Impact of Chronic Kidney Disease on Outcomes following Vascular Procedure in the Vascular Quality Initiative.

BACKGROUND: Chronic kidney disease (CKD) increases morbidity and mortality in most vascular procedures. However, a binary classification of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, which is often used in both modeling and clinical trials, may not be optimal for predicting clinical outcomes. OBJECTIVE: Determine the optimal eGFR cutoff for use in risk stratification and prediction models. METHODS: Vascular Quality Initiative (VQI) data for non-emergent, first-time OAR, EVAR, TEVAR, CEA, CAS, PVI, Supra- and infra-inguinal bypass were analyzed from to 2013-2023 and divided into cohorts based on eGFR (≥60, 45-59, 30-44, <30, and preoperative dialysis). χ2 and logistic regression were used to evaluate perioperative outcomes. RESULTS: Compared to patients with eGFR ≥60, those with eGFR 45-59 had similar odds of mortality following all procedures, except TEVAR. Driven by this group, the combined cohort showed a slight increase in the odds of mortality for eGFR 45-59 (0.6% vs. 0.7%, aOR 1.16, P=0.002). Those in the 30-44 group demonstrated increased odds of mortality both overall and in the individual procedure groups (0.6% vs. 1.2%, aOR 1.78, P<0.001). The odds of mortality continued to increase with worsening eGFR. The overall rate of new permanent dialysis was low for all eGFR cohorts, with a 0.02% difference between those with eGFR >60 and those in the 45-59 cohort (0.04% vs. 0.06%; a OR 1.65, P<0.001). The odds of permanent dialysis likewise continued to increase with decreasing eGFR. CONCLUSIONS: Rather than a binary eGFR cutoff of ≥60 and <60 to stratify patient risk, better risk stratification may be achieved by using five groups of ≥60, 45-59, 30-44, <30, and preoperative dialysis.

Retroperitoneal vs. Transperitoneal Approach for Non-Ruptured Open Conversion after Endovascular Aneurysm Repair.

OBJECTIVE: Several studies comparing the transperitoneal (TP) and retroperitoneal (RP) approach for AAA repair suggest that the RP approach may result in lower rates of perioperative mortality and morbidity. However, data comparing these approaches for open conversion are lacking. This study aims to evaluate the association between the type of approach and outcomes following open conversion after EVAR. METHODS: We included all patients who underwent open conversion after EVAR between 2010-2022 in Vascular Quality Initiative (VQI). Patients presenting with rupture were excluded. The primary outcome was perioperative mortality. The secondary outcomes included perioperative complications and 5-year mortality. Inverse probability weighting (IPW) was used to adjust for factors with statistical or clinical significance. Logistic regression was used to assess perioperative mortality and complications in the weighted cohort. 5-year mortality was evaluated using Kaplan-Meier and Cox regression. RESULTS: We identified 660 patients (39% RP) who underwent open conversion after EVAR. Compared with TP, RP patients were older (75 [IQR, 70-79] years vs. 73.5 [IQR, 68-79] years, p<.001), and more frequently had prior myocardial infarction (33% vs. 22%, p=.002). Compared with the TP approach, the RP approach was less frequently used in case of associated iliac aneurysm (19% vs. 27%, p=.026), but more frequently with associated renal bypass (7.8% vs. 1.7%, p<.001) and by high volume physicians (highest quintile, >7 AAA annually: 41% vs. 17%, p<.001) and in high volume centers (highest quintile, >35 AAA annually: 36% vs. 20%, p<.001). RP patients, compared with TP patients, were less likely to have external iliac or femoral distal anastomosis (8.2% vs. 21%, p<.001), and an infrarenal clamp (25% vs. 36%, p<.001). Unadjusted perioperative mortality was not significantly different between approaches (RP vs. TP: 3.8% vs. 7.5%; p=.077). After risk adjustment, RP patients had similar odds of perioperative mortality (aOR, 0.49; 95%CI, 0.22-1.10; p=.082), and lower odds of intestinal ischemia (aOR, 0.26; 95%CI, 0.08-0.86; p=.028) and in-hospital reintervention (aOR, 0.43; 95%CI, 0.22-0.85; p=.015). No significant differences were found in the other perioperative complications, and 5-year mortality (aHR, 0.79; 95%CI, 0.47-1.32; p=.37). CONCLUSIONS: - Our findings suggest that the RP approach may be associated with lower adjusted odds of perioperative complications compared with the TP approach. The RP approach should be considered for open conversion after EVAR when feasible.

Higher stroke risk after carotid endarterectomy and transcarotid artery revascularization is associated with relative surgeon volume ratio.

OBJECTIVE: Adoption of transcarotid artery revascularization (TCAR) by surgeons has been variable, with some still performing traditional carotid endarterectomy (CEA), whereas others have shifted to mostly TCAR. Our goal was to evaluate the association of relative surgeon volume of CEA to TCAR with perioperative outcomes. METHODS: The Vascular Quality Initiative CEA and carotid artery stent registries were analyzed from 2021 to 2023 for symptomatic and asymptomatic interventions. Surgeons participating in both registries were categorized in the following CEA to CEA+TCAR volume percentage ratios: 0.25 (majority TCAR), 0.26 to 0.50 (more TCAR), 0.51 to 0.75 (more CEA), and 0.76 to 1.00 (majority CEA). Primary outcomes were rates of perioperative ipsilateral stroke, death, cranial nerve injury, and return to the operating room for bleeding. RESULTS: There were 50,189 patients who underwent primary carotid revascularization (64.3% CEA and 35.7% TCAR). CEA patients were younger (71.1 vs 73.5 years, P < .001), with more symptomatic cases, less coronary artery disease, diabetes, and lower antiplatelet and statin use (all P < .001). TCAR patients had lower rates of smoking, obesity, and dialysis or renal transplant (all P < .001). Postoperative stroke after CEA was significantly impacted by the operator CEA to TCAR volume ratio (P = .04), with surgeons who perform majority TCAR and more TCAR having higher postoperative ipsilateral stroke (majority TCAR odds ratio [OR]: 2.15, 95% confidence interval [CI]: 1.16-3.96, P = .01; more TCAR OR: 1.42, 95% CI: 1.02-1.96, P = .04), as compared with those who perform majority CEA. Similarly, postoperative stroke after TCAR was significantly impacted by the CEA to TCAR volume ratio (P = .02), with surgeons who perform majority CEA and more CEA having higher stroke (majority CEA OR: 1.51, 95% CI: 1.00-2.27, P = .05; more CEA OR: 1.50, 95% CI: 1.14-2.00, P = .004), as compared with those who perform majority TCAR. There was no association between surgeon ratio and perioperative death, cranial nerve injury, and return to the operating room for bleeding for either procedure. CONCLUSIONS: The relative surgeon CEA to TCAR ratio is significantly associated with perioperative stroke rate. Surgeons who perform a majority of one procedure have a higher stroke rate in the other. Surgeons offering both operations should maintain a balanced practice and have a low threshold to collaborate as needed.

The association between sex and outcomes after thoracic endovascular repair for acute type B aortic dissection.

OBJECTIVE: Prior literature has found worse outcomes for female patients after endovascular repair of abdominal aortic aneurysm and mixed findings after thoracic endovascular aortic repair (TEVAR) for thoracic aortic aneurysm. However, the influence of sex on outcomes after TEVAR for acute type B aortic dissection (aTBAD) is not fully elucidated. METHODS: We identified patients who underwent TEVAR for aTBAD (<30 days) in the Vascular Quality Initiative 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 1626 patients, 33% of whom were female. At presentation, female patients were significantly older (65 [interquartile range: 54, 75] years vs 56 [interquartile range: 49, 68] years; P = .01). Regarding indications for repair, female patients had higher rates of pain (85% vs 80%; P = .02) and lower rates of malperfusion (23% vs 35%; P < .001), specifically mesenteric, renal, and lower limb malperfusion. Female patients had a lower proportion of proximal repairs in zone 2 (39% vs 48%; P < .01). After TEVAR for aTBAD, female sex was associated with comparable odds of perioperative mortality to males (8.1 vs 9.2%; adjusted odds ratio [aOR]: 0.79 [95% confidence interval (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: 1.01 [95% CI: 0.77-1.32]). On 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] | adjusted hazard ratio: 0.97 [0.95-0.99]) and higher odds of perioperative mortality when mesenteric malperfusion was present (OR: 2.71 [1.04-6.96]). CONCLUSIONS: Female patients were older, less likely to have complicated dissection, and had more distal proximal landing zones. After TEVAR for aTBAD, female sex was associated with similar perioperative and 5-year mortality to male sex, but lower odds of in-hospital cardiac complications. Interaction analysis showed that 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.

Practice patterns in utilization of atherectomy and embolic protection devices in inpatient and outpatient treatment settings.

OBJECTIVE: The frequency of atherectomy in lower extremity arterial disease has increased substantially over the past several years, specifically in the office-based laboratory (OBL) setting, yet the efficacy compared with other interventions and the consequences of distal embolization remain unknown. Embolic protection devices (EPDs) have been used at varying rates depending on physician and practice setting. Previous studies have described lesion characteristics to consider when weighing the benefits and drawbacks associated with device use. Our study focuses on the use of atherectomy and EPDs in femoropopliteal arterial disease to better characterize resource use trends and postoperative outcomes in the inpatient and OBL interventional settings. METHODS: We conducted a retrospective analysis on endovascular interventions performed for femoral-popliteal occlusive disease that were entered into the Vascular Quality Initiative data registry between 2017 and 2021. A one:one greedy match, adjusted analysis based on inpatient or OBL location of procedure was used to compare the groups. Hierarchical logistical regression with selective use of principal component analysis was used to further explore the differences in EPD use and immediate postoperative outcomes. A proportional hazard model was used to demonstrate differences in reintervention rates up to 2 years postoperatively between patients who underwent atherectomy in the inpatient vs OBL treatment setting. RESULTS: 2849 matched pairs were inlcuded in the final analysis. In our cohort, there was 22% EPD use overall, 40% in the hospital setting and 4.4% in the OBL setting (P < .001). Among the patients with available follow-up information, OBL intervention setting increased probability of reintervention by 18% at 2 years postoperatively compared with the inpatient setting; however, there was no difference associated with EPD placement and rate of reintervention. CONCLUSIONS: Use of EPDs in the OBL setting compared with the hospital setting is dramatically decreased; however, no increased incidence of postoperative complications was seen compared to procedures performed in the hospital setting when controlling for patient and lesion characteristics. Patients with available follow-up data were more likely to undergo ipsilateral reintervention between 6 months and 2 years postoperatively if atherectomy was done in the OBL setting. Dedicated studies are encouraged to ensure patient safety, effective resource allocation, and long-term efficacy of OBL atherectomy as an ever-growing number of peripheral arterial procedures are transitioned to the OBL setting.

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.

Association between Asian race and perioperative outcomes after carotid revascularization varies with Asian procedure density.

OBJECTIVE: Postoperative outcomes following carotid revascularization are understudied in Asian patients. We aimed to assess whether disease severity and postoperative outcomes following carotid revascularization differ between Asian and White patients, and whether this varies with Asian procedure density. METHODS: We analyzed the Vascular Quality Initiative Carotid Endarterectomy and Carotid Artery Stenting datasets from 2003 to 2021. Regions were divided into tertiles based on Asian procedure density. Propensity scores were used to match Asian and White patients based on patient factors and procedure type. The primary outcome variable was a collapsed composite of in-hospital ipsilateral stroke/death/myocardial infarction. χ2 tests were used to assess association between Asian race and disease severity, center and surgeon volume, and 1-year outcomes. Logistic and Cox regressions were performed between the matched cohorts. RESULTS: A total of 1766 Asian and 159,608 White patients underwent carotid revascularization, and we identified 2704 patients (1352 Asian and 1352 White) in the matched cohorts. Among propensity matched patients, all-comer Asian patients more commonly had >80% ipsilateral stenosis (63% vs 52%; P < .001) and a moderate/severe preoperative Rankin score (7.6% vs 5.1%; P = .007). The rate of in-hospital stroke/death/myocardial infarction was higher in Asian patients (2.6% vs 1.3%; P = .012), and this disparity was more pronounced in the lowest tertile of Asian procedure density (4.3% vs 0.5%; P < .001). Logistic regression in the propensity-matched cohort demonstrated Asian race was associated with lower odds of intervention at highest volume centers (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.2-0.3; P < .001) and by highest volume surgeons (OR, 0.3; 95% CI, 0.3-0.4; P < .001). Asian race was associated with higher odds of in-hospital stroke/death/myocardial infarction (OR, 2.0; 95% CI, 1.1-3.8; P = .031), and there was a significant interaction between Asian procedure density and the relationship between Asian race and this outcome (interaction P = .001). After accounting for center and surgeon volume, the association of Asian race and the composite outcome was mitigated (OR, 1.5; 95% CI, 0.7-3.3; P = .300). Cox regression between the matched cohorts demonstrated that Asian race was associated with lower 1-year mortality (hazard ratio, 0.5; 95% CI, 0.3-0.7; P = .001) and higher risk of 1-year reintervention (hazard ratio, 16; 95% CI, 1.8-142; P = .013). CONCLUSIONS: Asian patients are more likely to present with a higher degree of carotid stenosis, higher preoperative risk, and experience worse perioperative outcomes. The association of Asian race with perioperative stroke/death/myocardial infarction varies with Asian procedure density and is also confounded by center and surgeon volume. These results highlight the importance of understanding referral patterns and cultural effects on outcomes disparities in Asian patients.

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.

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.

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.

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.

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.

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.

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.

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.

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.