income and the incidence of 751 diagnostic codes determined upon hospital admission. We estimated age-standardised incidence rates and incidence rate ratios (IRRs) using Poisson regression, adjusted for birth cohort and stratified by sex. Participants were followed up until time of diagnosis, death, emigration, or until Dec 31, 2022., Findings: 4 541 309 individuals aged 30 years and older were registered as living in Denmark between Jan 1, 2013, and Dec 31, 2022. 121 083 were excluded due to limited or missing information about educational attainment. 4 420 226 individuals were included in the analysis of educational inequalities (2 232 200 [50%] were female and 2 188 026 [50%] were male). 23 708 were excluded due to absence of income information, and 4 396 518 were included in the analysis of income inequalities (2 223 217 (51%) were female and 2 173 301 (49%) were male). Socioeconomic differences in incidence rates were observed across all disease groups; incidence rates of most diseases decreased with higher educational attainment and income. The magnitude of the socioeconomic inequalities varied substantially. Among non-communicable diseases, the strongest positive association with regard to education was observed in chronic obstructive pulmonary disease for female individuals (low education vs high education, IRR 2·7 [95% CI 2·4-3·0]) and schizophrenia for male inividuals (low education vs high education, IRR 4·4 [2·2-8·8]), and the strongest negative association was in melanoma and other skin cancers for females (low education vs high education, IRR 0·7 [0·7-0·8]) and melanoma and skin cancers for males (low education vs high education, 0·7 [0·6-0·8]). With regard to income, for females, the strongest positive association was observed in schizophrenia (quartile 1 [Q1] vs quartile 4 [Q4], IRR 10·1 [6·1-17·2]), whereas the strongest negative association was in melanoma and other skin cancers (Q1 vs Q4, IRR 0·5 [0·5-0·6]). For males, the strongest positive assocation was schizophrenia (Q1 vs Q4, IRR 18·4 [95% CI 8·5-39·9]) and the strongest negative association was also melanoma and other skin cancers (Q1 vs Q4, IRR 0·5 [0·5-0·6]). The most prevalent disease category, other digestive diseases, was also strongly positively associated with education (low education vs high education, IRR 1·6 [95% CI 1·6-1·6] for females; IRR 1·5 [1·4-1·5] for males) and income (Q1 vs Q4, IRR 1·5 [1·5-1·5] for females; IRR 1·3 [1·3-1·4] for males)., Interpretation: Our study provides a detailed representation of the association between two socioeconomic indicators and disease incidence. A broad spectrum of diseases, and not only the most prevalent, show socioeconomic disparities. This finding highlights the need for not only policies that address specific diseases, but also universal policies addressing the root causes of socioeconomic disparities and their health consequences., Funding: The Novo Nordisk Foundation., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Percutaneous coronary intervention (PCI) is the preferred method of revascularization for chronic coronary syndromes. Outpatient PCI has demonstrated, in addition to its reliability and safety, the comfort of patients and the reduction of costs that weigh on our healthcare systems. Nevertheless, it remains largely underutilized in France, with significant disparities between centers, particularly between private and public ones. This article provides an overview of outpatient PCI in France based on the France PCI registry and allows us to position ourselves in relation to our European neighbors., Competing Interests: Déclaration de liens d'intérêts Les auteurs ne déclarent aucun lien d'intérêt en rapport avec ce travail., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

Background: Adjuvant anti-PD-1 therapy improves relapse free survival in stage III melanoma, but also leads to immune-related adverse events (irAEs). Older patients are of particular interest due to comorbidities and frailty, which may impact their ability to tolerate irAEs and benefit from anti-PD-1 therapy. This study aimed to explore associations between clinical parameters and the occurrence of grade ≥ 3 irAEs and recurrence-free survival (RFS) in older patients with radically resected stage III/IV cutaneous melanoma treated with adjuvant anti-PD-1 therapy., Methods: Patients aged ≥ 65 with resected stage III/IV cutaneous melanoma treated with adjuvant anti-PD-1 therapy between 2018 and 2022 were selected using real-world data from the nationwide Dutch Melanoma Treatment Registry (DMTR). A univariate and multivariable logistic regression was used to compare determinants of grade ≥ 3 irAEs, and univariate and multivariable Cox-proportional hazard models were fitted to identify factors influencing RFS., Results: The study included 885 patients, with 280 aged 75 and older. The incidence of grade ≥ 3 irAEs was 15.5 % in the 65-74 age group and 13.9 % in the ≥ 75 age group. No significant correlation was found between age and grade ≥ 3 irAEs. However, an increasing number of comorbidities was associated with a higher risk of grade ≥ 3 irAEs (multivariable analyses: OR 1.83, 95 % C.I. 0.99-3.40). The 1-year RFS rate of 80.0 % of this study was comparable to those reported in previous registration trials and real-world data. Having ≥ 3 comorbidities was significantly associated with a decrease in RFS (HR: 1.68, 95 % C.I. 1.15-2.44)., Conclusion: Older patients had similar benefit of adjuvant immunotherapy compared to older subgroups in previous trials. However, patients with multiple comorbidities were at increased risk of grade ≥ 3 irAEs and had a lower RFS. This should be considered when deciding upon adjuvant treatment., Competing Interests: Declaration of Competing Interest All remaining authors have declared no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The Registry of Fast Myocardial Perfusion Imaging with Next-Generation SPECT (REFINE SPECT) has been expanded to include more patients and CT attenuation correction imaging. We present the design and initial results from the updated registry. Methods: The updated REFINE SPECT is a multicenter, international registry with clinical data and image files. SPECT images were processed by quantitative software and CT images by deep learning software detecting coronary artery calcium (CAC). Patients were followed for major adverse cardiovascular events (MACEs) (death, myocardial infarction, unstable angina, late revascularization). Results: The registry included scans from 45,252 patients from 13 centers (55.9% male, 64.7 ± 11.8 y). Correlating invasive coronary angiography was available for 3,786 (8.4%) patients. CT attenuation correction imaging was available for 13,405 patients. MACEs occurred in 6,514 (14.4%) patients during a median follow-up of 3.6 y (interquartile range, 2.5-4.8 y). Patients with a stress total perfusion deficit of 5% to less than 10% (unadjusted hazard ratio [HR], 2.42; 95% CI, 2.23-2.62) and a stress total perfusion deficit of at least 10% (unadjusted HR, 3.85; 95% CI, 3.56-4.16) were more likely to experience MACEs. Patients with a deep learning CAC score of 101-400 (unadjusted HR, 3.09; 95% CI, 2.57-3.72) and a CAC of more than 400 (unadjusted HR, 5.17; 95% CI, 4.41-6.05) were at increased risk of MACEs. Conclusion: The REFINE SPECT registry contains a comprehensive set of imaging and clinical variables. It will aid in understanding the value of SPECT myocardial perfusion imaging, leverage hybrid imaging, and facilitate validation of new artificial intelligence tools for improving prediction of adverse outcomes incorporating multimodality imaging., (© 2024 by the Society of Nuclear Medicine and Molecular Imaging.)

Introduction and Objectives: This article presents the 2023 activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC)., Methods: All interventional cardiology laboratories in Spain were invited to participate in an online survey. Data analysis was carried out by an external company and subsequently reviewed and presented by the members of the ACI-SEC board., Results: A total of 119 hospitals participated. The number of diagnostic studies decreased by 1.8%, while the number of percutaneous coronary interventions (PCI) showed a slight increase. There was a reduction in the number of stents used and an increase in the use of drug-coated balloons. The use of intracoronary diagnostic techniques remained stable. For the first time, data on PCI guided by intracoronary imaging was reported, showing a 10% usage rate in Spain. Techniques for plaque modification continued to grow. Primary PCI increased, becoming the predominant treatment for myocardial infarction (97%). Noncoronary structural procedures continued their upward trend. Notably, the number of left atrial appendage closures, patent foramen ovale closures, and tricuspid valve interventions grew in 2023. There was also a significant increase in interventions for acute pulmonary embolism., Conclusions: The 2023 Spanish cardiac catheterization and coronary intervention registry indicates a stabilization in coronary interventions, together with an increase in complexity. There was consistent growth in procedures for both valvular and nonvalvular structural heart diseases., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Data describing the use of extracorporeal membrane oxygenation (ECMO) in pediatric acute liver failure (PALF) are scarce. Thus, we aimed to describe the use of ECMO in patients with PALF using the data from the Extracorporeal Life Support Organization (ELSO) Registry between January 1, 2010, to December 31, 2022. We described patients' characteristics at ECMO initiation, outcome, and factors associated with mortality. A total of 335 children underwent ECMO support in the context of PALF. Veno-arterial (VA) ECMO was the most prevalent mode (66.6%), followed by veno-venous (VV) ECMO (33.4%). Extracorporeal cardiopulmonary resuscitation (ECPR) was used in 21.5% of the cardiac arrest. In-hospital mortality was 66.6%. Both higher lactate (OR 1.128, CI 1.06-1.209, p < 0.001) and PaCO 2 (OR 1.022, CI 1.001-1.047, p 0.05) levels before ECMO reported greater odds of mortality. Low body weight, persistence of hyperlactatemia (OR 0.985, CI 0.973-0.997, p 0.013), and hyperbilirubinemia (OR 2.477, CI 1.042-6.100, p 0.045) after 24 h from ECMO deployment were associated to greater odds of mortality., Conclusions: Our results suggest that the use of ECMO for the management of respiratory and cardiac failure in patients with PALF should be considered with caution and that further research is needed to understand its role in this specific high-risk population., What Is Known: • Pediatric acute liver failure (PALF) is a clinical syndrome associated with significant morbidity and mortality. • Data on the use of extracorporeal membrane oxygenation (ECMO) in the context of PALF are scarce and controversial., What Is New: • ECMO to manage acute respiratory and/or cardiac failure in the context of PALF should be considered with caution. • Bleeding and thrombotic complications in children with acute liver failure receiving ECMO are similar to the ones reported in the general pediatric population., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are chimeric antigen receptor T-cell therapies that were evaluated in third and later line (3L+) relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in the ZUMA-1 and JULIET trials, respectively. As of October 2021, the DESCAR-T registry included 729 French patients with 3L+ r/r DLBCL who received axi-cel or tisa-cel. Using these data, propensity score matching was used to conduct an adjusted comparison between axi-cel and tisa-cel. Axi-cel was associated with statistically significant improvements in overall survival (OS) and progression-free survival (PFS), and significantly more frequent Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS), compared with tisa-cel. There was no significant difference in Grade ≥ 3 cytokine release syndrome (CRS). The current analysis assessed the cost-effectiveness of axi-cel versus tisa-cel in the treatment of 3L+ r/r DLBCL using propensity score-matched data from the DESCAR-T registry., Methods: A partitioned survival model was used to extrapolate costs and quality-adjusted life years (QALYs) over a lifetime. Survival curves for PFS and OS were based on independent mixture cure models fitted to digitized Kaplan-Meier data for the propensity score-matched DESCAR-T populations. Average duration of intensive care unit stays for each of axi-cel and tisa-cel in DESCAR-T were used to inform adverse event costs. Selected parametric survival distributions were based on clinical expert validation. Utility values were derived from ZUMA-1, and costs were obtained from French registries and published sources. List prices were used for both axi-cel and tisa-cel. Costs and outcomes were discounted at an annual rate of 2.5%., Results: Axi-cel is associated with an incremental cost-effectiveness ratio of €15,520 per QALY compared with tisa-cel., Conclusion: Based on explicit willingness-to-pay thresholds applied in Europe, axi-cel is expected to be a cost-effective use of healthcare resources in real-world clinical settings compared with tisa-cel in 3L+ r/r DLBCL., (© 2024. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.)

Research Question: What were the utilization, effectiveness and safety of assisted reproductive technology (ART) in Africa during 2020?, Design: Cross-sectional, cycle-based and retrospective summary data were collected from voluntarily participating ART centres., Results: During 2020, 37,063 ART procedures were reported by 67 centres in 15 countries. Autologous fresh transfers were predominant at 65.0%, whereas autologous frozen embryo transfers (FET) represented 26.2% and oocyte donation cycles remained less than 10%. Women undergoing autologous fresh embryo transfer had a mean age of 34.9 years and received a mean number of 2.4 embryos per transfer. The clinical pregnancy rate (CPR) per embryo transfer was 37.3% after fresh embryo transfer and 37.8% after frozen embryo transfer. The cumulative CPR per aspiration was 41.9% in autologous cycles. Most ART procedures resulted in a multiple delivery rate above 20%. After autologous ART, multiples were predominantly born preterm (twin and triplet deliveries 59.5% versus singleton 21.9% born before 37 weeks), with a substantially increased perinatal mortality compared with ART singletons (59.0‰ versus 22.2‰). Cycle-based data documented that elective single embryo transfer (eSET) provides the optimal balance of effectiveness (eSET CPR per embryo transfer 36.7%) and safety., Conclusion: This fourth report of the African Network and Registry for ART provides real-world evidence of ART utilization, practices and outcomes in Africa, which is relevant to many stakeholders. It critically informs and represents regional ART development based on national, regional and global cooperation., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: In patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI), antiplatelet medication usage is crucial for preventing thrombotic events. However, it requires careful monitoring, especially because of the risk of life-threatening bleeding complications. In hemorrhagic complications, assessment of patient background and risk of gastrointestinal bleeding (GIB) remain limited for GIB that develops during long-term observation after hospital discharge. This study aimed to examine the incidence of GIB and patient characteristics in CAD post-PCI., Methods: All CAD patients undergoing PCI for urgent, emergent, or elective indications were enrolled in the Keio Interhospital Cardiovascular Studies (JCD-KiCS)-PCI registry (January 2009 and December 2017) and followed up to 2 years after PCI discharge. From the JCD-KiCS PCI registry, 8864 patients (median [interquartile range [IQR]] age: non-GIB: 69.0 y [16 y], upper GIB (UGI): 72.0 y [15.5 y], lower GIB (LGI): 73.0 y [IQR: 13 y]) were categorized based on the occurrence of hospitalization-requiring GIB. Patient characteristics and detailed information regarding these GIB events, including the location (upper vs lower GI) and bleeding severity, were analyzed., Results: Overall, 36 patients experienced UGI, while 85 patients experienced LGI. The rates of dual antiplatelet therapy (DAPT) and triple therapy were significantly different among the non-GIB (n = 8734), UGI (n = 36) and LGI (n = 85) groups (DAPT [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)]: 64 [76.2 %] in the LGI group vs 24 [68.6 %] in the UGI group vs 7330 [84.6 %] in the non-GIB group; triple therapy [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)] + oral anticoagulant (OAC) (warfarin/direct oral anticoagulant [DOAC]): 17 [20.2 %] in the LGI group vs 8 [22.9 %] in the UGI group vs 836 [9.6 %] in the non-GIB group; p < 0.001). In the LGI and UGI groups, aspirin and warfarin were used in 2 (2.4 %) and 2 (5.7 %) patients, respectively, but not in combination with DOAC. The 2-year post-PCI hospitalization incidence for GIB was 1.4 % (LGI, 1.0 %; UGI, 0.4 %). The most common causes were colonic diverticular hemorrhage (43.5 %) for LGI and duodenal ulcer (21.9 %) for UGI. No significant differences were found in the cumulative 2-year post-PCI risks between the LGI and UGI groups (log-rank p = 0.97). Most GIB events were Bleeding Academic Research Consortium 2-equivalent (hemoglobin decrease <3 g/dL). Notably, the use of OACs at PCI discharge, bleeding complications within 72 h, and preprocedural anemia were significantly correlated with an increased GIB risk., Conclusions: The real-world incidence of LGI is two times higher than that of UGI in CAD patients undergoing PCI, and most events are mild. OAC use at PCI discharge is the strongest potential risk factor for GIB development., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Kohsaka has received an unrestricted research grant from Novartis and AstraZeneca. Dr. Hosoe received an unrestricted research grant from Medtronic Inc. The funder did not play a role in the study design, data collection, data analysis, publication decision, or manuscript preparation. The authors declare no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The risk of intracranial bleeding during anticoagulation for venous thromboembolism (VTE) is substantial and persists beyond the initial treatment phase. We aimed to refine risk-assessment through phase-specific prognostic scores., Methods: We identified data from 77,786 VTE patients in the RIETE registry from March 2009 to October 2023 to develop two prognostic scores for intracranial bleeding. Multivariable Cox regression was used to analyze distinct variables for the early (≤90 days) and late (>90 days) phases, with comparative validation against existing scores (modified ACCP, RIETE, VTE-BLEED, and CHAP)., Results: Intracranial bleeding occurred in 411 patients (0.53 %), with 208 cases in the early phase and 203 in the late phase. The 30-day mortality was 45 % and 35 %, respectively. Shared significant predictors for both phases include baseline abnormal mental status, brain cancer, recent intracranial bleeding, and epilepsy. Unique to early-phase bleeding were body weight, non-brain cancer, hypertension, dementia, thrombocytopenia, renal insufficiency, and thrombolytic therapy. Advanced age, pulmonary embolism initially, prior stroke, depression, treatment with direct oral anticoagulants, and use of corticosteroids predicted late-phase bleeding. Both prognostic scores showed a c-statistic of 0.68, outperforming existing scores., Conclusions: The study introduces two temporal prognostic scores for intracranial bleeding during anticoagulation for VTE. By discerning specific risk factors pertinent to each treatment phase, these scores outperform traditional models, offering an advanced tool for clinical decision-making. They hold significant potential for optimizing anticoagulation management and reducing bleeding-related mortality., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Neurotrauma registries (NTR) collect data on traumatic brain injuries (TBI) to advance knowledge, shape policies, and improve outcomes. This study reviews global NTRs from High-Income (HICs) and Low- and Middle-Income countries (LMICs). A systematic review was conducted using PubMed, Google Scholar, Embase, and Web of Science following PRISMA guidelines to identify relevant NTRs. Twenty-six articles were included, revealing ten different NTRs from Europe, North America, Latin America, the Middle East, and Asia. North America had the most registries at four, followed by Europe and Asia with two each, and Latin America and the Middle East with one each. The median database size was 1,734 patients (Range: 65-25,000), with the largest registry from the United States (FITBIR DB) and the smallest from Iran (NSCIR-IR). The longest data collection period was 32 years, with a mean age of 43.1 years (Range: 9.07-60.0). Males comprised 70 % of patients. Sixty-six percent of articles emphasized outcomes such as functionality, length of stay, and mortality. Key challenges identified included issues with missing data and incomplete records (n = 4), lack of standardization in data collection procedures (n = 3), staffing shortages (n = 5), lack of IT infrastructure (n = 3), and problems with reproducibility, particularly in high-income countries (n = 4). Our review highlights the need for a large-scale global NTR, addressing LMIC barriers through private-public partnerships with organized neurosurgery members., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objective: Peri-intubation complications are important sequelae of airway management in the emergency department (ED). Our objective was to quantify the increased risk of complications with multiple attempts at emergency airway intubation in the ED., Methods: This is a secondary analysis of a prospectively collected multicenter registry (National Emergency Airway Registry) consisting of attempted ED intubations among subjects aged >14 years. The primary exposure variable was the number of intubation attempts. The primary outcome measure was the occurrence of peri-intubation major complications within 15 min of intubation including hypotension, hypoxemia, vomiting, dysrhythmias, cardiac arrest, esophageal intubation, and failed airway with cricothyrotomy. We constructed multivariable logistic regression models to determine the associations between complications and the number of intubation attempts while controlling for measured pre-exposure variables., Results: There were 19,071 intubations in the NEAR database, of which 15,079 met inclusion for this analysis. Of these, 13,459 were successfully intubated on the first attempt, 1,268 on the second attempt, 269 on the third attempt, 61 on the fourth attempt, and 22 on the fifth or more attempt. A complication occurred in 2,137 encounters (14 %). Major complications accompanied 1,968 encounters (13 %) whereas minor complications affected 315 encounters (2 %). The most common major complication was hypoxia. In our multivariable logistic regression model, odds ratios with 95 % confidence intervals for the occurrence of major complications for multiple attempts compared to first-pass success were 4.4 (3.6-5.3), 7.4 (5.0-10.7), 13.9 (5.6-34.3), and 9.3 (2.1-41.7) for attempts 2-5+ (reference attempt 1), respectively., Conclusions: We found an independent association between the number of intubation attempts among ED patients undergoing emergency airway intubation and the risk of complications., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to disclose., (Published by Elsevier Inc.)

This study analyzes the epidemiology of pediatric drowning in Israel from 2010 to 2022, focusing on differences across age groups, sex, and regions. We conducted a retrospective cohort study using data from the Ministry of Health's administrative databases, covering all children aged 0-17 years who were seen in the emergency department, discharged after hospitalization, or died at the scene due to drowning, excluding cases of intentional harm or suicide. The primary outcome was the annual drowning rate per 100,000 children, categorized by age, sex, and region, along with hospitalization duration, intensive care unit admissions, and mortality rates. A total of 2101 drowning incidents were identified, with 9% resulting in death. Higher drowning rates were found in younger children (1-4 years) and teenagers (15-17 years), with notable differences by sex. Drowning rates were higher in coastal regions and more frequent during winter and spring. An increase in drowning rates was observed over the last 3 years of the study (2020-2022). Children hospitalized for more than 3 days had significantly higher mortality rates, both in general wards and intensive care units., Conclusions: Pediatric drowning is a persistent public health concern in Israel, with distinct seasonal, regional, age-specific, and sex-specific patterns in incidence and mortality. This study underscores the need for a comprehensive prevention strategy that includes year-round public education, environmental safety measures, and targeted interventions for high-risk groups to reduce drowning incidents and fatalities among children effectively., What Is Known: • Pediatric drowning represents a significant public health challenge globally, with varying rates. • In Israel, pediatric drowning is the second leading cause of death from all injury-related deaths. Thus far, the measures and interventions to reduce fatalities were not proven effective enough., What Is New: • Pediatric drowning in Israel, with a 9% mortality rate, revealed a biphasic rate varied by sex and is higher in coastal regions and during winter and spring. • There was a notable increase in drowning incidents during the last 3 years of the study period (2020-2022), coinciding with the COVID-19 pandemic., (© 2024. The Author(s).)

Aim: Periprosthetic joint infection (PJI) is one of the main causes of revision surgeries after total knee arthroplasty (TKA) and unicondylar knee replacement. Patient- and hospital-related risk factors must be evaluated to prevent PJI. This study identifies influencing factors and differences in infection rates between various types of implant., Methods: The basis for the data is the German Arthroplasty Register (EPRD). Septic revisions were calculated with the aid of Kaplan-Meier estimates, with septic revision surgery defined as the primary endpoint. Patients with constrained and unconstrained TKA or UKA were analysed using the Holm multiple log-rank test and the Cox proportional hazard model. The 300,998 cases of knee arthroplasty analysed included 254,144 (84.4%) unconstrained TKA, 9993 (3.3%) constrained TKA and 36,861 (12.3%) UKA, with a maximum follow-up of 7 years., Results: After 1 year, the PJI rate was 0.5% for UKA and 2.8% for TKA, whereas after 7 years it was 4.5% for UKA and 0.9% for TKA (p < 0.0001). In constrained TKA, the PJI rate was significantly increased compared with unconstrained TKA (p < 0.0001). After 1 year, the PJI rate was 2.0% for constrained TKA and 0.8% for unconstrained TKA, as well as 3.1% and 1.4% respectively after 7 years. Implantation of a constrained TKA (HR = 2.55), male sex (HR = 1.84), an increased Elixhauser Comorbidity Index score (HR = 1.18-1.56) and an implantation volume of less than 25 UKA per year (HR = 2.15) were identified as risk factors for revision surgeries; an Elixhauser Comorbidity Index score of 0 (HR = 0.80) was identified as a preventive factor., Conclusions: A reduced implantation volume and constrained knee arthroplasty are linked to a higher risk of PJI. Comorbidities (increased Elixhauser Comorbidity Index score), male sex and a low UKA-implantation volume were identified as risk factors for PJI. Patients who fulfil these criteria need specific infection prevention measures. Further analyses are required to investigate the potential influence of prevention and risk factor modification., Level of Evidence: III., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Objective: This post-hoc analysis of data extracted from a prospective study aimed to explore for the first time if the efficacy of fremanezumab in preventing difficult-to-treat migraine, according to ICHD-III, would differ between pre-menopausal and post-menopausal women., Methods: A total of 171 (aged 18-70 years) fremanezumab-treated female migraine patients for six consecutive months were classified to those at pre-menopausal ( n  = 82) or post-menopausal ( n  = 89). Monthly headache days (MHD), disability, and quality of life (QOL) outcomes were assessed at baseline and at week 24 post-fremanezumab within subgroups and were then compared between them. Safety and tolerability were also assessed., Results: In both groups, fremanezumab demonstrated significant reductions in MHDs, reduced disability, and higher QOL scores at week 24 post-treatment, compared to baseline. However, the between-subgroup comparison documented that pre-menopausal women and those at post-menopausal comparably benefited with significant reductions in overall MHDs ( p  = 0.883). Less disability, according to MIDAS ( p  = 0.696) and HIT-6 scores ( p  = 0.912), as well as higher QOL scores at week 24 post-fremanezumab, were also comparably evident in both groups. Safety was excellent across both subgroups., Conclusion: Fremanezumab can be considered a very effective treatment option for preventing migraines in difficult-to-treat women, aged 18-70 years, regardless of their menopausal status.

Background: Lipoprotein-associated phospholipase A 2 activity (Lp-PLA 2 -A) is a pivotal enzyme involved in the inflammatory process and atherosclerotic plaque vulnerability. This study aimed to investigate the potential of Lp-PLA 2 -A as a biomarker for reflecting artery-to-artery embolism (AAE), a critical mechanism with high risk of stroke recurrence in symptomatic intracranial atherosclerotic disease (sICAD)., Methods: The current analysis included a cohort of 1,908 patients with sICAD and baseline levels of Lp-PLA 2 -A from the Third China National Stroke Registry (CNSR-III). The baseline Lp-PLA 2 -A levels were quantified centrally using an automatic enzyme assay system. Diagnosis of sICAD was made by experienced stroke neurologists based on the presence of a cerebral infarction within the territory of a stenotic (>50 %) or occluded artery, or when clinical symptoms were consistent with the diagnosis. Infarct lesions affecting the cortex serve as imaging biomarkers for stroke mechanism involving AAE.The relationship between baseline Lp-PLA 2 -A quartile levels and the presence of cortical infarction was analyzed using multivariate logistic regression., Results: Compared to patients in the first Lp-PLA 2 -A quartile, those in the second, third and fourth quartiles demonstrated a significantly higher proportion of AAE. The proportion of patients with cortical infarction increased with rising Lp-PLA 2 -A quartiles, observed at 39.3 %, 47.1 %, 47.4 %, and 50.7 % for the first, second, third and fourth quartiles respectively (P for trend=0.004). Compared with the first quartile, the odds ratios (ORs) were 1.38 (95 % CI = 1.06-1.79) for the second, 1.33 (95 % CI = 1.02-1.72) for the third quartile and 1.48 (95 % CI = 1.14-1.92) for the fourth quartile. The association between higher Lp-PLA 2 -A and increased proportion of cortical infarction was also present in the subgroups defined by age <65 years, male, and high-sensitivity C-reactive protein ≥2 mg/L. In sensitivity analyses, the positive correlation between Lp-PLA 2 -A levels and proportion of cortical infarction remained consistent., Conclusions: This research highlights the significance of Lp-PLA 2 -A as a biomarker for reflecting stroke mechanism in sICAD. Additional studies are warranted to explore the potential of targeting Lp-PLA 2 -associated inflammatory pathways as a pivotal approach in arresting the advancement of intracranial atherosclerotic stenosis and reducing the incidence of embolic strokes., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier Inc.)

Background: Reports in the literature on talar head fractures are rare and limited to case reports and small case series., Questions/purposes: This study aimed to describe a national cohort of talar head fractures for fracture characteristics, associated injuries, treatment, and reoperations., Methods: We reviewed all radiographs of patients enrolled in the SFR between 2011 and 2021 showing talar head fractures (AO/OTA 81-A3). We excluded those with talar head avulsion fractures, misclassified, multiple registrations, or with a privacy notice in their medical records. The cohort was reviewed using medical records and radiographs at a minimum 2-year follow-up., Results: The study included 32 patients (33 fractures) ≥18 years of age. The median age was 32 (range 18-65) years, 84 % were men, and the main trauma mechanisms were motor vehicle accidents (28 %) and falls from heights (28 %) and graded as high-energy injuries in 50 % of the cases. 18 (55 %) were displaced and 15 (45 %) had comminuted fractures. 14 talar head fractures (42 %) had multiple injuries to the same foot. 21 patients (66 %) underwent surgical treatment, most commonly with screw fixation. Surgery was performed in 15 of 18 patients with displaced fractures. Four patients were reoperated, one with arthrodesis of the talonavicular joint and three for implant removal. No cases of avascular necrosis were identified., Conclusions: Talar head fractures are rare and occur mainly in men. They are associated with other foot injuries. Most talar head fractures are treated operatively. In this case series, we did not identify any case of avascular necrosis., Levels of Evidence: IV, retrospective observational cohort study., Competing Interests: Declaration of competing interest The authors declare none related to the present study., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Previous studies highlighted a more extensive phenotype for paediatric-onset than adult-onset inflammatory bowel disease (IBD). However, most lacked long-term follow-up, and some were conducted before the era of biologics., Aims: The aim of this study is to compare disease characteristics and treatment exposures between paediatric-onset and adult-onset IBD., Methods: From a registry that periodically and uniformly retrieves demographics, disease characteristics/phenotype, and treatments, we compared the characteristics of paediatric-onset (diagnosed at ≥6 and <18 years) and adult-onset IBD, diagnosed during 2000-2022 and with ≥12 months follow-up., Results: Of the 2837 patients with Crohn's disease and 1332 with ulcerative colitis, 3316 had adult-onset and 853 paediatric-onset IBD. The median follow-up was 6 years. Patients with paediatric-onset presented with more extensive disease and received more intensified therapies, including biologics and JAK inhibitors than those with adult-onset IBD. Paediatric-onset ulcerative colitis showed a higher prevalence of E3 extensive colitis including pancolitis and a greater requirement for systemic steroids, immunomodulators, and biologics than adult-onset ulcerative colitis. Paediatric-onset versus adult-onset Crohn's disease exhibited greater L3 ileocolonic involvement and perianal disease phenotype, and higher exposure to immunomodulators and biologics. Kaplan-Meier curve and Cox proportional hazards analyses showed significantly lower 15-year biologic-free survival from diagnosis among those with paediatric-onset IBD than with adult-onset IBD (p = <0.001), indicating greater and earlier use of biologics in the former., Conclusions: Paediatric-onset presents with more extensive disease with higher exposures to immunomodulators and biologic therapies than adult-onset IBD., (© 2024 The Author(s). Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Introduction: Intraoperative radiotherapy (IORT) with electrons has revealed to have higher rates of ipsilateral breast tumor recurrence (IBTR) than external beam radiotherapy in updated large-scale, randomized controlled trials in 2021. This study details the oncological outcomes of IORT with electron beams using our strict IORT policies. We have found new and important observations regarding the location of recurrence., Methods and Materials: This is a single institution registry of early-stage breast cancer patients who underwent lumpectomy and electron beam IORT with appropriate cone size. All patients met our pre-excision requirements. The primary endpoint was 5-year IBTR rate, with secondary endpoints being 5-year locoregional failure rate, 5-year distant metastasis rate, 5-year overall survival and, importantly, the failure patterns., Results: Between January 2011 and December 2022, 124 patients were recruited. The median follow-up was 6.7 years. The 5-year IBTR rate was 1.87% (95% CI 0.47-7.29%), which is much lower than the ELIOT trial and comparable with other accelerated partial breast irradiation (APBI) techniques. The 5-year locoregional failure rate was 3.68% (95% CI 1.40-9.52%), and the 5-year distant metastasis rate was 0.88% (95% CI 0.13-6.12%), while the 5-year overall survival rate was 97.52% (95% CI 92.44-99.19%). Six patients experienced IBTR. All recurrences were in surgical area, occurring superficial to the tumor bed and within 1 cm of the skin dermis. This failure pattern is very unique and might be explained by our hypothesis of the non-irradiated area beneath the skin., Conclusions: IORT with electron beams with strict patient selection criteria and strict large cone size is still an acceptable treatment for select patients with early-stage breast cancer. However, our new findings support extreme caution in the non-irradiated area beneath the skin around the tumor cavity. Given the constraints of our sample size, these findings should be interpreted cautiously and warrant further investigation in larger, more comprehensive studies., (© 2024. The Author(s).)

Background and Objectives: To identify predictors for relapse in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and to develop and validate a simple risk score for predicting relapse., Methods: In China National Registry of Neuro-Inflammatory Diseases (CNRID), we identified patients with MOGAD from March 2023 and followed up prospectively to September 2023. The primary endpoint was MOGAD relapse, confirmed by an independent panel. Patients were randomly divided into model development (75%) and internal validation (25%) cohorts. Prediction models were constructed and internally validated using Andersen-Gill models. Nomogram and relapse risk score were generated based on the final prediction models., Results: A total of 188 patients (comprising 612 treatment episodes) were included in cohorts. Female (HR: 0.687, 95% CI 0.524-0.899, p = 0.006), onset age 45 years or older (HR: 1.621, 95% CI 1.242-2.116, p < 0.001), immunosuppressive therapy (HR: 0.338, 95% CI 0.239-0.479, p < 0.001), oral corticosteroids >3 months (HR 0.449, 95% CI 0.326-0.620, p < 0.001), and onset phenotype ( p < 0.001) were identified as factors associated with MOGAD relapse. A predictive score, termed MOG-AR (Immunosuppressive therapy, oral Corticosteroids, Onset Age, Sex, Attack phenotype), derived in prediction model, demonstrated strong predictive ability for MOGAD relapse. MOG-AR score of 13-16 indicates a higher risk of relapse (HR: 3.285, 95% CI 1.473-7.327, p = 0.004)., Discussion: The risk of MOGAD relapse seems to be predictable. Further validation of MOG-AR score developed from this cohort to determine appropriate treatment and monitoring frequency is warranted., Trial Registration Information: CNRID, NCT05154370, registered December 13, 2021, first enrolled December 15, 2021.

Introduction: Data on implants of cardiac pacing systems in Spain in 2023 are presented., Methods: The registry is based on the information provided by centers to the recording platform of the Heart Rhythm Association after device implantations, through Cardiodispositivos, the online platform of the National Registry. Other information sources include: a) data transfers from the manufacturing and marketing industry; b) the European pacemaker patient card; and c) local databases submitted by the implanting centers., Results: In 2023, 112 hospitals participated in the registry (30 more than in 2022). A total of 24 343 device implantations were reported (48.1% more than in 2022) compared with 45 120 reported by Eucomed (European Confederation of Medical Suppliers Associations). Of these, 1646 were cardiac resynchronization therapy pacemakers. The devices showing the largest increases were leadless pacemakers, with 963 devices implanted, representing an 18.1% increase over 2022. The most frequent indication was atrioventricular block followed, for the first time, by atrial tachyarrhythmia with slow ventricular response. The number of devices included in remote monitoring also increased (cardiac resynchronization therapy defibrillators, 71%; cardiac resynchronization therapy pacemakers, 63%; and conventional pacemakers, 28%), although more moderately., Conclusions: In 2023, there was an increase in the number of institutions participating in the registry. The reporting of device implantations rose by 48.1%, and the implantation of leadless pacemakers grew by 18.1%. Remote monitoring also experienced modest growth compared with previous years., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Debridement, antibiotics, and implant retention (DAIR) is used to manage acute periprosthetic joint infections (PJIs) after total joint arthroplasty (TJA). Given the uncertain success of single or multiple DAIR attempts and possible long-term deleterious effects this treatment can create when trying to treat persistent infection, it is important to understand the frequency with which surgeons in the United States are attempting multiple debridements for PJI and whether those procedures are achieving the desired goal., Question/purposes: In the context of the American Joint Replacement Registry (AJRR), we asked: (1) What proportion of patients who undergo DAIR have only one DAIR, and what percentage of those patients have more than one? (2) Of the patients who undergo one or more DAIR procedures, what is the proportion who progress to additional surgical procedures? (3) What is the cumulative incidence of medical or surgical endpoints related to infection on the affected leg (other than additional DAIR procedures)?, Methods: DAIR procedures to treat PJI, defined by ICD-9/10 and CPT (Current Procedural Technology) codes, reported to the AJRR from 2012 to 2020 were merged with Centers for Medicare and Medicaid Services (CMS) data from 2012 to 2020 to determine the incidence of patients aged 65 and older who underwent additional PJI-related procedures on the same joint. Linking to CMS ensures no loss to follow-up or patient migration to a non-AJRR site. As of 2021, the AJRR captures roughly 35% of all arthroplasty procedures performed in the United States. Of the total 2.2 million procedures in the AJRR, only 0.2% of the procedures were eligible based on our inclusion criteria. Additionally, 61% of the total population is Medicare eligible, and thus, these patients are linked to CMS. Of the 5029 DAIR attempts after a TKA, 46% (2318) were performed in female patients. Similarly, there were a total of 798 DAIR attempts after a THA, and 50% (398) were performed in female patients. For the purposes of decreasing confounding factors, bilateral THAs and TKAs were excluded from the study population. When querying for eligible procedures from 2012 to 2020, the patient population was limited to those 65 years and older, and a subsequent reoperation for infection had to be reported after a primary TJA. This limited the patient population as most infections reported to AJRR resulted in a revision, and we were searching for DAIRs. Although 5827 TJAs were identified as a primary TJA with a subsequent infectious event, more than 65% (3788) of that population did not have a reported event. The following conditions were queried as secondary outcomes after the first DAIR: sepsis, cellulitis, postoperative infection, endocarditis, amputation, knee fusion, resection, drainage, arthrotomy, and debridement. To answer our first and second study questions, we used frequency testing from the available AJRR data. Because of competing risks and issues with incomplete data, we used the cumulative incidence function to evaluate the outcomes specific to study question 3., Results: Of the patients who underwent DAIR, 93% (5406 of 5827) had one DAIR and 8% (421 of 5827) had more than one. Among the DAIR population, at least 35% of TKAs and 38% of THAs were identified as having experienced an additional PJI-related event (an additional surgical procedure on the same joint, sustained an infectious endpoint in the linked CMS-AJRR dataset, or they had died). The cumulative incidence of developing a further medical or surgical condition related to the joint that had the initial DAIR were as follows: 48% (95% CI 42% to 54%) at 8 years after a DAIR following a TKA and 42% (95% CI 37% to 46%) at 4 years after a DAIR following a THA. The timepoints for TKA and THA are different because there are more longitudinal procedure data available for TKAs regarding DAIR procedures than for THAs., Conclusion: In this study, we used data from the AJRR to assess the incidences of single and multiple DAIR attempts and additional surgical- and infection-related sequalae. Continued investigation is required to determine the fate of infected joints that undergo DAIR with regard to ultimate patient outcome. Future cross-sectional studies using large datasets are necessary to assess functional outcomes and determine the risk of persistent infection after DAIR more precisely., Level of Evidence: Level III, therapeutic study., Competing Interests: All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2024 by the Association of Bone and Joint Surgeons.)

Background: Spinal cord lesions in multiple sclerosis (MS) have considerable impact on disability. High-efficacy disease-modifying treatments (hDMTs) are associated with greater reduction of relapses and new brain lesions compared to low-efficacy treatments (lDMTs). Knowledge on the impact of DMTs on cord lesion formation is limited as these outcome measures were not included in MS treatment trials. This study aims to investigate whether hDMTs reduce the formation of cord lesions more effectively than lDMTs., Methods: Patients with relapse-onset MS, a cord magnetic resonance imaging (MRI) within 6 months before/after initiation of their first DMT and ≥1 cord MRI at follow-up (interval > 6 months) were extracted from the MSBase registry (ACTRN12605000455662). Patients treated with hDMTs ≥90% or lDMTs ≥90% of follow-up duration were considered the hDMT and lDMT groups, respectively. Matching was performed using propensity scores. Cox proportional hazards models were used to estimate the hazards of new cord lesions, brain lesions and relapses., Results: Ninety-four and 783 satisfied hDMT and lDMT group criteria, respectively. Seventy-seven hDMT patients were matched to 184 lDMT patients. In the hDMT group there was no evidence of reduction of new cord lesions (hazard ratio [HR] 0.99 [95% CI 0.51, 1.92], p = 0.97), while there were fewer new brain lesions (HR 0.22 [95% CI 0.10, 0.49], p < 0.001) and fewer relapses (HR 0.45 [95% CI 0.28, 0.72], p = 0.004)., Conclusion: A potential discrepancy exists in the effect of hDMTs over lDMTs in preventing spinal cord lesions versus brain lesions and relapses. While hDMTs provided a significant reduction for the latter when compared to lDMTs, there was no significant reduction in new spinal cord lesions., (© 2024. The Author(s).)

Objectives: In gastroschisis, the intestines are exposed to amniotic fluid during pregnancy. The defect in the abdominal wall may also compress the mesentery and impair the intestinal blood supply. There is a varying degree of intestinal damage at birth. Complex gastroschisis is defined as gastroschisis with severe complications such as intestinal atresia, volvulus, necrosis and perforation. The aim of this study was to investigate long-term gastrointestinal morbidity and compare simple and complex cases., Methods: A nation-wide retrospective cohort study with data from national registers was conducted. All children born with gastroschisis in Sweden from 1 January 1997 to 31 December 2016 were included in the study. Exposure was complex gastroschisis and the primary outcomes were intestinal failure and bowel obstruction., Results: The study included 315 cases with gastroschisis, 260 classifieds as simple gastroschisis and 55 as complex. The median time to follow was 8 years. A significantly higher risk of developing intestinal failure (hazard ratio [HR]: 11.7) was found in complex cases. Nine percent of the complex cases underwent autologous gastrointestinal reconstructive surgery for intestinal failure, none of the simple cases did. The complex cases had a higher risk for bowel obstruction (HR: 4.3) with a higher proportion requiring surgery (18.2% vs. 6.9%) compared to simple cases., Conclusions: This nationwide study showed that the risk for intestinal failure and bowel obstruction is significantly higher for children with complex gastroschisis compared to simple gastroschisis. Most of the events occurred during the first 2 years of life., (© 2024 The Author(s). Journal of Pediatric Gastroenterology and Nutrition published by Wiley Periodicals LLC on behalf of European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

Introduction: Childhood obesity is associated with maternal obesity, but the link to gestational weight gain (GWG) is not fully elucidated. We examined the relationship between early pregnancy maternal body mass index (BMI) and GWG on early childhood growth., Material and Methods: Data from 30 197 mother-child pairs from Uppsala County Mother and Child Cohort were divided into 15 groups according to maternal BMI and GWG, based on World Health Organization classification and Institute of Medicine guidelines, respectively. Postnatal growth patterns were analyzed with linear mixed regression models within maternal BMI groups. Odds ratios of overweight and obesity at 4 years of age were assessed with logistic regression analyses. We treated children of mothers with normal weight and adequate GWG as the reference group, and all analyses were adjusted for potential confounders., Results: GWG was associated with infant BMI z-score at birth, independent of potential confounding factors. Independent of GWG, we observed an overall decrease in BMI z-score from 18 months to 5 years in children of mothers who were underweight, while an increase in BMI z-score was seen in children of mothers who were overweight or obese. In children of normal- and overweight mothers, the risk of childhood overweight and obesity was associated with excessive compared to adequate GWG (adjusted odds ratio [aOR] 1.17, 95% confidence interval [CI] 1.01-1.36 for normal-weight mothers, and aOR 1.25, 95% CI 1.04-1.51 for overweight mothers, respectively). Children of mothers with obesity and excessive GWG had the highest risk of being overweight or obese at 4 years (aOR 2.88, 95% CI 2.40-3.44, and 4.38, 95% CI 3.37-5.67, respectively). Associations did not differ between children of mothers with obesity class 1 and 2-3 when comparing excessive and adequate GWG (aOR 1.33, 95% CI 0.96-1.85, and 1.12, 95% CI 0.74-1.70, respectively)., Conclusions: Maternal GWG affects infant birth size and growth until 18 months, although maternal BMI is more crucial for childhood growth beyond 18 months. Further, children of mothers who are normal- or overweight and experience excessive GWG have an increased risk of obesity at 4 years., (© 2024 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Objectives: Mediastinal germ cell tumors are rare and few large-scale studies on mediastinal germ cell tumors are reported. We aimed to investigate the clinical characteristics and survival outcomes of patients with mediastinum germ cell tumors in Japan., Methods: A hospital-based cancer registry data in Japan was used to identify and enroll patients diagnosed with mediastinal germ cell tumors in 2012-2013. The datasets were registered from 80 institutions., Results: The selection criteria were met by 123 patients, the majority of whom were male. The median age at diagnosis was 39 years (range 25-89 years) and the most common age groups at diagnosis was 30-39 years, followed by 40-49 years and ≥ 50 years. The histology of non-seminoma (55.3%) was slightly more frequent than that of seminoma (44.7%). The most common histological subtype in non-seminoma was yolk sac tumor, followed by mixed germ cell tumor. The 5-year survival of seminoma and non-seminoma were 96.4% and 57.3%, respectively (p < 0.001). Non-seminomatous mediastinal germ cell tumors, malignant teratomas, mixed germ cell tumors, and yolk sac tumors had comparable survival rates, while those with choriocarcinoma showed the worst prognosis., Conclusions: This is the first report showing the clinical characteristics and survival outcomes of mediastinal germ cell tumors in Japan using a real-world large cohort database., (© 2024. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.)

Background: Familial chylomicronemia syndrome (FCS) is a rare autosomal recessive disorder. This study aimed to study the genotype distribution of FCS-causing genes in the United Kingdom, genotype-phenotype correlation, and clinical differences between FCS and multifactorial chylomicronemia syndrome (MCS)., Methods: The study included 154 patients (FCS, 74; MCS, 80) from the UK FCS national registry and the UK arm of the FCS International Quality Improvement and Service Evaluation Project., Results: FCS was relatively common in non-Europeans and those with parental consanguinity ( P <0.001 for both). LPL variants were more common in European patients with FCS (European, 64%; non-European, 46%), while the genotype was more diverse in non-European patients with FCS. Patients with FCS had a higher incidence compared with patients with MCS of acute pancreatitis (84% versus 60%; P =0.001), recurrent pancreatitis (92% versus 63%; P <0.001), unexplained abdominal pain (84% versus 52%; P <0.001), earlier age of onset (median [interquartile range]) of symptoms (15.0 [5.5-26.5] versus 34.0 [25.2-41.7] years; P <0.001), and of acute pancreatitis (24.0 [10.7-31.0] versus 33.5 [26.0-42.5] years; P <0.001). Adverse cardiometabolic features and their co-occurrence was more common in individuals with MCS compared with those with FCS ( P <0.001 for each). Atherosclerotic cardiovascular disease was more prevalent in individuals with MCS than those with FCS ( P =0.04). However, this association became nonsignificant after adjusting for age, sex, and body mass index. The prevalence of pancreatic complications and cardiometabolic profile of variant-positive MCS was intermediate between FCS and variant-negative MCS., Conclusions: The frequency of gene variant distribution varies based on the ethnic origin of patients with FCS. Patients with FCS are at a higher risk of pancreatic complications while the prevalence of atherosclerotic cardiovascular disease is lower in FCS compared with MCS. Carriers of heterozygous pathogenic variants have an intermediate phenotype between FCS and variant-negative MCS., Competing Interests: H. Soran received personal fees from Amgen, Akcea, Synageva, Napp, Novartis, Takeda, Sanofi, Pfizer, and Kowa and research grants and donations from Akcea, Pfizer, Merck Sharp & Dohme, Amgen, Genzyme-Sanofi, Synageva, Amryt, Synageva, and Alexion. A.S. Wierzbicki is a site investigator on trials from Akcea and Regeneron; received royalties from Elsevier for a book on familial chylomicronemia syndrome; and is a board member for the Familial Hyperlipidaemia group, Europe. D. Datta received honoraria for advisory board from Swedish Orphan Biovitrum. N. Forrester received honoraria for presentations from SOBI. Y. Teoh received speakers fee from Daiichi Sankyo and Amarin. P. Downie received honoraria from SOBI, Novartis, Amgen, and Daiichi Sankyo. R.A. Hegele received consulting fees from Acasti, Aegerion, Akcea/Ionis, Amgen, Arrowhead, HLS Therapeutics, Pfizer, Novartis, Regeneron, Sanofi, and UltraGenyx. The other authors report no conflicts.

Introduction: The evidence on complication rates after gynecological surgery is based on multiple types of studies, and the level of evidence is generally low. We aimed to validate the registration of complications in the Swedish National Quality Register of Gynecological Surgery (GynOp), by cross-linkage to multiple national registers., Material and Methods: A national register-based study using prospectively collected data was conducted, including women who had surgery on the uterus or adnexa for benign indications from January 1, 2017, to December 31, 2020. In Sweden, complications after gynecological surgery are registered in GynOp, and if the complication has rendered any interaction with healthcare, it is also in national health registers. The GynOp register, the National Patient Register, the Prescribed Drugs Register, and the Cause of Death Register were cross-linked. Complications in GynOp and complications according to ICD10 were analyzed, as well as the cause of death if occurring within 3 months of surgery and prescription of antibiotics ≤30 days. Comparisons between the registries were descriptive., Results: During the study period 32 537 surgeries were performed, of which 26 214 (80.6%) were minimally invasive. Complications were reported in GynOp for 569 women (1.7%) at surgery, 1045 (3.2%) while admitted, and 3868 (13.7%) from discharge to 3 months after surgery. In comparison, according to the Patient Register, 2254 women (6.9%) had postoperative complications within 3 months of discharge (difference of 6.8 percentage points [95% confidence interval 6.2-7.2]). Furthermore, 4117 individuals (12.7%) had a prescription of antibiotics ≤30 days which could indicate a postoperative infection. The rates of hemorrhage, wound dehiscence, and thrombosis were comparable between GynOp and the Patient Register while diagnoses not leading to contact with specialized care had higher rates in the quality register. The coverage of complications was 79.1% in GynOp and 46.1% in the Patient Register, using the total number of complications from both registers as the denominator., Conclusions: A higher frequency of complications is captured in GynOp than in the National Patient Register. Patient-reported outcomes assessed by a physician are beneficial in identifying complications indicating the importance of structured pre-defined follow-up over a set period., (© 2024 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Objective: Blood pressure (BP) lowering therapy in hypertension can markedly reduce the risk of cardiovascular diseases. In case of high-normal office blood pressure (oBP), the initiation of antihypertensive medication is recommended by guidelines in patients with very high cardiovascular risk. The aims of this study were to evaluate the presence of white-coat high-normal BP (WhHNBP) and masked hypertension in high-normal oBP and to explore the prevalence of untreated very high cardiovascular risk patients., Methods: Data of the Hungarian Ambulatory Blood Pressure Monitoring (ABPM) Registry between September 2020 and November 2023 were used in our analysis., Results: From 38 720 uploaded ABPM curves with clinical data, 4300 individuals were categorized as having high-normal oBP. Among those, 3285 (76.4%) were on antihypertensive treatment. Based on the ABPM recordings, high-normal BP was confirmed in 20.5% ( n  = 881), while WhHNBP was present in 27.6% ( n  = 1188) and masked hypertension in 51.9% ( n  = 2231). Similar results were found in treated and untreated subjects or patients as well. Independent predictors of WhHNBP were age [odds ratio (OR) 1.02 (95% confidence interval, 95% CI: 1.01-1.02), P  < 0.001], female sex [OR: 1.59 (1.32-1.92), P  < 0.001] and snoring [OR: 0.70 (0.57-0.86), P  < 0.001]. Independent predictors of masked hypertension were male sex [OR: 1.31 (1.12-1.54), P  < 0.001] and obesity [OR: 1.71 (1.39-2.09), P  < 0.001]. Five hundred and two individuals had very high cardiovascular risk with high-normal oBP and only 25 of them were untreated., Conclusion: In high-normal oBP, WhHNBP or masked hypertension is present in three out of four individuals. Most of the patients with high-normal oBP and very high cardiovascular risk are already treated with antihypertensive drugs., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The vasopressor dose needed is a common measure to assess the severity of cardiovascular failure, but there is no consensus on the ranges of vasopressor doses determining different levels of cardiovascular support. We aimed to identify cutoffs for determining low, intermediate and high doses of noradrenaline (norepinephrine), the primary vasopressor used in intensive care, based on association with hospital mortality., Methods: We conducted a binational registry study to determine cutoffs between low, intermediate and high noradrenaline doses. We required the cutoffs to be statistically rational and practical (rounded to the first decimal and easy to remember), and to result in increasing mortality with increasing doses. The highest noradrenaline dose in the first 24 h after intensive care unit (ICU) admission was used. The cutoffs were developed using data from 8079 ICU patients treated in the ICU at Kuopio University Hospital, Finland, between 2013 and 2019. Subsequently, the cutoffs were validated in the eICU database, including 39,007 ICU admissions to 29 ICUs in the United States of America in 2014-2015. The log-rank statistic, with the Contal and O'Quigley method, was used to determine the cutoffs resulting in the most significant split between the noradrenaline dose groups with regard to hospital mortality., Results: The two most prominent peaks in the log-rank statistic corresponded to noradrenaline doses 0.20 and 0.44 μg/kg/min. Accordingly, we determined three dose ranges: low (<0.2 μg/kg/min), intermediate (0.2-0.4 μg/kg/min) and high (>0.4 μg/kg/min). Mortality increased, whereas the number of patients decreased consistently with increasing noradrenaline doses in both cohorts. In the development cohort, hospital mortality was 6.5% in the group without noradrenaline administered and 14.0%, 26.4% and 40.2%, respectively, in the low-dose, intermediate-dose and high-dose groups. Compared to patients who received no noradrenaline, the hazard ratio for in-hospital death was 1.4 for the low-dose group, 4.0 for the intermediate-dose group and 7.5 for the high-dose group in the validation cohort (p < .001)., Conclusions: The highest noradrenaline dose is a useful measure for quantifying circulatory failure. Cutoffs 0.2 and 0.4 μg/kg/min seem to be suitable for defining low, intermediate and high doses., (© 2024 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)

Aims: To assess the level of adherence to glucagon-like peptide-1 receptor agonist (GLP-1RA) treatment using real-world data and to investigate the sociodemographic and clinical factors associated with discontinuation of GLP-1RAs., Methods: First-time users of GLP-1RAs with type 2 diabetes mellitus (T2DM), aged ≥18 years, in the period 2007 to 2020, were identified using Danish registries, allowing all participants a minimum of 18 months' follow-up. Adherence to GLP-1RA therapy (medication possession ratio >0.80) and discontinuation of GLP-1RA therapy was estimated at 6- and 12-month follow-ups. Multivariable cause-specific Cox regression was used to identify sociodemographic and clinical factors associated with risk of discontinuation., Results: In total, 44 343 first-time users of GLP-1RAs with T2DM were identified (mean age 58.6 years, 42.7% female, median duration of T2DM 6.8 years, median glycated haemoglobin level 65 mmol/mol). The absolute risk of discontinuing GLP-1RA treatment within 6 months was 14.2% (95% confidence interval [CI] 13.9-14.6) and 21.2% (95% CI 20.8-21.5) within 12 months. At 6 months, 50.4% were adherent to GLP-1RA therapy and at 12 months, 48.6% remained adherent. In the multivariable model, younger (<40 years) and older age (>75 years), higher Charlson Comorbidity Index score, lower household income, high school and longer university degree as educational attainment level, and longer diabetes duration were associated with a higher risk of discontinuing GLP-1RA treatment., Conclusion: Approximately one in five patients discontinued GLP-1RA therapy within the first 12 months and only half were adherent. Overall, lower socioeconomic status and higher comorbidity burden were associated with higher risk of discontinuing GLP-1RA treatment., (© 2024 John Wiley & Sons Ltd.)

Objective: Interstitial lung disease (ILD) is one of the most common pulmonary manifestations of rheumatoid arthritis (RA), but its prevalence has not been investigated in psoriatic arthritis (PsA). The role of methotrexate (MTX) in ILD development remains under debate. This study (1) compares the incidences of ILD in patients with RA or PsA initiating a first biologic disease-modifying antirheumatic drug (bDMARD) to that in the general population, and (2) investigates the role of MTX comedication on ILD incidence., Methods: Patients were identified in 5 rheumatology registries. Demographics, MTX use, and disease activity were retrieved. Matched subjects from the general population were available from 4 countries. Incidence of ILD during follow-up of up to 5 years was assessed through national patient registries. Subjects with prior ILD were excluded. Adjusted hazard ratios (HRs) were calculated for ILD incidence in patients vs the general population, and for MTX users vs nonusers., Results: During follow-up of 29,478 patients with RA and 10,919 patients with PsA initiating a first bDMARD and 362,087 population subjects, 225, 23, and 251 cases of ILD were identified, respectively. HRs for ILD (vs population subjects) were 9.7 (95% CI 7.97-11.91) in RA and 4.4 (95% CI 2.83-6.97) in PsA. HRs for ILD with MTX comedication (vs nonuse) were 1.0 (95% CI 0.72-1.25) in RA and 0.9 (95% CI 0.38-2.05) in PsA., Conclusion: Among patients with RA and PsA initiating a bDMARD, the risk of ILD was higher than in the general population, and was highest in RA. MTX comedication was not a risk determinant for ILD., (Copyright © 2024 by the Journal of Rheumatology.)

Purpose: To characterize the response and survival outcomes of yttrium-90 ( 90 Y) transarterial radioembolization (TARE) for unresectable, liver-dominant metastases from primary neoplasms other than colorectal carcinoma., Materials and Methods: This study included 1,474 patients enrolled in the Radiation-Emitting Society of Interventional Radiology (SIR)-Spheres in Nonresectable Liver Tumor registry who received resin 90 Y-TARE as part of their oncologic management for unresectable primary or secondary liver tumors (NCT02685631). Of these patients, 33% (481/1,474) were treated for liver metastases of noncolorectal origin (m-non-CRC) compared with 34% (497/1,474) treated for metastatic colorectal cancer (mCRC) and 34% (496/1,474) treated for hepatocellular carcinoma. Treatment response and cancer survival probabilities were computed and compared for each primary cancer type. The Kaplan-Meier method and log-rank test were used to compare survival outcomes., Results: Radiological responses were observed in 12 unique cancer types, mostly heavily pretreated malignancies refractory to multiple lines of systemic therapies. The overall use of resin 90 Y-TARE in m-non-CRC resulted in better treatment outcomes in terms of duration of response, progression-free survival, time to progression, and overall survival (P = .04, P = .02, P = .01, and P = .04, respectively). Analyses of cancer cell types revealed that metastatic neuroendocrine tumor, sarcoma, and ovarian, renal, prostate, and breast cancers were associated with superior treatment outcomes, whereas worse treatment outcomes were observed in metastatic lung, gastric, pancreatic, and esophageal cancers., Conclusions: Real-world data demonstrate the use of resin 90 Y-TARE in m-non-CRC refractory to standard chemotherapy. For some cell types, this expanded use achieved superior treatment outcomes relative to the reference standard of mCRC, suggesting the need for inquiry into broadened indications for 90 Y-TARE., (Copyright © 2024 SIR. Published by Elsevier Inc. All rights reserved.)

Background: Atopic dermatitis (AD) and allergic contact dermatitis (ACD) are inflammatory skin conditions whose association is not clearly defined., Objectives: To identify differences in ACD profile between patients with and without AD among those referred for patch testing. Additionally, to determine the prevalence of sensitisation to standard Spanish contact allergens in both groups., Methods: We analysed two groups (AD and non-AD) within the Spanish Registry of Research in Contact Dermatitis and Cutaneous Allergy (REIDAC). Contact allergy, clinical relevance and epidemiological data were compared between them., Results: A total of 5055 patients were included. Among them, 23% (1168) had a history or final diagnosis of AD. At least one positive reaction was seen in 468 (40%) of AD patients and 1864 (48%) of non-AD patients. In both groups, the most common positive reactions were to nickel sulphate, methylchloroisothiazolinone/methylisothiazolinone and cobalt chloride. Age-adjusted OR for sensitisation to nickel sulphate was 0.72 (95% CI: 0.61-0.86), indicating a decreased likelihood of sensitisation in AD patients compared to non-AD individuals., Conclusions: We did not find an increased presence of ACD in patients with AD referred for patch testing, exhibiting similar profiles to non-AD population, except for a negative relationship between AD and sensitisation to nickel sulphate., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Introduction: Previously published data are conflicting regarding the ability of tenecteplase versus alteplase to produce early recanalization of an intracranial large vessel occlusion. We compared the performance of each thrombolytic in a stroke network., Methods: We queried our prospectively collected code stroke registry for basilar, internal carotid, or proximal middle cerebral artery occlusion patients treated with intravenous thrombolysis from 11/17/2021-9/16/2023. The primary outcome was early recanalization, defined using angiographic or clinical criteria. Secondary and safety outcomes included 90-day functional independence and symptomatic intracranial hemorrhage. A multivariable regression analysis was performed to determine independent associations with the primary outcome., Results: 233 patients, with mean age 66.9 (16.6) years and median National Institutes of Health Stroke Scale score 15 (10-21), were included. One-hundred twenty-four of 233 (53.2 %) patients were treated with alteplase while 109/233 (46.8 %) were treated with tenecteplase. Endovascular thrombectomy was performed in 82 % of subjects. Early recanalization rates were similar between the groups (alteplase 22.6 %, tenecteplase 14.7 %; p = 0.14), as were rates of 90-day independent neurological function, symptomatic intracranial hemorrhage, and mortality. Patients with an internal carotid artery occlusion or with higher presenting stroke severity were less likely to achieve early recanalization., Conclusions: Tenecteplase and alteplase have similar rates of early recanalization, 90-day functional independence, and safety outcomes in large vessel occlusion patients. Occlusion site and stroke severity predict response to thrombolysis. Future studies may investigate other factors associated with a positive response to thrombolytics as expanded treatment indications are explored., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Andrew W. Asimos reports a relationship with RapidAI that includes: consulting or advisory. Joe D. Bernard reports a relationship with Viz.ai, Inc. that includes: equity or stocks. Joe D. Bernard reports a relationship with Stryker that includes: consulting or advisory. Joe D. Bernard reports a relationship with Terumo Interventional Systems that includes: consulting or advisory. Joe D. Bernard reports a relationship with RapidAI that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To investigate the role of the Omniflow II prosthesis in the prevention of vascular graft infection (VGI) in patients with peripheral arterial disease and to report on short-and mid-term graft-related morbidity., Material and Methods: Patients were included in prospective registry between October 2019 and March 2023. The primary endpoint was to report infection-related problems, operation-related wound problems, and short- and mid-term graft-related morbidity. Secondary endpoint was to report the bypass patency rates and limb salvage rates., Results: A total of 146 Omniflow II grafts were implanted in 125 patients. Sixty-seven patients (45.9%) received a femoral interposition graft, and 77 patients (52.7%) underwent ipsilateral bypass surgery (femoropopliteal or femorocrural). Forty-one patients (28.1%) underwent crural bypass surgery. Seventy-six patients (52.1%) had previous vascular operation in the groin. The mean follow-up time was 352 days (range 0-1108 days). 3.4% of the patients suffered a wound infection limited to the dermis, and in 8.2%, the subcutaneous tissue was involved. Five early VGI (3.4%) and one late VGI (0.7%) occurred. One year primary patency rate of above-the-knee bypass was significantly better compared to the bypass below the knee (74.5% ± 0.131 versus 54% ± 0.126 (P = 0.049)). This difference was not significantly different when below-the-knee bypass surgery was compared with crural bypass surgery (54% ± 0.126 versus 23.8% ± 0.080 (P = 0.098))., Conclusions: The performance of the Omniflow II prosthesis in the preventive setting is highly influenced by the anatomic location of the distal anastomosis. No influence on the incidence of postoperative wound problems could be observed. The rate of Omniflow II VGI in a high-risk population is similar to reported outcomes in other prosthetic grafts., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Chronic kidney disease (CKD) has been identified as an independent predictor of poorer long-term prognosis after endovascular aneurysm repair (EVAR) for complex abdominal aortic aneurysm (AAA). However, its impact on short-term perioperative outcomes is conflicting, which can be important for preoperative risk stratification. This study aimed to evaluate the 30-day outcomes of patients with CKD following non-ruptured complex EVAR in a national registry., Methods: Patients who had EVAR for complex AAA were identified in ACS-NSQIP targeted database from 2012-2022. Complex AAA included juxtarenal, suprarenal, or pararenal proximal extent, Type IV thoracoabdominal aneurysm, and/or aneurysms treated with Zenith Fenestrated endograft. Exclusion criteria included age<18 years, ruptured AAA, acute intraoperative conversion to open, emergency presentation, and dialysis. Multivariable logistic regression was used to compare 30-day postoperative outcomes of CKD and non-CKD patients, where demographics, baseline characteristics, aneurysm diameter, distant aneurysm extent, anesthesia, and concomitant procedures were adjusted., Results: There were 695 (39.33%) and 1072 (60.67%) patients with and without CKD, respectively, who underwent EVAR for complex AAA. Patients with and without CKD have comparable 30-day mortality (aOR = 1.165, 95 CI = 0.646-2.099, P = 0.61). However, CKD patients had a higher risk of renal complications (aOR = 2.647, 95 CI = 1.399-5.009, P < 0.01) including higher progressive renal insufficiency (aOR = 3.707, 95 CI = 1.329-10.338, P = 0.01) and acute renal failure requiring renal replacement therapy (aOR = 2.533, 95 CI = 1.139-5.633, P = 0.02). All other 30-day outcomes were comparable between CKD and non-CKD patients., Conclusion: Patients with CKD had similar 30-day mortality and morbidity rates but a higher risk of postoperative renal complications. Therefore, meticulous preoperative planning and postoperative management, which may include optimal hydration, appropriate contrast use, and close renal function monitoring, are essential for patients with CKD after complex EVAR., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: To summarize the prevalence of ALS in all 50 states and Washington, DC in the United States from 2011 to 2018 using data collected and analyzed by the National ALS Registry. In October 2010, the federal Agency for Toxic Substances and Disease Registry (ATSDR) launched the congressionally mandated Registry to determine the incidence and prevalence of ALS within the USA, characterize the demographics of persons with ALS, and identify the potential risk factors for the disease. This is the first analysis of state-level ALS prevalence estimates. Methods: ALS is not a notifiable disease in the USA, so the Registry uses a two-pronged approach to identify cases. The first approach uses existing national administrative databases (Medicare, Veterans Health Administration, and Veterans Benefits Administration). The second method uses a secure web portal to gather voluntary participant data and identify cases not included in the national administrative databases. Results: State-level age-adjusted average prevalence from 2011-2018 ranged from 2.6 per 100,000 persons (Hawaii) to 7.8 per 100,000 persons (Vermont), with an average of 4.4 per 100,000 persons in the US. New England and Midwest regions had higher prevalence rates than the national average. Conclusions: These findings summarize the prevalence of ALS for all 50 states from 2011 to 2018. This is a continuing effort to identify ALS cases on a national population basis. The establishment of the National ALS Registry has allowed for epidemiological trends of this disease and the assessment of potential risk factors that could cause ALS.