Long-term outcomes of carotid endarterectomy vs transfemoral carotid stenting in a Medicare-matched database.

BACKGROUND: Carotid endarterectomy (CEA) is associated with lower risk of perioperative stroke compared with transfemoral carotid artery stenting (TFCAS) in the treatment of carotid artery stenosis. However, there is discrepancy in data regarding long-term outcomes. We aimed to compare long-term outcomes of CEA vs TFCAS using the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database. METHODS: We assessed patients undergoing first-time CEA or TFCAS in Vascular Quality Initiative Vascular-Vascular Implant Surveillance and Interventional Outcomes Network from January 2003 to December 2018. Patients with prior history of carotid revascularization, nontransfemoral stenting, stenting performed without distal embolic protection, multiple or nonatherosclerotic lesions, or concomitant procedures were excluded. The primary outcome of interest was all-cause mortality, any stroke, and a combined end point of death or stroke. We additionally performed propensity score matching and stratification based on symptomatic status. RESULTS: A total of 80,146 carotid revascularizations were performed, of which 72,615 were CEA and 7531 were TFCAS. CEA was associated with significantly lower risk of death (57.8% vs 70.4%, adjusted hazard ratio [aHR], 0.46; 95% confidence interval [CI], 0.41-0.52; P < .001), stroke (21.3% vs 26.6%; aHR, 0.63; 95% CI, 0.57-0.69; P < .001) and combined end point of death and stroke (65.3% vs 76.5%; HR, 0.49; 95% CI, 0.44-0.55; P < .001) at 10 years. These findings were reflected in the propensity-matched cohort (combined end point: 34.6% vs 46.8%; HR, 0.53; 95% CI, 0.46-0.62) at 4 years, as well as stratified analyses of combined end point by symptomatic status (asymptomatic: 63.2% vs 74.9%; HR, 0.49; 95% CI, 0.43-0.58; P < .001; symptomatic: 69.9% vs 78.3%; HR, 0.51; 95% CI, 0.45-0.59; P < .001) at 10 years. CONCLUSIONS: In this analysis of North American real-world data, CEA was associated with greater long-term survival and fewer strokes compared with TFCAS. These findings support the continued use of CEA as the first-line revascularization procedure.

Prophylactic Perigraft Arterial Sac Embolization During EVAR: Minimizing Type II Endoleaks and Improving Sac Regression.

BACKGROUND: Type II endoleaks (ELII) are the most common complication following endovascular aneurysm repair (EVAR). Persistent ELII require continual surveillance and have been shown to increase the risk of Type I and III endoleaks, sac growth, need for intervention, conversion to open or even rupture, directly or indirectly. These are often difficult to treat following EVAR, and there are limited data regarding the effectiveness of prophylactic treatment of ELII. The aim of this study is to report the midterm outcomes of prophylactic perigraft arterial sac embolization (pPASE) performed in patients undergoing EVAR. METHODS: This is a comparison of 2 elective cohorts of those undergoing EVAR using the Ovation stent graft with and without prophylactic branch vessel and sac embolization. Patients who underwent pPASE at our institution had their data collected in a prospective, institutional review board-approved database. These were compared against the core lab-adjudicated data from the Ovation Investigational Device Exemption trial. Prophylactic PASE was performed at the time of EVAR with thrombin, contrast, and Gelfoam if the lumbar or mesenteric arteries were patent. Endpoints included freedom from ELII, reintervention, sac growth, all-cause mortality, and aneurysm-related mortality. RESULTS: Thirty-six patients (13.1%) underwent pPASE, while 238 patients (86.9%) had standard EVAR. Median follow-up was 56 months (33-60 months). The 4-year freedom from ELII estimates were 84% for the pPASE versus 50.7% for the standard EVAR group (P = 0.0002). All aneurysms in the pPASE group remained stable in size or demonstrated regression, whereas aneurysm sac expansion was seen in 10.9% of the standard EVAR group, P = 0.03. At 4 years, mean AAA diameter decreased by 11 mm (95% CI 8-15) in the pPASE group versus 5 mm (95% CI 4-6) for the standard EVAR group, P = 0.0005. There were no differences in the 4-year freedom from all-cause mortality and aneurysm-related mortality. However, the difference in reintervention for ELII trended toward significance (0.0% vs. 10.7%, P = 0.1). On multivariable analysis, pPASE was associated with a 76% reduction in ELII [(95% CI): 0.24 (0.08-0.65), P = 0.005]. CONCLUSIONS: These results suggest that pPASE in those undergoing EVAR is safe and effective in the prevention of ELII and significantly improves sac regression over standard EVAR while minimizing the need for reintervention.

Preoperative Spinal Drain Placement is Associated with Reduced Risk of Spinal Cord Ischemia in Patients Undergoing Thoracic Endovascular Aortic Repair for Aortic Dissection.

BACKGROUND: Spinal cord ischemia (SCI) is a rare but serious complication of Thoracic Endovascular Aortic Repair (TEVAR). Several measures including spinal drain (SD) placement have been proposed to reduce the risk of SCI in TEVARs performed for aneurysms. However, there are no specific large-scale data on potential benefits of SD placement in Stanford Type B aortic dissection (TBAD). We aimed to assess the impact of preoperative SD placement on preventing SCI during TEVARs performed for TBAD. METHODS: We included all TEVAR cases performed for TBAD in Vascular Quality Initiative (VQI) from 2012 to 2021. Patients with connective tissue disease, open conversion, rupture, proximal disease > zone 5, proximal landing zone <2 or SCI on presentation were excluded. One-to-one propensity score matching was used to balance patients on 34 dimensions by the nearest neighbor principle to compare patients based on preoperative SD placement. The primary outcome was SCI. Secondary outcomes included 30-day and 90-day mortality, perioperative complications, and 90-day2intervention. RESULTS: A total of 2,683 TEVARs were performed for TBAD with 1,227 (45.7%) undergoing preoperative SD placement. Propensity matching produced 672 well-matched pairs. In the matched cohort, SD placement was not associated with significant reduction in temporary SCI (3.0% vs. 3.7%, P = 0.45). However, SD placement was associated with significant reduction of the risk of permanent SCI at discharge (1.3% vs. 3.4%, P = 0.012). SD was also associated with lower risk of 30-day mortality (3.7% vs 6.4%, P = 0.025) and shorter length of stay but not 90-day mortality or 90-day reintervention. CONCLUSIONS: Our study suggests that preoperative SD placement in patients undergoing TEVAR for TBAD is beneficial in reducing the risk of permanent SCI without increasing risks of perioperative complications. Further prospective studies are necessary to confirm these findings.

Effect of Postoperative Stroke Timing on Perioperative Mortality After Carotid Revascularization.

BACKGROUND: In-hospital stroke (IHS) has been associated with worse outcomes than out-of-hospital stroke (OHS) due to delays in diagnosis and treatment. A paucity of studies exists comparing the timing of postoperative stroke after carotid revascularization. We aimed to study the effect of IHS versus OHS on postoperative mortality in carotid revascularization patients in a large-scale national database. METHODS: This is a retrospective cohort study of patients who underwent carotid artery stenting (CAS) and carotid endarterectomy (CEA) between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database. Statistical analysis included chi-squared test and multivariable logistic regression. Patients were divided based on postoperative stroke timing (no stroke, IHS, or OHS) as well as procedure type (CEA or CAS). RESULTS: A total of 31,304 carotid revascularizations were performed with 420 (1.3%) IHSs and 207 (0.7%) OHSs. On adjusted analysis, there was significantly higher perioperative mortality with both IHS [odds ratio (OR): 19.75, 95% confidence interval (CI): 13.61-28.18, P < 0.001] and OHS [OR: 29.73, 95% CI: 18.76-45.82, P < 0.001]. There was no difference in mortality after OHS versus IHS [OR: 1.51, 95% CI: 0.89-2.55, P = 0.161]. CONCLUSIONS: Any postoperative stroke after carotid revascularization significantly increased the odds of 30-day mortality. In contrast to previous studies demonstrating worse outcomes after IHS than OHS, we observed similar 30-day mortality between the 2 stroke categories. Improved follow-up and early recognition with rescue within carotid revascularization patients compared to the general population could potentially contribute to these results. However, overall mortality remains high for any postoperative stroke following carotid revascularization, emphasizing the importance of vigilant in-hospital monitoring and follow-up even after discharging the patient.

Immediate and delayed complications of inferior vena cava filters.

OBJECTIVE: Inferior vena cava (IVC) filter placement has increased dramatically in the past two decades. However, literature supporting the efficacy of these devices has been limited and controversial. In the present study, we have evaluated the predictors and rates of technical complications after IVC filter insertion in a large national database. METHODS: The Vascular Quality Initiative registry was explored (January 2013 to December 2020). Immediate complications were defined as venous injury requiring treatment, filter misplacement (failure to open, deployed >20 mm from intended site or in wrong vein, embolized to the heart), angulation >20°, and insertion site complications. Delayed complications were defined as migration, angulation >15°, fracture, caval and/or iliac thrombosis, filter thrombus, fragment embolization, and perforation. The Pearson χ2 test was used to compare the baseline characteristics between the patients who had developed immediate and/or delayed complications and those who had not. The predictors of these complications were evaluated using multivariable logistic regression, Cox proportional hazard regression, and Kaplan-Meier survival analysis. RESULTS: A total of 14,784 patients were included in the present analysis, with a median follow-up of 11 months (interquartile range, 4-16 months). The rate of immediate and delayed complications was 1.8% and 3.1%, respectively. Angulation (1.2%) was the most common immediate complication, and filter thrombosis (1.6%) was the most common delayed complication. Compared with the patients with no immediate complications, those with immediate complications were more likely to have had abnormal anatomy (6.0% vs 1.7%; P < .001) and a landing zone other than infrarenal (7.0% vs 4.2%; P = .02). Compared with their counterparts, those with delayed complications were less likely to have received statins (21.0% vs 29.5%; P = .006) and were more likely to have a family history of venous thromboembolism (8.0% vs 5.1%; P = .047). Logistic regression analysis revealed that renal vein visualization was associated a 50% reduction (adjusted odds ratio [aOR], 0.50; 95% confidence interval [CI], 0.27-0.92; P = .027) in the odds of immediate complications and female sex and abnormal anatomy were associated with a 41% (aOR, 1.41; 95% CI, 1.08-1.85; P = .013) and 244% (aOR, 3.44; 95% CI, 1.66-7.16; P < .001) increase in the odds of immediate complications, respectively. Immediate (P = .21) and delayed (P = .51) complications did not result in increased mortality. CONCLUSIONS: The immediate and delayed IVC filter complication rates were 1.8% and 3.1%, respectively, but the occurrence of complications was not associated with increased mortality. Female sex was associated with an increase in the development of immediate complications. The incidence of immediate complications might be mitigated if advanced imaging were used for renal vein visualization before IVC filter deployment. Delayed complications might be avoided if IVC filter retrieval were performed in a timely fashion and institutional retrieval protocols were optimized.

Long-term Outcomes Associated With Open vs Endovascular Abdominal Aortic Aneurysm Repair in a Medicare-Matched Database.

Importance: Endovascular aneurysm repair is associated with a significant reduction in perioperative mortality and morbidity compared with open aneurysm repair in the treatment of abdominal aortic aneurysm. However, this benefit decreases over time owing to increased reinterventions and late aneurysm rupture after endovascular repair. Objective: To compare long-term outcomes of endovascular vs open repair of abdominal aortic aneurysm. Design, Setting, and Participants: This multicenter retrospective cohort study used deidentified data with 6-year follow-up from the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database. Patients undergoing first-time elective endovascular or open abdominal aortic aneurysm repair from 2003 to 2018 were propensity score matched. Patients with ruptured abdominal aortic aneurysm, concomitant procedures, or prior history of abdominal aortic aneurysm repair, were excluded. Data were analyzed from January 1, 2003, to December 31, 2018. Exposures: First-time elective endovascular or open repair for abdominal aortic aneurysm. Main Outcomes and Measures: The primary long-term outcome of interest was 6-year all-cause mortality, rupture, and reintervention. Secondary outcomes included 30-day mortality and perioperative complications. Results: Among a total of 32 760 patients (median [IQR] age, 75 [70-80] years; 25 706 [78.5%] men) who underwent surgical abdominal aortic aneurysm repair, 28 281 patients underwent endovascular repair and 4479 patients underwent open repair. After propensity score matching, there were 2852 patients in each group. Open repair was associated with significantly lower 6-year mortality compared with endovascular repair (548 deaths [35.6%] vs 608 deaths [41.2%]; hazard ratio [HR], 0.83; 95% CI, 0.74-0.94; P = .002), with increases in mortality starting from 1 to 2 years (84 deaths [4.3%] vs 126 deaths [6.7%]; HR, 0.63; 95% CI, 0.48-0.83; P = .001) and 2 to 6 years (211 deaths [25.8%] vs 241 deaths [30.6%]; HR, 0.73; 95% CI, 0.61-0.88; P = .001). Open repair, compared with endovascular repair, also was associated with significantly lower rates of 6-year rupture (117 participants [5.8%] vs 149 participants [8.3%]; HR, 0.76; 95% CI, 0.60-0.97; P < .001) and reintervention (190 participants [11.6%] vs 267 participants [16.0%]; HR, 0.67; 95% CI, 0.55-0.80; P < .001). Open repair was associated with significantly higher odds of 30-day mortality (OR, 3.56; 95% CI, 2.41-5.26; P < .001) and complications. Conclusions and Relevance: These findings suggest that overall mortality after elective abdominal aortic aneurysm repair was higher with endovascular repair than open repair despite reduced 30-day mortality and perioperative morbidity after endovascular repair. Endovascular repair additionally was associated with significantly higher rates of long-term rupture and reintervention. These findings emphasize the importance of careful patient selection and long-term follow-up surveillance for patients who undergo endovascular repair.

In-hospital complications and long-term outcomes associated with timing of carotid endarterectomy.

OBJECTIVE: Carotid revascularization performed within 2 weeks of symptoms has proven to reduce risk of recurrent stroke in patients with symptomatic carotid artery stenosis. However, the optimal timing of revascularization within the 2-week window has yet to be determined. The objective of this study was to perform a comprehensive analysis of in-hospital and long-term outcomes of carotid endarterectomy (CEA) performed within different time intervals after most recent symptoms. METHODS: We analyzed 2003 to 2016 data from the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network. Only revascularizations performed for symptomatic carotid artery stenosis were included. Procedures were categorized as urgent (0-2 days from latest symptom), early (3-14 days), or late (15-180 days). The primary in-hospital outcome was stroke/death. The primary long-term outcomes of interest were 5-year recurrent ipsilateral stroke/death. Multivariable logistic regression, Kaplan-Meier analysis, and Cox regression were utilized to compare outcomes. RESULTS: A total of 18,970 revascularizations were included: 1130 (6.0%) urgent, 4643 (24.5%) early, and 13,197 (69.6%) late. Earlier CEA had increased odds of in-hospital stroke/death compared with late CEA (urgent: adjusted odds ratio, 1.9; 95% confidence interval [CI], 1.3-2.8; P = .001; early: adjusted odds ratio, 1.7; 95% CI, 1.3-2.2; P < .001). No differences were seen in 5-year risk of stroke/death (urgent: adjusted hazard ratio, 0.95; 95% CI, 0.79-1.15; P = .592; early: adjusted hazard ratio, 0.97; 95% CI, 0.87-1.07; P = .928). CONCLUSIONS: Urgent and early CEA were associated with increased perioperative risk without difference in 5-year outcomes compared with late CEA. Short-term recurrent stroke prevention could not be assessed. Updated population-based studies comparing recurrent stroke prevention with urgent or early revascularization vs best medical management are warranted.

In-Hospital Outcomes of Urgent, Early, or Late Revascularization for Symptomatic Carotid Artery Stenosis.

BACKGROUND AND PURPOSE: Advancements in carotid revascularization have produced promising outcomes in patients with symptomatic carotid artery stenosis. However, the optimal timing of revascularization procedures after symptomatic presentation remains unclear. The purpose of this study is to compare in-hospital outcomes of transcarotid artery revascularization (TCAR), transfemoral carotid stenting (TFCAS), or carotid endarterectomy (CEA) performed within different time intervals after most recent symptoms. METHODS: This is a retrospective cohort study of United States patients in the vascular quality initiative. All carotid revascularizations performed for symptomatic carotid artery stenosis between September 2016 and November 2019 were included. Procedures were categorized as urgent (0-2 days after most recent symptom), early (3-14 days), or late (15-180 days). The primary outcome of interest was in-hospital stroke and death. Secondary outcomes include in-hospital stroke, death, and transient ischemic attacks. Multivariable logistic regression was used to compare outcomes. RESULTS: A total of 18 643 revascularizations were included: 2006 (10.8%) urgent, 7423 (39.8%) early, and 9214 (49.42%) late. Patients with TFCAS had the highest rates of stroke/death at all timing cohorts (urgent: 4.0% CEA, 6.9% TFCAS, 6.5% TCAR, P=0.018; early: 2.5% CEA, 3.8% TFCAS, 2.9% TCAR, P=0.054; late: 1.6% CEA, 2.8% TFCAS, 2.3% TCAR, P=0.003). TFCAS also had increased odds of in-hospital stroke/death compared with CEA in all 3 groups (urgent adjusted odds ratio [aOR], 1.7 [95% CI, 1.0-2.9] P=0.03; early aOR, 1.6 [95% CI, 1.1-2.4] P=0.01; and late aOR, 1.9 [95% CI, 1.2-3.0] P=0.01). TCAR and CEA had comparable odds of in-hospital stroke/death in all 3 groups (urgent aOR, 1.9 [95% CI, 0.9-4], P=0.10), (early aOR, 1.1 [95% CI, 0.7-1.7], P=0.66), (late aOR, 1.5 [95% CI, 0.9-2.3], P=0.08). CONCLUSIONS: CEA remains the safest method of revascularization within the urgent period. Among revascularization performed outside of the 48 hours, TCAR and CEA have comparable outcomes.

Differences in Perioperative Outcomes after Carotid Revascularization between White and Non-white Patients.

BACKGROUND: Racial disparities in carotid endarterectomy (CEA) and carotid artery stenting (CAS) continue to persist. We aimed to provide a large-scale analysis of racial disparities in perioperative outcomes of carotid revascularization in a nationally representative cohort of patients, with sub-analyses stratifying by procedure type and symptomatic status. METHODS: We studied all patients undergoing carotid revascularization between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Database. Univariate methods were used to compare patients' demographic and medical characteristics. Multivariable logistic regression analysis was used to compare adjusted perioperative outcomes between white patients (WP) and non-white patients (NWP). Sub-analysis was performed stratifying by method of revascularization and symptomatic status. RESULTS: A total of 31,356 carotid revascularizations were performed in 26,550 (84.7%) white patients and 4,806 (15.3%) non-white patients. On adjusted analysis, NWP had increased odds of stroke (OR:1.2, 95%CI:1.1-1.5, P = 0.0496), unplanned return to the OR (OR:1.4, 95%CI:1.1-1.6, P < 0.001) and restenosis (OR:2.6, 95%CI:1.7-3.9, P < 0.001). On sub-analysis, NWP undergoing CAS had increased odds of stroke/death (OR:2.2, 95%CI:1.1-4.3, P = 0.025), stroke (OR:2.9, 95%CI:1.3-6.0, P = 0.007), and stroke/TIA (OR:2.1, 95%CI:1.0-4.2, P = 0.025). NWP undergoing CEA had increased odds of unplanned return to the OR (OR:1.4, 95%CI:1.2-1.6, P < 0.001) and restenosis (OR:2.7, 95%CI:1.7-4.0, P < 0.001). CONCLUSION: NWP had higher rates of 30-day stroke, driven primarily by higher rates of perioperative stroke/death in NWP undergoing CAS. NWP undergoing CEA did not have higher rates of stroke/death after adjusted analysis, although they had higher rates of unplanned return to OR and restenosis. Upon stratification for symptomatic status, the stroke/death rate between NWP and WP was shown to be non-significant.

The impact of carotid lesion calcification on outcomes of carotid artery stenting.

OBJECTIVE: The impact of carotid artery lesion calcification on adverse events following carotid artery stenting is not well-studied. Few reports associated heavily calcified lesions with high risk of perioperative stroke following transfemoral carotid artery stenting (TFCAS). With the advent of transcarotid artery revascularization (TCAR), we aimed to compare the outcomes of these two procedures stratified by the degree of lesion calcification. METHODS: Our cohort was derived from the Vascular Quality Initiative database for carotid artery stenting. Patients with missing information on the degree of carotid artery calcification were excluded. Patients were stratified into two groups: >50% (heavy) calcification and ≤50% (no/mild) calcification. The Student t test and the χ2 test were used to compare patients' baseline characteristics and crude outcomes, as appropriate. Clinically relevant and statistically significantly variables on univariable analysis were added to a logistic regression model clustered by center identifier. RESULTS: A total of 11,342 patients were included. Patients with >50% calcification were older, had more comorbidities, and more contralateral occlusion. There were more patients with prior ipsilateral carotid endarterectomy in the ≤50% calcification group. In patients who underwent TCAR, there were no significant differences between those who had >50% vs ≤50% carotid calcification in the odds of in-hospital adverse outcomes. However, in patients with heavy calcification who underwent TFCAS, there was a 50% to 60% increase in the odds of stroke (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.04-2.5; P = .03), stroke/transient ischemic attack (TIA) (OR, 1.6; 95% CI, 1.1-2.3; P = .013), and stroke/death (OR, 1.5; 95% CI, 1.02-2.08; P = .039). Compared with TFCAS in patients with heavy calcification, TCAR was associated with a 40% to 90% reduction in the odds of contralateral stroke (OR, 0.13; 95% CI, 0.04-0.4; P = .001), contralateral stroke/TIA (OR, 0.3; 95% CI, 0.1-0.87; P = .024), any stroke/TIA (OR, 0.6; 95% CI, 0.38-0.91; P = .02), death (OR, 0.3; 95% CI, 0.13-0.72; P = .006), stroke/death (OR, 0.5; 95% CI, 0.32-0.8; P = .004), and stroke/death/myocardial infarction (OR, 0.58; 95% CI, 0.39-0.87; P = .008). There were no significant differences in the odds of stroke and myocardial infarction. CONCLUSIONS: In this retrospective analysis of patients undergoing TFCAS vs TCAR in the Vascular Quality Initiative database, TCAR demonstrated favorable outcomes compared with TFCAS among patients with calcification greater than 50% of the carotid circumference. Advance burden of carotid artery calcification was associated with worse outcomes in patients undergoing TFCAS but not TCAR. These results are consistent with previously demonstrated superiority of flow reversal compared with distal embolic protection devices. Further research is needed to assess long-term outcomes and confirm the durability of TCAR in heavily calcified lesions.

Propensity score-matched analysis of 1-year outcomes of transcarotid revascularization with dynamic flow reversal, carotid endarterectomy, and transfemoral carotid artery stenting.

OBJECTIVE: Initial studies showed no significant differences in perioperative stroke or death between transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) and lower stroke/death rates after TCAR compared with transfemoral carotid artery stenting (TFCAS). This study focuses on the 1-year outcomes of ipsilateral stroke or death after TCAR, CEA, and TFCAS. METHODS: All patients undergoing TCAR, TFCAS, and CEA between September 2016 and December 2019 were identified in the Vascular Quality Initiative (VQI) database. The latest follow-up was September 3, 2020. One-to-one propensity score-matched analysis was performed for patients with available 1-year follow-up data for TCAR vs CEA and for TCAR vs TFCAS. Kaplan-Meier survival and Cox proportional hazard regression analyses were used to evaluate 1-year ipsilateral stroke or death after the three procedures. RESULTS: A total of 41,548 patients underwent CEA, 5725 patients underwent TCAR, and 6064 patients underwent TFCAS during the study period and had recorded 1-year outcomes. The cohorts were well-matched in terms of baseline demographics and comorbidities. Among 4180 TCAR vs CEA matched pairs of patients, there were no significant differences in 30-day stroke, death, and stroke/death. However, TCAR was associated with a lower risk of 30-day stroke/death/myocardial infarction (2.30% vs 3.25%; relative risk, 0.71; 95% confidence interval [CI], 0.55-0.91; P = .008), driven by a lower risk of myocardial infarction (0.55% vs 1.12%; hazard ratio [HR], 0.49; 95% CI, 0.30-0.81; P = .004). At 1 year, no significant difference was observed in the risk of ipsilateral stroke or death (6.49% vs 5.68%; HR, 1.14; 95% CI, 0.95-1.37; P = .157). Among 4036 matched pairs in the TCAR vs TFCAS group, TCAR was also associated with lower risk of perioperative stroke or death compared with TFCAS (1.83% vs 2.55%; HR, 0.72; 95% CI, 0.54-0.96; P = .027). At 1 year, the risks of ipsilateral stroke or death of TCAR and TFCAS were comparable (6.07% vs 7.07%; HR, 0.85; 95% CI, 0.71-1.01; P = .07). Symptomatic status did not modify the association in TCAR vs CEA. However, asymptomatic patients had favorable outcomes with TCAR vs TFCAS at 1 year (HR, 0.78; 95% CI, 0.62-0.98; P = .033). CONCLUSIONS: In this propensity score-matched analysis, no significant differences in ipsilateral stroke/death-free survival were observed between TCAR and CEA or between TCAR and TFCAS. The advantages of TCAR compared with TFCAS seem to be mainly in the perioperative period, which makes it a suitable minimally invasive option for surgically high-risk patients with carotid artery stenosis. Larger studies, with longer follow-up and data on restenosis, are warranted to confirm the mid- and long-term benefits and durability of TCAR.

Association of body mass index with outcomes after thoracic endovascular aortic repair in the vascular quality initiative.

OBJECTIVE: Although several studies have evaluated the impact of obesity on outcomes after abdominal aortic aneurysm repair, literature examining this association in thoracic endovascular aortic repair (TEVAR) is sparse. Here, we use a multi-institutional, international database to assess the role of body mass index (BMI) on adverse outcomes in patients who underwent TEVAR for descending thoracic aortic aneurysms (DTAA) and type B dissections (TBD). METHODS: A retrospective review of all patients who underwent TEVAR for DTAA or TBD from August 2014 to August 2020 was performed. Patients who were underweight (BMI <18.5 kg/m2) or obese (BMI ≥30 kg/m2) were compared with those of normal weight (≥18.5 to <30 kg/m2). Adjustment for confounding was done with multivariable logistic regression or Cox proportional hazards regression as appropriate for studying postoperative or 1-year outcomes. Primary outcomes were 30-day and 1-year mortality. Other outcomes included any postoperative complication, stroke, and spinal cord ischemia. RESULTS: A total of 3423 participants were included in the study, of whom 3.3% (n = 113) were underweight, 65.9% (n = 2253) had normal weight, and 30.8% (n = 1053) were obese. Compared with normal weight, there was no significant difference in 30-day mortality in underweight patients (odds ratio [OR], 1.81; 95% confidence interval [CI], 0.80-4.14; P = .156). Obese patients who underwent TEVAR for TBD had a 2.7-fold increase in the odds of 30-day mortality compared with normal weight (OR, 2.67; 95% CI, 1.52-4.68; P = .001). Obese and normal weight patients with DTAA had equivalent odds of 30-day mortality (OR, 1.32; 95% CI, 0.79-2.23; P = .292). The adjusted hazard of 1-year mortality was 2-fold higher in underweight patients compared with normal weight (hazard ratio, 2.15; 95% CI, 1.41-3.29; P < .001), driven by a higher risk of mortality among patients with thoracic aortic aneurysm (OR, 2.62; 95% CI, 1.63-4.21; P < .001). There was no significant difference in 1-year mortality risk between normal weight and obesity in both DTAA (OR, 0.77; 95% CI, 0.54-1.09; P = .146) and TBD (OR, 1.26; 95% CI, 0.85-1.86; P = .248). CONCLUSIONS: In this study, obese patients who underwent TEVAR for DTAA had comparable 30-day and 1-year mortality risk as normal weight individuals. Obese patients who underwent TEVAR for TBD demonstrated a 2.7-fold increase in the odds of 30-day mortality, but equivalent mortality risk as normal weight patients at 1 year. TEVAR represents a safe minimally invasive option for treatment of DTAA in obese patients. Future work should be directed toward minimizing perioperative mortality among patients with TBD to optimize TEVAR outcomes.

Polymer based endografts have improved rates of proximal aortic neck dilatation and migration.

BACKGROUND: Proximal aortic neck dilatation (PND) affects a considerable proportion of patients undergoing endovascular aneurysm repair (EVAR) and is associated with increased rates of type I endoleak (EL1), migration, and reinterventions. Although there are numerous studies investigating PND following the placement of endografts that utilize self-expanding stent (SES) technology, there are few reports for patients treated with endografts that utilize polymer-filled rings. The purpose of this study is to examine PND and graft migration after EVAR with the Ovation stent graft. METHODS: The study comprised patients who underwent EVAR as part of the prospective, international, multicenter Ovation stent graft trial. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Neck diameter was measured at the level of the lowest renal artery. PND was defined as neck enlargement of 3 mm or more. Graft migration was defined as distal movement >10 mm or movement ≤10 mm when resulting in secondary intervention. RESULTS: A total of 238 patients received this device during the study period. Patients were predominantly male (81%), with a mean age of 73 ± 8 years. Median follow-up was 58 months (IQR 36-60). Almost half the patients (110 patients, 46%) had challenging anatomy; defined as outside the instructions for use (IFU) with other commercially available stent grafts. 41 patients (17.2%) had a proximal neck length <10 mm and 93 (39%) had a minimum access vessel diameter <6 mm. The technical success rate was 100%. The 1-, 3- and 5-year overall survival rates were 96.6%, 86.2% and 74.9%, respectively. The immediate postoperative proximal neck diameter ranged from 16 mm to 31 mm with a mean of 22.4 ± 3 mm. During follow-up, ten patients (4.2%) developed PND. Freedom from PND estimates at 1, 3 and 5 years were 97.7%, 96%, and 93.6%, respectively. None of the patients developed endograft migration. CONCLUSIONS: The use of the Ovation stent graft was associated with low rates of PND despite challenging neck anatomy in 17% of patients. No graft migration was observed. The design of this endograft may explain its superiority to SES in preventing neck dilatation and migration even in patients with challenging neck anatomy. This is important, as we continue to see significant late failures of EVAR due to proximal neck degeneration.

Increased mortality with paclitaxel-eluting stents is driven by lesion length.

BACKGROUND: Endovascular stenting has become the first-line treatment of symptomatic peripheral artery disease of the femoropopliteal axis (FPA). Several randomized clinical trials have reported that paclitaxel-eluting stents (PESs) significantly reduce the rates of restenosis. However, a meta-analysis investigating paclitaxel-coated devices in the FPA showed a significant increase in all-cause mortality after the use of PES. The aim of this study was to compare the long-term, real-world outcomes of bare-metal stents (BMSs) and PESs for treating FPA occlusive disease. METHODS: A retrospective review of the medical records of 296 patients who underwent FPA stenting between January 2011 and December 2017 was performed. Patients were grouped into BMS and PES groups. The primary end point was all-cause mortality. Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency. A comparison between the two groups within TransAtlantic Inter-Society Consensus (TASC) II subgroups was also performed. RESULTS: Of the study cohort, 101 patients (34%) received PES, whereas 195 patients (66%) underwent BMS placement. Median follow-up time was 23 months (interquartile range, 7-40 months). The 2-year all-cause mortality estimates were 12% for the PES group compared with 11.4% for the BMS group (P = .26). There were no differences in the 2-year limb salvage (90.7% vs 92%; P = .4), primary patency (78.8% vs 81.1%; P = .62), primary assisted patency (100% vs 96.5%; P = .4), and secondary patency (100% vs 98.6%; P = .26) between the PES and the BMS groups, respectively (all P > .05). These findings persisted when patients were stratified by TASC II lesions. Among patients with TASC C and D lesions, the use of PES was associated with significantly higher 2-year all-cause mortality (23.9% vs 5.1%; P = .05). After adjustment for age and other potential confounders, PES use was associated with significant increase in all-cause mortality (adjusted hazard ratio, 2.3; 95% confidence interval, 1.31-27 P = .02) in TASC C and D patients. CONCLUSIONS: Consistent with the meta-analysis of several randomized clinical trials, the use of PES in a real-world setting was associated with a twofold increase in the risk of death. However, these findings were seen only among patients with TASC C and D lesions, who required multiple longer stents and potentially larger paclitaxel dose. There was no advantage in terms of patency in PES vs BMS in this population with extensive disease. Further studies of larger populations are required.