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Objective: To evaluate the risk for 90-day returns to care and long-term subsequent surgical interventions after primary endovascular aneurysm repair (EVAR) with an Endologix AFX Endovascular AAA System compared with three other high-volume endograft devices., Methods: We conducted a matched cohort study using data from Kaiser Permanente's Endovascular Stent Graft Registry. Patients aged ≥18 years who underwent primary EVAR for AAA in the health care system from January 1, 2011, to December 31, 2017, comprised the eligible study sample. The treatment group included patients who received an Endologix AFX or AFX2 device (n = 470). Patients who received one of three other high-volume endograft devices used within the health care system comprised the eligible comparison group (n = 2122). These patients were 2:1 propensity score matched without replacement to patients who received an Endologix device based on a number of patient and procedural characteristics. After the application of matching, conditional logistic regression was used to evaluate the likelihood for 90-day emergency department visit and readmission. Cause-specific Cox regression was used to evaluate the long-term risk of endoleak, graft revision, secondary reintervention (not including revision), conversion to open repair, and rupture during follow-up. Cox proportional hazards regression was used to evaluate the risk of mortality (overall and aneurysm related)., Results: The final matched study sample included 470 patients who received an Endologix AFX or AFX2 device and 940 patients who received a different high-volume device. compared with the other devices, AFX/AFX2 had a higher risk for type III endoleak (hazard ratio [HR], 38.79; 95% confidence interval [CI], 14.51-103.67), revision surgery >1 year after the primary EVAR (HR, 4.50; 95% CI, 3.10-6.54), rupture (HR, 6.52; 95% CI, 1.73-24.63), and aneurysm-related mortality (HR, 2.43; 95% CI, 1.32-4.47) was observed with the use of AFX/AFX2., Conclusions: In our matched cohort study, patients who received an Endologix AFX System during their primary EVAR had a higher risk for several adverse longitudinal outcomes, as well as aneurysm-related mortality, when compared with patients who received other high-volume devices. Patients who have received these devices should be monitored closely after EVAR., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: As endovascular aortic aneurysm repair (EVAR) matures into its third decade, measures such as long-term reintervention and readmission have become a focus of quality improvement efforts. Within a large United States integrated health care system, we describe time trends in the rates of long-term reinterventions utilization measures., Methods: Data from a United States multiregional EVAR registry was used to perform a descriptive study of 3891 adults who underwent conventional infrarenal EVAR for infrarenal abdominal aortic aneurysm between 2010 and 2019. Three-year follow-up was 96.7%. Outcomes included 1-, 3-, and 5-year graft revision (defined as a procedure involving placement of a new endograft component), secondary interventions (defined as a procedure necessary for maintenance of EVAR integrity [eg, coil embolization and balloon angioplasty/stenting]), conversion to open, interventions for type II endoleaks alone, and 90-day readmission. Crude cause-specific reintervention probabilities were calculated by operative year using the Aalen-Johansen estimator, with death as a competing risk and December 31, 2020 as the study end date., Results: Excluding interventions for type II endoleak alone, 1-year secondary intervention incidence decreased from 5.9% for EVARs in 2010 to 2.0% in 2019 (P < .001) and 3-year incidence decreased from 7.2% to 3.6% from 2010 to 2017 (P = .03). The 3-year incidences of graft revision (mean incidence, 3.4%) and conversion to open remained fairly stable (mean incidence, 0.6%) over time. The 3-year incidence of interventions for type II endoleak alone also decreased from 3.4% in 2010 to 0.7% in 2017 (P = .01). Ninety-day readmission rates decreased from 19.3% for index EVAR in 2010 to 9.2% in 2019 (P = .03)., Conclusions: Comprehensive data from a multiregional health care system demonstrates decreasing long-term secondary intervention and readmission rates over time in patients undergoing EVAR. These trends are not explained by evolving management of type II endoleaks and suggest improving graft durability, patient selection, or surgical technique. Further study is needed to define implant and anatomic predictors of different types of long-term reintervention., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI., Methods: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed., Results: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02)., Conclusions: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device., Study Design: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated., Results: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4)., Conclusions: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Prior work has established that performance on an endovascular simulator incorporating tactile feedback (haptics) correlates with previous endovascular experience and can be improved by training. This study was designed to test the ability to define and measure innate endovascular aptitude and empirically correct performance and to determine whether these are two different things., Methods: Subjects ranging in endovascular skill level from novice to expert were surveyed to determine video game experience and skill, endovascular level of training, and endovascular experience. They were then tested by using a standard protocol requiring timed advancement of a catheter and wire sequentially into each of three vessels arising from a simulated type I arch. Recorded trials were independently and blindly scored by two experienced endovascular faculty members by using a modification of a previously validated scale (Modified Reznick Scale; MRS). Summed scores were analyzed by frequency analysis and categorized as satisfactory and unsatisfactory on the basis of a clear bimodal distribution. Categorical outcome, time to task completion, and other variables were analyzed by means of linear regression, analysis of variance, and Welch modified two-sample t tests, as indicated., Results: A total of 61 subjects were enrolled: 42% students, 8% technicians, 19% surgeons, 13% cardiologists, and 18% radiologists. Of these, 62% were considered novices and 30% experts on the basis of previous experience; 56% of subjects worked in an endovascular-related occupation. MRS scores were highly correlated between raters (P < .0001) and showed a clear bimodal distribution, with subjects in any endovascular occupation (including technicians) scoring significantly better than all others (P < .0001). Hours of video games played per week were correlated highly with completion times (P < .001) and MRS scores (P < .001). Measures of formal training (number of endovascular cases and occupation) correlated highly with completion times (all P < .03) and MRS scores (all P < .008). In comparing completion times vs MRS scores, three groups were apparent: unskilled-inexperienced, skilled-inexperienced, and skilled-experienced, corresponding primarily to senior subjects without endovascular experience, younger subjects without endovascular experience, and formally trained endovascular physicians, respectively. Those judged intermediate in aptitude reduced times to the lowest possible level before improving their MRS scores., Conclusions: Although inherently subjective, the MRS yields reproducible scores that correlate with endovascular experience and formal training. Experts and novices with extensive video game experience achieve short completion times, whereas high MRS scores are achieved only by formally trained subjects. Innate endovascular aptitude and empirically correct performance may be two separate things, and aptitude may be acquirable through (or identified by) extensive nonmedical video game experience.

Objectives: The purpose of this study was to determine whether performance on a simulator model of carotid artery stenting correlates with previous endovascular experience and to assess the effects of repetition and training., Methods: Participants were stratified to untrained and advanced skill groups on the basis of number of endovascular procedures previously performed. Baseline performance was assessed by means of a pretest, and participants were randomized to practice and no-practice groups. Practice consisted of a 30-minute to 60-minute proctored session before taking a final test; those in the no-practice group proceeded directly to the final test without this session. Primary outcomes were completion of a standardized protocol and the length of time needed to complete all steps., Results: Twenty-nine subjects (16 untrained, 13 advanced) participated fully in the study. Ninety-two percent of participants in the advanced group successfully completed the pretest, versus 63% in the untrained group (P = .09); mean time to successful completion was 29.9 +/- 4.8 (mean +/- SD) versus 48.0 +/- 9.9 minutes, respectively (P < .001). Subjects who received no practice did not significantly improve their completion times between pretest and final test, whereas those who received practice did (novice, 47.9 +/- 7.0 minutes vs 24.5 +/- 2.9 minutes, P < .001; advanced, 29.6 +/- 3.1 minutes vs 20.2 +/- 4.1 minutes, P < .001). The group without previous training had significantly more time improvement from training than did the advanced group. Exit survey results showed that those who had the opportunity to practice more commonly believed that the simulator increased their endovascular skills and interest in vascular surgery (both P < .01 vs untrained group)., Conclusions: Performance on the carotid stenting simulator correlated with previous endovascular experience. Although both novice and advanced groups improved their time after a 30-minute to 60-minute proctored training session, improvement in the novice group was greater than that in the advanced group, which suggests that novices may benefit disproportionately from this type of training.