Comparison of open and endovascular left subclavian artery revascularization for zone 2 thoracic endovascular aortic repair.

OBJECTIVE: In patients undergoing elective thoracic endovascular aortic repair (TEVAR) and left subclavian artery (LSA) coverage, routine preoperative LSA revascularization is recommended. However, in the current endovascular era, the optimal surgical approach is debated. We compared baseline characteristics, procedural details, and perioperative outcomes of patients undergoing open or endovascular LSA revascularization in the setting of TEVAR. METHODS: Adult patients undergoing TEVAR with zone 2 proximal landing and LSA revascularization between 2013-2023 were identified in the Vascular Quality Initiative. We excluded patients with traumatic aortic injury, aortic thrombus, or ruptured presentations, and stratified based on revascularization type (open vs. any endovascular). Open LSA revascularization included surgical bypass or transposition. Endovascular LSA revascularization included single-branch, fenestration, or parallel stent grafting. Primary outcomes were stroke, spinal cord ischemia, and perioperative mortality (Pearson's χ2-test). Multivariable logistic regression was used to evaluate associations between revascularization type and primary outcomes. Secondarily, we studied other in-hospital complications and 5-year mortality (Kaplan-Meier, multivariable Cox-regression). Sensitivity analysis was performed in patients undergoing concomitant LSA revascularization to TEVAR. RESULTS: Of 2,489 patients, 1,842 (74%) underwent open and 647 (26%) received endovascular LSA revascularization. Demographics and comorbidities were similar between open and endovascular cohorts. Compared with open, endovascular revascularization had shorter procedure times (median 135 vs. 174min, p<.001), longer fluoroscopy time (median 23 vs. 16min, p<.001), lower estimated blood loss (median 100 vs. 123ml, p<.001), and less preoperative spinal drain use (40% vs. 49%, p<.001). Patients undergoing endovascular revascularization were more likely to present urgently (24% vs. 19%) or emergently (7.4% vs. 3.4%) (p<.001). Compared with open, endovascular patients experienced lower stroke rates (2.6% vs. 4.8%, p=.026; aOR 0.50[95%C.I., 0.25-0.90]), but had comparable spinal cord ischemia (2.9% vs. 3.5%, p=.60; 0.64[0.31-1.22]) and perioperative mortality (3.1% vs. 3.3%, p=.94; 0.71[0.34-1.37]). Compared with open, endovascular LSA revascularization had lower rates of overall composite in-hospital complications (20% vs. 27%, p<.001; 0.64[0.49-0.83]) and shorter overall hospital stay (7 vs. 8 days, p<.001). After adjustment, 5-year mortality was similar among groups (aHR 0.85[0.64-1.13]). Sensitivity analysis supported the primary analysis with similar outcomes. CONCLUSIONS: In patients undergoing TEVAR starting in zone 2, endovascular LSA revascularization had lower rates of postoperative stroke and overall composite in-hospital complications, but similar spinal cord ischemia, perioperative and 5-year mortality rates compared with open LSA revascularization. Future comparative studies are needed to evaluate the mid- to long-term safety of endovascular LSA revascularization and assess differences between specific endovascular techniques.

The Association between Sex and Outcomes following Thoracic Endovascular Repair for Acute Type B Aortic Dissection.

OBJECTIVE: Prior literature has found worse outcomes for females following endovascular repair of AAA and mixed findings following TEVAR for TAA. However, the influence of sex on outcomes after TEVAR for acute Type B aortic dissection (aTBAD) is not fully elucidated. METHODS: We identified patients undergoing TEVAR for acute type B aortic dissection (<30 days) in the Vascular Quality Initiative (VQI) from 2014 to 2022. We excluded patients with an entry tear or stent seal within the ascending aorta or aortic arch and patients with an unknown proximal tear location. Included patients were stratified by biological sex, and we analyzed perioperative outcomes and 5-year mortality with multivariable logistic regression and Cox regression analysis, respectively. Furthermore, we analyzed adjusted variables for interaction with female sex. RESULTS: We included 1,626 patients, 33% of whom were female. At presentation, females were significantly older (65 [IQR: 54,75] years vs 56 [IQR: 49,68] years; p= 0.01). Regarding indications for repair, females had higher rates of pain (85% vs 80%; p=0.02), and lower rates of malperfusion (23% vs 35%; p<0.001): specifically mesenteric, renal, and lower limb malperfusion. Females had a lower proportion of proximal repairs in zone 2 (39% vs 48%; p< 0.01). Following TEVAR for aTBAD, female sex was associated with comparable odds of perioperative mortality compared with males (8.1 vs 9.2%; Adjusted Odds Ratio (aOR): 0.79 [95% CI: 0.51-1.20]). Regarding perioperative complications, female sex was associated with lower odds for cardiac complications (2.3% vs 4.7%; aOR: 0.52 [95%CI: 0.26-0.97]), but all other complications were comparable between sexes. Compared with male sex, female sex was associated with similar risk for 5-year mortality (26% vs 23%; Adjusted Hazard Ratio (aHR): 1.01 [95%CI: 0.77-1.32]). Upon testing variables for interaction with sex, female sex was associated with lower perioperative and 5-year mortality at older ages relative to males (aOR: 0.96 [0.93-0.99] | aHR: 0.97 [0.95-0.99]) and higher odds of perioperative mortality when mesenteric malperfusion was present (OR: 2.71 [1.04-6.96]). CONCLUSION: Female patients were older, less likely to have complicated dissection, and had more distal proximal landing zones. Following TEVAR for aTBAD, female sex was associated with similar perioperative and 5-year mortality compared with male sex, but lower odds of in-hospital cardiac complications. Interaction analysis showed females were at additional risk for perioperative mortality when mesenteric ischemia was present. These data suggest that TEVAR for aTBAD overall has a similar safety profile in females as it does for males.

The Effect of One Year Aneurysm Sac Dynamics on Five Year Mortality and Continued Aneurysm Sac Evolution.

OBJECTIVE: One year aneurysm sac dynamics after endovascular abdominal aortic aneurysm repair (EVAR) were independently associated with greater risk of all-cause mortality in prior registry studies but were limited in completeness and granularity. This retrospective analysis aimed to study the impact of sac dynamics on survival within the Endurant Stent Graft Global Registry (ENGAGE) with five year follow up. METHODS: A total of 1 263 subjects were enrolled in the ENGAGE Registry between March 2009 and April 2011. One year aneurysm sac changes were calculated from one month post-operative imaging scans and the scan closest to the time of one year follow up. Sac regression was defined as a sac decrease of ≥ 5 mm and sac expansion as aneurysm sac growth ≥ 5 mm. The primary outcome was rate of five year all-cause mortality. Kaplan-Meier estimates for freedom from all-cause mortality were calculated. Multivariable Cox regression was used to determine the association between sac dynamics and all-cause mortality. RESULTS: At one year, 441 of the 949 study participants with appropriate imaging (46%) had abdominal aortic aneurysm sac regression, 462 (49%) remained stable, and 46 (4.8%) had sac expansion. For patients with sac regression, five year all-cause mortality was 20%, compared with 28% for stable sac (p = .007) and 37% for the sac expansion (p = .010) cohorts. After adjustment, sac expansion and stable sac cohorts were associated with greater all-cause mortality (expansion: hazard ratio [HR] 1.8; 95% CI 1.1 - 3.2; p = .032; stable: HR 1.4; 95% CI 1.1 - 1.9; p = .019). CONCLUSION: In the ENGAGE Global Registry, one year rate of sac regression was 46%, and one year sac regression was observed to be associated with greater five year survival, corroborating prior findings utilising data from vascular registries. Sac regression could become the new standard for success after EVAR.

A national census for the off-label treatment of complex aortic aneurysms.

OBJECTIVE: Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. METHODS: Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98). RESULTS: A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. CONCLUSIONS: Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Outcomes of carotid revascularization stratified by procedure in eGFR<30 and dialysis patients.

OBJECTIVE: Renal failure is a predictor of adverse outcomes in carotid revascularization. There has been debate regarding the benefit of revascularization in patients with severe CKD or on dialysis. METHODS: VQI patients undergoing TCAR, tfCAS, or CEA between 2016 and 2023 with eGFR <30 ml/min/1.73m2 or on dialysis were included. Patients were divided into cohorts based on procedure. Additional analyses were performed for patients on dialysis only and by symptomatology. Primary outcomes were perioperative stroke/death/MI (SDM). Secondary outcomes included perioperative death, stroke, MI, CNI and stroke/death. Inverse probability of treatment weighting (IPW) was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and pre-op symptoms. Chi-square and multivariable logistic regression analysis were used to evaluate the association of procedure with perioperative outcomes in the weighted cohort. Five-year survival was evaluated using Kaplan-Meier and weighted Cox regression. RESULTS: In the weighted cohort, 13,851 patients with eGFR of <30 (2,506 on dialysis) underwent TCAR (3,639, dialysis 704), tfCAS (1,975, 393) or CEA (8,237, 1,409) during the study period. Compared with TCAR, CEA had higher odds of stroke/death/MI (2.8% vs 3.6%, aOR 1.27 [1.00,1.61], p=.049), and MI (0.7% vs 1.5%, aOR 2.00 [1.31,3.05], p=.001)... Compared to TCAR, rates of SDM (2.8%vs5.8%), stroke (1.2%vs2.6%), death (0.9%vs2,4%)were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%, aOR 1.85[1.15, 2.97]p=.011) and CNI (0.3% vs 1.9%, aOR 7.23[3.28, 15.9] p<.001). Like the primary analysis, asymptomatic tfCAS patients demonstrated higher odds of death, and stroke/death. Symptomatic CEA patients demonstrated no difference in stroke, death or stroke/death. While tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, 5-year survival was similar for TCAR and CEA (eGFR <30: 75.1% vs 74.2%, aHR1.06, p=.3) and lower for tfCAS (eGFR <30: 75.1% vs 70.4%, aHR1.44, p<.001) CONCLUSION: CEA and TCAR had similar odds of stroke and death and are both a reasonable choice in this population; however, TCAR may be better in patients with increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, while patients with reduced eGFR have worse outcomes than their healthy peers, this analysis shows that the majority of patients survive long enough to benefit from the potential stroke risk reduction provided by all revascularization procedures.

The effect of controlled vs uncontrolled hypertension on outcomes of carotid revascularization procedures.

BACKGROUND: Hypertension (HTN) has been implicated as a strong predictive factor for poorer outcomes in patients undergoing various vascular procedures. However, limited research is available that examines the effect of uncontrolled HTN (uHTN) on outcomes after carotid revascularization. We aimed to determine which carotid revascularization procedure yields the best outcome in this patient population. METHODS: We studied patients undergoing carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), or transcarotid artery revascularization (TCAR) from April 2020 to June 2022 using data from the Vascular Quality Initiative. Patients were stratified into two groups: those with cHTN and those with uHTN. Patients with cHTN were those with HTN treated with medication and a blood pressure of <130/80 mm Hg. Patients with uHTN had a blood pressure of ≥130/80 mm Hg. Our primary outcomes were in-hospital stroke, death, myocardial infarction (MI), and 30-day mortality. Our secondary outcomes were postoperative hypotension or HTN, reperfusion syndrome, prolonged length of stay (LOS) (>1 day), stroke/death, and stroke/death/MI. We used logistic regression models for the multivariate analysis. RESULTS: A total of 34,653 CEA (uHTN, 11,347 [32.7%]), 8199 TFCAS (uHTN, 2307 [28.1%]), and 17,309 TCAR (uHTN, 4990 [28.8%]) patients were included in this study. There was no significant difference in age between patients with cHTN and patients with uHTN for each carotid revascularization procedure. However, compared with patients with cHTN, patients with uHTN had significantly more comorbidities. uHTN was associated with an increased risk of combined in-hospital stroke/death/MI after CEA (adjusted odds ratio [aOR], 1.56; 95% confidence interval [CI], 1.30-1.87; P < .001), TFCAS (aOR, 1.59; 95% CI, 1.21-2.08; P < .001), and TCAR (aOR, 1.39; 95% CI, 1.12-1.73; P = .003) compared with cHTN. Additionally, uHTN was associated with a prolonged LOS after all carotid revascularization methods. For the subanalysis of patients with uHTN, TFCAS was associated with an increased risk of stroke (aOR, 1.82; 95% CI, 1.39-2.37; P < .001), in-hospital death (aOR, 3.73; 95% CI, 2.25-6.19; P < .001), reperfusion syndrome (aOR, 6.24; 95% CI, 3.57-10.93; P < .001), and extended LOS (aOR, 1.87; 95% CI, 1.51-2.32; P < .001) compared with CEA. There was no statistically significant difference between the outcomes of TCAR compared with CEA. CONCLUSIONS: The results from this study show that patients with uHTN are at a higher risk of stroke and death postoperatively compared with patients with cHTN, highlighting the importance of treating HTN before undergoing elective carotid revascularization. Additionally, in patients with uHTN, TFCAS yields the worst outcomes, whereas CEA and TCAR proved to be safer interventions. Patients with uTHN with symptomatic carotid disease treated with CEA or TCAR have better outcomes compared with those treated with TFCAS.

Using Administrative Data to Better Treat Chronic Limb Threatening Ischemia.

Chronic limb threatening ischemia (CLTI) is the most severe manifestation of peripheral arterial disease and represents a particularly high-risk subgroup of patients. As such, efforts to better understand this complex patient population through well-designed clinical research studies are critical to improving CLTI care. Prospective randomized clinical trials (RCTs) remain the gold standard in clinical research, but these trials are resource-intensive and have highly selective patient populations, which limit their feasibility and generalizability. Alternatively, retrospective studies are less expensive than RCTs, have a larger sample size, and are more generalizable owing to a broader patient population. Health care administrative data provide rich sources of information that may be used for research purposes and are increasingly being used for the study of vascular surgery conditions, including CLTI. Although administrative data are collected for billing purposes, they may be leveraged to study a broad range of topics in vascular surgery including those related to health care delivery, epidemiology, health disparities, and outcomes. This review provides an overview of administrative data available for CLTI research, the strengths and limitations of these data sources, current areas of investigation, and future opportunities for further study with the goal of improving outcomes in this high-risk population.

Earned outcomes correlate with reliability-adjusted surgical mortality after abdominal aortic aneurysm repair and predict future performance.

OBJECTIVE: Cumulative, probability-based metrics are regularly used to measure quality in professional sports, but these methods have not been applied to health care delivery. These techniques have the potential to be particularly useful in describing surgical quality, where case volume is variable and outcomes tend to be dominated by statistical "noise." The established statistical technique used to adjust for differences in case volume is reliability-adjustment, which emphasizes statistical "signal" but has several limitations. We sought to validate a novel measure of surgical quality based on earned outcomes methods (deaths above average [DAA]) against reliability-adjusted mortality rates, using abdominal aortic aneurysm (AAA) repair outcomes to illustrate the measure's performance. METHODS: Earned outcomes methods were used to calculate the outcome of interest for each patient: DAA. Hospital-level DAA was calculated for non-ruptured open AAA repair and endovascular aortic repair (EVAR) in the Vascular Quality Initiative database from 2016 to 2019. DAA for each center is the sum of observed - predicted risk of death for each patient; predicted risk of death was calculated using established multivariable logistic regression modeling. Correlations of DAA with reliability-adjusted mortality rates and procedure volume were determined. Because an accurate quality metric should correlate with future results, outcomes from 2016 to 2017 were used to categorize hospital quality based on: (1) risk-adjusted mortality; (2) risk- and reliability-adjusted mortality; and (3) DAA. The best performing quality metric was determined by comparing the ability of these categories to predict 2018 to 2019 risk-adjusted outcomes. RESULTS: During the study period, 3734 patients underwent open repair (106 hospitals), and 20,680 patients underwent EVAR (183 hospitals). DAA was closely correlated with reliability-adjusted mortality rates for open repair (r = 0.94; P < .001) and EVAR (r = 0.99; P < .001). DAA also correlated with hospital case volume for open repair (r = -.54; P < .001), but not EVAR (r = 0.07; P = .3). In 2016 to 2017, most hospitals had 0% mortality (55% open repair, 57% EVAR), making it impossible to evaluate these hospitals using traditional risk-adjusted mortality rates alone. Further, zero mortality hospitals in 2016 to 2017 did not demonstrate improved outcomes in 2018 to 2019 for open repair (3.8% vs 4.6%; P = .5) or EVAR (0.8% vs 1.0%; P = .2) compared with all other hospitals. In contrast to traditional risk-adjustment, 2016 to 2017 DAA evenly divided centers into quality quartiles that predicted 2018 to 2019 performance with increased mortality rate associated with each decrement in quality quartile (Q1, 3.2%; Q2, 4.0%; Q3, 5.1%; Q4, 6.0%). There was a significantly higher risk of mortality at worst quartile open repair hospitals compared with best quartile hospitals (odds ratio, 2.01; 95% confidence interval, 1.07-3.76; P = .03). Using 2016 to 2019 DAA to define quality, highest quality quartile open repair hospitals had lower median DAA compared with lowest quality quartile hospitals (-1.18 DAA vs +1.32 DAA; P < .001), correlating with lower median reliability-adjusted mortality rates (3.6% vs 5.1%; P < .001). CONCLUSIONS: Adjustment for differences in hospital volume is essential when measuring hospital-level outcomes. Earned outcomes accurately categorize hospital quality and correlate with reliability-adjustment but are easier to calculate and interpret. From 2016 to 2019, highest quality open AAA repair hospitals prevented >40 perioperative deaths compared with the average hospital, and >80 perioperative deaths compared with lowest quality hospitals.

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.

Predictors of prolonged length of stay after elective carotid revascularization.

OBJECTIVE: Postoperative day-one discharge is used as a quality-of-care indicator after carotid revascularization. This study identifies predictors of prolonged length of stay (pLOS), defined as a postprocedural LOS of >1 day, after elective carotid revascularization. METHODS: Patients undergoing carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), and transfemoral carotid artery stenting (TFCAS) in the Vascular Quality Initiative between 2016 and 2022 were included in this analysis. Multivariable logistic regression analysis was used to identify predictors of pLOS, defined as a postprocedural LOS of >1 day, after each procedure. RESULTS: A total of 118,625 elective cases were included. pLOS was observed in nearly 23.2% of patients undergoing carotid revascularization. Major adverse events, including neurological, cardiac, infectious, and bleeding complications, occurred in 5.2% of patients and were the most significant contributor to pLOS after the three procedures. Age, female sex, non-White race, insurance status, high comorbidity index, prior ipsilateral CEA, non-ambulatory status, symptomatic presentation, surgeries occurring on Friday, and postoperative hypo- or hypertension were significantly associated with pLOS across all three procedures. For CEA, additional predictors included contralateral carotid artery occlusion, preoperative use of dual antiplatelets and anticoagulation, low physician volume (<11 cases/year), and drain use. For TCAR, preoperative anticoagulation use, low physician case volume (<6 cases/year), no protamine use, and post-stent dilatation intraoperatively were associated with pLOS. One-year analysis showed a significant association between pLOS and increased mortality for all three procedures; CEA (hazard ratio [HR],1.64; 95% confidence interval [CI], 1.49-1.82), TCAR (HR,1.56; 95% CI, 1.35-1.80), and TFCAS (HR, 1.33; 95%CI, 1.08-1.64) (all P < .05). CONCLUSIONS: A postoperative LOS of more than 1 day is not uncommon after carotid revascularization. Procedure-related complications are the most common drivers of pLOS. Identifying patients who are risk for pLOS highlights quality improvement strategies that can optimize short and 1-year outcomes of patients undergoing carotid revascularization.

Temporal Trends and Outcomes of Abdominal Aortic Aneurysm Care in the United States.

BACKGROUND: Endovascular aortic aneurysm repair (EVAR) has had a dynamic impact on abdominal aortic aneurysm (AAA) care, often supplanting open AAA repair (OAR). Accordingly, US AAA management is often highlighted by disparities in patient selection and guideline compliance. The purpose of this analysis was to define secular trends in AAA care. METHODS: The Society for Vascular Surgery Vascular Quality Initiative was queried for all EVARs and OARs (2011-2021). End points included procedure utilization, change in mortality, patient risk profile, Society for Vascular Surgery-endorsed diameter compliance, off-label EVAR use, cross-clamp location, blood loss, in-hospital complications, and post-EVAR surveillance missingness. Linear regression was used without risk adjustment for all end points except for mortality and complications, for which logistic regression with risk adjustment was used. RESULTS: In all, 66 609 EVARs (elective, 85% [n=55 805] and nonelective, 15% [n=9976]) and 13 818 OARs (elective, 70% [n=9706] and nonelective, 30% [n=4081]) were analyzed. Elective EVAR:OAR ratios were increased (0.2 per year [95% CI, 0.01-0.32]), while nonelective ratios were unchanged. Elective diameter threshold noncompliance decreased for OAR (24%→17%; P=0.01) but not EVAR (mean, 37%). Low-risk patients increasingly underwent elective repairs (EVAR, +0.4%per year [95% CI, 0.2-0.6]; OAR, +0.6 points per year [95% CI, 0.2-1.0]). Off-label EVAR frequency was unchanged (mean, 39%) but intraoperative complications decreased (0.5% per year [95% CI, 0.2-0.9]). OAR complexity increased reflecting greater suprarenal cross-clamp rates (0.4% per year [95% CI, 0.1-0.8]) and blood loss (33 mL/y [95% CI, 19-47]). In-hospital complications decreased for elective (0.7% per year [95% CI, 0.4-0.9]) and nonelective EVAR (1.7% per year [95% CI, 1.1-2.3]) but not OAR (mean, 42%). A 30-day mortality was unchanged for both elective OAR (mean, 4%) and EVAR (mean, 1%). Among nonelective OARs, an increase in both 30-day (0.8% per year [95% CI, 0.1-1.5]) and 1-year mortality (0.8% per year [95% CI, 0.3-1.6]) was observed. Postoperative EVAR surveillance acquisition decreased (67%→49%), while 1-year mortality among patients without imaging was 4-fold greater (9.2% versus imaging, 2.0%; odds ratio, 4.1 [95% CI, 3.8-4.3]; P<0.0001). CONCLUSIONS: There has been an increase in EVAR and a corresponding reduction in OAR across the United States, despite established concerns surrounding guideline adherence, reintervention, follow-up, and cost. Although EVAR morbidity has declined, OAR complication rates remain unchanged and unexpectedly high. Opportunities remain for improving AAA care delivery, patient and procedure selection, guideline compliance, and surveillance.

National registry insights on genetic aortopathies and thoracic endovascular aortic interventions.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) in patients with genetic aortopathies (GA) is controversial, given concerns of durability. We describe characteristics and outcomes after TEVAR in patients with GA. METHODS: All patients undergoing TEVAR between 2010 and 2023 in the Vascular Quality Iniatitive were identified and categorized as having a GA or not. Demographics, baseline, and procedural characteristics were compared among groups. Multivariable logistic regression was used to evaluate the independent association of GA with postoperative outcomes. Kaplan-Meier methods and multivariable Cox regression analyses were used to evaluate 5-year survival and 2-year reinterventions. RESULTS: Of 19,340 patients, 304 (1.6%) had GA (87% Marfan syndrome, 9% Loeys-Dietz syndrome, and 4% vascular Ehlers-Danlos syndrome). Compared with patients without GA, patients with GA were younger (50 years [interquartile range, 37-72 years] vs 70 years [interquartile range, 61-77 years]), more often presented with acute dissection (28% vs 18%), postdissection aneurysm (48% vs 17%), had a symptomatic presentation (50% vs 39%), and were less likely to have degenerative aneurysms (18% vs 47%) or penetrating aortic ulcer (and intramural hematoma) (3% vs 13%) (all P < .001). Patients with GA were more likely to have prior repair of the ascending aorta/arch (open, 56% vs 11% [P < .001]; endovascular, 5.6% vs 2.1% [P = .017]) or the descending thoracic aorta (open, 12% vs 2% [P = .007]; endovascular, 8.2% vs 3.6% [P = .011]). No significant differences were found in prior abdominal suprarenal repairs; however, patients with GA had more prior open infrarenal repairs (5.3% vs 3.2%), but fewer prior endovascular infrarenal repairs (3.3% vs 5.5%) (all P < .05). After adjusting for demographics, comorbidities, and disease characteristics, patients with GA had similar odds of perioperative mortality (4.6% vs 7.0%; adjusted odds ratio [aOR], 1.1; 95% confidence interval [CI], 0.57-1.9; P = .75), any in-hospital complication (26% vs 23%; aOR, 1.24; 95% CI, 0.92-1.6; P = .14), or in-hospital reintervention (13% vs 8.3%; aOR, 1.25; 95% CI, 0.84-1.80; P = .25) compared with patients without GA. However, patients with GA had a higher likelihood of postoperative vasopressors (33% vs 27%; aOR, 1.44; 95% CI, 1.1-1.9; P = .006) and transfusion (25% vs 23%; aOR, 1.39; 95% CI, 1.03-1.9; P = .006). The 2-year reintervention rates were higher in patients with GA (25% vs 13%; adjusted hazard ratio, 1.99; 95% CI, 1.4-2.9; P < .001), but 5-year survival was similar (81% vs 74%; adjusted hazard ratio, 1.02; 95% CI, 0.70-1.50; P = .1). CONCLUSIONS: TEVAR for patients with GA seemed to be safe initially, with similar odds for in-hospital complications, in-hospital reinterventions, and perioperative mortality, as well as similar hazards for 5-year mortality compared with patients without GA. However, patients with GA had higher 2-year reintervention rates. Future studies should assess long-term durability after TEVAR compared with the recommended open repair to appropriately weigh the risks and benefits of endovascular treatment in patients with GA.

Seven years of the transcarotid artery revascularization surveillance project, comparison to transfemoral stenting and endarterectomy.

OBJECTIVE: This study utilizes the latest data from the Vascular Quality Initiative (VQI), which now encompasses over 50,000 transcarotid artery revascularization (TCAR) procedures, to offer a sizeable dataset for comparing the effectiveness and safety of TCAR, transfemoral carotid artery stenting (tfCAS), and carotid endarterectomy (CEA). Given this substantial dataset, we are now able to compare outcomes overall and stratified by symptom status across revascularization techniques. METHODS: Utilizing VQI data from September 2016 to August 2023, we conducted a risk-adjusted analysis by applying inverse probability of treatment weighting to compare in-hospital outcomes between TCAR vs tfCAS, CEA vs tfCAS, and TCAR vs CEA. Our primary outcome measure was in-hospital stroke/death. Secondary outcomes included myocardial infarction and cranial nerve injury. RESULTS: A total of 50,068 patients underwent TCAR, 25,361 patients underwent tfCAS, and 122,737 patients underwent CEA. TCAR patients were older, more likely to have coronary artery disease, chronic kidney disease, and undergo coronary artery bypass grafting/percutaneous coronary intervention as well as prior contralateral CEA/CAS compared with both CEA and tfCAS. TfCAS had higher odds of stroke/death when compared with TCAR (2.9% vs 1.6%; adjusted odds ratio [aOR], 1.84; 95% confidence interval [CI], 1.65-2.06; P < .001) and CEA (2.9% vs 1.3%; aOR, 2.21; 95% CI, 2.01-2.43; P < .001). CEA had slightly lower odds of stroke/death compared with TCAR (1.3% vs 1.6%; aOR, 0.83; 95% CI, 0.76-0.91; P < .001). TfCAS had lower odds of cranial nerve injury compared with TCAR (0.0% vs 0.3%; aOR, 0.00; 95% CI, 0.00-0.00; P < .001) and CEA (0.0% vs 2.3%; aOR, 0.00; 95% CI, 0.0-0.0; P < .001) as well as lower odds of myocardial infarction compared with CEA (0.4% vs 0.6%; aOR, 0.67; 95% CI, 0.54-0.84; P < .001). CEA compared with TCAR had higher odds of myocardial infarction (0.6% vs 0.5%; aOR, 1.31; 95% CI, 1.13-1.54; P < .001) and cranial nerve injury (2.3% vs 0.3%; aOR, 9.42; 95% CI, 7.78-11.4; P < .001). CONCLUSIONS: Although tfCAS may be beneficial for select patients, the lower stroke/death rates associated with CEA and TCAR are preferred. When deciding between CEA and TCAR, it is important to weigh additional procedural factors and outcomes such as myocardial infarction and cranial nerve injury, particularly when stroke/death rates are similar. Additionally, evaluating subgroups that may benefit from one procedure over another is essential for informed decision-making and enhanced patient care in the treatment of carotid stenosis.

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.

Carotid endarterectomy and transcarotid artery revascularization can be performed with acceptable morbidity and mortality in patients with chronic kidney disease.

OBJECTIVE: Patients with chronic kidney disease (CKD) are considered a high-risk population, and the optimal approach to the treatment of carotid disease remains unclear. Thus, we compared outcomes following carotid revascularization for patients with CKD by operative approach of carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid arterial revascularization (TCAR). METHODS: The Vascular Quality Initiative was analyzed for patients undergoing carotid revascularizations (CEA, TFCAS, and TCAR) from 2016 to 2021. Patients with normal renal function (estimated glomular filtration rate >90 mL/min/1.72 m2) were excluded. Asymptomatic and symptomatic carotid stenosis were assessed separately. Preoperative demographics, operative details, and outcomes of 30-day mortality, stroke, myocardial infarction (MI), and composite variable of stroke/death were compared. Multivariable analysis adjusted for differences in groups, including CKD stage. RESULTS: A total of 90,343 patients with CKD underwent revascularization (CEA, n = 66,870; TCAR, n = 13,459; and TFCAS, n = 10,014; asymptomatic, 63%; symptomatic, 37%). Composite 30-day mortality/stroke rates were: asymptomatic: CEA, 1.4%; TCAR, 1.2%; TFCAS, 1.8%; and symptomatic: CEA, 2.7%; TCAR, 2.3%; TFCAS, 3.7%. In adjusted analysis, TCAR had lower 30-day mortality compared with CEA (asymptomatic: adjusted odds ratio [aOR], 0.4; 95% confidence interval [CI], 0.3-0.7; symptomatic: aOR, 0.5; 95% CI, 0.3-0.7), and no difference in stroke, MI, or the composite outcome of stroke/death in both symptom cohorts. TCAR had lower risk of other cardiac complications compared with CEA in asymptomatic patients (aOR, 0.7; 95% CI, 0.6-0.9) and had similar risk in symptomatic patients. Compared with TFCAS, TCAR patients had lower 30-day mortality (asymptomatic: aOR, 0.5; 95% CI, 0.2-0.95; symptomatic: aOR, 0.3; 95% CI, 0.2-0.4), stroke (symptomatic: aOR, 0.7; 95% CI, 0.5-0.97), and stroke/death (asymptomatic: aOR, 0.7; 95% CI, 0.5-0.97; symptomatic: aOR, 0.6; 95% CI, 0.4-0.7), but no differences in MI or other cardiac complications. Patients treated with TFCAS had higher 30-day mortality (aOR, 1.8; 95% CI, 1.2-2.5) and stroke risk (aOR, 1.3; 95% CI, 1.02-1.7) in symptomatic patients compared with CEA. There were no differences in MI or other cardiac complications. CONCLUSIONS: Among patients with CKD, TCAR and CEA showed rates of stroke/death less than 2% for asymptomatic patients and less than 3% for symptomatic patients. Given the increased risk of major morbidity and mortality, TFCAS should not be performed in patients with CKD who are otherwise anatomic candidates for TCAR or CEA.

Bailout Distal Internal Carotid Artery Stenting after Carotid Endarterectomy: Indications, Technique, and Outcomes.

BACKGROUND: Distal internal carotid artery (ICA) stenting may be employed as a bailout maneuver when an inadequate end point or clamp injury is encountered at the time of carotid endarterectomy (CEA) in a surgically inaccessible region of the distal ICA. We sought to characterize the indications, technique, and outcomes for this infrequently encountered clinical scenario. METHODS: We performed a retrospective review of all patients who underwent distal ICA stenting at the time of CEA at our institution between September 2008 and July 2022. Procedural details and postoperative follow-up were reviewed for each patient. RESULTS: Six patients were identified during the study period. All were male with an age range of 63 to 82 years. Five underwent carotid revascularization for asymptomatic carotid artery stenosis, and one patient was treated for amaurosis fugax. Three patients were on dual antiplatelet therapy preoperatively, whereas 2 were on aspirin monotherapy, and one was on aspirin and low-dose rivaroxaban. Five patients underwent CEA with patch angioplasty, and one underwent eversion CEA. The indication for stenting was distal ICA dissection due to clamp or shunt injury in 2 patients and an inadequate distal ICA end point in 4 patients. In all cases, access for stenting was obtained under direct visualization within the common carotid artery, and a standard carotid stent was deployed with its proximal aspect landing within the endarterectomized site. Embolic protection was typically achieved via proximal common carotid artery and external carotid artery clamping for flow arrest with aspiration of debris before restoration of antegrade flow. There was 100% technical success. Postoperatively, 2 patients were found to have a cranial nerve injury, likely occurring due to the need for high ICA exposure. Median length of stay was 2 days (range 1-7 days) with no instances of perioperative stroke or myocardial infarction. All patients were discharged on dual antiplatelet therapy with no further occurrence of stroke, carotid restenosis, or reintervention through a median follow-up of 17 months. CONCLUSIONS: Distal ICA stenting is a useful adjunct in the setting of CEA complicated by inadequate end point or vessel dissection in a surgically inaccessible region of the ICA and can minimize the need for high-risk extensive distal dissection of the ICA in this situation.

Why selective screening for asymptomatic carotid stenosis is currently appropriate: a special report.

INTRODUCTION: Two of the main reasons recent guidelines do not recommend routine population-wide screening programs for asymptomatic carotid artery stenosis (AsxCS) is that screening could lead to an increase of carotid revascularization procedures and that such mass screening programs may not be cost-effective. Nevertheless, selective screening for AsxCS could have several benefits. This article presents the rationale for such a program. AREAS COVERED: The benefits of selective screening for AsxCS include early recognition of AsxCS allowing timely initiation of preventive measures to reduce future myocardial infarction (MI), stroke, cardiac death and cardiovascular (CV) event rates. EXPERT OPINION: Mass screening programs for AsxCS are neither clinically effective nor cost-effective. Nevertheless, targeted screening of populations at high risk for AsxCS provides an opportunity to identify these individuals earlier rather than later and to initiate a number of lifestyle measures, risk factor modifications, and intensive medical therapy in order to prevent future strokes and CV events. For patients at 'higher risk of stroke' on best medical treatment, a prophylactic carotid intervention may be considered.

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.