Preoperative COVID-19 Vaccination is Associated with Decreased Perioperative Mortality after Major Vascular Surgery.

OBJECTIVE: The objective of this study was to examine the effect of corona virus 2019 (COVID-19) vaccination on perioperative outcomes after major vascular surgery. BACKGROUND DATA: COVID-19 vaccination is associated with decreased mortality in patients undergoing various surgical procedures. However, the effect of vaccination on perioperative mortality after major vascular surgery is unknown. METHODS: This is a multicenter retrospective study of patients who underwent major vascular surgery between December 2021 through August 2023. The primary outcome was all-cause mortality within 30 days of index operation or prior to hospital discharge. Multivariable models were used to examine the association between vaccination status and the primary outcome. RESULTS: Of the total 85,424 patients included, 19161 (22.4%) were unvaccinated. Unvaccinated patients were younger compared to vaccinated patients (mean age 68.44 +/- 10.37 y vs 72.11 +/- 9.20 y, P <0.001) and less likely to have comorbid conditions, including hypertension, congestive heart failure, chronic obstructive pulmonary disease, and dialysis. After risk factor adjustment, vaccination was associated with decreased mortality (OR 0.7, 95% CI 0.62 - 0.81, P <0.0001). Stratification by procedure type demonstrated that vaccinated patients had decreased odds of mortality after open AAA (OR 0.6, 95% CI 0.42-0.97, P =0.03), EVAR (OR 0.6, 95% CI 0.43-0.83, p 0.002), CAS (OR 0.7, 95% CI 0.51-0.88, P =0.004) and infra-inguinal lower extremity bypass (OR 0.7, 95% CI 0.48-0.96, P =0.03). CONCLUSIONS: COVID-19 vaccination is associated with reduced perioperative mortality in patients undergoing vascular surgery. This association is most pronounced for patients undergoing aortic aneurysm repair, carotid stenting and infrainguinal bypass.

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.

Blood flow assessment technology in aortic surgery: a narrative review.

Background and Objective: Blood flow assessment is an emerging technique that allows for assessment of hemodynamics in the heart and blood vessels. Recent advances in cardiovascular imaging technologies have made it possible for this technique to be more accessible to clinicians and researchers. Blood flow assessment typically refers to two techniques: measurement-based flow visualization using echocardiography or four-dimensional flow magnetic resonance imaging (4D flow MRI), and computer-based flow simulation based on computational fluid dynamics modeling. Using these methods, blood flow patterns can be visualized and quantitative measurements of mechanical stress on the walls of the ventricles and blood vessels, most notably the aorta, can be made. Thus, blood flow assessment has been enhancing the understanding of cardiac and aortic diseases; however, its introduction to clinical practice has been negligible yet. In this article, we aim to discuss the clinical applications and future directions of blood flow assessment in aortic surgery. We then provide our unique perspective on the technique's translational impact on the surgical management of aortic disease. Methods: Articles from the PubMed database and Google Scholar regarding blood flow assessment in aortic surgery were reviewed. For the initial search, articles published between 2013 and 2023 were prioritized, including original articles, clinical trials, case reports, and reviews. Following the initial search, additional articles were considered based on manual searches of the references from the retrieved literature. Key Content and Findings: In aortic root pathology and ascending aortic aneurysms, blood flow assessment can elucidate postoperative hemodynamic changes after surgical reconfiguration of the aortic valve complex or ascending aorta. In cases of aortic dissection, analysis of blood flow can predict future aortic dilatation. For complicated congenital aortic anomalies, surgeons may use preoperative imaging to perform "virtual surgery", in which blood flow assessment can predict postoperative hemodynamics for different surgical reconstructions and assist in procedural planning even before entering the operating room. Conclusions: Blood flow assessment and computational modeling can evaluate hemodynamics and flow patterns by visualizing blood flow and calculating biomechanical forces in patients with aortic disease. We anticipate that blood flow assessment will become an essential tool in the treatment planning and understanding of the progression of aortic disease.

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.

Utility of structured follow-up imaging after aortic surgery.

BACKGROUND: Although postoperative follow-up after aortic surgery is recommended by guidelines, its clinical utility is not well documented. We hypothesized that structured follow-up imaging by an aortic program would improve outcomes. We then documented radiologic findings on asymptomatic postoperative imaging. METHODS: All patients who survived to discharge after open thoracic aortic surgery between January 2017 and July 2021 were included, excluding endocarditis. Patients who followed at our center and received scheduled imaging were compared with patients who did not. Survival was analyzed by the method of Kaplan-Meier, and reintervention was assessed using the Fine-Gray subhazard function. Routine imaging was reviewed for aortic growth, pseudoaneurysm, and perigraft density. RESULTS: After aortic surgery, the cumulative incidence of follow-up was 38.6% at 3 years postoperatively. Patients with follow-up were more likely to have a dissection and fewer comorbidities but were similar in regards to socioeconomic factors and distance to hospital. After matching and accounting for immortal time bias, patients with follow-up had a greater reintervention rate (26.0% vs 9.0%) with similar survival (98.7% vs 95.2%, P = .110) at 4 years. The cumulative incidence of pseudoaneurysm, significant perigraft density, and growth ≥3 mm/year on routine imaging was 49.7% at 3 years. CONCLUSIONS: Implementation of structured follow-up imaging by an aortic program resulted in low clinical compliance. Follow-up was associated with increased rates of aortic reintervention. Clinically relevant radiologic findings were common on asymptomatic imaging and increased throughout 5-year follow-up rather than plateauing in the early postoperative period.

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.

Insulin Dependence is Associated with Poor Long-Term Outcomes Following AAA Repair.

BACKGROUND: While prior studies have confirmed the protective effect of diabetes on abdominal aortic aneurysm (AAA) development, much less is known about the effect of diabetes, and in particular insulin dependence, on outcomes following AAA repair. In this study, we aim to evaluate the role of insulin-dependent diabetes on short-term and long-term outcomes following open and endovascular AAA repair. METHODS: The Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry linking the Vascular Quality Initiative (VQI) data with Medicare claims, was queried for patients who underwent open or endovascular AAA repair from 2011 to the present. Exclusion criteria were unknown diabetes status, prior aortic intervention, maximum aneurysm diameter <45 mm at presentation, and Medicare Advantage coverage due to inconsistent follow-up. Patients were stratified based on diabetes status (no diabetes versus diabetes) and insulin dependence (no diabetes or non-insulin-dependent diabetes versus insulin-dependent diabetes). RESULTS: Of the 38,437 cases in the VISION endovascular aortic aneurysm (EVAR) and open aortic aneurysm repair (OAR) databases, 21,943 met inclusion criteria. Perioperative outcomes after OAR were comparable between diabetic and nondiabetic patients. However, diabetic patients undergoing EVAR were significantly more likely to have a postoperative myocardial infarction (1.0% vs 0.6%, P = 0.04) and have a 30-day readmission (10.9% vs 8.8%, P < 0.001). Insulin-dependent diabetic patients were more likely to require a 30-day readmission after OAR (24.5% vs 13.5%, P = 0.02) and EVAR (15.1% vs 9.0%, P < 0.001); however, only insulin-dependent diabetes mellitus (IDDM) patients undergoing EVAR experienced higher rates of postoperative myocardial infarction (1.9% vs 0.7%, P < 0.01). After propensity score matching, patients with IDDM undergoing EVAR were additionally at increased risk of mortality at 1-year, 3-year, and 5-year follow-up with the highest risk occurring at the 1-year mark (hazard ratio 1.79, P < 0.0001), while IDDM patients undergoing OAR were only at a significantly increased risk of mortality at 5-year follow-up (hazard ratio 1.90, P = 0.01). CONCLUSIONS: Patients with insulin-dependent diabetes have greater than 14% one-year mortality following open or endovascular aneurysm repair, compared to 8% for all others. Our findings raise questions about whether insulin-dependent diabetics should have a higher size threshold for prophylactic repair, although further studies are needed to address this question and consider the influence of glycemic control on these outcomes.

Central aortic versus axillary artery cannulation for aortic arch surgery.

Objective: Central aortic cannulation for aortic arch surgery has become more popular over the last decade; however, evidence comparing it with axillary artery cannulation remains equivocal. This study compares outcomes of patients who underwent axillary artery and central aortic cannulation for cardiopulmonary bypass during arch surgery. Methods: A retrospective review of 764 patients who underwent aortic arch surgery at our institution between 2005 and 2020 was performed. The primary outcome was failure to achieve uneventful recovery, defined as having experienced at least 1 of the following: in-hospital mortality, stroke, transient ischemic attack, bleeding requiring reoperation, prolonged ventilation, renal failure, mediastinitis, surgical site infection, and pacemaker or implantable cardiac defibrillator implantation. Propensity score matching was used to account for baseline differences across groups. A subgroup analysis of patients undergoing surgery for aneurysmal disease was performed. Results: Before matching, the aorta group had more urgent or emergency operations (P = .039), fewer root replacements (P < .001), and more aortic valve replacements (P < .001). After successful matching, there was no difference between the axillary and aorta groups in failure to achieve uneventful recovery, 33% versus 35% (P = .766), in-hospital mortality, 5.3% versus 5.3% (P = 1), or stroke, 8.3% versus 5.3% (P = .264). There were more surgical site infections in the axillary group, 4.8% versus 0.4% (P = .008). Similar results were seen in the aneurysm cohort with no differences in postoperative outcomes between groups. Conclusions: Aortic cannulation has a safety profile similar to that of axillary arterial cannulation in aortic arch surgery.

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.

Depressed Ejection Fraction Does Not Affect Perioperative Mortality After Thoracic Endovascular Aortic Repair for Type B Aortic Dissection.

BACKGROUND: Despite the expanded application of thoracic endovascular aortic repair (TEVAR) in patients with significant cardiac comorbidities, the effect of decreased left ventricular ejection fraction (EF) on outcomes remains unknown. The aim of this study was to compare outcomes in patients with normal and abnormal EFs undergoing TEVAR for type-B aortic dissection (TBAD). METHODS: The Vascular Quality Initiative database was reviewed from 2012 to 2020. Patients were categorized into severely reduced (EF ≤ 30%), reduced (EF 30-50%) and normal EF (EF>50%). Baseline characteristics, procedural details and 18-month outcomes were compared. Multivariable logistic regression identified factors associated with mortality, major adverse cardiac events (MACEs), and aortic-related reintervention. RESULTS: Of 1,993 patients, 38 (2%) and 208 (10%) patients had severely reduced ejection fraction (SREF) and reduced ejection fraction (REF). Patients with abnormal EF were more likely to have cardiac comorbidities and be prescribed angiotensin-converting enzyme inhibitors and anticoagulants. Perioperatively, patients with SREF were more likely to experience mortality (13.2% vs. 6.7% vs. 4.4%, P = 0.018), MACE (26.3% vs. 11.5% vs. 8%, P < 0.001), hemodialysis (13.5% vs. 5% vs. 2.9%, P = 0.001) and aortic related reintervention (21.1% vs. 13% vs. 10%, P = 0.041), compared to REF and normal ejection fraction (NEF) patients. However, these associations were not present on multivariable analysis. At 18 months, mortality was significantly higher in patients with SREF, which was confirmed on multivariable analysis, but depressed EF was not associated with increased aortic reintervention compared to NEF. CONCLUSIONS: SREF was not independently associated with perioperative mortality or MACE compared to NEF. REF had similar risk of morbidity and mortality compared to NEF in both the perioperative and early postoperative periods. TEVAR-related complications were similar among the cohorts. As such, TEVAR may be offered to appropriately selected patients regardless of EF.

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.

Urgent endarterectomy for symptomatic carotid occlusion is associated with a high mortality.

OBJECTIVE: Interventions for carotid occlusions undertaken are undertaken and the outcomes are poorly defined. We sought to study patients undergoing urgent carotid revascularization for symptomatic occlusions. METHODS: The Society for Vascular Surgery Vascular Quality Initiative database was queried from 2003 to 2020 to identify patients with carotid occlusions undergoing carotid endarterectomy. Only symptomatic patients undergoing urgent interventions within 24 hours of presentation were included. Patients were identified based on computed tomography and magnetic resonance imaging. This cohort was compared with symptomatic patients undergoing urgent intervention for severe stenosis (≥80%). The primary end points were perioperative stroke, death, myocardial infarction (MI) and composite outcomes as defined by the Society for Vascular Surgery reporting guidelines. Patient characteristics were analyzed to determine predictors of perioperative mortality and neurological events. RESULTS: We identified 390 patients who underwent urgent CEA for symptomatic occlusions. The mean age was 67.4 ± 10.2 years (range, 39-90 years). The cohort was predominantly male (60%) with associated risk factors for cerebrovascular disease, including hypertension (87.4%), diabetes (34.4%), coronary artery disease (21.6%), and current smoking (38.7%). This population had high use of medications, including statins (78.6%), P2Y12 inhibitors (32.0%), aspirin (77.9%), and renin-angiotensin inhibitors (43.7%) preoperatively. When compared with patients undergoing urgent endarterectomy for severe stenosis (≥80%), those with symptomatic occlusion were well-matched with regard to risk factors, but the severe stenosis cohort seemed to be managed better medically and less likely to present with cortical stroke symptoms. Perioperative outcomes were significantly worse for the carotid occlusion cohort, primarily driven by higher perioperative mortality (2.8% vs 0.9%; P < .001). The composite end point of stroke/death/MI was also significantly worse in the occlusion cohort (7.7% vs 4.9%; P = .014). On multivariate analysis, carotid occlusion was associated with increased mortality (odds ratio, 3.028; 95% confidence interval, 1.362-6.730; P = .007) and composite outcome of stroke, death, or MI (odds ratio, 1.790; 95% confidence interval, 1.135-2.822; P = .012). CONCLUSIONS: Revascularization for symptomatic carotid occlusion constitutes approximately 2% of carotid interventions captured in the Vascular Quality Initiative, affirming the rarity of this undertaking. These patients have acceptable rates of perioperative neurological events, but are at an elevated risk of overall perioperative adverse events, primarily driven by higher mortality, compared with those with severe stenosis. Carotid occlusion seems to be the most significant risk factor for the composite end point of perioperative stroke, death, or MI. Although intervention for a symptomatic carotid occlusion may be performed with acceptable rate of perioperative complications, judicious patient selection is warranted in this high-risk cohort.

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.