Real-world use of medical therapy in moderate asymptomatic carotid stenosis.

OBJECTIVE: Despite level 1 evidence demonstrating the benefit of carotid endarterectomy for the prevention of stroke in patients with severe asymptomatic carotid stenosis (ACS), there has been a trend toward recommending optimal medical therapy (OMT) alone. This recommendation has been promulgated based on the observation that modern advances in OMT reduce the overall stroke risk in the general population, but the success of this treatment strategy is dependent on patient and provider adherence. In current practice, patients with moderate ACS are nearly all treated with OMT alone. The objective of this study was to evaluate adherence to OMT in a cohort of patients with moderate ACS undergoing treatment with OMT alone. METHODS: Consecutive carotid duplex ultrasound examinations were reviewed for the years 2019 and 2020. Those with moderate (50%-69%) ACS based on Society for Vascular Surgery guidelines were included in the study. Patients were assessed for OMT at the time of the index duplex, the first follow-up visit, and at each subsequent follow-up visit until the end of the study. OMT was defined as abstinence from smoking, aspirin or other antiplatelet use, and statin or other lipid-lowering therapy. Patients were stratified based on their ability to achieve OMT, and each component was evaluated to identify shortfalls in therapy. RESULTS: A total of 323 duplex ultrasound examinations with moderate ACS in 255 patients were identified. Of the 255 patients, 143 (56.1%) were on OMT at the time of the first duplex; that number increased to 163 (63.9%) by the first follow-up visit and 175 (68.6%) by the completion of the study. There were 112 (43.9%) patients who were not on OMT at the time of the index duplex, 43 (38.4%) of whom achieved OMT over a median follow-up time of 2.7 years. By the end of follow-up, 86 (76.8%) were taking aspirin or another antiplatelet medication, 93 (83.0%) were on statin or other lipid-lowering therapy, and 74 (66.1%) were abstinent from smoking. Pre-duplex smoking was independently associated with failure to achieve OMT (hazard ratio: 0.452, P = .017). CONCLUSIONS: Among patients with moderate ACS who were not previously on OMT, the rate of OMT achievement is poor. Although advances in lipid management through statin therapy have been praised for their role in improving the effectiveness of OMT, smoking cessation represents an important target for improving uptake and as a result effectiveness of OMT.

Outcomes of endovascular intervention for atherosclerotic lesions confined to the popliteal artery.

OBJECTIVE: Most surgeons employ an endovascular-first approach to the treatment of peripheral arterial disease (PAD), but controversy remains regarding the ideal interventions for the management of isolated popliteal artery disease (IPAD). Indeed, there are a paucity of data that compare outcomes of popliteal stents vs other peripheral vascular interventions (PVIs). The goal of this study was to evaluate outcomes of PVIs in IPAD. METHODS: The Vascular Study Group of New England database was queried for all IPAD PVIs performed for atherosclerotic occlusive disease from 2010 to 2021. Those with at least 1 year of follow-up data available were included for analysis. The primary endpoint was 1-year freedom from a composite target lesion (TL) treatment failure that included restenosis >50% on duplex, reintervention, or ipsilateral major amputation. RESULTS: We included 689 procedures performed on 634 patients. Of these, 250 (36.3%) were treated with plain balloons (POBA), 215 (31.2%) had stents, 170 (24.7%) had special balloons (drug-coated, cutting, or lithotripsy), and 54 (7.8%) atherectomies were performed. Stent placement was associated with lower freedom from TL treatment failure (72.6%) than special balloon (81.2%; P = .048) and atherectomy (88.9%; P = .012), but not POBA (76.8%; P = .293). On multivariable logistic regression, stents (odds ratio, 0.637; P = .021) and preoperative P2Y12 inhibitor therapy (odds ratio, 0.683; P = .048) were both associated with lower freedom from intervention failure. CONCLUSIONS: Popliteal stent placement is associated with a higher rate of TL treatment failure at 1 year when compared with other PVIs including special balloon angioplasty and atherectomy, but not POBA, and should therefore be avoided in favor of special balloons or atherectomy whenever feasible.

Characteristics and Outcomes of Patients Undergoing Infrainguinal Bypass in the Endovascular Era.

BACKGROUND: The Society for Vascular Surgery (SVS) developed objective performance goals (OPGs) for lower extremity bypass (LEB) in chronic limb-threatening ischemia (CLTI) based on studies that included patients who were at good risk for open revascularization. In the endovascular era, many LEB patients have had prior interventions, and most would be considered high-risk by the original SVS OPG standards. The goal of this study is to characterize a contemporary patient population undergoing LEB for CLTI and determine if outcomes remain commensurate with the parameters established by the SVS OPG. MATERIALS AND METHODS: All patients who underwent LEB for CLTI over a 10-year period (2012-2021) were identified. Patients were stratified into low- and high-risk categories based upon the clinical, conduit, and anatomic parameters used in the SVS OPG. Limb salvage at 1 year and amputation-free survival, a composite outcome of major amputation and mortality, at 1 year were compared with the SVS OPG cohort. Primary, assisted, and secondary patency at 1 and 3 years were also evaluated using Kaplan-Meier survival analysis. RESULTS: There were 169 LEBs performed for CLTI. One hundred and two (60.36%) males, 101 (59.76%) current or former smokers, 115 (68.05%) with hypertension, 69 (40.83%) with diabetes mellitus, and 40 (23.67%) with coronary artery disease. Median age was 71.84 years, and mean follow-up was 2.17 years. 65 (38.46%) had a prior ipsilateral endovascular intervention, and 18 (10.65%) were redo bypasses. 21 (12.43%) were deemed clinically high-risk, 44 (26.04%) were high-risk conduits, and 118 (69.82%) had high-risk anatomic factors. Freedom from amputation at 1 year was 87.05% in this cohort which was similar to the overall SVS OPG cohort (88.9%). Amputation-free survival at 1 year was 77.78%, which was also similar to the overall SVS OPG cohort (76.5%). Primary patency at one and three years was 46.84% and 37.59%, assisted patency at one and three years was 61.87% and 44.81%, and secondary patency at one and three years was 72.13% and 61.16%. CONCLUSIONS: The majority of patients undergoing LEB in the endovascular era meet the SVS OPG criteria for high risk. Despite this, the 1-year limb salvage and amputation-free survival in this cohort were equivalent to the SVS OPG LEB cohort. This supports the continued use of LEB for limb salvage in high-risk patients and those who have failed endovascular approaches.

Use of an Assistant Surgeon Does not Mitigate the Effect of Lead Surgeon Volume on Outcomes Following Open Repair of Intact Abdominal Aortic Aneurysms.

OBJECTIVE/BACKGROUND: While higher lead surgeon volume has been associated with lower mortality following open abdominal aortic aneurysm (AAA) repair, little is known about the impact of using an attending surgeon as assistant surgeon. The aim of this study was to determine whether the presence of an assistant surgeon, particularly a high volume assistant, mitigates the relationship between lead surgeon volume and outcomes. METHODS: All Medicare beneficiaries who underwent intact, open AAA repair between 2003 and 2008 were evaluated and nested regression models were constructed to evaluate the relationship between surgeon and assistant volume and peri-operative mortality, adjusting for comorbid conditions and hospital volume. RESULTS: In total 28,590 repairs were studied, of which 19,284 (67.5%) were performed by a single surgeon and 9306 (32.5%) included an assistant surgeon. Of cases with an assistant, 12.3% included a high volume assistant surgeon. Lower volume surgeons more frequently used an assistant (lead surgeon Q1 volume: 40%; Q2: 36%; Q3: 34%; Q4: 29%; Q5: 27% [p < .01]). In cases with no assistant, adjusted peri-operative mortality varied monotonically with surgeon volume (Q1: 4.7%; Q2: 4.4%; Q3: 4.1%; Q4: 3.3%; Q5: 3.2%). However, the use of a high or a low volume assistant surgeon, compared with no attending surgeon as assistant, was not associated with lower peri-operative mortality in any lead surgeon volume quintile, even among those operations performed by the lowest volume lead surgeons. CONCLUSION: Employing an assistant surgeon does not improve outcomes amongst any quintile of volume of the lead surgeon. As surgeons perform fewer open AAA repairs in the modern era, these data imply that even the help of a high volume assistant surgeon may not mitigate the detrimental effect of a lower volume surgeon.

Three-Year Results of the Endurant Stent Graft System Post Approval Study.

BACKGROUND: Long-term data following endovascular aneurysm repair (EVAR) exist but are limited to endografts that are no longer in use. The aim of the ENGAGE Post Approval Study is to describe the long-term safety and effectiveness data following EVAR using the Endurant stent graft system. METHODS: From August 2011 to June 2012, 178 patients were enrolled and treated with the Endurant stent graft system. Clinical and radiologic data were prospectively collected and analyzed. The primary end point was abdominal aortic aneurysm (AAA)-related mortality, and secondary end points were overall mortality, endoleak, secondary interventions, and device-related complications. Kaplan-Meier estimates were used for late outcomes. RESULTS: A total of 178 patients underwent EVAR with the Endurant stent graft across 24 centers (82% men; median age 71, interquartile range [IQR] 66-79). Median aortic diameter was 55 mm (IQR 51-58 mm). There was a 98.9% technical success rate. Three-year clinical and radiographic follow-up data were available for 87% and 74% of patients, respectively. Median follow-up was 37 months (IQR 30-38 months). Three-year aneurysm-related mortality rate was 1.1%, with 2 deceased patients in the perioperative period. All-cause mortality rate at 3 years was 13%. No patients suffered from aneurysm rupture or underwent conversion to open repair through 3 years of follow-up. Only 11 patients (6.2%) had undergone reintervention at 3 years. Younger age was associated with reintervention (HR 3.3 per younger decade, 95% confidence interval 1.3-7.6, P < 0.01), but neck diameter, length, and angulation were not significantly associated with reintervention. CONCLUSIONS: The Endurant stent graft system provides a safe, durable approach to treating infrarenal AAA. No patients experienced late rupture or aneurysm-related mortality, and only 1 in 16 patients underwent reintervention by 3 years. The rate of reintervention with the Endurant graft appears to be lower than other contemporary grafts, despite more liberal "Instructions For Use" parameters, but further research including direct graft comparisons will be necessary to guide appropriate graft selection.

Treatment outcomes in diabetic patients with chronic limb-threatening ischemia.

OBJECTIVE: There are conflicting reports about outcomes after infrainguinal bypass for chronic limb-threatening ischemia (CLTI) in patients with diabetes. We compared perioperative outcomes between patients with and patients without diabetes in the current era. METHODS: The National Surgical Quality Improvement Program vascular module, 2011 to 2014, was used to identify patients undergoing infrainguinal revascularization for CLTI. Patients with and without diabetes were compared in terms of presentation, comorbidities, operative approach, and 30-day outcomes. Major adverse limb events (MALEs) included 30-day major reintervention or amputation, and major adverse cardiovascular events (MACEs) included 30-day myocardial infarction, cardiac arrest, stroke, or death. Multivariable logistic regression was used to adjust for baseline differences. RESULTS: We identified 8887 patients undergoing open (5744; 50% diabetic) or endovascular (3143; 62% diabetic) treatment for CLTI. Patients with diabetes were younger and more often nonwhite, nonsmokers, and obese. Patients with diabetes presented more often with tissue loss (71% vs 47%; P < .001) and were more likely to be treated with endovascular intervention (41% vs 29%; P < .001). The 30-day mortality was similar before (open, 3.1% vs 2.8% [P = .53]; endovascular, 2.6% vs 2.1% [P = .37]) and after adjustment for baseline differences (open: odds ratio [OR], 1.1 [95% confidence interval (CI), 0.7-1.5]; endovascular: OR, 1.2 [95% CI, 0.7-2.0]). Patients with diabetes had longer lengths of stay (open, 8 vs 6 days [P < .001]; endovascular, 3 vs 2 days [P < .001]) and higher 30-day readmission rates (open, 21% vs 18% [P < .01]; endovascular, 20% vs 15% [P < .01]); however, these differences were no longer significant after adjustment for baseline differences. Patients with diabetes had a higher rate of MACEs (7.0% vs 5.1%; P < .01) and lower rate of MALEs (8.1% vs 10%; P < .01) after bypass. After adjustment, patients with diabetes still had a lower rate of MALEs (OR, 0.7; 95% CI, 0.6-0.9) but no longer had a higher rate of MACEs (OR, 1.2; 95% CI, 0.9-1.6). CONCLUSIONS: CLTI patients with diabetes undergoing revascularization have similar 30-day outcomes compared with those without diabetes, although they appear to be at lower risk for MALEs after bypass. Prolonged length of stay and readmission in patients with diabetes is not due to underlying diabetic disease but likely secondary to other baseline comorbidities, such as higher rates of tissue loss. Concern for worse perioperative outcomes in patients with diabetes after lower extremity bypass is unsubstantiated and should not discourage a physician from performing an open bypass.

Regional variation in patient outcomes in carotid artery disease treatment in the Vascular Quality Initiative.

OBJECTIVE: Quality metrics were developed to improve outcomes after carotid artery revascularization; however, few studies have evaluated regional differences in perioperative outcomes. This study aimed to evaluate regional variation in mortality and perioperative outcomes after carotid endarterectomy (CEA) and carotid artery stenting (CAS). METHODS: We identified all patients who underwent CEA or CAS from 2009 to 2016 in the Vascular Quality Initiative. Patients were analyzed on the basis of their symptom status. We assessed variation in perioperative outcomes using χ2 analysis, Fisher exact test, and t-test, where appropriate. RESULTS: A total of 78,467 carotid interventions were identified; 85% were CEAs, with 69% of those asymptomatic. Within CAS, 39% were asymptomatic. Perioperative stroke/death varied across regions within both CAS groups (asymptomatic, 0%-5.8% [P = .03]; symptomatic, 2.4%-8.1% [P = .1]), and several regions did not meet the American Heart Association (AHA) guidelines of 3% for asymptomatic patients and 6% for symptomatic patients, which persisted after risk adjustment. For CEA, the stroke/death rates fell within the standards set by the AHA guidelines in all regions for both the unadjusted and risk-adjusted models; however, there was significant regional variation in the cohorts (asymptomatic, 0.9%-3.1% [P < .01]; symptomatic, 1.3%-4.9% [P < .01]). Variation in 30-day mortality was significant in symptomatic patients (asymptomatic: CEA, 0%-1.3% [P = .2], CAS, 0%-2.4% [P = .2]; symptomatic: CEA, 0%-1.8% [P < .01], CAS, 0%-4.6% [P = .01]). Rates of in-hospital stroke, postoperative myocardial infarction, prolonged length of stay (>2 days), and use of intravenous blood pressure medications all varied significantly across the regions. After CEA, there was significant variation in the rates of cranial nerve injuries (asymptomatic, 0.9%-4.9% [P < .01]; symptomatic, 1.5%-7.7% [P < .01]), return to the operating room (asymptomatic, 0.9%-3.4% [P < .01]; symptomatic, 0.6%-3.4% [P = .02]), and discharge on antiplatelet and statin (asymptomatic, 75%-87% [P < .01]; symptomatic, 78%-91% [P < .01]). After CAS, significant variation was found in the rates of access site complications (asymptomatic, 2.3%-18.2% [P < .01]; symptomatic, 1.4%-16.9% [P < .01]) and discharge on dual antiplatelet therapy (asymptomatic, 79%-94% [P < .01]; symptomatic, 83%-93% [P < .01]). CONCLUSIONS: Unwarranted regional variation exists in outcomes after carotid artery revascularization across the regions of the VQI. Significant variation was seen in a number of outcomes for which quality metrics currently exist, such as length of stay and discharge medications. In addition, after CAS, several regions failed to meet the AHA guidelines for stroke and death. Given these results, quality improvement projects should be targeted to improve adherence to current guidelines to promote best practices.

Statin therapy is associated with higher long-term but not perioperative survival after abdominal aortic aneurysm repair.

BACKGROUND: Although preoperative and perioperative statin therapy improves postoperative outcomes in several populations, few data examine its association with survival after abdominal aortic aneurysm (AAA) repair. In addition, no data exist regarding the benefits of starting statins in patients with AAA not currently taking them. METHODS: We performed a registry-based study of all patients undergoing repair of AAAs in the Vascular Quality Initiative between 2003 and 2017 without documented statin intolerance. In our primary analysis, we evaluated the association between preoperative statin therapy and long-term mortality, 30-day mortality, and in-hospital myocardial infarction and stroke. As a secondary analysis, we studied the cohort of patients not taking a statin preoperatively and compared their long-term mortality on the basis of whether they were discharged on a statin. To account for nonrandom assignment to treatment, we constructed propensity scores and applied inverse probability weighting. RESULTS: We identified 40,452 AAA repairs, of which 37,950 fit our entry criteria (29,257 endovascular and 8693 open). Overall, 25,997 patients (69%) were taking a statin preoperatively, with patients undergoing endovascular aneurysm repair more frequently taking a statin than those undergoing open repair (69% compared with 66%; P < .001). After propensity weighting, preoperative statin therapy was not associated with 30-day death or in-hospital stroke or myocardial infarction. However, patients taking statins preoperatively experienced higher adjusted 1-year (94% vs 90%) and 5-year (85% vs 81%) survival from the date of surgery compared with those who were not (P < .001 overall), although subgroup analysis showed that this applied only to intact or symptomatic aneurysms. Of the 11,941 patients not taking a statin preoperatively and discharged alive, 2910 (24%) started on a statin before discharge. In our secondary analysis of the subset of patients not taking statins preoperatively, those initiated on a statin before discharge experienced higher survival at 1 year (94% vs 91%) and 5 years (89% vs 81%; P < .001 overall) than those who remained off statin therapy, with the greatest absolute long-term survival difference in patients with rupture (87% vs 62%; P < .001 overall). CONCLUSIONS: Preoperative statin therapy is associated with higher long-term survival but not perioperative mortality and morbidity in patients undergoing AAA repair, and initiating statin therapy in previously statin-naive patients is associated with markedly higher survival. All patients with AAAs without contraindications should receive statin therapy. In patients not taking a statin at the time of AAA repair, clinicians should consider initiating one before discharge.

Fewer Complications in the Obese Following Lower Extremity Endovascular Interventions.

BACKGROUND: The prevalence of obesity is increasing in the United States; however, its impact on adverse outcomes in patients with peripheral vascular disease is not well studied. Obesity is associated with higher rates of complications following open bypass surgery, but limited data are available on its effect on endovascular intervention. This study aimed to identify whether obese patients suffer the same complications when undergoing lower extremity endovascular interventions. METHODS: All patients who underwent femoropopliteal or tibial endovascular interventions between 2011 and 2013 were identified in the Targeted Vascular Module of the National Surgical Quality Improvement Program. Patients were stratified into 5 groups based on their body mass index (BMI): underweight (<18.6), normal weight (18.6-24.9), overweight (25-29.9), obese (30-34.9), and morbidly obese (≥35). Those patients without a documented BMI or a defined target lesion were excluded. Baseline demographics, patient characteristics, operative details, and outcomes were compared using univariate analysis between the BMI groups. Multivariable logistic regression was used to account for patient demographics and operative details. RESULTS: 3,246 patients underwent endovascular interventions (78% femoropopliteal and 22% tibial). Of these, 137 (4%) were underweight, 881 (27%) were normal weight, 1,193 (37%) were overweight, 647 (20%) were obese, and 388 (12%) were morbidly obese. There were no differences in 30-day mortality; however, surgical site infection (SSI) was higher in the morbidly obese (5% vs. normal weight: 2%, P = 0.02), whereas untreated patency loss was lower (morbidly obese: 0.5%, obese: 1%, normal weight: 2%, P = 0.02). Other important 30-day outcomes, including bleeding and amputation, were similar across the BMI groups. Following multivariate analysis, SSI remained more common in the morbidly obese (odds ratio [OR]: 2.6, 95% confidence interval [CI]: 1.4-5.0), whereas untreated patency loss remained lower in both overweight and morbidly obese patients (overweight: OR 0.5, 95% CI: 0.2-0.9 and morbidly obese: OR: 0.2, 95% CI: 0.05-0.85). Length of stay >1 day was significantly lower in the overweight, obese, and morbidly obese (OR 0.7, 95% CI: 0.6-0.8; OR 0.6, 95% CI: 0.5-0.7; and OR 0.7, 95% CI: 0.5-0.9, respectively). CONCLUSIONS: Few major complications occur in the obese in the first 30 days following endovascular interventions, and obesity is not an independent predictor of 30-day mortality. Rates of postoperative SSIs are low overall, although they are highest in morbidly obese patients (5%, compared to 2% in normal weight patients). Given this knowledge, endovascular interventions are a prudent treatment option for this patient population.

Early reintervention after open and endovascular abdominal aortic aneurysm repair is associated with high mortality.

OBJECTIVE: Although reinterventions are generally considered more common after endovascular aneurysm repair (EVAR) than after open surgical repair (OSR), less is known about reintervention in the early postoperative period. Furthermore, there are few data regarding the impact of early reintervention on 30-day mortality. We sought to evaluate the rates and types of reintervention after abdominal aortic aneurysm (AAA) repair and the impact of reintervention on postoperative mortality. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) was queried from 2012 to 2014 for all intact, infrarenal AAA repairs. The 30-day reintervention was classified by Current Procedural Terminology (CPT) codes. Univariate analysis comparing patients with and without reintervention was performed with the Fisher exact test and Mann-Whitney U test. Logistic regression was used to identify predictors of reintervention and to assess the association between 30-day reintervention and mortality. RESULTS: We identified 5877 patients (OSR, 658 [11%]; EVAR, 5219 [89%]), of whom 261 underwent reintervention (OSR, 7.1%; EVAR, 4.1%; P < .01). Patients who underwent reintervention had larger aortic diameter (median, 5.7 cm vs 5.5 cm; P < .01), were more often symptomatic at presentation (16% vs 9.1%; P < .01), and were more likely to have renal insufficiency (7.7% vs 3.6%; P < .01) and history of prior abdominal operations (32% vs 26%; P = .04). Patients who underwent reintervention had higher 30-day mortality (OSR, 28% vs 2.8% [P < .001]; EVAR, 12% vs 1.0% [P < .001]) and major complications. Factors significantly associated with reintervention included open repair, diameter, symptom status, hypertension, and renal insufficiency. After adjusting for demographics, comorbidities, and type of repair, reintervention was independently associated with 30-day mortality after EVAR and OSR (odds ratio, 13; 95% confidence interval, 8-22; P < .001). CONCLUSIONS: Compared with EVAR, patients undergoing open infrarenal AAA repair were significantly more likely to undergo 30-day reintervention, which could be related to higher open anatomic complexity and lower experience of the surgeon with open repair. Reintervention after both EVAR and OSR was associated with a >10-fold increase in postoperative mortality, emphasizing the need to minimize the complications associated with reintervention.

A preoperative risk score for transfusion in infrarenal endovascular aneurysm repair to avoid type and cross.

OBJECTIVE: Preoperative type and cross are often routinely ordered before elective endovascular aneurysm repair (EVAR), but the cost of this practice is high, and transfusion is rare. We therefore aimed to stratify patients by their risk of transfusion to identify a cohort in whom a type and screen would be sufficient. METHODS: We queried the targeted vascular module of the National Surgical Quality Improvement Program (NSQIP) for all elective EVARs from 2011 to 2015. We included only infrarenal aneurysms and excluded ruptured aneurysms and patients transfused within 72 hours preoperatively. Two-thirds of the cases were randomly assigned to a model derivation cohort and one third to a validation cohort. We created and subsequently validated a risk model for transfusion within the first 24 hours of surgery (including intraoperatively), using logistic regression. RESULTS: Between 2011 and 2015, there were 4875 patients who underwent elective infrarenal EVAR, only 221 (4.5%) of whom received a transfusion within 24 hours of surgery. The frequency of transfusion during the study period declined monotonously from 6.5% in 2011 to 3.2% in 2015. The factors independently associated with transfusion were preoperative hematocrit <36% (odds ratio [OR], 3.4 [95% confidence interval, 2.1-5.4]; P < .001), aortic diameter (per centimeter increase: OR, 1.2 [1.03-1.4]; P = .02), preoperative dependent functional status (OR, 2.5 [1.1-5.5]; P = .03), and chronic obstructive pulmonary disease (OR, 1.7 [1.04-2.9]; P = .04). A risk prediction model based on these criteria produced a C statistic of 0.69 in the prediction cohort and 0.76 in the validation cohort and a Hosmer-Lemeshow goodness of fit of 0.62 and 0.14, respectively. A score of <3 of 9, corresponding to a <5% probability of transfusion, would avoid preoperative type and cross in 86% of patients. Of the 4203 patients (86%) with a hematocrit >36%, only 6 (0.1%) had a risk score of >3. CONCLUSIONS: Perioperative transfusion for EVAR is becoming increasingly uncommon and is predicted well by a transfusion risk score or simply a hematocrit of <36%. Application of this risk score would avoid unnecessary type and cross in the majority of patients, leading to significant savings in both time and cost.

Patient selection and perioperative outcomes of bypass and endovascular intervention as first revascularization strategy for infrainguinal arterial disease.

OBJECTIVE: The optimal initial revascularization strategy remains uncertain for patients with peripheral arterial disease. The purpose of this study was to evaluate current nationwide selection and perioperative outcomes of patients undergoing bypass or endovascular intervention for infrainguinal disease in those with no prior ipsilateral revascularization. METHODS: Patients undergoing nonemergent first-time infrainguinal revascularization were identified in the Targeted Vascular module of the National Surgical Quality Improvement Program (NSQIP) for 2011 to 2014 and stratified by symptom status (chronic limb-threatening ischemia [CLTI] or claudication). Patients treated with endovascular intervention were compared with those who underwent bypass. Multivariable logistic regression was used to evaluate current selection of patients and to establish independent associations between first-time procedures and postoperative outcomes. RESULTS: Of 5998 first-time infrainguinal revascularizations performed, 3193 were bypass procedures (63% for CLTI) and 2805 were endovascular interventions (64% for CLTI). Current patient characteristics associated with an endovascular-first approach as opposed to bypass-first in CLTI patients were age ≥80 years, tissue loss, nonsmoking, functional dependence, diabetes, dialysis, and tibial lesions, whereas age ≥80 years, nonwhite race, nonsmoking, diabetes, and tibial lesions were associated with an endovascular approach for claudication. In comparing first-time endovascular intervention with bypass, there was no difference in 30-day mortality in CLTI patients (univariate: 2.1% vs 2.2%; adjusted: odds ratio [OR], 0.7; 95% confidence interval [CI], 0.4-1.1) or claudication patients (0.3% vs 0.6%). Among CLTI patients, endovascular-first intervention was associated with lower rates of major adverse cardiovascular event (3.6% vs 4.7%; OR, 0.6; 95% CI, 0.4-0.9), surgical site infection (0.9% vs 7.7%; OR, 0.1; 95% CI, 0.1-0.2), bleeding (8.5% vs 17%; OR, 0.4; 95% CI, 0.3-0.5), unplanned reoperation (13% vs 17%; OR, 0.7; 95% CI, 0.5-0.8), and unplanned readmission (17% vs 18%; OR, 0.8; 95% CI, 0.7-0.9). Patients with claudication undergoing endovascular-first intervention also had lower rates of major adverse cardiovascular event (0.8% vs 1.6%; OR, 0.4; 95% CI, 0.2-0.95), surgical site infection (0.7% vs 6.6%; OR, 0.1; 95% CI, 0.04-0.2), bleeding (2.3% vs 6.0%; OR, 0.3; 95% CI, 0.2-0.5), unplanned reoperation (4.3% vs 6.6%; OR, 0.6; 95% CI, 0.4-0.9), and unplanned readmission (5.9% vs 9.0%; OR, 0.6; 95% CI, 0.4-0.8). Conversely, endovascular-first intervention was associated with a higher rate of secondary revascularizations within 30 days for CLTI (4.3% vs 3.1%; OR, 1.6; 95% CI, 1.04-2.3) but not for claudication (2.6% vs 1.9%; OR, 1.7; 95% CI, 0.9-3.4). CONCLUSIONS: An endovascular-first approach as a revascularization strategy for infrainguinal disease was associated with substantially lower early morbidity but not mortality, at the cost of higher rates of postoperative secondary revascularizations. As a national representation of first-time revascularizations, this study highlights the early endovascular perioperative benefit, although more robust long-term data are needed to adopt either one strategy or the other in select patients with peripheral arterial disease.

Racial disparities in outcomes after intact abdominal aortic aneurysm repair.

OBJECTIVE: We aimed to compare perioperative morbidity and mortality and late survival among black, white, and Asian patients undergoing intact abdominal aortic aneurysm (AAA) repair. METHODS: We identified all patients undergoing intact, infrarenal AAA repair in the Vascular Quality Initiative (VQI) from 2003 to 2017. We compared in-hospital outcomes by race using the Fisher exact and Kruskal-Wallis tests. Multivariable logistic and linear regression models of perioperative outcomes adjusted for differences in demographics, comorbidities, hospital volume, and procedure. We used Cox regression to evaluate late survival by race. RESULTS: In the cohort, 21,961 (94%) patients were white, 1215 (5.2%) were black, and 318 (1.4%) were Asian. Black patients were more likely to be symptomatic (black, 16%; white, 9.1%; Asian, 11%; P < .001) and to undergo endovascular aneurysm repair (EVAR; black, 87%; white, 83%; Asian, 84%; P < .001). There were no differences in 30-day mortality after EVAR (black, 1.1%; white, 1.1%; Asian, 0.8%; P = .80) or open repair (black; 4.3%; white, 2.6%; Asian, 1.9%; P = .33). However, black patients were more likely to receive new postoperative dialysis (black, 1.6%; white, 0.8%; Asian; 0.7%; P = .01) and to return to the operating room (black, 4.3%; white, 2.9%; Asian, 0.9%; P < .01). Mean hospital length of stay was longer in black patients after EVAR (black, 3.3 days; white, 2.6 days; Asian, 2.6 days; P < .001) and in Asian and black patients after open repair (black, 10.5 days; white, 8.5 days; Asian, 13.0 days; P < .001). After multivariable adjustment, black patients were more likely than white patients to have postoperative dialysis (odds ratio, 2.2; 95% confidence interval [CI], 1.3-3.6; P < .01) and return to the operating room (odds ratio, 1.6; 95% CI, 1.2-2.2; P < .01). Five-year survival was highest for Asian patients (black, 84%; white, 85%; Asian, 92%), even in the adjusted Cox model (Asian: hazard ratio, 0.6; 95% CI, 0.4-0.97; P = .04). CONCLUSIONS: Although perioperative mortality is comparable across races after AAA repair, black patients are more likely than white or Asian patients to develop new postoperative renal failure and return to the operating room, even after adjusting for differences in comorbidities, operative variables, and hospital volume. In addition, whereas Asian patients have the highest rate of postoperative myocardial infarction, they also have the highest late survival. Further studies are warranted to elucidate the mechanism of these disparities.

Long-term mortality benefit of renin-angiotensin system inhibitors in patients with chronic limb-threatening ischemia undergoing vascular intervention.

OBJECTIVE: The beneficial effect of renin-angiotensin system (RAS) inhibitors has been well-established in patients with cardiovascular disease; however, their effectiveness in patients with chronic limb-threatening ischemia (CLTI), a selected disease-burdened population, is largely unknown. The purpose of this study was to evaluate long-term outcomes of RAS inhibitor use in patients with CLTI undergoing a vascular intervention. METHODS: For this study, all patients with CLTI undergoing a first-time revascularization (bypass or endovascular) were analyzed at our institution between 2005 and 2014. Patients discharged on an RAS inhibitor (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker) were compared with those not on an RAS inhibitor. The inverse probability of treatment weighting with additional regression analyses were used to determine the long-term risk of mortality and major adverse events. A sensitivity analysis was performed to assess the dose-related therapeutic response of RAS inhibitors (low-dose vs high-dose therapy). RESULTS: Between 2005 and 2014, 1303 limbs from 1161 patients were identified. Of these patients, 52% were discharged on an RAS inhibitor, with 67% discharged on a high-dose therapy and 33% on a low-dose therapy. Patients discharged on an RAS inhibitor suffered more frequently from diabetes, hypertension, and myocardial infarction, whereas those not on an RAS inhibitor had more chronic kidney disease (all P < .05). There was no difference in the proportion of patients presenting with tissue loss. After adjustment for these and other baseline covariates, RAS inhibitor use was associated with less late mortality (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.65-0.94). Discharge on a high-dose RAS inhibitor was associated with lower mortality (HR, 0.70; 95% CI, 0.57-0.86), whereas a low-dose RAS inhibitor was not associated with less mortality (HR, 0.95; 95% CI, 0.73-1.24) compared with patients not prescribed an RAS inhibitor. This association remained significant when comparing high-dose with low-dose therapy (HR, 0.74; 95% CI, 0.55-0.98). No associations were found between RAS inhibitor use and major adverse limb event (HR, 0.95; 95% CI, 0.73-1.22), major amputation (HR, 0.82; 95% CI, 0.57-1.18), or reintervention (HR, 1.05; 95% CI, 0.85-1.31). These point estimates were not different for those on angiotensin-converting enzyme inhibitors vs angiotensin receptor blockers, nor were they affected by the type of revascularization. CONCLUSIONS: Patients with CLTI prescribed an RAS inhibitor at discharge demonstrated significantly less long-term mortality, whereas limb events were unaffected. These data indicate that, in these heavily burdened patients, the benefit is restricted to those on a high dose, which underscores the importance of attaining these doses.

Lifelong limb preservation: A patient-centered description of lower extremity arterial reconstruction outcomes.

BACKGROUND: Life expectancy is short for patients with critical limb ischemia (CLI), many of whom may fear amputation more than death. In light of the reduced life expectancy of these patients, the traditional 5-year freedom from amputation (FFA) statistic may not accurately address their concern. We developed a more relevant patient-centered calculation of major amputation risk during a patient's remaining lifetime to better answer the question, Will I ever lose my leg? METHODS: We identified all limbs undergoing first-time intervention for CLI in a large institutional database from 2005 to 2013. We calculated the traditional metrics of amputation-free survival (AFS, for which failure is death or amputation) and FFA (for which failure is amputation but deaths are censored and removed from further analysis). In addition, we propose a new term, lifelong limb preservation (LLP). LLP defines amputation as failure, but deaths are not censored and therefore reflect that LLP has been achieved. All deaths before 30 days were considered a failure in all three metrics, reflecting the risk of surgery. RESULTS: There were 1006 limbs identified as having first-time intervention for CLI (22% rest pain, 45% ulcer, 27% gangrene; 46% treated by angioplasty with or without stenting, 54% bypass). Using life-table analysis, 7-year AFS was 14% (561 events), FFA was 78% (123 events), and LLP was 86% (123 events). LLP was similar between patients undergoing angioplasty with or without stenting and bypass (7-year rates, 86% and 85%, respectively). For patients undergoing intervention for rest pain, 7-year rates were 14% for AFS, 84% for FFA, and 92% for LLP. For those undergoing treatment for ulcer, 7-year rates were 14% for AFS, 77% for FFA, and 86% for LLP. Finally, in those with gangrene, rates were 10% for AFS, 67% for FFA, and 79% for LLP. Using LLP, patients presenting with an ulcer can be told that although we cannot guarantee how long they will live, with revascularization there is approximately an 86% chance they will not lose the leg. CONCLUSIONS: These results show that the durability of our limb preservation efforts often exceeds the life expectancy of our patients. Using LLP as an outcomes assessment provides a more accurate and patient-centered answer to the question, If I have this procedure, will I ever lose my leg?

Adherence to lipid management guidelines is associated with lower mortality and major adverse limb events in patients undergoing revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The 2013 American College of Cardiology/American Heart Association lipid management guidelines recommend high-intensity statins for all patients ≤75 years old with chronic limb-threatening ischemia (CLTI) and moderate-intensity statins for CLTI patients >75 years old without contraindications or on dialysis, but these recommendations are based primarily on coronary and stroke data. We aimed to validate these guidelines in patients with CLTI and to assess current adherence to these recommendations. METHODS: We identified all patients with CLTI who underwent first-time revascularization (endovascular or surgical) at Beth Israel Deaconess Medical Center from 2005 to 2014. Patients were classified as taking high-intensity, moderate-intensity, low-intensity, or no statin postoperatively. Outcomes included death and major adverse limb event (MALE). Propensity scores were calculated for the probability of receiving guideline-recommended intensity of statin therapy to account for nonrandom assignment of treatments. Cox regression models were constructed and adjusted for the propensity scores and further adjusted for strong potential confounders. RESULTS: After excluding patients on hemodialysis (n = 252), we identified 1019 limbs from 931 patients with a median follow-up of 380 days. Patients discharged on the recommended statin intensity had higher rates of preoperative statin use, coronary artery disease, chronic kidney disease, stroke, atrial fibrillation, congestive heart failure, and coronary artery bypass grafting; they had lower smoking rates and were less likely to be ambulatory preoperatively. Overall, only 35% were taking the recommended statin dosage: 55% of those >75 years old and 20% of those ≤75 years old. In multivariable analysis including propensity scores where appropriate, discharge on any statin was associated with lower mortality (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.60-0.90; P < .01). Discharge on the recommended intensity of statin therapy was associated with lower mortality (HR, 0.73; 95% CI, 0.60-0.99; P < .05) and lower MALE rate (HR, 0.71; 95% CI, 0.51-0.97; P < .05). Patients >75 years old and ≤75 years old accrued similar benefit. In patients >75 years old, moderate-intensity statin therapy was associated with lower rates of death and MALE compared with high-intensity therapy but did not reach statistical significance. CONCLUSIONS: Use of the recommended intensity of statin therapy in compliance with 2013 American College of Cardiology/American Heart Association lipid management guidelines is associated with significantly improved survival and lower MALE rate in patients undergoing revascularization for CLTI. Adherence to current guidelines is an appealing target for quality improvement.

The impact of endovascular repair on management and outcome of ruptured thoracic aortic aneurysms.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has become an alternative to open repair for the treatment of ruptured thoracic aortic aneurysms (rTAAs). The aim of this study was to assess national trends in the use of TEVAR for the treatment of rTAA and to determine its impact on perioperative outcomes. METHODS: Patients admitted with an rTAA between 1993 and 2012 were identified from the National Inpatient Sample. Patients were grouped in accordance with their treatment: TEVAR, open repair, or nonoperative treatment. The primary outcomes were treatment trends over time and in-hospital death. Secondary outcomes included perioperative complications and length of stay. Trend analyses were performed using the Cochran-Armitage test for trend, and adjusted mortality risks were established using multivariable logistic regression analysis. RESULTS: A total of 12,399 patients were included, with 1622 (13%) undergoing TEVAR, 2808 (23%) undergoing open repair, and 7969 (64%) not undergoing surgical treatment. TEVAR has been increasingly used from 2% of total admissions in 2003-2004 to 43% in 2011-2012 (P < .001). Concurrently, there was a decline in the proportion of patients undergoing open repair (29% to 12%; P < .001) and nonoperative treatment (69% to 45%; P < .001). The proportion of patients undergoing surgical repair has increased for all age groups since 1993-1994 (P < .001 for all) but was most pronounced among those aged 80 years with a 7.5-fold increase. After TEVAR was introduced, procedural mortality decreased from 36% in 2003-2004 to 27% in 2011-2012 (P < .001); mortality among those undergoing nonoperative treatment remained stable between 63% and 60% (P = .167). Overall mortality after rTAA admission decreased from 55% to 42% (P < .001). Since 2005, mortality for open repair was 33% and 22% for TEVAR (P < .001). In adjusted analysis, open repair was associated with a twofold higher mortality than TEVAR (odds ratio, 2.0; 95% confidence interval, 1.7-2.5). CONCLUSIONS: TEVAR has replaced open repair as primary surgical treatment for rTAA. The introduction of endovascular treatment appears to have broadened the eligibility of patients for surgical treatment, particularly among the elderly. Mortality after rTAA admission has declined since the introduction of TEVAR, which is the result of improved operative mortality as well as the increased proportion of patients undergoing surgical repair.

Regional variation in outcomes for lower extremity vascular disease in the Vascular Quality Initiative.

BACKGROUND: Increased focus has been placed on perioperative and long-term outcomes in the treatment of peripheral artery disease (PAD), both for purposes of quality improvement and for assessment of performance at a surgeon and institutional level. This study evaluates regional variation in outcomes after treatment for PAD within the Vascular Quality Initiative (VQI). By describing the variation in practice patterns and outcomes across regions, we hope that each regionally based quality group can select which areas are most important for them to focus on as they will have access to their regional data to compare. METHODS: We identified all patients in the VQI who had infrainguinal bypass or endovascular intervention from 2009 to 2014. We compared variation in perioperative and 1-year outcomes stratified by symptom status and revascularization type among the 16 regional groups of the VQI. We analyzed variation in perioperative end points using χ2 analysis, and 1-year end points were analyzed using Kaplan-Meier and life-table analysis. RESULTS: We identified 15,338 bypass procedures for symptomatic PAD: 27% for claudication, 59% for chronic limb-threatening ischemia (CLI; 61% of these for tissue loss), and 14% for acute limb ischemia. We identified 33,925 endovascular procedures for symptomatic PAD: 42% for claudication, 48% for CLI (73% of these for tissue loss), and 10% for acute limb ischemia. Thirty-day mortality varied significantly after endovascular intervention for CLI (0.5%-3%; P < .001) but not for claudication (0.0%-0.5%, P = .77) or for bypass for claudication (0.0%-2.6%; P = .37) or CLI (0.0%-5.0%; P = .08). After bypass, rates of >2 units transfused red blood cells (claudication, 0.0%-13% [P < .001]; CLI, 6.9%-27% [P < .001]) varied significantly. In-hospital major amputation was variable after bypass for CLI (0.0%-4.3%; P = .004) but not for claudication (0.0%-0.6%; P = .98), as was postoperative myocardial infarction (claudication, 0.0%-4% [P = .36]; CLI, 0.8%-6% [P = .001]). One-year survival varied significantly for endovascular interventions for claudication (92%-100%; P < .001), bypass for CLI (85%-94% [P < .001]), and endovascular interventions for CLI (77%-96%; P < .001) but not after bypass for claudication (95%-100%; P = .57). CONCLUSIONS: In this real-world comparison among VQI regions, we found significant variation in perioperative and 1-year end points for patients with PAD undergoing bypass or endovascular intervention. This study highlights opportunities for quality improvement efforts to reduce variation and to improve outcomes.

Regional variation in patient selection and treatment for carotid artery disease in the Vascular Quality Initiative.

OBJECTIVE: Previous studies involving large administrative data sets have revealed regional variation in the demographics of patients selected for carotid endarterectomy (CEA) and carotid artery stenting (CAS) but lacked clinical granularity. This study aimed to evaluate regional variation in patient selection and operative technique for carotid artery revascularization using a detailed clinical registry. METHODS: All patients who underwent CEA or CAS from 2009 to 2015 were identified in the Vascular Quality Initiative (VQI). Deidentified regional groups were used to evaluate variation in patient selection, operative technique, and perioperative management. χ2 analysis was used to identify significant variation across regions. RESULTS: A total of 57,555 carotid artery revascularization procedures were identified. Of these, 49,179 patients underwent CEA (asymptomatic: median, 56%; range, 46%-69%; P < .01) and 8376 patients underwent CAS (asymptomatic: median, 36%; range, 29%-51%; P < .01). There was significant regional variation in the proportion of asymptomatic patients being treated for carotid stenosis <70% in CEA (3%-9%; P < .01) vs CAS (3%-22%; P < .01). There was also significant variation in the rates of intervention for asymptomatic patients older than 80 years (CEA, 12%-27% [P < .01]; CAS, 8%-26% [P < .01]). Preoperative computed tomography angiography or magnetic resonance angiography in the CAS cohort also varied widely (31%-83%; P < .01), as did preoperative medical management with combined aspirin and statin (CEA, 53%-77% [P < .01]; CAS, 62%-80% [P < .01]). In the CEA group, the use of shunt (36%-83%; P < .01), protamine (32%-89%; P < .01), and patch (87%-99%; P < .01) varied widely. Similarly, there was regional variation in frequency of CAS done without a protection device (1%-8%; P < .01). CONCLUSIONS: Despite clinical benchmarks aimed at guiding management of carotid disease, wide variation in clinical practice exists, including the proportion of asymptomatic patients being treated by CAS and preoperative medical management. Additional intraoperative variables, including the use of a patch and protamine during CEA and use of a protection device during CAS, displayed similar variation in spite of clear guidelines. Quality improvement projects could be directed toward improved adherence to benchmarks in these areas.

Female sex independently predicts mortality after thoracic endovascular aortic repair for intact descending thoracic aortic aneurysms.

OBJECTIVE: Whereas sex differences in the pathogenesis, presentation, and outcomes of repair for abdominal aortic aneurysms are well studied, less is known about sex differences after thoracic endovascular aortic repair (TEVAR). The goal of this study was to evaluate the association between sex and morbidity and mortality after TEVAR. METHODS: A retrospective review of all TEVARs in the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry from 2011 to 2015 was conducted, excluding those with dissection, trauma, and rupture. Statistical analysis was performed using the Fisher exact test and the Mann-Whitney U test for categorical and continuous variables. Multivariable logistic regression and Cox hazards modeling were used to account for differences in demographics, comorbidities, and aneurysm characteristics in 30-day mortality and long-term survival. RESULTS: We identified 2574 patients (40% women) who underwent TEVAR. Women were older, were less likely to be white, and had smaller aortic diameters but larger aortic size indices (aortic diameter/body surface area). Women also had more chronic obstructive pulmonary disease but less coronary artery disease and fewer coronary interventions. Women were more likely to be symptomatic at presentation and subsequently to have a nonelective procedure. Women had higher estimated blood loss >500 mL (20% vs 17%; P = .04), were more likely to be transfused (29% vs 21%; P < .001), and more frequently underwent iliac access procedures (4.3% vs 2.1%; P < .01). Operative time and left subclavian intervention were similar. Postoperatively, women had increased median hospital (5 vs 4 days; P < .001) and intensive care unit (2.5 vs 2 days; P < .001) lengths of stay and were less likely to be discharged home (75% vs 86%; P < .001). Mortality was higher for women at 30 days (5.4% vs 3.3%; P < .01) and 1 year (9.8% vs 6.3%; P < .01). After adjusting for age, aortic size index, symptoms, and comorbidities, female sex remained independently predictive of 30-day mortality (odds ratio, 1.5; 95% confidence interval, 1.1-2.1, P < .01) and long-term mortality (hazard ratio, 1.3; 95% confidence interval, 1.03-1.6; P = .02). CONCLUSIONS: Even after adjusting for differences in age and comorbidities, female patients have higher perioperative mortality and lower long-term survival after TEVAR. These findings, along with the rupture risk by sex, should be considered by clinicians in determining the timing of intervention.