Renin-Angiotensin-Aldosterone System Inhibitors Are Associated With Favorable Outcomes Compared to Beta Blockers in Reducing Mortality Following Abdominal Aneurysm Repair.

Background The best medical therapy to control hypertension following abdominal aortic aneurysm repair is yet to be determined. We therefore examined whether treatment with renin-angiotensin-aldosterone system inhibitors (RAASIs) versus beta blockers influenced postoperative and 1-year clinical end points following abdominal aortic aneurysm repair in a Medicare-linked database. Methods and Results All patients with hypertension undergoing endovascular aneurysm repair and open aneurysm repair in the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database between 2003 and 2018 were included. Patients were divided into 2 groups based on their preoperative and discharge medications, either RAASIs or beta blockers. Our cohort included 8789 patients, of whom 3523 (40.1%) were on RAASIs, and 5266 (59.9%) were on beta blockers. After propensity score matching, there were 3053 matched pairs of patients in each group. After matching, RAASI use was associated with lower risk of postoperative mortality (odds ratio [OR], 0.3 [95% CI, 0.1-0.6]), myocardial infarction (OR, 0.1 [95% CI, 0.03-0.6]), and nonhome discharge (OR, 0.6 [95% CI, 0.5-0.7]). Before propensity score matching, RAASI use was associated with lower 1-year mortality (hazard ratio [HR], 0.4 [95% CI, 0.4-0.5]) and lower risk of aneurysmal rupture (HR, 0.7 [95% CI, 0.5-0.9]). These results persisted after propensity score matching for mortality (HR, 0.4 [95% CI, 0.4-0.5]) and aneurysmal rupture (HR, 0.7 [95% CI, 0.5-0.9]). Conclusions In this large contemporary retrospective cohort study, RAASI use was associated with favorable postoperative outcomes compared with beta blockers. It was also associated with lower mortality and aneurysmal rupture at 1 year of follow-up.

Propensity-Score Matched Analysis of Three Years Survival of Trans Carotid Artery Revascularization Versus Carotid Endarterectomy in the Vascular Quality Initiative Medicare-Linked Database.

OBJECTIVE: Carotid endarterectomy (CEA) remains the gold standard procedure for carotid revascularization. Transfemoral carotid artery stenting (TFCAS) was introduced as a minimally invasive alternative procedure in patients who are at high risk for surgery. However, TFCAS was associated with an increased risk of stroke and death compared to CEA. BACKGROUND: Transcarotid artery revascularization (TCAR) has outperformed TFCAS in several prior studies and has shown similar perioperative and 1-year outcomes compared with CEA. We aimed to compare the 1-year and 3-year outcomes of TCAR versus CEA in the Vascular Quality Initiative (VQI)-Medicare-Linked [Vascular Implant Surveillance and Interventional Outcomes Network (VISION)] database. METHODS: The VISION database was queried for all patients undergoing CEA and TCAR between September 2016 to December 2019. The primary outcome was 1-year and 3-year survival. One-to-one propensity-score matching (PSM) without replacement was used to produce 2 well-matched cohorts. Kaplan-Meier estimates, and Cox regression was used for analyses. Exploratory analyses compared stroke rates using claims-based algorithms for comparison. RESULTS: A total of 43,714 patients underwent CEA and 8089 patients underwent TCAR during the study period. Patients in the TCAR cohort were older and were more likely to have severe comorbidities. PSM produced two well-matched cohorts of 7351 pairs of TCAR and CEA. In the matched cohorts, there were no differences in 1-year death [hazard ratio (HR)=1.13; 95% CI, 0.99-1.30; P =0.065]. At 3-years, TCAR was associated with slight increased risk of death (HR=1.16; 95% CI, 1.04-1.30; P =0.008). When stratifying by initial symptomatic presentation, the increased 3-year death associated with TCAR persisted only in symptomatic patients (HR=1.33; 95% CI, 1.08-1.63; P =0.008). Exploratory analyses of postoperative stroke rates using administrative sources suggested that validated measures of claims-based stroke ascertainment are necessary. CONCLUSIONS: In this large multi-institutional PSM analysis with robust Medicare-linked follow-up for survival analysis, the rate of death at 1 year was similar in TCAR and CEA regardless of symptomatic status. The slight increase in the risk of 3-year death in symptomatic patients undergoing TCAR is likely confounded by more severe comorbidities despite matching. A randomized controlled trial comparing TCAR to CEA is necessary to further determine the role of TCAR in standard-risk patients requiring carotid revascularization.

Risk of Stroke, Death, and Myocardial Infarction Following Transcarotid Artery Revascularization vs Carotid Endarterectomy in Patients With Standard Surgical Risk.

Importance: Carotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known. Objective: To compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk. Design, Setting, and Participants: This retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures. Exposures: Transcarotid artery revascularization vs carotid endarterectomy. Main Outcomes and Measures: The primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke. Results: After 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, -0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, -0.13% [95% CI, -0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67). Conclusions and Relevance: In this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.

Cost-Effectiveness Analysis of Open Versus Endovascular Revascularization for Chronic Mesenteric Ischemia.

BACKGROUND: Recent studies have shown a trend supporting endovascular revascularization (ER) in the treatment of chronic mesenteric ischemia (CMI). However, few studies have compared the cost effectiveness of ER and open revascularization (OR) for this indication. The purpose of this study is to conduct a cost-effectiveness analysis comparing open versus ER for CMI. METHODS: We built a Markov model with Monte Carlo microsimulation using transition probabilities and utilities from existing literature for CMI patients undergoing OR versus ER. Costs were derived from the hospital perspective using the 2020 Medicare Physician Fee Schedule. The model randomized 20,000 patients to either OR or ER and allowed for 1 subsequent reintervention with 3 other intervening health states: alive, alive with complications, and dead. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness. RESULTS: OR cost $4,532 for 1.03 QALYs while ER cost $5,092 for 1.21 QALYs, leading to an ICER of $3,037 per QALY gained in the ER arm. This ICER was less than our willingness to pay threshold of $100,000. Sensitivity analysis demonstrated that our model was most sensitive to costs, mortality, and patency rates after OR and ER. Probabilistic sensitivity analysis demonstrated ER would be considered cost effective 99% of iterations. CONCLUSIONS: This study found that while 5-year costs for ER were greater than OR, ER afforded greater QALYs than OR. Although ER is associated with lower long-term patency and higher rates of reintervention, it appears to be more cost effective than OR for the treatment of CMI.

The impact of completion and follow-up endoleaks on survival, reintervention, and rupture.

OBJECTIVE: Endoleaks may be seen at case completion of endovascular abdominal aortic aneurysm repair (EVAR), and the presence of an endoleak may impact outcomes. However, the clinical implications of various endoleaks seen during follow-up is not well-described. Therefore, we studied the impact of endoleaks at completion and at follow-up on mid-term outcomes. METHODS: We reviewed patients who underwent EVAR from 2003 to 2016 within the Vascular Quality Initiative-Medicare database and identified patients with endoleak at procedure completion and during follow-up, excluding those presenting with rupture. We stratified cohorts by presence of completion and follow-up endoleak subtypes. The primary outcome was 5-year survival, and secondary outcomes included 5-year freedom from reintervention and freedom from rupture. We used Kaplan-Meier estimates and log-rank tests to analyze differences in time-to-event endpoints. RESULTS: Of 21,745 patients with completion endoleak data, 5085 (23%) had an endoleak. Compared with those without endoleak, those with type I endoleaks had lower 5-year survival (69% vs 75%; P < .001), type II endoleaks had higher survival (79%; P < .001), and types III, IV, and indeterminate were not statistically different (73%, 73%, and 75%, respectively). Freedom from reintervention for types I and III endoleaks were significantly lower than no endoleak cohort (I: 76%; P < .001; III: 72%; P < .001 vs 83%), but freedom from rupture was higher for those with type II and III endoleak (95% and 97% vs 94%; P < .001). Of 14,479 patients with detailed follow-up endoleak data, 2290 (16%) had an endoleak. Compared with those without endoleak, types I and III had significantly lower 5-year survival (I: 80%; P = .002; III: 66%; P < .001 vs 84%), but there were no differences for types II (82%) and indeterminate (77%). Those with any type of follow-up endoleak had lower 5-year freedom from reintervention (I: 70%; P < .001; II: 76%; P = .006; III: 36%; P < .001; indeterminate: 60%; P = .007 vs 84%), and lower freedom from rupture (I: 92%; P < .001; II: 91%; P = .16; III: 88%; P = .01; indeterminate: 90%; P = .11 vs 94%). CONCLUSIONS: Compared with patients with no endoleak, those with type I completion endoleaks have lower 5-year survival and freedom from reintervention. Patients with types I and III follow-up endoleaks also have lower survival, and any endoleak at follow-up is associated with lower freedom from reintervention and freedom from rupture. These data highlight the importance of careful patient selection and close postoperative follow-up after EVAR, as the presence of endoleaks, specifically type I and III, over time portends worse outcomes.

Operative and long-term outcomes of combined and staged carotid endarterectomy and coronary bypass.

OBJECTIVE: Optimal temporal surgical management of significant carotid stenosis and coronary artery disease remains unknown. Carotid endarterectomy (CEA) and coronary artery bypass (CABG) are performed concurrently (CCAB) or in a staged (CEA-CABG or CABG-CEA) approach. Using the Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network-Medicare-linked dataset, this study compared operative and long-term outcomes after CCAB and staged approaches. METHODS: The Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network dataset was used to identify CEAs from 2011 to 2018 with combined CABG or CABG within 45 days preceding or after CEA. Patients were stratified based on concurrent or staged approach. Primary outcomes were stroke, myocardial infarction (MI), all-cause mortality, stroke and death as composite (SD) and all as composite within 30 days from the last procedure as well as in the long term. Univariate analysis and risk-adjusted analysis using inverse propensity weighting were performed. Kaplan-Meier curves of stroke, MI, and death were created and compared. RESULTS: There were 1058 patients included: 643 CCAB and 415 staged (309 CEA-CABG and 106 CABG-CEA). Compared with staged patients, those undergoing CCAB had a higher preoperative rate of congestive heart failure (24.8% vs 18.4%; P = .01) and decreased renal function (14.9% vs 8.5%; P < .01), as well as fewer prior neurological events (23.5% vs 31.4%; P < .01). Patients undergoing CCAB had similar weighted rate of 30-day stroke (4.6% vs 4.1%; P = .72), death (7.0% vs 5.0%; P = .32), and composite outcomes (stroke and death, 9.8% vs 8.5%; P = .56; stroke, death, and MI, 14.7% vs 17.4%; P = .31), but a lower weighted rate of MI (5.5% vs 11.5%; P < .01) vs the staged cohort. Long-term adjusted risks of stroke (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.54-1.36; P = .51) and mortality (HR, 1.02; 95% CI, 0.76-1.36; P=.91) were similar between groups, but higher risk of MI long-term was seen in those staged (HR, 1.49; 95% CI, 1.07-2.08; P = .02). CONCLUSIONS: In patients undergoing CCAB or staged open revascularization for carotid stenosis and coronary artery disease, the staged approach had an increased risk of postoperative cardiac event, but the short- and long-term rates of stroke and mortality seem to be comparable. Adverse cardiovascular event risk is high between operations when staged and should be a consideration when selecting an approach. Although factors leading to staged sequencing performance need further clarity, CCAB seems to be safe and should be considered an equally reasonable option.

Association of Renin-Angiotensin-Aldosterone System Inhibitor Usage Patterns with Midterm Amputation-Free Survival after Lower Extremity Bypass for Peripheral Arterial Disease.

BACKGROUND: Different renin-angiotensin-aldosterone system inhibitor (RAASI) usage patterns exist among patients undergoing lower extremity bypass (LEB) for peripheral arterial disease. We studied the association of RAASI usage patterns with LEB outcomes to determine which pattern is associated with improved survival after LEB. METHODS: We evaluated peripheral arterial disease patients who underwent LEB between January 2014 and December 2018 in the Vascular Quality Initiative-Medicare matched database. Study cohorts included no RAASI use, preoperative RAASI use only, postoperative RAASI use only, and continuous RAASI use both preoperatively and postoperatively. Logistic and Cox regression was used to adjust for potential confounders. Primary outcome was 2-year amputation-free survival (AFS). RESULTS: Of 19,012 patients included, 1,574 (8.3%) were on RAASIs preoperatively only, 1,051 (5.5%) postoperatively only, and 8,484 (45.2%) continuously. Compared to no RAASI use, isolated preoperative RAASI use was associated with 2.8-fold increased odds of 30-day mortality (adjusted Odds Ratio, 2.75; 95% confidence interval [CI], 2.15-3.51; P < 0.001) whereas continuous RAASI use had 56% lower odds of 30-day mortality (adjusted Odds Ratio, 0.44; 95% CI, 0.34-0.58; P < 0.001). Two-year AFS was 63.2% for no RAASI use and 60.4%, 66.2%, and 73.4% for preoperative, postoperative, and continuous RAASI use, respectively (P < 0.001). While no RAASI use and postoperative RAASI use had comparable adjusted risks of 2-year major amputation or death (adjusted Hazard Ratio [aHR], 0.94; 95% CI, 0.83-1.06; P = 0.312), this risk was 14% higher for preoperative RAASI use only (aHR, 1.14; 95% CI, 1.04-1.26; P = 0.006) and 23% lower for continuous RAASI use (aHR, 0.77; 95% CI, 0.72-0.82; P < 0.001). CONCLUSIONS: Isolated preoperative RAASI use was associated with worse 30-day mortality and 2-year AFS, while continuous RAASI use was associated with improved 30-day mortality and 2-year AFS. Optimum survival benefit may be derived from continuous RAAS inhibition in the preoperative and postoperative periods.

Open Repair Versus Endovascular Repair in the Treatment of Symptomatic Popliteal Artery Aneurysms.

BACKGROUND: Endovascular and open surgical modalities are currently used to treat popliteal artery aneurysms (PAA). However, there is limited data on the comparative durability of both repairs to guide physicians especially in the treatment of patients presenting symptomatic. We aimed to study the comparative effectiveness of endovascular PAA repair (EPAR) versus open PAA repair (OPAR). METHODS: The vascular quality initiative (VQI)-Medicare linked database was queried for patients with symptomatic PAA who underwent OPAR or EPAR from January 2010 to December 2018. Kaplan-Meier estimates, log-rank tests and multivariable Cox proportional hazard regression were employed to study the outcomes of amputation free survival (AFS), freedom from first reintervention, freedom from major amputation, and overall survival in 2 years following the index procedure. RESULTS: A total of 1,375 patients were studied, of which 23.7% (n = 326) were treated with EPAR. Patients treated with OPAR were younger, less likely to have coronary artery disease (CAD) and chronic kidney disease (CKD), but more likely to be smokers and to present with acute lower extremity ischemia. OPAR treated patients had better 2-year AFS (84.5% vs. 72.5%, P < 0.001) and overall survival (86.2% vs. 74.7%, P < 0.001). Freedom from major amputation at 2 years were comparable between EPAR and OPAR (95.5% vs. 97.7%, P = 0.164) in the overall cohort. Within the sub cohort of patients with acute limb ischemia, freedom from major amputation was significantly higher for OPAR compared to EPAR (97.4% vs. 90.6%, P = 0.021). After adjustment for confounders, OPAR was associated with decreased risk of amputation or death (aHR, 0.62; 95% CI, 0.48-0.80; P < 0.001) and mortality (aHR, 0.63; 95% CI, 0.48-0.81; P < 0.001) at 2 years. OPAR and EPAR had comparable adjusted risk of 2-year major amputation in the overall cohort. However, for patients presenting with acute limb ischemia OPAR was associated with 72% lower risk of 2-year major amputation compared to EPAR (aHR, 0.28; 95% CI, 0.10-0.83; P = 0.021). CONCLUSIONS: In this multi-institutional observational study of symptomatic popliteal aneurysms, OPAR was associated with significantly better amputation free and overall survival compared to EPAR. For patients with acute limb ischemia, OPAR was associated with reduced risk of amputation. These findings suggest that OPAR may be superior to EPAR in the treatment of symptomatic PAA. A consideration of OPAR as first line definitive treatment for symptomatic PAA patients who are good surgical candidates is suggested.

Outcomes of Endovascular-First Versus Bypass-First Approach for Patients With Chronic Limb-Threatening Ischemia Using a Medicare-Linked Database.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) has been increasing in prevalence and remains a significant cause of limb loss and disability and a strong predictor of cardiovascular mortality. Previous studies have demonstrated that endovascular and open repair are similarly effective. These findings led to a significant increase in the adoption of the less-invasive endovascular-first (EVF) approach. However, it remains unknown whether the 2 treatment modalities have similar durability in today's real-world setting. The aim of the present study was to compare the midterm outcomes of the EVF and bypass-first (BF) strategies in patients with CLTI. METHODS: We identified all patients who had undergone limb revascularization from January 2010 to December 2016 in the Vascular Quality Initiative Medicare-linked database. Patients with a history of previous revascularization and those who had undergone hybrid or suprainguinal procedures were excluded from the present study. The remaining patients were divided into 2 groups: EVF and BF. The main end points were 2-year limb salvage, freedom from reintervention, amputation-free survival (AFS), and freedom from all-cause mortality (ACM). RESULTS: The EVF approach was applied to 12,062 patients (70%) and the BF approach to 5,166 patients (30%). The median follow-up was 33 months (interquartile range [IQR]: 14-49). Patients in the EVF group were older and had more comorbidities and tissue loss. At 2 years, the BF group had achieved greater rates of limb salvage (86.4% vs. 82.1%; P < 0.001), freedom from reintervention (72% vs. 68%; P < 0.001), AFS (66.9% vs. 56.3%; P < 0.001), and freedom from ACM (75.7% vs. 66.1%; P < 0.001). After adjusting for potential confounders, an effect of the treatment strategy on limb salvage (adjusted hazard ratio [aHR], 1.03; 95% confidence interval [CI], 0.93-1.16; P = 0.55), reintervention (aHR, 0.95; 95% CI, 0.89-1.019; P = 0.06), AFS (aHR, 0.94; 95% CI, 0.89-1.007; P = 0.08), and ACM (aHR, 0.93; 95% CI, 0.87-1.001; P = 0.055) was not observed. CONCLUSIONS: The present study is the largest real-word analysis showing the noninferiority of the EVF approach in patients with CLTI, with similar limb salvage, durability, AFS, and ACM compared with the BF approach. However, level 1 evidence on the role of the revascularization strategy in these challenging patients is needed.

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

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

Cost-effectiveness of transcarotid artery revascularization versus carotid endarterectomy.

OBJECTIVE: Recent studies have demonstrated that transcarotid artery revascularization (TCAR) has comparable outcomes to the surgical gold standard, carotid endarterectomy (CEA). However, few studies have analyzed the cost of TCAR, and no study has evaluated its cost-effectiveness. The purpose of this study is to conduct a cost-effectiveness analysis comparing TCAR with CEA for carotid artery stenosis. METHODS: We built a Markov microsimulation using transition probabilities and utilities from existing literature for symptomatic patients undergoing TCAR or CEA. Costs were derived from literature then converted to 2019 dollars. The model included six health states with monthly cycle lengths: surgery, death, alive after surgery, alive after myocardial infarction, alive after stroke, and alive after stroke and death. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness. RESULTS: For symptomatic patients, CEA cost $7821 for 2.85 QALYs, whereas TCAR cost $19154 for 2.92 QALYs, leading to an ICER of $152,229 per QALY gained in the TCAR arm. Sensitivity analysis demonstrated that our model was most sensitive to probability of restenosis, costs of TCAR, and costs of CEA. Probabilistic sensitivity analysis demonstrated TCAR would be considered cost-effective in 49% of iterations. CONCLUSIONS: This study found that, although 5-year costs for TCAR were greater than CEA, TCAR afforded greater QALYs than CEA. TCAR became cost-effective at 6 years of follow-up.

Association of Medicaid Expansion with In-Hospital Outcomes After Abdominal Aortic Aneurysm Repair.

OBJECTIVES: Multiple studies have shown improved outcomes and higher utilization of care with the increase of insurance coverage. This study aims to assess whether Medicaid expansion (ME) has changed the utilization and outcomes of abdominal aortic aneurysm (AAA) repair in the United States. DESIGN: Retrospective observational study. MATERIALS: Data of patients undergoing AAA repair in the Vascular Quality Initiative (2010-2017). METHODS: Interrupted time-series (ITS) analysis was utilized to evaluate changes in annual trends of postoperative outcomes after elective AAA repair before and after 2014. We also assessed if these trend changes were significant by comparing the changes in states which adopted ME in 2014 versus nonexpansion states (NME), and conducting a difference-in-difference analysis. Primary outcomes included in-hospital mortality and adverse events (bowel and leg ischemia, cardiac, renal, respiratory, stroke and return to the OR). RESULTS: A total of 19,143 procedures were included (Endovascular: 85.8% and open: 14.2%), of which 40.9% were performed in ME States. Compared to preexpansion trends (P1), there was a 2% annual increase in elective AAA repair in ME states (P1: -1.8% versus P2: +0.2%, P< 0.01) with no significant change in NME (P1: +0.3% versus P2: +0.2%, P = 0.97). Among elective cases, annual trends in the use of EVAR increased by 2% in ME states (95% confidence interval (CI) = -0.1, 4.1, P = 0.06), compared to a 3% decrease in NME States [95%CI = -5.8, -0.6, P = 0.01) (PMEversusNME < 0.01]. There was no association between ME and in-hospital mortality. Nonetheless, it was associated with a decrease in the annual trends of in-hospital complications (ME: -1.4% (-2.1,-0.8) versus NME: +0.2% (-0.2, +0.8), P < 0.01). CONCLUSIONS: While no association between ME and increased survival was noted in states which adopted ME, there was a significant increase of elective AAA cases and EVAR utilization and a decrease in in-hospital complications in ME States.

Hospitalization Cost and In-hospital Outcomes Following Type B Thoracic Aortic Dissection Repair.

BACKGROUND: Several studies have reported lower mortality and morbidity after thoracic endovascular aortic repair (TEVAR) when compared to open surgical repair (OSR) in the treatment of type B aortic dissection (TbAD). However, there are few studies in the literature on the cost of both treatment options. Thus, the aim of this study is to focus on in-hospital outcomes and cost associated with TbAD repair procedures in a national database in the United States. METHODS: A retrospective review of the Premier Healthcare Database (PHD) between June 2009 and March 2015 was performed. ICD-9-CM codes were used to identify patients who underwent OSR or TEVAR for TbAD. Endpoints included in-hospital adverse events, in-hospital mortality and hospitalization cost. Logistic regression models and generalized linear models were used to assess the impact of treatment type on the main outcomes. RESULTS: Out of 1752 patients with TbAD, 54.3% underwent OSR and 45.7% underwent TEVAR. Patients in the TEVAR group were older [median age, 64 (IQR 54-73) vs. 59 (IQR 49-70), P < 1] and more likely to have preexisting comorbidities. IAE rates were 78.6% for the OSR group compared to 43.1% for the TEVAR group, P < 0.001. Patients in the OSR group showed significantly higher in-hospital mortality (15.3% vs. 5.9%, P < 0.001). After adjusting for potential confounders, OSR was associated with a 5-fold increase in IAE [aOR(95%CI): 4.8 (3.8-6.1), P < 0.001] and a 3-fold increase in in-hospital mortality [aOR(95%CI): 3.3 (2.1-5.1), P < 0.001]. In regards to charges related to the hospital stay, total cost was significantly higher among patients undergoing OSR $53,371 ($39,029-$80,471) vs. TEVAR $45,311 ($31,479-$67,960), P < 0.001. CONCLUSION: The present study shows that TEVAR presents an advantage in terms of morbidity, mortality and cost when compared to OSR in the treatment of TbAD. However, long-term cost-effectiveness of both procedures remains unknown. Further research is warranted to see whether the superiority of TEVAR is maintained over time.

Association of state tobacco control policies with active smoking at the time of intervention for intermittent claudication.

OBJECTIVE: Active smoking among patients undergoing interventions for intermittent claudication (IC) is associated with poor outcomes. Notwithstanding, current levels of active smoking in these patients are high. State-level tobacco control policies have been shown to reduce smoking in the general US population. We evaluated whether state cigarette taxes and 100% smoke-free workplace legislation are associated with active smoking among patients undergoing interventions for IC. METHODS: We queried the Vascular Quality Initiative database for peripheral endovascular interventions, infrainguinal bypasses, and suprainguinal bypasses for IC. Active smoking at the time of intervention was defined as smoking within one month of intervention. We implemented difference-in-differences analysis to isolate changes in active smoking owing to cigarette taxes (adjusted for inflation) and implementation of smoke-free workplace legislation. The difference-in-differences models estimated the causal effects of tobacco policies by adjusting for concurrent temporal trends in active smoking unrelated to cigarette taxes or smoke-free workplace legislation. The models controlled for age, sex, race/ethnicity, insurance type, diabetes, chronic obstructive pulmonary disease, state, and year. We tested interactions of taxes with age and insurance. RESULTS: Data were available for 59,847 patients undergoing interventions for IC in 25 states from 2011 to 2019. Across the study period, active smoking at the time of intervention decreased from 48% to 40%. Every $1.00 cigarette tax increase was associated with a 6-percentage point decrease in active smoking (95% confidence interval, -10 to -1 percentage points; P = .02), representing an 11% decrease relative to the baseline proportion of patients actively smoking. The effect of cigarettes taxes was greater in older patients and those on Medicare. Among patients aged 60 to 69 and 70 to 79 years, every $1.00 tax increase resulted in 14% and 21% reductions in active smoking relative to baseline subgroup prevalences of 53% and 29%, respectively (P < .05 for both); however, younger age groups were not affected by tax increases. Among insurance groups, only patients on Medicare exhibited a significant change in active smoking with every $1.00 tax increase (an 18% decrease relative to a 33% baseline prevalence; P = .01). The number of states implementing smoke-free workplace legislation increased from 9 to 14 by 2019; however, this policy was not significantly associated with active smoking prevalence. At follow-up (median, 12.9 months), $1.00 tax increases were still associated with decreased smoking prevalence (a 25% decrease relative to a 33% baseline prevalence; P < .001). CONCLUSIONS: Cigarette tax increases seem to be an effective strategy to decrease active smoking among patients undergoing interventions for IC. Older patients and Medicare recipients are the most responsive to tax increases.

Quantifying the risk-adjusted hospital costs of postoperative complications after lower extremity bypass in patients with claudication.

OBJECTIVE: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication. METHODS: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009-2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications. RESULTS: Overall, 7154 patients had undergone elective LEB for claudication during the study period. The median age was 66 years (interquartile range, 59-73 years), 67.5% were male, and 75.3% were white. Two thirds of patients (61.2%) had Medicare insurance, followed by private insurance (26.9%), Medicaid (7.7%), and other insurance (4.2%). In-hospital complications occurred in 8.5% of patients, including acute kidney injury in 3.0%, MALE in 2.8%, wound complications in 2.3%, and MACE in 1.0%. The overall median crude hospital cost was $11,783 (interquartile range, $8911-$15,767) per patient. The incremental increase in cost associated with a postoperative complication was significant, ranging from $6183 (95% confidence interval, $4604-$7762) for MALE to $10,485 (95% confidence interval, $6529-$14,441) for MACE after risk adjustment. CONCLUSIONS: Postoperative complications after elective LEB for claudication are not uncommon and increase the in-hospital costs by 46% to 78% depending on the complication. Surgical revascularization for claudication should be used sparingly in carefully selected patients.

Black patients have a higher burden of comorbidities but a lower risk of 30-day and 1-year mortality after thoracic endovascular aortic repair.

BACKGROUND: Racial disparities in open thoracic aortic aneurysm repair have been well-documented, with Black patients reported to suffer from poor outcomes compared with their White counterparts. It is unclear whether these disparities extend to the less invasive thoracic endovascular aortic repair (TEVAR). This study aims to examine the clinical characteristics, perioperative outcomes, and 1-year survival of Black vs White patients undergoing TEVAR in a national vascular surgery database. METHODS: The Vascular Quality Initiative database was retrospectively queried to identify all patients who underwent TEVAR between January 2011 and December 2019. The primary outcomes were 30-day mortality and 1-year survival after TEVAR. Secondary outcomes included various types of major postoperative complications. Multivariable logistic regression analyses were performed to identify predictors of 30-day mortality and perioperative complications. Multivariable Cox regression analysis was used to determine the predictors of 1-year survival. RESULTS: A total of 2669 patients with TEVAR were identified in the Vascular Quality Initiative, of whom 648 were Black patients (24.3%). Compared with White patients, Black patients were younger and had a higher burden of comorbidities, including hypertension, diabetes, congestive heart failure, dialysis dependence, and anemia. Black patients were more likely to be symptomatic, present with aortic dissection, and undergo urgent or emergent repair. There was no statistically significant difference in 30-day mortality between Black and White patients (3.4% vs 4.9%; P = .1). After adjustment for demographics, comorbidities, and operative factors, Black patients were independently associated with a 56% decrease in 30-day mortality risk compared with their White counterparts (odds ratio, 0.44; 95% confidence interval [CI], 0.22-0.85; P = .01) and not associated with an increased risk of perioperative complications (odds ratio, 0.90; 95% CI, 0.68-1.17; P = .42). Black patients also had a significantly better 1-year overall survival (log-rank, P = .024) and were associated with a significantly decreased 1-year mortality (hazard ratio, 0.65; 95% CI, 0.47-0.91; P = .01) after adjusting for multiple clinical factors. CONCLUSIONS: Although Black patients carried a higher burden of comorbidities, the racial disparities in perioperative outcomes and 1-year survival do not persist in TEVAR.

Racial and Gender Disparity in Aortoiliac Disease Open Revascularization Procedures.

BACKGROUND: The impact of race and gender on surgical outcomes has been studied in infrainguinal revascularization for peripheral arterial disease. The aim of this study is to explore how race and gender affect the outcomes of suprainguinal bypass (SIB) for aortoiliac occlusive disease. MATERIALS AND METHODS: Patients who underwent SIB were identified from the procedure-targeted National Surgical Quality Improvement Program data set (2011-2016). Patients were stratified into four groups: nonblack males, black males (BM), nonblack females, and black females (BF). Primary outcomes were 30-d major adverse cardiac events, a composite of myocardial infarction, stroke, or death; postoperative bleeding requiring transfusion or intervention; major amputation and prolonged length of stay (>10 d). Predictors of outcomes were determined by multivariable logistic regression analysis. RESULTS: About 5044 patients were identified. BM were younger, more likely to be smokers, less likely to be on antiplatelet drug or statin, and to receive elective SIB (all P ≤ 0.01). BFs were more likely to be diabetic and functionally dependent (all P ≤ 0.02). Major adverse cardiac events were not significantly different among all groups. BM had a threefold higher risk of amputation (adjusted odds ratio [OR] [95% confidence interval (95% CI)], 3.10 [1.50-6.43]; P < 0.002). Female gender was associated with bleeding in both races, that association was more drastic in BF (OR [95% CI], 2.43 [1.63-3.60]; P < 0.0001), whereas nonblack females (OR [95% CI], 1.46 [1.19-1.80]; P < 0.0001). BF had higher odds of prolonged length of stay (OR [95% CI]: 1.62 [1.08-2.42]; P < 0.019). CONCLUSIONS: In this large retrospective study, we demonstrated the racial and gender disparity in SIB outcomes. BM had more than threefold increase in amputation risk as compared with nonblack males. Severe bleeding risk was more than doubled in BF. Race and gender consideration is warranted in risk assessment when patients are selected for aortoiliac disease revascularization, which in turn necessitate preoperative risk modification and optimization in addition to enhancing their access to primary preventive care measures.

Real-world cost analysis of endovascular repair versus open repair in patients with nonruptured abdominal aortic aneurysms.

BACKGROUND: The aim of this study was to provide a nationwide, all-payer, real-world cost analysis of endovascular aortic aneurysm repair (EVAR) versus open aortic aneurysm repair (OAR) in patients with nonruptured abdominal aortic aneurysms (non-rAAA). METHODS: All non-rAAA patients registered between July 2009 and March 2015 in the Premier Healthcare Database were analyzed. The Student t-test and the χ2 test were used for continuous and categorical variables, respectively; median value comparisons were done with the Wilcoxon-Mann-Whitney rank-sum test. The in-hospital absolute mean total cost (sum of fixed cost and variable cost) and subcategories were analyzed after adjustment for inflation at July 2015. Fixed costs included all overhead costs while variables costs included in-hospital services including procedures, room and board, services provided by hospital staff, and pharmacy costs. Total cost was stratified based on admission type (emergency vs nonemergency), 75th percentile of length of hospital stay among individual procedures (expected vs extended stay), mortality, and complications. Student t-test and Fisher's analysis of variance were used for comparing mean cost. Year-wise comparison of mean cost was done with analysis of variance to look for a trend over time. RESULTS: Our study cohort included 38,809 non-rAAA patients (33,171 EVAR and 5638 OAR). The mean total cost of index admission was lower in EVAR in comparison with OAR ($32,052 vs $36,091; P < .001), with lower fixed costs ($11,309 vs $16,818; P < .001) and higher variable costs ($20,743 vs $19,272; P < .001). Cost of pharmacy, labor, operating room, room and board and other costs were significantly higher with OAR, whereas the supply cost was higher with EVAR. The expected hospital length of stay of patients who underwent EVAR was associated with a higher total cost ($27,271 vs $25,680; P < .001) and a higher variable cost ($18,186 vs $13,671; P < .001) than OAR patients. However, the extended hospital stay of patients who underwent EVAR had lower costs in all categories compared with the extended length of stay of those who underwent OAR. Mortality associated with EVAR was costlier than OAR associated mortality (mean $72,483 vs $59,804; P = .017). From 2009 to 2014, the mean total cost of EVAR increased significantly by 18.5% ($28,745 vs $34,049; P < .001) owing to a 7.8% increase in fixed costs ($10,931 vs $11,789; P < .001) and a 25.0% increase in variable costs ($17,804 vs $22,257; P < .001). The mean total cost OAR remained stable over time. CONCLUSIONS: Overall hospitalization costs associated with EVAR of non-rAAA was lower than the hospitalization cost of OAR. Interestingly, we found that, among patients who had an expected hospital length of stay, the hospitalization cost after OAR was significantly lower than after EVAR. The average hospitalization cost of OAR was stable during the 5 years study period, whereas the hospitalization cost of EVAR increased significantly over time. Further studies are required to identify reasons for increased costs associated with EVAR.

Impact of Gender on Outcomes Following Abdominal Aortic Aneurysm Repair.

OBJECTIVE: The purpose of this study is to use a large, nationally representative vascular database to assess differences in patient characteristics, aortic neck anatomy, and outcomes between men and women following open (open aneurysm repair [OAR]) and endovascular (endovascular aneurysm repair [EVAR]) abdominal aortic aneurysm (AAA) repair. METHODS: Patients undergoing AAA repair from 2003 to 2018 in Vascular Quality Initiative were identified and stratified by procedure (EVAR vs OAR). Thirty-day mortality and major in-hospital complications were assessed between genders within each operative cohort. An EVAR subset analysis was performed to assess differences in aortic neck anatomy; hostile neck anatomy was defined as length <15 mm (L < 15), angle >60° (A > 60), and/or diameter >28 mm (D > 28). Standard univariate and multivariable analyses were performed. RESULTS: A total of 50 213 patients were identified: 9263 (19%) OAR and 40 950 (82%) EVAR. In both cohorts, majority of patients were men (OAR 73% and EVAR 81%). Women were more likely to have a hostile neck (31.7% vs 24.1%, P < .001), L < 15 (19.8% vs 11.9%, P < .001), and A > 60 (11.5% vs 5.4%, P < .001). Men had larger aneurysm (mean, 57 vs 55 mm, P < .001) and were more likely to have D > 28 (14.0% vs 10.6%, P < .001). Women undergoing EVAR were more likely to undergo aortic extensions (21.9% vs 16.0%) and receive higher contrast volume. After adjusting for potential confounders, female gender was associated with 86% and 50% increased risk of 30-day mortality in OAR and EVAR, respectively. Women were more likely than men to experience renal, cardiac, and pulmonary complications only in the EVAR cohort. Women had a 2-fold increased odds of developing type 1 endoleak. CONCLUSION: Our study demonstrates unfavorable neck anatomy occurs more frequently in women compared to men. Women were also at an increased risk of developing major complications, particularly following EVAR. Careful patient selection is indicated in all patients to reduce complications, with special attention in women with hostile neck.

Impact of Medicaid Expansion of the Affordable Care on the Outcomes of Lower Extremity Bypass for Patients With Peripheral Artery Disease in the Vascular Quality Initiative Database.

OBJECTIVE: The aim of this study was to evaluate changes in the utilization and outcomes of surgery after Medicaid Expansion (ME) for patients with peripheral artery disease (PAD). SUMMARY BACKGROUND DATA: Recent studies have demonstrated increased insurance coverage and improved care with the Affordable Care Act's (ACA) state expansion of Medicaid. METHODS: Infrainguinal bypass procedures performed due to occlusive pathology in the Vascular Quality Initiative database between 2010 and 2017 were included. Primary outcomes including postoperative mortality and major adverse limb events (MALE) at 1-year of follow-up were analyzed using interrupted time-series analysis (ITS). RESULTS: Out of 26,446 infrainguinal bypass procedures, 13,955 (52.8%) were included in this analysis. ME states witnessed an annual decrease in infrainguinal surgery for acute ischemia [annual change in post vs pre-ME period (95% confidence interval): -4.3% (-7.5% to -1.0%), P = 0.02] and an increase in revascularization for claudication [3.7% (1.7%-5.6%), P = 0.01]. Among nonacute cases, elective procedures increased in ME states [3.9% (0.1%-7.7%), P = 0.05] along with a significant annual decrease in in-hospital mortality [-0.4% (-0.8 to -0.02), P = 0.04) and MALE at 1 year of follow up [-9.0% (-20.3 to 2.3), P = 0.09]. These results were statistically significant after comparing them with the annual trend changes in states which did not adopt ME. CONCLUSIONS: The adoption of ME in 2014 was associated with significant increase in the use of infrainguinal bypass for nonsevere and elective cases, along with improved in-hospital mortality and MALE at 1 year. Longer follow-up is needed to evaluate the impact of ME on other aspects of care and longer term outcomes of PAD patients.