Carotid endarterectomy and transcarotid artery revascularization can be performed with acceptable morbidity and mortality in patients with chronic kidney disease.

OBJECTIVE: Patients with chronic kidney disease (CKD) are considered a high-risk population, and the optimal approach to the treatment of carotid disease remains unclear. Thus, we compared outcomes following carotid revascularization for patients with CKD by operative approach of carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid arterial revascularization (TCAR). METHODS: The Vascular Quality Initiative was analyzed for patients undergoing carotid revascularizations (CEA, TFCAS, and TCAR) from 2016 to 2021. Patients with normal renal function (estimated glomular filtration rate >90 mL/min/1.72 m2) were excluded. Asymptomatic and symptomatic carotid stenosis were assessed separately. Preoperative demographics, operative details, and outcomes of 30-day mortality, stroke, myocardial infarction (MI), and composite variable of stroke/death were compared. Multivariable analysis adjusted for differences in groups, including CKD stage. RESULTS: A total of 90,343 patients with CKD underwent revascularization (CEA, n = 66,870; TCAR, n = 13,459; and TFCAS, n = 10,014; asymptomatic, 63%; symptomatic, 37%). Composite 30-day mortality/stroke rates were: asymptomatic: CEA, 1.4%; TCAR, 1.2%; TFCAS, 1.8%; and symptomatic: CEA, 2.7%; TCAR, 2.3%; TFCAS, 3.7%. In adjusted analysis, TCAR had lower 30-day mortality compared with CEA (asymptomatic: adjusted odds ratio [aOR], 0.4; 95% confidence interval [CI], 0.3-0.7; symptomatic: aOR, 0.5; 95% CI, 0.3-0.7), and no difference in stroke, MI, or the composite outcome of stroke/death in both symptom cohorts. TCAR had lower risk of other cardiac complications compared with CEA in asymptomatic patients (aOR, 0.7; 95% CI, 0.6-0.9) and had similar risk in symptomatic patients. Compared with TFCAS, TCAR patients had lower 30-day mortality (asymptomatic: aOR, 0.5; 95% CI, 0.2-0.95; symptomatic: aOR, 0.3; 95% CI, 0.2-0.4), stroke (symptomatic: aOR, 0.7; 95% CI, 0.5-0.97), and stroke/death (asymptomatic: aOR, 0.7; 95% CI, 0.5-0.97; symptomatic: aOR, 0.6; 95% CI, 0.4-0.7), but no differences in MI or other cardiac complications. Patients treated with TFCAS had higher 30-day mortality (aOR, 1.8; 95% CI, 1.2-2.5) and stroke risk (aOR, 1.3; 95% CI, 1.02-1.7) in symptomatic patients compared with CEA. There were no differences in MI or other cardiac complications. CONCLUSIONS: Among patients with CKD, TCAR and CEA showed rates of stroke/death less than 2% for asymptomatic patients and less than 3% for symptomatic patients. Given the increased risk of major morbidity and mortality, TFCAS should not be performed in patients with CKD who are otherwise anatomic candidates for TCAR or CEA.

Statin therapy is associated with improved perioperative outcomes and long-term mortality following carotid revascularization in the Vascular Quality Initiative.

OBJECTIVE: Statin therapy is the standard of care for patients with carotid artery stenosis given its proven cardiovascular benefits. However, the impact of statin therapy on outcomes in patients undergoing carotid revascularization in the Vascular Quality Initiative has not yet been evaluated. Therefore, our aim was to investigate the association of statin therapy with outcomes following carotid endarterectomy (CEA), transfemoral carotid artery stenting (tfCAS), and transcarotid artery revascularization (TCAR). METHODS: We identified all patients who underwent CEA, tfCAS, or TCAR in the Vascular Quality Initiative registry from January 2016 to September 2021. To compare outcomes, we stratified patients by procedure type and created 1:1 propensity score-matched cohorts of patients who received no preoperative statin therapy (within 36 hours of procedure) versus those who received preoperative statin therapy. Propensity scores incorporated demographic characteristics, comorbidities, carotid symptom status, preoperative medications, and physician and hospital procedural experience. The primary outcome was a composite end point of in-hospital stroke and/or death. As a secondary analysis, we performed repeat propensity score-matching by postoperative statin use (prescribed at discharge) and assessed 5-year mortality. Relative risks (RR) and hazard ratios (HR) were calculated using log binomial regression and Cox regression, respectively. RESULTS: Among 97,835 CEA, 20,303 tfCAS, and 22,371 TCAR patients, 15%, 17%, and 10% of patients did not receive preoperative statin therapy, respectively. Compared with statin use, no statin use was associated with a higher risk of in-hospital stroke or death among 13,434 matched CEA patients (no statin, 1.7% vs statin, 1.4%; RR, 1.2; 95% confidence interval [CI], 1.02-1.5) and among 2707 matched tfCAS patients (4.8% vs 2.8%; RR, 1.7; 95% CI, 1.3-2.3). However, there was no difference for this outcome by statin use among 2089 matched TCAR patients (1.8% vs 1.6%; RR, 1.1; 95% CI, 0.7-1.8). At 5 years, no statin therapy at discharge was associated with higher 5-year mortality after CEA (15% vs 10%; HR, 1.8; 95% CI, 1.6-2) and tfCAS (18% vs 14%; HR, 1.5; 95% CI, 1.2-1.8), but there was no difference after TCAR (14% vs 11%; HR, 1.3; 95% CI, 0.9-1.8). CONCLUSIONS: Compared with statin use, no statin use was associated with a higher risk of in-hospital stroke or death and 5-year mortality among CEA and tfCAS patients. Although there was no significant difference in outcomes among TCAR patients, this may in part be due to lower statistical power in this cohort. Overall, statin therapy is essential in the short- and long-term management of patients undergoing carotid revascularization. Our findings not only support current Society for Vascular Surgery recommendations for statin therapy in patients undergoing carotid revascularization, but they also highlight an important opportunity for quality improvement.

Racial disparities in treatment of ruptured abdominal aortic aneurysms.

OBJECTIVE: The Society for Vascular Surgery has recommended immediate transfer of patients with ruptured abdominal aortic aneurysms (rAAAs) to a regional center when feasible. However, Black patients might be less likely to be transferred and more likely to be turned down for repair. We, therefore, examined the transfer rates, turndown rates, and outcomes for Black vs White patients presenting with rAAAs in two large databases. METHODS: We examined all rAAA repairs in the Vascular Quality Initiative from 2003 to 2020 to evaluate the transfer rates and outcomes for Black vs White patients. We used the National Inpatient Sample from 2004 to 2015 to examine the turndown rates. Mixed effects logistic regression, Cox regression, and marginal effects modeling were used to study the interaction between race, insurance status, surgery type (open repair vs endovascular aortic aneurysm repair), and hospital volume. RESULTS: We identified 4935 patients with rAAAs in the Vascular Quality Initiative (6.2% Black) and 48,489 in the National Inpatient Sample (6.0% Black). The rates of transfer were high; however, Black patients were significantly less likely to undergo transfer before repair compared with White patients (49% Black vs 62% White; P = .002). The result was consistent in both crude and adjusted analyses when considering only stable patients and was not modified by insurance status, surgery type, or hospital volume. No significant differences were found in perioperative mortality (22% vs 26%; P = .098) or complications (52% vs 52%; P = .64). However, Black patients were significantly more likely to be turned down for repair (37% vs 28%; odds ratio, 1.5; 95% confidence interval, 1.2-1.9; P < .001). A significant interaction was found between race and insurance status with respect to turndown. Patients with private insurance had undergone surgery at a similar rate, regardless of race. However, among patients with Medicare or Medicaid/self-pay, Black patients were less likely than were White patients to undergo repair (Medicare, 64% vs 72%; P = .001; Medicaid/self-pay, 43% vs 61%; P = .031). Patients with Medicaid/self-pay were also less likely to undergo repair than were patients of the same race with either Medicare or private insurance (P < .05). CONCLUSIONS: We found that Black patients with rAAAs are poorly served by the current systems of interhospital transfer in the United States, because they less often undergo transfer before repair. Although the postoperative outcomes appeared similar, this finding could be falsely optimistic, because Black patients, especially the underinsured, were turned down for repair more often even after adjustment. Significant work is needed to better understand the reasons underlying these disparities and identify the targets to improve the care of Black patients with rAAAs.

The impact of neighborhood social disadvantage on abdominal aortic aneurysm severity and management.

OBJECTIVE: Recent studies have highlighted socioeconomic disparities in the severity and management of abdominal aortic aneurysm (AAA) disease. However, these studies focus on individual measures of social disadvantage such as income and insurance status. The area deprivation index (ADI), a validated measure of neighborhood deprivation, provides a more comprehensive assessment of social disadvantage. Therefore, we examined the impact of ADI on AAA severity and its management. METHODS: We identified all patients who underwent endovascular or open repair of an AAA in the Vascular Quality Initiative registry between 2003 and 2020. An ADI score of 1 to 100 was assigned to each patient based on their residential zip code, with higher ADI scores corresponding with increasing deprivation. Patients were categorized by ADI quintiles. Outcomes of interest included rates of ruptured AAA (rAAA) repair versus an intact AAA repair and rates of endovascular repair (EVAR) versus the open approach. Logistic regression was used to evaluate for an independent association between ADI quintile and these outcomes. RESULTS: Among 55,931 patients who underwent AAA repair, 6649 (12%) were in the lowest ADI quintile, 11,692 (21%) in the second, 15,958 (29%) in the third, 15,035 (27%) in the fourth, and 6597 (12%) in the highest ADI quintile. Patients in the two highest ADI quintiles had a higher proportion of rAAA repair (vs intact repair) compared with those in the lowest ADI quintile (8.8% and 9.1% vs 6.2%; P < .001). They were also less likely to undergo EVAR (vs open approach) when compared with the lowest ADI quintile (81% and 81% vs 88%; P < .001). There was an overall trend toward increasing rAAA and decreasing EVAR rates with increasing ADI quintiles (P < .001). In adjusted analyses, when compared with patients in the lowest ADI quintile, patients in the highest ADI quintile had higher odds of rAAA repair (odds ratio, 1.4; 95% confidence interval, 1.2-1.8; P < .001) and lower odds of undergoing EVAR (odds ratio, 0.54; 95% confidence interval, 0.45-0.65; P < .001). CONCLUSIONS: Among patients who underwent AAA repair in the Vascular Quality Initiative, those with higher neighborhood deprivation had significantly higher rates of rAAA repair (vs intact repair) and lower rates of EVAR (vs open approach). Further work is needed to better understand neighborhood factors that are contributing to these disparities to identify community-level targets for improvement.

Distal embolic protection use during transfemoral carotid artery stenting is associated with improved in-hospital outcomes.

OBJECTIVE: Despite current guidelines recommending the use of distal embolic protection during transfemoral carotid artery stenting (tfCAS) to prevent periprocedural stroke, there remains significant variation in the routine use of distal filters. We sought to assess in-hospital outcomes in patients undergoing tfCAS with and without embolic protection using a distal filter. METHODS: We identified all patients undergoing tfCAS in the Vascular Quality Initiative from March 2005 to December 2021 and excluded those who received proximal embolic balloon protection. We created propensity score-matched cohorts of patients who underwent tfCAS with and without attempted placement of a distal filter. Subgroup analyses of patients with failed vs successful filter placement and failed vs no attempt at filter placement were performed. In-hospital outcomes were assessed using log binomial regression, adjusted for protamine use. Outcomes of interest were composite stroke/death, stroke, death, myocardial infarction (MI), transient ischemic attack (TIA), and hyperperfusion syndrome. RESULTS: Among 29,853 patients who underwent tfCAS, 28,213 (95%) had a filter attempted for distal embolic protection and 1640 (5%) did not. After matching, 6859 patients were identified. No attempted filter was associated with significantly higher risk of in-hospital stroke/death (6.4% vs 3.8%; adjusted relative risk [aRR], 1.72; 95% confidence interval [CI], 1.32-2.23; P < .001), stroke (3.7% vs 2.5%; aRR, 1.49; 95% CI, 1.06-2.08; P = .022), and mortality (3.5% vs 1.7%; aRR, 2.07; 95% CI, 1.42-3.020; P < .001). In a secondary analysis of patients who had failed attempt at filter placement vs successful filter placement, failed filter placement was associated with worse outcomes (stroke/death: 5.8% vs 2.7%; aRR, 2.10; 95% CI, 1.38-3.21; P = .001 and stroke: 5.3% vs 1.8%; aRR, 2.87; 95% CI, 1.78-4.61; P < .001). However, there were no differences in outcomes in patients with failed vs no attempted filter placement (stroke/death: 5.4% vs 6.2%; aRR, 0.99; 95% CI, 0.61-1.63; P = .99; stroke: 4.7% vs 3.7%; aRR, 1.40; 95% CI, 0.79-2.48; P = .20; death: 0.9% vs 3.4%; aRR, 0.35; 95% CI, 0.12-1.01; P = .052). CONCLUSIONS: tfCAS performed without attempted distal embolic protection was associated with a significantly higher risk of in-hospital stroke and death. Patients undergoing tfCAS after failed attempt at filter placement have equivalent stroke/death to patients in whom no filter was attempted, but more than a two-fold higher risk of stroke/death compared with those with successfully placed filters. These findings support current Society for Vascular Surgery guidelines recommending routine use of distal embolic protection during tfCAS. If a filter cannot be placed safely, an alternative approach to carotid revascularization should be considered.

A retroperitoneal operative approach is associated with improved perioperative outcomes compared with a transperitoneal approach in open repair of complex abdominal aortic aneurysms.

OBJECTIVE: Several studies have demonstrated the advantages of a retroperitoneal (RP) vs a transperitoneal (TP) approach during open repair of infrarenal abdominal aortic aneurysms (AAAs). We compared the outcomes after open repair of complex AAAs (cAAAs) using an RP vs a TP approach and evaluated the relative use of these approaches over time. METHODS: We identified all patients who had undergone open intact cAAA repair in the Vascular Quality Initiative from 2003 to -2019 and created 1:1-propensity score-matched cohorts stratified by the operative approach (RP vs TP). The primary outcome was perioperative mortality. The secondary outcomes included perioperative complications and approach usage over time. To create 1:1 propensity score-matched cohorts, the patients were matched for demographics, comorbidities, and anatomic and/or intraoperative characteristics, including proximal clamp site and renal revascularization. The approach usage over time was determined by plotting the proportion of RP usage over time for the overall open cAAA cohort and subgroups of repairs using a supraceliac cross clamp, repair with concomitant renal revascularization, and repairs performed at high-volume centers (highest quintile, >11 cases annually). RESULTS: Of a total of 4613 patients, 2843 (62%) had undergone open cAAA repair using the TP approach and 1770 (38%) using the RP approach. Of the 1256 matched pairs, the RP approach was associated with lower risk of perioperative mortality compared with the TP approach (3.9% vs 6.8%; relative risk [RR], 0.57; 95% confidence interval [CI], 0.41-0.80; P = .001). Furthermore, the RP approach was associated with a lower risk of cardiac complications (7.2% vs 9.6%; RR, 0.75; 95% CI, 0.58-0.98), bowel ischemia (3.1% vs 5.4%; RR, 0.56; 95% CI, 0.39-0.84), and postoperative dialysis (3.3% vs 5.5%; RR, 0.59; 95% CI, 0.41-0.87). Overall, the proportion of patients who had undergone repair via an RP approach became lower over time (-1.0%/y; 95% CI, -1.5 to -0.5; P < .001). A similar trend in the decrease was found for the patients who had undergone repair with a supraceliac clamp (-2.3%/y; 95% CI, -3.6 to -1.0; P < .001) and in the high-volume hospitals (-2.1%/y; 95% CI, -3.4 to -0.8; P = .001), although no statistically significant decrease in RP usage was found for the patients who had undergone concomitant renal revascularization (-0.9%/y; 95% CI, -2.6 to 0.8; P = .28). CONCLUSIONS: For open cAAA repair, an RP approach was associated with lower perioperative mortality and complications compared with a TP approach. However, the relative usage of the RP approach has been decreasing over time. An increased adoption of the RP approach, when appropriate, might lead to improved outcomes with open cAAA repair.

Disparities in 5-year outcomes and imaging surveillance following elective endovascular repair of abdominal aortic aneurysm by sex, race, and ethnicity.

OBJECTIVES: Sex, racial, and ethnic disparities in postoperative outcomes following abdominal aortic aneurysm repair have been described, but differences in long-term outcomes are poorly understood. Our aim was to identify differences in 5-year outcomes and imaging surveillance after elective endovascular aortic aneurysm repair (EVAR) by sex, race, and ethnicity and to explore potential mechanisms underlying these differences. METHODS: We identified patients undergoing elective EVAR in the Vascular Quality Initiative from 2003 to 2017 with linkage to Medicare claims through 2018 for long-term outcomes. Our primary outcome was 5-year aneurysm rupture. Secondary outcomes were 5-year reintervention and mortality and 2-year loss-to-imaging follow-up (defined as no aortic imaging from 6 to 24 months after EVAR). We used Kaplan-Meier and Cox regression analyses to evaluate these outcomes by sex/race/ethnicity and constructed multivariable models to explore potential contributing factors. RESULTS: Among 16,040 patients, 11,764 (73%) were White males, 2891 (18%) were White females, 417 (2.6%) were Black males, 175 (1.1%) were Black females, 141 (0.9%) were Asian males, 34 (0.2%) were Asian females, 277 (1.7%) were Hispanic males, and 60 (0.4%) were Hispanic females. At 5 years, rupture rates were highest in Black females at 6.4% and lowest in white males at 2.3%. Compared with White males, rupture rates were higher in White females (hazard ratio [HR], 1.5; 95% confidence interval [CI], 1.1-2.0), Black females (HR, 2.5; 95% CI, 1.0-6.0), and Asian females (HR, 5.2; 95% CI, 1.3-21). White females also had higher mortality (HR, 1.2; 95% CI, 1.2-1.3) and loss-to-imaging-follow-up (HR, 1.2; 95% CI, 1.1-1.3), whereas Black females had higher mortality (HR, 1.4; 95% CI, 1.1-1.8) and reintervention (HR, 2.0; 95% CI, 1.4-2.8). Among other groups, Black males had higher reintervention (HR, 1.4; 95% CI, 1.0-1.8), and both Black and Hispanic males had higher loss-to-imaging-follow-up (Black: HR, 1.4; 95% CI, 1.1-1.7; Hispanic: HR, 1.3; 95% CI, 1.0-1.8). In adjusted analyses, White, Black, and Asian females remained at significantly higher risk for 5-year rupture after accounting for procedure year, clinical and anatomic characteristics, surgeon and hospital volume, and loss-to-imaging follow-up. CONCLUSIONS: Compared with White male patients, Black females had higher 5-year aneurysm rupture, reintervention, and mortality after elective EVAR, whereas White females had higher rupture, mortality and loss-to-imaging-follow-up. Asian females also had higher rupture, and Black males had higher reintervention and loss-to-imaging-follow-up. These populations may benefit from improved preoperative counseling and clinical outreach after EVAR. A larger-scale investigation of current practice patterns and their impact on sex, racial, and ethnic disparities in late outcomes after EVAR is needed to identify tangible targets for improvement.

Overview of screening eligibility in patients undergoing ruptured AAA repair from 2003 to 2019 in the Vascular Quality Initiative.

OBJECTIVE: Although efforts such as the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act have improved access to abdominal aortic aneurysm (AAA) screening, certain high-risk populations are currently excluded from the guidelines yet may benefit from screening. We therefore examined all patients who underwent repair of ruptured AAA (rAAA) to characterize those who are ineligible for screening under current guidelines and evaluate the potential impact of these restrictions on their disease. METHODS: We identified patients undergoing rAAA repair in the Vascular Quality Initiative (VQI) database between 2003 and 2019. These patients were stratified by AAA screening eligibility according to the Centers for Medicare and Medicaid reimbursement guidelines. We then described baseline characteristics to identify high-risk features of these cohorts. Groups with disproportionate representation in the screening-ineligible cohort were identified as potential targets of screening expansion. Trends over time in screening eligibility and the proportion of AAA repairs performed for rAAA were also analyzed. RESULTS: A total of 5340 patients underwent rAAA repair. The majority (66%) were screening-ineligible. When characterizing the screening-ineligible group by sex and risk factors (smoking history or family history of AAA), the largest contributors to screening ineligibility were males less than 65 years of age with a smoking history or family history of AAA (25%), males greater than 75 years of age with a smoking history (25%), and females older than 65 years of age with a smoking history (19%). In comparison with rAAAs prior to implementation of the SAAAVE act, the proportion of AAA repair performed for rupture among males undergoing AAA repair in the VQI decreased from 12% to 8% (P < .001), whereas in females, there was no change (P = .990). There was no statically significant difference in screening eligibility for either males (P = .762) or females (P = .335). CONCLUSIONS: Most patients who underwent rAAA repair were ineligible for initial AAA screening or aged out of the screening window. Furthermore, rAAA rates and screening ineligibility have not improved as much as expected since the passage of the SAAAVE Act. Our data suggest that three high-risk populations may benefit from expansion of AAA screening guidelines: males with a smoking history or family history of AAA between ages 55 and 64 years, female smokers older than 65 years, and male smokers older than 75 years who are otherwise in good health. Increased efforts to screen these high-risk populations may increase elective AAA repair and minimize the morbidity and mortality associated with rAAAs.

A randomized study of the safety and pharmacokinetics of GSK3358699, a mononuclear myeloid-targeted bromodomain and extra-terminal domain inhibitor.

AIMS: GSK3358699 is a mononuclear myeloid-targeted bromodomain and extra-terminal domain (BET) family inhibitor which demonstrates immunomodulatory effects in vitro. This phase 1, randomized, first-in-human study evaluated the safety, pharmacokinetics, and pharmacodynamics of GSK3358699 in healthy male participants (NCT03426995). METHODS: Part A (N = 23) included three dose-escalating periods of 1-40 mg of GSK3358699 or placebo in two cohorts in a single ascending-dose crossover design. Part C (N = 25) was planned as an initial dose of 10 mg of GSK3358699 or placebo daily for 14 days followed by selected doses in four sequential cohorts. RESULTS: In part A, exposure to GSK3358699 and its metabolite GSK3206944 generally increased with increasing doses. The median initial half-life ranged from 0.7 to 1.1 (GSK3358699) and 2.1 to 2.9 (GSK3206944) hours after a single dose of 1-40 mg. GSK3206944 concentrations in monocytes were quantifiable at 1-hour post-dose following 10 mg of GSK3358699 and 1 and 4 hours post-dose following 20-40 mg. Mean predicted percentage inhibition of ex vivo lipopolysaccharide-induced monocyte chemoattractant protein (MCP)-1 reached 75% with 40 mg of GSK3358699. GSK3358699 did not inhibit interleukin (IL)-6 and tumour necrosis factor (TNF). The most common adverse event (AE) was headache. Four AEs of nonsustained ventricular tachycardia were observed across parts A and C. One serious AE of atrial fibrillation (part C) required hospitalization. CONCLUSIONS: Single doses of GSK3358699 are generally well tolerated with significant metabolite concentrations detected in target cells. A complete assessment of pharmacodynamics was limited by assay variability. A causal relationship could not be excluded for cardiac-related AEs, resulting in an inability to identify a suitable repeat-dose regimen and study termination.

Protocolized Based Management of Cerebrospinal Fluid Drains in Thoracic Endovascular Aortic Aneurysm Repair Procedures.

BACKGROUND: Spinal cord ischemia (SCI) resulting in paraplegia is a devastating complication associated with thoracic endovascular aortic aneurysm repair (TEVAR) whose incidence has significantly declined over time. In this review, we present our experience with a multidisciplinary clinical protocol for cerebrospinal fluid (CSF) drain management in patients undergoing TEVAR. Furthermore, we aimed to characterize complications of CSF drain placement in a large, single center experience of patients who underwent TEVAR. METHODS: This retrospective review is of patients undergoing TEVAR with and without CSF drain placement between January 2014 and December 2019 at a single institution. Patient demographics, hospital course, and drain-related complications were analyzed to assess the incidence of CSF drain-related complications. RESULTS: A total of 235 patients were included in this study, of which 85 received CSF drains. Eighty patients (94.1%) were placed by anesthesiologists, while 5 (5.9%) were placed under fluoroscopic guidance by interventional neurosurgery. The most common level of placement was L3-L4 in 38 (44.7%) cases followed by L4-L5 in 36 (42.4%) cases. The mean duration of CSF drain was 1.9 ± 1.4 days. Complications due to CSF drainage occurred in 5 (5.9%) patients and included partial retainment of catheter, subdural edema, epidural hematoma, headache, and bleeding near the drain site. The overall 30-day mortality rate was 5.5% and did not differ between those who received a CSF drain and those who did not (P = 0.856). The overall incidence of SCI resulting in paraplegia was 1.7% in the studied patients. CONCLUSIONS: A protocol-based CSF drainage program for spinal cord protection involves a multifaceted approach in identification and selection of patients meeting criteria for prophylactic drain placement, direct closed loop communication, and perioperative management by an experienced team. Despite the inherent advantages of CSF drain placement, it is not without complications, thus risk and benefit need to be weighed in context of the procedure and the patient with close communication and team approach.

Aspartate transaminase to platelet ratio index and Model for End-Stage Liver Disease scores are associated with morbidity and mortality after endovascular aneurysm repair among patients with liver dysfunction.

BACKGROUND: Liver cirrhosis dramatically increases morbidity and mortality after open surgical procedures and is often a contraindication to open repair of abdominal aortic aneurysms. However, limited data have evaluated the effect of liver disease on outcomes after endovascular repair of aortic aneurysms. METHODS: The National Surgical Quality Improvement Program was used to evaluate all nonemergent endovascular aneurysm repairs (EVARs) from 2005 to 2016. The aspartate transaminase to platelet ratio index is a sensitive, noninvasive screening tool used to screen for liver disease and was calculated for all patients. A value >0.5 was used to identify those with significant liver fibrosis. Demographics, comorbidities, and 30-day outcomes were then compared between patients with and patients without fibrosis. Additional analysis was then completed to assess the effect of increasing Model for End-Stage Liver Disease (MELD) score on 30-day outcomes. Multivariable regression was used to account for differences in baseline factors. RESULTS: EVAR was performed on 18,484 patients including 2286 with liver fibrosis and 16,198 without. Patients with liver fibrosis had an increased 30-day mortality (1.5% vs 2.4%; P < .01) and significantly higher rates of major morbidities including return to the operating room, pulmonary complications, transfusion, and discharge other than home. After multivariable analysis, patients with liver fibrosis had a significant increase in 30-day mortality (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1-2.1), return to the operating room (OR, 1.5; 95% CI, 1.2-1.8), pulmonary complications (OR, 1.6; 95% CI, 1.2-2.0), transfusion (OR, 1.7; 95% CI, 1.5-2.0), and discharge other than home (OR, 1.5; 95% CI, 1.3-1.8). In further analysis, mortality also increased in a stepwise fashion with increasing MELD score (MELD <10, 1.3%; MELD 10-15, 2.3%; MELD >15, 4.7%; P < .01), as did major complications (MELD <10, 7%; MELD 10-15, 11%; MELD >15, 15%; P < .01). These increases persisted in adjusted analysis. CONCLUSIONS: Liver fibrosis significantly increases mortality and major morbidity after EVAR. The aspartate transaminase to platelet ratio index and MELD score should be used for preoperative risk stratification. Moreover, current 30-day morbidity and mortality rates among patients with MELD scores >10 exceed 5%, which is higher than the annual rupture risk for aneurysms <6 cm. Therefore, an increased size threshold of >6 cm may be warranted before EVAR in patients with liver fibrosis.

The role of transfemoral carotid artery stenting with proximal balloon occlusion embolic protection in the contemporary endovascular management of carotid artery stenosis.

OBJECTIVE: Recent data have shown that transcarotid artery revascularization (TCAR) with flow reversal provides a superior method of embolic protection compared with transfemoral carotid artery stenting (tfCAS) with distal embolic protection. Flow reversal or flow arrest systems with proximal endovascular balloon occlusion can also be used through the transfemoral approach; however, their outcomes compared with TCAR with flow reversal and tfCAS with distal embolic protection are poorly described. METHODS: We performed a retrospective review of all patients undergoing tfCAS with proximal balloon occlusion, tfCAS with distal embolic protection, and TCAR with flow reversal in the Society for Vascular Surgery Vascular Quality Initiative from March 2005 to May 2019. We assessed in-hospital outcomes in propensity score-matched cohorts of patients using tfCAS with proximal balloon occlusion as the comparison cohort. The primary outcome was stroke or death. Secondary end points included the individual outcomes of stroke, death, transient ischemic attack (TIA), and myocardial infarction. RESULTS: Of the 24,232 patients undergoing carotid artery stenting, 561 (2.3%) procedures were performed through tfCAS with proximal balloon occlusion, 18,126 (74%) through tfCAS with distal embolic protection, and 5545 (22.9%) through TCAR with flow reversal. After matching, 463 pairs of patients undergoing tfCAS with proximal balloon occlusion and tfCAS with distal embolic protection were identified. There were no differences in stroke or death (proximal balloon, 3.2%; distal embolic protection, 3.7%; relative risk [RR], 0.88; 95% confidence interval [CI], 0.45-1.73; P = .73), stroke (2.4% vs 2.6%; RR, 0.92; 95% CI, 0.42-2.00; P = .83), death (1.1% vs 1.5%; RR, 0.71; 95% CI, 0.41-3.15; P = .80), TIA (1.7% vs 1.5%; RR, 1.14; 95% CI, 0.41-3.15; P = .80), or myocardial infarction (0.4% vs 0.6%; RR, 0.67; 95% CI, 0.11-3.99; P = .65). However, after matching 357 pairs of patients undergoing tfCAS with proximal balloon occlusion and TCAR with flow reversal, tfCAS with proximal balloon occlusion was associated with higher rates of stroke or death (3.1% vs 0.8%; RR, 3.67; 95% CI, 1.02-13.14; P = .03) and a trend toward higher rates of stroke (2.5% vs 0.8%; RR, 3.00; 95% CI, 0.81-11.08; P = .08) and death (0.8% vs 0.0%; P = .08), but no statistically significant differences in TIA (0.8% vs 0.8%; P > .99) or myocardial infarction (0.6% vs 0.3%; RR, 2.00; 95% CI, 0.18-22.06; P = .56). CONCLUSIONS: Compared with tfCAS with distal embolic protection, tfCAS with proximal balloon occlusion has similar major outcomes. However, tfCAS with proximal balloon occlusion does not offer the same degree of embolic protection compared with TCAR with flow reversal, given the significantly higher risk of perioperative stroke or death.

Thresholds for Abdominal Aortic Aneurysm Repair in England and the United States.

BACKGROUND: Thresholds for repair of abdominal aortic aneurysms vary considerably among countries. METHODS: We examined differences between England and the United States in the frequency of aneurysm repair, the mean aneurysm diameter at the time of the procedure, and rates of aneurysm rupture and aneurysm-related death. Data on the frequency of repair of intact (nonruptured) abdominal aortic aneurysms, in-hospital mortality among patients who had undergone aneurysm repair, and rates of aneurysm rupture during the period from 2005 through 2012 were extracted from the Hospital Episode Statistics database in England and the U.S. Nationwide Inpatient Sample. Data on the aneurysm diameter at the time of repair were extracted from the U.K. National Vascular Registry (2014 data) and from the U.S. National Surgical Quality Improvement Program (2013 data). Aneurysm-related mortality during the period from 2005 through 2012 was determined from data obtained from the Centers for Disease Control and Prevention and the U.K. Office of National Statistics. Data were adjusted with the use of direct standardization or conditional logistic regression for differences between England and the United States with respect to population age and sex. RESULTS: During the period from 2005 through 2012, a total of 29,300 patients in England and 278,921 patients in the United States underwent repair of intact abdominal aortic aneurysms. Aneurysm repair was less common in England than in the United States (odds ratio, 0.49; 95% confidence interval [CI], 0.48 to 0.49; P<0.001), and aneurysm-related death was more common in England than in the United States (odds ratio, 3.60; 95% CI, 3.55 to 3.64; P<0.001). Hospitalization due to an aneurysm rupture occurred more frequently in England than in the United States (odds ratio, 2.23; 95% CI, 2.19 to 2.27; P<0.001), and the mean aneurysm diameter at the time of repair was larger in England (63.7 mm vs. 58.3 mm, P<0.001). CONCLUSIONS: We found a lower rate of repair of abdominal aortic aneurysms and a larger mean aneurysm diameter at the time of repair in England than in the United States and lower rates of aneurysm rupture and aneurysm-related death in the United States than in England. (Funded by the Circulation Foundation and others.).

In-hospital versus postdischarge major adverse events within 30 days following lower extremity revascularization.

OBJECTIVE: Studies using hospital discharge data likely underestimate postoperative morbidity and mortality after lower extremity revascularization because they fail to capture postdischarge events. However, the degree of underestimation and the timing of postdischarge complications are not well-characterized. METHODS: We used the American College of Surgeons National Surgical Quality Improvement Program procedure-targeted vascular databases from 2011 to 2015 to tabulate 30-day adverse events (in hospital and after discharge) for lower extremity bypass (LEB) and percutaneous vascular interventions (PVIs) performed for claudication and chronic limb-threatening ischemia (CLTI). RESULTS: A total of 14,125 patients underwent lower extremity revascularization, 8909 patients (63%) with LEB and 5216 (37%) with PVI. For CLTI, total 30-day mortality was similar between PVI and LEB (2.3% vs 2.1%; P = .61), but in-hospital deaths only accounted for 43% of PVI mortality and only 65% of LEB mortality (P ≤ .001). Major adverse cardiac events occurred in 2.9% of PVI patients and 4.6% of LEB patients (P < .001), with postdischarge events accounting for 37% of PVI events and 18% of LEB (P ≤ .001). Although the 30-day reoperation rates were 14% for PVI and 18% for LEB (P < .001), almost one-half occurred after discharge (PVI 46% vs LEB 44%; P = .55). Any postoperative major adverse events (MAEs) occurred in 22% of patients after PVI and 31% after LEB, with more than one-half occurring after discharge (PVI 56% vs LEB 53%; P = .17). For claudicants, total 30-day mortality was 0.4% for PVI and 0.7% for LEB (P = .32), with the vast majority of events occurring after discharge (PVI 90% vs LEB 50%; P = .049). The 30-day reoperation rates were 5.2% for PVI and 8.0% for LEB (P < .001), with more than one-half occurring after discharge (PVI 63% vs LEB 53%; P = .09). Any MAEs occurred in 7.0% of patients after PVI and 17% after bypass, with the majority occurring after discharge (PVI 65% vs LEB 63%; P = .66). CONCLUSIONS: Most MAEs occur less frequently after PVI than LEB. However, a significant number of major of adverse events after lower extremity revascularization occur after leaving the hospital, especially after PVI, which may overestimate its benefits compared with LEB if only in-hospital data are evaluated. These data demonstrate the importance of reporting 30-day rather than in-hospital outcomes when evaluating postoperative adverse events.

Thirty-Day Outcomes After Open Revascularization for Acute Mesenteric Ischemia From the American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND: Open revascularization for acute mesenteric ischemia (AMI) is associated with high perioperative morbidity and mortality; however, results from contemporary studies are varied. Therefore, we evaluated 30-day mortality after open revascularization for AMI and identified preoperative factors associated with mortality. METHODS: We performed a retrospective cohort study of patients in the American College of Surgeons National Surgical Quality Improvement Program database undergoing open mesenteric revascularization for AMI from 2005 to 2017. The primary outcome was 30-day mortality. We used multivariable logistic regression to identify preoperative factors independently associated with 30-day mortality. RESULTS: The study cohort included 918 patients; their median age was 70 years (interquartile range: 59-80 years), 62% were female, and 90% were white. Thirty-day mortality after open revascularization for AMI was 32%, specifically 35% after embolectomy, 31% after thromboendarterectomy, and 28% after mesenteric bypass. Mortality was higher in patients requiring concomitant bowel resection (38% vs. 29%, respectively, P < 0.01). The preoperative factor most strongly associated with 30-day mortality was disseminated cancer (odds ratio = 8.8, 95% confidence interval = 2.4-32, P = 0.001). Other factors independently associated with mortality were renal dysfunction, preoperative intubation, preoperative blood transfusion, diabetes, elevated preoperative international normalized ratio, elevated preoperative white blood cell count, and increasing age. CONCLUSIONS: In this retrospective cohort study using a real-world, nationwide cohort, open revascularization for AMI was associated with high mortality, with nearly one-third of patients dying within 30 days of their operation. The factors identified to be independently associated with 30-day mortality, particularly disseminated cancer, preoperative renal dysfunction, and elevated preoperative WBC count, are an important tool for preoperative risk stratification.

Black patients present with more severe vascular disease and a greater burden of risk factors than white patients at time of major vascular intervention.

BACKGROUND: Although many studies have demonstrated racial disparities after major vascular surgery, few have identified the reasons for these disparities, and those that did often lacked clinical granularity. Therefore, our aim was to evaluate differences in initial vascular intervention between black and white patients. METHODS: We identified black and white patients' initial carotid, abdominal aortic aneurysm (AAA), and infrainguinal peripheral artery disease (PAD) interventions in the Vascular Quality Initiative (VQI) registry from 2009 to 2014. We excluded nonblack or nonwhite patients as well as those with Hispanic ethnicity, asymptomatic PAD, or a history of prior ipsilateral interventions. We compared baseline characteristics and disease severity at time of intervention on a national and regional level. RESULTS: We identified 76,372 patients (9% black), including 35,265 carotid (5% black), 17,346 AAA (5% black), and 23,761 PAD interventions (18% black). For all operations, black patients were younger, more likely female, and had more insulin-dependent diabetes, hypertension, congestive heart failure, renal dysfunction, and dialysis dependence. Black patients were less likely to be on a statin before AAA (62% vs 69%; P < .001) or PAD intervention (61% vs 67%; P < .001) and also less likely to be discharged on an antiplatelet and statin regimen after these procedures (AAA, 60% vs 64% [P = .01]; PAD, 64% vs 67% [P < .001]). Black patients presented with more severe disease, including higher proportions of symptomatic carotid disease (36% vs 31%; P < .001), symptomatic or ruptured AAA (27% vs 16%; P < .001), and chronic limb-threatening ischemia (73% vs 62%; P < .001). Black patients more often presented with concurrent iliac artery aneurysms at the time of AAA repair (elective open AAA repair, 46% vs 26% [P < .001]; elective endovascular aneurysm repair, 38% vs 23% [P < .001]). CONCLUSIONS: Black patients present with more advanced disease at the time of initial major vascular operation. Efforts to control risk factors, identify and treat arterial disease in a timely fashion, and optimize medical management among black patients may provide opportunity to improve current disparities.

Preoperative anemia is associated with mortality after carotid endarterectomy in symptomatic patients.

OBJECTIVE: Preoperative anemia and blood transfusions are associated with worse outcomes after surgery. However, the impact of preoperative anemia and transfusions on outcomes after carotid endarterectomy (CEA) is unknown. METHODS: CEA patients from 2011 to 2015 in the American College of Surgeons National Surgical Quality Improvement Program Targeted Vascular module were compared by the presence of preoperative anemia (hematocrit <36%) after stratification by symptom status. Multivariable analysis accounted for differences in baseline characteristics. We included an interaction term in our multivariable model to assess whether the effect of anemia differed significantly between patients who received a perioperative transfusion and those who did not, with 30-day mortality as our primary outcome. RESULTS: Of 16,068 patients, 6734 (42%) were symptomatic, of whom 1500 (22%) had anemia. Of the 9334 asymptomatic patients, 1935 (21%) had anemia. Both symptomatic and asymptomatic anemic patients were more likely to be transfused perioperatively compared with nonanemic patients, with 7.0% vs 0.4%, and 5.8% vs 0.7% (both P < .001). Among symptomatic patients, those with anemia compared with those without had a higher rate of 30-day mortality (2.5% vs 0.7%; P < .001). After adjustment, anemic symptomatic patients had a higher 30-day mortality risk (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.9-5.0; P < .001) compared with nonanemic symptomatic patients. In addition, in symptomatic patients, we found a significant interaction between anemia and perioperative transfusion on the outcome of 30-day mortality (P = .004), with a higher risk in perioperatively transfused symptomatic patients with anemia (OR, 7.8; 95% CI, 3.4-18.0; P < .001) than in symptomatic patients with anemia who did not receive a perioperative transfusion (OR, 2.3; 95% CI, 1.4-3.9; P = .002). In asymptomatic patients, anemic and nonanemic patients had comparable 30-day mortality rates (0.9% vs 0.6%; P = .2). After adjustment, anemia was not associated with 30-day mortality in asymptomatic patients (OR, 1.0; 95% CI, 0.5-2.0; P = .9), nor did we identify an interaction between anemia and perioperative transfusion in asymptomatic patients (P = .1). Patients who received a preoperative transfusion had a higher 30-day mortality rate than anemic patients not receiving preoperative transfusion in both symptomatic (n = 31, 9.7% vs 2.5%; P = .04) and asymptomatic patients (n = 21, 9.5% vs 0.9%; P = .02). CONCLUSIONS: Preoperative anemia is a risk factor for 30-day mortality after CEA in symptomatic patients but not in asymptomatic patients. These results should be factored into the selection of symptomatic patients for CEA and dissuade treatment of asymptomatic patients scheduled for CEA who need a preoperative transfusion.

Vascular fellow and resident experience performing infrapopliteal revascularization with endovascular procedures and vein bypass during training.

OBJECTIVE: Endovascular aneurysm repair has led to a significant reduction in vascular trainee experience in the surgical treatment of aortic aneurysms. We sought to evaluate whether the vascular training paradigm or the "endovascular first" approach to lower extremity vascular disease has had a similar effect on trainee experience with infrapopliteal endovascular therapy and vein bypass. METHODS: Deidentified data were provided by the Vascular Surgery Board on the number of procedures performed by each 2014 fellowship and residency (0 + 5) graduate during training. Data were analyzed using parametric and nonparametric methods, where appropriate. RESULTS: Of 125 trainees (109 fellows, 16 residents), 33 (27%) performed 10 or fewer infrapopliteal vein bypasses and 37 (29%) performed 10 or fewer infrapopliteal endovascular procedures during their training. Eleven trainees (9%) performed 10 or fewer of both procedures. There was a positive correlation between number of infrapopliteal vein bypass and endovascular procedures performed (r = 0.19; P = .03). There was no difference between fellows and residents in the mean number of bypass operations performed during training (17.3 vs 19.1; P = .50; range, 0-53). However, residents performed more infrapopliteal endovascular procedures than fellows did (median, 29 vs 16; P = .03; range, 0-128). CONCLUSIONS: More than one in four graduates of both training paradigms finish with a low number of infrapopliteal bypasses and endovascular interventions. The number of these procedures needed for proficiency is not known. Vascular surgery training programs should critically evaluate the number of infrapopliteal procedures required to achieve proficiency.

The impact of race on outcomes after carotid endarterectomy in the United States.

OBJECTIVE: Black patients undergoing carotid endarterectomy (CEA) in the United States are more often symptomatic at presentation and have more comorbidities compared with white patients. However, the impact of race on outcomes after CEA is largely unknown. METHODS: We identified CEA patients in the Vascular Quality Initiative registry (2012-2017) and compared them by race (black vs white). All other nonwhite races (891 [1.4%]) and Hispanics (2222 [3.4%]) were excluded. We used multilevel logistic regression to account for differences in demographics and comorbidities. We assessed long-term survival using multivariable Cox regression. The primary outcome was perioperative stroke/death, with long-term survival as a secondary outcome. RESULTS: We included 57,622 CEA patients; 2909 (5.0%) were black, of whom 983 (34%) were symptomatic. Of the 54,713 white patients, 16,132 (30%) were symptomatic. Black patients, compared with white patients, had a higher vascular disease burden and were less likely to be operated on in a high-volume hospital or by a high-volume surgeon. In addition, black symptomatic patients, compared with white symptomatic patients, were more often operated on <2 weeks after the index neurologic symptom (47% vs 40%; P < .001). Perioperative stroke/death was comparable between black and white patients (symptomatic, 2.8% vs 2.2% [P = .2]; asymptomatic, 1.6% vs 1.3% [P = .2]), as was unadjusted survival at 3 years (93% vs 93%; P = .7). However, after adjustment, black patients did experience better long-term survival compared with white patients (hazard ratio, 0.8; 95% confidence interval, 0.7-0.9; P = .01). On multilevel logistic regression, race was not associated with perioperative stroke/death (odds ratio, 1.0; 95% confidence interval, 0.8-1.3; P = .98). CONCLUSIONS: Despite the greater prevalence of vascular risk factors in black patients and racial inequalities in surgical treatment, rates of perioperative stroke/death and unadjusted survival were similar between white and black patients. Moreover, black patients experienced better adjusted long-term survival after CEA.

Treatment outcomes in diabetic patients with chronic limb-threatening ischemia.

OBJECTIVE: There are conflicting reports about outcomes after infrainguinal bypass for chronic limb-threatening ischemia (CLTI) in patients with diabetes. We compared perioperative outcomes between patients with and patients without diabetes in the current era. METHODS: The National Surgical Quality Improvement Program vascular module, 2011 to 2014, was used to identify patients undergoing infrainguinal revascularization for CLTI. Patients with and without diabetes were compared in terms of presentation, comorbidities, operative approach, and 30-day outcomes. Major adverse limb events (MALEs) included 30-day major reintervention or amputation, and major adverse cardiovascular events (MACEs) included 30-day myocardial infarction, cardiac arrest, stroke, or death. Multivariable logistic regression was used to adjust for baseline differences. RESULTS: We identified 8887 patients undergoing open (5744; 50% diabetic) or endovascular (3143; 62% diabetic) treatment for CLTI. Patients with diabetes were younger and more often nonwhite, nonsmokers, and obese. Patients with diabetes presented more often with tissue loss (71% vs 47%; P < .001) and were more likely to be treated with endovascular intervention (41% vs 29%; P < .001). The 30-day mortality was similar before (open, 3.1% vs 2.8% [P = .53]; endovascular, 2.6% vs 2.1% [P = .37]) and after adjustment for baseline differences (open: odds ratio [OR], 1.1 [95% confidence interval (CI), 0.7-1.5]; endovascular: OR, 1.2 [95% CI, 0.7-2.0]). Patients with diabetes had longer lengths of stay (open, 8 vs 6 days [P < .001]; endovascular, 3 vs 2 days [P < .001]) and higher 30-day readmission rates (open, 21% vs 18% [P < .01]; endovascular, 20% vs 15% [P < .01]); however, these differences were no longer significant after adjustment for baseline differences. Patients with diabetes had a higher rate of MACEs (7.0% vs 5.1%; P < .01) and lower rate of MALEs (8.1% vs 10%; P < .01) after bypass. After adjustment, patients with diabetes still had a lower rate of MALEs (OR, 0.7; 95% CI, 0.6-0.9) but no longer had a higher rate of MACEs (OR, 1.2; 95% CI, 0.9-1.6). CONCLUSIONS: CLTI patients with diabetes undergoing revascularization have similar 30-day outcomes compared with those without diabetes, although they appear to be at lower risk for MALEs after bypass. Prolonged length of stay and readmission in patients with diabetes is not due to underlying diabetic disease but likely secondary to other baseline comorbidities, such as higher rates of tissue loss. Concern for worse perioperative outcomes in patients with diabetes after lower extremity bypass is unsubstantiated and should not discourage a physician from performing an open bypass.