Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Atherosclerosis Is a Smooth Muscle Cell-Driven Tumor-Like Disease.

BACKGROUND: Atherosclerosis, a leading cause of cardiovascular disease, involves the pathological activation of various cell types, including immunocytes (eg, macrophages and T cells), smooth muscle cells (SMCs), and endothelial cells. Accumulating evidence suggests that transition of SMCs to other cell types, known as phenotypic switching, plays a central role in atherosclerosis development and complications. However, the characteristics of SMC-derived cells and the underlying mechanisms of SMC transition in disease pathogenesis remain poorly understood. Our objective is to characterize tumor cell-like behaviors of SMC-derived cells in atherosclerosis, with the ultimate goal of developing interventions targeting SMC transition for the prevention and treatment of atherosclerosis. METHODS: We used SMC lineage tracing mice and human tissues and applied a range of methods, including molecular, cellular, histological, computational, human genetics, and pharmacological approaches, to investigate the features of SMC-derived cells in atherosclerosis. RESULTS: SMC-derived cells in mouse and human atherosclerosis exhibit multiple tumor cell-like characteristics, including genomic instability, evasion of senescence, hyperproliferation, resistance to cell death, invasiveness, and activation of comprehensive cancer-associated gene regulatory networks. Specific expression of the oncogenic mutant KrasG12D in SMCs accelerates phenotypic switching and exacerbates atherosclerosis. Furthermore, we provide proof of concept that niraparib, an anticancer drug targeting DNA damage repair, attenuates atherosclerosis progression and induces regression of lesions in advanced disease in mouse models. CONCLUSIONS: Our findings demonstrate that atherosclerosis is an SMC-driven tumor-like disease, advancing our understanding of its pathogenesis and opening prospects for innovative precision molecular strategies aimed at preventing and treating atherosclerotic cardiovascular disease.

Long-term costs to Medicare associated with endovascular and open repairs of infrarenal and complex abdominal aortic aneurysms.

OBJECTIVE: The vast majority of patients with abdominal aortic aneurysms (AAAs) undergoing repairs receive endovascular interventions (EVARs) instead of open operations (OARs). Although EVARs have better short-term outcomes, OARs have improved longer-term durability and require less radiographic follow-up and monitoring, which may have significant implications on health care economics surrounding provision of AAA care nationally. Herein, we compared costs associated with EVAR and OAR of both infrarenal and complex AAAs. METHODS: We examined patients undergoing index elective EVARs or OARs of infrarenal and complex AAAs in the 2014-2019 Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Network (VQI-VISION) dataset. We defined overall costs as the aggregated longitudinal costs associated with: (1) the index surgery; (2) reinterventions; and (3) imaging tests. We evaluated overall costs up to 5 years after infrarenal AAA repair and 3 years for complex AAA repair. Multivariable regressions adjusted for case-mix when evaluating cost differences between EVARs vs OARs. RESULTS: We identified 23,746 infrarenal AAA repairs (8.7% OAR, 91% EVAR) and 2279 complex AAA repairs (69% OAR, 31% EVAR). In both cohorts, patients undergoing EVARs were more likely to be older and have more comorbidities. The cost for the index procedure for EVARs relative to OARs was lower for infrarenal AAAs ($32,440 vs $37,488; P < .01) but higher among complex AAAs ($48,870 vs $44,530; P < .01). EVARs had higher annual imaging and reintervention costs during each of the 5 postoperative years for infrarenal aneurysms and the 3 postoperative years for complex aneurysms. Among patients undergoing infrarenal AAA repairs who survived 5 years, the total 5-year cost of EVARs was similar to that of OARs ($35,858 vs $34,212; -$223 [95% confidence interval (CI), -$3042 to $2596]). For complex AAA repairs, the total cost at 3 years of EVARs was greater than OARs ($64,492 vs $42,212; +$9860 [95% CI, $5835-$13,885]). For patients receiving EVARs for complex aneurysms, physician-modified endovascular grafts had higher index procedure costs ($55,835 vs $47,064; P < .01) although similar total costs on adjusted analyses (+$1856 [95% CI, -$7997 to $11,710]; P = .70) relative to Zenith fenestrated endovascular grafts among those that were alive at 3 years. CONCLUSIONS: Longer-term costs associated with EVARs are lower for infrarenal AAAs but higher for complex AAAs relative to OARs, driven by reintervention and imaging costs. Further analyses to characterize the financial viability of EVARs for both infrarenal and complex AAAs should evaluate hospital margins and anticipated changes in costs of devices.

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.

Decreasing prevalence of centers meeting the Society for Vascular Surgery abdominal aortic aneurysm guidelines in the United States.

OBJECTIVE: Based on data supporting a volume-outcome relationship in elective aortic aneurysm repair, the Society of Vascular Surgery (SVS) guidelines recommend that endovascular aortic repair (EVAR) be localized to centers that perform ≥10 operations annually and have a perioperative mortality and conversion-to-open rate of ≤2% and that open aortic repair (OAR) be localized to centers that perform ≥10 open aortic operations annually and have a perioperative mortality ≤5%. However, the number and distribution of centers meeting the SVS criteria remains unclear. This study aimed to estimate the temporal trends and geographic distribution of Centers Meeting the SVS Aortic Guidelines (CMAG) in the United States. METHODS: The SVS Vascular Quality Initiative was queried for all OAR, aortic bypasses, and EVAR from 2011 to 2019. Annual OAR and EVAR volume, 30-day elective operative mortality for OAR or EVAR, and EVAR conversion-to-open rate for all centers were calculated. The SVS guidelines for OAR and EVAR, individually and combined, were applied to each institution leading to a CMAG designation. The proportion of CMAGs by region (West, Midwest, South, and Northeast) were compared by year using a χ2 test. Temporal trends were estimated using a multivariable logistic regression for CMAG, adjusting by region. RESULTS: Overall, 67,865 patients (49,264 EVAR; 11,010 OAR; 7591 aortic bypasses) at 336 institutions were examined. The proportion of EVAR CMAGs increased nationally by 1.7% annually from 51.6% (n = 33/64) in 2011 to 67.1% (n = 190/283) in 2019 (ß = .05; 95% confidence interval [CI], 0.01-0.09; P = .02). The proportion of EVAR CMAGs across regions ranged from 27.3% to 66.7% in 2011 to 63.9% to 72.9% in 2019. In contrast, the proportion of OAR CMAGs has decreased nationally by 1.8% annually from 32.8% (n = 21/64) in 2011 to 16.3% (n = 46/283) in 2019 (ß = -.14; 95% CI, -0.19 to -0.10; P < .01). Combined EVAR and OAR CMAGs were even less frequent and decreased by 1.5% annually from 26.6% (n = 17/64) in 2011 to 13.1% (n = 37/283) in 2019 (ß = -.12; 95% CI, -0.17 to -0.07; P < .01). In 2019, there was no significant difference in regional variation of the proportion of combined EVAR and OAR CMAGs (P = .82). CONCLUSIONS: Although an increasing proportion of institutions nationally meet the SVS guidelines for EVAR, a smaller proportion meet them for OAR, with a concerning downward trend. These data question whether we can safely offer OAR at most institutions, have important implications about sufficient OAR exposure for trainees, and support regionalization of OAR.

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.

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.

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.

Five Year Survival in Medicare Patients Undergoing Interventions for Peripheral Arterial Disease: a Retrospective Cohort Analysis of Linked Registry Claims Data.

OBJECTIVE: To justify the up front risks of offering elective interventions for intermittent claudication (IC), patients should have reasonable life expectancy to derive durable clinical benefits. Open surgery for chronic limb threatening ischaemia (CLTI) is maximally beneficial in patients surviving ≥ 2 years. The aim was to assess long term survival after IC and CLTI interventions. METHODS: In a retrospective cohort analysis, the Vascular Quality Initiative (VQI) registry from 1 January 2010 to 31 May 2021 was queried for peripheral vascular intervention (PVI), infra-inguinal bypasses (IIB), and supra-inguinal bypasses (SIB) for IC and CLTI across 286 US centres. VQI linkage to Medicare insurance claims provided five year survival data. Multivariable analysis identified factors associated with five year mortality. RESULTS: There were 31 457 PVIs (44.7% IC, 55.3% CLTI), 7 978 IIBs (26.9% IC, 73.1% CLTI), and 2 149 SIBs (50.1% IC, 49.9% CLTI) recorded in the VQI. Among the PVI, IIB, and SIB cohorts, average ages were 75, 73, and 72 years, respectively. Respective five year mortality after PVI for IC and CLTI was 37.2% and 71.1%; after IIB for IC and CLTI it was 37.8% and 60%; and after SIB for IC and CLTI it was 33.8% and 53.8%. On multivariable analysis, across all procedures, end stage renal disease, CLTI, congestive heart failure, anaemia, chronic obstructive pulmonary disease, and prior amputation were independently associated with increased mortality. Pre-admission home living and pre-operative aspirin use were independently associated with decreased mortality. CONCLUSION: Long term survival in Medicare patients undergoing interventions in VQI centres for peripheral arterial disease is poor. Two thirds of CLTI patients and over one third of IC patients were not alive at five years. Intervening for IC in patients with high mortality risk should be avoided. For CLTI patients identified with decreased survival likelihood, intervention durability may be less important than invasiveness. Pre-operative medical optimisation should always be undertaken.

Low-volume surgeons can have better outcomes at certain hospital settings for open abdominal aortic repairs.

OBJECTIVE: The volume-outcomes relationship is cross-cutting among open abdominal aortic operations, where higher-volume surgeons have better perioperative outcomes. However, there has been minimal focus on low-volume surgeons and how to improve their outcomes. This study sought to identify if there are any differences in outcomes among low-volume surgeons for open abdominal aortic surgeries by different hospital settings. METHODS: We used the 2012-2019 Vascular Quality Initiative registry to identify all patients who underwent open abdominal aortic surgery for aneurysmal or aorto-iliac occlusive disease by a low-volume surgeon (<7 operations annually). We categorized high-volume hospitals using three distinct definitions: those that performed ≥10 operations annually, those with at least one high-volume surgeon, and by the number of surgeons (1-2 surgeons, 3-4 surgeons, 5-7 surgeons, and 8+ surgeons). Outcomes included 30-day perioperative mortality, overall complications, and failure-to-rescue. We compared outcomes among low-volume surgeons using univariable and multivariable logistic regressions across each of these three hospital categorizations. RESULTS: Among 14,110 patients who underwent open abdominal aortic surgery, 10,252 (7 3%) were performed by 1155 low-volume surgeons. Two-thirds of these patients (66%) underwent their surgery at a high-volume hospital, fewer than one-third (30%) at a hospital that had at least one high-volume surgeon, and one-half (49%) at hospitals with at least five surgeons. Among all patients operated on by low-volume surgeons, rates of 30-day mortality were 3.8%, perioperative complications were 35.3%, and failure-to-rescue were 9.9%. Low-volume surgeons operating at high-volume hospitals for aneurysmal disease had lower rates of perioperative death (adjusted odds ratio [aOR], 0.66; 95% confidence interval [CI], 0.48-0.90) and failure-to-rescue (aOR, 0.70; 95% CI, 0.50-0.98), but similar rates of complications (aOR, 1.06; 95% CI, 0.89-1.27). Similarly, patients undergoing their operation at hospitals that had at least one high-volume surgeon had lower rates of death (aOR, 0.71; 95% CI, 0.50-0.99) for aneurysmal disease. Patient outcomes among low-volume surgeons for aorto-iliac occlusive disease did not vary by hospital setting. CONCLUSIONS: The majority of patients undergoing open abdominal aortic surgery have a low-volume surgeon, where outcomes are slightly better for those taking place at a high-volume hospital. Focused and incentivized interventions may be needed to improve outcomes among low-volume surgeons across all practice settings.

Analysis of Early Death after Elective Open Abdominal Aortic Aneurysm Repair.

BACKGROUND: Mortality after open abdominal aortic aneurysm repair is a quality measure and early death may represent a technical complication or poor patient selection. Our objective was to analyze patients who died in the hospital within postoperative day (POD) 0-2 after elective abdominal aortic aneurysm repair. METHODS: The Vascular Quality Initiative was queried from 2003-2019 for elective open abdominal aortic aneurysm repairs. Operations were categorized as in-hospital death on POD 0-2 (POD 0-2 Death), in-hospital death beyond POD 2 (POD ≥3 Death), and those alive at discharge. Univariable and multivariable analyses were performed. RESULTS: There were 7,592 elective open abdominal aortic aneurysm repairs with 61 (0.8%) POD 0-2 Death, 156 (2.1%) POD ≥3 Death, and 7,375 (97.1%) alive at discharge. Overall, median age was 70 years and 73.6% were male. Iliac aneurysm repair and surgical approach (anterior/retroperitoneal) were similar among groups. POD 0-2 Death, compared to POD ≥3 Death and those alive at discharge, had the longest renal/visceral ischemia time, more commonly had proximal clamp placement above both renal arteries, an aortic distal anastomosis, longest operative time, and largest estimated blood loss (all P < 0.05). Postoperative vasopressor usage, myocardial infarction, stroke, and return to the operating room were most frequent in POD 0-2 Death and extubation in the operating room was least frequent (all P < 0.001). Postoperative bowel ischemia and renal failure occurred most commonly among POD ≥3 Death (all P < 0.001).On multivariable analysis, POD 0-2 Death was associated with congestive heart failure, prior peripheral vascular intervention, female sex, preoperative aspirin use, lower center volume quartile, renal/visceral ischemia time, estimated blood loss, and older age (all P < 0.05). CONCLUSIONS: POD 0-2 Death was associated with comorbidities, center volume, renal/visceral ischemia time, and estimated blood loss. Referral to high-volume aortic centers could improve 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.

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.

Postoperative disability and one-year outcomes for patients suffering a stroke after carotid endarterectomy.

OBJECTIVE: Although post-carotid endarterectomy (CEA) strokes are rare, they can be devastating. The degree of disability that patients develop after such events and its effects on long-term outcomes are unclear. Our goal was to assess the extent of postoperative disability in patients suffering strokes after CEA and evaluate its association with long-term outcomes. METHODS: The Vascular Quality Initiative CEA registry (2016-2020) was queried for CEAs performed for asymptomatic or symptomatic indications in patients with preoperative modified Rankin Scale (mRS) scores of 0 to 1. The mRS grades stroke-related disability as 0 (none), 1 (not significant), 2 to 3 (moderate), 4 to 5 (severe), and 6 (dead). Patients suffering postoperative strokes with recorded mRS scores were included. Postoperative stroke-related disability based on mRS and its association with long-term outcomes were analyzed. RESULTS: Among 149,285 patients undergoing CEA, there were 1178 patients without preoperative disability who had postoperative strokes and reported mRS scores. Mean age was 71 ± 9.2 years, and 59.6% of patients were male. Regarding ipsilateral cortical symptoms within 6 months preoperatively, 83.5% of patients were asymptomatic, 7.3% had transient ischemic attacks, and 9.2% had strokes. Postoperative stroke-related disability was classified as mRS 0 (11.6%), 1 (19.5%), 2 to 3 (29.4%), 4 to 5 (31.5%), and 6 (8%). One-year survival stratified by postoperative stroke-related disability was 91.4% for mRS 0, 95.6% for mRS 1, 92.1% for mRS 2 to 3, and 81.5% for mRS 4 to 5 (P < .001). Multivariable analysis demonstrated that while severe postoperative disability was associated with increased death at 1 year (hazard ratio [HR], 2.97; 95% confidence interval [CI], 1.5-5.89; P = .002), moderate postoperative disability had no such association (HR, 0.95; 95% CI, 0.45-2; P = .88). One-year freedom from subsequent ipsilateral neurological events or death stratified by postoperative stroke-related disability was 87.8% for mRS 0, 93.3% for mRS 1, 88.5% for mRS 2 to 3, and 77.9% for mRS 4 to 5 (P < .001). Severe postoperative disability was independently associated with increased ipsilateral neurological events or death at 1 year (HR, 2.34; 95% CI, 1.25-4.38; P = .01). However, moderate postoperative disability exhibited no such association (HR, 0.92; 95% CI, 0.46-1.82; P = .8). CONCLUSIONS: The majority of patients without preoperative disability who suffered strokes after CEA developed significant disability. Severe stroke-related disability was associated with higher 1-year mortality and subsequent neurological events. These data can improve informed consent for CEA and guide prognostication after postoperative strokes.

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.

Aortobifemoral reconstruction in open abdominal aortic aneurysm repair is associated with increased morbidity and mortality.

OBJECTIVE: Much attention has been given to the influence of anatomic and technical factors, such as maximum abdominal aortic aneurysm diameter and proximal clamp position, in open abdominal aortic aneurysm repair (OSR). However, no studies have rigorously examined the correlation between site of distal anastomosis and OSR outcomes despite conventional wisdom that more proximal sites of anastomosis are preferrable when technically feasible. This study aimed to test the association between sites of distal anastomosis and clinical outcomes for patients undergoing primary elective OSR. METHODS: Our study included 5683 patients undergoing primary elective OSR at 233 centers from 2014 to 2020. Using a variety of statistical methods to account for potential confounders, including multivariable logistic regression and Cox proportional hazards modeling, as well as subgroup analysis, we examined the association between site of distal anastomosis and clinical outcomes in elective OSR. Primary outcomes were major in-hospital complication rate, 30-day mortality, and long-term survival. RESULTS: Patients undergoing elective aortobifemoral reconstruction (n = 672) exhibited significantly increased rates of smoking, chronic obstructive pulmonary disease, and peripheral artery disease in comparison to patients undergoing elective OSR with distal anastomosis to the aorta (n = 2298), common iliac artery (n = 2163), or external iliac artery (n = 550). Patients undergoing aorto-aortic tube grafting were significantly less likely to exhibit iliac aneurysmal disease and significantly more likely to be undergoing elective OSR with a suprarenal or supraceliac proximal clamp position. Using multivariable logistic regression and Cox proportional hazards analysis to control for important confounders, such as age, smoking status, and medical history, we found that distal anastomosis to the common femoral artery was associated with increased odds of major in-hospital complications (adjusted odds ratio, 1.79; 95% confidence interval, 1.46-2.18; P < .001) and reduced long-term survival (adjusted hazard ratio, 1.44; 95% confidence interval, 1.09-1.89; P = .010). We observed no significant differences in 30-day mortality across sites of distal anastomosis in our study population. CONCLUSIONS: It is generally accepted that more proximal sites of distal anastomosis should be selected in OSR when technically feasible. Our findings support this hypothesis by demonstrating that distal anastomosis to the common femoral artery is associated with increased perioperative morbidity and reduced long-term survival. Careful diligence regarding optimization of preoperative health status, perioperative care, and long-term follow-up should be applied to mitigate major complications in this patient population.

The impact of aorto-uni-iliac graft configuration on outcomes of endovascular repair for ruptured abdominal aortic aneurysms.

INTRODUCTION: Endovascular aneurysm repair has improved outcomes for ruptured abdominal aortic aneurysms (rAAA) compared with open repair. We examined the impact of aorto-uni-iliac (AUI) vs standard bifurcated endograft configuration on outcomes in rAAA. METHODS: Patients 18 years or older in the Vascular Quality Initiative database who underwent endovascular aneurysm repair for rAAA from January 2011 to April 2020 were included. Patient characteristics were analyzed by graft configuration: AUI or standard bifurcated. Primary and secondary outcomes included 30-day mortality, postoperative major adverse events (myocardial infarction, stroke, heart failure, mesenteric ischemia, lower extremity embolization, dialysis requirement, reoperation, pneumonia, or reintubation), and 1-year mortality. A subset propensity-score matched cohort was also analyzed. RESULTS: We included 2717 patients: 151 had AUI and 2566 had standard bifurcated repair. There was no significant difference between the groups in terms of age, major medical comorbidities, anatomic aortic neck characteristics, or rates of conversion to open repair. Patients who underwent AUI were more commonly female (30% vs 22%, P = .011) and had a history of congestive heart failure (19% vs 12%, P = .013). Perioperatively, patients who underwent AUI had a significantly higher incidence of cardiac arrest (15% vs 7%, P < .001), greater intraoperative blood loss (1.3 L vs 0.6 L, P < .001), longer operative duration (218 minutes vs 138 minutes, P < .0001), higher incidence of major adverse events (46.3% vs 33.3%, P = .001), and prolonged intensive care unit (7 vs 4.7 days, P = .0006) and overall hospital length of stay (11.4 vs 8.1 days, P = .0003). Kaplan-Meier survival analyses demonstrated significant differences in 30-day (31.1% vs 20.2%, log-rank P = .001) and 1-year mortality (41.7% vs 27.7%, log-rank P = .001). The propensity-score matched cohort demonstrated similar results. CONCLUSIONS: The AUI configuration for rAAA appears to be implemented in a sicker cohort of patients and is associated with worse perioperative and 1-year outcomes compared with a bifurcated graft configuration, which was also seen on propensity-matched analysis. Standard bifurcated graft configuration may be the preferred approach in the management of rAAA unless AUI configuration is mandated by patient anatomy or other extenuating circumstances.

Insurance status is associated with urgent carotid endarterectomy and worse postoperative outcomes.

OBJECTIVE: Underinsured patients can experience worse preoperative medical optimization. We aimed to determine whether insurance status was associated with carotid endarterectomy (CEA) urgency and postoperative outcomes. METHODS: We analyzed the Society for Vascular Surgery Vascular Quality Initiative Carotid Endarterectomy dataset from January 2012 to January 2021. Univariable and multivariable methods were used to analyze the differences across the insurance types for the primary outcome variable: CEA urgency. The analyses were limited to patients aged <65 years to minimize age confounding across insurers. We also examined differences in preoperative medical optimization and symptomatic disease and postoperative outcomes. A secondary analysis was performed to examine the effect of CEA urgency on the postoperative outcomes. RESULTS: A total of 27,331 patients had undergone first-time CEA. Of these patients, 4600 (17%) had Medicare, 3440 (13%) had Medicaid, 17,917 (65%) had commercial insurance, and 1374 (5%) were uninsured. The Medicaid and uninsured patients had higher rates of urgent operation compared with Medicare (20.0% and 34.7% vs 14.4%; P < .001), with no differences in the commercial group vs the Medicare group. Additionally, Medicaid and uninsured patients had lower rates of aspirin, statin, and/or antiplatelet use (93.6% and 93.5% vs 95.8%; P < .001) and higher rates of symptomatic disease (42.1% and 57.6% vs 36.2%; P < .001) compared with Medicare patients. The rate of perioperative stroke/death was higher for the Medicaid and uninsured patients than for the Medicare patients (1.63% and 1.89% vs 1.02%; P = .017 and P = .01, respectively), with no differences in the commercial group. Multivariable analysis demonstrated that compared with Medicare, Medicaid and uninsured status were associated with increased odds of an urgent operation (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.1-1.5; and OR, 2.3; 95% CI, 2.0-2.7, respectively), symptomatic disease (OR, 1.2; 95% CI, 1.1-1.4; and OR, 2.2; 95% CI, 1.9-2.5, respectively), and perioperative stroke/death (OR, 1.6; 95% CI, 1.1-2.4; and OR, 1.8; 95% CI, 1.1-3.0, respectively) and a decreased odds of aspirin, statin, and/or antiplatelet use (OR, 0.71; 95% CI, 0.6-0.9; and OR, 0.76; 95% CI, 0.6-0.99, respectively). Additionally, the rates of perioperative stroke/death were higher for patients who had required urgent surgery compared with elective surgery (2.8% vs 1.0%; P < .001). Multivariable analysis demonstrated increased odds of perioperative stroke/death for patients who had required urgent surgery (OR, 2.4; 95% CI, 1.9-3.1). CONCLUSIONS: Medicaid and uninsured patients were more likely to require urgent CEA, in part because of poor preoperative medical optimization. Additionally, urgent operation was independently associated with worse postoperative outcomes. These results highlight the need for improved preoperative follow-up for underinsured populations.

Neuroprotective association of preoperative renin-angiotensin system blocking agents use in patients undergoing carotid interventions.

OBJECTIVE: The optimal medical management strategy in the periprocedural period for patients undergoing carotid artery interventions is not well described. Renin-angiotensin-system blocking (RASB) agents are considered to be among the first line anti-hypertensive agents; however, their role in the perioperative period is unclear. The objective of this study was to examine the relationship between the use of RASB agents on periprocedural outcomes in patients undergoing carotid interventions-carotid endarterectomy (CEA), transfemoral carotid artery stenting (CAS), and transcervical carotid artery revascularization (TCAR). METHOD: The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing CAS, CEA, and TCAR between 2003 and 2020. Patients were stratified into two groups based upon their use of RASB agents in the periprocedural period. The primary endpoint was periprocedural neurologic events (including both strokes and transient ischemic attacks (TIAs)). The secondary endpoints were peri-procedural mortality and significant cardiac events, including myocardial infarction, dysrhythmia, and congestive heart failure. RESULTS: Over 150,000 patients were included in the analysis: 13,666 patients underwent TCAR, 13,811 underwent CAS, and 125,429 underwent CEA for carotid artery stenosis. Overall, 52.2% of patients were maintained on RASB agents. Among patients undergoing CEA, patients on RASB agents had a significantly lower rate of periprocedural neurologic events (1.7% versus 2.0%, p =0.001). The peri-procedural neurological event rate in the TCAR cohort was similarly reduced in those treated with RASB agents, but did not reach statistical significance (2.0% vs 2.4%, p = 0.162). Among patients undergoing CAS, there was no difference in perioperative neurologic events between the RASB treated and untreated cohorts (3.4% vs 3.2%, p = 0.234); however, the use of RASB agents was significantly associated with lower mortality (1.2% vs 1.7%, p =0.001) with CAS. The use of preoperative RAS-blocking agents did not appear to affect the overall rates of adverse cardiac events with any of the three carotid intervention types, or periprocedural mortality following CEA or TCAR. On multivariable analysis, the use of RAS-blocking agents was independently associated with lower rates of post-procedural neurologic events in patients undergoing CEA (OR 0.819, CI 0.747-0.898; p = 0.01) and TCAR (OR 0.869, CI 0.768-0.984; p = 0.026), but not in those undergoing CAS (OR 0.967, CI 0.884-1.057; p = 0.461). CONCLUSION: The use of peri-procedural RASB agents was associated with a significantly decreased rate of neurologic events in patients undergoing both CEA and TCAR. This effect was not observed in patients undergoing CAS. As carotid interventions warrant absolute minimization of perioperative complications in order to provide maximum efficacy with regard to stroke protection, the potential neuro-protective effect associated with RASB agents use following CEA and TCAR warrants further examination.