Racial and sex disparities in inpatient outcomes of patients with ruptured abdominal aortic aneurysms in the United States.

BACKGROUND: Ruptured abdominal aortic aneurysm (AAA) is a medical emergency that requires immediate surgical intervention. The aim of this analysis was to identify the sex- and race-specific disparities that exist in outcomes of patients hospitalized with this condition in the United States using the National Inpatient Sample (NIS) to identify targets for improvement and support of specific patient populations. METHODS: In this descriptive, retrospective study, we analyzed the patients admitted with a primary diagnosis of ruptured AAA between January 1, 2016, and December 31, 2020, using the NIS database. We compared demographics, comorbidities, and in-hospital outcomes in AAA patients, and compared these results between different racial groups and sexes. RESULTS: A total of 22,395 patients with ruptured AAA were included for analysis. Of these, 16,125 patients (72.0%) were male, and 6270 were female (28.0%). The majority of patients (18,655 [83.3%]) identified as Caucasian, with the remaining patients identifying as African American (1555 [6.9%]), Hispanic (1095 [4.9%]), Asian or Pacific Islander (470 [2.1%]), or Native American (80 [0.5%]). Females had a higher risk of mortality than males (OR, 1.7; 95% confidence interval [CI], 1.45-1.96; P < .001) and were less likely to undergo endovascular aortic repair (OR, 0.70; 95% CI, 0.61-0.81; P < .001) or fenestrated endovascular aortic repair (OR, 0.71; 95% CI, 0.55-0.91; P = .007). Relative to Caucasian race, patients who identified as African American had a lower risk of inpatient mortality (OR, 0.50; 95% CI, 0.37-0.68; P < .001). CONCLUSIONS: In this retrospective study of the NIS database from 2016 to 2020, females were less likely to undergo endovascular intervention and more likely to die during their initial hospitalization. African American patients had lower rates in-hospital mortality than Caucasian patients, despite a higher burden of comorbidities. Future studies are needed to elucidate the potential factors affecting racial and sex disparities in ruptured AAA outcomes, including screening practices, rupture risk stratification, and more personalized guidelines for both elective and emergent intervention.

Differences in Perioperative Outcomes after Carotid Revascularization between White and Non-white Patients.

BACKGROUND: Racial disparities in carotid endarterectomy (CEA) and carotid artery stenting (CAS) continue to persist. We aimed to provide a large-scale analysis of racial disparities in perioperative outcomes of carotid revascularization in a nationally representative cohort of patients, with sub-analyses stratifying by procedure type and symptomatic status. METHODS: We studied all patients undergoing carotid revascularization between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Database. Univariate methods were used to compare patients' demographic and medical characteristics. Multivariable logistic regression analysis was used to compare adjusted perioperative outcomes between white patients (WP) and non-white patients (NWP). Sub-analysis was performed stratifying by method of revascularization and symptomatic status. RESULTS: A total of 31,356 carotid revascularizations were performed in 26,550 (84.7%) white patients and 4,806 (15.3%) non-white patients. On adjusted analysis, NWP had increased odds of stroke (OR:1.2, 95%CI:1.1-1.5, P = 0.0496), unplanned return to the OR (OR:1.4, 95%CI:1.1-1.6, P < 0.001) and restenosis (OR:2.6, 95%CI:1.7-3.9, P < 0.001). On sub-analysis, NWP undergoing CAS had increased odds of stroke/death (OR:2.2, 95%CI:1.1-4.3, P = 0.025), stroke (OR:2.9, 95%CI:1.3-6.0, P = 0.007), and stroke/TIA (OR:2.1, 95%CI:1.0-4.2, P = 0.025). NWP undergoing CEA had increased odds of unplanned return to the OR (OR:1.4, 95%CI:1.2-1.6, P < 0.001) and restenosis (OR:2.7, 95%CI:1.7-4.0, P < 0.001). CONCLUSION: NWP had higher rates of 30-day stroke, driven primarily by higher rates of perioperative stroke/death in NWP undergoing CAS. NWP undergoing CEA did not have higher rates of stroke/death after adjusted analysis, although they had higher rates of unplanned return to OR and restenosis. Upon stratification for symptomatic status, the stroke/death rate between NWP and WP was shown to be non-significant.

A systematic review and meta-analysis on early mortality after abdominal aortic aneurysm repair in females in urgent and elective settings.

OBJECTIVE: Females represent a group of patients with higher mortality after abdominal aortic aneurysm (AAA), endovascular (EVAR), or open surgical (OSR), repair. This systematic review aimed to evaluate the 30-day mortality after AAA repair in females, comparing both EVAR and OSR, in elective and urgent settings. METHODS: The protocol of the review was registered to the PROSPERO database (CRD42021242686). A search of the English literature was conducted, using PubMed, EMBASE, and CENTRAL databases, from inception to March 5, 2021, using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA). Only studies reporting on 30-day mortality of AAA repair, in urgent and elective settings, comparing EVAR and OSR, in the female population were eligible. Patients were stratified according to the need for elective or urgent repair. Symptomatic and ruptured cases were included into the urgent group. Individual studies were assessed for risk of bias using the (Risk Of Bias In Non-randomised Studies - of Interventions) ROBINS-I tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to evaluate the quality of evidence. The primary outcome was 30-day mortality after AAA repair in the female population, comparing EVAR and OSR. The outcomes were summarized as odds ratio, along with their 95% confidence intervals (CIs), through a paired meta-analysis. RESULTS: Eight studies reported data on 30-day mortality following AAA repair. A total of 56,982 females (22,995 EVAR vs 33,987 OSR) were included. A significantly reduced total 30-day mortality rate was recorded among females that underwent EVAR compared with OSR (odds ratio [OR], 0.25; 95% CI, 0.23-0.27; P < .001; Ι2 = 86%). In addition, a reduced 30-day mortality was found in females that underwent elective EVAR compared with OSR (OR, 0.37; 95% CI, 0.33-0.41; P < .001; Ι2 = 48%). Despite the fact that OSR was more frequently offered in the urgent setting (OR, 0.21; 95% CI, 0.19-0.23; P < .001; Ι2 = 84%), EVAR was associated with a reduced 30-day mortality (OR, 0.48; 95% CI, 0.40-0.57; P < .001; Ι2 = 0%). CONCLUSIONS: In females, EVAR is associated with lower 30-day mortality in both elective and urgent AAA repair, although it appears as less likely to be offered in the setting of urgent AAA repair.

Doença arterial obstrutiva periférica: um estudo comparativo entre revascularizações abertas e endovasculares realizadas em caráter de urgência no sistema público de saúde do Brasil entre 2010 e 2020 / Peripheral artery disease: a comparison of urgent open and endovascular revascularizations on the public health system in Brazil, from 2010 to 2020

RESUMO Contexto A doença arterial obstrutiva periférica apresenta alta prevalência, sendo associada a elevado risco de eventos cardiovasculares. A intervenção cirúrgica ou endovascular faz-se necessária na isquemia crítica do membro. Objetivos Avaliar a distribuição de realização de revascularizações abertas e endovasculares nas diferentes regiões do Brasil, analisando os custos para o sistema de saúde e a mortalidade relacionada a esses procedimentos. Métodos Foi realizado um estudo epidemiológico observacional transversal descritivo para avaliar as cirurgias abertas e endovasculares realizadas no sistema público de saúde do Brasil entre 2010 e 2020. Os dados foram coletados através do Departamento de Informática do SUS (Datasus). Resultados No período analisado, foram registradas 83.218 internações para realização de cirurgias abertas e endovasculares, com um custo total de R$ 333.989.523,17. Houve predominância das internações para os procedimentos percutâneos (56.132) em relação aos cirúrgicos convencionais (27.086). As Regiões Sudeste e Sul concentraram a maior parte do total de procedimentos realizados no país (83%), enquanto a Região Norte foi a que apresentou a menor taxa de internação. Observou-se uma tendência decrescente para os procedimentos abertos, e uma tendência crescente para os endovasculares. A média de permanência hospitalar foi menor nos procedimentos endovasculares (5,3 dias) em relação aos abertos (10,2 dias). Além disso, notou-se uma maior taxa de mortalidade hospitalar relacionada à revascularização aberta em relação à endovascular (5,24% versus 1,56%). Conclusões As técnicas endovasculares consistiram em uma abordagem dominante no tratamento cirúrgico da isquemia crítica, apresentando menor taxa de mortalidade hospitalar e menor tempo de internação quando comparada às cirurgias abertas.

ABSTRACT Background Peripheral artery disease (PAD) has high prevalence and is associated with high risk of cardiovascular events. Surgical or endovascular intervention is necessary in chronic limb-threatening ischemia. Objectives To evaluate the distribution of open and endovascular revascularizations in different regions of Brazil, analyzing the health system costs and mortality related to these procedures. Methods A descriptive, cross-sectional, observational, epidemiological study was carried out to evaluate open and endovascular surgeries performed on the SUS public healthcare system in Brazil, from 2010 to 2020. Data were collected from the SUS Department of Informatics (Datasus). Results Over the period analyzed, 83,218 admissions for open and endovascular surgeries were registered, with a total cost of R$ 333,989,523.17. There were more hospital admissions for percutaneous procedures (56,132) than for conventional surgery (27,086). Most of the procedures (83%) were performed in the country's Southeast and South regions, while the North region had the lowest number of procedures. Over the period evaluated, there was a decreasing trend for open procedures and an increasing trend for endovascular procedures. The average hospital stay was shorter for endovascular procedures (5.3 days) than for open surgery (10.2 days). The analysis of mortality related to these procedures revealed a higher rate of in-hospital mortality associated with open revascularization than with endovascular (5.24% vs. 1.56%). Conclusions Endovascular techniques constituted the primary approach for revascularization treatment in critical limb-threatening ischemia, with a lower in-hospital mortality rate and shorter hospital stay when compared to open surgeries.

How Does Female Sex Affect Complex Endovascular Aortic Repair? A Single Centre Cohort Study.

OBJECTIVE: There is growing evidence of a female patient disadvantage in complex endovascular aortic repair using fenestrated and branched endografts (FB-EVAR) primarily related to peri-procedural events including ischaemic and access vessel complications. This study aimed to determine the impact of sex differences on treatment patterns, and in hospital outcomes in a single centre cohort. METHODS: This was a retrospective cross sectional single centre cohort study of all consecutive FB-EVAR procedures provided to patients with asymptomatic pararenal and thoraco-abdominal aortic aneurysm (TAAA) between 1 January 2010 and 28 February 2021. Adjusted multivariable logistic regression models were developed using backward (Wald) elimination of variables to determine the independent impact of female sex on short term outcomes. RESULTS: In total, 445 patients (24.3% females, median age 73.0 years, IQR 66, 78) were included. Female patients had a smaller aneurysm diameter, less frequent coronary artery disease (29.6% vs. 44.8%, p = .007) and history of myocardial infarction (2.8% vs. 15.4%, p < .001) when compared with males. Females were more frequently treated for TAAA than males (49.1% vs. 25.2%, p < .001). The median length of post-procedural hospital stay was 10 days in females and 9 in males. In adjusted analyses, female sex was independently associated with higher mortality (odds ratio [OR] 10.135, 95% CI 2.264 - 45.369), post-procedural complications (OR 2.500, 95% CI 1.329 - 4.702), spinal cord ischaemia (OR 4.488, 95% CI 1.610 - 12.509), sepsis (OR 4.940, 95% CI 1.379 - 17.702), and acute respiratory insufficiency (OR 3.283, 95% CI 1.015 - 10.622) after pararenal aortic aneurysm repair during the hospital stay. CONCLUSION: In this analysis of consecutively treated patients, female sex was associated with increased in hospital mortality, peri-procedural complications, and spinal cord ischaemia after elective complex endovascular repair of pararenal aortic aneurysm, while no differences were revealed in the TAAA subgroup. These results suggest that sex related patient selection and peri-procedural management should be studied in future research.

Investigating the "Weekend Effect" on Outcomes of Patients Undergoing Endovascular Mechanical Thrombectomy for Ischemic Stroke.

OBJECTIVES: With growing evidence of its efficacy for patients with large-vessel occlusion (LVO) ischemic stroke, the use of endovascular thrombectomy (EVT) has increased. The "weekend effect," whereby patients presenting during weekends/off hours have worse clinical outcomes than those presenting during normal working hours, is a critical area of study in acute ischemic stroke (AIS). Our objective was to evaluate whether a "weekend effect" exists in patients undergoing EVT. METHODS: This retrospective, cross-sectional analysis of the 2016-2018 Nationwide Inpatient Sample data included patients ≥18 years with documented diagnosis of ischemic stroke (ICD-10 codes I63, I64, and H34.1), procedural code for EVT, and National Institutes of Health Stroke Scale (NIHSS) score; the exposure variable was weekend vs. weekday treatment. The primary outcome was in-hospital death; secondary outcomes were favorable discharge, extended hospital stay (LOS), and cost. Logistic regression models were constructed to determine predictors for outcomes. RESULTS: We identified 6052 AIS patients who received EVT (mean age 68.7±14.8 years; 50.8% female; 70.8% White; median (IQR) admission NIHSS 16 (10-21). The primary outcome of in-hospital death occurred in 560 (11.1%); the secondary outcome of favorable discharge occurred in 1039 (20.6%). The mean LOS was 7.8±8.6 days. There were no significant differences in the outcomes or cost based on admission timing. In the mixed-effects models, we found no effect of weekend vs. weekday admission on in-hospital death, favorable discharge, or extended LOS. CONCLUSION: These results demonstrate that the "weekend effect" does not impact outcomes or cost for patients who undergo EVT for LVO.

Outcomes after clipping and endovascular coiling for aneurysmal subarachnoid hemorrhage among dual-eligible beneficiaries.

Dual-eligible beneficiaries, individuals with both Medicare and Medicaid coverage, represent a high-cost and vulnerable population; however, literature regarding outcomes is sparse. We characterized outcomes in dual-eligible beneficiaries treated for aneurysmal subarachnoid hemorrhage (aSAH) compared to Medicare only, Medicaid only, private insurance, and self-pay. A 10-year cross-sectional study of the National Inpatient Sample was conducted. Adult aSAH emergency admissions treated by neurosurgical clipping or endovascular coiling were included. Multivariable regression was used to adjust for confounders. A total of 57,666 patients met inclusion criteria. Dual-eligibles comprised 2.8% of admissions and were on average younger (62.4 years) than Medicare (70.0 years), older than all other groups, and had higher mean National Inpatient Sample-Subarachnoid Hemorrhage Severity Scores than all other groups (p ≤ 0.001). Among patients treated by clipping, dual-eligibles were less often discharged to home compared to Medicare (adjusted odds ratio (aOR) = 0.51, 95% CI = 0.30-0.87, p < 0.05) and all other insurance groups, p < 0.01. Likewise, those who received coiling were less often discharged to home compared to Medicaid (aOR = 0.41, 95% CI = 0.23-0.73), private (aOR = 0.42, 95% CI = 0.23-0.76) and self-pay patients (aOR = 0.24, 95% CI = 0.12-0.46). They also had increased odds of poor National Inpatient Sample-Subarachnoid Hemorrhage Outcome Measures compared to Medicaid, private, and self-pay patients, all p < 0.05. There were no differences in inpatient mortality or total complications. In conclusion, dual-eligible patients had higher aSAH severity scores, less often discharged home, and among patients who received coiling, dual-eligibles had increased odds of poor outcome. Dual-eligible patients with aSAH represent a vulnerable population that may benefit from targeted clinical and public policy initiatives.

Not all risk scores are created equal: A comparison of risk scores for abdominal aortic aneurysm repair in administrative data and quality improvement registries.

OBJECTIVE: Accurate and contemporary prognostic risk prediction is essential to inform clinical decision-making surrounding abdominal aortic aneurysm (AAA) care. Therefore, we validated and compared three different in-hospital mortality risk scores in one administrative and two quality improvement registries. METHODS: We included patients who had undergone elective AAA repair from 2012 to 2015 in the National Inpatient Sample (NIS), Vascular Quality Initiative (VQI; excluding the New England region), and the National Surgical Quality Improvement Program (NSQIP) datasets to validate three risk scores: Medicare, the Vascular Study Group of New England (VSGNE), and Glasgow Aneurysm Score (GAS). The receiver operating characteristic area under the curve (AUC) of all risk scores was calculated, and their discrimination was compared within a dataset using the Delong test and between datasets using a Z test. We constructed graphic calibration curves for the Medicare and VSGNE risk scores and compared the calibration using an integrated calibration index, which indicates the weighted average of the absolute difference between the calibration curve and the diagonal line of perfect calibration. RESULTS: We identified a total of 25,461 NIS, 18,588 VQI, and 8051 NSQIP patients who had undergone elective open or endovascular AAA repair. Overall, the Medicare risk score was more likely to overestimate mortality in the quality improvement registries and the VSGNE risk score underestimated mortality in all the databases. After endovascular AAA repair, the Medicare risk score had a higher AUC in the NIS than in the GAS (P < .001) but not compared with the VSGNE risk score (P = .54). The VSGNE risk score was associated with a significantly higher receiver operating characteristic AUC compared with the Medicare (P < .001) and GAS (P < .001) risk scores in the VQI registry. Also, the VSGNE risk score showed improved calibration compared with the Medicare risk score across all three databases (P < .001 for all). After open repair, the Medicare risk score showed improved calibration compared with the VSGNE risk score in the NIS (P < .001). However, in the VQI registry, the VSGNE risk score compared with the Medicare risk score had significantly better discrimination (P = .008) and calibration (P < .001). CONCLUSIONS: Overall, the VSGNE risk score performed best in the quality improvement registries but underestimated mortality. However, the Medicare risk score demonstrated better calibration in the administrative dataset after open repair. Although the VSGNE risk score appeared to perform better in the quality improvement registries, its overly optimistic mortality estimates and its reliance on detailed anatomic and clinical variables reduces its broader applicability to other databases.

Epidemiological Analysis of 37,424 Carotid Artery Stenosis Intervention Procedures During 11 Years in the Public Health System in Brazil: Stenting has Been More Common Than Endarterectomy.

BACKGROUND: Stroke is a leading cause of death worldwide, with carotid atherosclerosis accounting for 10-20% of cases. In Brazil, the Public Health System provides care for roughly two-thirds of the population. No studies, however, have analysed large-scale results of carotid bifurcation surgery in Brazil. METHODS: This study aimed to describe rates of carotid artery stenting (CAS) and carotid endarterectomy (CEA) performed between 2008 and 2019 in the country through web scraping of publicly available databases. RESULTS: Between 2008 and 2019, 37,424 carotid bifurcation revascularization procedures were performed, of which 22,578 were CAS (60.34%) and 14,846 (39.66%) were CEA. There were 620 in-hospital deaths (1.66%), 336 after CAS (1.48%) and 284 after CEA (1.92%) (P = 0.032). Governmental reimbursement was US$ 77,216,298.85 (79.31% of all reimbursement) for CAS procedures and US$ 20,143,009.63 (20.69%) for CEA procedures. The average cost per procedure for CAS (US$ 3,062.98) was higher than that for CEA (US$ 1,430.33) (P = 0.008). CONCLUSIONS: In Brazil, the frequency of CAS largely surpassed that of CEA. In-hospital mortality rates of CAS were significantly lower than those of CEA, although both had mortality rates within the acceptable rates as dictated by literature. The cost of CAS, however, was significantly higher. This is a pioneering analysis of carotid artery disease management in Brazil that provides, for the first time, preliminary insight into the fact that the low adoption of CEA in the country is in opposition to countries where utilization rates are higher for CEA than for CAS.

Cost-effectiveness of transcarotid artery revascularization versus carotid endarterectomy.

OBJECTIVE: Recent studies have demonstrated that transcarotid artery revascularization (TCAR) has comparable outcomes to the surgical gold standard, carotid endarterectomy (CEA). However, few studies have analyzed the cost of TCAR, and no study has evaluated its cost-effectiveness. The purpose of this study is to conduct a cost-effectiveness analysis comparing TCAR with CEA for carotid artery stenosis. METHODS: We built a Markov microsimulation using transition probabilities and utilities from existing literature for symptomatic patients undergoing TCAR or CEA. Costs were derived from literature then converted to 2019 dollars. The model included six health states with monthly cycle lengths: surgery, death, alive after surgery, alive after myocardial infarction, alive after stroke, and alive after stroke and death. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness. RESULTS: For symptomatic patients, CEA cost $7821 for 2.85 QALYs, whereas TCAR cost $19154 for 2.92 QALYs, leading to an ICER of $152,229 per QALY gained in the TCAR arm. Sensitivity analysis demonstrated that our model was most sensitive to probability of restenosis, costs of TCAR, and costs of CEA. Probabilistic sensitivity analysis demonstrated TCAR would be considered cost-effective in 49% of iterations. CONCLUSIONS: This study found that, although 5-year costs for TCAR were greater than CEA, TCAR afforded greater QALYs than CEA. TCAR became cost-effective at 6 years of follow-up.

Outcomes after EVAR in females are similar to males.

INTRODUCTION: Women are less likely to develop infrarenal abdominal aortic aneurysm; however, when they do, it is almost always associated with challenging anatomy, more rapid aneurysmal growth rate and earlier rupture. Women generally have poorer outcomes following open aneurysm repair; and in this respect, the present study aims to evaluate if it is so after endovascular repair. METHODS: A retrospective analysis of our database was performed for patients underwent endovascular aneurysm repair (EVAR) between January 2013-March 2020. 249 elective EVAR patients were evaluated. Patients were categorized according to gender and 26 patients (10.4%) were female. Demographics and pre-peri-postoperative findings were compared. Propensity score matching (ratio 1:1) was performed to reduce selection bias. RESULTS: In the overall unmatched cohort, female population had more diabetes mellitus (p = 0.016) and hypertension (p = 0.005). However, coronary artery disease (p = 0.005) and coronary artery bypass grafting (p = 0.006) were more in male gender. Non-IFU implantation was higher in female group (38.5% vs. 11.5%, p = 0.025). After propensity matching, even though it was not statistically significant, early mortality for female gender was higher when compared to male gender (7.7% and 0%, respectively, p = 0.490). In the follow-up period, no difference in all-cause mortality, secondary interventions or complications have been observed between the genders. CONCLUSION: Challenging anatomy and subsequently treated patients outside IFU may be the reasons for higher morbidity and mortality in women. However, despite these factors female and male patients revealed equivalent early and late results.

Could Gender Impact on Immediate and Long-term Carotid Artery Stenting Outcome? Insight from an Italian Single Center Experience.

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.

Differences in Comorbidities Between Women and Men Treated with Elective Repair for Abdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis.

OBJECTIVES: Elective abdominal aortic aneurysm (AAA) repair is performed to prevent rupture. For reasons as yet unknown, the 30-day mortality risk after elective AAA repair is higher in women than in men. We hypothesised that this higher risk might be related to differences in comorbidity. METHODS: Systematic review (PROSPERO CRD42019133314) according to PRISMA guidelines. A search in the EMBASE/MEDLINE/CENTRAL databases identified 1870 studies that included patients who underwent elective AAA repair (final search February 17th, 2021). Ultimately, 28 studies were included and all reported comorbidities were categorised into 17 comorbidity groups. Additionally, 15 groups of clearly defined comorbidities were used for sensitivity analysis. For both groups, meta-analyses of each comorbidity were performed to estimate the difference in pooled prevalence between women and men with a random effects model. RESULTS: When analysing data of all reported comorbidities (17 groups), smoking [risk difference (RD) 11%, 95% confidence interval (CI) 4-18], diabetes (RD 3%, 95% CI 2-4), ischaemic heart disease (RD 12%, 95% CI 8-16), arrhythmia (RD 3%, 95% CI 0.4-5), liver disease (RD 0.1%, 95% CI 0.01-0.2), and cancer (RD 3%, 95% CI 2-4)) were less prevalent in women, whereas, hypertension (RD 4%, 95% CI 3-6) and pulmonary disease (RD 4%, 95% CI 3-5) were more prevalent in women. At the time of surgery women were significantly older than men (74.9 years versus 72.4; mean difference 2.4 years (95% CI 2.1-2.7)). In the sensitivity analysis of 15 comorbidity groups, the same comorbidities remained significantly different between women and men, except smoking and arrhythmia. Women had a higher mortality risk than men (RD 1%, 95% CI 1-2). CONCLUSIONS: Although women undergoing elective AAA repair have fewer baseline comorbidities than men, their 30-day mortality risk is higher. In-depth studies on the cause of death in women after elective AAA repair are needed to explain this discrepancy in mortality.

A Review of UK-based National and International Scientific Meeting Published Abstracts in Response to the Draft NICE Aortic Aneurysm Guidelines.

BACKGROUND: UK National Institute for Health and Care Excellence (NICE) draft clinical guidelines (CG) (2018) regarding aortic aneurysm repair were disputed internationally. We aim to appraise the academic response to the draft CG in terms of quantity and scientific quality by reviewing published conference abstracts from three major national and international, UK meetings. METHODS: Abstracts related to aortic practice from The Vascular Societies Annual Scientific Meeting, British Society for Endovascular Therapy (BSET) & Charing Cross (CX) meetings from 2019 were reviewed for methodology, sample size, data collection period, scientific quality and conclusions that supported or conflicted the draft guideline. RESULTS: A total of 549 abstracts were identified from VSGBI, BSET and CX abstract books of which, 226 (41.2%) were related to aortic practices. Of these, 115 (50.9%) were related to EVAR. Twenty-two of these abstracts (19.1%) were identified as having findings relevant to the draft guidelines. Eighteen (15.7%) were identified as findings that potentially conflict the draft CG and 4 (3.5%) that could support the initial recommendations. Six abstracts (5.2%) made direct reference to or challenged the draft CG. The median data collection period was 4 years. The median sample size was 102 patients. In general, scientific quality was poor, with 82% of selected abstracts were graded at level 2b. CONCLUSION: We have demonstrated a concerted response to the draft NICE clinical guidelines relating to the treatment of abdominal aortic aneurysms at three large scientific meetings. As a result of which and other factors, significant changes were made to the finalized NG156. There is still paucity in evidence regarding the long-term safety and cost-effectiveness of EVAR.

Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium.

OBJECTIVE: Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs. METHODS: The data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia). RESULTS: Of the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P = .043) but a lower prevalence of coronary artery disease (33% vs 52%; P < .0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P < .001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P < .001), experienced lower technical success (93% vs 98%; P = .002), and were less likely to be discharged to home (72% vs 83%; P = .009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P = .64), freedom from reintervention (81.7% vs 85.3%; P = .10), target vessel instability (87.5% vs 89.2%; P = .31), and survival (89.6% vs 91.7%; P = .26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P = .006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P = .46). CONCLUSIONS: Women undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated.

Late outcomes after endovascular and open repair of large abdominal aortic aneurysms.

OBJECTIVE: The risk of aortic abdominal aneurysm (AAA) rupture increases with an increasing aneurysm diameter. However, the effect of the AAA diameter on late outcomes after aneurysm repair is unclear. Therefore, we assessed the association of a large AAA diameter with late outcomes for patients undergoing open and endovascular AAA repair. METHODS: We identified all patients who had undergone elective open or endovascular infrarenal aneurysm repair from 2003 to 2016 in the Vascular Quality Initiative linked to Medicare claims for long-term outcomes. A large AAA diameter was defined as a diameter >65 mm. We assessed the 5-year reintervention, rupture, mortality, and follow-up rates. We constructed propensity scores and used inverse probability-weighted Kaplan-Meier estimations and Cox proportional hazard models to identify independent associations between large AAA repair and our outcomes. RESULTS: Of the 21,119 aneurysm repairs identified, 15.2% were for large AAAs. Of the 21,119 repairs, 19,017 were endovascular and 2102 were open. The large AAA cohort was less likely to have undergone endovascular aneurysm repair (EVAR; 84.9% vs 91%; P < .001), more likely to be older (median age, 76 vs 75 years; P < .001), and were less likely to be women (16.2% vs 21.7%; P < .001). After EVAR, patients with large AAAs had had lower adjusted 5-year freedom from reintervention (73.9% vs 84.6%; P < .001), freedom from rupture (88.5% vs 93.6%; P < .001), survival (58.0% vs 66.4%; P < .001), and freedom from loss to follow-up (77.7% vs 83.3%; P < .001) compared with patients with smaller AAAs. However, after open repair, the adjusted 5-year freedom from reintervention (95.8% vs 93.3%; P = .11), freedom from rupture (97.4% vs 97.8%; P = .32), survival (70.4% vs 74.0%; P = .13), and loss to follow-up (60.5% vs 62.8%; P = .86) were similar to the results for patients with smaller AAAs. For patients with large AAAs, the adjusted 5-year survival was lower after EVAR than that after open repair (55.3% vs 63.7%) but not after smaller AAA repair (67.3% vs 70.6%). CONCLUSIONS: The 5-year adjusted reintervention, ruptures, mortality, and loss to follow-up rates for patients who had undergone large AAA EVAR were higher than those for patients who had undergone small AAA EVAR and large AAA open repair. Therefore, for patients with large AAAs who are medically fit, open repair should be strongly considered. Furthermore, these findings highlight the necessity for rigorous long-term follow-up after EVAR.

Effect of Insurance Status on Outcomes of Acute Ischemic Stroke Patients Receiving Intra-Arterial Treatment: Results from the Paul Coverdell National Acute Stroke Program.

BACKGROUND: Stroke continues to be a leading cause of death and disability in the United States. Rates of intra-arterial reperfusion treatments (IAT) for acute ischemic stroke (AIS) are increasing, and these treatments are associated with more favorable outcomes. We sought to examine the effect of insurance status on outcomes for AIS patients receiving IAT within a multistate stroke registry. METHODS: We used data from the Paul Coverdell National Acute Stroke Program (PCNASP) from 2014 to 2019 to quantify rates of IAT (with or without intravenous thrombolysis) after AIS. We modeled outcomes based on insurance status: private, Medicare, Medicaid, or no insurance. Outcomes were defined as rates of discharge to home, in-hospital death, symptomatic intracranial hemorrhage (sICH), or life-threatening hemorrhage during hospitalization. RESULTS: During the study period, there were 486,180 patients with a clinical diagnosis of AIS (mean age 70.6 years, 50.3% male) from 674 participating hospitals in PCNASP. Only 4.3% of patients received any IAT. As compared to private insurance, uninsured patients receiving any IAT were more likely to experience in-hospital death (AOR 1.36 [95% CI 1.07-1.73]). Medicare (AOR 0.78 [95% CI 0.71-0.85]) and Medicaid (AOR 0.85 [95% CI 0.75-0.96]) beneficiaries were less likely but uninsured patients were more likely (AOR 1.90 [95% CI 1.61-2.24]) to be discharged home. Insurance status was not found to be independently associated with rates of sICH. CONCLUSIONS: Insurance status was independently associated with in-hospital death and discharge to home among AIS patients undergoing IAT.

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease.

OBJECTIVE: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. METHODS: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. RESULTS: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. CONCLUSIONS: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Is Endovascular Therapy for Stroke Cost-Effective Globally? A Systematic Review of the Literature.

OBJECTIVES: Cost-effectiveness of endovascular therapy (EVT) is a key consideration for broad use of this approach for emergent large vessel occlusion stroke. We evaluated the evidence on cost-effectiveness of EVT in comparison with best medical management from a global perspective. MATERIALS AND METHODS: This systematic review of studies published between January 2010 and May 2020 evaluated the cost effectiveness of EVT for patients with large vessel occlusion acute ischemic stroke. The gain in quality adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER), expressed as cost per QALY resulting from EVT, were recorded. The study setting (country, economic perspective), decision model, and data sources used in economic models of EVT cost-effectiveness were recorded. RESULTS: Twenty-five original studies from 12 different countries were included in our review. Five of these studies were reported from a societal perspective; 18 were reported from a healthcare system perspective. Two studies used real-world data. The time horizon varied from 1 year to a lifetime; however, 18 studies reported a time horizon of >10 years. Twenty studies reported using outcome data from randomized, controlled clinical trials for their models. Nineteen studies reported using a Markov model. Incremental QALYs ranged from 0.09-3.5. All studies but 1 reported that EVT was cost-effective. CONCLUSIONS: Evidence from different countries and economic perspectives suggests that EVT for stroke treatment is cost-effective. Most cost-effectiveness studies are based on outcome data from randomized clinical trials. However, there is a need to study the cost-effectiveness of EVT based solely on real-world outcome data.

Women have similar mortality but higher morbidity than men after elective endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Sex disparities regarding outcomes for women after open and endovascular abdominal aortic aneurysm repair have been well-documented. The purpose of this study was to review whether these disparities were also present at our institution for elective endovascular aneurysm repair (EVAR) and whether specific factors predispose female patients to negative outcomes. METHODS: All elective EVARs were identified from our three sites (Florida, Minnesota, and Arizona) from 2000 to 2018. The primary outcome was in-hospital mortality and three-year mortality. Secondary outcomes included complications requiring return to the operating room, length of hospitalization (LOH), intensive care unit (ICU) days, and location of discharge after hospitalization. Multivariable logistic regression models were used to assess for the risk of complications. RESULTS: There were 1986 EVARs; 1754 (88.3%) were performed in male and 232 (11.7%) in female patients. Female patients were older (79 years [interquartile range (IQR), 72-83 years] vs 76 years [IQR, 70-81 years]; P < .001), had a lower body mass index (median, 26.1 kg/m2 [IQR, 22.1-31.0 kg/m2] vs 28.3 kg/m2 [IQR, 25.3-31.6 kg/m2]; P < .001 and hematocrit (median, 37.6% [IQR, 33.4%-40.6%] vs 39.4% [IQR, 35.6%-42.6%]; P < .001) and had higher glomerular filtration rate (median, 84.4 mL/min per 1.73m2 [IQR, 62.3-103 mL/min/1.73 m2] vs 51.1 mL/min/1.73 m2 [IQR, 41.8-60.8 mL/min/1.73 m2]; P < .001. Female patients were also more likely to be active smokers (15.3% vs 13.1%; P < .001) and have chronic obstructive pulmonary disease (24.7% vs 15.3%; P = .001). They were less likely to have coronary artery disease (31.6% vs 45.6%; P < .001). Aneurysms in women were slightly smaller in size (median, 54 mm [IQR, 50.0-58.0 mm] vs 55 mm [IQR, 51.0-60.0 mm]; P = .004). In-hospital mortality and mortality at the 3-year follow-up was not significant between female and male patients (0.86% vs 0.17%; P = .11 and 38.4% vs 36.2%; P = .57). However, female patients returned to the operating room with a greater frequency than male patients (3.9% vs 1.4%; P = .011). LOH (mean, 3.4 ± 3.8 days vs 2.5 ± 2.4 days; P < .001) and ICU days (mean, 0.3 ± 2.0 days vs 0.1 ± 0.5 days; P < .001) were longer for female patients. After hospitalization, female patients were discharged to rehabilitation facilities in greater proportion (12.7% vs 3.1%; P < .001) than their male counterparts. On multivariable analysis, female sex was associated with a return to the operating room (odds ratio, 6.4; 95% confidence interval [CI], 1.4-3.5; P = .02), longer LOH (Coef 4.0; 95% CI, 1.0-2.5; P = .00007), more ICU days (Coef 2.8; 95% CI, 1.1-3.0; P = .005), and a greater likelihood of posthospitalization rehabilitation facility placement (odds ratio, 5.8; 95% CI, 1.5-2.4; P = .0001). CONCLUSIONS: Our three-site, single-institution data support sex disparities to the detriment of female patients regarding return to the operating room after EVAR, LOH, ICU days, and discharge to rehabilitation facility. However, we found no differences for in-hospital or 3-year mortality.