Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Device regulation and surveillance in vascular care: Challenges and opportunities.

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.

The impact of the Affordable Care Act Medicaid Expansion in Medicare beneficiaries with peripheral artery disease.

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME (n = 25) versus those who were in states that did not (n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality (p = 0.15) or amputation (p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD.

Patient decision-making in the era of transcarotid artery revascularization.

OBJECTIVE: The National Coverage Determination on carotid stenting by Medicare in October 2023 stipulates that patients participate in a shared decision-making (SDM) conversation with their proceduralist before an intervention. However, to date, there is no validated SDM tool that incorporates transcarotid artery revascularization (TCAR) into its decision platform. Our objective was to elicit patient and surgeon experiences and preferences through a qualitative approach to better inform the SDM process surrounding carotid revascularization. METHODS: We performed longitudinal perioperative semistructured interviews of 20 participants using purposive maximum variation sampling, a qualitative technique designed for identification and selection of information-rich cases, to define domains important to participants undergoing carotid endarterectomy or TCAR and impressions of SDM. We also performed interviews with nine vascular surgeons to elicit their input on the SDM process surrounding carotid revascularization. Interview data were coded and analyzed using inductive content analysis coding. RESULTS: We identified three important domains that contribute to the participants' ultimate decision on which procedure to choose: their individual values, their understanding of the disease and each procedure, and how they prefer to make medical decisions. Participant values included themes such as success rates, "wanting to feel better," and the proceduralist's experience. Participants varied in their desired degree of understanding of carotid disease, but all individuals wished to discuss each option with their proceduralist. Participants' desired medical decision-making style varied on a spectrum from complete autonomy to wanting the proceduralist to make the decision for them. Participants who preferred carotid endarterectomy felt outcomes were superior to TCAR and often expressed a desire to eliminate the carotid plaque. Those selecting TCAR felt it was a newer, less invasive option with the shortest procedural and recovery times. Surgeons frequently noted patient factors such as age and anatomy, as well as the availability of long-term data, as reasons to preferentially select one procedure. For most participants, their surgeon was viewed as the most important source of information surrounding their disease and procedure. CONCLUSIONS: SDM surrounding carotid revascularization is nuanced and marked by variation in patient preferences surrounding autonomy when choosing treatment. Given the mandate by Medicare to participate in a SDM interaction before carotid stenting, this analysis offers critical insights that can help to guide an efficient and effective dialog between patients and providers to arrive at a shared decision surrounding therapeutic intervention for patients with carotid disease.

Inter-Rater Reliability for the Amputation Endpoint in the National Vascular Quality Initiative.

BACKGROUND: National quality reporting efforts after revascularization for peripheral artery disease (PAD) are ongoing. Validation of endpoints are necessary in national quality registries. OBJECTIVES: This study sought to examine the interrater reliability for the endpoint of major amputation at 1 year in the Vascular Quality Initiative (VQI) registry and the Medicare-linked Vascular Quality Initiative registry (VQI-VISION) against electronic health record (EHR) review. METHODS: Surgical or endovascular revascularization procedures between January 1, 2010, and December 31, 2017, in the VQI registry and VQI-VISION for 2 academic health systems were queried. Major amputation data were abstracted by trained data collectors for the VQI and derived from Current Procedural Terminology codes for VQI-VISION. Cases underwent protocolized adjudication for the endpoint of major amputation by EHR review. Paired tests were used to evaluate the sensitivity and specificity. Spearman's ρ and Cohen's κ were used to evaluate interrater reliability. RESULTS: Amputation endpoints for 1,936 revascularizations were examined. Compared with major amputation data in EHR review, the sensitivity for the VQI registry was 35.9% and the specificity was 99.4% (ρ = 0.53; κ = 0.48). For VQI-VISION, sensitivity was 67.7% and specificity was 98.9% (ρ = 0.75; κ = 0.74). For any amputation in VQI data, sensitivity was 35.3% and specificity was 99.3% (ρ = 0.53; κ = 0.46), and for VQI-VISION, they were 71.6% and 97.7%, respectively (ρ = 0.75; κ = 0.74). CONCLUSIONS: Almost two-thirds of the amputations in the VQI registry and one-third of amputations in VQI-VISION were missing at 1 year compared against adjudicated EHR review. In preparing for national reporting systems for major amputation tracking, data collection system reform is needed.

Changes in global mortality from aortic aneurysm.

OBJECTIVE: Globally, there has been a marked increase in aortic aneurysm-related deaths between 1990 and 2019. We sought to understand the underlying etiologies for this mortality trend by examining secular changes in both demographics and the prevalence of risk factors, and how these changes may vary across sociodemographic index (SDI) regions. METHODS: We queried the Global Burden of Disease Study (GBD) for aortic aneurysm deaths from 1990 to 2019 overall and by age group. We identified the percentage of aortic aneurysm deaths attributable to each risk factor identified by GBD modeling (smoking, hypertension, lead exposure, and high sodium diet) and their respective changes over time. We then analyzed aneurysm mortality by SDI region. RESULTS: The number of aortic aneurysm-related deaths have increased from 94,968 in 1990 to 172,427 in 2019, signifying an 81.6% increase, which greatly exceeds the 18.2% increase in all-cause mortality observed over the same time interval. Examination of age-specific mortality demonstrated that the number of aortic aneurysm deaths markedly correlated with advancing age. However, when considering rate of death rather than mortality count, overall age-standardized death rates decreased 18% from 2.72 per 100,000 in 1990 to 2.21 per 100,000 in 2019. Analysis of the specific risk factors associated with aneurysm death revealed that the percentage of deaths attributable to smoking decreased from 45.6% in 1990 to 34.6% in 2019, and deaths attributable to hypertension decreased from 38.7% to 34.7%. Globally, hypertension surpassed smoking as the leading risk factor. The reported rate of death was consistently greater as SDI increased, and this effect was most pronounced among low-middle and middle SDI regions (173.2% and 170.4%, respectively). CONCLUSIONS: Despite an overall increase in the number of aneurysm deaths, there was a decrease in the age-standardized death rate, demonstrating that the observed increased number of aortic aneurysm deaths between 1990 and 2019 was primarily driven by an overall increase in the age of the global population. Fortunately, it appears that the increase in overall aneurysm-related deaths has been modulated by improved risk factor modification, in particular smoking. Given the rise in aneurysm-related deaths, global expansion of vascular specialty capabilities is warranted and will serve to amplify improvements in population-based aneurysm health achieved with risk factor control.

A Retrospective Analysis of Surgical Acuity & Procedure Volume Before & During the COVID-19 Pandemic.

INTRODUCTION: In March 2020, the American College of Surgeons recommended postponing elective procedures amid the COVID-19 pandemic. We used Medicare claims to analyze changes in surgical and interventional procedure volumes from 2016 to 2021. METHODS: We studied 37 common surgical and interventional procedures using 5% Medicare claims files from January 1, 2016, through December 31, 2021. Procedures were classified according to American College of Surgeons guidelines as low, intermediate, or high acuity, and counts were analyzed per calendar year quarter (Q1-Q4), with stratification by sex and race/ethnicity. RESULTS: We observed 1,840,577 procedures and identified two periods of marked decline. In Q2 2020, overall procedure counts decreased by 32.2%, with larger declines in low (41.1%) and intermediate (30.8%) acuity procedures. High acuity procedures declined the least (18.2%). Overall volumes increased afterward but never returned to baseline. Another marked decline occurred in Q4 2021, with all acuity levels having declined to a similar extent (40.1%, 44.2%, and 46.9% for low, intermediate, and high acuity, respectively). High and intermediate acuity procedures declined more in Q4 2021 than Q2 2020 (P = 0.002). Similar patterns were observed across sex and race/ethnicity strata. CONCLUSIONS: Two major procedural volume declines occurred between 2020 and 2022 during the COVID-19 pandemic in the United States. High acuity (life or limb threatening) procedures were least affected in the first decline (Q2 2020) but not spared in second decline (Q4 2021). Future efforts should prioritize preserving high-acuity access during times of stress.

Treatment Variability Among Patients Hospitalized for Chronic Limb-Threatening Ischemia: An Analysis of the 2016 to 2018 US National Inpatient Sample.

BACKGROUND: Little is known about treatment variability across US hospitals for patients with chronic limb-threatening ischemia (CLTI). METHODS AND RESULTS: Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient- and hospital-related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19-1.38), 1.86 (1.77-1.95), 1.65 (1.55-1.74), 1.37 (1.28-1.45), and 1.42 (1.27-1.55), respectively. CONCLUSIONS: Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.

An Endovascular- Versus a Surgery-First Revascularization Strategy for Chronic Limb-Threatening Ischemia: A Meta-Analysis of Randomized Controlled Trials.

Timely revascularization is essential for limb salvage and to reduce mortality in patients with chronic limb-threatening ischemia (CLTI). In patients who are candidates for endovascular therapy and surgical bypass, the optimal revascularization strategy remains uncertain. Recently published randomized controlled trials (RCTs) have presented conflicting results. We conducted a trial-level meta-analysis to compare the outcomes between endovascular-first and surgery-first strategies for revascularization. PubMed, Web of Science, and the Cochrane Library were searched to identify RCTs comparing the outcomes of endovascular-first versus surgery-first strategies for revascularization in patients with CLTI. Data were pooled for major outcomes and their aggregate risk ratios (RRs) with 95% confidence intervals were calculated using a random-effects model. Kaplan-Meier curves for amputation-free survival and overall survival time were plotted using the pooled aggregated data from published curves, with their corresponding hazard ratios (HRs) and 95% confidence intervals reported for up to 5 years of follow-up. A total of 3 RCTs with 2,627 patients (1,312 endovascular-first and 1,315 surgery-first) were included in the meta-analysis. Of these, 1,864 patients (70.9%) were men and 347 (13.2%) were older than 80 years. Comparing the endovascular-first and surgery-first approaches, there was no significant difference in the overall (HR 0.92 [0.83 to 1.01], p = 0.09) or amputation-free survival (HR 0.98 [0.92 to 1.03], p = 0.42), reintervention (RR 1.24 [0.74 to 2.07], p = 0.41), major amputation, (RR 1.16 [0.87 to 1.54], p = 0.31), or therapeutic crossover (RR 0.92 [0.37 to 2.26], p = 0.85). In conclusion, data from available RCTs suggest that there is no difference in clinical outcomes between endovascular-first and surgery-first revascularization strategies for CLTI. A planned patient-level meta-analysis may provide further insight.

Decision aids for patients with carotid stenosis.

BACKGROUND: Shared decision-making tools have been underused by clinicians in real-world practice. Changes to the National Coverage Determination by Medicare for carotid stenting greatly expand the coverage for patients, but simultaneously require a shared decision-making interaction that involves the use of a validated tool. Accordingly, our objective was to evaluate the currently available decision aids for carotid stenosis. METHODS: We conducted a review of the literature for published work on decision aids for the treatment of carotid disease. RESULTS: Four publications met inclusion criteria. We found the format of the decision aid impacted patient comprehension and decision making, although patient characteristics also played a role in the therapeutic decisions made. Notably, none of the available decision aids included the widely adopted transcarotid artery revascularization as an option. CONCLUSIONS: Further work is needed in the development of a widespread validated decision aid instrument for patients with carotid stenosis.

Adoption and Diffusion of Transcarotid Artery Revascularization in Contemporary Practice.

BACKGROUND: In 2015, the FDA approved transcarotid artery revascularization (TCAR) as an alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS) for high-risk patients with carotid stenosis. This was granted in the absence of level 1 evidence to support TCAR. We aimed to document trends in TCAR utilization, its diffusion over time, and the clinical phenotypes of patients undergoing TCAR, CEA, and TF-CAS. METHODS: We used the Vascular Quality Initiative to study patients who underwent TCAR. We calculated the number of TCARs performed and the percent of TCAR utilization versus CEA/TF-CAS. Using data from before TCAR was widespread, we calculated propensity scores for patients to receive CEA. We applied this model to patients undergoing carotid revascularization from 2016 to 2022 and grouped patients by the procedure they ultimately underwent, examining overlap in score distribution to measure patient similarity. We measured the trend of in-hospital stroke/death after TCAR. RESULTS: We studied 31 447 patients who underwent TCAR from January 1, 2016 to March 31, 2022. The number of centers performing TCAR increased from 29 to 606. In 2021, TCAR represented 22.5% of carotid revascularizations at centers offering all 3 procedures. The percentage of patients that underwent TCAR who met approved high-risk criteria decreased from 88.5% to 80.9% (P<0.001). Those with a prior ipsilateral carotid procedure decreased from 20.6% in 2016 to 12.0% in 2021 (P<0.001). Patients undergoing TCAR after stroke increased from 19.7% to 30.7% (P<0.001). Propensity-score overlap was 55.4% for TCAR/CEA, and 58.6% for TCAR/TF-CAS, demonstrating that TCAR patients have a clinical phenotype mixed between those who undergo CEA and TF-CAS. The average in-hospital stroke/death risk after TCAR was 2.3% in 2016 and 1.7% in 2022 (P trend: 0.954). CONCLUSIONS: TCAR now represents nearly 1-in-4 procedures at centers offering it. TCAR was increasingly performed among standard-risk patients and as a first-line procedural option after stroke. The absence of level 1 evidence underscores the importance of high-quality registry-based analyses to document TCAR's real-world outcomes and durability.

Therapeutic anticoagulation after index peripheral endovascular intervention in patients with claudication.

OBJECTIVE: Antiplatelet agents are commonly used after peripheral endovascular intervention (PVI). However, the effect of full-dose anticoagulation on outcomes after PVI is not well-established. We sought to investigate whether full-dose anticoagulation after PVI is associated with adverse events. METHODS: We utilized the Vascular Quality Initiative to study patients undergoing index PVI for claudication (2010-2019), stratified by the presence or absence of an anticoagulant on discharge. The primary outcomes were 2-year patency, major adverse limb events (MALE), and mortality. We built a propensity score adjusting for comorbidities and employed inverse probability weighting to estimate the association of anticoagulation with outcomes. RESULTS: We identified 26,240 patients; 9.1% were discharged on an anticoagulant. Patients receiving any anticoagulation had a significantly higher risk of mortality (adjusted hazard ratio [aHR], 1.61; 95% confidence interval [CI], 1.35-1.92), but not MALE, or patency loss. Patients receiving a vitamin K antagonist had a significantly higher risk of patency loss (aHR, 1.32; 95% CI, 1.09-1.60), MALE (aHR, 1.33; 95% CI, 1.13-1.57), and mortality (aHR, 1.46; 95% CI, 1.27-1.69). Patients on an oral Factor Xa inhibitors had a significantly lower risk of patency loss (aHR, 0.61; 95% CI, 0.41-0.93) but increased mortality (aHR, 1.51; 95% CI, 1.19-1.92). CONCLUSIONS: Therapeutic anticoagulation after PVI is associated with higher risk of all-cause mortality. Although oral Factor Xa inhibitors are associated with decreased risk of patency loss, vitamin K antagonists are associated with higher risk of patency loss, MALE, and death. Further prospective studies are necessary to study the safety and efficacy of full-dose anticoagulation after PVI.

Readmission After Lower Extremity Bypass Following Discharge to a Rehabilitation or Nursing Facility.

INTRODUCTION: Hospital readmission after lower extremity arterial bypass (LEB) is common. Patients are often discharged to a facility after LEB as a bridge to home. Our objective was to define the association between discharge to a facility and readmission after LEB. METHODS: We used the Vascular Quality Initiative to study patients who underwent LEB from 2017 to 2022. The primary exposure was discharge location. The primary outcome was 30-d hospital readmission. RESULTS: We included 6076 patients across 147 centers. The overall 30-d readmission rate was 18%. Readmission occurred among 15% of patients discharged home, 22% of patients discharged to a rehabilitation facility, and 25% of patients discharged to a nursing home. After controlling for patient and procedural factors, there was no significant association between discharge location and 30-d readmission (rehabilitation versus home odds ratio: 1.06, 95% confidence interval: 0.87-1.29; nursing facility versus home odds ratio: 1.21, 95% confidence interval: 0.99-1.47). Female sex, end-stage renal disease, diabetes, heart failure, pulmonary disease, smoking, preoperative functional impairment, tibial bypass target, critical limb threatening or acute ischemia, and postoperative complications including surgical site infection, change in renal function and graft thrombosis were associated with an increased likelihood of readmission. CONCLUSIONS: Patients discharged home after LEB experienced a similar likelihood of readmission as those discharged to a facility. While discharge to a facility may aid in care transitions, it did not appear to lead to reduced 30-d readmissions. The recommended discharge location should be predicated on patient care needs and not as a perceived mechanism to reduce readmissions.

Five Year Survival in Medicare Patients Undergoing Interventions for Peripheral Arterial Disease: a Retrospective Cohort Analysis of Linked Registry Claims Data.

OBJECTIVE: To justify the up front risks of offering elective interventions for intermittent claudication (IC), patients should have reasonable life expectancy to derive durable clinical benefits. Open surgery for chronic limb threatening ischaemia (CLTI) is maximally beneficial in patients surviving ≥ 2 years. The aim was to assess long term survival after IC and CLTI interventions. METHODS: In a retrospective cohort analysis, the Vascular Quality Initiative (VQI) registry from 1 January 2010 to 31 May 2021 was queried for peripheral vascular intervention (PVI), infra-inguinal bypasses (IIB), and supra-inguinal bypasses (SIB) for IC and CLTI across 286 US centres. VQI linkage to Medicare insurance claims provided five year survival data. Multivariable analysis identified factors associated with five year mortality. RESULTS: There were 31 457 PVIs (44.7% IC, 55.3% CLTI), 7 978 IIBs (26.9% IC, 73.1% CLTI), and 2 149 SIBs (50.1% IC, 49.9% CLTI) recorded in the VQI. Among the PVI, IIB, and SIB cohorts, average ages were 75, 73, and 72 years, respectively. Respective five year mortality after PVI for IC and CLTI was 37.2% and 71.1%; after IIB for IC and CLTI it was 37.8% and 60%; and after SIB for IC and CLTI it was 33.8% and 53.8%. On multivariable analysis, across all procedures, end stage renal disease, CLTI, congestive heart failure, anaemia, chronic obstructive pulmonary disease, and prior amputation were independently associated with increased mortality. Pre-admission home living and pre-operative aspirin use were independently associated with decreased mortality. CONCLUSION: Long term survival in Medicare patients undergoing interventions in VQI centres for peripheral arterial disease is poor. Two thirds of CLTI patients and over one third of IC patients were not alive at five years. Intervening for IC in patients with high mortality risk should be avoided. For CLTI patients identified with decreased survival likelihood, intervention durability may be less important than invasiveness. Pre-operative medical optimisation should always be undertaken.

Sex differences in outcomes among adults undergoing abdominal aortic aneurysm repair.

OBJECTIVE: Although the differences in short-term outcomes between male and female patients in abdominal aortic aneurysm (AAA) repair have been well studied, it remains unclear if these sex disparities extend to other long-term adverse outcomes after AAA repair, such as reintervention and late rupture. METHODS: We performed a retrospective cohort study of 13,007 patients who underwent either endovascular (EVAR) or open AAA repair (OAR) between 2003 and 2015 using data from the Vascular Quality Initiative registries. Eligible patients were linked to fee-for-service Medicare claims to identify late outcomes of rupture and aneurysm-specific reintervention. RESULTS: The mean age of our cohort was 76 ± 6.7 years, 22% were female, 94% were White, and 77% underwent EVAR. The 10-year rupture incidence was slightly higher for women at 4.8 per 1000 person-years, vs 3.9 for men, but this difference was not statistically significant after risk adjustment (hazard ratio [HR] = 1.13, 95% confidence interval [CI]: 0.74-1.73). Likewise, we found no sex difference in reintervention rates (5.1 vs 4.8 in women per 1000 person-years) even after risk adjustment (HR = 0.95, 95% CI: 0.83-1.09). Regression models suggest effect modification by repair type for reintervention, where women who underwent index EVAR had a higher risk of reintervention than men (HR = 1.08, 95% CI: 0.93-1.26), whereas women who underwent OAR were at a lower risk of reintervention than men (HR = 0.79, 95% CI: 0.58-1.08); however, neither effect reached statistical significance within each subgroup. In addition, we found that the risk of reintervention for women vs men varied by clinical presentation, where women were less likely to undergo reintervention after an elective or symptomatic AAA repair but were more likely to undergo reintervention after a repair for AAA rupture (HR = 1.70, 95% CI: 1.05-2.75). CONCLUSIONS: Male and female patients who underwent AAA repair had similar rates of reintervention and late aneurysm rupture in the 10 years after their procedure. However, our findings suggest that repair type and clinical presentation may affect the role of sex in clinical outcomes and warrant further exploration in these subgroups.

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.

The financial burden associated with endovascular repair of thoracoabdominal and pararenal aortic aneurysms using physician-modified fenestrated-branched endografts.

OBJECTIVE/BACKGROUND: Endovascular thoracoabdominal and pararenal aortic aneurysm repair is more complex and requires more devices than infrarenal aneurysm repair. It is unclear if current reimbursement covers the cost of delivering this more advanced form of vascular care. The objective of this study was to evaluate the economics of fenestrated-branched (FB-EVAR) physician-modified endograft (PMEG) repairs. METHODS: We obtained technical and professional cost and revenue data for four consecutive fiscal years (July 1, 2017, to June 30, 2021) at our quaternary referral institution. Inclusion criteria were patients who underwent PMEG FB-EVAR in a uniform fashion by a single surgeon for thoracoabdominal/pararenal aortic aneurysms. Patients in industry-sponsored clinical trials or receiving Cook Zenith Fenestrated grafts were excluded. Financial data were analyzed for the index operation. Technical costs were divided into direct costs that included devices and billable supplies and indirect costs including overhead. RESULTS: 62 patients (79% male, mean age: 74 years, 66% thoracoabdominal aneurysms) met inclusion criteria. The mean aneurysm size was 6.0 cm, the mean total operating time was 219 minutes, and the median hospital length of stay was 2 days. PMEGs were created with a mean number of 3.7 fenestrations, using a mean of 8.6 implantable devices per case. The average technical cost per case was $71,198, and the average technical reimbursement was $57,642, providing a net negative technical margin of $13,556 per case. Of this cohort, 31 patients (50%) were insured by Medicare remunerated under diagnosis-related group code 268/269. Their respective average technical reimbursement was $41,293, with a mean negative margin of $22,989 per case, with similar findings for professional costs. The primary driver of technical cost was implantable devices, accounting for 77% of total technical cost per case over the study period. The total operating margin, including technical and professional cost and revenue, for the cohort during the study period was negative $1,560,422. CONCLUSIONS: PMEG FB-EVAR for pararenal/thoracoabdominal aortic aneurysms produces a substantially negative operating margin for the index operation driven largely by device costs. Device cost alone already exceeds total technical revenue and presents an opportunity for cost reduction. In addition, increased reimbursement for FB-EVAR, especially among Medicare beneficiaries, will be important to facilitate patient access to such innovative technology.

Health Disparities in Peripheral Artery Disease: A Scientific Statement From the American Heart Association.

Peripheral artery disease (PAD) affects 200 million individuals worldwide. In the United States, certain demographic groups experience a disproportionately higher prevalence and clinical effect of PAD. The social and clinical effect of PAD includes higher rates of individual disability, depression, minor and major limb amputation along with cardiovascular and cerebrovascular events. The reasons behind the inequitable burden of PAD and inequitable delivery of care are both multifactorial and complex in nature, including systemic and structural inequity that exists within our society. Herein, we present an overview statement of the myriad variables that contribute to PAD disparities and conclude with a summary of potential novel solutions.