Early outcomes of endovascular repairs of the aortic arch using thoracic branch endoprosthesis.

OBJECTIVE: The only commercially available thoracic branched endoprosthesis (TBE) for treatment of the aortic arch was released in 2022. Limited data outside of clinical trial results have been reported. This study describes the demographics, anatomic details, and outcomes for patients treated for zone 0 to 2 using TBEs outside of a clinical trial. METHODS: All patients treated using TBEs for zone 0 to 2 were included. Patients treated as part of the clinical trial for zone 0 to 1 (n = 6) were excluded. Patient demographics, comorbidities, anatomic and operative details, and outcomes were reported. Outcomes and survival were then compared between groups. RESULTS: Of 40 patients, six patients underwent repair of zone 0, three of zone 1, and 31 of zone 2. There were no differences in demographics, comorbidities, or operative details by zone of treatment; however, the frequency of genetic aortopathy differed (zone 0: 0%; zone 1: 67%; and zone 2: 6.4%; P < .01). Seventy-three percent of patients were treated for dissection vs 27% with isolated aneurysms. Of the patients, 2.5% were treated for rupture, 22% were treated for symptomatic aneurysms, and 75% were treated electively. Forty-eight percent of repairs included a proximal cuff, and 83% received distal extension. Technical success was achieved in 100% of patients. Mean fluoroscopy time was 18 minutes, and median fluoroscopy dose was 416 mGy. Sixty percent of patients had prior aortic ascending/arch repair. TBE was planned as part of a complete thoracoabdominal repair in 45% of patients. Thirty-day mortality was 2.5% overall, with a single death in a zone 0 patient that occurred at day 1 due to a myocardial infarction. There were no reinterventions within 30 days. All other outcomes were similar. The 30-day stroke rate was 5.0%. The strokes occurred at day 6 (zone 1) and day 15 (zone 2); however, both were due to occlusion of a prior proximal surgical bypass and unrelated to the TBE side branch or embolization. Specifically, both patients had occlusion of a branch of their prior zone 1 or zone 2 arch replacement. An endoleak occurred in 7.5% of patients at 30-day follow-up (type II: 5.0%; unknown: 2.5%). At a mean follow-up of 6.6 months, 100% of side branches were patent. CONCLUSIONS: Repair of the aortic arch including TBE can be performed electively and urgently with acceptable stroke and death rates. TBE provides a valuable tool for patients requiring complete repair of a thoracoabdominal aneurysm. Continued investigation is underway to assess long-term safety and efficacy outside of the clinical trial.

National trends in utilization of surgeon-modified grafts for complex and thoracoabdominal aortic aneurysms.

INTRODUCTION: Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is. METHODS: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. RESULTS: A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher. CONCLUSIONS: PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.

Editor's Choice - An Endovascular Approach to Abdominal Aortic Aneurysm Rupture is Associated With Improved Outcomes for Patients With Prior Aortic Repair.

OBJECTIVE: To assess whether outcomes of rupture repair differ by aortic repair history and determine the ideal approach for rupture repair in patients with previous aortic repair. METHODS: This retrospective review included all patients who underwent repair of a ruptured infrarenal abdominal aortic aneurysm from 2003 - 2021 recorded in the Vascular Quality Initiative (VQI) registry. Pre-operative characteristics and post-operative outcomes and long term survival were compared between patients with and without prior aortic repair. To assess the impact of open and endovascular approaches to rupture, a subgroup analysis was then performed among patients who ruptured after a prior infrarenal aortic repair. Univariable and adjusted analyses were performed to account for differences in patient characteristics and operative details. RESULTS: A total of 6 197 patients underwent rupture repair during the study period, including 337 (5.4%) with prior aortic repairs. Univariable analysis demonstrated an increased 30 day mortality rate in patients with prior repairs vs. without (42 vs. 36%; p = .034), and prior repair was associated with increased post-operative renal failure (35 vs. 21%; p < .001), respiratory complications (32 vs. 24%; p < .001), and wound complications (9 vs. 4%; p < .001). Following adjustment, all outcomes were similar with the exception of bowel ischaemia, which was decreased among patients with prior repair (OR 0.7, 95% CI 0.6 - 0.9). Subgroup analysis demonstrated that patients with a prior aortic repair history who underwent open rupture repair had increased odds for 30 day death (OR 1.3, 95% CI 1.2 - 1.7) and adverse secondary outcomes compared with those managed endovascularly. CONCLUSION: Prior infrarenal aortic repair was not independently associated with increased morbidity or mortality following rupture repair. Patients with a prior aortic repair history demonstrated statistically significantly higher mortality and morbidity when treated with an open repair compared with an endovascular approach. An endovascular first approach to rupture should be strongly encouraged whenever feasible in patients with prior aortic repair.

Outcomes of Staged Repairs of Complex Endovascular Repairs of Thoracoabdominal Aortic Aneurysms.

BACKGROUND: Endovascular treatment allows for the staging of thoracoabdominal aortic aneurysm repairs (eTAAAs) in an effort to decrease the risk of spinal cord ischemia (SCI), but data are limited. METHODS: We studied all eTAAAs in the Vascular Quality Initiative from 2014 to 2021. Inverse probability weighting was used to compare perioperative and long-term outcomes of staged and single-stage repairs. Thoracoabdominal life-altering events (TALEs) are the composite endpoint consisting of death/stroke/permanent SCI/permanent dialysis. RESULTS: There were 3,258 total operations during the study period. In total, 841 cases (26%) were staged repairs, and 2,417 (74%) were completed in a single stage, but in the cohort of patients with extensive aneurysms, 44% were staged. Staging methods included thoracic endograft (78%), branch (23%), and iliac (5%). Staged repairs were more often employed by high-volume surgeons at high-volume centers; for larger, more extensive aneurysms, with higher rates of prior aortic surgery. After adjustment, staged repair and single-stage treatment were associated with similar odds of all perioperative outcomes and including mortality, TALE, acute kidney injury, stroke, dialysis, and SCI, as well as long-term survival. This was consistent in the subgroups of patients with extensive aneurysms undergoing elective procedures. Of note, first-stage thoracic endografts were associated with 2.6% mortality, 7.3% TALE, 1.5% dialysis, and 4.1% SCI, and 25% of patients did not undergo a second stage. First-stage procedures accounted for one-third of perioperative complications including half of the deaths in the staged cohort. CONCLUSIONS: Staged eTAAA repairs were associated with similar perioperative and long-term complications to single-stage treatments. However, first stage procedures are associated with significant morbidity and mortality, and one-quarter of patients never complete their repairs. These data demonstrate the necessity of evaluating the outcomes of all patients planned for staged procedures, not only those who make it to the final stage. More data are needed as to the optimal method of spinal cord protection for these challenging aneurysms.

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.

Racial disparities in treatment of ruptured abdominal aortic aneurysms.

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

Outcomes of Complex Endovascular Treatment of Post-Dissection Aneurysms.

OBJECTIVE: Reports of endovascular treatment of chronic post-dissection aneurysms are limited to high volumes centres, posing questions about generalisability. METHODS: All endovascular repairs of intact pararenal and thoraco-abdominal aneurysms in the Vascular Quality Initiative from 2014 to 2021 were studied, and peri-operative and long term outcomes were compared between repairs of degenerative and post-dissection aneurysms. Peri-operative outcomes were compared using mixed effects logistic regression, and long term outcomes using Medicare linkage. RESULTS: There were 123 patients who completed treatment for post-dissection aneurysms and 3 635 for degenerative aneurysms, with 36% of post-dissection repairs and 6.7% of degenerative repairs performed in a staged fashion (p < .001). The majority (84%) of post-dissection aneurysms were extensive thoraco-abdominal aneurysms (TAAAs: Crawford Type 1, 2, 3, 5), compared with 22% of degenerative aneurysms (p < .001). Physician modified endografts were the primary repair type for post-dissection (73%), while commercially available fenestrated grafts were the dominant repair for degenerative (48%). The first stage of staged procedures was associated with a 2.8% peri-operative mortality rate, 5.1% spinal cord ischaemia, and 8.9% thoraco-abdominal life altering events (the composite of peri-operative death, stroke, permanent spinal cord ischaemia, and dialysis). Th final stage procedure and fluoroscopy times were similar, but technical success was lower in post-dissection repairs (75% vs. 83%, p = .018), both due to issues with the main endograft or bridging vessels (11% vs. 6.6%, p = .055), and types 1and 3 endoleak at completion (17% vs. 10%, p = .035). In addition, high volume surgeons had two fold higher odds of technical success than their low volume counterparts. Adjusted peri-operative outcomes were similar between pathology types, including when comparisons were restricted to extensive TAAAs. Crude and adjusted three year survival were similar, but three year re-interventions were significantly higher following post-dissection repairs (p < .001). CONCLUSION: Complex endovascular repair of chronic post-dissection aneurysms is feasible but is associated with high rates of re-interventions and non-trivial rates of lack of technical success. More data are needed to evaluate the long term durability of these procedures, and the utility of centralising these complex procedures.

Disparities in reporting and representation by sex, race, and ethnicity in endovascular aortic device trials.

OBJECTIVE: Vulnerable populations, including women and racial and ethnic minorities, have been historically underrepresented in clinical trials. We, therefore, studied the demographics of patients enrolled in pivotal endovascular aortic device trials in the United States. METHODS: We queried the Food and Drug Administration (FDA) medical devices database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999 to November 2021. These included abdominal endovascular aortic repair (EVAR), thoracic EVAR (TEVAR), fenestrated EVAR (FEVAR) devices, and dissection stents. Multiple cases of approval for expanded indications were included separately. The primary outcomes included the proportion of trials reporting participant sex, race, and ethnicity and the proportion of enrolled participants across sex, racial, and ethnic groups. RESULTS: The FDA provided 29 approvals from 29 trials of 24 devices: 15 EVAR devices (52%), 12 TEVAR devices (41%), 1 FEVAR device (3.4%), and 1 dissection stent (3.4%). These trials had included 4046 patients. Of the 29 trials, all had reported on the sex of the participants, and the median female enrollment was 21% (interquartile range [IQR], 11%-34%). The EVAR trials had the lowest female enrollment (11%; IQR, 8.7%-13%) compared with 41% (IQR, 27%-45%) in the TEVAR trials, 21% in the FEVAR trial, and 34% in the dissection stent trial (P < .01 for the difference). Only 52% of the trials had reported the three most common racial groups (White, Black, Asian), and only 48% had reported Hispanic ethnicity. The TEVAR trials were the most likely to report all three racial groups and Hispanic ethnicity (92% and 75%, respectively), while the EVAR trials had the lowest reporting rates (13% and 20%, respectively). Where reported, the median enrollment of racial and ethnic groups across the trials was as follows: Black patients, 9.8% (FEVAR, 0%; EVAR, 1.9%; TEVAR, 12%; dissection stent, 25%; P = .01); Asian patients, 2.4% (EVAR, 0.6%; FEVAR, 2.4%; TEVAR, 2.5%; dissection stent, 11%; P = .24); and Hispanic patients, 3.8% (EVAR, 1.3%; FEVAR, 2.4%; TEVAR, 3.9%; dissection stent, 4.1%; P = .75). CONCLUSIONS: Racial and ethnic minority groups were underrepresented and underreported in pivotal aortic device trials that led to FDA approval. Female patients were also underrepresented in these aortic trials, especially for EVAR. These data suggest the need for standardization of reporting practices and minimum thresholds for minority and female participation in pivotal trials to promote equitable representation.

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.

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.

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.

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.

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.

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.

Clinical impact of sex on carotid revascularization.

BACKGROUND: The impact of sex in the management of carotid disease is unclear in the current literature. Therefore, we evaluated the effect of sex on perioperative outcomes following carotid endarterectomy (CEA) and carotid artery stenting (CAS). METHODS: We included patients who underwent CEA or CAS between 2012 and 2017 in the Vascular Quality Initiative database. Our primary outcome was perioperative stroke/death. Secondary outcomes were in-hospital stroke, 30-day mortality, and in-hospital MI. We compared perioperative outcomes between female and male patients, stratified by treatment modality and symptom status, and used multivariable regression to account for differences in baseline characteristics. RESULTS: A total of 83,436 patients underwent either a CEA (71,383) or CAS (12,053). Asymptomatic and symptomatic CEA females were less likely to be on a preoperative antiplatelet agent, when compared to males. Females overall, were less likely to be on a preoperative statin and more likely to have chronic obstructive pulmonary disease. Within the CAS cohort, females were more likely to have a previous ipsilateral CEA. There were no differences between males and females in major adverse events following CEA for asymptomatic disease. Following CEA for symptomatic disease, there was no difference in stroke/death rate or in-hospital stroke. However, females experienced a higher 30-mortality after adjustment (univariate: 1.0% vs 0.7%, P = .04; adjusted: odds ratio [OR], 1.4:1.02-1.94). Following CAS for asymptomatic disease, females experienced a higher rate of perioperative stroke/death (2.9% vs 1.9% P = .02; OR, 1.5: 1.05-2.03) and in-hospital stroke (2.1% vs 1.2% P = .01; OR, 1.8: 1.20-2.60). There were no differences in outcomes for symptomatic females vs males undergoing CAS. CONCLUSIONS: Females with carotid disease less frequently receive optimal medical treatment with antiplatelet agents and statins. This is an important target area for quality improvement issue in both females and males. Furthermore, among symptomatic CEA patients the female sex is associated with higher mortality and among asymptomatic CAS patients, females experience higher rates of stroke/death. These findings suggest that careful patient selection is necessary in the treatment of female patients. Quality improvement projects should be created to further investigate and eliminate the disparities of optimal medical management between the sexes.