Effect of junctional reflux on the venous clinical severity score in patients with insufficiency of the great saphenous vein (JURY study).

OBJECTIVE: Effective treatment options are available for chronic venous insufficiency associated with superficial venous reflux. Although many patients with C2 and C3 disease based on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification have combined great saphenous vein (GSV) and saphenofemoral junction (SFJ) reflux, some may not have concomitant SFJ reflux. Several payors have determined that symptom severity in patients without SFJ reflux does not warrant treatment. In patients planned for venous ablation, we tested whether Venous Clinical Severity Scores (VCSS) are equivalent in those with GSV reflux alone compared with those with both GSV and SFJ reflux. METHODS: This cross-sectional study was conducted at 10 centers. Inclusion criteria were: candidate for endovenous ablation as determined by treating physician; 18 to 80 years of age; GSV reflux with or without SFJ reflux on ultrasound; and C2 or C3 disease. Exclusion criteria were prior deep vein thrombosis; prior vein ablation on the index limb; ilio-caval obstruction; and renal, hepatic, or heart failure requiring prior hospitalization. An a priori sample size was calculated. We used multiple linear regression (adjusted for patient characteristics) to compare differences in VCSS scores of the two groups at baseline, and to test whether scores were equivalent using a priori equivalence boundaries of +1 and -1. In secondary analyses, we tested differences in VCSS scores in patients with C2 and C3 disease separately. RESULTS: A total of 352 patients were enrolled; 64.2% (n = 226) had SFJ reflux, and 35.8% (n = 126) did not. The two groups did not differ by major clinical characteristics. The mean age of the cohort was 53.9 ± 14.3 years; women comprised 74.2%; White patients 85.8%; and body mass index was 27.8 ± 6.1 kg/m2. The VCSS scores in patients with and without SFJ reflux were found to be equivalent; SFJ reflux was not a significant predictor of VCSS score; and mean VCSS scores did not differ significantly (6.4 vs 6.6, respectively, P = .40). In secondary subset analyses, VCSS scores were equivalent between C2 patients with and without SFJ reflux, and VCSS scores of C3 patients with SFJ reflux were lower than those without SFJ reflux. CONCLUSIONS: Symptom severity is equivalent in patients with GSV reflux with or without SFJ reflux. The absence of SFJ reflux alone should not determine the treatment paradigm in patients with symptomatic chronic venous insufficiency. Patients with GSV reflux who meet clinical criteria for treatment should have equivalent treatment regardless of whether or not they have SFJ reflux.

Risk factors and treatment interventions associated with incomplete thrombus resolution and pulmonary hypertension after pulmonary embolism.

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.

Ability of Caprini and Padua risk-assessment models to predict venous thromboembolism in a nationwide Veterans Affairs study.

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.

Association of Continued Use of SGLT2 Inhibitors From the Ambulatory to Inpatient Setting With Hospital Outcomes in Patients With Diabetes: A Nationwide Cohort Study.

OBJECTIVE: Limited data are available on the continuation of outpatient sodium glucose cotransporter 2 inhibitors (SGLT2is) during hospitalization. The objective was to evaluate associations of SGLT2i continuation in the inpatient setting with hospital outcomes. RESEARCH DESIGN AND METHODS: This nationwide cohort study used Veterans Affairs health care system data of acute care hospitalizations between 1 April 2013 and 31 August 2021. A total of 36,505 admissions of patients with diabetes with an outpatient prescription for an SGLT2i prior to hospitalization were included. The exposure was defined as SGLT2i continuation during hospitalization. Admissions where SGLT2i was continued were compared with admissions where it was discontinued. The primary outcome was in-hospital mortality. Secondary outcomes were acute kidney injury (AKI) and length of stay (LOS). Negative binomial propensity score-weighted and zero-truncated analyses were used to compare outcomes and adjusted for multiple covariates, including demographics and comorbidities. RESULTS: Mean (SE) age was 67.2 (0.1) and 67.5 (0.1) years (P = 0.03), 97.0% and 96.6% were male (P = 0.1), 71.3% and 72.1% White, and 20.8% and 20.5% Black (P = 0.52) for the SGLT2i continued and discontinued groups, respectively. After adjustment for covariates (age, sex, race, BMI, Elixhauser Comorbidity Index, procedures/surgeries, and insulin use), the SGLT2i continued group had a 45% lower mortality rate (incidence rate ratio [IRR] 0.55, 95% CI 0.42-0.73, P < 0.01), no difference in AKI (IRR 0.96, 95% CI 0.90-1.02, P = 0.17), and decreased LOS (4.7 vs. 4.9 days) (IRR 0.95, 95% CI 0.93-0.98, P < 0.01) versus the SGLT2i discontinued group. Similar associations were observed across multiple sensitivity analyses. CONCLUSIONS: Continued SGLT2i during hospitalization among patients with diabetes was associated with lower mortality, no increased AKI, and shorter LOS.

Growing Deficit in New Cancer Diagnoses 2 Years Into the COVID-19 Pandemic: A National Multicenter Study.

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.

Prediction of bleeding in patients being considered for venous thromboembolism prophylaxis.

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.

Ability of Caprini and Padua Risk-Assessment Models to Predict Venous Thromboembolism in a Nationwide Study.

Background: Venous thromboembolism (VTE) is a preventable complication of hospitalization. Risk-stratification is the cornerstone of prevention. The Caprini and Padua are the most commonly used risk-assessment models to quantify VTE risk. Both models perform well in select, high-risk cohorts. While VTE risk-stratification is recommended for all hospital admissions, few studies have evaluated the models 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 1,298 VA facilities nationwide between January 2016 and December 2021. Caprini and Padua scores were generated using the VA's national data repository. We first assessed 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 versus non-surgical patients, after excluding patients with upper extremity DVT, in patients hospitalized ≥72 hours, after including all-cause mortality in the composite outcome, and after accounting for prophylaxis in the predictive model. We used area under the receiver-operating characteristic curves (AUC) 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 0-28 (median, interquartile range: 4, 3-6); Padua scores ranged from 0-13 (1, 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% CI 0.56-0.56], Padua 0.59 [0.58-0.59]). Prediction remained low for surgical (Caprini 0.54 [0.53-0.54], Padua 0.56 [0.56-0.57]) and non-surgical patients (Caprini 0.59 [0.58-0.59], Padua 0.59 [0.59-0.60]). There was no clinically meaningful change in predictive performance in patients admitted for ≥72 hours, after excluding upper extremity DVT from the outcome, after including all-cause mortality in the outcome, or after accounting for ongoing VTE prophylaxis. Conclusions: Caprini and Padua risk-assessment model scores have low ability to predict VTE events in a cohort of unselected consecutive hospitalizations. Improved VTE risk-assessment models must be developed before they can be applied to a general hospital population.

Left ventricular systolic dysfunction during acute pulmonary embolism.

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.

Mid-term Surgery Outcomes in Patients With COVID-19: Results From a Nationwide Analysis.

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.

Clinical outcomes and echocardiographic characteristics between African American and Caucasian patients with acute pulmonary embolism.

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.

Systematic review of venous thromboembolism risk categories derived from Caprini score.

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.

Partial COVID-19 vaccination associated with reduction in postoperative mortality and SARS-CoV-2 infection.

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.

Transcarotid revascularization outcomes do not differ by patient age or sex.

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.

Association Between Foot Surgery Type and Subsequent Healing in Veterans With Moderate-to-Severe Diabetic Foot Infections.

BACKGROUND: Diabetic foot infections are a common precursor to lower extremity amputations. The treatment of diabetic foot infections involves both medical and surgical management, of which limb-sparing surgeries are increasingly preferred over amputations at or above the ankle to preserve mobility and quality of life. The outcomes following these limb-sparing surgeries are not well described. METHODS: This was a single-center, retrospective cohort study of 90 Veterans with moderate-to-severe diabetic foot infections between 2017 and 2019 from the Veterans Affairs Maryland Health Care System. The exposure was foot surgery with bone resection (ie, toe amputation, metatarsal resection, transmetatarsal amputation) vs debridement alone. The outcome was healing within 1 year. We used log-binomial regression to assess the association between foot surgery type and healing, stratify by infection location, and evaluate potential confounding variables. RESULTS: The cumulative incidence of healing after foot surgery with bone resection was greater than that following debridement (risk ratio [RR], 1.80 [95% confidence interval {CI}, 1.17-2.77]). This association was modified by infection location and greater for toe infections (RR, 4.52 [95% CI, 1.30-15.7]) than other foot infections (RR, 1.19 [95% CI, .69-2.02]). We found no evidence of confounding by comorbidities or infection severity. CONCLUSIONS: For patients with toe infections, foot surgery with bone resection was associated with better healing than debridement alone. The multiple specialties caring for patients with diabetic foot infections need a stronger common knowledge base-from studies like this and future studies-to better counsel patients about their treatment and prognosis.

Learning curve and proficiency metrics for transcarotid artery revascularization.

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 (R2 = 0.91; P < .0001) and adjusted technical adverse events (R2 = 0.86; P < .0001). The skin-to-skin time correlated with adjusted technical adverse events (R2 = 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.

COVID-19 Vaccination Associated With Reduced Postoperative SARS-CoV-2 Infection and Morbidity.

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.

Evaluating the optimal training paradigm for transcarotid artery revascularization based on worldwide experience.

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.