Impact of the type of anesthesia on adverse events during transcarotid artery revascularization.

OBJECTIVES: The use of local or regional anesthesia (LRA) is encouraged during transcarotid artery revascularization (TCAR) since the procedure is performed through a small incision. LRA permits neurologic evaluation during the procedure and may reduce periprocedural cardiac morbidity compared to 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 versus 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, Univ 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 1,456 physicians between 2012 and 2021. A majority (83%) of patients received GA, and this proportion increased over time (R2=0.74, p<0.0001). 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<0.0001), and anatomic risk-factors in the GA group (p<0.0001); 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<0.0001). When comparing GA vs. LRA, clinical adverse events (1.49% [95% CI 1.3,1.8] vs 1.55% [1.2,2.0], p=0.78), technical adverse events (5.6% [5.2,6.2] vs 5.3% [4.5,6.3], p=0.47), and intraprocedural performance measures did not differ by type of anesthesia. CONCLUSIONS: Almost 2/3rds 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, while 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.

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.

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.

Impact of the COVID-19 pandemic on diagnosis of new cancers: A national multicenter study of the Veterans Affairs Healthcare System.

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.

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.

Lack of association between cognitive impairment and systemic inflammation in asymptomatic carotid stenosis.

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-1ß, 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.

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.

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.

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.

Safety of the transradial approach to carotid stenting.

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.

A Nation-Wide Review of Elective Surgery and COVID-Surge Capacity.

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.

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.

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.

Increased complications in patients who test COVID-19 positive after elective surgery and implications for pre and postoperative screening.

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.

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.

Prevalence and clinical outcomes of hospitalized patients with upper extremity deep vein thrombosis.

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/m2). 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.