Citations

Abstract The use of chimeric antigen receptor (CAR) T-cell therapy is increasing for adult B-cell acute lymphoblastic leukemia (B-ALL), with 3 CD19 CAR T-cell products commercially available. Several key clinical questions related to best practices for CAR T-cell administration in this population exist, and limited prospective randomized trials have been conducted to fill these knowledge gaps. Thus, to help guide clinical practice, we conducted a modified Delphi study to develop and validate consensus recommendations on the administration of commercially available CAR T-cell therapy for adults with B-ALL. Consensus panelists (n = 9) included principal investigators (PIs) from Real World Outcomes Collaborative of CAR T-Cell Therapy in Adult ALL (ROCCA) consortium sites and were selected based on expertise and CAR T-cell center volume. Final panel consensus recommendations were distributed for rating by the remaining PIs from ROCCA consortium sites, which served as the validation group (n = 27). Consensus topics included patient selection, bridging and pre–CAR T-cell leukemia staging, lymphodepletion, and CAR T-cell treatment setting, specific toxicity prevention and management, post–CAR T-cell response assessment and disease monitoring, and the role of consolidation and/or maintenance therapies after CAR T-cell therapy. Initially, 58 recommendation statements were evaluated for consensus. After 2 panel meetings, a total of 34 statements achieved consensus rating among the expert panel. After rating by the validation group, all but 1 recommendation statement continued to meet consensus, for a total of 33 consensus recommendation statements on the administration of CAR T-cell therapy in adult B-ALL.

ABSTRACT Background Anemia is an established marker of cardiovascular disease severity and risk which leads to elevations in resting myocardial blood flow (MBF) and impaired myocardial flow reserve (MFR) in patients without obstructive coronary artery disease (CAD). Anemia can potentially be detected opportunistically from blood pool density changes on computed tomography (CT) imaging. Objectives We evaluated relationships between chamber density measurements with hemoglobin, positron emission tomography (PET) findings, and cardiovascular events. Methods We included 33460 patients from 13 sites in the REFINE-PET who underwent PET and 24368 patients undergoing lung cancer screening chest CT. A deep learning model segmented cardiac chambers from CT images, then quantified chamber density. We evaluated the relationship between chamber density measures with resting MBF and MFR, as well as associations with death or myocardial infarction (MI). Results We included a total of 57,828 patients. A higher density in myocardium compared to left ventricle blood pool was associated with reduced MFR (adjusted odds ratio 3.02 per SD increase, 95% confidence interval[CI] 2.72 – 3.38) and an increased risk of death or MI in (adjusted hazard ratio[HR] 1.38 per SD increase, 95% CI 1.26-1.51). Having myocardial density higher than blood pool density was also associated with cardiovascular death in patients undergoing low-dose chest CT (adjusted HR 1.73, 95% CI 1.20-2.52). Conclusions In a large multimodality dataset, lower cardiac chamber density is associated with impaired MFR and independently associated with cardiovascular events. These biomarkers can be automatically extracted from CT to provide physiologic insights and potentially guide patient care. CONDENSED ABSTRACT Anemia is an important marker of cardiovascular disease severity and predictor of cardiovascular events. We utilized deep learning to measure cardiac chamber density on computed tomography imaging as a surrogate for anemia in 57,828 patients from two large multicenter studies. A higher density in myocardium compared to left ventricle blood pool was associated with reduced MFR and an increased risk of death or MI in patients undergoing positron emission tomography, and an increased risk of cardiovascular death in patients undergoing low-dose computed tomography. These biomarkers can provide additionally physiologic insights which could be used to guide patient care.

The creation of an arteriovenous fistula in a uremic pig induces cardiac remodeling, which resembles contemporary clinical findings in patients with end-stage kidney disease (ESKD) and includes increased end-diastolic volumes and cardiomyocyte hypertrophy, potentially driven by fibrosis and senescence. This novel large animal model may now enable mechanistic and therapeutic studies aiming to ease the unacceptably high burden of cardiovascular disease on patients with ESKD.

Introduction The integration of telehealth into clinical care has increased access to substance use disorder (SUD) treatment. However, drug screen monitoring has largely remained tied to in-person visits, preventing a fully virtual workflow. We evaluated the acceptability, appropriateness, feasibility, and usability of video-observed oral fluid (VOOF) self-collection as an approach to address this implementation gap. Methods Participants receiving SUD treatment in outpatient ( n = 13) or residential ( n = 15) settings completed a video-recorded oral fluid self-collection protocol, followed by the Acceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure, and System Usability Scale. Results Most participants had multiple SUDs ( n = 23, 82.1%), and nearly all had co-occurring mental illness ( n = 27, 96.4%). The majority completed study measures ( n = 23, 82.1%) and returned collection kits ( n = 25, 89.2%). Acceptability, appropriateness, and feasibility all exceeded established thresholds (>3), with respective means of 3.5 (SD 1.1), 3.8 (SD 1.1), and 3.4 (SD 1.3). Usability scores were below average and more variable (mean = 51.8, SD 20.4). Scores did not significantly differ by care setting. Discussion This early-stage pilot found that VOOF self-collection was generally acceptable, appropriate, and feasible among individuals with SUD in real-world care settings. Usability scores were below average, with technical challenges related to video recording and upload likely contributing. Integrating VOOF within digital treatment platforms may streamline the user experience and improve usability while better aligning drug screen monitoring with the growth of telehealth in SUD treatment. This approach may benefit individuals experiencing transportation barriers and those in rural areas who live significant distances from testing sites.

ABSTRACT Background Superior vena cava isolation (SVCI) is performed as an adjunct to pulmonary vein isolation (PVI) for atrial fibrillation, yet whether an empiric or trigger‐guided strategy is preferable remains uncertain. Prior meta‐analyses have been largely restricted to index procedures in paroxysmal AF and have not explicitly stratified by ablation strategy. We sought to address these gaps through a systematic review of available randomized evidence. Methods Major databases were searched through November 2025 for RCTs comparing PVI+SVCI versus PVI alone. Trials were stratified by strategy: empiric SVCI (performed irrespective of SVC ectopy) or trigger‐guided SVCI (performed only upon demonstrated SVC triggers). The primary outcome was atrial tachyarrhythmia recurrence (≥30 s) beyond the blanking period. Random‐effects models, pre‐specified subgroup analyses, meta‐regression, and GRADE certainty assessment were performed. Results Eight RCTs ( n = 1231) were included; most enrolled paroxysmal AF, while two incorporated non‐paroxysmal AF subtypes and one evaluated repeat ablation procedures. Overall, SVCI+PVI significantly reduced recurrence versus PVI alone (97/604 vs. 135/627; RR 0.77, 95% CI 0.61–0.97; p = 0.03; I 2 = 0%). On stratified analysis, empiric SVCI demonstrated a significant recurrence reduction (RR 0.70, 95% CI 0.53–0.92; p = 0.01; I 2 = 0%), while trigger‐guided SVCI did not reach statistical significance (RR 0.80, 95% CI 0.37–1.74; p = 0.57; I 2 = 52%). In paroxysmal AF ( n = 1038), adjunctive SVCI significantly reduced recurrence compared with PVI alone (RR 0.68, 95% CI 0.52–0.90; p = 0.01; I 2 = 0%). Fluoroscopy time was longer with SVCI; total procedure duration was comparable. Major complications were infrequent but numerically higher with SVCI+PVI (15/604 vs. 7/627; RR 1.96, 95% CI 0.87–4.38; p = 0.10). Meta‐regression identified no significant effect modifiers. GRADE certainty was high for overall and empiric analyses, and moderate for trigger‐guided SVCI. Conclusions Empiric SVCI significantly reduced AT/AF recurrence as an adjunct to PVI, while trigger‐guided SVCI did not demonstrate a significant benefit. These findings suggest SVC isolation confers benefit independent of prior trigger documentation, supporting the role of empiric SVCI as an adjunct to AF ablation.

Expert consensus recommendations from 21 academic centers were established for appropriate radiography utilization at 12 potentially low-yield anatomic sites through a multidisciplinary process endorsed by six major American medical societies.

Purpose: To compare reported intraoperative failure-mode profiles between preloaded and manually loaded intraocular lens (IOL) delivery systems using U.S. Food and Drug Administration (FDA) device reports. Setting: FDA Manufacturer and User Facility Device Experience (MAUDE) database, United States. Design: Retrospective cross-sectional study. Methods: MAUDE reports from January 1, 2016 through December 31, 2025 were reviewed. Reports describing intraoperative IOL loading, delivery, or positioning issues were included when injector type was specified. Structured MAUDE fields served as the primary data source, and free-text narratives were analyzed using automated natural language processing to supplement classification when consistent with structured fields. Comparisons were performed using within-group proportions, and multivariable logistic regression estimated adjusted odds ratios (aORs) controlling for report year, manufacturer, lens platform, and reporting entity. Results: Of 57,435 FDA device reports, 14,460 intraoperative reports met inclusion criteria; 10,567 (73.1%) involved preloaded systems and 3,893 (26.9%) manually loaded systems. Manually loaded systems showed higher reporting of IOL damage (66.0% vs 45.4%; aOR 3.06, 95% CI 2.78–3.37; p<0.001) and loading issues (aOR 5.53, 95% CI 3.99–7.66; p<0.001). Preloaded systems showed higher reporting of delivery failures (40.5% vs 21.8%; aOR 3.91, 95% CI 3.51–4.35; p<0.001), lens positioning issues (aOR 1.27, 95% CI 1.01–1.62; p=0.041), and material or optics abnormalities (aOR 3.53, 95% CI 1.96–6.35; p<0.001). Conclusions: Preloaded and manually loaded IOL delivery systems demonstrated distinct failure-mode profiles within FDA device reports. These findings characterized reporting patterns rather than population-level risk and may inform device design and post-market surveillance priorities.

We describe the case of a man in his 60s with metastatic melanoma on encorafenib/binimetinib and nivolumab/relatlimab, with a history of immune checkpoint inhibitor (ICI)-induced acute interstitial nephritis, who presented with acute-onset nausea, vomiting and profuse watery diarrhoea. Investigations excluded infectious causes, and flexible sigmoidoscopy with biopsy demonstrated lymphocytic colitis. His symptoms persisted despite discontinuation of Braftovi-Mektovi (BRAF–MEK) therapy and required escalation of corticosteroid therapy and budesonide initiation. This case highlights the diagnostic challenges of differentiating ICI-mediated colitis from adverse events of targeted therapy and underscores the importance of endoscopic and histological confirmation in guiding treatment.