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Temporal trends demonstrate improved survival for many types of common pediatric cancer. Studies have not examined improvement in very rare pediatric cancers or compared these improvements to more common cancers. In this cohort study of the Surveillance, Epidemiology, and End Results (SEER) registry, we examined patients from 1975 to 2016 who were 0-19 years of age at the time of diagnosis. Cancers were grouped by decade of diagnosis and 3 cancer frequency groups: Common, Intermediate, and Rare. Trends in mortality across decades and by cancer frequency were compared using Kaplan-Meier curves and adjusted Cox proportional hazards models. A total of 50,222 patients were available for analysis, with the top 10 cancers grouped as Common (67%), 13 cancers grouped with Intermediate (24%), and 37 cancers as Rare (9%). Rare cancers had higher rates of children who were older and Black. 5-year survival increased from 63% to 86% across all cancers from the 1970s to the 2010s. The hazard ratio (HR) for mortality decreased from the reference point of 1 in the 1970s to 0.27 (95% CI: 0.25-0.30) in the 2010s in Common cancers, while the HR only dropped to 0.60 (0.49-0.73) over that same period for rare cancers. Pediatric oncology patients have experienced dramatic improvement in mortality since the 1970s, with mortality falling by nearly 75% in common cancers. Unfortunately, rare pediatric cancers continue to lag behind more common and therefore better studied cancers, highlighting the need for a renewed focus on research efforts for children with these rare diseases.

Background/purpose: Studies have demonstrated existing racial and ethnic disparities in multiple aspects of pediatric oncology. The purpose of this study was to examine how racial and ethnic disparities in mortality among pediatric oncology patients have changed over time. We examined mortality by race and ethnicity over time within the Surveillance, Epidemiology, and End Results (SEER) registry., Methods: Patients <20 years-old from 1975 to 2016 (n = 49,861) were selected for the analysis. Demographic characteristics, cancer diagnosis, and mortality data were extracted. Patients were divided by race and ethnicity: 1) non-Latino White, 2) Black, 3) Latino, and 4) Other Race. The interaction between race/ethnicity and decade was evaluated to better understand how disparities in mortality have changed over time., Results: Unadjusted mortality among all cancers improved significantly, with 5-year mortality decreasing from the 1970s to the 2010s (log-rank: p < 0.001) for all race/ethnicity groups. However, improvements in mortality were not equal, with 5-year overall survival (OS) improving from 62.7 % in the 1970s to 87.5 % (Δ = 24.8 %) in the 2010s for White patients but only improving from 59.9 % to 80.8 % (Δ = 20.9 %) for Black patients (p < 0.01). The interaction between Race/Ethnicity and decade demonstrated that the Hazard Ratio (HR) for mortality worsened for Black [HR (95 % Confidence Interval): 1.10 (1.05-1.15) and Latino [1.11 (1.07-1.17)] patients compared to White, non-Latino patients., Conclusion: There has been a dramatic improvement in survival across pediatric oncology patients since 1975. However, the improvement has not been shared equally across racial/ethnic categories, with overall survival worsening over time for racial/ethnic minorities compared to White patients., Level of Evidence: III., Competing Interests: Conflict of interset The authors have no competing interests to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Venous thromboembolism (VTE) is a preventable cause of hospitalization-related morbidity and mortality. VTE prevention requires accurate risk stratification. Federal agencies mandated VTE risk assessment for all hospital admissions. We have shown that the widely used Caprini (30 risk factors) and Padua (11 risk factors) VTE risk-assessment models (RAMs) have limited predictive ability for VTE when used for all general hospital admissions. Here, we test whether combining the risk factors from all 23 available VTE RAMs improves VTE risk prediction., Methods: We analyzed data from the first hospitalizations of 1,282,014 surgical and non-surgical patients admitted to 1298 Veterans Affairs facilities nationwide between January 2016 and December 2021. We used logistic regression to predict VTE within 90 days of admission using risk factors from all 23 available VTE RAMs. Area under the receiver operating characteristic curves (AUC), sensitivity, specificity, and positive (PPV) and negative predictive values (NPV) were used to quantify the predictive power of our models. The metrics were computed at two diagnostic thresholds that maximized (1) the value of sensitivity + specificity-1; and (2) PPV and were compared using McNemar's test. The Delong-Delong test was used to compare AUCs., Results: After excluding those with missing data, 1,185,633 patients (mean age, 66 years; 93% male; and 72% White) were analyzed, of whom 33,253 (2.8%) had a VTE (deep venous thrombosis [DVT], n = 19,218, 1.6%; pulmonary embolism [PE], n = 10,190, 0.9%; PE + DVT, n = 3845, 0.3%). Our composite RAM included 102 risk factors and improved prediction of VTE compared with the Caprini RAM risk factors (AUC composite model: 0.74; AUC Caprini risk-factor model: 0.63; P < .0001). When the sum of sensitivity and specificity-1 was maximized, the composite model demonstrated small improvements in sensitivity, specificity and PPV; NPV was high in both models. When PPV was maximized, the PPV of the composite model was improved but remained low. The nature of the relationship between NPV and PPV precluded any further gain in PPV by sacrificing NPV and sensitivity., Conclusions: Using a composite of 102 risk factors from all available VTE RAMs, we improved VTE prediction in a large, national cohort of >1 million general hospital admissions. However, neither model has a sensitivity or PPV that permits it to be a reliable predictor of VTE. We demonstrate the limits of currently available VTE risk prediction tools; no available RAM is ready for widespread use in the general hospital population., Competing Interests: Disclosures None., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: The use of local or regional anesthesia (LRA) is encouraged during transcarotid artery revascularization (TCAR) because the procedure is performed through a small incision. LRA permits neurologic evaluation during the procedure and may reduce periprocedural cardiac morbidity compared with general anesthesia (GA). There is limited and conflicting information regarding the preferred anesthesia to use during TCAR. We compared periprocedural clinical and technical complications, and intraprocedural performance metrics of TCAR performed under GA vs LRA., Methods: Patient, lesion, physician, and procedural information was collected in a worldwide quality assurance program of consecutive TCAR procedures. A composite clinical adverse event rate (death, stroke, transient ischemic attack, myocardial infarction) and a composite technical adverse event rate (aborted procedure, conversion to carotid endarterectomy, bleeding, dissection, cranial-nerve injury, device failure) in the periprocedural period were computed. Four intraprocedural performance measures (flow-reversal time, fluoroscopy time, contrast volume, and skin-to-skin time) were recorded. Deidentified data were analyzed independently at the Center for Vascular Research, University of Maryland. Poisson regressions were used to assess the impact of anesthesia type on adverse event rates. Linear regressions were used to compare performance measures., Results: A total of 27,043 TCARs were performed by 1456 physicians between 2012 and 2021. A majority of patients (83%) received GA, and this proportion increased over time (R 2  = 0.74; P < .0001). Some physicians (33.4%) used LRA in some of their procedures; only 2.7% used LRA in all of their procedures. Clinical risk factors were more common in the LRA group (P < .0001) and anatomic risk factors in the GA group (P < .0001); these differences were adjusted for in subsequent analyses. LRA was more likely to be used by vascular surgeons and by physicians with higher prior transfemoral carotid stenting experience (P < .0001). When comparing GA vs LRA, clinical adverse events (1.49%; 95% confidence interval [CI], 1.3-1.8 vs 1.55%; 95% CI, 1.2-2.0; P = .78), technical adverse events (5.6%; 95% CI, 5.2-6.2 vs 5.3%; 95% CI, 4.5-6.3; P = .47), and intraprocedural performance measures did not differ by type of anesthesia., Conclusions: Almost two-thirds of physicians performed TCAR exclusively under GA, and the overall proportion of procedures performed under GA increased over time. A larger fraction of patients with severe medical risk factors received LRA vs GA, whereas a larger fraction of patients with anatomic risk-factors received GA. Periprocedural clinical and technical adverse events did not differ by type of anesthesia. Intraprocedural performance metrics that drive procedural cost were similar between groups; potential differences in procedural cost driven by anesthetic choice require further study., Competing Interests: Disclosures R.C. reports stockholder of Silk Road Medical Inc. S.M reports executive Medical Director of Silk Road Medical Inc., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Venous thromboembolism (VTE) is a preventable complication of hospitalization. Risk-stratification is the cornerstone of prevention. The Caprini and Padua are two of the most commonly used risk-assessment models (RAMs) to quantify VTE risk. Both models perform well in select, high-risk cohorts. Although VTE RAMs were designed for use in all hospital admissions, they are mostly tested in select, high-risk cohorts. We aim to evaluate the two RAMs in a large, unselected cohort of patients., Methods: We analyzed consecutive first hospital admissions of 1,252,460 unique surgical and non-surgical patients to 1298 Veterans Affairs facilities nationwide between January 2016 and December 2021. Caprini and Padua scores were generated using the Veterans Affairs' national data repository. We determined the ability of the two RAMs to predict VTE within 90 days of admission. In secondary analyses, we evaluated prediction at 30 and 60 days, in surgical vs non-surgical patients, after excluding patients with upper extremity deep vein thrombosis, in patients hospitalized ≥72 hours, after including all-cause mortality in a composite outcome, and after accounting for prophylaxis in the predictive model. We used area under the receiver operating characteristic curves (AUCs) as the metric of prediction., Results: A total of 330,388 (26.4%) surgical and 922,072 (73.6%) non-surgical consecutively hospitalized patients (total N = 1,252,460) were analyzed. Caprini scores ranged from 0 to 28 (median, 4; interquartile range [IQR], 3-6); Padua scores ranged from 0-13 (median, 1; IQR, 1-3). The RAMs showed good calibration and higher scores were associated with higher VTE rates. VTE developed in 35,557 patients (2.8%) within 90 days of admission. The ability of both models to predict 90-day VTE was low (AUCs: Caprini, 0.56; 95% confidence interval [CI], 0.56-0.56; Padua, 0.59; 95% CI, 0.58-0.59). Prediction remained low for surgical (Caprini, 0.54; 95% CI, 0.53-0.54; Padua, 0.56; 95% CI, 0.56-0.57) and non-surgical patients (Caprini, 0.59; 95% CI, 0.58-0.59; Padua, 0.59; 95% CI, 0.59-0.60). There was no clinically meaningful change in predictive performance in any of the sensitivity analyses., Conclusions: Caprini and Padua RAM scores have low ability to predict VTE events in a cohort of unselected consecutive hospitalizations. Improved VTE RAMs must be developed before they can be applied to a general hospital population., Competing Interests: Disclosures C.D.M. has served as a consultant to Bayer, Incyte, Merck, Pfizer, and Takeda., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Residual pulmonary vascular occlusion (RPVO) affects one half of patients after a pulmonary embolism (PE). The relationship between the risk factors and therapeutic interventions for the development of RPVO and chronic thromboembolic pulmonary hypertension is unknown., Methods: This retrospective review included PE patients within a 26-month period who had baseline and follow-up imaging studies (ie, computed tomography [CT], ventilation/perfusion scans, transthoracic echocardiography) available. We collected the incidence of RPVO, percentage of pulmonary artery occlusion (%PAO), baseline CT %PAO, most recent CT %PAO, and difference between the baseline and most recent %PAO on CT (Δ%PAO)., Results: A total of 354 patients had imaging reports available; 197 with CT and 315 with transthoracic echocardiography. The median follow-up time was 144 days (interquartile range [IQR], 102-186 days). RPVO was present in 38.9% of the 354 patients. The median Δ%PAO was -10.0% (IQR, -32% to -1.2%). Fewer patients with a provoked PE developed RPVO (P ≤ .01), and the initial troponin level was lower in patients who developed RPVO (P = .03). The initial thrombus was larger in the patients who received advanced intervention vs anticoagulation (baseline CT %PAO: median, 61.2%; [IQR, 27.5%-75.0%] vs median, 12.5% [IQR, 2.5%-40.0%]; P ≤ .0001). Catheter-directed thrombolysis (CDT; median Δ%PAO, -47.5%; IQR, -63.7% to -8.7%) and surgical pulmonary embolectomy (SPE; median Δ%PAO, -42.5; IQR, -68.1% to -18.7%) had the largest thrombus reduction compared with anticoagulation (P = .01). Of the 354 patients, 76 developed pulmonary hypertension; however, only 14 received pulmonary hypertension medications and 12 underwent pulmonary thromboendarterectomy. Cancer (odds ratio [OR], 1.7) and planned prolonged anticoagulation (>1 year; OR, 2.20) increased the risk of RPVO. In contrast, the risk was lower for men (OR, 0.61), patients with recent surgery (OR, 0.33), and patients treated with SPE (OR, 0.42). A larger Δ%PAO was found in men (coefficient, -8.94), patients with a lower body mass index (coefficient, -0.66), patients treated with CDT (coefficient, -18.12), and patients treated with SPE (coefficient, -21.69). A lower Δ%PAO was found in African-American patients (coefficient, 7.31)., Conclusions: The use of CDT and SPE showed long-term benefit in thrombus reduction., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Large decreases in cancer diagnoses were seen early in the COVID-19 pandemic. However, the evolution of these deficits since the end of 2020 and the advent of widespread vaccination is unknown., Methods: This study examined data from the Veterans Health Administration (VA) from 1 January 2018 through 28 February 2022 and identified patients with screening or diagnostic procedures or new cancer diagnoses for the four most common cancers in the VA health system: prostate, lung, colorectal, and bladder cancers. Monthly procedures and new diagnoses were calculated, and the pre-COVID era (January 2018 to February 2020) was compared with the COVID era (March 2020 to February 2022)., Results: The study identified 2.5 million patients who underwent a diagnostic or screening procedure related to the four cancers. A new cancer was diagnosed for 317,833 patients. During the first 2 years of the pandemic, VA medical centers performed 13,022 fewer prostate biopsies, 32,348 fewer cystoscopies, and 200,710 fewer colonoscopies than in 2018-2019. These persistent deficits added a cumulative deficit of nearly 19,000 undiagnosed prostate cancers and 3300 to 3700 undiagnosed cancers each for lung, colon, and bladder. Decreased diagnostic and screening procedures correlated with decreased new diagnoses of cancer, particularly cancer of the prostate (R = 0.44) and bladder (R = 0.27)., Conclusion: Disruptions in new diagnoses of four common cancers (prostate, lung, bladder, and colorectal) seen early in the COVID-19 pandemic have persisted for 2 years. Although reductions improved from the early pandemic, new reductions during the Delta and Omicron waves demonstrate the continued impact of the COVID-19 pandemic on cancer care., (© 2023. Society of Surgical Oncology.)

Background: Venous thromboembolism (pulmonary embolism and deep vein thrombosis) is an important preventable cause of in-hospital death. Prophylaxis with low doses of anticoagulants reduces the incidence of venous thromboembolism but can also cause bleeding. It is, therefore, important to stratify the risk of bleeding for hospitalized patients when considering pharmacologic prophylaxis. The IMPROVE (international medical prevention registry on venous thromboembolism) and Consensus risk assessment models (RAMs) are the two tools available for such patients. Few studies have evaluated their ability to predict bleeding in a large, unselected cohort of patients. We assessed the ability of the IMPROVE and Consensus bleeding RAMs to predict bleeding within 90 days of hospitalization in a comprehensive analysis encompassing all hospitalized patients, regardless of surgical vs nonsurgical status., Methods: We analyzed consecutive first hospital admissions of 1,228,448 unique surgical and nonsurgical patients to 1298 Veterans Affairs facilities nationwide between January 2016 and December 2021. IMPROVE and Consensus scores were generated using data from a repository of their common electronic medical records. We assessed the ability of the two RAMs to predict bleeding within 90 days of admission. We used area under the receiver operating characteristic curves to determine the prediction of bleeding by each RAM., Results: Of 1,228,448 hospitalized patients, 324,959 (26.5%) were surgical and 903,489 (73.5%) were nonsurgical. Of these patients, 68,372 (5.6%) had a bleeding event within 90 days of admission. The Consensus RAM scores ranged from -5.60 to -1.21 (median, -4.93; interquartile range, -5.60 to -4.93). The IMPROVE RAM scores ranged from 0 to 22 (median, 3.5; interquartile range, 2.5-5). Both showed good calibration, with higher scores associated with higher bleeding rates. The ability of both RAMs to predict 90-day bleeding was low (area under the receiver operating characteristic curve 0.61 for the IMPROVE RAM and 0.59 for the Consensus RAM). The predictive ability was also low at 30 and 60 days for surgical and nonsurgical patients, patients receiving prophylactic, therapeutic, or no anticoagulation, and patients hospitalized for ≥72 hours. Prediction was also low across different bleeding outcomes (ie, any bleeding, gastrointestinal bleeding, nongastrointestinal bleeding, and bleeding or death)., Conclusions: In this large, unselected, nationwide cohort of surgical and nonsurgical hospital admissions, increasing IMPROVE and Consensus bleeding RAM scores were associated with increasing bleeding rates. However, both RAMs had low ability to predict bleeding at 0 to 90 days after admission. Thus, the currently available RAMs require modification and rigorous reevaluation before they can be applied universally., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Determine mid-term postoperative outcomes among coronavirus disease 2019 (COVID-19)-positive (+) patients compared with those who never tested positive before surgery., Background: COVID-19 is thought to be associated with prohibitively high rates of postoperative complications. However, prior studies have only evaluated 30-day outcomes, and most did not adjust for demographic, clinical, or procedural characteristics., Methods: We analyzed data from surgeries performed at all Veterans Affairs hospitals between March 2020 and 2021. Kaplan-Meier curves compared trends in mortality and Cox proportional hazards models estimated rates of mortality and pulmonary, thrombotic, and septic postoperative complications between patients with a positive preoperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test [COVID (+)] and propensity score-matched COVID-negative (-) patients., Results: Of 153,741 surgical patients, 4778 COVID (+) were matched to 14,101 COVID (-). COVID (+) status was associated with higher postoperative mortality ( P <0.0001) with a 6-month survival of 94.2% (95% confidence interval: 93.2-95.2) versus 96.0% (95% confidence interval: 95.7.0-96.4) in COVID (-). The highest mortality was in the first 30 postoperative days. Hazards for mortality and postoperative complications in COVID (+) decreased with increasing time between testing COVID (+) and date of surgery. COVID (+) patients undergoing elective surgery had similar rates of mortality, thrombotic and septic complications, but higher rates of pulmonary complications than COVID (-) patients., Conclusions: This is the first report of mid-term outcomes among COVID-19 patients undergoing surgery. COVID-19 is associated with decreased overall and complication-free survival primarily in the early postoperative period, delaying surgery by 5 weeks or more reduces risk of complications. Case urgency has a multiplicative effect on short-term and long-term risk of postoperative mortality and complications., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Heart failure increases the risk of death in acute pulmonary embolism (PE). The role of the left ventricle (LV) in acute PE is not well defined., Objective: To identify the prevalence of LV systolic dysfunction, morphology, and prognosis of the LV during an acute PE., Methods: Retrospective study (26-months) of patients diagnosed with an acute PE presenting with LV systolic dysfunction at the University of Maryland., Results: Among 769 acute PE patients, 78 (10.5 %) had LV systolic dysfunction and 42 (53.8 %) had history of cardiac disease. Patients without history of cardiac disease were younger (mean age [SD] 54.9 [16.8] vs. 62.6 [16.6]; p = 0.04), had a higher BMI (31.2 [12.2] vs. 29.2 [7.7]; p = 0.005), and less hypertension (20 [34.5 %] vs. 38 [65.5 %]; p = 0.0005). A massive PE was most common in patients without history of cardiac disease (8[22.2 %] vs. 2[4.7 %], p = 0.02). There was no difference in clot burden, but right ventricular strain was more frequently seen in patients without history cardiac disease in the initial CT (p = 0.001). The median troponin and lactate were similar in both groups. In 41 patients with follow-up echocardiograms, improvement in LVEF% was observed in patients without cardiac history (median Δ LVEF% [IQR]; 20 [6.2-25.0]). While patients with cardiac disease did not demonstrate similar changes (median Δ LVEF% [IQR]; 0 [-5-17.5]; p = 0.01). In hospital mortality was 12.8 % with no difference between both groups (p = 0.17)., Conclusion: Pulmonary embolism can be associated with LV systolic dysfunction, even in patients without history of cardiac disease., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objective: Hospital-acquired venous thromboembolism (VTE, including pulmonary embolism [PE] and deep vein thrombosis [DVT]) is a preventable cause of hospital death. The Caprini risk assessment model (RAM) is one of the most commonly used tools to assess VTE risk. The RAM is operationalized in clinical practice by grouping several risk scores into VTE risk categories that drive decisions on prophylaxis. A correlation between increasing Caprini scores and rising VTE risk is well-established. We assessed whether the increasing VTE risk categories assigned on the basis of recommended score ranges also correlate with increasing VTE risk., Methods: We conducted a systematic review of articles that used the Caprini RAM to assign VTE risk categories and that reported corresponding VTE rates. A Medline and EMBASE search retrieved 895 articles, of which 57 fulfilled inclusion criteria., Results: Forty-eight (84%) of the articles were cohort studies, 7 (12%) were case-control studies, and 2 (4%) were cross-sectional studies. The populations varied from postsurgical to medical patients. There was variability in the number of VTE risk categories assigned by individual studies (6 used 5 risk categories, 37 used 4, 11 used 3, and 3 used 2), and in the cutoff scores defining the risk categories (scores from 0 alone to 0-10 for the low-risk category; from ≥5 to ≥10 for high risk). The VTE rates reported for similar risk categories also varied across studies (0%-12.3% in the low-risk category; 0%-40% for high risk). The Caprini RAM is designed to assess composite VTE risk; however, two studies reported PE or DVT rates alone, and many of the other studies did not specify the types of DVTs analyzed. The Caprini RAM predicts VTE at 30 days after assessment; however, only 17 studies measured outcomes at 30 days; the remaining studies had either shorter or longer follow-ups (0-180 days)., Conclusions: The usefulness of the Caprini RAM is limited by heterogeneity in its implementation across centers. The score-derived VTE risk categorization has significant variability in the number of risk categories being used, the cutpoints used to define the risk categories, the outcome being measured, and the follow-up duration. This factor leads to similar risk categories being associated with different VTE rates, which impacts the clinical and research implications of the results. To enhance generalizability, there is a need for studies that validate the RAM in a broad population of medical and surgical patients, identify standardized risk categories, define risk of DVT and PE as distinct end points, and measure outcomes at standardized follow-up time points., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Despite socioeconomic disparities, no association between clinical presentation and poor outcomes explains a higher mortality in African Americans with pulmonary embolism (PE). The objective is to identify the co-morbidities and echocardiographic characteristics associated with increased mortality in African American patients., Methods: This is a cross-sectional study of Caucasian or African American patients with PE diagnosed between October 2015 and December 2017 at University of Maryland Medical Center. The outcomes were in-hospital death, length of stay, and bleeding., Results: There were 303 African Americans and 343 Caucasians. Caucasians were older ( p = 0.007), males ( p = 0.01) with history of coronary artery revascularization (CABG ( p = 0.001), coronary stents ( p = 0.001)), trauma ( p = 0.007), and/or recent surgeries ( p = 0.0001). African Americans exhibited higher rates of diabetes ( p = 0.01), chronic kidney disease ( p = 0.0005), and smoking ( p = 0.04). Severity of PE was similar between groups and there was no difference in clot burden size. African Americans had more right ventricular strain on Computer Tomography ( p = 0.001) and echocardiogram ( p = 0.004); also, underfilled left ventricles ( p = 0.02) and higher right ventricular systolic pressures ( p = 0.001). There was no difference in hospital mortality (7.1% vs. 7.9%, p = 0.71), length of stay (13.1 ± 16.7 vs 12.8 ± 14.9, p = 0.80) and bleeding (9.0% vs.8.3%. p = 0.72). Mortality was higher in African Americans who received advanced therapies (3.8% vs. 18.8%, p = 0.02). The risk of death increased with age (OR 1.04; 95%CI 1.020-1.073) and with advanced therapies (OR 2.43; 95%CI 1.029-5.769)., Conclusions: Differences in co-morbidities, radiologic findings, and echocardiographic characteristics that may contribute to higher mortality in African American patients, specifically those receiving advanced therapies.

Background: There are currently no data to guide decisions about delaying surgery to achieve full vaccination., Methods: We analyzed data from patients undergoing surgery at any of the 1,283 VA medical facilities nationwide and compared postoperative complication rates by vaccination status., Results: Of 87,073 surgical patients, 20% were fully vaccinated, 15% partially vaccinated, and 65% unvaccinated. Mortality was reduced in full vaccination vs. unvaccinated (Incidence Rate Ratio 0.77, 95% CI [0.62, 0.94]) and partially vaccinated vs. unvaccinated (0.75 [0.60, 0.94]). Postoperative COVID-19 infection was reduced in fully (0.18 [0.12, 0.26]) and partially vaccinated patients (0.34 [0.24, 0.48]). Fully vaccinated compared to partially vaccinated patients, had similar postoperative mortality (1.02, [0.78, 1.33]), but had decreased COVID-19 infection (0.53 [0.32, 0.87]), pneumonia (0.75 [0.62, 0.93]), and pulmonary failure (0.79 [0.68, 0.93])., Conclusions: Full and partial vaccination reduces postoperative complications indicating the importance of any degree of vaccination prior to surgery., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Transcarotid artery revascularization (TCAR) is a hybrid approach to carotid revascularization. Limited information is available on the differences in periprocedural complications and performance measures of TCAR for men compared with women and for older vs younger adults., Methods: The patient, lesion, and physician characteristics were collected for all TCAR procedures performed by each physician worldwide in an international quality assurance database between March 3, 2009 and May 7, 2020. Clinical composite (ie, death, stroke, transient ischemic attack, myocardial infarction) and technical composite (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, device failure) adverse events within 24 hours of the procedure were recorded. Four performance measures were recorded: flow-reversal time, fluoroscopy time, contrast volume, and skin-to-skin time. Poisson regressions were used to assess the effects of age and sex on the incidence of clinical and technical composite adverse events. Linear regressions were used to compare the four performance measures., Results: A total of 18,240 TCARs were performed by 1273 physicians; 34.9% of the patients were women and 37.5% were symptomatic. The overall incidence of clinical and technical composite adverse events was low. The adjusted clinical (1.62% [95% confidence interval (CI), 1.17%-2.23%] vs 1.35% [95% CI, 1.01%-1.79%]; P = .22) and technical (7.84% [95% CI, 6.85%-8.97%] vs 7.80% [95% CI, 6.94%-8.77%]; P = .93) composite adverse event rates did not vary for women vs men. The adjusted clinical (P = .65) and technical (P = .55) composite adverse event rates also did not vary by age. The adjusted skin-to-skin time was shorter for the women (76.6 minutes; 95% CI, 74.6-78.6) than for the men (77.7 minutes; 95% CI, 75.7-79.6; P = .002). Significant differences were found by age group for fluoroscopy time, flow-reversal time, and skin-to-skin time, although the magnitude of these differences was small (<1 minute for each)., Conclusions: The clinical and technical outcomes of TCAR are not affected by age or sex. We found clinically minor differences in the procedural performance measures when stratified by age and sex. In addition to being safe for younger individuals, TCAR could also be the preferred method for performing carotid stenting in women and older patients, in particular, older women., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: When introduced to a new procedure, physicians improve their performance and reduce their procedural adverse event rates rapidly during the initial cases and then improvement slows, signaling that proficiency has been achieved. Determining when they have acquired proficiency has important implications for procedural innovation, education, credentialing, and patient safety. We analyzed the worldwide experience with transcarotid artery revascularization (TCAR), a hybrid approach to carotid revascularization, to identify the (1) procedural performance measures associated with clinical and technical adverse events; (2) target levels of performance measures that minimize adverse event rates; and (3) number of TCAR cases needed to achieve the target levels for the performance measures., Methods: The patient, lesion, and physician characteristics were collected for each TCAR procedure performed by each physician worldwide in an international quality assurance database. Four procedural performance measures were recorded for each procedure: flow-reversal time, fluoroscopy time, contrast volume, and total skin-to-skin time. Composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, device failure), occurring within 24 hours were also recorded. Correlations between each performance measure and the clinical and technical adverse event rates were computed. The inflection points in the performance measures were identified at which no further improvements occurred in the adverse event rates. Finally, the minimum number of TCAR cases required to achieve the target performance measure levels was computed., Results: A total of 18,240 procedures performed by 1273 physicians were analyzed. Of the 18,240 patients, 34.9% were women and 62.5% were asymptomatic. The flow-reversal time correlated with clinical adverse events adjusted for age, sex, and symptomatic status (R 2  = 0.91; P < .0001) and adjusted technical adverse events (R 2  = 0.86; P < .0001). The skin-to-skin time correlated with adjusted technical adverse events (R 2  = 0.92; P < .0001). A reduction in flow-reversal times to <13.1 minutes and the skin-to-skin time to <81 minutes did not translate into further improvements in the adverse event rates. A minimum of 26 TCAR cases was required to achieve the target flow-reversal time, and a minimum of 15 cases was required to achieve the target skin-to-skin time., Conclusions: The flow-reversal time and skin-to-skin time are appropriate performance measures for establishing the level of expertise of physicians as they acquire skills to perform TCAR. A target time of ≤13.1 minutes for flow-reversal and 81 minutes for skin-to-skin time minimized the adverse event rates. Familiarity with the steps involved in performing TCAR was achieved after ≥15 cases, and minimizing clinical adverse events occurred after ≥26 cases., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Asymptomatic carotid atherosclerotic stenosis (ACAS) is associated with cognitive impairment. Systemic inflammation occurs in patients with systemic atherosclerosis and is also associated with cognitive impairment. The goal of this study was to determine if cognitive impairment in patients with ACAS is the result of systemic inflammation., Methods: A cross-sectional analysis of 104 patients (63 patients with ACAS, 41 controls) with cognitive function and inflammatory biomarker assessments was performed. Venous blood was assayed for proinflammatory biomarkers (IL-1β, IL-6, IL-6R, IL-8, IL-17, tumor necrosis factor-α, matrix metalloproteinase [MMP]-1, MMP-2, MMP-7, MMP-9, vascular cell adhesion molecule, and high-sensitivity C-reactive protein). The patients also underwent comprehensive cognitive testing to compute five domain-specific cognitive scores per patient. We first assessed the associations between carotid stenosis and cognitive function, and between carotid stenosis and systemic inflammation in separate regression models. We then determined whether cognitive impairments persisted in patients with carotid stenosis after accounting for inflammation by adjusting for inflammatory biomarker levels in a combined model., Results: Patients with ACAS and control patients differed in age, race, coronary artery disease prevalence, and education. Stenosis patients had worse cognitive scores in two domains: learning and memory (P = .05) and motor and processing speed (P = .002). Despite adjusting for inflammatory biomarker levels, patients with ACAS still demonstrated deficits in the domains of learning and memory and motor and processing speed., Conclusions: Although systemic atherosclerosis-induced inflammation is a well-recognized cause for cognitive impairment, our data suggest that it is not the primary underlying mechanism behind cognitive impairments seen in ACAS. Cognitive impairments in learning and memory and motor and processing speed seen in patients with ACAS persist after adjusting for systemic inflammation. Thus, alternative mechanisms should be explored to account for the observed functional impairments., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The coronavirus disease 2019 (COVID-19) pandemic caused disruptions in treatment for cancer. Less is known about its impact on new cancer diagnoses, where delays could cause worsening long-term outcomes. This study quantifies decreases in encounters related to prostate, lung, bladder and colorectal cancers, procedures that facilitate their diagnosis, and new diagnoses of those cancers in the COVID era compared to pre-COVID era., Methods: All encounters at Veterans' Affairs facilities nationwide from 2016 through 2020 were reviewed. The authors quantified trends in new diagnoses of cancer and in procedures facilitating their diagnosis, from January 1, 2018 onward. Using 2018 to 2019 as baseline, reductions in procedures and new cancer diagnoses in 2020 were estimated. Calculated absolute and percentage differences in annual volume and observed-to-expected volume ratios were calculated. Heat maps and funnel plots of volume changes were generated., Results: From 2018 through 2020, there were 4.1 million cancer-related encounters, 3.9 million relevant procedures, and 251,647 new cancers diagnosed. Compared to the annual averages in 2018 through 2019, colonoscopies in 2020 decreased by 45% whereas prostate biopsies, chest computed tomography scans, and cystoscopies decreased by 29%, 10%, and 21%, respectively. New cancer diagnoses decreased by 13% to 23%. These drops varied by state and continued to accumulate despite reductions in pandemic-related restrictions., Conclusion: The authors identified substantial reductions in procedures used to diagnose cancer and subsequent reductions in new diagnoses of cancer across the United States because of the COVID-19 pandemic. A nomogram is provided to identify and resolve these unmet health care needs and avoid worse long-term cancer outcomes., Lay Summary: The disruptions due to the COVID-19 pandemic have led to substantial reductions in new cancers being diagnosed. This study quantifies those reductions in a national health care system and offers a method for understanding the backlog of cases and the resources needed to resolve them., (© 2021 American Cancer Society.)

Background: The COVID-19 pandemic has necessitated the adoption of protocols to minimize risk of periprocedural complications associated with SARS-CoV-2 infection. This typically involves a preoperative symptom screen and nasal swab RT-PCR test for viral RNA. Asymptomatic patients with a negative COVID-19 test are cleared for surgery. However, little is known about the rate of postoperative COVID-19 positivity among elective surgical patients, risk factors for this group and rate of complications., Methods: This prospective multicenter study included all patients undergoing elective surgery at 170 Veterans Health Administration (VA) hospitals across the United States. Patients were divided into groups based on first positive COVID-19 test within 30 days after surgery (COVID[-/+]), before surgery (COVID[+/-]) or negative throughout (COVID[-/-]). The cumulative incidence, risk factors for and complications of COVID[-/+], were estimated using univariate analysis, exact matching, and multivariable regression., Results: Between March 1 and December 1, 2020 90,093 patients underwent elective surgery. Of these, 60,853 met inclusion criteria, of which 310 (0.5%) were in the COVID[-/+] group. Adjusted multivariable logistic regression identified female sex, end stage renal disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, cirrhosis, and undergoing neurosurgical procedures as risk factors for being in the COVID[-/+] group. After matching on current procedural terminology code and month of procedure, multivariable Poisson regression estimated the complication rate ratio for the COVID[-/+] group vs. COVID[-/-] to be 8.4 (C.I. 4.9-14.4) for pulmonary complications, 3.0 (2.2, 4.1) for major complications, and 2.6 (1.9, 3.4) for any complication., Discussion: Despite preoperative COVID-19 screening, there remains a risk of COVID infection within 30 days after elective surgery. This risk is increased for patients with a high comorbidity burden and those undergoing neurosurgical procedures. Higher intensity preoperative screening and closer postoperative monitoring is warranted in such patients because they have a significantly elevated risk of postoperative complications., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The multicenter prospective CREST-2 Registry (C2R) provides recent experience in performing carotid artery stenting (CAS) for interventionists to ensure safe performance of CAS., Objective: To determine the periprocedural safety of CAS performed using a transradial approach relative to CAS performed using a transfemoral approach., Methods: Patients with ≥70% asymptomatic and ≥50% symptomatic carotid stenosis, ≤80 years of age and at standard or high risk for carotid endarterectomy (CEA) are eligible for the C2R. The primary endpoint was a composite of severe access-related complications. Comparisons were made using propensity-score matched logistic regression., Results: The mean age of the cohort was 67.6 ± 8.2 years and 1906 (35.1%) were female. Indications for CAS included 4063 (74.9%) for primary atherosclerosis. A total of 2868 (52.8%) cases underwent CAS for asymptomatic disease. Transradial access was used in 213 (3.9%) patients. The transradial cohort had lower use of general anesthesia (1.5% vs. 6.3%, p = 0.007) and higher use of distal embolic protection (96.7% vs. 89.4%, p = 0.0004). There were no significant differences between radial and femoral access groups in terms of a composite of major access-related complications (0% vs. 1.1%) or a composite of periprocedural stroke or death (3.3% vs. 2.4%; OR = 1.4 [confidence intervals 0.6, 3.1]; p = 0.42)., Conclusion: We found no significant differences in rates of major access-related complications or periprocedural stroke or death with CAS performed using transradial compared to transfemoral access. Our results support incorporation of the transradial approach to clinical trials comparing CAS to other revascularization techniques., (© 2021 Wiley Periodicals LLC.)

Background: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases., Methods: Physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures, (2) supervised training on human cadavers, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, or device failure, occurring within 24 hours were recorded). Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training., Results: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates, adjusted for age, sex, and symptomatic status, were 1.0% (95% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians., Conclusions: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Upper extremity (UE) deep vein thrombosis (DVT) is a common and increasing complication in hospitalized patients. The objective of the present study was to determine the prevalence, treatment strategies, complications, and outcomes of UE-DVT., Methods: We performed a retrospective single-institution study of patients with a diagnosis of UE-DVT from January 2016 through February 2018 (26 months). Patients aged ≥18 years who had been admitted to the hospital and who had had positive UE duplex ultrasound findings for acute UE-DVT were included in the present study. The outcomes were in-hospital mortality, major bleeding, pulmonary embolism (PE), and recurrent UE-DVT., Results: Among 63,045 patients admitted to the hospital, 1000 (1.6%) had been diagnosed with UE-DVT. Of 3695 UE venous duplex ultrasound examinations performed during the study period, almost one third (27.0%) were positive for acute UE-DVT. The mean age was 55.0 ± 17.2 years, and most patients were men (58.3%), white (49.2%), and overweight (mean body mass index, 29.4 ± 10.3 kg/m 2 ). The most affected vein was the right internal jugular vein (54.8%). Most of the patients (96.9%) has been receiving venous thromboembolism prophylaxis or anticoagulation therapy at the diagnosis. Most patients (77.8%) had had an intravenous device (IVD) in place at the diagnosis. Most of the patients (84.4%) were treated with anticoagulation therapy in the hospital but only one half (54.5%) were discharged with anticoagulation therapy. In-hospital mortality was 12.1% unrelated to UE-DVT, major bleeding occurred in 47.6% of the patients during hospitalization (fatal bleeding, 1%), PE was diagnosed in 4.8% of the patients, and 0.7% were fatal. Recurrent UE-DVT occurred in 6.1% of the patients. On multivariable analysis, the risk of death was increased by older age, cancer, intensive care unit admission, concomitant lower extremity DVT, and bleeding before the UE-DVT diagnosis. The presence of an IVD increased the risk of PE and the risk of recurrent UE-DVT. The risk of major bleeding was increased by the presence of an IVD, female sex, and concomitant lower extremity DVT., Conclusions: UE-DVT is a common complication in hospitalized patients (1.6%). Consequent acute PE and recurrent DVT remain important complications, as does bleeding. It is unclear whether standard thromboprophylaxis effectively protects against UE-DVT. More studies dedicated to UE-DVT are required to provide appropriate guidance on prophylaxis and treatment., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to determine the effect of COVID-19 vaccination on postoperative mortality, pulmonary and thrombotic complications, readmissions and hospital lengths of stay among patients undergoing surgery in the United States., Background: While vaccination prevents COVID-19, little is known about its impact on postoperative complications., Methods: This is a nationwide observational cohort study of all 1,255 Veterans Affairs facilities nationwide. We compared patients undergoing surgery at least 2 weeks after their second dose of the Pfizer BioNTech or Moderna vaccines, to contemporary propensity score matched controls. Primary endpoints were 30-day mortality and postoperative COVID-19 infection. Secondary endpoints were pulmonary or thrombotic complications, readmissions, and hospital lengths of stay., Results: 30,681 patients met inclusion criteria. After matching, there were 3,104 in the vaccination group (1,903 received the Pfizer BioNTech, and 1,201 received the Moderna vaccine) and 7,438 controls. Full COVID-19 vaccination was associated with lower rates of postoperative 30-day COVID-19 infection (Incidence Rate Ratio and 95% confidence intervals, 0.09 [0.01,0.44]), pulmonary complications (0.54 [0.39, 0.72]), thrombotic complications (0.68 [0.46, 0.99]) and decreased hospital lengths of stay (0.78 [0.69, 0.89]). Complications were also low in vaccinated patients who tested COVID-19 positive before surgery but events were too few to detect a significant difference compared to controls., Conclusion: COVID-19 vaccination is associated with lower rates of postoperative morbidity. The benefit is most pronounced among individuals who have never had a COVID-19 infection before surgery., Competing Interests: The authors report no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The COVID-19 pandemic has resulted in over 225,000 excess deaths in the United States. A moratorium on elective surgery was placed early in the pandemic to reduce risk to patients and staff and preserve critical care resources. This report evaluates the impact of the elective surgical moratorium on case volumes and intensive care unit (ICU) bed utilization., Methods: This retrospective review used a national convenience sample to correlate trends in the weekly rates of surgical cases at 170 Veterans Affairs Hospitals around the United States from January 1 to September 30, 2020 to national trends in the COVID-19 pandemic. We reviewed data on weekly number of procedures performed and ICU bed usage, stratified by level of urgency (elective, urgent, emergency), and whether an ICU bed was required within 24 hours of surgery. National data on the proportion of COVID-19 positive test results and mortality rates were obtained from the Center for Disease Control website., Results: 198,911 unique surgical procedures performed during the study period. The total number of cases performed from January 1 to March 16 was 86,004 compared with 15,699 from March 17 to May 17. The reduction in volume occurred before an increase in the percentage of COVID-19 positive test results and deaths nationally. There was a 91% reduction from baseline in the number of elective surgeries performed allowing 78% of surgical ICU beds to be available for COVID-19 positive patients., Conclusion: The moratorium on elective surgical cases was timely and effective in creating bed capacity for critically ill COVID-19 patients. Further analyses will allow targeted resource allocation for future pandemic planning., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Catheter-based intervention (CBI) has become an increasingly popular option for treating pulmonary embolism (PE); however, the real benefits are unknown. The purpose of the present study was to compare the outcomes of patients treated with CBI with the outcomes of those treated with medical or surgical approaches., Methods: We performed a retrospective analysis of patients admitted from October 2015 to December 2017 with a diagnosis of acute PE. We compared patients aged ≥18 years with a diagnosis of acute PE treated with CBI against a control group identified by propensity score matching. The control group was divided into those who had undergone surgical pulmonary embolectomy (SPE) as the surgical group and those who had not undergone SPE as the medical group. The primary outcome was mortality (in-hospital and overall mortality). The secondary outcomes were major bleeding, length of hospital stay, thrombus resolution, right ventricle improvement in systolic function and dilatation, and recurrent PE., Results: Of the 108 patients, 30 were in the CBI group and 78 were in the control group (62 in the medical group and 16 in the surgical group). The patient characteristics on admission were similar, except for the body mass index, which was greater in the CBI group (P = .03). No difference was found in clinical severity, clot burden, right ventricle function, or biomarkers. Recurrent PE was less frequent in the CBI group than in the medical group (0% vs 6.4%). Otherwise, no significant differences were found in the outcomes between the CBI and medical groups. When CBI was compared with the surgical group, SPE was associated with improved mortality (0% vs 16.6%) but a longer median length of hospital stay (median, 7 days; interquartile range, 3-12 days; vs median, 8 days; interquartile range, 6.5-17 days)., Conclusions: The use of CBI reduced the number of recurrent PE events compared with the medically treated patients; however, the mortality was higher than that in the surgical group., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The role of exercise therapy after acute pulmonary embolism (PE) is unknown. Exercise therapy is safely used after myocardial infarction and chronic obstructive pulmonary disease. The aim of this study was to investigate the safety of exercise therapy after acute PE., Methods: We implemented a 3-month exercise program after acute PE. Outcomes were death, bleeding, readmissions, recurrent events, changes in peak VO2 and quality of life (QoL)., Results: A total of 23 patients were enrolled and received anticoagulation; no adverse events were reported during the exercise period. One death, 1 DVT and 5 readmissions were reported due to non-exercise related reasons. Functional capacity improved as evidenced by an increased peak VO2 at 3 months (+3.9 ± 5.6 mL/kg/min; p = 0.05). Improvement in QoL was observed at 6-months on the functional (+17.0 ± 22.6, p = 0.03) and physical health factor scales (+0.9 ± 4.6, p = 0.03)., Conclusion: Exercise therapy is feasible and safe in appropriately anticoagulated patients after PE.

Background: The CREST-2 Registry (C2R) was approved by National Institute of Neurological Disorders and Stroke-National Institutes of Health in September 2014 with Centers for Medicare & Medicaid Services, U.S. Food and Drug Administration, and industry collaboration to enroll patients undergoing CAS. The registry credentials interventionists and promotes optimal patient selection, procedural-technique, and outcomes., Objectives: This study reports periprocedural outcomes in a cohort of carotid artery stenting (CAS) performed for asymptomatic and symptomatic carotid stenosis., Methods: Asymptomatic patients with ≥70% and symptomatic patients with ≥50% carotid stenosis, ≤80 years of age, and at standard or high risk for carotid endarterectomy are eligible for enrollment. Interventionists are credentialed by a multispecialty committee that reviews experience, lesion selection, technique, and outcomes. The primary endpoint was a composite of stroke and death (S/D) in the 30-day periprocedural period. Myocardial infarction and access-site complications were assessed as secondary outcomes., Results: As of December 2018, 187 interventionists from 98 sites in the United States performed 2,219 CAS procedures in 2,141 patients with primary atherosclerosis (78 were bilateral). The mean age of the cohort was 68 years, 65% were male, and 92% were white; 1,180 (55%) were for asymptomatic disease, and 961 (45%) were for symptomatic disease. All U.S. Food and Drug Administration-approved stents and embolic protection devices were represented. The 30-day rate of S/D was 1.4% for asymptomatic, 2.8% for symptomatic, and 2.0% for all patients., Conclusions: C2R is the first national registry for CAS cosponsored by federal and industry partners. CAS was performed by experienced operators using appropriate patient selection and optimal technique. In that setting, a broad group of interventionists achieved very low periprocedural S/D rates for asymptomatic and symptomatic patients., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)