The Effect of Social Determinants of Health in Treating Chronic Limb- Threatening Ischemia.

Social determinants of health (SDOHs) are broadly defined as nonmedical factors that impact the outcomes of one's health. SDOHs have been increasingly recognized in the literature as profound and modifiable factors on the outcomes of vascular care in peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI) despite surgical and technological advancements. In this paper, we briefly review the SDOH and its impact on the management and outcome of patients with CLTI. We highlight the importance of understanding how SDOH impacts our patient population so the vascular community may provide more effective, inclusive, and equitable care.

Racial Disparities in Treatment Indications and Outcomes for Limb Ischemia.

BACKGROUND: Studies suggest that the Affordable Care Act (ACA) of 2014 has improved access to vascular care and vascular outcomes among patients suffering from peripheral arterial disease (PAD). We sought to examine the racial disparities that exist in patients with PAD who have undergone lower extremity bypass (LEB) or a peripheral vascular intervention (PVI) using the Vascular Quality initiative (VQI) database. METHODS: The VQI infrainguinal and PVI datasets were queried for patients receiving elective and urgent LEB or PVI between 2016, 2 years after ACA implementation, and in 2021. Patients undergoing interventions urgently/emergently or for aneurysm were excluded. The primary outcome was major adverse limb event (MALE-defined as any vascular reintervention or above-ankle amputation) free survival at 1 year. Standard statistical methods were utilized as appropriate. RESULTS: A total of 17,455 LEB and 87,475 PVIs were included in this analysis. Black persons present at a younger age when compared to non-Hispanic White persons (NHW) and are more likely to have diabetes, hypertension, end-stage renal disease (ESRD), and higher rates of prior amputation. Black persons are more likely to present with chronic limb-threatening ischemia (CLTI) rather than claudication, and in a more urgent setting. Postoperative outcomes show higher rates of major amputations among racial minorities, specifically Black persons for both LEB (1.8% vs. 0.8% P < 0.001) and PVI (20.8% vs. 16.8% P < 0.001). Black persons are at higher risk of 1-year MALE for LEB (36.7% vs. 29.9% P < 0.001) and PVI (31.0% vs. 21.7%; P < 0.001). Even after adjusting for confounding variables, Black persons have a higher risk of 1-year MALE for LEB, with an adjusted hazard ratio (aHR) of 1.15 (95% CI [1.05-1.26], P = 0.003) and PVI (aHR 1.18 95% CI [1.12-1.24], P < 0.001). Other major determinates of 1-year MALE on multivariate Cox regression included CLTI (LEB aHR 1.57 95% CI [1.43-1.72], P < 0.001; PVI aHR 2.29 95% CI [2.20-2.39], P < 0.001) and history of prior amputation (LEB aHR 1.35 95% CI [1.17-1.56], P < 0.001; PVI aHR 1.5 95% CI [1.4-1.6], P < 0.001). CONCLUSIONS: Compared to NHW persons, Black persons present with more advanced vascular disease regardless of the operative indication. Black persons are also at significantly higher risk of 1-year MALE. Despite some advances in more accessible care through the ACA of 2014, our observations suggest that Black persons still have significantly worse outcomes due to variety of variables that need further investigation.

Increased Medicaid eligibility of Affordable Care Act: Evidence of improved outcomes for patients with peripheral artery disease.

Peripheral artery disease (PAD) is a debilitating disease that disproportionately affects people of low socioeconomic status and racial minority individuals. These groups also tend to have lower rates of revascularization and worse outcomes, including higher rates of major amputation. In 2010, the Affordable Care Act (ACA) was signed into law, providing better opportunities for health care access to millions of uninsured Americans, although the implementation of different components started at a later date. Political issues led to uneven adaptation by states of the different ACA components. In states that adopted Medicaid expansion under the ACA, similar to that under the Massachusetts Health Care Reform Law of 2006, patients of low socioeconomic status and racial minority patients gained better access to health care. This review article will examine the disparities that exist in peripheral artery disease outcomes, as well as the effects of the ACA and Medicaid expansion on revascularization, limb salvage, and major amputation rates.

Variations in Practice Patterns for Peripheral Vascular Interventions Across Clinical Settings.

BACKGROUND: Peripheral vascular interventions (PVIs) for lower extremity peripheral artery disease have been increasing, particularly in the office-based setting. Our goal was to evaluate practice patterns for PVI by site of service using a contemporary real-world dataset. METHODS: The Vascular Quality Initiative PVI registry was queried from 2010-2021. Site of service was classified as hospital/inpatient, hospital/outpatient, and ambulatory/office-based center. Patient demographics, comorbidities, procedural details, and periprocedural outcomes were analyzed. RESULTS: There were 54,897 hospital/inpatient (43.2%), 64,105 hospital/outpatient (50.4%), and 8,179 ambulatory/office-based center (6.4%) PVI. When comparing the 2 outpatient settings, ambulatory/office-based center patients were older than hospital/outpatient (mean age 70.7 vs. 68.7 years), more often female sex (41.4% vs. 39.1%), never smokers (27.5% vs. 18.5%), primary Medicare (61.6% vs. 55.9%), nonambulatory (6.5% vs. 4.7%), less often with coronary artery disease (30.2% vs. 34.1%), chronic obstructive pulmonary disease (18.1% vs. 26.9%), congestive heart failure (13% vs. 17.2%), obesity (30.9% vs. 33.6%), and less often on a statin (71.4% vs. 76.1%) (P < 0.001). Ambulatory/office-based center procedures were more likely for claudication (60.1% vs. 55.8%), more often involved femoro-popliteal (73.1% vs. 64.6%) and infrapopliteal (36.7% vs. 24.3%), and less often iliac interventions (24.1% vs. 33.6%) (P < 0.001).Overall, atherectomy was used in 14.2% of hospital/inpatient, 19.4% of hospital/outpatient, and 63.4% of ambulatory/office-based center procedures. Stents were used in 41.8% of hospital/inpatient, 45.1% of hospital/outpatient, and 48.8% of ambulatory/office-based center procedures. However, stent grafts were used in 12.5% of hospital/inpatient, 8.8% of hospital/outpatient, and only 1.3% of ambulatory/office-based center procedures. On multivariable analysis, compared with hospital/inpatient, atherectomy use was associated with ambulatory/office-based center setting (Odds ratio 10.9, 95% confidence interval 10.3-11.5, P < 0.001) and hospital/outpatient setting (Odds ratio 1.57, 95% confidence interval 1.51-1.62, P < 0.001). Periprocedure complications including hematoma requiring intervention (0.3%), any stenosis/occlusion (0.2%), and distal embolization (0.6%) were quite low across all settings. CONCLUSIONS: There are substantial variations in patient populations, procedural indications, and types of interventions undertaken during PVI across different locations. Ambulatory/office-based procedures more commonly treat claudicants, use atherectomy, and less often use stent grafts. Further research is warranted to investigate long-term trends in practice patterns and long-term outcomes, for PVI in the ever-expanding ambulatory/office-based setting.

Carotid endarterectomy remains cost-effective for the surgical management of carotid stenosis.

OBJECTIVE: Transcarotid arterial revascularization (TCAR) has gained popularity as an alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS), potentially combining the benefits of a minimally invasive approach with a lower risk of procedural stroke compared with TFCAS. Emerging evidence shows TCAR to have excellent perioperative outcomes. However, the cost-effectiveness of TCAR is not well-understood. METHODS: Incorporating data from Carotid Revascularization Endarterectomy vs Stenting Trial (CREST), the Vascular Quality Initiative Surveillance Project, and local cost data, we compared the cost-effectiveness of these three treatment modalities (TFCAS, CEA, and TCAR) for both symptomatic and asymptomatic carotid stenosis using a Markov state-transition model to quantify lifetime costs in United States dollars and effectiveness in quality-adjusted life-years (QALYs). We accounted for perioperative stroke and myocardial infarction, as well as long-term risks of stroke and restenosis. Based on CREST, we assumed a start age of 69 years and a cost-effectiveness acceptability threshold of $100,000/QALYs gained. Sensitivity analyses were performed. RESULTS: In the base-case scenario, TCAR cost $160,642/QALY gained compared with CEA, greater than the frequently cited $100,000/QALY gained threshold. TFCAS was more expensive and less effective than other strategies, largely due to a greater periprocedural stroke risk. In one-way sensitivity analysis, if TCAR stroke risk was <0.9% (base-case risk, 1.4%), than it was economically favorable compared with CEA at its current procedural cost. Alternatively, if TCAR procedural costs were reduced by approximately $2000 (base-case cost, $15,182), it would also become economically favorable. In a probabilistic sensitivity analysis, varying all parameters simultaneously over distributions, CEA was favored in 80% of model iterations at $100,000/QALY, with TCAR favored in 19%. CONCLUSIONS: At current cost and outcomes, TCAR does not meet a traditional cost-effectiveness threshold to replace CEA as the primary treatment modality for carotid stenosis. TFCAS is the least cost-effective strategy for carotid revascularization. Given these observations, TCAR should be limited to select patients, specifically those at high physiologic and anatomic risk from CEA. However, TCAR can become cost-effective if its cost is reduced. Given the current outcomes and cost, CEA remains the most cost-effective treatment for carotid revascularization.

Contemporary management of acute and chronic mesenteric ischemia: 10-year experience from a multihospital healthcare system.

OBJECTIVE: Endovascular and hybrid methods have been increasingly used to treat mesenteric ischemia. However, the long-term outcomes and risk of symptom recurrence remain unknown. The objective of the present study was to define the predictors of postoperative morbidity, mortality, and patency loss for acute mesenteric ischemia (AMI) and chronic mesenteric ischemia (CMI). METHODS: The inpatient and follow-up records for all patients who had undergone revascularization for AMI and CMI from 2010 to 2020 at a multicenter hospital system were reviewed. Patency and mortality were evaluated with Cox regression, visualized with Kaplan-Meier curves, and compared using log-rank testing. Patency was further evaluated using Fine-Gray regression with death as a competing risk. The postoperative major adverse events (MAE) and 30-day mortality were evaluated with logistic regression. RESULTS: A total of 407 patients were included, 148 with AMI and 259 with CMI. For the AMI group, the 30-day mortality was 31%. Open surgery was associated with lower rates of bowel resection (odds ratio [OR], 0.23; 95% confidence interval [CI], 0.13-0.61). The etiology of AMI also did not change the outcomes (OR, 1.30; 95% CI, 0.77-2.19). Adjusted analyses indicated that a history of diabetes (OR, 2.77; 95% CI, 1.37-5.61) and sepsis on presentation (OR, 2.32; 95% CI, 1.18-4.58) were independently associated with an increased risk of 30-day MAE. In the CMI group, open surgery and chronic kidney disease were associated with a higher incidence of MAE (OR, 3.03; 95% CI, 1.14-8.05; OR, 2.37; 95% CI, 1.31-4.31). In contrast, chronic kidney disease (OR, 3.02; 95% CI, 1.10-8.37) and inpatient status before revascularization (OR, 2.78; 95% CI, 1.01-7.61) were associated with increased 30-day mortality. For the CMI group, the endovascular cohort had experienced greater rates of symptom recurrence (29% vs 13%) with a faster onset (endovascular, 64 days; vs bypass, 338 days). CONCLUSIONS: AMI remains a morbid disease despite the evolving revascularization techniques. An open approach should remain the reference standard because it reduces the likelihood of bowel resection. For CMI, endovascular interventions have improved the postoperative morbidity but have also resulted in early symptom recurrence and reintervention. An endovascular-first approach should be the standard of care for CMI with close surveillance.

The U.S. Preventive Services Task Force Abdominal Aortic Aneurysm Screening Guidelines Negligibly Impacted Repair Rates in Male Never-Smokers and Female Smokers.

OBJECTIVE: In 2014, in addition to male smokers aged 65-75 years, the U.S. Preventive Services Task Force (USPSTF) recommended abdominal aortic aneurysm (AAA) screening for male never-smokers aged 65-75 years with cardiovascular risk factors (Grade C). The USPSTF evolved from a negative to neutral position on screening for female smokers aged 65-75 years (Grade I). We sought to determine whether 2014 guidelines resulted in more AAA repairs in these populations. METHODS: We queried the Vascular Quality Initiative national database (2013-2018) for elective endovascular aortic repairs and open aortic repairs. We implemented difference-in-differences (DID) analysis, a causal inference technique that adjusts for secular time trends, to isolate changes in repair numbers due to the 2014 USPSTF guidelines. Our DID models compared changes in repair numbers in patient groups targeted by the USPSTF updates (intervention group) to those in unaffected, older patient groups (control), before and after 2014. The first model compared changes in repair numbers between male never-smokers aged 65-75 years (intervention group) and 76-85 years (control). The second model compared repair numbers between female smokers aged 65-75 years (intervention group) and 76-85 years (control). RESULTS: There was no significant change in male never-smokers (n = 1,295) aged 65-75 (42%) vs. 76-85 (58%) undergoing AAA repairs after guideline updates, averaged over 4.5 years (+2.4 percentage points; 95% Confidence Interval [CI] -.56-5.26). However, when their primary insurer was Medicare, male never-smokers aged 65-75 years compared with 76-85 years underwent significantly more repairs over 4.5 years (+3.69 percentage points; 95% CI.16-7.22; representing a 10.4% relative increase from baseline in the proportion of male never-smokers on Medicare undergoing AAA repair). Comparing female smokers (n = 2,312) aged 65-75 (54%) vs. 76-85 (46%), there was no significant change in repairs over 4.5 years (-.66 percentage points; 95% CI -4.57-3.26). CONCLUSIONS: The USPSTF 2014 AAA guidelines were associated with modestly increased repairs in male never-smokers aged 65-75 years only on Medicare. There was no impact among female smokers. Higher-grade recommendations and improved guideline adherence may be requisites for change.

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.

Association of Medicaid Expansion with Tunneled Dialysis Catheter Use at the Time of First Arteriovenous Access Creation.

BACKGROUND: In the United States, many low-income patients initiating hemodialysis are uninsured before qualifying for Medicare. Inadequate access to predialysis care may delay their arteriovenous (AV) access creation and increase tunneled dialysis catheter (TDC) use. The 2014 Affordable Care Act expanded eligibility for Medicaid among low-income adults, but not every state adopted this measure. We evaluated whether Medicaid expansion was associated with decreased TDC use for hemodialysis initiation. METHODS: We queried the United States Vascular Quality Initiative state-level database for non-Medicare patients undergoing initial AV access creation from 2011 to 2018. We evaluated associations of receiving initial AV access in states that expanded Medicaid with concurrent TDC use, survival, and insurance coverage. RESULTS: Data were available for patients in 31 states: 19 states expanded Medicaid from January 2014 to February 2015. Among 8462 patients in the postexpansion period from March 2015 to December 2018, 58% were in Medicaid expansion states. Patients in Medicaid expansion states less often had concurrent TDCs (40% vs. 48%, P < 0.001). In multivariable analysis, Medicaid expansion was independently associated with fewer TDCs (OR 0.7, 95% CI 0.6-0.8, P < 0.001). Three-year survival was similar between patients in Medicaid expansion and nonexpansion states (84.7% vs. 85.2%, P = 0.053). Multivariable cox-regression confirmed the finding (HR 0.95, 95% CI 0.82-1.1, P = 0.482). In difference-in-differences analysis, Medicaid expansion was associated with a 9.2-percentage point increase in Medicaid coverage (95% CI 2.7-15.8, P = 0.009). Hispanic patients exhibited a 30.1-percentage point increase in any insurance coverage (95% CI 0.3-59.9, P = 0.048). CONCLUSIONS: Patients in Medicaid expansion states were less likely to have TDCs during initial AV access creation, suggesting earlier predialysis care. Hispanic patients benefited from increased insurance coverage. Expanding insurance options for the underserved may improve quality metrics and cost-savings for hemodialysis patients.

Single- versus multiple-stage catheter-directed thrombolysis for acute iliofemoral deep venous thrombosis does not have an impact on iliac vein stent length or patency rates.

BACKGROUND: Incomplete venous thrombolysis and residual nonstented iliac vein disease are known predictors of recurrent deep venous thrombosis (DVT). Controversy exists as to whether the number of thrombolysis sessions affects total stent treatment length or stent patency. The goal of this study was to evaluate the outcomes of patients who underwent single vs multiple catheter-directed lysis sessions with regard to stent extent and patency. METHODS: Consecutive patients who underwent thrombolysis and stenting for acute iliofemoral DVT between 2007 and 2018 were identified and divided into two groups on the basis of the number of treatments performed (one vs multiple sessions). Operative notes and venograms were reviewed to determine the number of lytic sessions performed and stent information, including size, location, total number, and length treated. End points included total stent length, 30-day and long-term patency, and post-thrombotic syndrome (Villalta score ≥5). The χ2 comparisons, logistic regression, and survival analysis were used to determine outcomes. RESULTS: There were 79 patients who underwent lysis and stenting (6 bilateral interventions; mean age, 45.9 ± 17 years; 48 female). Ten patients (12 limbs) underwent single-stage treatment with pharmacomechanical thrombolysis, and the remaining 69 (73 limbs) had two to four operating room sessions combining pharmacomechanical and catheter-directed thrombolysis. Patients who underwent a single-stage procedure were older and more likely to have a malignant disease. These patients received less tissue plasminogen activator compared with the multiple-stage group (17.2 ± 2.2 mg vs 27.6 ± 11.6 mg; P = .008). Average stent length was 8.8 ± 5.2 cm for the single-stage group vs 9.2 ± 4.6 cm for the multiple-stage group (P = .764). Patients who underwent a single-stage procedure had no difference in average length of stay from that of patients who underwent multiple sessions (8.5 days vs 5.9 days; P = .269). The overall 30-day rethrombosis rate was 7.3%. Two-year patency was 72.2% and 74.7% for the single and multiple stages, respectively (P = .909). The major predictors for loss of primary patency were previous DVT (hazard ratio [HR], 5.99; P = .020) and incomplete lysis (HR, 5.39; P = .014) but not number of procedures (HR, 0.957; P = .966). The overall post-thrombotic syndrome rate was 28.4% at 5 years and was also not associated with the number of treatment sessions. CONCLUSIONS: Single- vs multiple-stage thrombolysis for DVT is not associated with a difference in extent of stent coverage. Patency rates remain high for iliac stenting irrespective of the number of lytic sessions, provided lysis is complete and the diseased segments are appropriately stented.

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.

Implementation of drug-eluting stents for the treatment of femoropopliteal disease provides significant cost-to-system savings in a single-state outpatient simulation.

OBJECTIVES: Initial data on drug-eluting stents (DES) shows that they may increase the durability of endovascular treatment of superficial femoral artery disease compared with traditional bare-metal stents (BMS). Observed decreased target lesion revascularization (TLR) rates have potential for cost savings despite an increased initial cost. The purpose of this study was to run a simulation model of progressive transition from BMS to DES over 5 years evaluating the overall cost impact of that transition. METHODS: Florida State Ambulatory Databases were searched for all patients undergoing superficial femoral artery stenting in 2013 using Current Procedural Terminology codes 37226 and 37227. A simulation model was developed to estimate the impact of a progressive transition from BMS to DES over a 5-year horizon in this patient population. Cost estimates were determined from available cost charge ratio data. For the 5-year model, 2013 served as the initial year with each subsequent year based on the expected number of interventions per year. Up to one TLR per patient was assumed for the model. The 5-year TLR rates for DES and other parameter estimates were based on pooled data from the literature. Institutional data were used to estimate that up to 48% of superficial femoral artery lesions would fit the instructions for use for the Zilver PTX (Cook Medical, Bloomington, Ind), which is currently the only DES approved by the U.S. Food and Drug Administration for peripheral interventions. The net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared with a scenario of BMS only. Multiple sensitivity analyses were performed on the base scenario. RESULTS: We identified 4107 peripheral interventions in the first year that fit our study. The overall cost for these procedures in Florida database was $51,362,142.00. In the base case scenario, DES was introduced slowly into the population at a rate of 8% per year up to 48% at the end of the model. This strategy resulted in an overall cost savings of $1,688,953.72 compared with the model with BMS alone. Sensitivity analyses including slower adoption of DES up to only 24% at 5 years, a 20% increase in TLR rates per year for the DES, and a 10% reduction in TLR rates per year for BMS still resulted in a net savings. As long as the additional cost of a DES compared with BMS is less than $677, the DES model remains less expensive. CONCLUSIONS: The adoption of DES in lieu of traditional BMS can lead to significant cost savings in a single state model over a short time horizon.

Improved access to health care in Massachusetts after 2006 Massachusetts Healthcare Reform Law is associated with a significant decrease in mortality among vascular surgery patients.

BACKGROUND: Access to medical care, by adequate insurance coverage, has a direct impact on outcomes for patients undergoing vascular procedures. We evaluated in-hospital mortality for patients undergoing index vascular procedures before and after the Massachusetts Healthcare Reform Law (MHRL) in 2006, which mandated insurance for all Massachusetts residents, both in Massachusetts and throughout the United States. METHODS: The National Inpatient Sample was queried to identify patients undergoing interventions for peripheral arterial disease, carotid artery stenosis, and abdominal aortic aneurysms based on International Classification of Diseases, Ninth Revision, Clinical Modification procedural and diagnostic codes. The cohort was then divided into patients treated within Massachusetts (MA) and non-Massachusetts (NMA) hospitals. Two time intervals were examined: before (2003-2006, P1) and after the MHRL (2007-2011, P2). The primary outcome of interest included in-hospital mortality. Patients in MA and NMA hospitals were described in terms of demographics and presentation by time interval (P2 vs P1) compared using χ2 and t-tests. Weighted logistic regression with term modeling change in the odds ratio (OR) for P2 was performed to test and to estimate trends in mortality. Time (year of procedure) and region interactions were investigated by inclusion of time-region interactions in our analyses. Subgroup analysis was performed for P2 vs P1 among nonwhite, nonelderly, and low-income patients. RESULTS: We identified 306,438 patients who underwent repair of abdominal aortic aneurysm, lower extremity bypass, or carotid endarterectomy in MA and NMA hospitals. MA hospital patients had an increase in both Medicaid and private insurance status after the MHRL (P1 = 2.6% and 21% vs P2 = 3.3% and 21.7%, respectively; P = .034). In-hospital mortality trended down for all groups across the entire study. In comparing P2 vs P1 trends, MA hospital odds of mortality per year was lowered by 26% (OR, 0.74; 95% confidence interval [CI], 0.56-0.99; P = .042) not seen in NMA hospitals (OR, 1.03; 95% CI, 0.97-1.09; P = .405). Time and region interaction terms indicated significant time trend difference in both unadjusted (P = .031) and adjusted (P = .033) analysis in MA hospitals not observed in NMA hospitals. This pattern continued when the samples were stratified by procedure. Patients undergoing vascular procedures in MA hospitals had a significantly lowered OR of mortality, with fewer patients presenting at late disease stages in P2 vs P1. Nonelderly patients in Massachusetts, who benefit from the Medicaid expansion provided by the MHRL, had a profound 92% drop in odds of mortality in P2 vs P1 (OR, 0.08; 95% CI, 0.010-0.641; P = .017) compared with the 14% drop in NMA (OR, 0.86; 95% CI, 0.709-1.032; P = .103). CONCLUSIONS: The 2006 MHRL is associated with a decrease in mortality for patients undergoing index vascular surgery procedures in MA compared with NMA hospitals. This study suggests that governmental policy may play a key role in positively affecting the outcomes for patients.

Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery.

OBJECTIVE: Drug-coated balloons (DCBs) may increase durability of endovascular treatment of superficial femoral artery (SFA) disease while avoiding stent-related risks. The purpose of this study was to use meta-analytic data of DCB studies to compare the cost-effectiveness of potential SFA treatments: DCB, drug-eluting stent (DES), plain old balloon angioplasty (POBA), or bare-metal stent (BMS). METHODS: A search for randomized controlled trials comparing DCB with POBA for treatment of SFA disease was performed. Hazard ratios were extracted to account for the time-to-event primary outcome of target lesion revascularization. Odds ratios were calculated for the secondary outcomes of primary patency (PP) and major amputation. Incorporating pooled data from the meta-analysis, cost-effectiveness analysis, assuming a payer perspective, used a decision model to simulate patency at 1 year and 2 years for each index treatment modality: POBA, BMS, DCB, or DES. Costs were based on current Medicare outpatient reimbursement rates. RESULTS: Eight studies (1352 patients) met inclusion criteria for meta-analysis. DCB outperformed POBA with respect to target lesion revascularization over time (pooled hazard ratio, 0.41; P < .001). Risk of major amputation at 12 months was not significantly different between groups. There was significantly improved 1-year PP in the DCB group compared with POBA (pooled odds ratio, 3.30; P < .001). In the decision model, the highest PP at 1 year was seen in the DES index therapy strategy (79%), followed by DCB (74%), BMS (71%), and POBA (64%). With a baseline cost of $9259.39 per patent limb at 1 year in the POBA-first group, the incremental cost per patent limb for each other strategy compared with POBA was calculated: $14,136.10/additional patent limb for DCB, $38,549.80/limb for DES, and $59,748,85/limb for BMS. The primary BMS option is dominated by being more expensive and less effective than DCB. Compared directly with DCB, DES costs $87,377.20 per additional patent limb at 1 year. Based on the projected PP at 1 year in the decision model, the number needed to treat for DES compared with DCB is 20. At current reimbursement, the use of more than two DCBs per procedure would no longer be cost-effective compared with DES. At 2 years, DCB emerges as the most cost-effective index strategy with the lowest overall cost and highest patency rates over that time horizon. CONCLUSIONS: Current data and reimbursements support the use of DCB as a cost-effective strategy for endovascular intervention in the SFA; any additional effectiveness of DES comes at a high price. Use of more than one DCB per intervention significantly decreases cost-effectiveness.

Medicare Facility Diagnosis-Related Groups Have Outpaced Individual Physician Payment.

BACKGROUND: We set out to compare the rates of Medicare reimbursement to physicians versus hospitals for several major vascular procedures over a period of 5 years. METHODS: We queried the Wolters Kluwer MediRegs database to collect Medicare reimbursement data from fiscal years 2011 to 2015. We surveyed reimbursements for carotid endarterectomy, carotid angioplasty and stenting, femoropopliteal bypass, and lower extremity fem-pop revascularization with stenting. Based on data availability, we surveyed physician reimbursement data on the national level and in both medically overserved and underserved areas. Hospital reimbursement rates were examined on a national level and by hospitals' teaching and wage index statuses. RESULTS: We found that for all 4 vascular procedures, Medicare reimbursements to hospitals increased by a greater percentage than to physicians. By region, underserved areas had lower physician reimbursements than the national average, while the opposite was true for overserved areas. Additionally, for hospital Medicare reimbursements, location in a high wage index accounted for a significant increase in reimbursement over the national average, with teaching status contributing to this increase in a smaller extent. CONCLUSIONS: These data on Medicare reimbursements indicate that payments to hospitals are increasing more significantly than to physicians. This disparity in pay changes affects both independent and academic vascular surgeons. Medicare should consider pay increases to independent providers in accordance to the hospital pay increase.

Assessment of open operative vascular surgical experience among general surgery residents.

BACKGROUND: General surgeons have traditionally performed open vascular operations. However, endovascular interventions, vascular residencies, and work-hour limitations may have had an impact on open vascular surgery training among general surgery residents. We evaluated the temporal trend of open vascular operations performed by general surgery residents to assess any changes that have occurred. METHODS: The Accreditation Council for Graduate Medical Education's database was used to evaluate graduating general surgery residents' cases from 1999 to 2013. Mean and median case volumes were analyzed for carotid endarterectomy, open aortoiliac aneurysm repair, and lower extremity bypass. Significance of temporal trends were identified using the R(2) test. RESULTS: The average number of carotid endarterectomies performed by general surgery residents decreased from 23.1 ± 14 (11.6 ± 9 chief, 11.4 + 10 junior) cases per resident in 1999 to 10.7 ± 9 (3.4 ± 5 chief, 7.3 ± 6 junior) in 2012 (R(2) = 0.98). Similarly, elective open aortoiliac aneurysm repairs decreased from 7.4 ± 5 (4 ± 4 chief, 3.4 ± 4 junior) in 1999 to 1.3 ± 2 (0.4 ± 1 chief, 0.8 ± 1 junior) in 2012 (R(2) = 0.98). The number of lower extremity bypasses decreased from 21 ± 12 (9.5 ± 7 chief, 11.8 ± 9 junior) in 1999 to 7.6 ± 2.6 (2.4 ± 1.3 chief, 5.2 + 1.8 junior) in 2012 (R(2) = 0.94). Infrapopliteal bypasses decreased from 8.1 ± 3.8 (3.5 ± 2.2 chief, 4.5 ± 2.9 junior) in 2001 to 3 ± 2.2 (1 ± 1.6 chief, 2 ± 1.6 junior) in 2012 (R(2) = 0.94). CONCLUSIONS: General surgery resident exposure to open vascular surgery has significantly decreased. Current and future graduates may not have adequate exposure to open vascular operations to be safely credentialed to perform these procedures in future practice without advanced vascular surgical training.

Occurrence of "never events" after major open vascular surgery procedures.

OBJECTIVE: "Never events" refers to harmful hospital-acquired conditions that the Centers for Medicare and Medicaid Services identified in 2008 as largely preventable and that would no longer be reimbursed. Our goal was to identify the incidence, predictive factors, temporal trend, and associated consequences of never events after major open vascular surgery procedures. METHODS: The Nationwide Inpatient Sample (NIS) (2003-2011) was queried to identify never events applicable to vascular surgery patients, including air embolism, catheter-based urinary tract infections (UTIs), stage 3 and 4 pressure ulcers, falls/trauma, blood incompatibility, vascular catheter infections, complications of poor glucose control, retained foreign objects, and wrong-site surgery. We specifically evaluated open abdominal aortic aneurysm repair, carotid endarterectomy, and lower extremity bypass/femoral endarterectomy. Multivariable logistic regression was used to predict never events based on preoperative variables. Multivariable logistic and gamma regression models were used to study mortality, hospital length of stay (LOS), and charges. RESULTS: Never events were identified in 774 of 267,734 patients. The distribution of never events were falls/trauma (59%), pressure ulcers (19%), catheter-based UTI (9%), vascular catheter infection (6%), complications of poor glucose control (5%), and retained objects (4%). Rates of falls and catheter-based UTIs have increased since 2008. Multivariable predictors of any never event included lower extremity bypass, abdominal aortic aneurysm, weight loss, nonelective admission, paralysis, repair, congestive heart failure, altered mental status, renal failure, weekend admission, diabetes, female gender, and age. Race, insurance, hospital type, income level, geography, July to September admission, and other comorbidities were not predictive. After risk factor adjustment, never events were associated with increased perioperative mortality (odds ratio, 2.7; 95% confidence interval [CI], 1.5-34.8; P < .001), LOS (means ratio, 1.9; 95% CI, 1.7-2.0; P < .001), and total charges (means ratio, 1.7; 95% CI, 1.6-1.8; P < .001). CONCLUSIONS: Never events after major vascular surgery are associated with a number of perioperative factors and are predictive of increased charges, LOS, and mortality. Falls and catheter-based UTIs have increased in frequency since the Centers for Medicare and Medicaid Services announced that it would no longer reimburse for these complications. This study establishes baseline never event rates in the vascular surgery patient population and identifies high-risk patients to target for quality improvement.

The effect of anesthesia type on major lower extremity amputation in functionally impaired elderly patients.

OBJECTIVE: Patients undergoing major lower extremity amputations are at risk for a wide variety of perioperative complications. Elderly patients with any functional impairment have been shown to be at high risk for these adverse events. Our goal was to determine the association between the type of anesthesia-general anesthesia (GA) and regional/spinal anesthesia (RA)-on perioperative outcomes after lower extremity amputation in these elderly and functionally impaired patients. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) data set (2005-2012) was queried to identify all patients aged ≥75 years with partial or total functional impairment who underwent major lower extremity amputations. Propensity matching and multivariate analysis were performed to isolate the effect of anesthesia type. RESULTS: We identified 3260 patients (50% male), 2558 GA patients and 702 RA patients, who were a mean age of 82 years. Anatomic distribution was 59% above-the-knee and 41% below-the-knee amputations. Patients undergoing GA were more likely to have impaired sensorium (9% vs 6%; P = .035), be on anticoagulation or have a bleeding disorder (33% vs 17%; P < .001), have had a previous operation ≤30 days (16% vs 10%; P < .001), and be operated on by a nonvascular surgeon (16% vs 12%; P = .033). GA was associated with shorter anesthesia time to surgery (36 ± 48 vs 42 ± 49 minutes; P < .001) but a similar operative time (66 ± 33 vs 64 ± 33 minutes; P = .292) compared with RA. After propensity matching, rates of 30-day mortality (14% vs 12%; P = .135), postoperative myocardial infarction/cardiac arrest (2.9% vs 3.1%; P = .756), pulmonary complications (7.3% vs 6.7%; P = .632), stroke (0.7% vs 0.9%; P = .694), urinary tract infections (6.7% vs 6.5%; P = .887), and wound complications (7.6% vs 7.6%; P = .999) were similar in patients undergoing GA and RA, respectively. Median length of stay was similar in both groups (5 vs 5.5 days; P = .309). Multivariable analyses confirmed that anesthesia type did not significantly affect morbidity and mortality. CONCLUSIONS: The mode of anesthesia, GA vs RA, did not have significant effect on perioperative outcomes after major lower extremity amputation in the functionally impaired geriatric population. These findings provide an evidence base that will allow surgeons, anesthesiologists, and patients to make an informed decision about anesthesia type for their procedure.

Perspectives on endovascular training in traditional 5+2 vascular surgery fellowship training programs.

This study aimed to compare expectations and experiences of fellows to those of faculty in vascular surgery fellowship programs with regard to endovascular training. Anonymous surveys were sent to fellows (n = 235) and program directors (n = 147), with 79 fellows and 65 faculty members responding. Fellows noted higher expectations of their endovascular skills prior to starting fellowship than the faculty group reported expecting. Faculty assessed fellows' pre-training endovascular skills at a significantly lower level than the fellows' self-assessment. Fellows were significantly less satisfied with the structured aspects of endovascular training than the faculty believed them to be. Only 3% of fellows vs. 32% of faculty felt that the presence of an endovascular simulator affected how residents ranked fellowship programs during the match. In conclusion, incoming fellows in vascular surgery fellowship programs have high expectations of themselves, but may overestimate their actual pre-training endovascular skills. Fellows desire more structured endovascular training, which is not recognized by faculty. Endovascular simulators are valued, but may not be a significant draw in the match process.

Mortality of acute mesenteric ischemia remains unchanged despite significant increase in utilization of endovascular techniques.

INTRODUCTION: In this study, we evaluated if increase in utilization of endovascular surgery has affected in-hospital mortality rates among patients with acute mesenteric ischemia. METHODS: The National Inpatient Sample (2003-2011) was queried for acute mesenteric ischemia using ICD-9 code for acute mesenteric ischemia (557.1). This cohort was divided into patients treated with open vascular surgery (open vascular group) and by endovascular therapies (endovascular group) based on the ICD-9CM procedure codes. Multivariable logistic regression was used to determine temporal trend for mortality while adjusting for confounding variables. RESULTS: There was 1.45-fold increase in utilization of endovascular techniques in this study. In-hospital mortality rate, total median charges and length of stay were significantly lower among the endovascular group than the open vascular group despite having significantly higher Elixhauser comorbidities index (3 ± 0.1 vs. 2.7 ± 0.1, p = .003). Over the course of the study period, there was no change in the overall mortality rate despite higher endovascular utilization. Factors associated with increased mortality included age, open surgical repair (Odds ratio: 1.45, 95% Confidence Interval: 1.10-1.91, p = .016) and bowel resection Odds ratio: 2.88, 95% Confidence Interval: 2.01-4.12). CONCLUSION: The mortality rate for acute mesenteric ischemia remains unchanged throughout this contemporary study. Open surgical intervention, bowel resection and age were associated with increased mortality. Endovascular group patients had better survival despite higher morbidity indices.