Vascular Quality Initiative Research Articles

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

BackgroundHypertension (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. MethodsWe 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. ResultsA 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. ConclusionsThe 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.

Long-Term Mortality Predictors Using a Machine-Learning Approach in Patients With Chronic Limb-Threatening Ischemia After Peripheral Vascular Intervention.

Patients with chronic limb-threatening ischemia (CLTI) face a high long-term mortality risk. Identifying novel mortality predictors and risk profiles would enable individual health care plan design and improved survival. We aimed to leverage a random survival forest machine-learning algorithm to identify long-term all-cause mortality predictors in patients with CLTI undergoing peripheral vascular intervention. Patients with CLTI undergoing peripheral vascular intervention from 2017 to 2018 were derived from the Medicare-linked VQI (Vascular Quality Initiative) registry. We constructed a random survival forest to rank 66 preprocedural variables according to their relative importance and mean minimal depth for 3-year all-cause mortality. A random survival forest of 2000 trees was built using a training sample (80% of the cohort). Accuracy was assessed in a testing sample (20%) using continuous ranked probability score, Harrell C-index, and out-of-bag error rate. A total of 10 114 patients were included (mean±SD age, 72.0±11.0 years; 59% men). The 3-year mortality rate was 39.1%, with a median survival of 1.4 years (interquartile range, 0.7-2.0 years). The most predictive variables were chronic kidney disease, age, congestive heart failure, dementia, arrhythmias, requiring assisted care, living at home, and body mass index. A total of 41 variables spanning all domains of the biopsychosocial model were ranked as mortality predictors. The accuracy of the model was excellent (continuous ranked probability score, 0.172; Harrell C-index, 0.70; out-of-bag error rate, 29.7%). Our random survival forest accurately predicts long-term CLTI mortality, which is driven by demographic, functional, behavioral, and medical comorbidities. Broadening frameworks of risk and refining health care plans to include multidimensional risk factors could improve individualized care for CLTI.

Predictors of prolonged length of stay after elective carotid revascularization

ObjectivePostoperative 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. MethodsPatients 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. ResultsA 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). ConclusionsA 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.

Variability in short-term mortality following repair of ruptured abdominal aortic aneurysms across centers and physicians

BackgroundVariation in the care management of repairs for ruptured infrarenal abdominal aortic aneurysms between centers and physicians, such as procedural volumes, may explain differences in mortality outcomes. First, we quantified the center and physician variability associated with 30- and 90-day mortality risk after ruptured open surgical repair (rOSR) and ruptured endovascular aneurysm repair (rEVAR). Second, we explored wheter part of this variability was attributable to procedural volume at the center and physician levels. MethodsTwo cohorts including rOSR and rEVAR procedures between 2013 and 2019 were analyzed from the Vascular Quality Initiative database. Thirty- and 90-day all-cause mortality rates were derived from linked Medicare claims data. The median odds ratio (MOR) (median mortality risk from low- to high-risk cluster) and intraclass correlation coefficient (ICC) (variability attributable to each cluster) for 30- and 90-day mortality risks associated with center and physician variability were derived using patient-level adjusted multilevel logistic regression models. Procedural volume was calculated at the center and physician levels and stratified by quartiles. The models were sequentially adjusted for volumes, and the difference in ICCs (without vs with accounting for volume) was calculated to describe the center and physician variability in mortality risk attributable to volumes. ResultsWe included 450 rOSRs (mean age, 74.5 ± 7.6 years; 23.5% female) and 752 rEVARs (76.4 ± 8.4 years; 26.1% female). After rOSRs, the 30- and 90-day mortality rates were 32.9% and 38.7%, respectively. No variability across centers and physicians was noted (30- and 90-day MORs ≈1 and ICCs ≈0%). Neither center nor physician volume was associated with 30-day (P = .477 and P = .796) or 90-day mortality (P = .098 and P = .559). After rEVAR, the 30- and 90-day mortality rates were 21.3% and 25.5%, respectively. Significant center variability (30-day MOR, 1.82 [95% confidence interval (CI), 1.33-2.22]; ICC, 11% [95% CI, 2%-36%]; and 90-day MOR, 1.76 [95% CI, 1.37-2.09]; ICC, 10% [95% CI, 3%-30%]), but negligeable variability across physicians (30- and 90-day MORs ≈1 and ICCs ≈0%) were noted. Neither center nor physician volume were associated with 30-day (P = .076 and P = .336) or 90-day mortality risk (P = .066 and P = .584). The center variability attributable to procedural volumes was negligeable (difference in ICCs, 1% for 30-day mortality; 0% for 90-day mortality). ConclusionsVariability in practice from center to center was associated with short-term mortality outcomes in rEVAR, but not for rOSR. Physician variability was not associated with short-term mortality for rOSR or rEVAR. Annualized center and physician volumes did not significantly explain these associations. Further work is needed to identify center-level factors affecting the quality of care and outcomes for ruptured abdominal aortic aneurysms.

Polyvascular disease is common in patients undergoing carotid endarterectomy and lower extremity bypass and is associated with worse outcomes

BackgroundPolyvascular disease is strongly associated with increased risk of cardiovascular morbidity and mortality. However, its prevalence in patients undergoing carotid and lower extremity surgical revascularization and its impact on outcomes are unknown. MethodsThe Vascular Quality Initiative was queried for carotid endarterectomy (CEA) or infrainguinal lower extremity bypass (LEB), 2013-2019. Polyvascular disease was defined as presence of atherosclerotic occlusive disease in more than one arterial bed: carotid, coronary, and infrainguinal. Primary outcomes were (1) composite perioperative myocardial infarction (MI) or death and (2) 5-year survival. Patient characteristics and perioperative outcomes were evaluated using the χ2 test and multivariable logistic regression. Survival was analyzed using Kaplan-Meier method and Cox proportional hazards multivariable models. ResultsPolyvascular disease was identified in 47% of CEA (39.0% in 2 arterial beds, 7.6% in 3 arterial beds; n = 93,736) and 47% of LEB (41.0% in 2 arterial beds, 5.7% in 3 arterial beds; n = 25,223). For both CEA and LEB, patients with polyvascular disease had more comorbidities including hypertension, congestive heart disease, chronic obstructive pulmonary disease, smoking, diabetes mellitus, and end-stage renal disease (P < .0001). Perioperative MI/death rates increased with increasing number of vascular beds affected following CEA (0.9% in 1 bed vs 1.5% in 2 beds vs 2.7% in 3 beds; P < .001) and LEB (2.2% in 1 bed vs 5.3% in 2 beds vs 6.6% in 3 beds; P < .001). Polyvascular disease was associated independently with perioperative MI/death after CEA (odds ratio, 1.59; 95% confidence interval [CI], 1.40-1.81;P < .0001) and LEB (odds ratio, 1.78; 95% CI, 1.52-2.08; P < .0001). Five-year survival was decreased in patients with polyvascular disease after CEA (82% in 3 beds vs 88% in 2 beds vs 92% in 1 bed; P < .01) and LEB (72% in 3 beds vs 75% in 2 beds vs 84% in 1 bed; P < .01) in a dose-dependent manner, with the lowest 5-year survival observed in those with three arterial beds involved. Polyvascular disease was independently associated with 5-year mortality after CEA (hazard ratio, 1.33; 95% CI, 1.24-1.40; P = .0001) and LEB (hazard ratio, 1.30; 95% CI, 1.20-1.41; P = .0001). ConclusionsPolyvascular disease is common in patients undergoing CEA and LEB and is associated with a higher risk of perioperative MI/death and decreased long-term survival. After revascularization, patients with polyvascular disease should be considered for more aggressive cardioprotective medications and closer follow-up.

Spinal cord ischemia and reinterventions following thoracic endovascular repair for acute type B aortic dissections

ObjectiveThe technical aspects of thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection (TBAD), specifically the location of proximal seal zone (PSZ) (need to cover the left subclavian artery [LSA]), distal seal zone (DSZ) (length of aortic coverage), benefit of LSA revascularization, and prophylactic lumbar drainage are still debated. Each of these issues has potential benefits but also has known risks. This study aims to identify factors associated with reintervention and spinal cord ischemia (SCI) following TEVAR for acute TBAD with a zone 3 entry tear. MethodsThe Vascular Quality Initiative was queried for TEVARs performed for acute TBAD with zone 3 entry tear, zone 3 proximal zone of disease, treated with TEVAR extending between zone 2 and zone 5. The primary outcomes were SCI and related reintervention. Secondary outcomes were stroke, arm ischemia, and retrograde type A dissection (RTAD). The exposure variables were PSZ 2 vs 3, DSZ 4 vs 5, prophylactic lumbar drain, and LSA revascularization. Univariate analyses were conducted with χ2 analysis, and multivariable logistic regression was used to evaluate association with outcomes. ResultsOf 583 patients who met inclusion criteria, 266 had PSZ 2 and 317 had PSZ 3. On univariate analysis, PSZ 2 was associated with a higher rate of reintervention, but PSZ2 was not significant on multivariable analysis after accounting for age, sex, race, smoking, PSZ, DSZ, prophylactic lumbar drain, and LSA patency. PSZ 2 was not associated with SCI, arm ischemia, or RTAD. PSZ 2 was associated with a trend towards a higher rate of stroke. DSZ 4 and DSZ 5 were performed in 161 and 422 TEVARs, respectively, and DSZ 5 was associated with a higher rate of SCI on univariate (3 [1.9%] vs 39 [9.2%]; P = .01) and multivariable (odds ratio, 7.384; 95% confidence interval, 2.193-24.867; P = .001) analyses. Prophylactic lumbar drain placement was not statistically significantly associated with SCI, but lack of postoperative LSA patency was associated with SCI (odds ratio, 2.966; 95% confidence interval, 1.016-8.656; P = .05). ConclusionsThis study found that PSZ 2 was not associated with lower reinterventions or higher rates of SCI but trended towards a higher rate of stroke than PSZ 3. Additionally, DSZ 5 was strongly associated with SCI when compared with DSZ 4, highlighting the importance of limiting aortic coverage to coverage of the proximal entry tear when possible.

Complications of Varicose Vein Interventions in the Vascular Quality Initiative

Complications of Varicose Vein Interventions in the Vascular Quality Initiative

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

ObjectiveThis 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. MethodsUtilizing 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. ResultsA 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). ConclusionsAlthough 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.

Factors Associated with Clinical Failure of Vein Ablation in the Vascular Quality Initiative

Factors Associated with Clinical Failure of Vein Ablation in the Vascular Quality Initiative

Risk score for one-year mortality following emergent infra-inguinal bypass

ObjectiveThe purpose of this study is to identify variables that place patients at higher risk for mortality following emergent infra-inguinal bypass. Further, this study will create a risk score for mortality following emergent infra-inguinal bypass to help tailor postoperative and long-term patient management. MethodsIn the Vascular Quality Initiative, we identified 2126 patients who underwent emergent infra-inguinal artery bypass. Two primary outcomes were investigated: 30 day mortality following emergent infra-inguinal bypass; and 1-year mortality following emergent infra-inguinal bypass. The first step in analysis was univariable analysis for each outcome with χ2 analysis for categorical variables and Student t-test for comparison of means of ordinal variables. Next, binary logistic regression analysis was performed for each outcome utilizing variables that achieved a univariable P value ≤ .10. Factors with a multivariable P value ≤ .05 were included in the risk score, and points were weighted and assigned based on the respective regression beta-coefficient in the multivariable regression. ResultsVariables with a significant multivariable association (P < .05) with 1-year mortality were: increasing age; body mass index less than 20 kg/m2; coronary artery disease; active hemodialysis at time of presentation; anemia at admission; prosthetic conduit for emergent bypass; postoperative myocardial infarction; postoperative acute renal insufficiency; perioperative stroke; baseline non-ambulatory status; new onset hemodialysis requirement perioperatively; need for bypass revision or thrombectomy during index admission; lack of statin prescription at discharge; lack of antiplatelet medication at discharge; and, lack of anticoagulation at time of hospital discharge. Pertinent negatives included all sociodemographic variables including rural living status, insurance status, and Area Deprivation Index home area. The risk score achieved an area under the curve of 0.820, and regression analysis of the risk score achieved an overall accuracy of 87.9% with 97.7% accuracy in predicting survival, indicating the model performs better in determining which patients will survive rather than precisely determining who will experience 1-year mortality. ConclusionsDischarge medications are the primary modifiable variable impacting survival after emergent infra-inguinal bypass surgery. In the absence of contraindication, all these patients should be discharged on antiplatelet, statin, and anticoagulant medications after emergent infra-inguinal bypass as they significantly enhance survival. Social determinants of health do not impact survival among patients treated with emergent infra-inguinal bypass at Vascular Quality Initiative centers. A risk score for mortality at 1 year after emergent infra-inguinal bypass has been created that has excellent accuracy.

Intravascular Ultrasound Use is Associated with Improved Patency in Lower Extremity Peripheral Arterial Interventions

ObjectivesIntravascular ultrasound (IVUS) facilitates detailed visualization of endoluminal anatomy not adequately appreciated on conventional angiography. However, it is unclear if IVUS use improves clinical outcomes of peripheral vascular interventions (PVI) for peripheral arterial disease (PAD). This study aimed to evaluate the impact of IVUS on 1-year outcomes of PVI in the vascular quality initiative (VQI). MethodsThe VQI-PVI modules were reviewed (2016-2020). All patients with available one-year follow up after lower extremity PVI were included and grouped as IVUS-PVI or non-IVUS PVI based on use of IVUS. Propensity matching (1:1) was performed using demographics and comorbidities. One-year major amputation and patency rates were compared. A generalized estimating equation (GEE) model was used to identify predictors of 1-year outcomes. Subgroup analysis based on Trans-Atlantic Inter-Society Consensus (TASC) classification, treatment length and treatment modalities were performed using same modeling approaches. ResultsThere were 56,633 procedures (non-IVUS PVI=55,302 vs IVUS-PVI=1,331) in 44,042 patients. Propensity matching yielded a total cohort of 1,854 patients matched (1:1), with no baseline differences. LER for claudication was performed in 60.4%, while one-third (33.9%) had chronic limb threatening ischemia (CLTI). IVUS was more commonly used for lesions >15cm in length (46.6% vs 43.3%) and for aortoiliac disease (31.8% vs 27.2%). Rates of atherectomy and stenting were significantly higher with IVUS-PVI (21.1% vs 16.8%), while balloon angioplasty was less common (13.5% vs 24.4%). One-year patency was better with IVUS-PVI (97.7% vs 95.2%, p=0.004). On subgroup analysis, IVUS (OR 2.20, 95% CI 1.29- 3.75) was associated with improved patency in CLTI patients, TASC C or D lesions, and treatment length >15cm. Adjunctive IVUS use during PVI did not significantly impact 1-year amputation (OR 1.7, 95%CI 0.78-3.91). On multivariable regression, adjunctive use of IVUS (OR 2.46 95%CI 1.43-4.25) and aortoiliac interventions (OR 2.91, 95%CI 1.09-7.75) were independent predictors of patency. Treatment modalities such as atherectomy, stenting or balloon angioplasty did not significantly impact patency at 1-year. ConclusionIVUS during lower extremity PVI is associated with improved 1-year patency, when compared to angiography alone. Certain subgroups, such as CLTI patients, lesions>15cm, and TASC C or D lesions might benefit from adjunctive use of IVUS.

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

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

Earned outcomes correlate with reliability-adjusted surgical mortality after abdominal aortic aneurysm repair and predict future performance

ObjectiveCumulative, probability-based metrics are regularly used to measure quality in professional sports, but these methods have not been applied to health care delivery. These techniques have the potential to be particularly useful in describing surgical quality, where case volume is variable and outcomes tend to be dominated by statistical “noise.” The established statistical technique used to adjust for differences in case volume is reliability-adjustment, which emphasizes statistical “signal” but has several limitations. We sought to validate a novel measure of surgical quality based on earned outcomes methods (deaths above average [DAA]) against reliability-adjusted mortality rates, using abdominal aortic aneurysm (AAA) repair outcomes to illustrate the measure’s performance. MethodsEarned outcomes methods were used to calculate the outcome of interest for each patient: DAA. Hospital-level DAA was calculated for non-ruptured open AAA repair and endovascular aortic repair (EVAR) in the Vascular Quality Initiative database from 2016 to 2019. DAA for each center is the sum of observed – predicted risk of death for each patient; predicted risk of death was calculated using established multivariable logistic regression modeling. Correlations of DAA with reliability-adjusted mortality rates and procedure volume were determined. Because an accurate quality metric should correlate with future results, outcomes from 2016 to 2017 were used to categorize hospital quality based on: (1) risk-adjusted mortality; (2) risk- and reliability-adjusted mortality; and (3) DAA. The best performing quality metric was determined by comparing the ability of these categories to predict 2018 to 2019 risk-adjusted outcomes. ResultsDuring the study period, 3734 patients underwent open repair (106 hospitals), and 20,680 patients underwent EVAR (183 hospitals). DAA was closely correlated with reliability-adjusted mortality rates for open repair (r = 0.94; P < .001) and EVAR (r = 0.99; P < .001). DAA also correlated with hospital case volume for open repair (r = −.54; P < .001), but not EVAR (r = 0.07; P = .3). In 2016 to 2017, most hospitals had 0% mortality (55% open repair, 57% EVAR), making it impossible to evaluate these hospitals using traditional risk-adjusted mortality rates alone. Further, zero mortality hospitals in 2016 to 2017 did not demonstrate improved outcomes in 2018 to 2019 for open repair (3.8% vs 4.6%; P = .5) or EVAR (0.8% vs 1.0%; P = .2) compared with all other hospitals. In contrast to traditional risk-adjustment, 2016 to 2017 DAA evenly divided centers into quality quartiles that predicted 2018 to 2019 performance with increased mortality rate associated with each decrement in quality quartile (Q1, 3.2%; Q2, 4.0%; Q3, 5.1%; Q4, 6.0%). There was a significantly higher risk of mortality at worst quartile open repair hospitals compared with best quartile hospitals (odds ratio, 2.01; 95% confidence interval, 1.07-3.76; P = .03). Using 2016 to 2019 DAA to define quality, highest quality quartile open repair hospitals had lower median DAA compared with lowest quality quartile hospitals (−1.18 DAA vs +1.32 DAA; P < .001), correlating with lower median reliability-adjusted mortality rates (3.6% vs 5.1%; P < .001). ConclusionsAdjustment for differences in hospital volume is essential when measuring hospital-level outcomes. Earned outcomes accurately categorize hospital quality and correlate with reliability-adjustment but are easier to calculate and interpret. From 2016 to 2019, highest quality open AAA repair hospitals prevented >40 perioperative deaths compared with the average hospital, and >80 perioperative deaths compared with lowest quality hospitals.

Carotid endarterectomy and transcarotid artery revascularization can be performed with acceptable morbidity and mortality in patients with chronic kidney disease

ObjectivePatients with chronic kidney disease (CKD) are considered a high-risk population, and the optimal approach to the treatment of carotid disease remains unclear. Thus, we compared outcomes following carotid revascularization for patients with CKD by operative approach of carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid arterial revascularization (TCAR). MethodsThe Vascular Quality Initiative was analyzed for patients undergoing carotid revascularizations (CEA, TFCAS, and TCAR) from 2016 to 2021. Patients with normal renal function (estimated glomular filtration rate >90 mL/min/1.72 m2) were excluded. Asymptomatic and symptomatic carotid stenosis were assessed separately. Preoperative demographics, operative details, and outcomes of 30-day mortality, stroke, myocardial infarction (MI), and composite variable of stroke/death were compared. Multivariable analysis adjusted for differences in groups, including CKD stage. ResultsA total of 90,343 patients with CKD underwent revascularization (CEA, n = 66,870; TCAR, n = 13,459; and TFCAS, n = 10,014; asymptomatic, 63%; symptomatic, 37%). Composite 30-day mortality/stroke rates were: asymptomatic: CEA, 1.4%; TCAR, 1.2%; TFCAS, 1.8%; and symptomatic: CEA, 2.7%; TCAR, 2.3%; TFCAS, 3.7%. In adjusted analysis, TCAR had lower 30-day mortality compared with CEA (asymptomatic: adjusted odds ratio [aOR], 0.4; 95% confidence interval [CI], 0.3-0.7; symptomatic: aOR, 0.5; 95% CI, 0.3-0.7), and no difference in stroke, MI, or the composite outcome of stroke/death in both symptom cohorts. TCAR had lower risk of other cardiac complications compared with CEA in asymptomatic patients (aOR, 0.7; 95% CI, 0.6-0.9) and had similar risk in symptomatic patients. Compared with TFCAS, TCAR patients had lower 30-day mortality (asymptomatic: aOR, 0.5; 95% CI, 0.2-0.95; symptomatic: aOR, 0.3; 95% CI, 0.2-0.4), stroke (symptomatic: aOR, 0.7; 95% CI, 0.5-0.97), and stroke/death (asymptomatic: aOR, 0.7; 95% CI, 0.5-0.97; symptomatic: aOR, 0.6; 95% CI, 0.4-0.7), but no differences in MI or other cardiac complications. Patients treated with TFCAS had higher 30-day mortality (aOR, 1.8; 95% CI, 1.2-2.5) and stroke risk (aOR, 1.3; 95% CI, 1.02-1.7) in symptomatic patients compared with CEA. There were no differences in MI or other cardiac complications. ConclusionsAmong patients with CKD, TCAR and CEA showed rates of stroke/death less than 2% for asymptomatic patients and less than 3% for symptomatic patients. Given the increased risk of major morbidity and mortality, TFCAS should not be performed in patients with CKD who are otherwise anatomic candidates for TCAR or CEA.

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

ObjectiveThe 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. MethodsWe 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. ResultsFrom 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. ConclusionsThe 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.

The association between frailty and outcomes following ruptured abdominal aortic aneurysm repair

ObjectiveEndovascular aortic repair (EVAR) is a less invasive method than the more physiologically stressful open surgical repair (OSR) for patients with anatomically appropriate abdominal aortic aneurysms (AAAs). Early postoperative outcomes are associated with both patients; physiologic reserve and the physiologic stresses of the surgical intervention. Among frail patients with reduced physiologic reserve, the stress of an aortic rupture in combination with the stress of an operative repair are less well tolerated, raising the risk of complications and mortality. This study aims to evaluate the difference in association between frailty and outcomes among patients undergoing minimally invasive EVAR and the physiologically more stressful OSR for ruptured AAAs (rAAAs). MethodsOur retrospective cohort study included adults undergoing rAAA repair in the Vascular Quality Initiative from 2010 to 2022. The validated Risk Analysis Index (RAI) (robust, ≤20; normal, 21-29; frail, 30-39; very frail, ≥40) quantified frailty. The association between the primary outcome of 1-year mortality and frailty status as well as repair type were compared using multivariable Cox models generating adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs). Interaction terms evaluated the association’s moderation. ResultsWe identified 5806 patients (age, 72 ± 9 years; 77% male; EVAR, 65%; robust, 6%; normal, 48%; frail, 36%; very, frail 10%) with a 53% observed 1-year mortality rate following rAAA repair. OSR (aHR, 1.43; 95% CI, 1.19-1.73) was associated with increased 1-year mortality when compared with EVAR. Increasing frailty status (frail aHR, 1.26; 95% CI, 1.00-1.59; very frail aHR, 1.64; 95% CI, 1.26-2.13) was associated with increased 1-year mortality, which was moderated by repair type (P-interaction < .05). OSR was associated with increased 1-year mortality in normal (aHR, 1.49; 95% CI, 1.20-1.87) and frail (aHR, 1.51; 95% CI, 1.20-1.89), but not among robust (aHR, 0.88; 95% CI, 0.59-1.32) and very frail (aHR, 1.29; 95% CI, 0.97-1.72) patients. ConclusionsFrailty and OSR were associated with increased adjusted risk of 1-year mortality following rAAA repair. Among normal and frail patients, OSR was associated with an increased adjusted risk of 1-year mortality when compared with EVAR. However, there was no difference between OSR and EVAR among robust patients who can well tolerate the stress of OSR and among very frail patients who are unable to withstand the surgical stress from rAAA regardless of repair type.

Assessment of fitness for open repair in patients with infrarenal abdominal aortic aneurysms

ObjectiveEndovascular aortic repair (EVAR) was originally designed as a treatment modality for patients with abdominal aortic aneurysms (AAAs) deemed unfit for open repair. However, the definition of “unfit for open repair” is largely subjective and heterogenous. The purpose of this study was to compare patients deemed unfit for open repair who underwent EVAR to a matched cohort who underwent open repair for infrarenal AAAs. MethodsThe Vascular Quality Initiative of the Society for Vascular Surgery was queried for patients who underwent EVAR and open infrarenal AAA repair from 2003 to 2022. Patients that underwent EVAR were included if they were deemed unfit for open repair by the operating surgeon. EVAR patients deemed unfit because of a hostile abdomen were excluded. Patients in both the open and EVAR datasets were excluded if their repair was deemed non-elective or if they had prior aortic surgery. EVAR patients were matched to a cohort of open patients. The primary outcome for this study was 1-year mortality. Secondary outcomes included 30-day mortality, major adverse cardiac events, pulmonary complications, non-home discharge, reinterventions, and 5-year survival. ResultsA total of 5310 EVAR patients were identified who were deemed unfit for open repair. Of those, 3028 EVAR patients (57.0%) were able to be matched 1:1 to a cohort of open patients. Open patients had higher rates of major adverse cardiac events (20.2% vs 4.4%; P < .001), pulmonary complications (12.8% vs 1.6%; P < .001), non-home discharges (28.5% vs 7.9%; P < .001), and 30-day mortality (4.5% vs 1.4%; P < .001). There were no differences in early survival, but open repair had better middle and late survival compared with EVAR over the course of 5 years. A total of 74 EVAR patients (2.4%) had reinterventions during the study period. EVAR patients that required interventions had higher 1-year (40.5% vs 7.3%; P < .001) and 5-year mortality (43.2% vs 14.1%; P < .001) compared with those that did not require reinterventions. EVAR patients who had reinterventions had higher 1-year (40.5% vs 6.3%; P < .001) and 5-year (43.2% vs 20.3%; P = .006) mortality compared with their matched open cohort. ConclusionsPatients undergoing EVAR for AAAs who are deemed unfit for open repair have better perioperative morbidity and mortality compared with open repair. However, patients who had an open repair had better middle and late survival over the course of 5 years. The categorization of unfitness for open surgery may be inaccurate and re-evaluation of this terminology/concept should be undertaken.

Comparison of mortality and amputation after lower extremity bypass versus peripheral vascular intervention in patients with chronic limb-threatening ischemia and comorbid chronic kidney disease

ObjectiveComorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. MethodsIndividuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. ResultsOf 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. ConclusionsRegardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.

Center-level outcomes following elective fenestrated endovascular aortic aneurysm repair in the Vascular Quality Initiative database

ObjectiveHospital volume is associated with mortality after open aortic aneurysm repair. Fenestrated and branched endovascular aortic repair (B-FEVAR) has been increasingly used for repair of complex thoracoabdominal and juxtarenal aneurysms, but evidence of a center-volume relationship is limited. We aimed to measure the association of center volume with in-hospital mortality, postoperative outcomes, and 1-year survival following B-FEVAR. MethodsPatients undergoing elective endovascular thoracoabdominal and complex abdominal aneurysm repair with branch intervention (2014-2021) listed within the national Vascular Quality Initiative Thoracic Endovascular Aortic Repair/Complex EVAR database were analyzed. Centers were grouped into quartiles by mean annual procedure volume. Multivariable regression was used to evaluate the effect of center volume on in-hospital mortality adjusting for baseline and procedural characteristics. Kaplan-Meier estimation, log rank test, and mixed effects Cox regression were used to evaluate 1-year survival. ResultsA total of 4302 adult elective F-BEVAR procedures were identified at a total of 163 centers. In-hospital mortality did not differ by hospital volume (quartile [Q]1 = 35/1059 [3.3%]; Q2 = 30/1063 [2.8%]; Q3 = 33/1120 [2.9%]; and Q4 = 44/1060 [4.2%]; P = .308). The high volume group had a higher rate of major complication (Q1 = 14.9%; Q2 = 12.8%; Q3 = 13.3%; and Q4 = 20.1%; adjusted P < .001). Physician-modified grafts were more frequently employed in high-volume centers (Q1 = 4.5%; Q2 = 18.7%; Q3 = 11.3%; and Q4 = 19.2%; P < .001), with a decreased incidence of any endoleak noted at the end of the procedure (Q1 = 34.9%; Q2 = 32.8%; Q3 = 30.0%; and Q4 = 29.0%; P = .003). In the multivariable analysis, in-hospital mortality was not associated with center volume, comparing very low volume to medium- and high-volume centers (odds ratio [95% confidence interval] vs Q4: Q1 = 1.1 [0.6-1.9], Q2 = 0.6 [0.4-1.1], and Q3 = 0.9 [0.5-1.5]; all P > .05). No significant difference was found in 1-year survival between center volume groups. ConclusionsIn-hospital mortality is not associated with procedure volume within centers performing complex endovascular aortic repair. However, complication rates and endoleak may be associated with procedure volume. Long-term outcomes by annualized procedure volume, specifically graft durability and sac expansion, should be investigated.

Anticoagulation in Patients with Premature Peripheral Artery Disease Undergoing Lower Extremity Revascularization

ObjectivesPremature peripheral artery disease (PAD), defined by lower extremity revascularization (LER) at age ≤ 50 years, is associated with poor major adverse limb events. The early onset of disease is thought to be influenced by genetic factors that regulate homeostasis of the vascular wall and coagulation. The aim of this study is to investigate the effect of anticoagulation as an adjunct to antiplatelet therapy on the outcomes of LER in patients with premature PAD. MethodsThere were 8,804 patients with premature PAD on pre- and post-operative antiplatelet therapy only and 1,236 patients on pre- and post-operative anticoagulation plus antiplatelet therapy in the Vascular Quality Initiative (VQI) peripheral vascular intervention, infra-, and suprainguinal files. Propensity score matching (2:1) was performed between patients with premature PAD who were on antiplatelet therapy and those on anticoagulation plus antiplatelet therapy. Perioperative and one-year outcomes were analyzed including reintervention, major amputation, and mortality. ResultsPatients on anticoagulation were more likely to have coronary artery disease (48.7% vs 41.2%, P<.001), congestive heart failure (20.2% vs 13.1%, P<.001), and have undergone prior LER (73.9% vs 49.2%, P<.001) compared to patients on antiplatelet therapy only. They were also less likely to be independently ambulatory (74.2% vs 81.8%, P<.001) and be on a statin medication (66.8% vs 74.3%, P<.001) compared to patients on antiplatelet therapy only. Patients on anticoagulation were also less likely to be treated for claudication (38.1% vs 48.6%, P<.001), and less likely to be treated with an endovascular procedure (64.8% vs 73.8%, P<.001). After matching for baseline characteristics, there were 1,256 patients on antiplatelet therapy only and 628 patients on anticoagulation. Patients on anticoagulation were more likely to require a return to the operating room (3.7% vs 1.6%, P<.001) and had higher perioperatively mortality (1.1% vs 0.3%, P=.032), but major amputation was not significantly different (1.8% vs 1.6%, P=.798) compared to patients on antiplatelet therapy alone. At one-year, amputation-free survival was higher in patients on antiplatelets only compared to patients on anticoagulation and antiplatelet medications (87.5% vs 80.9%, log-rank P=.001). ConclusionAnticoagulation in addition to antiplatelet therapy in patients with premature PAD undergoing lower extremity revascularization is associated with increased reintervention and mortality at one year.