Mortality and hospitalization trends for aortic aneurysms and dissections in Mexico.

BACKGROUND: In Mexico, there is a paucity of evidence on mortality and hospitalization patterns associated with aortic aneurysms and dissections. OBJECTIVE: To analyze national databases and describe the epidemiological characteristics of different aortic pathologies. MATERIAL AND METHODS: Retrospective, cross-sectional, observational study, in which mortality and hospitalization attributed to aortic aneurysms and dissections were analyzed. Statistical analysis was performed on Stata 16. RESULTS: A total of 6,049 deaths were documented in the general population, which included 2,367 hospitalizations and 476 (20.1%) in-hospital deaths. In addition, a statistically significant age difference was found between mean age at death in the general population (69.5 years) and the in-hospital death group (64.1 years, p < 0.001). As for hospitalizations secondary to ruptured abdominal aortic aneurysms, 149 cases were identified, with a mean age of 65.6 years, out of whom 53 (35.5%) were under 65 years of age, with a mean age of 47.8 years. CONCLUSIONS: Epidemiological reports of aortic pathology in Mexico are scarce; therefore, implementation of screening and detection programs for aortic pathologies is necessary in order to address the disparities identified in this analysis.

ANTECEDENTES: Existe evidencia escasa en México respecto a la mortalidad y patrones del ingreso hospitalario asociados a aneurismas y disecciones aórticos. OBJETIVO: Analizar las bases de datos nacionales y describir las características epidemiológicas de diferentes patologías aórticas agudas. MATERIAL Y MÉTODOS: Estudio transversal y observacional de una base de datos retrospectiva, en el que se analizó la mortalidad y hospitalización atribuidas a aneurismas y disecciones aórticos. El análisis estadístico se realizó en Stata 16. RESULTADOS: Se documentaron 6049 muertes en la población general, 2367 hospitalizaciones y 476 muertes intrahospitalarias. Adicionalmente, se encontró una diferencia estadísticamente significativa entre las medias de edad de fallecimiento de la población general (65.5 años) y de los pacientes que murieron en el hospital (64.1 años), p < 0.001. En cuanto a las hospitalizaciones secundarias a aneurisma de aorta abdominal roto, 149 casos fueron evidenciados con una media de edad de 65.6 años; 53 (35.5 %) de estos tenía menos de 65 años, con una media de edad de 47.8 años. CONCLUSIONES: Los reportes epidemiológicos de patología aórtica en México son escasos, por ello la implementación de programas de tamizaje y la detección de patologías aórticas son necesarias para mejorar las disparidades encontradas en este análisis.

Physician-modified versus chimney endografting for pararenal aortic aneurysms: a systematic review and meta-analysis.

INTRODUCTION: We performed a systematic review and meta-analysis to assess the existing published evidence regarding the safety and efficacy of the endovascular aortic repair with chimney technique (ch-EVAR) and physician-modified stent-grafts (PMSGs) for the treatment of pararenal aortic aneurysm repair. EVIDENCE ACQUISITION: A systematic search of all relevant studies reported until October 2023 according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines was performed. The pooled 30-day mortality, peri- and postoperative complication rates were estimated using fixed or random effect methods. EVIDENCE SYNTHESIS: A total of 679 study titles were identified by the initial search strategy, of which 16 were considered eligible for inclusion in the meta-analysis. A total of 1094 patients (ch-EVAR N.=861 and PMSG N.=233) (90% male) were identified. The pooled 30-day mortality rate was 3.4% for ch-EVAR and 2.6% for PMSG. The major adverse events (MAE) in the early period was 14.7% for ch-EVAR and 18.5% PMSG, respectively. Higher occlusion rate was observed of the chimney stents grafts (8.2%) than the bridging stents (1.4%) during the follow-up period. CONCLUSIONS: Ch-EVAR and physician-modified technology are safe with low 30-day mortality in elective settings for pararenal aortic aneurysms repair. No significant differences were seen between the two surgical methods regarding the early major adverse events rate. However, higher occlusion rate for the chimneys can be expected over time.

Early multicentric outcomes of the on-label and CE-marked combination of the Endurant with the Radiant chimney graft for the chimney endovascular aortic repair (EnChEVAR): The LaMuR Registry.

BACKGROUND: The aim of this study was to evaluate the early results of the CE-marked standardized device combination consisting of Endurant and the Radiant chimney graft (En-ChEVAR) for the treatment of juxtarenal aortic aneurysms. METHODS: We analyzed multicentric non-industry sponsored case series evaluating the EnChEVAR technique for patients treated between December 2022 and February 2024. Clinical, perioperative procedure-related and radiological data were collected. The primary outcome measure was the freedom of a type Ia gutter-related endoleak at postoperative computed tomography angiography (CTA). Secondary outcome measures included early type Ia endoleak-related reinterventions, target vessel complications including dissection or loss of target vessel, major adverse events, and mortality. Continuous variables were presented as median (interquartile range [IQR]) and categorical variables as count and percentage. RESULTS: Ten patients were included in the present study. Eight (80%) were males, in nine cases a single chimney was implanted, and the other one was a double chimney graft placement. The treated aneurysms had an infrarenal neck length of 3.4 (1.2) mm. The rate of main body oversizing was 30%. The new neck length after chimney graft placement was 18 (3) mm. The median procedural time was 130 (17) mm, contrast medium use was 109 (26) mL, radiation time was 45 (12) min. The technical success was 100%. No type Ia endoleak was detected at the postoperative CTA. There were no target vessel issues. No major adverse events or death were observed. CONCLUSIONS: First reported cohort of patients treated with EnChEVAR demonstrated reproducible clinical and procedural outcomes within the 3 vascular centers with total exclusion of the aneurysms, patent renal arteries, and no evidence of gutter-related type IA endoleak. Further evidence with larger sample size of treated patients and longer follow-up are needed.

Postoperative serum mir-28-5p level has predictive value for the prognosis after endovascular abdominal aortic aneurysm repair.

BACKGROUND: We explored the clinical significance of miR-28-5p pre- and post-endovascular abdominal aortic aneurysm repair (EVAR) in abdominal aortic aneurysm (AAA) patients. METHODS: Subjects included AAA patients receiving EVAR and non-AAA people without statistical differences from AAA patient in comorbidities/Framingham risk score. Fasting elbow venous blood (4 mL) was collected in the morning of the day of EVAR surgery and in the morning of 3 months post-EVAR. Pre-/post-EVAR serum miR-28-5p expression, AAA maximum diameter alterations, CD3+/CD4+/CD8+/TC/TG pre-/post-EVAR, and the correlations between miR-28-5p and AAA maximum diameter were investigated. Prediction of miR-28-5p on post-EVAR mortality, prognosis, and independent factors of post-EVAR death were analyzed using receiver operating characteristic curve (ROC)/Kaplan-Meier curve/univariable and multivariable Cox regression. According to the cut-off value of ROC curve for postoperative miR-28-5p was the cut-off value, and the patients were classified into the miR-28-5p high- and low-expression groups. The survival or death of both groups were compared after 48-month follow-up. RESULTS: Serum miR-28-5p levels in AAA patients dropped post-EVAR. AAA patients showed notable differences in CD3+/CD4+/CD8+/TC/TG levels pre-/post-EVAR. The miR-28-5p low-expression group exhibited higher CD3+/CD4+ and lower CD8+/TC/TG levels. We observed a positive correlation between post-EVAR miR-28-5p and AAA maximum diameter and between the pre-/post-EVAR miR-28-5p fold change and the AAA maximum diameter change. Postoperative miR-28-5p demonstrated good predictive value for postoperative death. Hypertension, Framingham risk score, TC, TG, and miR-28-5p were independent influencing factors of post-EVAR death. CONCLUSION: EVAR decreased serum miR-28-5p expression in AAA patients. Post-operative miR-28-5p level and pre-/post-operative fold change level are positively-correlated with AAA diameter.

Comparison between the outcomes of transfemoral access and transfemoral access with adjunct upper extremity access in patients undergoing endovascular aortic repair: A pilot systematic review and meta-analysis.

Endovascular aortic repair is an emerging novel intervention for the management of abdominal aortic aneurysms. It is crucial to compare the effectiveness of different access sites, such as transfemoral access (TFA) and upper extremity access (UEA). An electronic literature search was conducted using PubMed, EMBASE, and Google Scholar databases. The primary endpoint was the incidence of stroke/transient ischemic attack (TIA), while the secondary endpoints included technical success, access-site complications, mortality, myocardial infarction (MI), spinal cord ischemia, among others. Forest plots were constructed for the pooled analysis of data using the random-effects model in Review Manager, version 5.4. Statistical significance was set at p < 0.05. Our findings in 9403 study participants (6228 in the TFA group and 3175 in the UEA group) indicate that TFA is associated with a lower risk of stroke/TIA [RR: 0.55; 95% CI: 0.40-0.75; p = 0.0002], MI [RR: 0.51; 95% CI: 0.38-0.69; p < 0.0001], spinal cord ischemia [RR: 0.41; 95% CI: 0.32-0.53, p < 0.00001], and shortens fluoroscopy time [SMD: -0.62; 95% CI: -1.00 to -0.24; p = 0.001]. Moreover, TFA required less contrast agent [SMD: -0.33; 95% CI: -0.61 to -0.06; p = 0.02], contributing to its appeal. However, no significant differences emerged in technical success [p = 0.23], 30-day mortality [p = 0.48], ICU stay duration [p = 0.09], or overall hospital stay length [p = 0.22]. Patients with TFA had a lower risk of stroke, MI, and spinal cord ischemia, shorter fluoroscopy time, and lower use of contrast agents. Future large-scale randomized controlled trials are warranted to confirm and strengthen these findings.

Associations of Preoperative Nutritional Status and Sarcopenia With Mortality in Patients With Abdominal Aortic Aneurysm After Open and Endovascular Abdominal Aortic Aneurysm Repair: A Retrospective Study.

OBJECTIVE: The effect of preoperative malnutrition and sarcopenia on outcomes in patients with abdominal aortic aneurysm (AAA) after open surgical repair (OSR) and endovascular abdominal aortic aneurysm repair is undefined. The authors conducted the study to address this issue in this population. DESIGN: A retrospective observational study. SETTING: A large tertiary hospital. PARTICIPANTS: Patients with AAA who underwent OSR and endovascular aneurysm repair (EVAR). INTERVENTIONS: Evaluation of nutritional status (Nutritional Risk Screening 2002 [NRS 2002] and the Controlling Nutritional Status [CONUT] scores), muscle size (skeletal muscle index), and postoperative parameters. MEASUREMENTS AND MAIN RESULTS: A total of 199 patients were reviewed from January 2020 to December 2022. Patients weew categorized into group A (CONUT <4) and group B (CONUT ≥4) based on whether their CONUT scores were less than 4. The mortality (p = 0.004) and the incidence of Clavien-Dindo class III complications (p = 0.007) in group B were higher than those in group A. CONUT score was an independent risk factor for midterm mortality (hazard ratio 1.329; 95% CI, 1.104-1.697; p = 0.002) and Clavien-Dindo class III complications (odds ratio 1.225; 95% CI, 1.012-1.482; p = 0.037) according to univariate and multivariate analyses, whereas NRS 2002 score and sarcopenia were not. Kaplan-Meier curves showed a lower midterm survival rate in group B (log-rank p < 0.001). CONCLUSION: In patients with AAA undergoing OSR or EVAR, a CONUT score ≥4 was associated with increased Clavien-Dindo class III complications and mortality. Preoperative nutritional status should be evaluated and optimized in this high-risk population.

Body mass index and the risk of abdominal aortic aneurysm presence and postoperative mortality: a systematic review and dose-response meta-analysis.

BACKGROUND: The clinical data regarding the relationships between BMI and abdominal aortic aneurysm (AAA) are inconsistent, especially for the obese and overweight patients. The aims of this study were to determine whether obesity is associated with the presence of AAA and to investigate the quantitative relationship between BMI and the risk of AAA presence and postoperative mortality. MATERIALS AND METHODS: PubMed, Web of Science, and Embase databases were used to search for pertinent studies updated to December 2023. The pooled relative risk (RR) with 95% CI was estimated by conventional meta-analysis based on random effects model. Dose-response meta-analyses using robust-error meta-regression (REMR) model were conducted to quantify the associations between BMI and AAA outcome variables. Subgroup analysis, sensitivity analysis, and publication bias analysis were performed according to the characteristics of participants. RESULTS: Eighteen studies were included in our study. The meta-analysis showed a higher prevalence of AAA with a RR of 1.07 in patients with obesity. The dose-response meta-analysis revealed a nonlinear relationship between BMI and the risk of AAA presence. A 'U' shape curve reflecting the correlation between BMI and the risk of postoperative mortality in AAA patients was also uncovered, suggesting the 'safest' BMI interval (28.55, 31.05) with the minimal RR. CONCLUSIONS: Obesity is positively but nonlinearly correlated with the increased risk of AAA presence. BMI is related to AAA postoperative mortality in a 'U' shaped curve, with the lowest RR observed among patients suffering from overweight and obesity. These findings offer a preventive strategy for AAA morbidity and provide guidance for improving the prognosis in patients undergone AAA surgical repair.

A Greek Multicentre Study Assessing the Outcome of Late Rupture After Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Late rupture after endovascular aortic aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA) is an increasing complication associated with a high mortality rate. This study aimed to analyse the causes and outcomes in patients with AAA rupture after EVAR. METHODS: A multi-institutional Greek study of late ruptures after EVAR between 2008 - 2022 was performed. Primary outcomes were intra-operative and in hospital death. RESULTS: A total of 70 patients presented with late rupture after EVAR (proportion of ruptured EVARs among all EVARs, 0.6%; 69 males; mean age 77.2 ± 6.7 years). The mean time interval between EVAR and late rupture was 72.3 months (range 6 - 180 months). In all cases the cause of rupture was the presence of an endoleak (type I, 73%) with sac enlargement. Moreover, 34% of subjects with rupture after EVAR had been lost to follow up and 32% underwent a secondary intervention. Additionally, 57 patients (81%) were treated by conversion to open surgical repair (COSR) and the remainder by endovascular correction of endoleak (ECE). Eleven intra-operative deaths (16%) were recorded. The overall in hospital mortality rate was 41% (23% ECE vs. 46% COSR; p = .21). Of the patients who presented as initially haemodynamically stable, 23% died during hospitalisation, while the respective mortality rate for patients who presented as unstable was 78% (odds ratio [OR] 11.8, 95% confidence interval [CI] 3.6 - 39.1; p < .001). Multivariable logistic regression analysis revealed that severity of haemodynamic shock was the most significant risk factor for intra-operative (OR 7.15, 95% CI 1.58 - 32.40; p = .010) and in hospital death (OR 9.53, 95% CI 2.79 - 32.58; p < .001). CONCLUSION: These data underline the devastating prognosis of late rupture after EVAR. Haemodynamic status at presentation was an important predictive factor for death both in the ECE and COSR groups. Rigorous follow up and prompt evaluation of an unstable patient in case of rupture after EVAR is recommended.

Propensity score analysis demonstrates no long term survival benefit from contemporary endovascular aneurysm repair compared to open in Aotearoa New Zealand.

BACKGROUND: Current guidelines for AAA management are based on landmark trials comparing EVAR and open aneurysm repair (OAR) conducted more than 20 years ago. Important advancements have been made in peri-operative care but the impact of EVAR and OAR on long-term patient survival has not been well reported using contemporary data. The objective of this study was to compare the short and long-term outcomes of OAR and EVAR in the recent era. METHODS: This retrospective observational study included all patients undergoing intact AAA repair in NZ from 1st of January 2011 until 31st of December 2019. Data was collected from national administrative and clinical vascular databases and matched using unique identifiers. Time-to-event survival analyses was conducted using cox proportional hazard models to adjust for confounders and propensity score matching were used. RESULTS: Two thousand two hundred and ninety-seven patients had an intact AAA repair with a median (IQR) age of 75 (69-80) years; 494 (21.2%) patients were females and 1206 (53%) underwent EVAR. The 30-day mortality for OAR and EVAR was 4.8% and 1.2%. The median (IQR) follow up was 5.2 (2.3-9.2) years. After propensity matching for co-variates, the study cohort consisted of 835 patients in each matched group. Patients undergoing EVAR had a higher overall mortality (HR 1.48 (95% CI: 1.26-1.74) after adjusting for confounders compared to OAR. CONCLUSION: Analysis of survival following EVAR and OAR in the current era demonstrates that patients that underwent EVAR had a lower 30-day mortality. However, in the long-term after adjusting for confounders OAR had a better overall survival.

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices.

Importance: The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues. Objective: To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system. Design, Setting, and Participants: This retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse. Exposure: Implantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021. Main Outcomes and Measures: The primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed. Results: In total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, -2.1% to 4.1%). Conclusions and Relevance: The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

Evaluation of the prognostic value of computed tomography-derived body composition in patients undergoing endovascular aneurysm repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) is the most common mode of repair of abdominal aortic aneurysms (AAA) in the UK. EVAR ranges from standard infrarenal repair to complex fenestrated and branched EVAR (F/B-EVAR). Sarcopenia is defined by lower muscle mass and function, which is associated with inferior perioperative outcomes. Computed tomography-derived body composition analysis offers prognostic value in patients with cancer. Several authors have evaluated the role of body composition analysis in predicting outcomes in patients undergoing EVAR; however, the evidence base is limited by heterogeneous methodology. METHODS: Six hundred seventy-four consecutive patients (58 (8.6%) female, mean (SD) age 74.4 (6.8) years) undergoing EVAR and F/B-EVAR at three large tertiary centres were retrospectively recruited. Subcutaneous and visceral fat indices (SFI and VFI), psoas and skeletal muscle indices, and skeletal muscle density were measured at the L3 vertebral level from pre-operative computed tomographies. The maximally selected rank statistic technique was used to define optimal thresholds to predict mortality. RESULTS: There were 191 deaths during the median follow-up period of 60.0 months. Mean (95% CI) survival in the low SMI versus high SMI subgroups was 62.6 (58.5-66.7) versus 82.0 (78.7-85.3) months (P < 0.001). Mean (95% CI) survival in the low SFI versus high SFI subgroups was 56.4 (48.2-64.7) versus 77.1 (74.2-80.1) months (P < 0.001). One-year mortality in the low SMI versus high SMI subgroups was 10% versus 3% (P < 0.001). Low SMI was associated with increased odds of one-year mortality (OR 3.19, 95% CI 1.60-6.34, P < 0.001). Five-year mortality in the low SMI versus high SMI subgroups was 55% versus 28% (P < 0.001). Low SMI was associated with increased odds of five-year mortality (OR 1.54, 95% CI 1.11-2.14, P < 0.01). On multivariate analysis of all patients, low SFI (HR 1.90, 95% CI 1.30-2.76, P < 0.001) and low SMI (HR 1.88, 95% CI 1.34-2.63, P < 0.001) were associated with poorer survival. On multivariate analysis of asymptomatic AAA patients, low SFI (HR 1.54, 95% CI 1.01-2.35, P < 0.05) and low SMI (HR 1.71, 95% CI 1.20-2.42, P < 0.01) were associated with poorer survival. CONCLUSIONS: Low SMI and SFI are associated with poorer long-term survival following EVAR and F/B-EVAR. The relationship between body composition and prognosis requires further evaluation, and external validation of the thresholds proposed in patients with AAA is required.

A stable aneurysm sac after endovascular aneurysm repair as a predictor for mortality: An in-depth analysis.

OBJECTIVE: The aim of the present study was to compare the long-term survival of patients with a stable aneurysm sac vs those with aneurysm sac regression after endovascular aneurysm repair (EVAR) and to identify the independent risk factors for aneurysm sac regression and mortality after EVAR. METHODS: We reviewed all the patients who had undergone EVAR from 2005 to 2018 with computed tomography angiography available at 1 year of follow-up. Aneurysm sac regression was defined as a diameter decrease of >10%. We used multivariable regression to identify the independent risk factors for sac regression. Kaplan-Meier analysis and Cox regression were performed to test the differences in 5-year mortality between a stable sac diameter and sac regression. RESULTS: The inclusion criteria were met by 325 patients, with 185 in the sac regression group and 140 in the stable sac group. Multivariable logistic regression analysis showed that treatment of a ruptured aneurysm was an independent risk factor for aneurysm sac regression (hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.07-0.96). Age (HR, 1.05; 95% CI, 1.01-1.09), ischemic heart disease (HR, 1.94; 95% CI, 1.13-3.31), neck thrombus (HR, 2.72; 95% CI, 1.07-6.95), and a type II endoleak (HR, 19.21; 95% CI, 7.32-50.40) were independent risk factors for a stable aneurysm sac diameter. Multivariable Cox regression showed a significantly increased risk of mortality for patients with a stable aneurysm sac after EVAR (odds ratio, 2.25; 95% CI, 1.36-3.72). No significant differences were found in cause of death between the two groups. CONCLUSIONS: A stable aneurysm sac after EVAR was associated with increased mortality. Age, ischemic heart disease, neck thrombus, and a type II endoleak were independent risk factors for a stable aneurysm sac. However, a well-founded explanation for this finding is still lacking. Future research should focus on aggressive treatment of type II endoleaks and inflammatory processes as potential pathophysiologic mechanisms.

Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm: a randomized, double-blind, placebo-controlled study.

Mortality remains high after emergency open surgery for a ruptured abdominal aortic aneurysm (RAAA). The aim of the present study was to assess, if intravenous (IV) Interferon (IFN) beta-1a improve survival after surgery by up-regulating Cluster of differentiation (CD73). This is a multi-center phase II double-blind, 2:1 randomized, parallel group comparison of the efficacy and safety of IV IFN beta-1a vs. placebo for the prevention of death after open surgery for an infra-renal RAAA. All study patients presented a confirmed infra-renal RAAA, survived the primary emergency surgery and were treated with IFN beta-1a (10 µg) or matching placebo for 6 days after surgery. Major exclusion criteria included fatal hemorrhagic shock, chronic renal replacement therapy, diagnosed liver cirrhosis, severe congestive heart failure, advanced malignant disease, primary attempt of endovascular aortic repair (EVAR), and per-operative suprarenal clamping over 30 min. Main outcome measure was all-cause mortality at day 30 (D30) from initial emergency aortic reconstruction. The study was pre-maturely stopped due to a reported drug-drug interaction and was left under-powered. Out of 40 randomized patients 38 were included in the outcome analyses (27 IFN beta-1a and 11 placebo). There was no statistically significant difference between treatment groups at baseline except more open-abdomen and intestinal ischemia was present in the IFN beta-1a arm. D30 all-cause mortality was 22.2% (6/27) in the IFN beta-1a arm and 18.2% (2/11) in the placebo arm (OR 1.30; 95% CI 0.21-8.19). The most common adverse event relating to the IFN beta-1a was pyrexia (20.7% in the IFN beta-1a arm vs. 9.1% in the placebo arm). Patients with high level of serum CD73 associated with survival (P = 0.001) whereas the use of glucocorticoids and the presence of IFN beta-1a neutralizing antibodies associated with a poor CD73 response and survival. The initial aim of the trial, if postoperative INF beta-1a treatment results on better RAAA survival, could not be demonstrated. Nonetheless the anticipated target mechanism up-regulation of CD73 was associated with 100% survival. According to present results the INF beta-1a induced up-regulation of serum CD73 was blocked with both use of glucocorticoids and serum IFN beta-1a neutralizing antibodies. The study was pre-maturely stopped due to interim analysis after a study concerning the use if IV IFN beta-1a in ARDS suggested that the concomitant use of glucocorticoids and IFN beta-1a block the CD73 induction. Trial registration: ClinicalTrials.gov NCT03119701. Registered 19/04/2017 (retrospectively registered).

A meta-analysis of safety and efficacy of endovascular aneurysm repair in aneurysm patients with severe angulated infrarenal neck.

OBJECTIVES: A growing number of abdominal aortic aneurysms with severe angulated neck anatomy is treated by endovascular means. However, contradictory early and late outcomes have been reported. Our review and outcome analysis attempted to evaluate the available literature and provide clinicians with a base for clinical implementation and future research. MATERIALS AND METHODS: A systematic review of the literature was undertaken to identify the outcomes of endovascular aneurysm repair in patients with severe infrarenal neck angulation (SNA ≥ 60°) vs non-severe neck angulation (NSNA). Outcome measures included perioperative complications, type 1a endoleak, neck-related secondary procedures, stent graft migration, aneurysm rupture, increase (>5mm) in sac diameter, all-cause and aneurysm-related mortality (PROSPERO Nr.: CRD42021233253). RESULTS: Six observational studies reporting on 5981 patients (1457 with SNA and 4524 with NSNA) with a weighted mean follow-up period of 1.8 years were included. EVAR in SNA compared with NSNA was associated with a higher rate of type 1a endoleak at 30 days (4.0% vs 1.8%; p< 0.00001), at 1 year (2.8% vs 1.9%; p<0.03), at 2 years (4.9% vs 2.1%; p< 0.0002), at 3 years (5.6% vs 2.6%; p< 0.0001). The rate of neck-related secondary procedures was significantly higher at 1 year (6.6% vs 3.9%; p<0.05) and at 3 years (13.1% vs 9%; p<0.05). Graft migration, aneurysm sack increase, aneurysm rupture and all-cause mortality were not statistically different at mid-term. CONCLUSIONS: The use of EVAR in severely angulated infrarenal aortic necks is associated with a high rate of early and mid-term complications. However, aortic related and all-causes mortality are not higher compared to patients with NSNA. Therefore, EVAR should be cautiously used in patients with SNA.

Treatment Outcome Trends for Non-Ruptured Abdominal Aortic Aneurysms: A Nationwide Prospective Cohort Study.

OBJECTIVE: The Dutch Surgical Aneurysm Audit (DSAA) initiative was established in 2013 to monitor and improve nationwide outcomes of aortic aneurysm surgery. The objective of this study was to examine whether outcomes of surgery for intact abdominal aortic aneurysms (iAAA) have improved over time. METHODS: Patients who underwent primary repair of an iAAA by standard endovascular (EVAR) or open surgical repair (OSR) between 2014 and 2019 were selected from the DSAA for inclusion. The primary outcome was peri-operative mortality trend per year, stratified by OSR and EVAR. Secondary outcomes were trends per year in major complications, textbook outcome (TbO), and characteristics of treated patients. The trends per year were evaluated and reported in odds ratios per year. RESULTS: In this study, 11 624 patients (74.8%) underwent EVAR and 3 908 patients (25.2%) underwent OSR. For EVAR, after adjustment for confounding factors, there was no improvement in peri-operative mortality (aOR [adjusted odds ratio] 1.06, 95% CI 0.94 - 1.20), while major complications decreased (2014: 10.1%, 2019: 7.0%; aOR 0.91, 95% CI 0.88 - 0.95) and the TbO rate increased (2014: 68.1%, 2019: 80.9%; aOR 1.13, 95% CI 1.10 - 1.16). For OSR, the peri-operative mortality decreased (2014: 6.1%, 2019: 4.6%; aOR 0.89, 95% CI 0.82 - 0.98), as well as major complications (2014: 28.6%, 2019: 23.3%; aOR 0.95, 95% CI 0.91 - 0.99). Furthermore, the proportion of TbO increased (2014: 49.1%, 2019: 58.3%; aOR 1.05, 95% CI 1.01 - 1.10). In both the EVAR and OSR group, the proportion of patients with cardiac comorbidity increased. CONCLUSION: Since the establishment of this nationwide quality improvement initiative (DSAA), all outcomes of iAAA repair following EVAR and OSR have improved, except for peri-operative mortality following EVAR which remained unchanged.

Comparative analysis of open abdominal aortic aneurysm repair outcomes across national registries.

OBJECTIVE: In a recent analysis, we discovered lower mortality after open abdominal aortic aneurysm repair (OAAA) in the Society for Vascular Surgery Vascular Quality Initiative (VQI) database when compared with previously published reports of other national registries. Understanding differentials in these registries is essential for their utility because such datasets increasingly inform clinical guidelines and health policy. METHODS: The VQI, American College of Surgeons National Surgical Quality Improvement Program (NSQIP), and National Inpatient Sample (NIS) databases were queried to identify patients who had undergone elective OAAA between 2013 and 2016. χ2 tests were used for frequencies and analysis of variance for continuous variables. RESULTS: In total, data from 8775 patients were analyzed. Significant differences were seen across the baseline characteristics included. Additionally, the availability of patient and procedural data varied across datasets, with VQI including a number of procedure-specific variables and NIS with the most limited clinical data. Length of stay, primary insurer, and discharge destination differed significantly. Unadjusted in-hospital mortality also varied significantly between datasets: NIS, 5.5%; NSQIP, 5.2%; and VQI, 3.3%; P < .001. Similarly, 30-day mortality was found to be 3.5% in VQI and 5.9% in NSQIP (P < .001). CONCLUSIONS: There are fundamental important differences in patient demographic/comorbidity profiles, payer mix, and outcomes after OAAA across widely used national registries. This may represent differences in outcomes between institutions that elect to participate in the VQI and NSQIP compared with patient sampling in the NIS. In addition to avoiding direct comparison of information derived from these databases, it is critical these differences are considered when making policy decisions and guidelines based on these "real-world" data repositories.

Non-guideline-compliant endovascular abdominal aortic aneurysm repair in women is associated with increased mortality and reintervention compared with men.

OBJECTIVE: Sex-based disparities in surgical outcomes have emerged as an important focus in contemporary healthcare delivery. Likewise, the appropriate usage of endovascular abdominal aortic aneurysm repair (EVAR) in the United States remains a subject of ongoing controversy, with a significant number of U.S. EVARs failing to adhere to the Society for Vascular Surgery (SVS) clinical practice guideline (CPG) diameter thresholds. The purpose of the present study was to determine the effect of sex among patients undergoing EVAR that was not compliant with the SVS CPGs. METHODS: All elective EVAR procedures for abdominal aortic aneurysms without a concomitant iliac aneurysm (≥3.0 cm) in the SVS Vascular Quality Initiative were analyzed (2015-2019; n = 25,112). SVS CPG noncompliant repairs were defined as a size of <5.5 cm for men and <5.0 cm for women. The primary endpoint was 30-day mortality. The secondary endpoints were all-cause mortality, complications, and reintervention. Logistic regression was performed to control for surgeon- and patient-level factors. Freedom from the endpoints was determined using the Kaplan-Meier method. RESULTS: Noncompliant EVAR was performed in 9675 patients (38.5%). Although men were significantly more likely to undergo such procedures (90% vs 10%; odds ratio [OR], 3.1; 95% confidence interval [CI], 2.9-3.4; P < .0001), the 30-day mortality was greater for the women than the men (1.8% vs 0.5%; P = .0003). Women also experienced significantly higher rates of multiple complications, including postoperative myocardial infarction (1% vs 0.3%; P = .006), respiratory failure (1.4% vs 0.6%; P = .01), intestinal ischemia (0.7% vs 0.2%; P = .003), access vessel hematoma (3% vs 1.2%; P = .0006), and iliac access vessel injury (2.4% vs 0.8%; P < .0001). Additionally, women experienced increased overall 1-year reintervention rates (11.5% vs 5.8%; P < .0001). In the adjusted analysis, 30-day mortality and any in-hospital complication risk remained significantly greater for the women (30-day death: OR, 3.1; 95% CI, 1.6-5.8; P = .0005; in-hospital complication: OR, 1.9; 95% CI, 1.4-2.6; P < .0001). Women also experienced increased reintervention rates over time compared with men (OR, 1.5; 95% CI, 1.1-2.2; P = .02). CONCLUSIONS: Although men were more likely to undergo non-CPG compliant EVAR, women experienced increased short-term morbidity and 30-day mortality and higher rates of reintervention when undergoing non-CPG compliant EVAR. These unanticipated findings necessitate increased scrutiny of current U.S. sex-based EVAR practice and should caution against the use of non-CPG compliant EVAR for women.