Systemic immunosuppression does not affect revascularization outcomes in patients with chronic limb-threatening ischemia.

OBJECTIVE: Many patients with chronic limb-threatening ischemia (CLTI) have additional comorbidities requiring systemic immunosuppression. Few studies have analyzed whether these medications may inhibit graft integration and effectiveness, or conversely, whether they may prevent inflammation and/or restenosis. Therefore, our study aim was to examine the effect of systemic immunosuppression vs no immunosuppression on outcomes after any first-time lower extremity revascularization for CLTI. METHODS: We identified all patients undergoing first-time infrainguinal bypass graft (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution between 2005 and 2014. Patients were stratified by procedure type and immunosuppression status, defined as ≥6 weeks of any systemic immunosuppression therapy ongoing at the time of intervention. Immunosuppression vs nonimmunosuppression were the primary comparison groups in our analyses. Primary outcomes included perioperative complications, reintervention, primary patency, and limb salvage, with Kaplan-Meier and Cox proportional hazard models used for univariate and multivariate analyses, respectively. RESULTS: Among 1312 patients, 667 (51%) underwent BPG and 651 (49%) underwent PTA/S, of whom 65 (10%) and 95 (15%) were on systemic immunosuppression therapy, respectively. Whether assessing BPG or PTA/S patients, there were no differences noted in perioperative outcomes, including perioperative mortality, myocardial infarction, stroke, hematoma, or surgical site infection (P > .05). For BPG patients, Kaplan-Meier analysis and log-rank testing demonstrated no significant difference in three-year reintervention (37% vs 33% [control]; P = .75), major amputation (27% vs 15%; P = .64), or primary patency (72% vs 66%; P = .35) rates. Multivariate analysis via Cox regression confirmed these findings (immunosuppression hazard ratio [HR] for reintervention, 0.95; 95% CI, 0.56-1.60; P = .85; for major amputation, HR, 1.44; 95% CI, 0.70-2.96; P = .32; and for primary patency. HR, 0.97; 95% CI, 0.69-1.38; P = .88). For PTA/S patients, univariate analysis revealed similar rates of reintervention (37% vs 39% [control]; P = .57) and primary patency (59% vs 63%; P = .21); however, immunosuppressed patients had higher rates of major amputation (23% vs 12%; P = .01). After using Cox regression to adjust for baseline demographics, as well as operative and anatomic characteristics, immunosuppression was not associated with any differences in reintervention (HR, 0.75; 95% CI, 0.49-1.16; P = .20), major amputation (HR, 1.46; 95% CI, 0.81-2.62; P = .20), or primary patency (HR, 0.84; 95% CI, 0.59-1.19; P = .32). Sensitivity analyses for the differences in makeup of immunosuppression regimens (steroids vs other classes) did not alter the interpretation of any findings in either BPG or PTA/S cohorts. CONCLUSIONS: Our findings demonstrate that patients with chronic systemic immunosuppression, as compared with those who are not immunosuppressed, does not have a significant effect on late outcomes after lower extremity revascularization, as measured by primary patency, reintervention, or major amputation.

One-year aneurysm-sac dynamics are associated with reinterventions and rupture following infrarenal endovascular aneurysm repair.

OBJECTIVE: One-year aneurysm sac changes have previously been found to be associated with mortality and may have the potential to guide personalized follow-up following endovascular aneurysm repair (EVAR). In this study, we examined the association of these early sac changes with long-term reintervention and rupture. METHODS: We identified all patients undergoing first-time EVAR for intact abdominal aortic aneurysm between 2003 and 2018 in the Vascular Quality Initiative with linkage to Medicare claims for long-term outcomes. We included patients with an imaging study at 1 year postoperatively. Aneurysm sac behavior was defined as per the Society for Vascular Surgery guidelines: stable sac (<5 mm change), sac regression (≥5 mm), and sac expansion (≥5 mm). Outcomes included mortality, reintervention, and rupture within 8 years, which were assessed with Kaplan-Meier methods and multivariable Cox regression analysis. Secondarily, we utilized polynomial spline interpolation to demonstrate the continuous relationship of diameter change to 8-year hazard of reintervention, rupture, or mortality as a composite outcome. RESULTS: Of 31,185 EVAR patients, 16,102 (52%) had an imaging study at 1 year and were included in this study. At 1 year, 44% of sacs remained stable, 49% regressed, and 6.2% displayed expansion. Following risk adjustment, compared with a stable sac at 1 year, sac regression was associated with lower 8-year mortality (49% vs 53%; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.85-0.99; P = .036), reintervention rate (8.9% vs 15%; HR, 0.58; 95% CI, 0.50-0.68; P < .001), and rupture rate (2.0% vs 4.0%; HR, 0.45; 95%CI, 0.29-0.69; P < .001). Conversely, compared with a stable sac, sac expansion was associated with higher 8-year mortality (64% vs 53%; HR, 1.31; 95% CI, 1.14-1.51; P < .001) and reintervention rate (27% vs 15%; HR, 1.98; 95% CI, 1.57-2.51; P < .001), but similar risk of rupture (7.2% vs 4.0%; HR, 1.61; 95% CI, 0.88-2.96; P = .12). Polynomial spline interpolation demonstrated that, compared with no diameter change at 1 year, increased sac regression was associated with an incrementally lower risk of late outcomes, whereas increased sac expansion was associated with an incrementally higher risk of late outcomes. CONCLUSIONS: Following EVAR, compared with a stable sac at 1-year imaging, sac regression and expansion are associated with a lower and higher risk respectively of long-term mortality, reinterventions, and ruptures. Moreover, the amount of regression or expansion seems to be incrementally associated with these late outcomes, too. Future studies are needed to determine how to improve 1-year sac regression, and whether it is safe to extend follow-up intervals for patients with regressing sacs.

Editor's Choice -- Age Stratified Midterm Survival Following Endovascular Versus Open Repair of Juxtarenal Abdominal Aortic Aneurysms.

OBJECTIVE: Age stratified mortality was examined following fenestrated endovascular aneurysm repair (F-EVAR) vs. open repair of juxtarenal abdominal aortic aneurysms (AAAs) METHODS: All patients undergoing first time elective F-EVAR and complex open aneurysm repair (c-OAR) for juxtarenal AAA in the Vascular Quality Initiative between 2014 and 2021 were identified. Open repairs were compared with commercially available fenestrated endovascular aneurysm repair and physician modified endografts (PMEGs). Patients were stratified into three age groups (< 65, 65 - 75, > 75 years). Primary outcomes were peri-operative and five year mortality, and inverse probability weighted risk adjustment was performed to account for baseline differences. RESULTS: Overall, 1 961 patients underwent F-EVAR (82% commercial F-EVAR, 18% PMEG) and 3 385 patients underwent c-OAR. Across age groups, the distribution of F-EVAR (vs. c-OAR) was: < 65 years: 23%, 65 - 75 years: 33%, > 75 years: 52%. After adjustment, among patients < 65 years, compared with c-OAR, F-EVAR was associated with similar peri-operative mortality (0.9% vs. 2.1%; hazard ratio [HR] 0.40, 95% confidence interval [CI] 0.07 - 1.44], p = .22), and five year mortality (13% vs. 9.5%; HR 1.44, 95% CI 0.71 - 2.90, p = .31). Among patients aged 65 - 75 years, between juxtarenal AAA repair modalities, compared with c-OAR, F-EVAR was associated with a significantly lower risk of peri-operative mortality (2.2% vs. 5.0%; HR 0.50, 95% CI 0.30 - 0.79, p = .004), and five year mortality (13% vs. 13%; HR 0.94, 95% CI 0.65 - 1.36, p = .74). Similarly, among patients > 75 years, compared with c-OAR, F-EVAR was associated with lower peri-operative mortality (2.2% vs. 6.5%; HR 0.26, 95% CI 0.13 - 0.47, p < .001), but with similar five year mortality (18% vs. 21%; HR 0.83, 95% CI 0.57 - 1.20, p = .31). CONCLUSION: Among patients with a juxtarenal AAA, F-EVAR was associated with a lower peri-operative mortality compared with c-OAR in patients ≥ 65 years, but was similar in those < 65 years. At five years, F-EVAR was associated with similar mortality in all age groups, though there was a non-significant trend for a higher mortality rate in younger patients.

Statin therapy is associated with improved perioperative outcomes and long-term mortality following carotid revascularization in the Vascular Quality Initiative.

OBJECTIVE: Statin therapy is the standard of care for patients with carotid artery stenosis given its proven cardiovascular benefits. However, the impact of statin therapy on outcomes in patients undergoing carotid revascularization in the Vascular Quality Initiative has not yet been evaluated. Therefore, our aim was to investigate the association of statin therapy with outcomes following carotid endarterectomy (CEA), transfemoral carotid artery stenting (tfCAS), and transcarotid artery revascularization (TCAR). METHODS: We identified all patients who underwent CEA, tfCAS, or TCAR in the Vascular Quality Initiative registry from January 2016 to September 2021. To compare outcomes, we stratified patients by procedure type and created 1:1 propensity score-matched cohorts of patients who received no preoperative statin therapy (within 36 hours of procedure) versus those who received preoperative statin therapy. Propensity scores incorporated demographic characteristics, comorbidities, carotid symptom status, preoperative medications, and physician and hospital procedural experience. The primary outcome was a composite end point of in-hospital stroke and/or death. As a secondary analysis, we performed repeat propensity score-matching by postoperative statin use (prescribed at discharge) and assessed 5-year mortality. Relative risks (RR) and hazard ratios (HR) were calculated using log binomial regression and Cox regression, respectively. RESULTS: Among 97,835 CEA, 20,303 tfCAS, and 22,371 TCAR patients, 15%, 17%, and 10% of patients did not receive preoperative statin therapy, respectively. Compared with statin use, no statin use was associated with a higher risk of in-hospital stroke or death among 13,434 matched CEA patients (no statin, 1.7% vs statin, 1.4%; RR, 1.2; 95% confidence interval [CI], 1.02-1.5) and among 2707 matched tfCAS patients (4.8% vs 2.8%; RR, 1.7; 95% CI, 1.3-2.3). However, there was no difference for this outcome by statin use among 2089 matched TCAR patients (1.8% vs 1.6%; RR, 1.1; 95% CI, 0.7-1.8). At 5 years, no statin therapy at discharge was associated with higher 5-year mortality after CEA (15% vs 10%; HR, 1.8; 95% CI, 1.6-2) and tfCAS (18% vs 14%; HR, 1.5; 95% CI, 1.2-1.8), but there was no difference after TCAR (14% vs 11%; HR, 1.3; 95% CI, 0.9-1.8). CONCLUSIONS: Compared with statin use, no statin use was associated with a higher risk of in-hospital stroke or death and 5-year mortality among CEA and tfCAS patients. Although there was no significant difference in outcomes among TCAR patients, this may in part be due to lower statistical power in this cohort. Overall, statin therapy is essential in the short- and long-term management of patients undergoing carotid revascularization. Our findings not only support current Society for Vascular Surgery recommendations for statin therapy in patients undergoing carotid revascularization, but they also highlight an important opportunity for quality improvement.

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.

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.

OBJECTIVE: Current guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). METHODS: We identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding. RESULTS: Of the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR. CONCLUSIONS: Compared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

The impact of neighborhood social disadvantage on abdominal aortic aneurysm severity and management.

OBJECTIVE: Recent studies have highlighted socioeconomic disparities in the severity and management of abdominal aortic aneurysm (AAA) disease. However, these studies focus on individual measures of social disadvantage such as income and insurance status. The area deprivation index (ADI), a validated measure of neighborhood deprivation, provides a more comprehensive assessment of social disadvantage. Therefore, we examined the impact of ADI on AAA severity and its management. METHODS: We identified all patients who underwent endovascular or open repair of an AAA in the Vascular Quality Initiative registry between 2003 and 2020. An ADI score of 1 to 100 was assigned to each patient based on their residential zip code, with higher ADI scores corresponding with increasing deprivation. Patients were categorized by ADI quintiles. Outcomes of interest included rates of ruptured AAA (rAAA) repair versus an intact AAA repair and rates of endovascular repair (EVAR) versus the open approach. Logistic regression was used to evaluate for an independent association between ADI quintile and these outcomes. RESULTS: Among 55,931 patients who underwent AAA repair, 6649 (12%) were in the lowest ADI quintile, 11,692 (21%) in the second, 15,958 (29%) in the third, 15,035 (27%) in the fourth, and 6597 (12%) in the highest ADI quintile. Patients in the two highest ADI quintiles had a higher proportion of rAAA repair (vs intact repair) compared with those in the lowest ADI quintile (8.8% and 9.1% vs 6.2%; P < .001). They were also less likely to undergo EVAR (vs open approach) when compared with the lowest ADI quintile (81% and 81% vs 88%; P < .001). There was an overall trend toward increasing rAAA and decreasing EVAR rates with increasing ADI quintiles (P < .001). In adjusted analyses, when compared with patients in the lowest ADI quintile, patients in the highest ADI quintile had higher odds of rAAA repair (odds ratio, 1.4; 95% confidence interval, 1.2-1.8; P < .001) and lower odds of undergoing EVAR (odds ratio, 0.54; 95% confidence interval, 0.45-0.65; P < .001). CONCLUSIONS: Among patients who underwent AAA repair in the Vascular Quality Initiative, those with higher neighborhood deprivation had significantly higher rates of rAAA repair (vs intact repair) and lower rates of EVAR (vs open approach). Further work is needed to better understand neighborhood factors that are contributing to these disparities to identify community-level targets for improvement.

Asian race is associated with peripheral arterial disease severity and postoperative outcomes.

OBJECTIVE: The nature of peripheral arterial disease and postoperative outcomes are understudied in Asian patients. We aimed to determine if there are disparities in disease severity at the time of presentation and postoperative outcomes with regard to Asian race. METHODS: We analyzed the Society for Vascular Surgery Vascular Quality Initiative Peripheral Vascular Intervention dataset from 2017 to 2021, which includes endovascular lower extremity interventions. Propensity scores were used to match White and Asian patients based on age, sex, comorbidities, ambulatory/functional status, and intervention level. Differences were examined with regard to Asian race across all patients in the United States, Canada, and Singapore, and separately in the United States and Canada only. The primary outcome was emergent intervention. We also examined differences in severity of disease and postoperative outcomes. RESULTS: A total of 80,312 White and 1689 Asian patients underwent peripheral vascular intervention. After propensity score matching, we identified 1669 matched pairs of patients across all centers including Singapore and 1072 matched pairs in the United States and Canada only. Among the matched cohort consisting of all centers, Asian patients had a higher rate of emergent intervention to prevent limb loss (5.6% vs 1.7%, P < .001). The majority of Asian patients presented with chronic limb threatening ischemia at a higher rate than White patients within the cohort including Singapore (71% vs 66%, P = .005). Within both propensity-matched cohorts, the rate of in-hospital death was higher in Asian patients (all centers: 3.1% vs 1.2%, P < .001; United States and Canada only: 2.1% vs 0.8%, P = .010). Logistic regression demonstrated greater odds of emergent intervention in Asian patients from all centers including Singapore (odds ratio [OR], 3.3; 95% confidence interval [CI], 2.2-5.1, P < .001) but not in the United States and Canada only (OR, 1.4; 95% CI, 0.8-2.8, P = .261). In addition, Asian patients had greater odds of in-hospital death in both matched cohorts (all centers: OR, 2.6; 95% CI, 1.5-4.4, P < .001; United States and Canada: OR, 2.5; 95% CI, 1.1-5.8, P = .026). Asian race was associated with a greater risk of loss of primary patency at 18 months (all centers: hazard ratio, 1.5; CI, 1.2-1.8, P = .001; United States and Canada only: hazard ratio, 1.5; CI, 1.2-1.9, P = .002). CONCLUSIONS: Asian patients are more likely to present with advanced peripheral arterial disease and undergo emergent intervention to prevent limb loss, in addition to having worse postoperative outcomes and long-term patency. These results highlight the need for improved screening and postoperative follow-up in this understudied population.

Distal embolic protection use during transfemoral carotid artery stenting is associated with improved in-hospital outcomes.

OBJECTIVE: Despite current guidelines recommending the use of distal embolic protection during transfemoral carotid artery stenting (tfCAS) to prevent periprocedural stroke, there remains significant variation in the routine use of distal filters. We sought to assess in-hospital outcomes in patients undergoing tfCAS with and without embolic protection using a distal filter. METHODS: We identified all patients undergoing tfCAS in the Vascular Quality Initiative from March 2005 to December 2021 and excluded those who received proximal embolic balloon protection. We created propensity score-matched cohorts of patients who underwent tfCAS with and without attempted placement of a distal filter. Subgroup analyses of patients with failed vs successful filter placement and failed vs no attempt at filter placement were performed. In-hospital outcomes were assessed using log binomial regression, adjusted for protamine use. Outcomes of interest were composite stroke/death, stroke, death, myocardial infarction (MI), transient ischemic attack (TIA), and hyperperfusion syndrome. RESULTS: Among 29,853 patients who underwent tfCAS, 28,213 (95%) had a filter attempted for distal embolic protection and 1640 (5%) did not. After matching, 6859 patients were identified. No attempted filter was associated with significantly higher risk of in-hospital stroke/death (6.4% vs 3.8%; adjusted relative risk [aRR], 1.72; 95% confidence interval [CI], 1.32-2.23; P < .001), stroke (3.7% vs 2.5%; aRR, 1.49; 95% CI, 1.06-2.08; P = .022), and mortality (3.5% vs 1.7%; aRR, 2.07; 95% CI, 1.42-3.020; P < .001). In a secondary analysis of patients who had failed attempt at filter placement vs successful filter placement, failed filter placement was associated with worse outcomes (stroke/death: 5.8% vs 2.7%; aRR, 2.10; 95% CI, 1.38-3.21; P = .001 and stroke: 5.3% vs 1.8%; aRR, 2.87; 95% CI, 1.78-4.61; P < .001). However, there were no differences in outcomes in patients with failed vs no attempted filter placement (stroke/death: 5.4% vs 6.2%; aRR, 0.99; 95% CI, 0.61-1.63; P = .99; stroke: 4.7% vs 3.7%; aRR, 1.40; 95% CI, 0.79-2.48; P = .20; death: 0.9% vs 3.4%; aRR, 0.35; 95% CI, 0.12-1.01; P = .052). CONCLUSIONS: tfCAS performed without attempted distal embolic protection was associated with a significantly higher risk of in-hospital stroke and death. Patients undergoing tfCAS after failed attempt at filter placement have equivalent stroke/death to patients in whom no filter was attempted, but more than a two-fold higher risk of stroke/death compared with those with successfully placed filters. These findings support current Society for Vascular Surgery guidelines recommending routine use of distal embolic protection during tfCAS. If a filter cannot be placed safely, an alternative approach to carotid revascularization should be considered.

Clinical presentation, outcomes, and threshold for repair by sex in degenerative saccular vs fusiform aneurysms in the descending thoracic aorta.

OBJECTIVE: Saccular-shaped thoracic aortic aneurysms (TAAs) are often treated at smaller diameters compared with fusiform TAAs, despite a lack of strong clinical evidence to support this practice. The aim of this study was to examine differences in presentation, treatment, and outcomes between saccular TAAs and fusiform TAAs in the descending thoracic aorta. We also examined the need for sex-specific treatment thresholds for TAAs. METHODS: All Vascular Quality Initiative (VQI) patients undergoing thoracic endovascular aneurysm repair (TEVAR) for degenerative TAAs in the descending thoracic aorta from 2012 through 2022 were reviewed. Patients were stratified by urgency: emergent/urgent vs elective repairs (ruptured/symptomatic). Demographics, comorbidities, anatomical/procedural characteristics, and outcomes for fusiform TAAs and saccular TAAs were compared. Cumulative distribution curves were used to plot the proportion of patients who underwent emergent/urgent repair according to sex-stratified aortic diameter. RESULTS: Among 655 emergent/urgent TEVARs, 37% were performed for saccular TAAs, whereas among 1352 elective TEVARs, 35% had saccular TAA morphology. Compared with fusiform TAAs, saccular TAAs more frequently underwent emergent/urgent (ruptured/symptomatic) TEVAR below the repair threshold in both females (<50 mm: 38% vs 10%; relative risk, 3.39; 95% confidence interval [CI], 2.04-5.70; P < .001), and males (<55 mm: 47% vs 21%; relative risk, 2.26; 95% CI, 1.60-3.18; P < .001). Moreover, among patients with emergent/urgent fusiform TAAs, females presented at smaller diameters compared with males, whereas there was no difference in preoperative aneurysm diameter among patients with saccular TAAs. Regarding outcomes, emergent/urgent treated saccular TAAs had similar postoperative outcomes and 5-year mortality compared with fusiform TAAs. Nevertheless, in the elective cohort, patients with saccular TAAs had similar postoperative mortality compared with those with fusiform TAAs, but a lower rate of postoperative spinal cord ischemia (0.7% vs 3.2%; P = .010). Furthermore, patients with saccular TAAs had a higher rate of 5-year mortality compared with their fusiform counterparts (23% vs 17%; hazard ratio, 1.53; 95% CI, 1.12-2.10; P = .010). CONCLUSIONS: Patients with saccular TAAs underwent emergent/urgent TEVAR at smaller diameters than those with fusiform TAAs, supporting current clinical practice guideline recommendations that saccular TAAs warrant treatment at smaller diameters. Furthermore, these data support a sex-specific treatment threshold for patients with fusiform TAAs, but not for those with saccular TAAs. Although there were no differences in outcomes following TEVAR between morphologies in the emergent/urgent cohort, patients with saccular TAAs who were treated electively were associated with higher 5-year mortality compared with those with fusiform TAAs.

The effect of supraceliac versus infraceliac landing zone on outcomes following fenestrated endovascular repair of juxta-/pararenal aortic aneurysms.

OBJECTIVE: With increasing experience in fenestrated endovascular aneurysm repair (FEVAR) over time, devices designed to treat juxta-/pararenal aortic aneurysms have evolved in complexity to extend to more proximal landing zones and incorporate more target vessels. We assessed perioperative outcomes in patients who underwent juxta-/pararenal FEVAR with supraceliac vs infraceliac sealing in the Vascular Quality Initiative. METHODS: We identified all patients who underwent elective FEVAR (commercially available FEVAR and physician-modified endografts) for juxta-/pararenal aortic aneurysms in the Vascular Quality Initiative between 2014 and 2021. Supraceliac sealing was defined as proximal sealing in aortic zone 5, or zone 6 with a celiac scallop/fenestration/branch or celiac occlusion. Primary outcomes were perioperative and 3-year mortality. Secondary outcomes included completion endoleaks, in-hospital complications, and factors associated with 3-year mortality. We calculated propensity scores and used inverse probability-weighted Cox regression and logistic regression modeling to assess outcomes. RESULTS: Among 1486 patients identified, 1246 patients (84%) underwent infraceliac sealing, and 240 patients (16%) underwent supraceliac sealing. Of the supraceliac patients, 74 (31%) had a celiac scallop, 144 (60%) had a celiac fenestration/branch, and 22 (9.2%) had a celiac occlusion (intentional or unintentional). After risk-adjusted analyses, there were no differences in perioperative mortality following supraceliac sealing compared with infraceliac sealing (2.3% vs 2.5%; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.26-1.8; P = .42), or 3-year mortality (12% vs 15%; HR, 0.89; 95% CI, 0.53-1.5; P = .67). Compared with infraceliac sealing, supraceliac sealing was associated with lower odds of type-IA completion endoleaks (odds ratio [OR], 0.24; 95% CI, 0.05-0.67), but higher odds of any complication (12% vs 6.9%; OR, 1.6; 95% CI, 1.01-2.5) including cardiac complications (5.5% vs 1.9%; OR, 2.6; 95% CI, 1.3-5.1), lower extremity ischemia (3.0% vs 0.9%; OR, 3.2; 95% CI, 1.02-9.5), and acute kidney injury (16% vs 11%; OR, 1.6; 95% CI, 1.05-2.3). Though non-significant, there was a trend towards higher risk of spinal cord ischemia following supraceliac sealing compared with infraceliac sealing (1.7% vs 0.8%; OR, 2.2; 95% CI, 0.70-6.4). There were no differences in bowel ischemia between groups (1.7% vs 1.5%; OR, 0.83; 95% CI, 0.24-1.23). A more proximal aneurysm disease extent was associated with higher 3-year mortality (HR zone 8 vs 9, 1.7; 95% CI, 1.1-2.5), whereas procedural characteristics had no influence. CONCLUSIONS: Compared with sealing at an infraceliac level, supraceliac sealing was associated with lower risk of type IA endoleaks and similar mortality. However, clinicians should be aware that supraceliac sealing was associated with higher perioperative morbidity. Future studies with longer follow-up are needed to adequately assess durability differences to comprehensively weigh the risks and benefits of utilizing a higher sealing zone within the visceral aorta for juxta-/pararenal FEVAR.

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.

Thoracoabdominal aortic aneurysm life-altering events following endovascular aortic repair in the Vascular Quality Initiative.

OBJECTIVE: Endovascular aortic aneurysm repair (EVAR) has lower rates of postoperative mortality and morbidity when compared with open repair. However, endovascular repair still carries the risk of postoperative dialysis, paralysis, and stroke. This study examined the rates of postoperative mortality and morbidity stratified by type of endovascular aortic aneurysm repair. METHODS: All patients who underwent EVAR in the Vascular Quality Initiative registry from January 2011 to May 2022 were identified. Patients were stratified by repair type: infrarenal EVAR, complex EVAR, thoracic endovascular aortic repair (TEVAR), extent I to III thoracoabdominal aortic aneurysm (TAAA) repair, or aortic arch repair. The primary outcome was postoperative thoracoabdominal aortic aneurysm life-altering events (TALE) across the different treatment groups. TALE was defined as a composite outcome of postoperative mortality, dialysis, paralysis, and/or stroke. Mixed effect logistic regression modeling was used to identify procedural and anatomic factors that were independently associated with TALE. RESULTS: A total of 52,592 EVARs, 3768 complex EVARs, 3899 TEVARs, 1139 extent I to III TAAA repairs, and 479 arch repairs were identified. TALE was observed in 1.2% of EVARs, 4.8% of complex EVARs, 6.0% of TEVARs, 10% of extent I to III TAAA repairs, and 14% of arch repairs. More proximal landing zone was associated with higher odds of TALE after complex EVAR (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.2-3.1; P = .008), TEVAR (OR, 2.2; 95% CI, 1.4-3.5; P = .001), and extent I to III TAAA repair (OR, 2.7; 95% CI, 1.5-4.9; P = .001). Aortic diameter >65 mm was associated with higher odds of TALE after infrarenal EVAR (OR, 1.8; 95% CI, 1.4-2.3; P < .001), complex EVAR (OR, 1.6; 95% CI, 1.1-2.3; P = .010), TEVAR (OR, 2.7; 95% CI, 2.0-3.8; P < .001), and arch repair (OR, 2.4; 95% CI, 1.3-4.4; P = .007). The use of parallel grafting technique (chimney/snorkel/periscope) during extent I to III TAAA repair was also associated with higher odds of TALE (OR, 1.8; 95% CI, 1.1-3.2; P = .032). Preoperative chronic kidney disease was also associated with higher odds of TALE after infrarenal EVAR (OR, 4.3; 95% CI, 3.0-5.7; P < .001), complex EVAR (OR, 5.2; 95% CI, 3.3-8.2; P < .001), TEVAR (OR, 4.5; 95% CI, 2.8-7.1; P < .001), and extent I to III TAAA repair (OR, 3.2; 95% CI, 1.6-6.7; P = .001). CONCLUSIONS: Although TALE was originally described for TAAA repairs, TALE may occur after complex EVAR, TEVAR, and arch repairs as well. Therefore, TALE and its component parts should be used to evaluate the efficacy of all aortic repairs and for preoperative counseling. Additionally, surgeons should be aware of anatomic and procedural characteristics that are associated with higher odds of TALE. The anticipated need for such interventions during aortic repair should be factored into preoperative risk assessment of patients.

Mortality analysis of endovascular aneurysm sealing versus endovascular aneurysm repair.

BACKGROUND: Endovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR. METHODS: We compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses. RESULTS: After weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46). CONCLUSIONS: Within the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.

Thromboprophylaxis Timing After Blunt Solid Organ Injury: A Systematic Review and Meta-analysis.

INTRODUCTION: Trauma patients with blunt abdominal solid organ injuries are at high risk for venous thromboembolism (VTE), but the optimal time to safely administer chemical thromboprophylaxis is controversial, especially for patients who are managed nonoperatively due to increased risk of hemorrhage. We sought to compare failure of nonoperative management (NOM) and VTE events based on timing of chemical thromboprophylaxis initiation. METHODS: A systematic review was conducted in PubMed and Embase databases. Studies were included if they evaluated timing of initiation of chemical thromboprophylaxis in trauma patients who underwent NOM of blunt solid organ injuries. Outcomes included failure of NOM and incidence of VTE. A random-effects meta-analysis was performed comparing patients who received late (>48 h) versus early thromboprophylaxis initiation. RESULTS: Twelve retrospective cohort studies, comprising 21,909 patients, were included. Three studies, including 6375 patients, provided data on adjusted outcomes. Pooled adjusted analysis demonstrated no difference in failure of NOM in patients receiving late versus early thromboprophylaxis (odds ratio [OR] 0.92, 95% confidence interval [CI]:0.4-2.14). When including all unadjusted studies, even those at high risk of bias, there remained no difference in failure of NOM (OR 1.16, 95% CI:0.72-1.86). In the adjusted analysis for VTE events, which had 6259 patients between two studies, patients receiving late chemical thromboprophylaxis had a higher risk of VTE compared with those who received early thromboprophylaxis (OR 1.89, 95% CI:1.15-3.12). CONCLUSIONS: Based on current observational evidence, initiation of prophylaxis before 48 h is associated with lower VTE rates without higher risk of failure of NOM.

The Impact of Proximal Neck Anatomy on the 5-Year Outcomes Following Endovascular Aortic Aneurysm Repair With the Ovation Stent Graft.

PURPOSE: Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). We investigated the impact of proximal neck anatomy on the outcomes following EVAR with the Ovation abdominal stent graft (Endologix, Irving, Calif). METHODS: We used prospectively collected data from the Effectiveness of Custom Seal with Ovation: Review of the Evidence database, compromised of pooled data from 6 clinical trials and the European Post-Market Registry of patients undergoing elective infrarenal EVAR (2009-2017). We investigated the impact of short neck length (<10 mm), wide neck diameter (≥28 mm), reverse taper shape (>10%), and neck angulation (>45°) on the outcomes. The primary outcome was type IA endoleak. Secondary outcomes included any type I/III endoleak, sac expansion, aneurysm-related reinterventions, and all-cause and aneurysm-related mortality, and a combined endpoint of type IA endoleak, graft migration, AAA-related reintervention, conversion, and aneurysm rupture. We used Kaplan-Meier analysis and Cox proportional hazards models to estimate the 30 day and 5 year rates and assess univariate and risk-adjusted differences. RESULTS: Of the 1020 patients, 60 patients had a short neck, 113 had a wide neck diameter, 279 were reverse taper shaped, and 99 had neck angulation >45°. Wide proximal neck was associated with higher 5 year type IA endoleak estimates compared with favorable neck anatomy (7.1% vs 4.3%; p=0.02). No association with 5 year type IA endoleak was found for short neck length (1.7% vs 4.3%; p=0.52), reverse taper shape (3.2% vs 4.3%; p=0.99), or neck angulation (6.1% vs 4.3%; p=0.13). A wide neck diameter compared with favorable anatomy was also associated with higher 5 year estimates of graft migration (3.8% vs 0.4%; p=0.03) and the combined neck-related adverse outcome endpoint (16% vs 9.5%; p=0.002). The estimates of aneurysm sac expansion, rupture, and overall and aneurysm-related mortality were similar between the hostile proximal neck anatomy cohorts and favorable anatomy. CONCLUSION: Wide proximal neck is associated with higher 5 year type IA endoleak rates for patients treated with the Ovation stent graft. However, short neck length, reverse taper shape, and neck angulation are not associated with higher 5 year type IA endoleak rates. CLINICAL IMPACT: Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair of abdominal aortic aneurysms. The Ovation stent graft platform uses a different proximal sealing method using a polymer inflatable ring, aiming to improve sealing between the graft and aortic wall. This study demonstrated that short, angulated, and reverse taper-shaped neck anatomy did not result in increased type IA endoleak estimates in patients treated with the Ovation stent graft platform. Potentially, the different sealing mechanisms played a role in mitigating the historically worse outcomes in patients with short, angulated, and reverse taper-shaped neck anatomy.

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.

Racial and ethnic disparities in 3-year outcomes following infrainguinal bypass for chronic limb-threatening ischemia.

OBJECTIVE: Black and Hispanic patients have had higher rates of chronic limb-threatening ischemia (CLTI) and experienced worse perioperative outcomes after lower extremity bypass compared with White patients. The underlying reasons for these disparities have remained unclear, and data on 3-year outcomes are limited. Therefore, we examined the differences in 3-year outcomes after open infrainguinal bypass for CLTI stratified by race/ethnicity and explored the potential factors contributing to these differences. METHODS: We identified all CLTI patients who had undergone primary open infrainguinal bypass in the Vascular Quality Initiative registry from 2003 to 2017 with linkage to Medicare claims through 2018 for the 3-year outcomes. Our primary outcomes were the 3-year rates of major amputation, reintervention, and mortality. We also recorded the 30-day major adverse limb events (MALE) defined as major amputation or reintervention. We used Kaplan-Meier estimation methods and multivariable Cox regression analyses to evaluate the outcomes stratified by race/ethnicity and identify contributing factors. RESULTS: Of the 7108 patients with CLTI, 5599 (79%) were non-Hispanic White, 1053 (15%) were Black, 48 (1%) were Asian, and 408 (6%) were Hispanic patients. Compared with White patients, Black patients had higher rates of 3-year major amputation (Black vs White, 32% vs 19%; hazard ratio [HR], 1.9; 95% confidence interval [CI], 1.7-2.2), reintervention (Black vs White, 61% vs 57%; HR, 1.2; 95% CI, 1.1-1.3), and 30-day MALE (Black vs White, 8.1% vs 4.9%; HR, 1.3; 95% CI, 1.2-1.4) but lower mortality (Black vs White, 38% vs 42%; HR, 0.9; 95% CI, 0.8-0.99). Hispanic patients also experienced higher rates of amputation (Hispanic vs White, 27% vs 19%; HR, 1.6; 95% CI, 1.3-2.0), reintervention (Hispanic vs White, 70% vs 57%; HR, 1.4; 95% CI, 1.2-1.6), and MALE (Hispanic vs White, 8.7% vs 4.9%; HR, 1.5; 95% CI, 1.3-1.7. However, mortality was similar between the two groups (Hispanic vs White, 38% vs 42%; HR, 0.88; 95% CI, 0.76-1.0). The low number of Asian patients prevented a meaningful assessment of amputation (Asian vs White, 20% vs 19%; HR, 0.93; 95% CI, 0.44-2.0), reintervention (Asian vs White, 55% vs 57%; HR, 0.79; 95% CI, 0.51-1.2), MALE (Asian vs White, 8.5% vs 4.9%; HR, 0.71; 95% CI, 0.46-1.1), or mortality (Asian vs White, 36% vs 42%; HR, 0.83; 95% CI, 0.52-1.3). In the adjusted analyses, the association of Black race and Hispanic ethnicity with amputation and reintervention was explained by differences in the demographic characteristics (ie, age, sex) and baseline comorbidities (ie, tobacco use, diabetes, renal disease). CONCLUSIONS: Compared with White patients, Black and Hispanic patients had higher 3-year major amputation and reintervention rates. However, mortality was lower for Black patients than for the White patients and similar between Hispanic and White patients. Disparities in amputation and reintervention were partly attributable to differences in demographic characteristics and the higher prevalence of comorbidities in Black and Hispanic patients with CLTI. Future work is necessary to determine whether interventions to improve access to care and reduce the burden of comorbidities in these populations will confer limb salvage benefits.

Effect of postoperative antithrombotic therapy on lower extremity outcomes after infrapopliteal bypass for chronic limb-threatening ischemia.

OBJECTIVE: Although the current guidelines have recommended single antiplatelet therapy (SAPT) for patients undergoing revascularization for chronic limb-threatening ischemia (CLTI), antithrombotic management has varied by patient and provider. Our aim was to examine the effects of different postoperative antithrombotic regimens on 3-year clinical outcomes after infrapopliteal bypass for CLTI. METHODS: We identified patients who had undergone infrapopliteal bypass for CLTI in the Vascular Quality Initiative (VQI) registry from 2003 to 2017 with linkage to Medicare claims for long-term outcomes. We divided the patients into three cohorts according to the discharge antithrombotic regimen: SAPT (aspirin or clopidogrel), dual antiplatelet therapy (DAPT; aspirin and clopidogrel), or anticoagulation (AC) plus any antiplatelet (AP) agent. To reduce selection bias, we restricted the analysis cohorts to patients treated by providers who discharged >50% of patients with each antithrombotic regimen. Our primary outcome was 3-year major adverse limb events (MALE; major amputation or reintervention). The secondary outcomes included 3-year major amputation, reintervention, and mortality. We used Kaplan-Meier and Cox regression analyses to assess these outcomes stratified by antithrombotic regimen and adjusted for demographic, comorbid, clinical, and operative differences between the treatment groups with clustering at the center level. RESULTS: Among 1812 patients (median follow-up, >2 years), 693 (38%) were discharged with SAPT, 544 (30%) with DAPT, and 575 (32%) with AC+AP. At 3 years, the MALE rates were 75% with DAPT, 74% with AC+AP, and 68% with SAPT. In adjusted analyses with SAPT as the reference group, no differences were found in 3-year MALE with DAPT (adjusted hazard ratio [aHR], 1.0; 95% confidence interval [CI], 0.85-1.3; P = .71) or AC+AP (aHR, 1.1; 95% CI, 0.96-1.3; P = .14). Across the treatment groups, we also found no differences in the individual end points of 3-year major amputation (DAPT: aHR, 0.98; 95% CI, 0.72-1.3; AC+AP: aHR, 1.3; 95% CI, 0.96-1.7), reintervention (DAPT: aHR, 1.0; 95% CI, 0.84-1.3; AC+AP: aHR, 1.1; 95% CI, 0.96-1.3), or mortality (DAPT: aHR, 1.1; 95% CI, 0.88-1.4; AC+AP: aHR, 0.95; 95% CI, 0.74-1.2). In a sensitivity analysis evaluating patients treated by providers who discharged >60%, >70%, or >80% of patients with these regimens, the association between antithrombotic regimen and MALE was unchanged. CONCLUSIONS: Compared with SAPT, DAPT and anticoagulation therapy were not associated with improved outcomes among Medicare beneficiaries who had undergone infrapopliteal bypass for CLTI at VQI participating centers. These findings support current guidelines recommending SAPT after lower extremity bypass and suggest that the routine use of DAPT or anticoagulation therapy might not provide clinical benefit in this high-risk, elderly population. However, further evaluation of the risks and benefits of various antithrombotic regimens in relevant subgroups is warranted.

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.