A Contemporary Evaluation of the Centers for Medicare and Medicaid Services High-Risk Indicators for Carotid Endarterectomy.

OBJECTIVE: Compare stroke/death outcomes across Carotid Endarterectomy (CEA), Transcarotid Artery Revascularization (TCAR), and Transfemoral Carotid Artery Stenting (TFCAS) using Centers for Medicare & Medicaid Services (CMS) high-risk criterion. SUMMARY BACKGROUND DATA: Existing literature has revealed inconsistencies with CMS risk guidelines. With recent approval for TCAR and TFCAS in standard risk patients, an updated analysis of guidelines is needed. METHODS: Data from the Vascular Quality Initiative (VQI) (2016-2023) on CEA, TFCAS, or TCAR patients were used. We used inverse probability of treatment weighting to compare in-hospital stroke/death rates across procedures for high-risk criteria: contralateral occlusion (CLO), prior CEA, CAS, radiation, neck surgery, moderate to severe CHF, severe COPD (on home O2), unstable angina, recent MI (<6 mo.), and age (≥75 years-old). RESULTS: A total of 199,050 patients were analyzed, of whom 122,737 (62%) patients underwent CEA, 50,095 (25%) TCAR, and 26,218 (13%) TFCAS. TCAR had lower odds of stroke/death compared to CEA in patients with CLO (aOR=0.73 [95%CI:0.55-0.98], P=0.035) and radiation (aOR=0.44[95%CI:0.23-0.82], P=0.010). Contrary to CMS criteria, CEA patients did not have higher stroke/death in patients with prior CEA, CAS, neck surgery, moderate to severe CHF, severe COPD, unstable angina, recent MI, or age (≥75) compared to TCAR and TFCAS. CONCLUSIONS: While CMS high-risk criteria have traditionally been recognized as contraindications for CEA, our study reveals inconsistencies-with CEA performing similarly to TCAR and significantly better than TFCAS in patients with prior CEA, moderate to severe CHF, recent MI, or age (≥75). As a result, the definition of high-risk criteria may warrant reconsideration.

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.

Modality-specific outcomes of patients undergoing carotid revascularization in the setting of recent myocardial infarction.

OBJECTIVE: Recent myocardial infarction (MI) represents a real challenge in patients requiring any vascular procedure. There is currently a lack of data on the effect of preoperative MI on the outcomes of carotid revascularization methodology (carotid enterectomy [CEA], transfemoral carotid artery stenting [TFCAS], or transcarotid artery revascularization [TCAR]). This study looks to identify modality-specific outcomes for patients with recent MI undergoing carotid revascularization. METHODS: Data was collected from the Vascular Quality Initiative (2016-2022) for patients with carotid stenosis in the United States and Canada with recent MI (<6 months) undergoing CEA, TFCAS, or TCAR. In-hospital outcomes after TFCAS vs CEA and TCAR vs CEA were compared. TCAR vs TFCAS were compared in a secondary analysis. We used logistic regression models to compare the outcomes of these three procedures in patients with recent MI, adjusting for potential confounders. Primary outcomes included 30-day in-hospital rates of stroke, death, and MI. Secondary outcomes included stroke/death, stroke/death/MI, postoperative hypertension, postoperative hypotension, prolonged length of stay (>2 days), and 30-day mortality. RESULTS: The final cohort included 1217 CEA (54.2%), 445 TFCAS (19.8%), and 584 TCAR (26.0%) cases. Patients undergoing CEA were more likely to have prior coronary artery bypass graft/percutaneous coronary intervention and to use anticoagulant. Patients undergoing TFCAS were more likely to be symptomatic, have prior congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, and undergo urgent operations. Patients undergoing TCAR were more likely to have higher rates of American Society of Anesthesiologists class IV to V, P2Y12 inhibitor, and protamine use. In the univariate analysis, CEA was associated with a lower rate of ipsilateral stroke (P = .079), death (P = .002), and 30-day mortality (P = .007). After adjusting for confounders, TFCAS was associated with increased risk of stroke/death (adjusted odds ratio [aOR], 2.69; 95% confidence interval [CI], 1.36-5.35; P = .005) and stroke/death/MI (aOR, 1.67; 95% CI, 1.07-2.60; P = .025) compared with CEA. However, TCAR had similar outcomes compared with CEA. Both TFCAS and TCAR were associated with increased risk of postoperative hypotension (aOR, 1.62; 95% CI, 1.18-2.23; P = .003 and aOR, 1.74; 95% CI, 1.31-2.32; P ≤ .001, respectively) and decreased risk of postoperative hypertension (aOR, 0.59; 95% CI, 0.36-0.95; P = .029 and aOR, 0.50; 95% CI, 0.36-0.71; P ≤ .001, respectively) compared with CEA. CONCLUSIONS: Although recent MI has been established as a high-risk criterion for CEA and an approved indication for TFCAS, this study showed that CEA is safer in this population with lower risk of stroke/death and stroke/death/MI compared with TFCAS. TCAR had similar stroke/death/MI outcomes in comparison to CEA in patients with recent MI. Further prospective studies are needed to confirm our findings.

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

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

Investigation of the Weekend Effect on Peri-Operative Complications and Mortality Following Carotid Revascularization.

OBJECTIVE: Outcomes for weekend surgical interventions are associated with higher rates of mortality and complications compared to weekday interventions. While prior investigations have reported the 'weekend effect' for carotid endarterectomy (CEA), this association remains unclear for Transcarotid Artery Revascularization (TCAR) and Transfemoral Carotid Artery Stenting (TFCAS). We investigated the weekend effect for all three carotid revascularization methods. METHODS: We queried the Vascular Quality Initiative (VQI) for patients undergoing CEA, TCAR, and TFCAS between 2016-2022. Chi-square and logistic regression modeling analyzed outcomes including in-hospital stroke, death, MI, and 30-day mortality by weekend vs. weekday intervention. Backward stepwise regression was utilized to identify significant confounding variables and were ultimately included in each final logistic regression model. Logistic regression of outcomes was substratified by symptomatic status. Secondary multivariable analysis compared outcomes between the three revascularization methods by weekend vs. weekday interventions. RESULTS: 155,962 procedures were analyzed including 103,790 CEA, 31,666 TCAR and 20,506 TFCAS. Of these, 1988 CEA, 246 TCAR and 820 TFCAS received weekend interventions. Logistic regression demonstrated no significant differences for TCAR, and increased odds of in-hospital stroke/death/MI for CEA [OR:1.31,(1.04-1.65)] and TFCAS [OR:1.46,(1.09-1.96)] weekend procedures. Asymptomatic TCAR patients had nearly triple the odds of 30-day mortality [OR:2.85,(1.06-7.68), P=0.038]. Similarly, odds of in-hospital death were nearly tripled for asymptomatic CEA [OR:2.89,(1.30-6.43), P=0.009] and asymptomatic TFCAS [OR:2.78,(1.34-5.76), P=0.006] patients. Secondary analysis demonstrated that CEA and TCAR had no significant differences for all outcomes. TFCAS was associated with increased odds of stroke and death compared to CEA and TCAR. CONCLUSION: In this observational cohort study, we found that weekend carotid revascularization is associated with increased odds of complications and mortality. Furthermore, asymptomatic weekend patients perform worse in the CEA and TFCAS procedural groups. Among the three revascularization methods, TFCAS is associated with the highest odds of perioperative stroke and mortality. As such, our findings suggest that TFCAS procedures should be avoided over the weekend, in favor of CEA or TCAR. In patients who are poor candidates for CEA, TCAR offers the lowest morbidity and mortality for weekend procedures.

Long-term outcomes in the smoking claudicant after peripheral vascular interventions.

OBJECTIVE: Emphasis on tobacco cessation, given the urgent and emergent nature of vascular surgery, is less prevalent than standard elective cases such as hernia repairs, cosmetic surgery, and bariatric procedures. The goal of this study is to determine the effect of active smoking on claudicating individuals undergoing peripheral vascular interventions (PVIs). Our goal is to determine if a greater emphasis on education should be placed on smoking cessation in nonurgent cases scheduled through clinic visits and not the Emergency Department. METHODS: This study was performed using the multi-institution de-identified Vascular Quality Initiative/Medicare-linked database (Vascular Implant Surveillance and Interventional Outcomes Network [VISION]). Claudicants who underwent PVI for peripheral arterial occlusive disease between 2004 and 2019 were included in our study. Our final sample consisted of a total of 18,726 patients: 3617 nonsmokers (19.3%) (NSs), 9975 former smokers (53.3%) (FSs), and 5134 current smokers (27.4%) (CSs). We performed propensity score matching on 29 variables (age, gender, race, ethnicity, treatment setting [outpatient or inpatient], obesity, insurance, hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, previous coronary artery bypass graft, carotid endarterectomy, major amputation, inflow treatment, prior bypass or PVI, preoperative medications, level of treatment, concomitant endarterectomy, and treatment type [atherectomy, angioplasty, stent]) between NS vs FS and FS vs CS. Outcomes were long-term (5-year) overall survival (OS), limb salvage (LS), freedom from reintervention (FR), and amputation-free survival (AFS). RESULTS: Propensity score matching resulted in 3160 well-matched pairs of NS and FS and 3750 well-matched pairs of FS and CS. There was no difference between FS and NS in terms of OS (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.82-1.09; P = .43), FR (HR, 0.96; 95% CI, 0.89-1.04; P = .35), or AFS (HR, 0.90; 95% CI, 0.79-1.03; P = .12). However, when compared with CS, we found FS to have a higher OS (HR, 1.18; 95% CI, 1.04-1.33; P = .01), less FR (HR, 0.89; 95% CI, 0.83-0.96; P = .003), and greater AFS (HR, 1.16; 95% CI, 1.03-1.31; P = .01). CONCLUSIONS: This multi-institutional Medicare-linked study looking at elective PVI cases in patients with peripheral artery disease presenting with claudication found that FSs have similar 5-year outcomes in comparison to NSs in terms of OS, FR, and AFS. Additionally, CSs have lower OS and AFS when compared with FSs. Overall, this suggests that smoking claudicants should be highly encouraged and referred to structured smoking cessation programs or even required to stop smoking prior to elective PVI due to the perceived 5-year benefit.

The obesity paradox exists for perioperative complications and mortality following lower extremity arterial bypass surgery.

OBJECTIVE: The obesity paradox refers to a phenomenon by which obese individuals experience lower risk of mortality and even protective associations from chronic disease sequelae when compared with the non-obese and underweight population. Prior literature has demonstrated an obesity paradox after cardiac and other surgical procedures. However, the relationship between body mass index (BMI) and perioperative complications for patients undergoing major open lower extremity arterial revascularization is unclear. METHODS: We queried the Vascular Quality Initiative for individuals receiving unilateral infrainguinal bypass between 2003 and 2020. We used multivariable logistic regression to assess the relationship of BMI categories (underweight [<18.5 kg/m2], non-obese [18.5-24.9 kg/m2], overweight [25-29.9 kg/m2], Class 1 obesity [30-34.9 kg/m2], Class 2 obesity [35-39.9 kg/m2], and Class 3 obesity [>40 kg/m2]) with 30-day mortality, surgical site infection, and adverse cardiovascular events. We adjusted the models for key patient demographics, comorbidities, and technical and perioperative characteristics. RESULTS: From 2003 to 2020, 60,588 arterial bypass procedures met inclusion criteria for analysis. Upon multivariable logistic regression with the non-obese category as the reference group, odds of 30-day mortality were significantly decreased among the overweight (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.53-0.78), Class 1 obese (OR, 0.65; 95% CI, 0.52-0.81), Class 2 obese (OR, 0.66; 95% CI, 0.48-0.90), and Class 3 obese (OR, 0.61; 95% CI, 0.39-0.97) patient categories. Conversely, odds of 30-day mortality were increased in the underweight patient group (OR, 1.58; 95% CI, 1.16-2.13). Furthermore, a BMI-dependent positive association was present, with odds of surgical site infections with patients in Class 3 obesity having the highest odds (OR, 2.10; 95% CI, 1.60-2.76). Finally, among the adverse cardiovascular event outcomes assessed, only myocardial infarction (MI) demonstrated decreased odds among overweight (OR, 0.82; 95% CI, 0.71-0.96), Class 1 obese (OR, 0.78; 95% CI, 0.65-0.93), and Class 2 obese (OR, 0.66; 95% CI, 0.51-0.86) patient populations. Odds of MI among the underweight and Class 3 obesity groups were not significant. CONCLUSIONS: The obesity paradox is evident in patients undergoing lower extremity bypass procedures, particularly with odds of 30-day mortality and MI. Our findings suggest that having higher BMI (overweight and Class 1-3 obesity) is not associated with increased mortality and should not be interpreted as a contraindication for lower extremity arterial bypass surgery. However, these patients should be under vigilant surveillance for surgical site infections. Finally, patients that are underweight have a significantly increased odds of 30-day mortality and may be more suitable candidates for endovascular therapy.

Endovascular therapy versus bypass for chronic limb-threatening ischemia in a real-world practice.

OBJECTIVE: The recent Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) study showed that bypass was superior to endovascular therapy (ET) in patients with chronic limb-threatening ischemia (CLTI) deemed suitable for either approach who had an available single-segment great saphenous vein (GSV). However, the superiority of bypass among those lacking GSV was not established. We aimed to examine comparative treatment outcomes from a real-world CLTI population using the Vascular Quality Initiative-Medicare-linked database. METHODS: We queried the Vascular Quality Initiative-Medicare-linked database for patients with CLTI who underwent first-time lower extremity revascularization (2010-2019). We performed two one-to-one propensity score matchings (PSMs): ET vs bypass with GSV (BWGSV) and ET vs bypass with a prosthetic graft (BWPG). The primary outcome was amputation-free survival. Secondary outcomes were freedom from amputation and overall survival (OS). RESULTS: Three cohorts were queried: BWGSV (N = 5279, 14.7%), BWPG (N = 2778, 7.7%), and ET (N = 27,977, 77.6%). PSM produced two sets of well-matched cohorts: 4705 pairs of ET vs BWGSV and 2583 pairs of ET vs BWPG. In the matched cohorts of ET vs BWGSV, ET was associated with greater hazards of death (hazard ratio [HR] = 1.34, 95% confidence interval [CI], 1.25-1.43; P < .001), amputation (HR = 1.30, 95% CI, 1.17-1.44; P < .001), and amputation/death (HR = 1.32, 95% CI, 1.24-1.40; P < .001) up to 4 years. In the matched cohorts of ET vs BWPG, ET was associated with greater hazards of death up to 2 years (HR = 1.11, 95% CI, 1.00-1.22; P = .042) but not amputation or amputation/death. CONCLUSIONS: In this real-world multi-institutional Medicare-linked PSM analysis, we found that BWGSV is superior to ET in terms of OS, freedom from amputation, and amputation-free survival up to 4 years. Moreover, BWPG was superior to ET in terms of OS up to 2 years. Our study confirms the superiority of BWGSV to ET as observed in the BEST-CLI trial.

Association of stroke or death with severity of carotid lesion calcification in patients undergoing carotid artery stenting.

OBJECTIVE: Carotid artery stenting (CAS) for heavily calcified lesions is controversial due to concern for stent failure and increased perioperative stroke risk. However, the degree to which calcification affects outcomes is poorly understood, particularly in transcarotid artery revascularization (TCAR). With the precipitous increase in TCAR use and its expansion to standard surgical-risk patients, we aimed to determine the impact of lesion calcification on CAS outcomes to ensure its safe and appropriate use. METHODS: We identified patients in the Vascular Quality Initiative who underwent first-time transfemoral CAS (tfCAS) and TCAR between 2016 and 2021. Patients were stratified into groups based on degree of lesion calcification: no calcification, 1% to 50% calcification, 51% to 99% calcification, and 100% circumferential calcification or intraluminal protrusion. Outcomes included in-hospital and 1-year composite stroke/death, as well as individual stroke, death, and myocardial infarction outcomes. Logistic regression was used to evaluate associations between degree of calcification and these outcomes. RESULTS: Among 21,860 patients undergoing CAS, 28% patients had no calcification, 34% had 1% to 50% calcification, 35% had 51% to 99% calcification, and 3% had 100% circumferential calcification/protrusion. Patients with 51% to 99% and circumferential calcification/protrusion had higher odds of in-hospital stroke/death (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.02-1.6; P = .034; OR, 1.9; 95% CI, 1.1-2.9; P = .004, respectively) compared with those with no calcification. Circumferential calcification was also associated with increased risk for in-hospital myocardial infarction (OR, 3.5; 95% CI, 1.5-8.0; P = .003). In tfCAS patients, only circumferential calcification/protrusion was associated with higher in-hospital stroke/death odds (OR, 2.0; 95% CI, 1.2-3.4; P = .013), whereas for TCAR patients, 51% to 99% calcification was associated with increased odds of in-hospital stroke/death (OR, 1.5; 95% CI, 1.1-2.2; P = .025). At 1 year, circumferential calcification/protrusion was associated with higher odds of ipsilateral stroke/death (12.4% vs 6.6%; hazard ratio, 1.64; P = .002). CONCLUSIONS: Among patients undergoing CAS, there is an increased risk of in-hospital stroke/death for lesions with >50% calcification or circumferential/protruding plaques. Increasing severity of carotid lesion calcification is a significant risk factor for stroke/death in patients undergoing CAS, regardless of approach.

Predictors of prolonged length of stay after elective carotid revascularization.

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

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

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

Outcomes following carotid revascularization for stroke stratified by Modified Rankin Scale and time of intervention.

OBJECTIVES: The relationship between baseline Modified Rankin Scale (mRS) in patients with prior stroke and optimal timing of carotid revascularization is unclear. Therefore, we evaluated the timing of transfemoral carotid artery stenting (tfCAS), transcarotid artery revascularization (TCAR), and carotid endarterectomy (CEA) after prior stroke, stratified by preoperative mRS. METHODS: We identified patients with recent stroke who underwent tfCAS, TCAR, or CEA between 2012 and 2021. Patients were stratified by preoperative mRS (0-1, 2, 3-4, or 5) and days from symptom onset to intervention (time to intervention; ≤2 days, 3-14 days, 15-90 days, and 91-180 days). First, we performed univariate analyses comparing in-hospital outcomes between separate mRS or time-to-intervention cohorts for all carotid intervention methods. Afterward, multivariable logistic regression was used to adjust for demographics and comorbidities across groups, and outcomes between the various intervention methods were compared. Primary outcome was the in-hospital stroke/death rate. RESULTS: We identified 4260 patients who underwent tfCAS, 3130 patients who underwent TCAR, and 20,012 patients who underwent CEA. Patients were most likely to have minimal disability (mRS, 0-1 [61%]) and least likely to have severe disability (mRS, 5 [1.5%]). Patients most often underwent revascularization in 3 to 14 days (45%). Across all intervention methods, increasing preoperative mRS was associated with higher procedural in-hospital stroke/death (all P < .03), whereas increasing time to intervention was associated with lower stroke/death rates (all P < .01). After adjustment for demographics and comorbidities, undergoing tfCAS was associated with higher stroke/death compared with undergoing CEA (adjusted odds ratio, 1.6; 95% confidence interval, 1.3-1.9; P < .01) or undergoing TCAR (adjusted odds ratio, 1.3; 95% confidence interval, 1.0-1.8; P = .03). CONCLUSIONS: In patients with preoperative stroke, optimal timing for carotid revascularization varies with stroke severity. Increasing preoperative mRS was associated with higher procedural in-hospital stroke/death rates, whereas increasing time to-intervention was associated with lower stroke/death rates. Overall, patients undergoing CEA were associated with lower in-hospital stroke/deaths. To determine benefit for delayed intervention, these results should be weighed against the risk of recurrent stroke during the interval before intervention.

Non-White Patients Have a Higher Risk of Stroke Following Transcarotid Artery Revascularization.

INTRODUCTION: Carotid artery revascularization has traditionally been performed by either a carotid endarterectomy or carotid artery stent. Large data analysis has suggested there are differences in perioperative outcomes with regards to race, with non-White patients (NWP) having worse outcomes of stroke, restenosis and return to the operating room (RTOR). The introduction of transcarotid artery revascularization (TCAR) has started to shift the paradigm of carotid disease treatment. However, to date, there have been no studies assessing the difference in postoperative outcomes after TCAR between racial groups. METHODS: All patients from 2016 to 2021 in the Vascular Quality Initiative who underwent TCAR were included in our analysis. Patients were split into two groups based on race: individuals who identified as White and a second group that comprised all other races. Demographic and clinical variables were compared using Student's t-Test and chi-square test of independence. Logistic regression analysis was performed to determine the impact of race on perioperative outcomes of stroke, myocardial infarction (MI), death, restenosis, RTOR, and transient ischemic attack (TIA). RESULTS: The cohort consisted of 22,609 patients: 20,424 (90.3%) White patients and 2185 (9.7%) NWP. After adjusting for sex, diabetes, hypertension, coronary artery disease, history of prior stroke or TIA, symptomatic status, and high-risk criteria at time of TCAR, there was a significant difference in postoperative stroke, with 63% increased risk in NWP (odds ratio = 1.63, 95% confidence interval: 1.11-2.40, P = 0.014). However, we found no significant difference in the odds of MI, death, postoperative TIA, restenosis, or RTOR when comparing NWP to White patients. CONCLUSIONS: This study demonstrates that NWP have increased risk of stroke but similar outcomes of death, MI, RTOR and restenosis following TCAR. Future studies are needed to elucidate and address the underlying causes of racial disparity in carotid revascularization.

The Double Burden: Deciphering Chronic Limb-Threatening Ischemia in End-Stage Renal Disease.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) in patients with end-stage renal disease (ESRD) poses significant challenges in clinical management due to its unique pathology and poor treatment outcomes. This review calls for a tailored classification and risk assessment for these patients to guide better revascularization choices with early minor amputation as a first-line strategy in advanced stages. METHODS: This review consolidates key findings from recent literature on CLTI in ESRD, focusing on disease mechanisms, treatment options, and patient outcomes. It evaluates the literature to clarify the decision-making process for managing CLTI in ESRD. RESULTS: CLTI in ESRD patients often results in worse clinical outcomes, such as nonhealing wounds, increased limb loss, and higher mortality rates. While the literature reveals ongoing debates regarding the optimal revascularization method, recent retrospective studies and meta-analyses suggest potential benefits of endovascular treatment (EVT) over open bypass surgery (OB) in reducing mortality and wound complications, with comparable amputation-free survival rates. CONCLUSIONS: The selection of revascularization methods in ESRD patients with CLTI is complex, necessitating individualized strategies. The importance of early detection and timely intervention is critical to decelerate disease progression and improve revascularization outcomes. There is a shift in these treatment strategies toward less invasive endovascular procedures, acknowledging the limitations these patients face with open revascularization surgeries. Considering early minor amputations after revascularization could prevent worse consequences, reflecting a shift in the approach to managing CLTI in ESRD patients.

Perioperative Blood Transfusion Is Associated with Worse 30-Day Mortality and Complications After Thoracic Endovascular Aortic Repair.

BACKGROUND: It is not uncommon for patients requiring vascular surgery, and in particular aortic surgery, to have increased requirements for blood transfusion. However, studies examining the effects of perioperative transfusion for thoracic endovascular aortic repair (TEVAR) are limited. Using large multicenter data, we aimed to study the impact of perioperative blood transfusion on 30-day mortality and complications after TEVAR. METHODS: A total of 9,263 patients who underwent TEVAR were included in this retrospective study from the multicenter Vascular Quality Initiative cohort spanning 2010-2022. We excluded patients who were post-traumatic, anemic (World Health Organization criteria: hemoglobin < 12 g/dl and < 13 g/dl for females and males respectively), who underwent open conversions or presented with ruptured aneurysms. Primary outcomes were 30-day mortality and stroke. Secondary outcomes were postop congestive heart failure (CHF), respiratory complications, spinal cord ischemia (SCI), myocardial infarction (MI) and any postop complications (composite variable). Poisson regression with robust variance was performed to determine the risk of post op outcomes comparing patients who received red blood cells (RBCs) to those who did not. RESULTS: Comparing patients without any transfusion (n = 8,223), perioperative transfusion of 1-3 units (n = 735) was associated with 3-fold increased risk of 30-day mortality (adjusted relative risk [aRR] 3.30, 95% confidence interval [CI] 2.39,4.57, P < 0.001), almost 2-fold increased risk of stroke (aRR 1.98, 95% CI 1.24,3.15, P = 0.004), 2.7-fold increased risk of SCI (aRR 2.66, 95% CI 1.87-3.77, P < 0.001), 3-fold increased risk of MI (aRR 3.40, 95% CI 2.30, 5.03, P < 0.001), 2-fold increased risk of CHF (aRR 2.04, 95% CI 1.09, 3.83, P = 0.03), 3.5-fold increased risk of respiratory complications (aRR 3.49, 95% CI 2.67, 4.56, P < 0.001), and 2-fold increased risk of any postop complication (aRR 2.36, 95% CI 2.04, 2.73, P < 0.001). These effects were even higher in patients transfused 4 or more units (n = 305) than seen in the effects seen in those transfused 1-3 units; comparing each group to patients who received none. CONCLUSIONS: In hemodynamically stable patients undergoing TEVAR for nonemergent/emergent and nontraumatic indications, transfusion of any amount perioperatively is associated with worse 30-day mortality, stroke, SCI, MI, CHF, and respiratory complications. A conservative transfusion approach and multidisciplinary care to identify complications and rescue TEVAR patients who receive any amount of RBCs perioperatively might help improve outcomes. Future studies to understand the mechanisms of outcomes for transfused patients are needed.

Small Arteriovenous Anastomosis in Fistula Creation: Establishing a Functional Vascular Access while Minimizing Steal Syndrome.

BACKGROUND: The size selection of the arteriovenous (AV) anastomosis in dialysis access creation requires a careful balance: the diameter must be large enough to accommodate sufficient flow for hemodialysis but small enough to minimize the complication of steal syndrome. Steal syndrome affects up to 10% of patients after creation of dialysis access with sometimes devastating consequences. Conventional teaching recommends a 7-10 mm anastomosis. We sought to assess the efficacy of using a smaller (5-6 mm) anastomosis in new arteriovenous fistula (AVF) creation. METHODS: We conducted a comparative retrospective analysis of patients who underwent fistula creation with a small versus regular size anastomosis at any upper extremity anatomic site between March 2019 and October 2020 at our institution. Anatomic sites included radiocephalic, brachiocephalic, and brachiobasilic. All AV anastomoses were measured intraoperatively to be 5-6 mm in diameter for the small size groups and 8-10 mm for the regular size group. Endpoints included steal syndrome, functional patency, primary patency, and secondary patency. RESULTS: Out of 110 patients who underwent an AVF creation, 59.1% received a 5-6 mm anastomosis with a median follow-up time of 10 ± 6 months. Patients' demographics and comorbidities were relatively similar between the 2 groups except for a higher rate of hyperlipidemia (55.4% vs. 28.9%, P = 0.008) in the small size group. Patients in the small size group were more likely to undergo a radiocephalic fistula (40% vs. 4.5%, P < 0.001) and to have a smaller mean vein diameter on preoperative duplex ultrasound (3.2±1 mm vs. 3.9±1 mm, P = 0.0016) when compared to their regular size counterparts. During follow-up, none of the patients in the small group developed steal syndrome (0% vs. 9%, P = 0.015). At 1 year, patients in the regular size group achieved higher rates of primary patency (67.9% vs. 46.9%, P = 0.02); however, no difference was seen in 1-year primary-assisted patency (84.9% vs. 73.6%, P = 0.3), secondary patency (89.6% vs. 79.5%, P = 0.3), or functional patency (87.7% vs. 82.2%, P = 0.64) between the small and regular size groups, respectively. CONCLUSIONS: The use of a 5-6 mm anastomosis in the creation of new AVFs of the upper extremities appears to be a technically safe option for dialysis access. Our experience suggests that smaller anastomosis still creates enough flow to maintain a functional AV access while minimizing the incidence of steal syndrome. Additionally, even with smaller vein sizes preoperative, adequate dialysis access can be created via a small sized anastomosis, including distal arm access. Larger studies with longer follow-up are needed to evaluate long-term outcomes of small anastomosis fistulas.

Postoperative Outcomes and One-Year Mortality of Patients on Chronic Anticoagulation Medications Undergoing Infrainguinal Bypass.

BACKGROUND: Patients requiring open infrainguinal bypass (IIB) frequently are taking chronic anticoagulation (AC) medications. Taking these medications in the preoperative setting may affect the outcomes of surgery. This study aims to evaluate postoperative outcomes and 1-year mortality of patients taking chronic AC medications that undergo IIB. METHODS: Using data obtained from the Vascular Quality Initiative from January 2011 to October 2021, patients on warfarin or any direct oral anticoagulants (DOAC) within 30 days of IIB were compared with patients not taking chronic AC medications. The primary outcomes were in-hospital, 30-day, and 1-year mortality. The secondary outcomes included total procedure time, need for perioperative packed red blood cell transfusion, prolonged length of hospital stay, postoperative myocardial infarction or stroke, and graft patency at discharge. A subgroup analysis was performed comparing patients taking warfarin with those taking DOACs. Univariate analyses and multivariate logistic regression, Kaplan Meier survival, and Cox regression analyses were used to analyze the data for postoperative and 1-year outcomes, respectively. RESULTS: A total of 55,076 patients underwent IIB during the study period, and 11,547 (20.97%) were on chronic AC prior to surgery. The 2 cohorts differed significantly in almost every demographic and clinical characteristic. Multivariate analyses adjusting for 45 potential confounders revealed that there was no significant difference in in-hospital, 30-day, and 1-year mortality. The total procedure time for the chronic AC cohort was on average 11.46 ± 2.16 min longer (P ≤ 0.001) and there was a greater risk of prolonged length of stay in the hospital (adjusted odds ratio [aOR]: 1.19, 95% confidence interval [CI]: 1.13-1.26, P < 0.001). These patients also returned to the operating room (OR) at a greater rate (aOR: 1.12, 95% CI: 1.05-1.19; P = 0.016) and demonstrated a significantly lower rate of graft patency at discharge (aOR: 0.73, 95% CI: 0.62-0.86, P = 0.001). On subgroup analysis, multivariate analysis demonstrated lower 30-day mortality for the DOAC group in comparison to the warfarin group (aOR: 0.74, 95% CI: 0.57-0.94, P = 0.015), but no significant differences in in-hospital and 1-year mortality. CONCLUSIONS: Patients taking AC medications within 30 days prior to IIBs may require more perioperative red blood cell transfusions, longer hospitalizations, and return to the OR at a greater rate. They are also at an increased risk for loss of graft patency at discharge. However, these patients are not at increased risk of in-hospital, 30-day, or 1-year mortality. IIB can, therefore, be performed safely in patients taking chronic AC medications.

A Single-Institution Case Series of Total Endovascular Relining for Type 3 Endoleaks in Traditional Endovascular Aneurysm Repair (EVAR) Grafts with Raised Bifurcations.

BACKGROUND: The endovascular repair of infrarenal abdominal aortic aneurysms can be performed with a wide variety of devices. Many of these grafts elevate the aortic bifurcation which can limit future repairs if the graft material fails thereby creating a type III endoleak to aorto-uniliac grafts. Many manufacturers have grafts susceptible to this, but we have seen this in the Medtronic AneuRx graft. Our goal is to provide technical details and outcomes regarding a novel technique to reline these grafts while maintaining inline flow to the iliac arteries. METHODS: This was a single-institution review of patients who had endoleaks requiring intervention after a previously placed graft with an elevated aortic bifurcation. Primary outcomes included technical success defined as placement of all planned devices, resolution of type III endoleak, aneurysm size at follow-up, and requirement of reintervention. Secondary outcomes included 30-day complications, aneurysm-related mortality, and all-cause mortality. Technical details of the operation include back-table deployment of an Ovation device, modification of the deployment system tether and pre-emptive placement of an up and over 0.014″ wire. The wire is placed up and over and hung outside the contralateral gate. Once the main body is introduced above the old graft, the 0.014" is snared from the contralateral side and externalized. The main body is then able to be seated at the bifurcation as the limb is not fully deployed and then device deployment is completed per instructions for use. RESULTS: Our study consists of 4 individuals, 3 of which had an abdominal aortic aneurysm initially managed with an AneuRx endovascular aneurysm repair and 1 with a combination of Gore and Cook grafts. All 4 patients were male with an average age of 84.5 years at time of reline. All patients had at least 10 years between initial surgery and reline at our institution. Primary outcomes revealed no type 1 or 3 endoleaks at follow-up, technical success was 100% and 1 patient required reintervention for aneurysm growth and type 2 endoleak. In terms of our secondary outcomes, there was 1 postoperative complication which was cardiac dysfunction secondary to demand ischemia, aneurysm-related mortality was 0% and all-cause mortality was 25% at average follow-up of 2.44 years. CONCLUSIONS: As individuals continue to age, there are more patients who would benefit from less invasive reinterventions following endovascular aneurysm repair. Whether this is due to aortic degeneration, stent migration, or stent material damage is not always known. In this study, we present an endovascular approach to treating type III endoleak patients with a previous graft and elevated aortic bifurcation using Ovation stent grafts and found no evidence of type 1 or 3 endoleaks on follow-up imaging. This approach may allow patients with type III endoleak the option of a minimally invasive, percutaneous approach where they previously would not have had one.

Patients with Prior Exposure to a Combination of Statins & Angiotensin-Converting Enzyme Inhibitors (ACE-Is)/Angiotensin Receptor Blockers (ARBs) Have Better Outcomes after Carotid Revascularization than Patients with Prior Exposure to Statins Alone: A MultiCenter Analysis.

BACKGROUND: Statin use has been studied and confirmed to have a beneficial impact on perioperative carotid endarterectomy (CEA) and carotid artery stenting (CAS) outcomes. The benefits of Angiotensin-converting enzyme inhibitors (ACE-I) in hypertension, ischemic heart disease, heart failure, diabetes mellitus, and renal disease are well-known; however, the impact of continuing or withholding ACE-Is/angiotensin receptor blockers (ARBs) on CEA and CAS outcomes is not addressed well in the literature. This study aimed to evaluate the impact of preoperative statin use combined with ACE-Is/ARBs in patients undergoing CEA or CAS on mortality and morbidity using a multi-institutional database. METHODS: Using the data of all patients who underwent carotid artery revascularization, including CEA, transcarotid artery revascularization, and transfemoral carotid artery stenting from 2016 to 2021 in the Vascular Quality Initiative data, we determined as our primary outcome 30-day mortality/stroke after carotid revascularization based on periop exposure to statins alone, or the combination of statins and ACE-Is/ARBs. Secondary outcomes were postop myocardial infarction and postop congestive heart failure. Poisson regression with robust variance was used to determine postop outcomes comparing the combination of statin and ACE-Is/ARBs group with statins alone group. RESULTS: A total of 131,285 patients were included in the study, with 59,860 (46%) patients receiving statin only, and 71,425 (54%) receiving both statin and ACE-Is/ARBs preoperatively. Both patient groups differed significantly in preop clinical and demographic characteristics. After adjusting for potential confounders, the statins plus ACE-I/ARB group had a 12% lower risk of postop mortality/stroke (Incident Rate Ratio comparing Statin/ACE group to Statins Only group [IRR] 0.88, 95% confidence interval 0.81-0.95, P = 0.001), 18% lower risk of postop congestive heart failure (IRR 0.82, 95% CI 0.68-0.98, P = 0.029), and similar risk of postop myocardial infarction (IRR 1.05 95% confidence interval 0.91-1.20, P = 0.54) compared to the statin-only group. CONCLUSION: Statins combined with ACE-Is/ARBs perioperatively offer better protection compared to statins alone in patients undergoing carotid revascularization surgery. We recommend the continuation of ACE-Is/ARBs use in patients undergoing carotid revascularization, especially if they have concurrent hypertension. Further prospective studies are needed to evaluate the benefit of adding ACE-Is/ARBs.

Long-Term Patency Between Brachiocephalic and Brachiobasilic Fistulas: A Single Institution Review.

OBJECTIVE: Dialysis access is a fundamental procedure performed by vascular surgeons. Commonly, upper extremity access is utilized via a brachiobasilic fistula (BBF) or brachiocephalic fistula (BCF). BCF is preferred due to ease compared to BBF without documented improved function. Few studies compare patency outcomes between BBF and BCF over time. Our goal was to evaluate the difference in outcomes between BBF and BCF. METHODS: This is a retrospective review of patients with BCF or BBF between 2019-2022. Patients were split by procedure: BCF and BBF. Data collected included demographics, vein size, tunneled catheter, and previous access. Primary outcomes included primary patency (PP), primary assisted patency (PAP) and secondary patency (SP). Secondary outcomes included 30-day complications, access abandonment, interventions and mortality. Linear regression, Kaplan-Meier and log-rank test were performed. RESULTS: Our study had 184 patients, 109 (59%) with BCF and 75 (41%) with BBF. There were no differences in demographics except for BMI and vein size (BBF: 4 vs BCF: 3.6mm, p=0.020). There was no difference in PP at one year (41% vs 47%, p=0.547) or SP at two years (73% vs 84%, p=0.058) in BBF vs BCF. However, PAP was significantly greater in BCF (80% vs 67%, p=0.030) at one year. Secondary outcomes revealed no difference in wound complications (1% vs 0%, p=0.408), access abandonment (35% vs 28%, p=0.260), or number of interventions (1 vs 1, p=0.712) in BBF vs BCF. Mortality was significantly greater in the BBF patients (19% vs 6%, p=0.005). On adjusted analysis, BBF had 43 minutes longer operative time (p<0.001) and 22cc greater blood loss (p<0.0001). CONCLUSION: In this single center review comparing BBF and BCF, no difference was seen between BBF and BCF in terms of primary patency or secondary patency. Even with larger vein size, BBF did not confer a benefit in long term patency or access abandonment. Additionally, BBF did not confer decreased procedures to maintain patency and BBF had greater operative length and blood loss, as well as mortality. We believe this study demonstrates that for patients who must use an upper extremity location, when the cephalic vein is satisfactory, using the cephalic vein is preferred as it does not negatively impact long-term patency.