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Acute leukemia (AL) and myelodysplastic syndrome (MDS) are uncommon in chronic lymphocytic leukemia (CLL). We retrospectively identified 95 patients with CLL, also diagnosed with AL (n=38) or MDS (n=57), either concurrently (n=5) or subsequent (n=90) to CLL diagnosis and report their outcomes. Median number of CLL treatments prior to AL and MDS was 2 (0-9) and 1 (0-8), respectively; the most common regimen was purine analog combined with alkylating agent±CD20 monoclonal antibody. Twelve cases had no prior CLL treatment. Among 38 cases with AL, 33 had acute myelogenous leukemia (AML), 3 had acute lymphoid leukemia (ALL; 1 Philadelphia chromosome positive), 1 had biphenotypic and 1 had extramedullary (bladder) AML. Unfavorable AML karyotype was noted in 26, and intermediate risk in 7 patients. There was no association between survival from AL and number of prior CLL regimens or karyotype. Expression of CD7 on blasts was associated with shorter survival. Among MDS cases, all International Prognostic Scoring System (IPSS) were represented; karyotype was unfavorable in 36, intermediate in 6 and favorable in 12 patients; 10 experienced transformation to AML. Shorter survival from MDS correlated with higher risk IPSS, poor-risk karyotype and increased number of prior CLL treatments. Overall, outcomes for patients with CLL subsequently diagnosed with AL or MDS were very poor; AL/MDS occurred without prior CLL treatment. Effective therapies for these patients are desperately needed.

Objective: To (1) determine how intended users interact with and use the BD Odon Device in simulation, (2) use these findings to alter progressively the design of the BD Odon Device and (3) validate that these changes have improved the ability of practitioners to use the BD Odon Device.Design: Human factors evaluation study.Setting: Simulation suite designed to mimic delivery room.Population or Sample: Three hundred and ninety simulated operative births, performed by 100 practising clinicians.Methods: Simulated operative vaginal births performed using the BD Odon Device and the device Instructions for use were subjected to three formative human factors evaluations and one human factors validation test. Following each evaluation, findings were reviewed and the design of the BD Odon Device and Instructions for use were modified.Main Outcome Measures: Successful performance of an operative vaginal birth using the BD Odon Device in accordance with provided training and Instructions for use.Results: Using version two of the BD Odon Device, and following exposure to face-to-face training and written instructions, 25% of accouchers were able successfully to perform a simulated operative vaginal birth. In the final evaluation, following device design and training material alterations, all accouchers were able successfully to perform a simulated operative vaginal birth using version four of the BD Odon Device.Conclusions: Human factors evaluations have enabled a multi-professional device and training materials design team to alter the design of the BD Odon Device and the Instructions for use in an evidence-based fashion. This process has resulted in a device which has a predictable and likely safe pattern of use.Tweetable Abstract: Human Factors evaluations help make the BD Odon Device safe and usable for clinical practice. [ABSTRACT FROM AUTHOR]

Transition from design to adoption of innovations must be evidence-based and inform product development, regulatory approval and adoption. [ABSTRACT FROM AUTHOR]

Background: Most survival prediction models for coronary artery bypass grafting surgery are limited to in-hospital or 30-day end points. We estimate a long-term survival model using data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database and Centers for Medicare and Medicaid Services.Methods and Results: The final study cohort included 348 341 isolated coronary artery bypass grafting patients aged ≥65 years, discharged between January 1, 2002, and December 31, 2007, from 917 Society of Thoracic Surgeons-participating hospitals, randomly divided into training (n=174 506) and validation (n=173 835) samples. Through linkage with Centers for Medicare and Medicaid Services claims data, we ascertained vital status from date of surgery through December 31, 2008 (1- to 6-year follow-up). Because the proportional hazards assumption was violated, we fit 4 Cox regression models conditional on being alive at the beginning of the following intervals: 0 to 30 days, 31 to 180 days, 181 days to 2 years, and >2 years. Kaplan-Meier-estimated mortality was 3.2% at 30 days, 6.4% at 180 days, 8.1% at 1 year, and 23.3% at 3 years of follow-up. Harrell's C statistic for predicting overall survival time was 0.732. Some risk factors (eg, emergency status, shock, reoperation) were strong predictors of short-term outcome but, for early survivors, became nonsignificant within 2 years. The adverse impact of some other risk factors (eg, dialysis-dependent renal failure, insulin-dependent diabetes mellitus) continued to increase.Conclusions: Using clinical registry data and longitudinal claims data, we developed a long-term survival prediction model for isolated coronary artery bypass grafting. This provides valuable information for shared decision making, comparative effectiveness research, quality improvement, and provider profiling. [ABSTRACT FROM AUTHOR]

Traditionally, the goal of therapy in chronic lymphocytic leukemia (CLL) has been palliative, with first-line therapy using alkylating agents and/or involved field radiotherapy (depending on the stage of disease and sites of involvement) because of the older age of affected patients and the low rate of complete remissions (CRs) with no improvement in overall survival despite treatment. With increasing knowledge about the biology, molecular genetics, and prognostic factors of the disease, the philosophy of care for patients with CLL has evolved from palliation to aiming for a potential cure, especially in younger patients. Furthermore, multiple treatment options have emerged, including purine analogues, monoclonal antibodies, and potentially stem cell transplantation. These have been associated with higher frequencies of CRs and longer durations of responses compared to conventional chemotherapy. In addition, a subset of patients treated with chemoimmunotherapy can achieve durable CRs and molecular remissions. This may translate into improved disease-free survival and potentially a 'cure.' Because of the heterogeneous nature of CLL, new prognostic markers are currently being incorporated into clinical trials to determine their role in routine clinical practice. This review summarizes current therapeutic regimens that are being evaluated in patients with CLL and management of disease-related complications. [ABSTRACT FROM AUTHOR]

The QSkin Sun and Health Study comprises a cohort of 43 794 men and women aged 40-69 years randomly sampled from the population of Queensland, Australia in 2011. The cohort was established to study the development of skin cancer and melanoma in the population with the highest reported incidence of these diseases in the world. At baseline, besides demographic items and general medical history, information about standard pigmentary characteristics (including hair and eye colour, freckling tendency, tanning ability and propensity to sunburn), past and recent history of sun exposure and sunburns, sun protection behaviours, use of tanning beds and history of skin cancer was collected by self-completed questionnaire. Participants have given their consent for data linkage to the universal national health insurance scheme and for linkage to cancer registries and pathology databases, thus ensuring complete ascertainment of all future skin cancer and melanoma occurrences and medical treatments and other cancer events. Linkage to these registers will occur at predetermined intervals. Approval to access QSkin data can be obtained on application to the study investigators and submission of a formal research plan that has previous approval from the human research ethics committee of the applicant's institution. [ABSTRACT FROM AUTHOR]

Some CLL patients who develop progressive disease (PD) during treatment with covalent Bruton tyrosine kinase inhibitors (cBTKi) acquire pathway resistance mutations in BTK or PLCG2. Here, we report gene mutation data from paired baseline and PD peripheral blood samples from 52 patients (zanubrutinib, n=24; ibrutinib, n=28) who, at an early median follow-up time of 25.7 months, progressed on zanubrutinib or ibrutinib treatment in the ALPINE trial (NCT03734016). No BTK mutations were observed at baseline; at PD, eight patients (zanubrutinib, n=5, ibrutinib, n=3) acquired a total of 17 BTK mutations. Among BTK mutations, 82.4% (zanubrutinib, n=11/14; ibrutinib, n=3/3) were at C481. Non-C481 mutations were detected in 12.5% (3/24) of zanubrutinib-treated patients (L528W: n=2, cancer cell fraction [CCF]=9.58% and 17.6%; A428D, n=1, CCF=37.03%); these were not detected in ibrutinib-treated patients. At baseline, 48/52 patients had ≥1 driver gene mutation/s, most frequently in: NOTCH1 (n=21), TP53 (n=19), BRAF (n=10), SF3B1 (n=8), and ATM (n=8). At PD, acquired driver gene mutations were observed in one zanubrutinib-treated patient (TP53, XPO1) and five ibrutinib-treated patients (TP53, n=1 patient; SETD2, n=1; SF3B1, n=1; ASXL1, n=2). Baseline driver gene mutations were not associated with later development of BTK mutations, but patients with ≥2 baseline driver gene mutations were more likely to acquire BTK mutations at PD. In conclusion, patients in this data set had a short treatment duration and a low incidence of BTK mutations, suggesting that mechanisms other than BTK/PLCG2 mutations are driving most instances of early PD. NCT03734016., (Copyright © 2025 American Society of Hematology.)

Background: Cardiovascular disease (CVD) is the leading cause of mortality and disability globally. We examined healthcare service utilization and costs attributable to CVD in Ireland in the period before the introduction of a major healthcare reform in 2016., Methods: Secondary analysis of data from 8113 participants of the first wave of The Irish Longitudinal Study on Ageing. Cardiovascular disease was defined as having a self-reported doctor's diagnosis of myocardial infarction, angina, heart failure, stroke, atrial fibrillation, or transient ischaemic attack. Participants self-reported the utilization of healthcare services in the year preceding the interview. Negative binomial regression with average marginal effects (AMEs) was used to estimate the incremental number of general practitioner (GP) and outpatient department (OPD) visits, accident and emergency department attendances and hospitalizations in population with CVD relative to population without CVD. We calculated the corresponding costs at individual and population levels, by gender and age groups., Results: The prevalence of CVD was 18.2% (95% CI: 17.3, 19.0) Participants with CVD reported higher utilization of all healthcare services. In adjusted models, having CVD was associated with incremental 1.19 [95% confidence interval (CI): 0.99, 1.39] GP and 0.79 (95% CI: 0.65, 0.93) OPD visits. There were twice as many incremental hospitalizations in males with CVD compared to females with CVD [AME (95% CI): 0.20 (0.16, 0.23) vs. 0.10 (0.07, 0.14)]. The incremental cost of healthcare service use in population with CVD was an estimated €352.2 million (95% CI: €272.8, €431.7), 93% of which was due to use of secondary care services., Conclusion: We identified substantially increased use of healthcare services attributable to CVD in Ireland. Continued efforts aimed at CVD primary prevention and management are required., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: The Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD) was expanded in 2017 to include more granular detail on thoracic aortic surgeries. We describe the first validated risk model in thoracic aortic surgery from the STS ACSD., Methods: The study population consisted of patients undergoing nonemergent isolated ascending aortic aneurysm repair by open or clamped distal anastomoses, including those requiring aortic root or valve replacement. Model outcomes included operative mortality, 30-day major morbidity (cardiac reoperation, deep sternal wound infection, stroke, prolonged ventilation, renal failure), and a composite of both. To select the predictors, univariate associations and clinical face validity of models were examined. Models were evaluated by their ability to distinguish between patients with and without specific outcomes (discrimination) and their predictive accuracy (calibration)., Results: Between 2017 and 2021, 24,051 eligible patients underwent ascending aortic aneurysm surgery at 905 hospitals. Procedures included 8913 aortic root replacements, 2135 valve-sparing root replacements, 7545 ascending aortic replacements with aortic valve replacement, and 5458 ascending aortic replacements. Circulatory arrest was performed in 7316 (30.4%) cases. Operative mortality was 1.9%, and 12.2% of patients experienced major morbidity including 2.4% incidence of stroke. The adjusted C statistics for the model were 0.74, 0.67, and 0.67 for mortality, morbidity, and the composite, respectively. Previous stroke and circulatory arrest were associated with new stroke. Genetic aortopathy was associated with less mortality., Conclusions: A new STS ACSD risk model to predict mortality and morbidity after ascending aneurysm surgery has been developed, and predictors of better and worse outcomes have been identified., Competing Interests: Disclosures Nimesh Desai reports a relationship with W. L. Gore & Associates Inc that includes: consulting or advisory; with Terumo Medical Corp that includes: consulting or advisory; with Artivion, Inc that includes: consulting or advisory; with Edwards Lifesciences Corporation that includes: consulting or advisory; and with Baxter International Inc that includes: consulting or advisory. Hiroo Takayama reports a relationship with Edwards Lifesciences which includes consulting and advisory and W.L. Gore which includes consulting and advisory. Eric Roselli reports a relationship with Artivion, Inc that includes: consulting or advisory and a licensing agreement; with Cook Medical Inc that includes: consulting or advisory; with Edwards Lifesciences Corporation that includes: consulting or advisory; with W. L. Gore & Associates Inc that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with JenaValve Technology Inc that includes: speaking and lecture fees; with LifeNet Inc that includes: speaking and lecture fees; and with Terumo Aortic that includes: speaking and lecture fees. 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. Published by Elsevier Inc.)

Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) progressing after chimeric antigen receptor T-cell therapy (CAR T) have dismal outcomes. The prespecified post-CAR T expansion cohort of the ELM-1 study investigated the efficacy and safety of odronextamab, a CD20×CD3 bispecific antibody, in patients with disease progression after CAR T. Sixty patients received IV odronextamab weekly for 4 cycles followed by maintenance until progression. The primary endpoint was objective response rate (ORR) by independent central review. The median number of prior lines of therapy was 3 (range 2-9), 71.7% were refractory to CAR T, and 48.3% relapsed within 90 days of CAR T. After a median follow-up of 16.2 months, ORR and complete response (CR) rate were 48.3% and 31.7%, respectively. Responses were similar across prior CAR T products and time to relapse on CAR T. Median duration of response was 14.8 months and median duration of CR was not reached. Median progression-free survival and overall survival were 4.8 months and 10.2 months, respectively. The most common treatment-emergent adverse event was cytokine release syndrome (48.3%; no Grade ≥3 events). No cases of immune effector cell-associated neurotoxicity syndrome were reported. Grade ≥3 infections occurred in 12 patients (20.0%), two of which were COVID-19. Odronextamab monotherapy demonstrated encouraging efficacy and generally manageable safety, supporting its potential as an off-the-shelf option for post-CAR T patients. This trial was registered at www.clinicaltrials.gov as #NCT02290951., (Copyright © 2024 American Society of Hematology.)

Abstract: The ALPINE trial established the superiority of zanubrutinib over ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma; here, we present data from the final comparative analysis with extended follow-up. Overall, 652 patients received zanubrutinib (n = 327) or ibrutinib (n = 325). At an overall median follow-up of 42.5 months, progression-free survival benefit with zanubrutinib vs ibrutinib was sustained (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.54-0.84), including in patients with del(17p)/TP53 mutation (HR, 0.51; 95% CI, 0.33-0.78) and across multiple sensitivity analyses. Overall response rate remained higher with zanubrutinib compared with ibrutinib (85.6% vs 75.4%); responses deepened over time with complete response/complete response with incomplete bone marrow recovery rates of 11.6% (zanubrutinib) and 7.7% (ibrutinib). Although median overall survival has not been reached in either treatment group, fewer zanubrutinib patients have died than ibrutinib patients (HR, 0.77 [95% CI, 0.55-1.06]). With median exposure time of 41.2 and 37.8 months in zanubrutinib and ibrutinib arms, respectively, the most common nonhematologic adverse events included COVID-19-related infection (46.0% vs 33.3%), diarrhea (18.8% vs 25.6%), upper respiratory tract infection (29.3% vs 19.8%), and hypertension (27.2% vs 25.3%). Cardiac events were lower with zanubrutinib (25.9% vs 35.5%) despite similar rates of hypertension. Incidence of atrial fibrillation/flutter was lower with zanubrutinib vs ibrutinib (7.1% vs 17.0%); no cardiac deaths were reported with zanubrutinib vs 6 cardiac deaths with ibrutinib. This analysis, at 42.5 months median follow-up, demonstrates that zanubrutinib remains more efficacious than ibrutinib with an improved overall safety/tolerability profile. This trial was registered at www.ClinicalTrials.gov as #NCT03734016., (© 2024 American Society of Hematology. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)

Background: The relationship between the extent and severity of stress-induced ischemia and the extent and severity of anatomic coronary artery disease (CAD) in patients with obstructive CAD is multifactorial and includes the intensity of stress achieved, type of testing used, presence and extent of prior infarction, collateral blood flow, plaque characteristics, microvascular disease, coronary vasomotor tone, and genetic factors. Among chronic coronary disease participants with site-determined moderate or severe ischemia, we investigated associations between ischemia severity on stress testing and the extent of CAD on coronary computed tomography angiography., Methods: Clinically indicated stress testing included nuclear imaging, echocardiography, cardiac magnetic resonance imaging, or nonimaging exercise tolerance test. Among those with preserved renal function who underwent coronary computed tomography angiography, we examined relationships between ischemia and CAD by coronary computed tomography angiography, overall, and by stress test modality, regardless of subsequent randomization. Core laboratories categorized ischemia as severe, moderate, mild, or none, while the extent and severity of anatomic CAD were categorized based on the modified Duke prognostic index., Results: Among 3601 participants with interpretable stress tests and coronary computed tomography angiography, ischemia severity was weakly associated with CAD extent/severity (r=0.27), with modest variability in strength of association by modality: nuclear (n=1532; r=0.40), echocardiography (n=827; r=0.15), cardiac magnetic resonance imaging (n=108; r=0.31), and exercise tolerance test (n=1134; r=0.18). The extent of infarction on nuclear imaging and echocardiography was weakly associated with CAD extent/severity., Conclusions: Overall, ischemia severity on stress testing showed weak to moderate associations with the anatomic extent of CAD in this cohort with moderate or severe ischemia on local interpretation and controlled symptoms., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522., Competing Interests: Dr Reynolds reports grants from the National Heart, Lung, and Blood Institute, during the conduct of the study, and consulting fees from HeartFlow; she receives support from Abbott Vascular (donation of optical coherence tomography catheters for an unrelated research study) and Biotelemetry, Inc (donation of telemetry monitors for an unrelated research study). Dr Berman receives software royalties from Cedars-Sinai Medical Center, outside the submitted work. Dr Chaitman reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study and personal fees from Merck, Novo Nordisk, Sanofi, Lilly, Johnson and Johnson, Daiichi Sankyo, Tricida, Relypsa, Imbria, and Xylocor, outside the submitted work. Dr Kwong reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Min reports grants from the National Heart, Lung, and Blood Institute, during the conduct of the study; other from Cleerly, Inc, grants; and other from GE Healthcare and Arineta, outside the submitted work. Dr Leipsic is a consultant and has stock options in HeartFlow and Circle CVI and received research grant from GE Healthcare, outside the submitted work. Dr Mancini reports grants from the National Heart, Lung, and Blood Institute, during the conduct of the study; grants and personal fees from Amgen, grants and personal fees from Sanofi, Boehringer Ingelheim, AstraZeneca, Bayer, Janssen, Novo Nordisk, and HLS Therapeutics; and grants from Novartis, outside the submitted work. Dr Budoff reports grant support from General Electric, outside the submitted work. Dr Hague reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Senior reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study and speaker fees from Bracco, Lantheus Medical Imaging Boston USA, and Philips Healthcare, outside the submitted work. Dr Bhargava reports grants from the National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Celutkiene reported personal fees from Boehringer Ingelheim, AstraZeneca, Bayer, and Novartis. Dr Bainey received unrestricted research grant support from the Heart and Stroke Foundation of Canada, AstraZeneca, and Bayer; speaker honoraria from AstraZeneca, Bayer, Bristol-Myers Squibb-Pfizer Alliance, and Boehringer Ingelheim-Eli Lilly Alliance; consultancy and advisory board memberships in AstraZeneca, Abbott Vascular, Bayer, Bristol-Myers Squibb-Pfizer Alliance, and Boehringer Ingelheim-Eli Lilly Alliance; and proctorship honoraria from Abbott Vascular. Dr Doerr reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Ong reports speaker honoraria from Abbott Medical, Phillips, Bayer Healthcare, Pfizer, and Medtronic and research funding from the Berthold Leibinger Foundation, Ditzingen, Germany. Dr Steg reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study and research grants from Amarin, Bayer, Sanofi, and Servier; he serves as a member of the Steering Committee, Clinical Events Committee, or Data and Safety Monitoring Board for clinical trials conducted in Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Idorsia, Myokardia, Novartis, Pfizer, Sanofi, and Servier; consulting or speaker’s fees from Amgen, Novo Nordisk, and Regeneron. Dr Chow holds the Saul and Edna Goldfarb Chair in Cardiac Imaging Research; receives research support from TD Bank, CV Diagnostix and AusculSciences, and Siemens Healthineers; and has equity interest in General Electric. Dr Phillips has served as a consultant for Novo Nordisk. Dr Mark reports grants from the National Heart, Lung, and Blood Institute, during the conduct of the study, and grants from HeartFlow and Merck, outside the submitted work. Dr Spertus reports grants from the National Heart, Lung, and Blood Institute, during the conduct of the study; personal fees from Bayer, Novartis, AstraZeneca, Amgen, Janssen, and United Healthcare; grants from the American College of Cardiology; and personal fees from Blue Cross Blue Shield of Kansas City, outside the submitted work; in addition, Dr Spertus has a patent Copyright to Seattle Angina Questionnaire with royalties paid and Equity in Health Outcomes Sciences. Dr O’Brien reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Boden reports grants from the National Heart, Lung, and Blood Institute, during the conduct of the study; grants from Abbvie, Amarin, and Amgen; and personal fees from Amgen, Cleveland Clinic Clinical Coordinating Center, and Janssen, outside the submitted work. Dr Bangalore reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study; grants and personal fees from Abbott Vascular; and personal fees from Biotronik, Pfizer, Amgen, and Reata, outside the submitted work. Dr Stone reports grants and personal fees from the National Heart, Lung, and Blood Institute during the conduct of the study; speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; is a consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, Apollo Therapeutics, Cardiomech, Gore, Robocath, Miracor, Vectorious, Abiomed, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, and HighLife; and equity/options in Ancora, Cagent, Applied Therapeutics, Biostar Family of Funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Institutional disclosures: Dr Stone’s employer, Mount Sinai Hospital; Dr Stone receives research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Family disclosure: Dr Stone’s daughter is an employee at IQVIA. Dr Maron reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Hochman was the PI for the ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) for which, in addition to support by the National Heart, Lung, and Blood Institute grant, devices and medications were provided by Abbott Vascular; Medtronic, Inc.; Abbott Laboratories (formerly St. Jude Medical, Inc); Royal Philips NV (formerly Volcano Corporation); Arbor Pharmaceuticals, LLC; AstraZeneca Pharmaceuticals, LP; Merck Sharp & Dohme Corporation; and Omron Healthcare, Inc; and financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP. She is a PI for ISCHEMIA-EXTEND (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches Extended Follow-Up). The other authors report no conflicts.

Background: Whether revascularisation (REV) improves outcomes in patients with three-vessel coronary artery disease (3V-CAD) is uncertain., Aims: Our objective was to evaluate outcomes with REV (percutaneous coronary intervention [PCI] or coronary artery bypass graft surgery [CABG]) versus medical therapy in patients with 3V-CAD., Methods: ISCHEMIA participants with 3V-CAD on coronary computed tomography angiography without prior CABG were included. Outcomes following initial invasive management (INV) with REV (PCI or CABG) versus initial conservative management (CON) with medical therapy alone were evaluated. Regression modelling was used to estimate the outcomes if all participants were to undergo prompt REV versus those assigned to CON. Outcomes were cardiovascular (CV) death/myocardial infarction (MI), death, CV death, and quality of life. Bayesian posterior probability for benefit (Pr [benefit]) for 1 percentage point lower 4-year rates with REV versus CON were evaluated., Results: Among 1,236 participants with 3V-CAD (612 INV/624 CON), REV was associated with lower 4-year CV death/MI (adjusted 4-year difference: -4.4, 95% credible interval [CrI] -8.7 to -0.3 percentage points, Pr [benefit]=94.8%) when compared with CON, with similar results for PCI versus CON (-5.8, 95% CrI: -10.8 to -0.5 percentage points, Pr [benefit]=96.4%) and CABG versus CON (-3.7, 95% CrI: -8.8 to 1.5 percentage points, Pr [benefit]=84.7%). Adjusted 4-year REV versus CON differences were as follows: death -1.2 (95% CrI: -4.7 to 2.2) percentage points, CV death -2.3 (95% CrI: -5.5 to 0.8) percentage points, with similar results for PCI and for CABG. The Pr (benefit) for death with REV (PCI or CABG) versus CON was 49-63%. The adjusted 12-month Seattle Angina Questionnaire-7 summary score differences favoured REV: REV versus CON 4.6 (95% CrI: 2.7-6.4) percentage points; PCI versus CON 3.6 (95% CrI: 1.2-5.8) percentage points and CABG versus CON 4.3 (95% CrI: 1.5-6.9) percentage points with high Pr (benefit)., Conclusions: In participants with 3V-CAD, REV (either PCI or CABG) was associated with a lower 4-year CV death/MI rate and improved quality of life, with similar results for PCI versus CON and CABG versus CON. The differences in all-cause mortality between REV and CON were small with wide confidence intervals. (ClinicalTrials.gov: NCT01471522).

Background and Aims: The aim of this study was to determine the prognostic value of coronary computed tomography angiography (CCTA)-derived atherosclerotic plaque analysis in ISCHEMIA., Methods: Atherosclerosis imaging quantitative computed tomography (AI-QCT) was performed on all available baseline CCTAs to quantify plaque volume, composition, and distribution. Multivariable Cox regression was used to examine the association between baseline risk factors (age, sex, smoking, diabetes, hypertension, ejection fraction, prior coronary disease, estimated glomerular filtration rate, and statin use), number of diseased vessels, atherosclerotic plaque characteristics determined by AI-QCT, and a composite primary outcome of cardiovascular death or myocardial infarction over a median follow-up of 3.3 (interquartile range 2.2-4.4) years. The predictive value of plaque quantification over risk factors was compared in an area under the curve (AUC) analysis., Results: Analysable CCTA data were available from 3711 participants (mean age 64 years, 21% female, 79% multivessel coronary artery disease). Amongst the AI-QCT variables, total plaque volume was most strongly associated with the primary outcome (adjusted hazard ratio 1.56, 95% confidence interval 1.25-1.97 per interquartile range increase [559 mm3]; P = .001). The addition of AI-QCT plaque quantification and characterization to baseline risk factors improved the model's predictive value for the primary outcome at 6 months (AUC 0.688 vs. 0.637; P = .006), at 2 years (AUC 0.660 vs. 0.617; P = .003), and at 4 years of follow-up (AUC 0.654 vs. 0.608; P = .002). The findings were similar for the other reported outcomes., Conclusions: In ISCHEMIA, total plaque volume was associated with cardiovascular death or myocardial infarction. In this highly diseased, high-risk population, enhanced assessment of atherosclerotic burden using AI-QCT-derived measures of plaque volume and composition modestly improved event prediction., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Mortality after congenital heart surgery is an important metric across benchmarking, quality, and reporting initiatives. All rely on estimates from prior years, and how well these reflect current outcomes is unclear., Methods: Index operations from The Society of Thoracic Surgeons Congenital Database (2014-2019) were included. Adjusted operative mortality in "past" 4-year and 1-year intervals vs the most recent year ("present") was evaluated using Bayesian hierarchical logistic regression with results presented as odds ratios and 95% credible intervals (CrI)., Results: Among 115,699 operations (106 hospitals), overall present observed mortality was 2.5%. Regression to the mean was evident, and individual hospital's present vs past adjusted mortality were only weakly correlated (-0.11 vs past 1-year data, 0.22 vs past 4-year data). A significant relationship was found between past and present mortality only for the group of hospitals in the highest mortality quartile, most prominent for past 4-year data (adjusted odds ratio vs lowest mortality quartile, 2.04; 95% CrI, 1.44-2.80). The proportion of present hospital mortality variation explained by past mortality quartile was 52% (95% CrI, 20%-90%) using past 4-year data and only 27% (95% CrI, 92%-83%) using past 1-year data. Overall 66% of hospitals changed mortality quartiles from past to present (30% by ≥2 quartiles)., Conclusions: Past mortality relates to present primarily for groups of hospitals at the extremes, with past 4-year data more informative than past 1-year data. For individual hospitals, past may differ from present, regression to the mean is common, and many change quartiles. Past mortality should be used thoughtfully and not as the sole factor informing present decision making., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)