The impact of completion and follow-up endoleaks on survival, reintervention, and rupture.

OBJECTIVE: Endoleaks may be seen at case completion of endovascular abdominal aortic aneurysm repair (EVAR), and the presence of an endoleak may impact outcomes. However, the clinical implications of various endoleaks seen during follow-up is not well-described. Therefore, we studied the impact of endoleaks at completion and at follow-up on mid-term outcomes. METHODS: We reviewed patients who underwent EVAR from 2003 to 2016 within the Vascular Quality Initiative-Medicare database and identified patients with endoleak at procedure completion and during follow-up, excluding those presenting with rupture. We stratified cohorts by presence of completion and follow-up endoleak subtypes. The primary outcome was 5-year survival, and secondary outcomes included 5-year freedom from reintervention and freedom from rupture. We used Kaplan-Meier estimates and log-rank tests to analyze differences in time-to-event endpoints. RESULTS: Of 21,745 patients with completion endoleak data, 5085 (23%) had an endoleak. Compared with those without endoleak, those with type I endoleaks had lower 5-year survival (69% vs 75%; P < .001), type II endoleaks had higher survival (79%; P < .001), and types III, IV, and indeterminate were not statistically different (73%, 73%, and 75%, respectively). Freedom from reintervention for types I and III endoleaks were significantly lower than no endoleak cohort (I: 76%; P < .001; III: 72%; P < .001 vs 83%), but freedom from rupture was higher for those with type II and III endoleak (95% and 97% vs 94%; P < .001). Of 14,479 patients with detailed follow-up endoleak data, 2290 (16%) had an endoleak. Compared with those without endoleak, types I and III had significantly lower 5-year survival (I: 80%; P = .002; III: 66%; P < .001 vs 84%), but there were no differences for types II (82%) and indeterminate (77%). Those with any type of follow-up endoleak had lower 5-year freedom from reintervention (I: 70%; P < .001; II: 76%; P = .006; III: 36%; P < .001; indeterminate: 60%; P = .007 vs 84%), and lower freedom from rupture (I: 92%; P < .001; II: 91%; P = .16; III: 88%; P = .01; indeterminate: 90%; P = .11 vs 94%). CONCLUSIONS: Compared with patients with no endoleak, those with type I completion endoleaks have lower 5-year survival and freedom from reintervention. Patients with types I and III follow-up endoleaks also have lower survival, and any endoleak at follow-up is associated with lower freedom from reintervention and freedom from rupture. These data highlight the importance of careful patient selection and close postoperative follow-up after EVAR, as the presence of endoleaks, specifically type I and III, over time portends worse outcomes.

Racial Differences in Isolated Aortic, Concomitant Aortoiliac, and Isolated Iliac Aneurysms: This is a Retrospective Observational Study.

OBJECTIVE: Our aim was to describe the racial and ethnic differences in presentation, baseline and operative characteristics, and outcomes after aortoiliac aneurysm repair. SUMMARY OF BACKGROUND DATA: Previous studies have demonstrated racial and ethnic differences in prevalence of abdominal aortic aneurysms and showed more complex iliac anatomy in Asian patients. METHODS: We identified all White, Black, Asian, and Hispanic patients undergoing aortoiliac aneurysm repair in the VQI from 2003 to 2019. We compared baseline comorbidities, operative characteristics, and perioperative outcomes by race and ethnicity. RESULTS: In our 60,435 patient cohort, Black patients, followed by Asian patients, were most likely to undergo repair for aortoiliac (W:23%, B:38%, A:31%, H:22%, P < 0.001) and isolated iliac aneurysms (W:1.0%, B:3.1%, A:1.5%, H:1.6%, P < 0.001), and White and Hispanic patients were most likely to undergo isolated aortic aneurysm repair (W:76%, B:59%, A:68%, H:76%, P < 0.001). Black patients were more likely to undergo symptomatic repair and underwent rupture repair at a smaller aortic diameter. The iliac aneurysm diameter was largest in Black and Asian patients. Asian patients were most likely to have aortic neck angulation above 60 degree, graft oversizing above 20%, and completion endoleaks. Also, Asian patients were more likely to have a hypogastric artery aneurysm and to undergo hypogastric coiling. CONCLUSION: Asian and Black patients were more likely to undergo repair for aortoiliac and isolated iliac aneurysms compared to White and Hispanic patients who were more likely to undergo repair for isolated aortic aneurysms. Moreover, there were significant racial differences in the demographics and anatomic characteristics that could be used to inform operative approach and device development.

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

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

The association between device instructions for use adherence and outcomes after elective endovascular aortic abdominal aneurysm repair.

OBJECTIVE: Aortic neck anatomy has a significant impact on the complexity of endovascular aortic aneurysm repair (EVAR), with concern that neck characteristics outside of the instructions for use (IFU) may result in worse outcomes. Therefore, this study determined the impact of neck characteristics outside of the IFU on perioperative and 1-year outcomes and mid-term survival after EVAR. METHODS: We identified all patients undergoing elective infrarenal EVAR from December 2014 to May 2020 in the Vascular Quality Initiative database. Neck characteristics outside of the IFU were determined based the specific device IFU neck characteristics (neck diameter, length, and angulation). Patients without 1-year follow-up were excluded for the 1-year outcomes analyses (n = 6138 [40%]). We used multivariable adjusted logistic regression and Cox proportional hazard models to identify the independent associations between neck characteristics outside of the IFU and our outcomes. RESULTS: Of the 15,448 patients identified, 22.1% had neck characteristics outside of the IFU, including 6.6% with a infrarenal angle, 6.8% with a neck length, 10.4% with a neck diameter, and 1.1% with a suprarenal angulation outside of the IFU. Of these, 2.4% had more than one neck characteristic outside of the IFU. Patients with neck characteristics outside of the IFU were more often female (27.9% vs 15.0%; P < .001) and were older (median age, 75 years vs 73 years; P < .001). EVAR patients with neck characteristics outside of the IFU had higher rates of type Ia endoleaks at completion (4.8% vs 2.5%; P < .001), perioperative mortality (1.2% vs 0.6%; P < .001), 1-year sac expansion (7.1% vs 5.3%; P = .017), and 1-year reinterventions (4.4% vs 3.2%; P = .03). In multivariable adjusted analyses, neck characteristics outside of the IFU were independently associated with type Ia completion endoleaks (OR, 1.6; 95% CI, 1.3-2.0; P < .001), perioperative mortality (OR, 1.8; 95% CI, 1.2-2.7; P = .005), 1-year sac expansion (OR, 1.4; 95% CI, 1.0-1.8; P = .025), and 1-year reinterventions (OR, 1.4; 95% CI, 1.0-1.9; P = .039). The unadjusted midterm survival was lower for patients with neck characteristics outside of the IFU than for patients without (5-year survival 84.0% vs 86.7%; log-rank P < .001). However, after adjustment, survival was similar for patients with neck characteristics outside of the IFU to those within (hazard ratio, 1.1; 95% CI, 1.0-1.3; P = .22). CONCLUSIONS: Neck characteristics outside of the IFU are independently associated with completion type Ia endoleaks, perioperative mortality, 1-year sac expansion, and 1-year reinterventions among patients undergoing elective EVAR. These results indicate that continued effort is needed to improve the proximal seal in patients with neck characteristics outside of the IFU undergoing EVAR. Also, in patients with severe hostile neck characteristics, alternative approaches such as open repair, use of a fenestrated or branched device, or endoanchors should be considered.

A significant proportion of current endovascular aortic aneurysm repair practice fails to meet Society for Vascular Surgery clinical practice guideline recommended abdominal aortic aneurysm diameter treatment thresholds in the Vascular Quality Initiative.

BACKGROUND: There is mounting controversy surrounding the appropriate use of endovascular aortic aneurysm repair (EVAR) in contemporary practice. Persistent debate hinges on durability, cost, and survival. Accordingly, guidelines have attempted to clarify appropriate EVAR indications. The purpose of this analysis was to examine trends in EVAR practice throughout the United States and measure compliance with Society for Vascular Surgery (SVS) clinical practice diameter guidelines (CPGs). METHODS: We analyzed all elective repairs in the SVS Vascular Quality Initiative (VQI) EVAR registry from 2015 to 2019 (n = 25,112) and included patients with aneurysms confined to the infrarenal abdominal aorta. Center and surgeon variation with CPG diameter compliance was examined. Using a previously validated logistic regression model for risk adjustment, patients were stratified into predicted 1-year mortality risk tertiles and comparisons were made between patients meeting diameter guidelines (men ≥5.5;women ≥5.0 cm) and those who did not. RESULTS: Non-diameter-compliant EVAR occurred in 38.5% (n = 9675; diameter compliant, 61.5% [n = 15,437]). There was significant variation in CPG diameter compliance when stratified by VQI participating centers (range, 21%-95%; median, 61%; P < .001). This observation was amplified when categorized at the surgeon level (range, 0-100%; median, 63%; P < .0001). Notably, 82% of VQI surgeons (n = 852 of 1048) were non-diameter-compliant in more than 20% of their repairs. Moreover, among the 38.5% of patients failing to meet CPG diameter thresholds, 22.4% (n = 2171) were at high physiologic risk as determined by the validated SVS-VQI 1-year mortality calculator. Notably, the 1-year survival for the high-physiologic risk patients receiving non-guideline-compliant EVAR was worse compared with low- to intermediate-risk patients who were treated within recommended CPGs (92 ± 2% vs 97 ± 1%; log-rank P < .0001). CONCLUSIONS: A significant percentage of current US EVAR practice fails to adhere to the SVS diameter guidelines, as highlighted by the tremendous variation among VQI centers and surgeons. Furthermore, as noted by the 22% of patients undergoing noncompliant repair deemed to be at high physiologic risk, patient selection for EVAR seems to be suboptimal. Surprisingly, these findings are observed among the majority of VQI surgeons performing EVAR. In light of issues surrounding durability and cost, efforts to constrain observed deviation from recommended therapeutic size threshold guidelines would likely serve to improve abdominal aortic aneurysm care throughout the United States.

Sex-specific criteria for repair should be utilized in patients undergoing aortic aneurysm repair.

OBJECTIVE: Female patients are more likely to undergo repair of intact and ruptured abdominal aortic aneurysm (AAA) at smaller aortic diameter compared with male patients. By adjusting for inherent anatomic differences between sexes, aortic size index (ASI) and aortic height index (AHI) may provide an additional method for guiding treatment. We therefore analyzed sex-specific criteria for AAA repair using aortic diameter, ASI, and AHI. METHODS: We identified all patients who underwent AAA repair between 2003 and 2019 in the Vascular Quality Initiative database. The Dubois and Dubois formula was used to calculate body surface area; aortic diameter was divided by body surface area to calculate ASI. Aortic diameter was divided by height to calculate AHI. Cumulative distribution curves were used to plot the proportion of patients who underwent repair of ruptured aneurysm according to aortic diameter, ASI, and AHI. Multivariable logistic regression modeling was used to identify the association of female sex with perioperative mortality and any major postoperative complication. RESULTS: We identified 55,647 patients, of whom 12,664 were female (20%). For both intact and rupture repair, female patients were older, less likely to undergo endovascular aneurysm repair, and more likely to have comorbid conditions. Female patients underwent repair at smaller median aortic diameter compared with male patients for intact (5.4 vs 5.5 cm; P < .001) and rupture repair (6.7 vs 7.7 cm; P < .001). However, ASI was higher in female patients for both intact (3.1 vs 2.7 cm/m2; P < .001) and rupture repair (3.8 vs 3.7 cm/m2; P < .001), whereas AHI was higher in female patients for intact repair (3.3 vs 3.1 cm/m; P < .001) but lower for rupture repair (4.1 vs 4.3 cm/m; P < .001). When analyzing the cumulative distribution of rupture repair in male patients, 12% of rupture repairs were performed at an aortic diameter below 5.5 cm. To achieve the same proportion of rupture repair in female patients, the repair diameter was only 4.9 cm. However, when ASI and AHI were used, female and male patients both reached 12% of rupture repair at an ASI of 2.7 cm/m2 and an AHI of 3.0 cm/m. CONCLUSIONS: Our study provides data to strongly support the sex-specific 5.0-cm aortic diameter threshold suggested for repair in female patients by the Society for Vascular Surgery. The high percentage of patients undergoing rupture repair below 5.5 cm in male patients and 5.0 cm in female patients highlights the need to better identify patients at risk of rupture at smaller aortic diameters.

Long-term implications of elective evar that is non-compliant with clinical practice guideline diameter thresholds.

OBJECTIVE: Compliance with Society for Vascular Surgery (SVS) abdominal aortic aneurysm (AAA) clinical practice guideline (CPG)-diameter thresholds is variable for endovascular aneurysm repair (EVAR). To evaluate the implications and appropriateness of repairs that are noncompliant with current guidelines, we investigated the long-term outcomes, adherence to imaging follow-up, and associated health care costs in patients undergoing EVAR for AAA who do or do not meet recommended diameter thresholds. METHODS: All patients receiving elective EVAR from 2003 to 2016 in the SVS Vascular Quality Initiative with linked Medicare claims were reviewed. Weekend procedures and isolated iliac aneurysms, as well as symptomatic and ruptured presentations, were excluded. Diameter thresholds for noncompliant repairs were defined as: men <55 mm; women <50 mm who did not have an iliac diameter ≥30 mm. We evaluated adherence to postoperative imaging surveillance, reimbursement amounts, reintervention, rupture, and all-cause mortality. We defined an EVAR quality metric as performance of the index procedure with freedom from conversion to open repair, 5-year rupture-free survival, and adherence to minimum imaging surveillance (at least one computed tomography scan documented between 6 and 24 months postoperatively). RESULTS: Among 19,018 elective EVARs, 35% did not meet CPG diameter thresholds (26% within 5 mm of threshold). The rate of noncompliant repairs increased over time (24% in 2003 vs 36% in 2016; P < .001). Patients undergoing noncompliant repairs were younger, less likely to have multiple comorbidities, and more likely to receive EVAR with adherence to instructions for use criteria (89% vs 79%; P < .001). Patients undergoing noncompliant repairs had greater 5-year freedom from reintervention (86% vs 81%; P < .001), rupture-free survival (94% vs 92%; P = .01), and overall survival rates (71% vs 61%; P < .001) compared with repairs that complied with CPG diameter thresholds. Although noncompliant repairs had higher rates of 1-year imaging surveillance, overall differences were modest (68% vs 65%; P = .003). Importantly, for the entire cohort, follow-up imaging surveillance decreased over time (93% in 2003 vs 63% in 2014; P < .001). Notably, although noncompliant repairs had higher rates of achieving the composite quality metric compared with compliant repairs (43% vs 38%; P < .001), failure occurred with a significant majority of all repairs. CONCLUSIONS: Compliance with SVS-endorsed CPG diameter thresholds for elective EVAR is poor, and rates of noncompliance are increasing. Noncompliant repairs appear to be offered more commonly to patients with fewer comorbidities and favorable anatomy, and these repairs are associated with improved rates of reintervention, rupture, and survival compared with procedures meeting CPG diameter thresholds. Importantly, noncompliant repairs fail to meet minimum quality standards in a majority of cases, which underscores the need for further policies to improve the overall quality and appropriateness of AAA care delivery nationally.

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

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

Complications after thoracic endovascular aortic repair for ruptured thoracic aortic aneurysms remain high compared with elective repair.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) for ruptured thoracic aortic aneurysms is associated with increased perioperative mortality and morbidity compared with intact repair. The purpose of our study was to evaluate the factors associated with the presentation of ruptured aneurysms and adverse outcomes after repair. METHODS: The Vascular Quality Initiative (VQI) registry was queried (2010-2020) to identify patients who had undergone TEVAR for ruptured and intact thoracic aortic aneurysms. The primary outcome was to identify the factors associated with ruptured thoracic aortic aneurysms. The secondary outcomes included perioperative mortality and morbidity, 5-year survival, and the identification of factors associated with adverse outcomes after TEVAR. RESULTS: Of the 3039 patients identified with a thoracic aortic aneurysm, 2806 (92%) had undergone repair for an intact aneurysm and 233 (8%) had undergone repair for a ruptured aneurysm. Chronic kidney disease was associated with a greater odds of a presentation with a ruptured aneurysm (odds ratio [OR], 3.1; 95% confidence interval [CI], 2.0-4.9; P < .001). The factors associated with a lower odds of rupture included prior aortic aneurysm repair (OR, 0.71; 95% CI, 0.49-0.97; P = .05), prior smoker (OR, 0.36; 95% CI, 0.24-0.53; P < .001), preoperative beta-blocker therapy (OR, 0.57; 95% CI, 0.41-0.80; P = .001), and preoperative statin therapy (OR, 0.68; 95% CI, 0.49-0.94; P = .020). TEVAR for ruptured thoracic aortic aneurysms was associated with higher perioperative mortality (rupture vs intact, 27% vs 4.6%; OR, 6.6; 95% CI 4.3-10; P < .001) and the composite outcome of mortality, new dialysis, paralysis, and stroke (38% vs 9.5%; OR, 5.1; 95% CI, 3.5-7.4; P < .001). The 5-year survival was significantly lower after TEVAR for ruptured thoracic aortic aneurysms (50% vs 76%; P < .001; hazard ratio, 0.39; 95% CI, 0.29-0.52; P < .001). Preoperative statin therapy was associated with higher 5-year survival (hazard ratio, 1.3; 95% CI, 1.0-1.6; P = .021). CONCLUSIONS: TEVAR for ruptured thoracic aortic aneurysms results in increased perioperative mortality and morbidity and lower 5-year survival compared with TEVAR for intact aneurysms. Patients with prior aortic aneurysm repair, prior smoking, and preoperative beta-blocker or statin therapy were less likely to present with ruptured thoracic aneurysms. This correlation might be attributed to increased exposure to cardiovascular healthcare providers and, thus, subsequently increased screening and surveillance, allowing for elective repair of thoracic aortic aneurysms.

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.

Preoperative statin therapy is associated with higher 5-year survival after thoracic endovascular aortic repair.

OBJECTIVE: Statin use is associated with higher long-term survival after abdominal aortic aneurysm repair. However, the association between statin use and survival after thoracic endovascular aortic repair (TEVAR) has not been established. METHODS: We performed a review of prospectively collected data of all patients who had undergone TEVAR in the Vascular Quality Initiative between 2014 and 2020. We excluded patients aged <18 years, those who had presented with trauma, and those who had received custom-manufactured or physician-modified devices. We evaluated the association between preoperative statin therapy and in-hospital mortality and complications and 5-year mortality. We also analyzed the trend of preoperative statin use in elective cases for the previous 7 years. To account for nonrandom assignment to treatment, we used propensity score matching of patient characteristics, comorbidities, pathology, and urgency for preoperative statin use. We used logistic regression and Cox regression for the short-term and 5-year outcomes, respectively. RESULTS: Of 6266 patients who had undergone TEVAR and met the inclusion criteria, 3331 (53%) patients had been taking a statin preoperatively, including 1148 of 2267 (64%) treated for aneurysmal disease. After propensity score matching, 1875 patients were in each cohort. Preoperative statin use was associated with lower rates of any perioperative complication (16.7% vs 19.6%; odds ratio, 0.82; 95% confidence interval [CI] 0.69-0.97; P = .022). Overall, preoperative statin use was also associated with lower 5-year mortality (18.8% vs 24.5%; hazard ratio [HR], 0.74; 95% CI, 0.63-0.89; P = .001). When stratified by urgency, preoperative statin use was associated with lower 5-year mortality after elective TEVAR (14.9% vs 22.4%; HR, 0.62; 95% CI, 0.49-0.79; P < .001) but not after urgent or emergent TEVAR (27.4% vs 29.1%; HR, 0.89; 95% CI, 0.70-1.14; P = .37). When stratified by pathology, preoperative statin use was associated with significantly lower 5-year mortality for patients with aneurysms (HR, 0.63; 95% CI, 0.48-0.83; P = .001). Although the mortality was also lower for patients with dissection and "other" pathology, these differences did not reach statistical significance. Between 2014 and 2019, a significant increase had occurred in statin use among patients undergoing elective TEVAR, from 56% in 2014 to 64% in 2019 (P = .007). CONCLUSIONS: Preoperative statin therapy is associated with lower perioperative complication rates and 5-year mortality for patients undergoing TEVAR. All patients with known thoracic aortic pathology should receive statin therapy unless contraindications for the drug are present. For patients undergoing elective TEVAR, the statin prescription percentage should be considered a quality metric, and further implementation research should occur to improve preoperative statin use.

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.

Epidemiology of endovascular and open repair for abdominal aortic aneurysms in the United States from 2004 to 2015 and implications for screening.

BACKGROUND: Contemporary national trends in the repair of ruptured abdominal aortic aneurysms (AAAs) and intact AAAs are relatively unknown. Furthermore, screening is only covered by insurance for patients aged 65 to 75 years with a family history of AAAs and for men with a positive smoking history. It is unclear what proportion of patients who present with a ruptured AAA would have been candidates for screening. METHODS: Using the National Inpatient Sample from 2004 to 2015, we identified ruptured and intact AAA admissions and repairs using the International Classification of Diseases codes. We generated the screening-eligible cohort using previously identified proportions of male smokers (87%) and all patients with a family history of AAAs (10%) and applied these proportions to patients aged 65 to 75 years. We accounted for those who could have had a previous AAA diagnosis (17%), either from screening or an incidental detection in patients aged >75 years who had presented with AAA rupture. The primary outcomes were treatment and in-hospital mortality between patients meeting the criteria for screening vs those who did not. RESULTS: We evaluated 65,125 admissions for ruptured AAAs and 461,191 repairs for intact AAAs. Overall, an estimated 45,037 admitted patients (68%) and 25,777 patients who had undergone repair for ruptured AAAs (59%) did not meet the criteria for screening. Of the patients who did not qualify, 27,653 (63%) were aged >75 years, 10,603 (24%) were aged <65 years, and 16,103 (36%) were women. Endovascular AAA repair (EVAR) increased for ruptured AAAs from 10% in 2004 to 55% in 2015 (P < .001), with operative mortality of 35%. EVAR increased for intact AAAs from 45% in 2004 to 83% in 2015 (P < .001), with operative mortality of 2.0%. CONCLUSIONS: Most patients who had undergone repair for ruptured AAAs did not qualify for screening. EVAR was the primary treatment of both ruptured and intact AAAs with relatively low in-hospital mortality. Therefore, expansion of the screening criteria to include selected women and a wider age range should be considered.

A comparison of administrative data and quality improvement registries for abdominal aortic aneurysm repair.

OBJECTIVE: Databases are essential in evaluating surgical outcomes and gauging the implementation of new techniques. However, there are important differences in how data from administrative databases and surgical quality improvement (QI) registries are collected and interpreted. Therefore, we aimed to compare trends, demographics, and outcomes of open and endovascular abdominal aortic aneurysm (AAA) repair in an administrative database and two QI registries. METHODS: We identified patients undergoing open and endovascular repair of intact and ruptured AAAs between 2012 and 2015 within the National Inpatient Sample (NIS), the National Surgical Quality Improvement Program (NSQIP), and the Vascular Quality Initiative (VQI). We described the differences and trends in overall AAA repairs for each data set. Moreover, patient demographics, comorbidities, mortality, and complications were compared between the data sets using Pearson χ2 test. RESULTS: A total of 140,240 NIS patients, 10,898 NSQIP patients, and 26,794 VQI patients were included. Ruptured repairs composed 8.7% of NIS, 11% of NSQIP, and 7.9% of VQI. Endovascular aneurysm repair (EVAR) rates for intact repair (range, 83%-84%) and ruptured repair (range, 51%-59%) were similar in the three databases. In general, rates of comorbidities were lower in NIS than in the QI registries. After intact EVAR, in-hospital mortality rates were similar in all three databases (NIS 0.8%, NSQIP 1.0%, and VQI 0.8%; P = .06). However, after intact open repair and ruptured repair, in-hospital mortality was highest in NIS and lowest in VQI (intact open: NIS 5.4%, NSQIP 4.7%, and VQI 3.5% [P < .001]; ruptured EVAR: NIS 24%, NSQIP 20%, and VQI 16% [P < .001]; ruptured open: NIS 36%, NSQIP 31%, and VQI 26% [P < .001]). After stratification by intact and ruptured presentation and repair strategy, several discrepancies in morbidity rates remained between the databases. Overall, the number of cases in NSQIP represents 7% to 8% of the repairs in NIS, and the number of cases in VQI grew from 12% in 2012 to represent 23% of the national sample in 2015. CONCLUSIONS: NIS had the largest number of patients as it represents the nationwide experience and is an essential tool to evaluate trends over time. The lower in-hospital mortality seen in NSQIP and VQI questions the generalizability of the studies that use these QI registries. However, with a growing number of hospitals engaging in granular QI initiatives, these QI registries provide a valuable resource to potentially improve the quality of care provided to all patients.

Thoracic Endovascular Aortic Repair With Left Subclavian Artery Coverage Is Associated With a High 30-Day Stroke Incidence With or Without Concomitant Revascularization.

Purpose: To evaluate the perioperative stroke incidence following thoracic endovascular aortic repair (TEVAR) with differing left subclavian artery (LSA) coverage and revascularization approaches in a real-world setting of a nationwide clinical registry. Materials and Methods: The National Surgical Quality Improvement Program registry was interrogated from 2005 to 2017 to identify all nonemergent TEVAR and/or open LSA revascularization procedures. In this time frame, 2346 TEVAR cases met the selection criteria for analysis. The 30-day stroke incidence was compared between patients undergoing TEVAR with (n=888) vs without (n=1458) LSA coverage, for those with (n=228) vs without (n=660) concomitant LSA revascularization among those with coverage, and following isolated LSA revascularization for occlusive disease (n=768). Multivariable logistic regression was employed for risk-adjusted analyses and to identify factors associated with stroke following TEVAR. Results of the regression analyses are presented as the adjusted odds ratio (OR) with 95% confidence interval (CI). Results: The stroke incidence was 2.3% following TEVAR without vs 5.2% with LSA coverage (p<0.001). In TEVARs with LSA coverage, the stroke incidence was 7.5% when the LSA was concomitantly revascularized and 4.4% without concomitant revascularization, while stroke occurred in 0.5% of isolated LSA revascularizations. Of 33 TEVAR patients experiencing a perioperative stroke, 8 (24%) died within 30 days. LSA coverage was associated with stroke both with concomitant revascularization (OR 4.0, 95% CI 2.2 to 7.5, p<0.001) and without concomitant revascularization (OR 2.2, 95% CI 1.3 to 3.8, p=0.002). Other preoperative factors associated with stroke were dyspnea (OR 1.8, 95% CI 1.1 to 3.0, p=0.014), renal dysfunction (OR 2.2, 95% CI 1.0 to 3.8, p=0.049), and international normalized ratio ≥2.0 (OR 3.6, 95% CI 1.0 to 13, p=0.045). Conclusion: Stroke following TEVAR with LSA coverage occurs frequently in the real-world setting, and concurrent LSA revascularization was not associated with a lower stroke incidence.

Stroke rate after endovascular aortic interventions in the Society for Vascular Surgery Vascular Quality Initiative.

OBJECTIVE: The stroke rate after endovascular aneurysm repair (EVAR), particularly complex EVAR such as fenestrated EVAR (FEVAR) and chimney EVAR (chEVAR), is not well defined. Whereas stroke is a well-established risk of thoracic endovascular aortic repair (TEVAR), the impact of procedural characteristics on stroke remains unclear. Therefore, we characterized the risk of stroke after endovascular aortic interventions in the Vascular Quality Initiative database and identified procedural characteristics associated with stroke. METHODS: We performed a retrospective cohort study of patients undergoing infrarenal EVAR, complex EVAR, and TEVAR within the Vascular Quality Initiative between 2011 and 2019. Complex EVAR included FEVAR (with either a Food and Drug Administration-approved custom-manufactured device or physician-modified endovascular graft) and chEVAR. We excluded emergent procedures. The primary outcome was in-hospital stroke. We used multivariable logistic regression to identify procedural characteristics associated with stroke. RESULTS: We identified 41,540 EVARs, 1371 complex EVARs, and 4600 TEVARs. The in-hospital stroke rate was 0.1% after EVAR, 0.9% after complex EVAR, and 2.9% after TEVAR. In patients undergoing EVAR, aneurysm diameter >6.5 mm (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1-2.7; P = .03) and use of a proximal extension cuff (OR, 3.3; 95% CI, 1.4-7.9; P < .01) were independently associated with stroke. Among complex EVARs, stroke rate was 0.7% after FEVAR with a custom-manufactured device, 0.4% after FEVAR with a physician-modified endovascular graft, and 2.1% after chEVAR (P = .08). In multivariable analysis, arm access was associated with 8.4-fold higher odds of stroke (95% CI, 1.7-41; P < .01). Whereas chEVAR was associated with higher odds of stroke in crude analysis, this association did not persist after adjustment for arm access (OR, 1.0; 95% CI, 0.2-4.4; P = .99). In patients undergoing TEVAR, more proximal landing zones were associated with higher risk of stroke compared with zone 4/5 (zone 3: OR, 2.0 [95% CI, 0.9-4.2]; zone 2: OR, 3.8 [95% CI, 1.8-8.2]; zone 0/1: OR, 6.3 [95% CI, 2.8-14]). In terms of procedural characteristics, any involvement of the left subclavian artery was associated with stroke (bypass: OR, 2.5 [95% CI, 1.5-4.0]; stent: OR, 2.7 [95% CI, 0.9-8.5]; covered or occluded: OR, 2.5 [95% CI, 1.5-4.1]). CONCLUSIONS: Stroke, although rare after elective EVAR, is substantially more common after complex EVAR and TEVAR. Increasing procedural complexity in complex EVAR and TEVAR is associated with a higher stroke rate, a risk that should be factored into clinical decision-making. The strong association between stroke and upper extremity access during complex EVAR is alarming and warrants further study.

In-hospital outcomes alone underestimate rates of 30-day major adverse events after carotid artery stenting.

OBJECTIVE: Outcome studies using databases collecting only hospital discharge data underestimate morbidity and mortality because of failure to capture postdischarge events. The proportion of postdischarge major adverse events is well characterized in patients undergoing carotid endarterectomy (CEA) but has yet to be characterized after carotid artery stenting (CAS). METHODS: We retrospectively reviewed all patients undergoing CAS from 2011 to 2017 using the American College of Surgeons National Surgical Quality Improvement Program procedure targeted database to evaluate rates of 30-day major adverse events, stratified by in-hospital and postdischarge occurrences. The primary outcome was 30-day stroke/death. Multivariable analysis using purposeful selection was used to identify independent factors associated with in-hospital, postdischarge, and 30-day stroke/death events. RESULTS: Of the 899 patients undergoing CAS, reporting of in-hospital outcomes alone would yield a stroke/death rate of 2.7%, substantially underestimating the 30-day stroke/death rate of 4.0%. In fact, 35% of stroke/deaths, 27% of strokes, 73% of deaths, 35% of cardiac events, and 35% of stroke/death/cardiac events occurred after discharge. More postdischarge stroke/death events occurred after treatment of symptomatic compared with asymptomatic patients (47% vs 27%; P < .001). During this same study period, the 30-day stroke/death rate after CEA was 2.6%, with similar proportions of postdischarge strokes (28% vs 27%; P = .51) compared with CAS but lower proportions of postdischarge deaths (55% vs 73%; P < .001). After CAS, patients experiencing postdischarge stroke/death events had a shorter postoperative length of stay compared with patients with in-hospital stroke/death (1 [1-2] vs 5 [3-10] days; P < .001). Chronic obstructive pulmonary disease was independently associated with postdischarge stroke/death (odds ratio [OR], 4.4; 95% confidence interval [CI], 1.2-16; P = .02) after CAS. Nonwhite ethnicity was independently associated with overall 30-day stroke/death (OR, 3.4; 95% CI, 1.4-7.9; P < .01), whereas statin use was associated with not having stroke/death within 30 days (OR, 0.5; 95% CI, 0.2-1.0; P = .049). CONCLUSIONS: More than one-quarter of perioperative strokes occur following discharge after both CAS and CEA. A higher proportion of postdischarge deaths occur after CAS in symptomatic patients, which may reflect treatment of a population of higher risk patients. Further investigation is needed to elucidate the cause of postdischarge stroke to develop methods to reduce these complications.

Five-year survival following endovascular repair of ruptured abdominal aortic aneurysms is improving.

OBJECTIVE: Increasing experience and improving technology have led to the expansion of endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysms (AAA). We investigated whether the 5-year survival after both EVAR and open repair for ruptured AAA changed over the last 14 years. METHODS: We identified repairs for ruptured infrarenal AAA within the Vascular Quality Initiative registry between 2004 and 2018. We compared the 5-year survival of both EVAR and open repair between the early (2004-2012) and late (2013-2018) cohorts. In addition, we compared EVAR with open repair in the early and late cohorts. We used propensity score modeling to create matching cohorts for each analysis. Kaplan-Meier analysis was used to estimate survival proportions and univariate Cox proportional hazards analysis was used to compare differences in hazard of mortality in the matched cohorts. RESULTS: We identified 4638 ruptured AAA repairs. This included 409 EVARs in the early cohort and 2250 in the late cohort, as well as 558 open repairs in the early cohort and 1421 in the late cohort. Propensity matching resulted in 366 matched pairs of late vs early EVAR and 391 matched-pairs of late vs early open repair. When comparing EVAR with open repair, propensity matching resulted in 277 matched pairs of early EVAR versus open, and 1177 matched pairs of late EVAR versus open. In matched EVAR patients, 5-year survival was higher in the late cohort (63% vs 49%; hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.61-0.97; P = .027), whereas there was no difference between matched late vs early for open repair patients (52% vs 59%; HR, 1.04; 95% CI, 0.85-1.28; P = .69). In the early cohort, there was no survival difference between EVAR and open repair (51% vs 46%; HR, 0.88; 95% CI, 0.69-1.11; P = .28). However, in the late cohort EVAR was associated with higher survival compared with open repair (63% vs 54%; HR, 0.69; 95% CI, 0.60-0.79; P < .001). CONCLUSIONS: The 5-year survival after EVAR for ruptured AAA has improved over time, whereas survival after open repair remained constant. Consequently, the relative survival benefit of EVAR over open repair has increased over time, which should encourage further adoption of EVAR for ruptured AAA.

Injuries related to bicycle accidents: an epidemiological study in The Netherlands.

BACKGROUND: This study aims to analyze the incidence and outcomes of bicycle-related injuries in hospitalized patients in The Netherlands. METHODS: Bicycle accidents resulting in hospitalization in a level-I trauma center in The Netherlands between 2007 and 2017 were retrospectively identified. We subcategorized data of patients involved in a regular bicycle, race bike, off-road bike or e-bike accident. The primary outcomes were mortality rate and incidence of multitrauma. Secondary outcomes were differences between bicycle subcategories. Independent risk factors were identified using multivariable logistic regression. All variables with a p value < 0.20 in univariable analysis were entered in multivariable analysis. RESULTS: We identified 1986 patients. The mortality rate after emergency room admission was 5.7%, and 41.0% were multitraumas. A higher age, multitrauma and cerebral haemorrhages were independent risk factors for in hospital mortality. Independent risk factors found for multitrauma were a higher age, two-sided trauma, e-bike accidents and cerebral haemorrhage. CONCLUSION: Bicycle accidents resulting in hospitalization have a high mortality rate. Furthermore, a high incidence of multitrauma, fractures and cerebral haemorrhages were found. Considering the increasing incidence of bicycle accident victims needing hospital admission, new and more efficient prevention strategies are essential.