Publications

OBJECTIVE: The high frequency of reinterventions after fenestrated endovascular aortic repair (FEVAR) with physician-modified endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal.

METHODS: We performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the United States Food and Drug Administration in support of an investigational device exemption trial. We excluded patients with aortic dissection (n = 5), type I to III thoracoabdominal aneurysms (n = 13), non-elective procedures (n = 4), and prior aortic surgery other than EVAR (n = 8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary FEVAR). The primary outcomes were freedom from reintervention and sac dynamics (regression as ≥5 mm decrease, expansion as ≥5 mm increase, and stability as <5 mm increase or decrease) at 3 years. Secondary outcomes were perioperative mortality and 3-year survival.

RESULTS: Of the 92 patients included, 56 (61%) underwent primary FEVAR and 36 (39%) underwent secondary FEVAR. Secondary FEVAR patients were older (78 years [interquartile range (IQR), 74.5-83.5 years] vs 73 years [IQR, 69-78.5 years]; P < .001), more frequently male (86% vs 68%; P = .048), and had larger aneurysms (72.5 mm [IQR, 65.5-81 mm] vs 59 mm [IQR, 55-65 mm]; P < .001). Perioperative mortality was 1.8% for primary FEVAR and 2.7% for secondary FEVAR (P = .75). At 3 years, overall survival was 84% for primary FEVAR and 71% for secondary FEVAR (P = .086). Freedom-from reintervention was significantly higher for primary FEVAR than secondary FEVAR, specifically 82% vs 38% at 3 years (P < .001). Primary FEVAR also had more desirable sac dynamics relative to secondary FEVAR at 3 years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded; P = .038).

CONCLUSIONS: FEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary FEVAR, less than a quarter of patients have undergone reintervention at 3 years, and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary FEVAR, over one-half of patients have undergone reintervention and over one-third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary FEVAR.

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.

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.

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 and 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 (SCI), 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 analyses were performed in patients undergoing concomitant LSA revascularization to TEVAR.

RESULTS: Of 2489 patients, 1842 (74%) underwent open and 647 (26%) endovascular LSA revascularization. Demographics and comorbidities were similar between open and endovascular cohorts. Compared with open, endovascular revascularization had shorter procedure times (median, 135 minutes vs 174 minutes; P < .001), longer fluoroscopy times (median, 23 minutes vs 16 minutes; P < .001), lower estimated blood loss (median, 100 mL vs 123 mL; 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; adjusted odds ratio [aOR], 0.50 [95% confidence interval (CI), 0.25-0.90]), but had comparable SCI (2.9% vs 3.5%; P = .60; aOR, 0.64 [95% CI, 0.31-1.22]) and perioperative mortality (3.1% vs 3.3%; P = .94; aOR, 0.71 [95% CI, 0.34-1.37]). Compared with open, endovascular LSA revascularization had lower rates of overall composite in-hospital complications (20% vs 27%; P < .001; aOR, 0.64 [95% CI, 0.49-0.83]) and shorter overall hospital stay (7 vs 8 days; P < .001). After adjustment, 5-year mortality was similar among groups (adjusted hazard ratio, 0.85; 95% CI, 0.64-1.13). Sensitivity analyses 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 SCI, perioperative mortality, 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.

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 chronic kidney disease or on dialysis.

METHODS: Patients in the Vascular Quality Initiative undergoing transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (tfCAS), or CEA between 2016 and 2023 with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 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/myocardial infarction (MI) (SDM). Secondary outcomes included perioperative death, stroke, MI, cranial nerve injury, and stroke/death. Inverse probability of treatment weighting was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and preoperative symptoms. The χ2 test 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 an eGFR of <30 (2506 on dialysis) underwent TCAR (3639; 704 on dialysis), tfCAS (1975; 393 on dialysis), or CEA (8237; 1409 on dialysis) during the study period. Compared with TCAR, CEA had higher odds of SDM (2.8% vs 3.6%; adjusted odds ratio [aOR], 1.27; 95% confidence interval [CI], 1.00-1.61; P = .049), and MI (0.7% vs 1.5%; aOR, 2.00; 95% CI, 1.31-3.05; P = .001). Compared with TCAR, rates of SDM (2.8% vs 5.8%), stroke (1.2% vs 2.6%), and death (0.9% vs 2.4%) were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%; aOR, 1.85; 95% CI, 1.15-2.97; P = .011) and cranial nerve injury (0.3% vs 1.9%; aOR, 7.23; 95% CI, 3.28-15.9; P < .001). Like in 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. Although tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, the 5-year survival was similar for TCAR and CEA (eGFR <30, 75.1% vs 74.2%; aHR, 1.06; P = .3) and lower for tfCAS (eGFR <30, 75.1% vs 70.4%; aHR, 1.44; P < .001).

CONCLUSIONS: 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 an increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, although patients with a 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.

OBJECTIVE: The outcomes of carotid revascularization in patients with prior carotid artery stenting (CAS) remain understudied. Prior research has not reported the outcomes after transcarotid artery revascularization (TCAR) in patients with previous CAS. In this study, we compared the peri-operative outcomes of TCAR, transfemoral CAS (tfCAS) and carotid endarterectomy (CEA) in patients with prior ipsilateral CAS using the Vascular Quality Iniatitive.

METHODS: Using Vascular Quality Initiative data from 2016 to 2023, we identified patients who underwent TCAR, tfCAS, or CEA after prior ipsilateral CAS. We included covariates such as age, race, sex, body mass index, comorbidities (hypertension, diabetes, prior coronary artery disease, prior coronary artery bypass grafting/percutaneous coronary intervention, congestive heart failure, renal dysfunction, smoking, chronic obstructive pulmonary disease, and anemia), symptom status, urgency, ipsilateral stenosis, and contralateral occlusion into a regression model to compute propensity scores for treatment assignment. We then used the propensity scores for inverse probability weighting and weighted logistic regression to compare in-hospital stroke, in-hospital death, stroke/death, postoperative myocardial infarction (MI), stroke/death/MI, 30-day mortality, and cranial nerve injury (CNI) after TCAR, tfCAS, and CEA. We also analyzed trends in the proportions of patients undergoing the three revascularization procedures over time using Cochrane-Armitage trend testing.

RESULTS: We identified 2137 patients undergoing revascularization after prior ipsilateral carotid stenting: 668 TCAR patients (31%), 1128 tfCAS patients (53%), and 341 CEA patients (16%). In asymptomatic patients, TCAR was associated with a lower yet not statistically significant in-hospital stroke/death than tfCAS (TCAR vs tfCAS: 0.7% vs 2.0%; adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.11-1.05; P = .06), and similar odds of stroke/death with CEA (TCAR vs CEA: 0.7% vs 0.9%; aOR, 0.80; 95% CI, 0.16-3.98; P = .8). Compared with CEA, TCAR was associated with lower odds of postoperative MI (0.1% vs 14%; aOR, 0.02; 95% CI, 0.00-0.10; P < .001), stroke/death/MI (0.8% vs 15%; aOR, 0.05; 95% CI, 0.01-0.25; P < .001), and CNI (0.1% vs 3.8%; aOR, 0.04; 95% CI, 0.00-0.30; P = .002) in this patient population. In symptomatic patients, TCAR had an unacceptably elevated in-hospital stroke/death rate of 5.1%, with lower rates of CNI than CEA. We also found an increasing trend in the proportion of patients undergoing TCAR following prior ipsilateral carotid stenting (2016 to 2023: 14% to 41%), with a relative decrease in proportions of tfCAS (61% to 45%) and CEA (25% to 14%) (P < .001).

CONCLUSIONS: In asymptomatic patients with prior ipsilateral CAS, TCAR was associated with lower odds of in-hospital stroke/death compared with tfCAS, with comparable stroke/death but lower postoperative MI and CNI rates compared with CEA. In symptomatic patients, TCAR was associated with unacceptably higher in-hospital stroke/death rates. In line with the postprocedure outcomes, there has been a steady increase in the proportion of patients with prior ipsilateral stenting undergoing TCAR over time.

OBJECTIVE: Current literature reports conflicting findings regarding the effect of diabetes mellitus (DM) on outcomes of abdominal aortic aneurysm (AAA) repair. In this study we examined the effect of DM and its management on outcomes after open AAA repair (OAR) and endovascular AAA repair (EVAR).

METHODS: We identified all patients undergoing OAR or EVAR for infrarenal AAA between 2003 and 2018 in the Vascular Quality Initiative registry data linked with Medicare claims. We excluded patients with missing DM status. Patients were stratified by their preoperative DM status, and then further stratified by DM management: dietary, noninsulin antidiabetic medications (NIMs), or insulin. Outcomes of interest included 1-year aneurysm sac dynamics, 8-year aneurysm rupture, reintervention, and all-cause mortality. These outcomes were analyzed with the χ2 test, Kaplan-Meier methods, and multivariable Cox regression analyses.

RESULTS: We identified 34,021 EVAR patients and 4127 OAR patients, of whom 20% and 16% had DM, respectively. Of all DM patients, 22% were managed by dietary management, 59% by NIM, and 19% by insulin. After EVAR, DM patients were more likely to have stable sacs, whereas non-DM patients were more likely to have sac regression at 1 year. Compared with non-DM, DM was associated with a significantly lower risk for 8-year rupture in EVAR (EVAR hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.51-0.92). Compared with non-DM, NIM was associated with lower risk of rupture within 8-years for both EVAR and OAR (EVAR HR, 0.64; 95% CI, 0.44-0.94; OAR HR, 0.29; 95% CI, 0.41-0.80), whereas dietary control and insulin had a similar rupture risk compared with non-DM. However, compared with non-DM, DM was associated with a higher risk of 8-year all-cause mortality after EVAR and OAR (DM vs non-DM: EVAR HR, 1.17; 95% CI, 1.11-1.23; OAR HR, 1.16; 95% CI, 1.00-1.36). After further DM management substratification, compared with non-DM, management with NIM and insulin were associated with a higher 8-year mortality in EVAR and OAR (EVAR: NIM HR, 1.12; 95% CI, 1.05-1.20; insulin: HR, 1.40; 95% CI, 1.26-1.55; OAR: NIM HR, 1.27; 95% CI, 1.06-1.54; and insulin: HR, 1.57; 95% CI, 1.15-2.13). Finally, there was a similar risk of reintervention across the DM and non-DM populations for EVAR and OAR.

CONCLUSIONS: DM was associated with a lower adjusted risk of rupture after EVAR as well as OAR in patients managed with NIM. Nevertheless, just as in patients without AAA, preoperative DM was associated with a higher adjusted risk of all-cause mortality. Further study is needed to evaluate for differences in aneurysm-related mortality between DM and non-DM patients, and studies are planned to evaluate the independent effect of NIM on aneurysm-related outcomes.

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OBJECTIVE: Our aim was to describe the racial and ethnic differences in presentation, baseline and operative characteristics, and outcomes after aortoiliac aneurysm repair.

SUMMARY OF BACKGROUND DATA: Previous studies have demonstrated racial and ethnic differences in prevalence of abdominal aortic aneurysms and showed more complex iliac anatomy in Asian patients.

METHODS: We identified all White, Black, Asian, and Hispanic patients undergoing aortoiliac aneurysm repair in the VQI from 2003 to 2019. We compared baseline comorbidities, operative characteristics, and perioperative outcomes by race and ethnicity.

RESULTS: In our 60,435 patient cohort, Black patients, followed by Asian patients, were most likely to undergo repair for aortoiliac (W:23%, B:38%, A:31%, H:22%, P < 0.001) and isolated iliac aneurysms (W:1.0%, B:3.1%, A:1.5%, H:1.6%, P < 0.001), and White and Hispanic patients were most likely to undergo isolated aortic aneurysm repair (W:76%, B:59%, A:68%, H:76%, P < 0.001). Black patients were more likely to undergo symptomatic repair and underwent rupture repair at a smaller aortic diameter. The iliac aneurysm diameter was largest in Black and Asian patients. Asian patients were most likely to have aortic neck angulation above 60 degree, graft oversizing above 20%, and completion endoleaks. Also, Asian patients were more likely to have a hypogastric artery aneurysm and to undergo hypogastric coiling.

CONCLUSION: Asian and Black patients were more likely to undergo repair for aortoiliac and isolated iliac aneurysms compared to White and Hispanic patients who were more likely to undergo repair for isolated aortic aneurysms. Moreover, there were significant racial differences in the demographics and anatomic characteristics that could be used to inform operative approach and device development.

BACKGROUND: Endovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR.

METHODS: We compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses.

RESULTS: After weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46).

CONCLUSIONS: Within the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.