Citations

Purpose: There are reported barriers to implementation of esophageal screening during the videofluoroscopic swallow study (VFSS) completed by the speech-language pathologist (SLP). Often, patients referred to the SLP for a VFSS have an esophageal component that may explain their complaint. In this article, authors explore roadblocks to esophageal screening and potential roadmaps to improve patient care through standardization of esophageal screening procedures. Conclusions: A strong body of literature supports physiologic, anatomic, and disease state relationships of the oropharynx and esophagus. Despite this, the assessment of the oropharynx and esophagus is dichotomized. There remain billing limitations for same-day esophagram and VFSS, and the well-documented esophageal screen provides a view of bolus flow in an upright, typical eating position with consideration of oropharyngeal function to provide a comprehensive view of the continuous process of swallowing from mouth to stomach. The continued practice of evaluating the oropharynx without consideration of the esophagus poses a threat to patient safety and may delay care. A collaborative, multidisciplinary effort among healthcare professionals to create streamlined practice parameters, update position statements, and enhance education parameters will allow for cohesive practices among professionals. Assessment of the swallow mechanism is incomplete without consideration of the entire continuum.

Background Robotic-assisted TKA may allow for more reproducible balancing and implant positioning. However, few RCTs have directly compared modern robotic-assisted TKA to conventional TKA. Questions/purposes (1) Do patients undergoing robotic-assisted TKA perform better on the Timed Up and Go (TUG) test and Stair Climb test (SCT) than patients undergoing conventional TKA at 1 and 6 months after surgery? (2) Do patients undergoing robotic-assisted TKA demonstrate better patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D, and VAS scores, than patients undergoing conventional TKA at 1 and 6 months after surgery? (3) Do patients undergoing robotic-assisted TKA demonstrate better radiographic alignment and position than patients undergoing conventional TKA? Methods In this double-blind RCT, 60 patients were randomized to robotic-assisted TKA (n = 30) or conventional TKA (n = 30) without the use of a tensioning device. All care was otherwise standardized, using mechanical alignment guides. The primary outcome measures were the TUG and SCT tests; results were collected by a blinded observer at 6 months postoperatively. These time points were chosen based on the maximal early improvement in patient-reported outcomes and bimodal distribution of the TUG and SCT tests, worsening in the immediate postoperative period, and improving within the first 6 months. Secondary outcome measures were KOOS, EQ-5D, and VAS scores; radiographic measurements; and operative time. Standard bivariate statistical analysis was conducted. The mean ± SD age of the cohort was 66 ± 7 years, with no differences between groups (p = 0.21). Ninety-three percent (28 of 30) of patients in the robotic-assisted group were White versus 97% (29 of 30) in the conventional TKA group (p > 0.99). Women made up 57% (17) of the robotic-assisted cohort and 60% (18) of the conventional TKA cohort. No differences were noted between the robotic-assisted and conventional TKA groups in BMI, Charlson comorbidity index, or American Society of Anesthesiologists (ASA) classification. Results Patients undergoing robotic-assisted TKA did not perform better than those who underwent conventional TKA on the TUG (11 versus 11 seconds; p = 0.88) or SCT (15 versus 15 seconds; p = 0.93) tests. Patients undergoing robotic-assisted TKA did not demonstrate better mean ± SD scores on the KOOS pain subscale than patients undergoing conventional TKA (86 ± 14 versus 80 ± 17; p = 0.15). Patients undergoing robotic-assisted TKA did not demonstrate better radiographic alignment and position than patients undergoing conventional TKA based on hip-knee-ankle angle (178° versus 178°; p = 0.89). No differences between the two groups were noted at the 1-month follow-up in TUG and SCT test results. Conclusion In this study, patients who underwent robotically assisted TKA did no better in terms of function, patient-reported outcomes, or radiographic measures than did patients who underwent conventional TKA. Until or unless future studies demonstrate benefits of robotically assisted TKA that are large enough for patients to perceive, we recommend against its use. Level of Evidence Level I, therapeutic study.

Objective To provide evidence‐based and expert guidance for the treatment and management of non‐renal systemic lupus erythematosus (SLE); treatment and management of lupus nephritis are addressed in a separate guideline. Methods Clinical questions for treatment and management of SLE were developed in the PICO format (population, intervention, comparator, and outcome). Systematic literature reviews were developed for each PICO question, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess evidence quality and formulate recommendations. The Voting Panel achieved a consensus of ≥70% agreement on the direction (for or against) and strength (strong or conditional) of each recommendation. Results We present recommendations and ungraded, consensus‐based good practice statements for the treatment and management of SLE that are applicable to pediatric and adult patients. Recommendations emphasize uniform treatment with hydroxychloroquine, limiting duration of glucocorticoid use, and early introduction of conventional and/or biologic immunosuppressive therapies to achieve and maintain control of SLE inflammation (remission or a low level of disease activity), reduce SLE‐related morbidity and mortality, and minimize medication‐related toxicities. Conclusion This guideline presents direction regarding treatment and management of SLE and provides a foundation for well‐informed, shared clinician–patient decision‐making. These recommendations should not be used to limit or deny access to therapies, as treatment decisions may vary due to the unique clinical situation and personal preferences of each person with SLE.

Objective To provide evidence‐based and expert guidance for the treatment and management of non‐renal systemic lupus erythematosus (SLE); treatment and management of lupus nephritis are addressed in a separate guideline. Methods Clinical questions for treatment and management of SLE were developed in the PICO format (population, intervention, comparator, and outcome). Systematic literature reviews were developed for each PICO question, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess evidence quality and formulate recommendations. The Voting Panel achieved a consensus of ≥70% agreement on the direction (for or against) and strength (strong or conditional) of each recommendation. Results We present recommendations and ungraded, consensus‐based good practice statements for the treatment and management of SLE that are applicable to pediatric and adult patients. Recommendations emphasize uniform treatment with hydroxychloroquine, limiting duration of glucocorticoid use, and early introduction of conventional and/or biologic immunosuppressive therapies to achieve and maintain control of SLE inflammation (remission or a low level of disease activity), reduce SLE‐related morbidity and mortality, and minimize medication‐related toxicities. Conclusion This guideline presents direction regarding treatment and management of SLE and provides a foundation for well‐informed, shared clinician–patient decision‐making. These recommendations should not be used to limit or deny access to therapies, as treatment decisions may vary due to the unique clinical situation and personal preferences of each person with SLE.

Background The Woven EndoBridge (WEB) device represents an innovative solution for cerebral aneurysm occlusion, particularly for challenging wide-neck bifurcation aneurysms. However, factors affecting sustained occlusion remain poorly understood. We utilized machine learning to attempt to identify predictors of favorable long-term outcomes following WEB treatment. Methods In this multicenter retrospective study, we collected patient demographics, aneurysm characteristics, procedural details, and clinical outcomes. The primary endpoint was improvement in occlusion status, defined as maintained Raymond-Roy Occlusion Classification (RROC) grade 1, or improvement from grade 2 to 1, or from grade 3 to either 2 or 1 on final angiographic follow up. The dataset was split into training (75%) and validation (25%) sets. The CatBoost algorithm was selected based on performance metrics, with Shapley Additive exPlanations (SHAP) values calculated to determine feature importance. Furthermore, a multivariable binomial logistic regression model was performed to validate machine learning findings. Results Among 720 aneurysms from 36 hospitals, 84% showed improvement in occlusion at follow up. Both machine learning and multivariable logistic regression identified aneurysm height as the most consistent correlate of nonimprovement (odds ratio (OR) 0.90 per mm, p = 0.022). In the CatBoost model, the highest-ranking features by SHAP included aneurysm height, patient age, treatment acuity, ACom location, WEB-SLS device, bifurcation anatomy, aneurysm multiplicity, baseline modified Rankin Scale, access route, and partial thrombosis. Conclusions Machine-learning and regression analyses identified consistent predictors of occlusion improvement after WEB treatment, with aneurysm height most strongly linked to nonimprovement. These insights may guide patient selection and follow up. Findings require cautious interpretation and external validation in larger cohorts.

Abstract Purpose: Relapse is a major cause of failure in human papillomavirus–independent head and neck squamous cell carcinoma. Clinicopathologic criteria for adjuvant treatment remain imprecise and have not changed for decades. We investigated whether ctDNA in lymphatic exudate collected via surgical drains (“lymph”) 24 hours after surgery identified molecular residual disease (MRD) and compared its performance with time-matched plasma. Experimental Design: Using an ultra-sensitive tumor-informed sequencing approach, tumor variants were called in lymph and plasma to classify patients as ctDNA positive or ctDNA negative, trained in an initial cohort of 36 patients, and replicated in an independent cohort of 37 patients. Progression-free survival was compared in ctDNA(+) versus ctDNA(–) patients. Results: Lymph identified MRD in two independent multi-site cohorts (initial cohort sensitivity = 76% and specificity = 63%; log-rank P = 0.01; replication cohort sensitivity = 65% and specificity = 70%; log-rank P = 0.04). Lymph performance was enhanced in locoregional relapse (sensitivity = 78% and specificity = 67%; log-rank P = 0.0004) and generalized to early-stage patients. Analysis of matched plasma collected at this early timepoint was not predictive of recurrence (sensitivity = 35% and specificity = 72%; log-rank P = 0.7). In patients with intermediate-risk pathology, lymph ctDNA was associated with recurrence (sensitivity = 88% and specificity = 67%; log-rank P = 0.0008), suggesting an opportunity for improved stratification of patients who may benefit from additional adjuvant treatment. Conclusions: Postoperative lymph is a novel, proximal, and early source of MRD with the potential to introduce more precision into adjuvant therapy decision-making and improve outcomes, especially for patients with intermediate-risk human papillomavirus–independent head and neck squamous cell carcinoma.

Importance The Breast Cancer Index (BCI) previously identified premenopausal patients with tumors in which the ratio of expression of HOXB13 relative to IL17BR (hereafter, BCI [H/I]–low tumors) as likely to derive greatest benefit from ovarian function suppression (OFS)–containing adjuvant therapy in the Suppression of Ovarian Function Trial (SOFT) trial. Objectives To assess BCI as a predictive biomarker of benefit from exemestane plus OFS vs tamoxifen plus OFS and to validate BCI as a prognostic biomarker for premenopausal patients. Design, Setting, and Participants This prognostic study used a prospective-retrospective translational design within the Tamoxifen and Exemestane (TEXT) and SOFT trials (enrolled November 2003 to April 2011). Blinded BCI testing in all available tumor samples was completed in March 2024. Premenopausal women with hormone receptor–positive breast cancer randomized to tamoxifen plus OFS or exemestane plus OFS who had BCI assessed were included. Analysis occurred from March to August 2024. Exposure 5 years of adjuvant tamoxifen plus OFS or exemestane plus OFS. Main Outcomes and Measures The primary outcomes were breast cancer-free interval (BCFI) for predictive analyses and distant recurrence-free interval (DRFI) for prognostic analyses after a median follow-up of 13 years in the TEXT cohort. Secondary objectives examined the predictive performance of BCI (H/I) in the combined TEXT and SOFT cohort overall and in prespecified clinical subgroups. Results Of 1782 patients in the TEXT study, 1034 (58.0%) had BCI (H/I)–low tumors; 915 (51.3%) of patients had N0 disease and 1077 (60.4%) were younger than 45 years. Patients with BCI (H/I)–low tumors had a 6.6% absolute benefit in 12-year BCFI (HR, 0.61; 95% CI, 0.44-0.85) for exemestane plus OFS vs tamoxifen plus OFS, while those with BCI (H/I)–high tumors had a 6.3% absolute benefit (HR, 0.78; 95% CI, 0.57-1.07; P for interaction = .29). Results were consistent in the combined TEXT plus SOFT cohort (2896 patients) and adjusting for clinicopathological variables. Clinical subgroup analyses consistently showed benefit of exemestane plus OFS vs tamoxifen plus OFS for BCI (H/I)–low tumors, and more variable relative treatment effects among BCI (H/I)–high tumors, including by age. Post hoc exploratory time-varying estimates suggested the treatment × BCI associations may differ in years 0 to 5 vs greater than 5 years. BCI and BCI N+ as continuous indices were prognostic for distant recurrence in N0 (HR, 1.27; 95% CI, 1.11-1.44; P < .001) and N1 (HR, 1.58; 95% CI, 1.21-2.05; P < .001) cancers. The 12-year DRFI was 96.3%, 90.3%, and 84.9% for BCI low-, intermediate-, and high-risk N0 cancers, respectively. Conclusions and Relevance In this study of premenopausal women with hormone receptor–positive breast cancer, BCI (H/I) status did not clearly predict greater benefit of adjuvant exemestane plus OFS vs tamoxifen plus OFS for women with BCI (H/I)–low tumors than for those with BCI (H/I)–high tumors; BCI continuous indices were reconfirmed as prognostic for premenopausal women. These findings support prior results of SOFT, which compared tamoxifen-alone vs OFS with either exemestane or tamoxifen, indicating premenopausal patients with BCI (H/I)–low tumors may benefit from more intensive endocrine therapy.

Background: Breast cancer polygenic risk scores (PRS) and traditional risk models (e.g., the Gail model [Gail]) are known to contribute largely independent information, but it is unclear how the overlap varies by ancestry, age, disease type (invasive breast cancer, DCIS), and risk threshold. Methods: In a retrospective case–control study, we evaluated risk prediction performance in 180,398 women (161,849 of European ancestry; 18,549 of Asian ancestry). Odds ratios (ORs) from logistic regression models and the area under the receiver operating characteristic curve (AUC) were estimated. Results: PRS for invasive disease showed a stronger association in younger (<50 years) women (OR = 2.51, AUC = 0.622) than in women ≥ 50 years (OR = 2.06, AUC = 0.653) of European ancestry. PRS performance in Asians was lower (OR range = 1.62–1.64, AUC = 0.551–0.600). Gail performance was modest across groups and poor in younger Asian women (OR = 0.94–0.99, AUC = 0.523–0.533). Age interactions were observed for both PRS (p < 0.001) and Gail (p < 0.001) in Europeans, whereas in Asians, age interaction was observed only for Gail (invasive: p < 0.001; DCIS: p = 0.002). PRS identified more high-risk individuals than Gail in Asian populations, especially ≥50 years, while Gail identified more in Europeans. Overlap between PRS, Gail, and family history was limited at higher thresholds. Calibration analysis, comparing empirical and model-based ROC curves, showed divergence for both PRS and Gail (p < 0.001), which indicates miscalibration. In Europeans, family history and prior biopsies drove Gail discrimination. In younger Asians, age at first live birth was influential. Conclusions: PRS adds value to risk stratification beyond traditional tools, especially in younger women and Asian ancestry populations.

Background: Etripamil nasal spray is a fast-acting, calcium channel blocker in development for the conversion of paroxysmal supraventricular tachycardia (PSVT) outside of a health-care setting. Studies have demonstrated the favorable safety and efficacy of self-administered etripamil in restoring sinus rhythm (SR) and reducing emergency department visits. Purpose: This report analyzes the efficacy, safety, and test-dose tolerability of etripamil across PSVT clinical studies. Methods: We systemically examined randomized, controlled and open-label trials evaluating etripamil in patients with PSVT. Efficacy measures included the proportion of patients converting from PSVT to SR within 30 minutes and the median times to conversion across all Phase 3 studies. Safety data for treatment-emergent adverse events (TEAEs), serious AEs, and test dose tolerability from Phase 2/3 studies were summarized descriptively. Results: NODE-1, NODE-301 Part 1, NODE-301 Part 2 (RAPID, including RAPID Extension, RAPID Open Label, RAPID Open Label Extension periods), NODE-302, and NODE-303 studies were analyzed (Table 1). The Kaplan-Meier estimate of etripamil exposed patients converting to SR within 30 minutes (n= 622) was 59.6% (range, 53.6% to 64.3%) with a median time to conversion of 18.5 minutes (95% CI, 15.7 to 21.0). The proportions of RCT placebo group patients converting from SVT to SR by 30 minutes ranged from 26.7% to 34.7%. Estimates of conversion of SVT to SR with etripamil at 60 minutes for individual studies ranged from 63.2% to 73.5% (Figure). Combined analysis showed mainly the occurrence of mild, transient TEAEs, primarily nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis (Table 2). 1,107 patients took at least one etripamil test dose while in SR; no significant change in average baseline heart rate or blood pressure was observed within 45 minutes of administration, and test dose failure occurred in only 16 patients (1.4%). Conclusions: Across multiple clinical studies of acute PSVT management, self-administered etripamil consistently demonstrated robust efficacy and a favorable safety profile for acute PSVT management. Safety data and the low rate of test dose failures indicate favorable tolerability, suggesting no need for a pretreatment test dose. These findings support the potential of etripamil as a patient-administered therapy for PSVT, which may reduce reliance on emergency care.

Background: Atrial arrhythmia recurrence after surgical ablation remains challenging to predict and integrating novel biomarkers may improve risk stratification. Objective: To evaluate whether combining preoperative transthoracic echocardiography (TTE) with artificial intelligence-enabled ECG (AI-ECG) scores enhances prediction of atrial fibrillation/flutter (AF/AFl) recurrence post surgical ablation. Methods: We retrospectively analyzed 1,696 patients undergoing Surgical AF/AFl Ablation between 2006 and 2025 with preoperative TTE and post-blanking ECGs. Clinical variables, TTE indices, and AI-ECG scores (AF probability, ECG-estimated age, HFpEF, LV dysfunction, and aortic stenosis scores) were assessed. The primary outcome was time to AF/AFl recurrence. Univariate/multivariable Cox models and a Random Survival Forest (RSF) model (80:20, training: testing) were developed to identify predictors. Results: Of 1,696 patients (mean age 67.3±10.2 years; 61.7% male) undergoing surgical AF/AFl ablation, 949 (56%) experienced AF/AFl recurrence during a median follow-up of 3.14 years. Patients with recurrence had larger left atria (mean LA area 30.4 vs 24.5 cm 2 , p < 0.001), more diastolic dysfunction (mitral inflow E-wave velocity 1.015 m/s vs 0.896 m/s , p < 0.001), and adverse AI-ECG biomarkers. In multivariable analysis, independent predictors of recurrence included a higher ECG-AF score (p < 1 x 10 -300 ), an older AI-ECG age (p = 0.0002), LA area (p = 0.046), body mass index (p = 0.036), and elevated diastolic blood pressure (HR 1.008 per mmHg, 95% CI 1.002 – 1.014; p = 0.010). The final Cox model achieved a C-index of ~0.67 and stratified patients into risk quartiles with 3-year freedom-from-arrhythmia rates of ~85% (lowest-risk) vs ~43% (highest-risk). An RSF model yielded a slightly higher test C-index (≈0.69), suggesting modest improvement with non-linear modeling. Conclusions: Preoperative AI-ECG biomarkers (AF probability, age discordance) and TTE markers of atrial remodeling independently predicted AF/AFl recurrence after surgical AF/AFl ablation and integration of these metrics improved risk stratification.