Impact of Chronic Kidney Disease on Outcomes following Vascular Procedure in the Vascular Quality Initiative.

BACKGROUND: Chronic kidney disease (CKD) increases morbidity and mortality in most vascular procedures. However, a binary classification of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, which is often used in both modeling and clinical trials, may not be optimal for predicting clinical outcomes. OBJECTIVE: Determine the optimal eGFR cutoff for use in risk stratification and prediction models. METHODS: Vascular Quality Initiative (VQI) data for non-emergent, first-time OAR, EVAR, TEVAR, CEA, CAS, PVI, Supra- and infra-inguinal bypass were analyzed from to 2013-2023 and divided into cohorts based on eGFR (≥60, 45-59, 30-44, <30, and preoperative dialysis). χ2 and logistic regression were used to evaluate perioperative outcomes. RESULTS: Compared to patients with eGFR ≥60, those with eGFR 45-59 had similar odds of mortality following all procedures, except TEVAR. Driven by this group, the combined cohort showed a slight increase in the odds of mortality for eGFR 45-59 (0.6% vs. 0.7%, aOR 1.16, P=0.002). Those in the 30-44 group demonstrated increased odds of mortality both overall and in the individual procedure groups (0.6% vs. 1.2%, aOR 1.78, P<0.001). The odds of mortality continued to increase with worsening eGFR. The overall rate of new permanent dialysis was low for all eGFR cohorts, with a 0.02% difference between those with eGFR >60 and those in the 45-59 cohort (0.04% vs. 0.06%; a OR 1.65, P<0.001). The odds of permanent dialysis likewise continued to increase with decreasing eGFR. CONCLUSIONS: Rather than a binary eGFR cutoff of ≥60 and <60 to stratify patient risk, better risk stratification may be achieved by using five groups of ≥60, 45-59, 30-44, <30, and preoperative dialysis.

Outcomes following carotid revascularization in patients with prior ipsilateral carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: The outcomes of carotid revascularization in patients with prior carotid artery stenting (CAS) remain understudied. Prior research has not reported the outcomes after transcarotid artery revascularization (TCAR) in patients with previous CAS. In this study, we compared the peri-operative outcomes of TCAR, transfemoral CAS (tfCAS) and carotid endarterectomy (CEA) in patients with prior ipsilateral CAS using the Vascular Quality Iniatitive. METHODS: Using Vascular Quality Initiative data from 2016 to 2023, we identified patients who underwent TCAR, tfCAS, or CEA after prior ipsilateral CAS. We included covariates such as age, race, sex, body mass index, comorbidities (hypertension, diabetes, prior coronary artery disease, prior coronary artery bypass grafting/percutaneous coronary intervention, congestive heart failure, renal dysfunction, smoking, chronic obstructive pulmonary disease, and anemia), symptom status, urgency, ipsilateral stenosis, and contralateral occlusion into a regression model to compute propensity scores for treatment assignment. We then used the propensity scores for inverse probability weighting and weighted logistic regression to compare in-hospital stroke, in-hospital death, stroke/death, postoperative myocardial infarction (MI), stroke/death/MI, 30-day mortality, and cranial nerve injury (CNI) after TCAR, tfCAS, and CEA. We also analyzed trends in the proportions of patients undergoing the three revascularization procedures over time using Cochrane-Armitage trend testing. RESULTS: We identified 2137 patients undergoing revascularization after prior ipsilateral carotid stenting: 668 TCAR patients (31%), 1128 tfCAS patients (53%), and 341 CEA patients (16%). In asymptomatic patients, TCAR was associated with a lower yet not statistically significant in-hospital stroke/death than tfCAS (TCAR vs tfCAS: 0.7% vs 2.0%; adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.11-1.05; P = .06), and similar odds of stroke/death with CEA (TCAR vs CEA: 0.7% vs 0.9%; aOR, 0.80; 95% CI, 0.16-3.98; P = .8). Compared with CEA, TCAR was associated with lower odds of postoperative MI (0.1% vs 14%; aOR, 0.02; 95% CI, 0.00-0.10; P < .001), stroke/death/MI (0.8% vs 15%; aOR, 0.05; 95% CI, 0.01-0.25; P < .001), and CNI (0.1% vs 3.8%; aOR, 0.04; 95% CI, 0.00-0.30; P = .002) in this patient population. In symptomatic patients, TCAR had an unacceptably elevated in-hospital stroke/death rate of 5.1%, with lower rates of CNI than CEA. We also found an increasing trend in the proportion of patients undergoing TCAR following prior ipsilateral carotid stenting (2016 to 2023: 14% to 41%), with a relative decrease in proportions of tfCAS (61% to 45%) and CEA (25% to 14%) (P < .001). CONCLUSIONS: In asymptomatic patients with prior ipsilateral CAS, TCAR was associated with lower odds of in-hospital stroke/death compared with tfCAS, with comparable stroke/death but lower postoperative MI and CNI rates compared with CEA. In symptomatic patients, TCAR was associated with unacceptably higher in-hospital stroke/death rates. In line with the postprocedure outcomes, there has been a steady increase in the proportion of patients with prior ipsilateral stenting undergoing TCAR over time.

Axillary de-escalation after neoadjuvant chemotherapy for advanced lymph node involvement in breast cancer.

INTRODUCTION: Sentinel lymph node biopsy reduces morbidity in patients with clinically node-positive breast cancer who achieve axillary pathologic complete response following neoadjuvant therapy (NACT). De-escalation trials primarily addressed cN1 disease, with underrepresentation of cN2 disease. This study evaluates the role of de-escalation in patients with cN2 breast cancer. METHODS: A retrospective analysis of the National Cancer Database (2013-2020) included women over 18 with T1-2 invasive breast cancer and clinical N2 disease who received NACT followed by ALND or SLNB then ALND. The primary outcome was pathologic nodal status post-NACT. RESULTS: Of 5852 cN2 patients treated, 18.15 â€‹% achieved ypN0, 0.97 â€‹% had isolated tumor cells, 19.14 â€‹% were ypN1, 49.64 â€‹% were ypN2, and 12.20 â€‹% were ypN3 following NACT. Achieving ypN0 was associated with pCR in the breast, HER2-positive and triple-negative receptor status, cT2 tumors, and younger age. CONCLUSION: Despite some patients with cN2 disease achieving ypN0, most exhibited residual axillary disease post-NACT. These findings indicate that axillary de-escalation may not be feasible for most patients with cN2 disease, underscoring the importance of meticulous patient selection and assessment.

Outcomes of carotid revascularization stratified by procedure in patients with an estimated glomerular filtration rate of <30 and dialysis patients.

OBJECTIVE: Renal failure is a predictor of adverse outcomes in carotid revascularization. There has been debate regarding the benefit of revascularization in patients with severe chronic kidney disease or on dialysis. METHODS: Patients in the Vascular Quality Initiative undergoing transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (tfCAS), or CEA between 2016 and 2023 with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 or on dialysis were included. Patients were divided into cohorts based on procedure. Additional analyses were performed for patients on dialysis only and by symptomatology. Primary outcomes were perioperative stroke/death/myocardial infarction (MI) (SDM). Secondary outcomes included perioperative death, stroke, MI, cranial nerve injury, and stroke/death. Inverse probability of treatment weighting was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and preoperative symptoms. The χ2 test and multivariable logistic regression analysis were used to evaluate the association of procedure with perioperative outcomes in the weighted cohort. Five-year survival was evaluated using Kaplan-Meier and weighted Cox regression. RESULTS: In the weighted cohort, 13,851 patients with an eGFR of <30 (2506 on dialysis) underwent TCAR (3639; 704 on dialysis), tfCAS (1975; 393 on dialysis), or CEA (8237; 1409 on dialysis) during the study period. Compared with TCAR, CEA had higher odds of SDM (2.8% vs 3.6%; adjusted odds ratio [aOR], 1.27; 95% confidence interval [CI], 1.00-1.61; P = .049), and MI (0.7% vs 1.5%; aOR, 2.00; 95% CI, 1.31-3.05; P = .001). Compared with TCAR, rates of SDM (2.8% vs 5.8%), stroke (1.2% vs 2.6%), and death (0.9% vs 2.4%) were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%; aOR, 1.85; 95% CI, 1.15-2.97; P = .011) and cranial nerve injury (0.3% vs 1.9%; aOR, 7.23; 95% CI, 3.28-15.9; P < .001). Like in the primary analysis, asymptomatic tfCAS patients demonstrated higher odds of death and stroke/death. Symptomatic CEA patients demonstrated no difference in stroke, death, or stroke/death. Although tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, the 5-year survival was similar for TCAR and CEA (eGFR <30, 75.1% vs 74.2%; aHR, 1.06; P = .3) and lower for tfCAS (eGFR <30, 75.1% vs 70.4%; aHR, 1.44; P < .001). CONCLUSIONS: CEA and TCAR had similar odds of stroke and death and are both a reasonable choice in this population; however, TCAR may be better in patients with an increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, although patients with a reduced eGFR have worse outcomes than their healthy peers, this analysis shows that the majority of patients survive long enough to benefit from the potential stroke risk reduction provided by all revascularization procedures.

Seven years of the transcarotid artery revascularization surveillance project, comparison to transfemoral stenting and endarterectomy.

OBJECTIVE: This study utilizes the latest data from the Vascular Quality Initiative (VQI), which now encompasses over 50,000 transcarotid artery revascularization (TCAR) procedures, to offer a sizeable dataset for comparing the effectiveness and safety of TCAR, transfemoral carotid artery stenting (tfCAS), and carotid endarterectomy (CEA). Given this substantial dataset, we are now able to compare outcomes overall and stratified by symptom status across revascularization techniques. METHODS: Utilizing VQI data from September 2016 to August 2023, we conducted a risk-adjusted analysis by applying inverse probability of treatment weighting to compare in-hospital outcomes between TCAR vs tfCAS, CEA vs tfCAS, and TCAR vs CEA. Our primary outcome measure was in-hospital stroke/death. Secondary outcomes included myocardial infarction and cranial nerve injury. RESULTS: A total of 50,068 patients underwent TCAR, 25,361 patients underwent tfCAS, and 122,737 patients underwent CEA. TCAR patients were older, more likely to have coronary artery disease, chronic kidney disease, and undergo coronary artery bypass grafting/percutaneous coronary intervention as well as prior contralateral CEA/CAS compared with both CEA and tfCAS. TfCAS had higher odds of stroke/death when compared with TCAR (2.9% vs 1.6%; adjusted odds ratio [aOR], 1.84; 95% confidence interval [CI], 1.65-2.06; P < .001) and CEA (2.9% vs 1.3%; aOR, 2.21; 95% CI, 2.01-2.43; P < .001). CEA had slightly lower odds of stroke/death compared with TCAR (1.3% vs 1.6%; aOR, 0.83; 95% CI, 0.76-0.91; P < .001). TfCAS had lower odds of cranial nerve injury compared with TCAR (0.0% vs 0.3%; aOR, 0.00; 95% CI, 0.00-0.00; P < .001) and CEA (0.0% vs 2.3%; aOR, 0.00; 95% CI, 0.0-0.0; P < .001) as well as lower odds of myocardial infarction compared with CEA (0.4% vs 0.6%; aOR, 0.67; 95% CI, 0.54-0.84; P < .001). CEA compared with TCAR had higher odds of myocardial infarction (0.6% vs 0.5%; aOR, 1.31; 95% CI, 1.13-1.54; P < .001) and cranial nerve injury (2.3% vs 0.3%; aOR, 9.42; 95% CI, 7.78-11.4; P < .001). CONCLUSIONS: Although tfCAS may be beneficial for select patients, the lower stroke/death rates associated with CEA and TCAR are preferred. When deciding between CEA and TCAR, it is important to weigh additional procedural factors and outcomes such as myocardial infarction and cranial nerve injury, particularly when stroke/death rates are similar. Additionally, evaluating subgroups that may benefit from one procedure over another is essential for informed decision-making and enhanced patient care in the treatment of carotid stenosis.

Learning curve of transfemoral carotid artery stenting in the Vascular Quality Initiative registry.

OBJECTIVE: With the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data. METHODS: We identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians. RESULTS: We analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. CONCLUSIONS: In-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications.

An Analysis of Trainee Status of the Primary Care Physician and Ambulatory Care Outcomes.

PURPOSE: Prior studies report disparities in outcomes for patients cared for by trainees versus faculty physicians at academic medical centers. This study examined the effect of having a trainee as the primary care physician versus a faculty member on routine population health outcomes after adjusting for differences in social determinants of health and primary care retention. METHOD: This cohort study assessed 38,404 patients receiving primary care at an academic hospital-affiliated practice by 60 faculty and 110 internal medicine trainees during academic year 2019. The effect of primary care practitioner trainee status on routine ambulatory care metrics was modeled using log-binomial regression with generalized estimating equation methods to account for physician-level clustering. Risk estimates before and after adjusting for social determinants of health and loss to follow-up are presented. RESULTS: Trainee and faculty cohorts had similar distributions of acute illness burden; however, patients in the trainee cohort were significantly more likely to identify as a race other than White (2,476 [52.6%] vs 14,785 [38.5%], P < .001), live in a zip code associated with poverty (1,688 [35.9%] vs 9,122 [23.8%], P < .001), use public health insurance (1,021 [21.7%] vs 6,108 [15.9%], P < .001), and have limited English proficiency (1,415 [30.1%] vs 5,203 [13.6%], P < .001). In adjusted analyses, trainee status of primary care physician was not associated with lack of breast cancer screening but was associated with missed opportunities to screen for colorectal cancer (relative risk [RR], 0.77; 95% confidence interval [CI], 0.68-0.88), control type 2 diabetes mellitus (RR, 0.78; 95% CI, 0.64-0.94), and control hypertension (RR, 0.80; 95% CI, 0.69-0.94). CONCLUSIONS: Primary care physician trainee status was associated with poorer quality of care in the ambulatory setting after adjusting for differences in socioeconomic factors and loss to follow-up, highlighting a potential ambulatory training gap.

Limited English proficiency and reported receipt of colorectal cancer screening among adults 45-75 in 2019 and 2021.

Introduction: Substantial barriers to screening exist for medically underserved populations, especially adults with limited English proficiency (LEP). We examined the proportion of US adults aged 45-75 up-to-date with colorectal cancer (CRC) screening by LEP after 2018. The American Cancer Society began recommending CRC screening for adults 45-49 in 2018. Methods: We analyzed cross-sectional data of adults 45-75 years old participating in the 2019 or 2021 National Health Interview Survey (N = 25,611). Adults were considered up-to-date with screening if they reported any stool test within 1 year, stool-DNA testing within 3 years, or colonoscopy within 10 years. Adults who interviewed in a language other than English were considered to have LEP. Adults not up-to-date with screening were asked if a healthcare professional (HCP) recommended screening, and if so which test(s). Regression models conducted in 2022-2023 evaluated receipt of screening, adjusting for sociodemographics, year, and healthcare access. Results: Overall, 54.0 % (95 % CI 53.1-54.9 %) of participants were up-to-date with screening (9.4 % aged 45-49 vs 75.5 % aged 65-75); prevalence increased from 2019 (52.9 %) to 2021(55.2 %). Adults with LEP (vs English proficiency) were less likely to be up-to-date with screening (31.6 % vs. 56.8 %, [aPR 0.86 (0.77-0.96)]). Among adults not up-to-date, 15.0 % reported their HCP recommended screening (8.4 % among adults with LEP). Conclusions: Nearly half of US adults were not up-to-date with CRC screening in 2019 and 2021 and few reported being recommended screening. Adults with LEP and those 45-49 were least likely to be screened suggesting targeted interventions are needed for these populations.

Efficacy of Botulinum A Injection to the Laryngeal Adductor Compartment for Treatment of Cough.

OBJECTIVES: Studies examining electromyography (EMG)-guided laryngeal onobotulinumtoxinA (BTxA) injection for chronic cough reveal promising efficacy, however, are limited by small cohorts and absent quantifiable outcomes. It further remains unclear if pulmonary disease limits efficacy, or if vagal motor neuropathy prognosticates response. We hypothesize BTxA injection results in qualitative improvement in cough, decrease in Cough Severity Index (CSI), no change in Voice Handicap Index-10 (VHI-10), and complication rates comparable to historical data. We also examine the correlation of pulmonary comorbidities and vocal fold hypomobility with treatment efficacy. STUDY DESIGN: Retrospective review. METHODS: Charts for patients receiving percutaneous adductor compartment BTxA injection for cough were reviewed for the binary outcome of patient-reported presence or absence of improvement. Generalized estimating equations regression models were used to analyze the change in CSI (ΔCSI) and the correlation of ΔCSI with qualitative outcomes. Multivariable analyses were used to examine correlation of vocal fold hypomobility and pulmonary disease with qualitative outcomes and ΔCSI. RESULTS: Forty-seven patients underwent 197 BTxA injections from June 2012 to June 2022. A statistical proportion of 0.698 (0.599-0.813, p < 0.0001) or 69.8% of injections resulted in subjective improvement. Mean ΔCSI was -2.12 (0.22-4.02, p < 0.05), indicating overall improvement. With and without subjective improvement, estimated ΔCSI was -4.43 and +2.68, respectively (p < 0.0001). VHI-10 did not change (0.69, p = 0.483). Neither pulmonary disease nor vocal fold hypomobility correlated with subjective improvement or ΔCSI. Dysphagia occurred following 15 (7.6%) injections with no aspiration pneumonia or hospitalization. CONCLUSIONS: BTxA injection to the laryngeal adductors may effectively treat cough with limited risk for serious complications. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1749-1756, 2024.

Impact of Physician Experience on Stroke or Death Rates in Transfemoral Carotid Artery Stenting: Insights from the Vascular Quality Initiative.

Objective: With the recent expansion of the Centers for Medicare and Medicaid Services (CMS) coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. This study evaluates the tfCAS learning curve using VQI data. Methods: We analyzed tfCAS patient data from 2005-2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. Primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/MI, 30-day mortality, and in-hospital stroke/TIA. The relationship between outcomes and procedure counts was analyzed using Cochran Armitage test and a generalized linear model with restricted cubic splines, validated using generalized estimating equations. Results: We analyzed 43,147 procedures by 2,476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2% to 1.7%), in-hospital stroke/death/MI (5.8% to 1.7%), 30-day mortality (4.6% to 2.8%), in-hospital stroke/TIA (5.0% to 1.1%) (all p-values<0.05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1% to 1.6%), in-hospital stroke/death/MI (2.6% to 1.6%), 30-day mortality (1.7% to 0.4%), and in-hospital stroke/TIA (2.8% to 1.6%) with increasing physician experience (all p-values<0.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. Conclusions: In-hospital stroke/death and 30-day mortality rates post-tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. With the recent CMS coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased post-operative complications.

Discordant Breast and Axillary Pathologic Response to Neoadjuvant Chemotherapy.

INTRODUCTION: Neoadjuvant chemotherapy (NAC) for breast cancer has the advantage of determining in vivo response to treatment, enabling more conservative surgery, and facilitating the understanding of tumor biology. Pathologic complete response (pCR) after NAC is a predictor of improved overall survival. However, some patients demonstrate a discordant response to NAC between the breast and axillary nodes. This study was designed to identify factors that correlate to achieving a breast pCR without an axillary node pCR following NAC and explore the potential clinical implications. METHODS: The National Cancer Database was used to identify patients diagnosed with clinical T1-4, N1-3 breast cancer between 2004 and 2017. Patients underwent NAC followed surgical resection of the breast cancer and axillary node surgery. Multivariable analyses were used to identify clinical and pathologic factors associated with discordant pathologic response. RESULTS: In total, 13,934 patients met the inclusion criteria. Of these, 4292 (30.8%) patients demonstrated a breast pCR without a corresponding axillary pCR on final pathology. After adjusting for covariates, factors associated with higher discordance between axillary response in our cohort of breast pCR patients included older age (≥ 54), treatment at a community facility, T1 tumors, HR-positive, HER2 negative, low-grade tumors, and cN2/3 disease. CONCLUSIONS: Discordance between breast and axillary pCR is not infrequent and may be related to a number of patient-related factors and tumor characteristics impacting nodal response to NAC. Further investigation into differing responses to NAC is warranted to better understand the mechanism of this phenomenon and to determine how these findings may influence treatment.

Prevalence and Predictors of Inappropriate Antithrombotic Prescription in Patients Presenting With Traumatic Brain Injury.

BACKGROUND AND OBJECTIVES: A growing proportion of the US population is on antithrombotic therapy (AT), most significantly within the older subpopulation. Decision to use AT is a balance between the intended benefits and known bleeding risk, especially after traumatic brain injury (TBI). Preinjury inappropriate AT offers no benefit for the patient and also increases the risk of intracranial hemorrhage and worse outcome in the setting of TBI. Our objective was to examine the prevalence and predictors of inappropriate AT among patients presenting with TBI to a Level-1 Trauma Center. METHODS: A retrospective chart review was performed on all patients with TBI and preinjury AT who presented to our institution between January 2016 and September 2020. Demographic and clinical data were collected. Appropriateness of AT was determined through established clinical guidelines. Clinical predictors were determined by logistic regression. RESULTS: Of 141 included patients, 41.8% were female (n = 59) and the average age (mean ± SD) was 80.6 ± 9.9. The prescribed antithrombotic agents included aspirin (25.5%, n = 36), clopidogrel (22.7%, n = 32), warfarin (46.8%, n = 66), dabigatran (2.1%, n = 3), rivaroxaban (Janssen) (10.6%, n = 15), and apixaban (Bristol-Myers Squibb Co.) (18.4%, n = 26). The indications for AT were atrial fibrillation (66.7%, n = 94), venous thromboembolism (13.4%, n = 19), cardiac stent (8.5%, n = 12), and myocardial infarction/residual coronary disease (11.3%, n = 16). Inappropriate antithrombotic therapy use varied significantly by antithrombotic indication ( P < .001) with the highest rates seen with venous thromboembolism. Predictive factors also include age ( P = .005) with higher rates younger than 65 years and older than 85 years and female sex ( P = .049). Race and antithrombotic agent were not significant predictors. CONCLUSION: Overall, 1 in 10 patients presenting with TBI were found to be on inappropriate AT. Our study is the first to describe this problem and warrants investigation into possible workflow interventions to prevent post-TBI continuation of inappropriate AT.

Rationale and Design of the Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension (GoFresh) Trial.

BACKGROUND: Poor diet quality significantly contributes to hypertension disparities affecting Black adults. While the Dietary Approaches to Stop Hypertension (DASH) eating pattern lowers blood pressure (BP), access to DASH-patterned groceries is a major barrier for residents of urban food deserts. METHODS: The Groceries for Black Residents of Boston to Stop Hypertension among Adults without Treated Hypertension (GoFresh) study is one of five projects in the RESTORE Network, an AHA-funded initiative focused on hypertension prevention. GoFresh is testing whether online, dietitian-assisted, home-delivered, DASH-patterned groceries lowers BP among Black adults with elevated BP. This individual-level, parallel-arm trial will enroll up to 176 Black adults with SBP (systolic blood pressure) between 120 and <150 mm Hg residing in Boston-area communities with reduced grocery store access. Following randomization, half of the participants will be assigned to weekly sessions with a dietitian who will assist participants in ordering DASH-patterned groceries online for home delivery; the remainder will receive a $500 monthly stipend. Both interventions will last 3 months, followed by a 9-month maintenance phase. RESULTS: The primary outcome is the difference in SBP after 3 months. Secondary outcomes include a change in 24-hour ambulatory BP, body mass index, 24-hour urine sodium and potassium, hemoglobin A1C, lipids, fruit and vegetable intake, and saturated fat intake. Qualitative interviews with 45 participants 6 months after baseline assessments will determine barriers and facilitators to long-term maintenance of DASH-patterned grocery shopping. DISCUSSION: Findings from this study will inform ongoing work on scalable interventions to prevent hypertension among Black adults with implications for public and healthcare-based food supplementation programs. TRIAL REGISTRATION: NCT05121337. Registered on 16 November 2021, at ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05121337.

Older adults' perspectives on primary care telemedicine during the COVID-19 pandemic.

BACKGROUND: Prior to the COVID-19 pandemic there were many barriers to telemedicine primary care for adults ≥65 years including insurance coverage restrictions and having lower digital access and literacy. With the pandemic, insurance coverage broadened and many older adults utilized telemedicine creating an opportunity to learn from their experiences to inform future policy. METHODS: Between April 2020 and June 2021, we conducted a cross-sectional multimethod study of English-speaking, cognitively-intact, adults ≥65, who had a phone-only and/or video telemedicine visit with their primary care physician within one large Massachusetts health system (10 different practices) since March 2020. The study questionnaire asked participants their overall satisfaction with telemedicine (7-point scale) and to compare telemedicine with in-person care. We used linear regression to examine the association between participants' demographics, Charlson comorbidity score, and survey completion date with their satisfaction score. The questionnaire also included open-ended questions on perceptions of telemedicine; which were analyzed using qualitative methods. RESULTS: Of 278 eligible patients reached, 208 completed the questionnaire; mean age was 74.4 years (±4.4), 61.5% were female, 91.4% were non-Hispanic White, 64.4% had ≥1 comorbidity, and 47.2% had a phone-only visit. Regardless of their age, participants reported being satisfied with telemedicine; median score was 6.0 on the 7-point scale (25th percentile = 5.0 and 75th percentile = 7.0). Non-Whites satisfaction scores were on average 1 point lower than those of non-Hispanic Whites (p = 0.02). Those with comorbidity reported scores that on average were 0.5 points lower than those without comorbidity (p = 0.07). Overall, 39.5% felt their telemedicine visit was worse than in-person care; 4.9% thought it was better. Participants appreciated telemedicine's convenience but described frustrating technical challenges. While participants preferred in-person care, most wanted telemedicine to remain available. CONCLUSIONS: Adults ≥65 reported being satisfied with primary care telemedicine during the pandemic's first 14 months and wanted telemedicine to remain available.

Evaluation of Load-To-Strength Ratios in Metastatic Vertebrae and Comparison With Age- and Sex-Matched Healthy Individuals.

Vertebrae containing osteolytic and osteosclerotic bone metastases undergo pathologic vertebral fracture (PVF) when the lesioned vertebrae fail to carry daily loads. We hypothesize that task-specific spinal loading patterns amplify the risk of PVF, with a higher degree of risk in osteolytic than in osteosclerotic vertebrae. To test this hypothesis, we obtained clinical CT images of 11 cadaveric spines with bone metastases, estimated the individual vertebral strength from the CT data, and created spine-specific musculoskeletal models from the CT data. We established a musculoskeletal model for each spine to compute vertebral loading for natural standing, natural standing + weights, forward flexion + weights, and lateral bending + weights and derived the individual vertebral load-to-strength ratio (LSR). For each activity, we compared the metastatic spines' predicted LSRs with the normative LSRs generated from a population-based sample of 250 men and women of comparable ages. Bone metastases classification significantly affected the CT-estimated vertebral strength (Kruskal-Wallis, p < 0.0001). Post-test analysis showed that the estimated vertebral strength of osteosclerotic and mixed metastases vertebrae was significantly higher than that of osteolytic vertebrae (p = 0.0016 and p = 0.0003) or vertebrae without radiographic evidence of bone metastasis (p = 0.0010 and p = 0.0003). Compared with the median (50%) LSRs of the normative dataset, osteolytic vertebrae had higher median (50%) LSRs under natural standing (p = 0.0375), natural standing + weights (p = 0.0118), and lateral bending + weights (p = 0.0111). Surprisingly, vertebrae showing minimal radiographic evidence of bone metastasis presented significantly higher median (50%) LSRs under natural standing (p < 0.0001) and lateral bending + weights (p = 0.0009) than the normative dataset. Osteosclerotic vertebrae had lower median (50%) LSRs under natural standing (p < 0.0001), natural standing + weights (p = 0.0005), forward flexion + weights (p < 0.0001), and lateral bending + weights (p = 0.0002), a trend shared by vertebrae with mixed lesions. This study is the first to apply musculoskeletal modeling to estimate individual vertebral loading in pathologic spines and highlights the role of task-specific loading in augmenting PVF risk associated with specific bone metastatic types. Our finding of high LSRs in vertebrae without radiologically observed bone metastasis highlights that patients with metastatic spine disease could be at an increased risk of vertebral fractures even at levels where lesions have not been identified radiologically.

Moral Distress and Moral Injury Among Attending Neurosurgeons: A National Survey.

BACKGROUND: "Moral distress" describes the psychological strain a provider faces when unable to uphold professional values because of external constraints. Recurrent or intense moral distress risks moral injury, burnout, and physician attrition but has not been systematically studied among neurosurgeons. OBJECTIVE: To develop a unique instrument to test moral distress among neurosurgeons, evaluate the frequency and intensity of scenarios that may elicit moral distress and injury, and determine their impact on neurosurgical burnout and turnover. METHODS: An online survey investigating moral distress, burnout, and practice patterns was emailed to attending neurosurgeon members of the Congress of Neurological Surgeons. Moral distress was evaluated through a novel survey designed for neurosurgical practice. RESULTS: A total of 173 neurosurgeons completed the survey. Half of neurosurgeons (47.7%) reported significant moral distress within the past year. The most common cause was managing critical patients lacking a clear treatment plan; the most intense distress was pressure from patient families to perform futile surgery. Multivariable analysis identified burnout and performing ≥2 futile surgeries per year as predictors of distress (P < .001). Moral distress led 9.8% of neurosurgeons to leave a position and 26.6% to contemplate leaving. The novel moral distress survey demonstrated excellent internal consistency (Cronbach alpha = 0.89). CONCLUSION: We developed a reliable survey assessing neurosurgical moral distress. Nearly, half of neurosurgeons suffered moral distress within the past year, most intensely from external pressure to perform futile surgery. Moral distress correlated with burnout risk caused 10% of neurosurgeons to leave a position and a quarter to consider leaving.

Primary Care Providers' Perceptions of the Acceptability, Appropriateness, and Feasibility of a Mammography Decision Aid for Women Aged 75 and Older.

Background. Clinicians need to find decision aids (DAs) useful for their successful implementation. Therefore, we aimed to conduct an exploratory study to learn primary care clinicians' (PCPs) perspectives on a mammography DA for women ≥75 to inform its implementation. Methods. We sent a cross-sectional survey to 135 PCPs whose patients had participated in a randomized trial of the DA. These PCPs practiced at 1 of 11 practices in Massachusetts or North Carolina. PCPs were asked closed-ended and open-ended questions on shared decision making (SDM) around mammography with women ≥75 and on the DA's acceptability, appropriateness, and feasibility. Results. Eighty PCPs participated (24 [30%] from North Carolina). Most (n = 69, 86%) thought that SDM about mammography with women ≥75 was extremely/very important and that they engaged women ≥75 in SDM around mammography frequently/always (n = 49, 61%). Regarding DA acceptability, 60% felt the DA was too long. Regarding appropriateness, 70 (89%) thought it was somewhat/very helpful and that it would help patients make more informed decisions; 55 (70%) would recommend it. Few (n = 6, 8%) felt they had other resources to support this decision. Regarding feasibility, 53 (n = 67%) thought it would be most feasible for patients to receive the DA before a visit from medical assistants rather than during or after a visit or from health educators. Most (n = 62, 78%) wanted some training to use the DA. Limitations. Sixty-nine percent of PCPs in this small study practiced in academic settings. Conclusions. Although PCPs were concerned about the DA's length, most found it helpful and informative and felt it would be feasible for medical assistants to deliver the DA before a visit. Implications. Study findings may inform implementation of this and other DAs.

Variation in Breast Cancer Risk Model Estimates Among Women in Their 40s Seen in Primary Care.

Background: The Gail, Breast Cancer Surveillance Consortium (BCSC), and Tyrer-Cuzick breast cancer risk prediction models are recommended for use in primary care. Calculating breast cancer risk is particularly important for women in their 40s when deciding on mammography, with some guidelines recommending screening for those with 5-year risk similar to women age 50 (≥1.1%). Yet, little is known about risk estimate agreement among models for these women. Materials and Methods: Four hundred nine Boston-area women 40-49 years of age completed a risk questionnaire before a primary care visit to compute their breast cancer risk. The kappa statistic was used to examine when (1) Gail and BCSC agreed on 5-year risk ≥1.1%; (2) Gail estimated 5-year risk ≥1.7% and Tyrer-Cuzick estimated 10-year risk ≥5% (guideline thresholds for recommending prevention medications); and when (3) Gail and Tyrer-Cuzick agreed on lifetime risk ≥20% (threshold for breast MRI using Tyrer-Cuzick). Results: Participant mean age was 44.1 years, 56.7% were non-Hispanic white, and 7.8% had a first-degree relative with breast cancer. Of 266 with breast density information to estimate both Gail and BCSC, the models agreed on 5-year risk being ≥1.1% for 36 women, kappa = 0.34 (95% confidence interval: 0.23-0.45). Gail and Tyrer-Cuzick estimates led to agreement about prevention medications for 8 women, kappa 0.41 (0.20-0.61), and models agreed on lifetime risk ≥20% for 3 women, kappa 0.08 (-0.01 to 0.16). Conclusions: There is weak agreement on breast cancer risk estimates generated by risk models recommended for primary care. Using different models may lead to different clinical recommendations for women in their 40s.

Organoid Sensitivity Correlates with Therapeutic Response in Patients with Pancreatic Cancer.

PURPOSE: Pancreatic ductal adenocarcinoma (PDAC) remains a significant health issue. For most patients, there are no options for targeted therapy, and existing treatments are limited by toxicity. The HOPE trial (Harnessing Organoids for PErsonalized Therapy) was a pilot feasibility trial aiming to prospectively generate patient-derived organoids (PDO) from patients with PDAC and test their drug sensitivity and correlation with clinical outcomes. EXPERIMENTAL DESIGN: PDOs were established from a heterogeneous population of patients with PDAC including both basal and classical PDAC subtypes. RESULTS: A method for classifying PDOs as sensitive or resistant to chemotherapy regimens was developed to predict the clinical outcome of patients. Drug sensitivity testing on PDOs correlated with clinical responses to treatment in individual patients. CONCLUSIONS: These data support the investigation of PDOs to guide treatment in prospective interventional trials in PDAC.