Vascular Quality Initiative Research Articles

Abstract 4138488: Association Between Guideline-directed Medical Therapy and Reintervention Risk at 2 Years Following Peripheral Vascular Interventions

Introduction: Patients with peripheral artery disease (PAD) undergoing peripheral vascular interventions (PVI) face frequent reinterventions. The association between the use of guideline-directed medical therapy (GDMT) and reintervention risk is unclear, we therefore aimed to study the association between GDMT and 2-year reintervention risk using the largest national vascular registry. Methods: PVI procedures in patients with claudication or chronic limb-threatening ischemia between 2017-2018 were abstracted from the Vascular Quality Initiative (VQI) registry. GDMT was defined as statin, antiplatelet, and ACE/ARB if hypertensive prescribed at discharge. Reintervention was obtained from Medicare claims data. Propensity score of no GDMT vs. GDMT was calculated using 22 preprocedural variables followed by 1:1 matching of patients. The 2-year cumulative incidence of reintervention and subhazard ratios (sHR) for 2-year reintervention risk in no GDMT vs. GDMT were assessed using Aalen-Johansen method and Fine-Gray model, respectively, to account for the competing risk of death. Results: A total of 13,244 patients (6,622 by GDMT group) were included after 1:1 matching (mean age 72.0 ± 9.9, female 38.9%, white 79.4% Black or African American 15.3%) . At 2 years, the cumulative incidence of reintervention was 43.0% (95% CI 41.0%-44.9%) for patients with no GDMT vs. 41.2% (95%CI 39.4-43.0) for the GDMT group (P=0.293). Not receiving GDMT was not associated with 2-year risk of reintervention (sHR: 1.03 95%CI 0.97-1.10; P=0.293). Conclusion: Around 40% of patients undergoing a PVI will have a reintervention at 2 years. The receipt of GDMT at discharge was not associated with a lower reintervention risk at 2 years, as currently assessed. Further granular measures of GDMT should integrate adherence information, as well as information on other lifestyle and cardiovascular risk management to obtain a more complete assessment of a potential association with reintervention risk.

Abstract 4140149: Differences in Interventional Treatment Outcomes of Peripheral Arterial Disease between African American Females, African American Males, and Caucasian Females

Introduction: Several recent publications demonstrated worse outcomes of interventional treatment of peripheral arterial disease (PAD) in patients of African American (AA) descent compared to Caucasians (C), and in female patients compared to male patients. However, studies addressing sex differences in outcomes, included predominantly white female patients. To our knowledge, there are no published studies specifically addressing outcomes of interventional treatment of PAD in female patients of African American descent. Aims: 1. To determine if the outcomes of interventional treatment of PAD in female patients of African American (FAA) descent differ from male African American patients (MAA), and Caucasian female patients (FC). If such differences exist, to identify factors associated with it. Methods: This study has a cross-sectional design with systematically retrospective data collection by the National Vascular Quality Initiative. Included in this study was data on patients treated with endovascular and open surgical options for symptomatic PAD. Statistical analysis was done using IBM Statistic SPSS V25. Results: 447,263 unique cases containing required data were available in the VQI database. Among them, 171,250 were female patients, of which 32,966 were FAA, 126,519 FC, and 39,461 MAA. This race and gender distribution is not significantly different from the US population structure (US Census Bureau 2023). 1 However, female to male ratio was higher in AA (0.83) compared to C (0.58, p<0.0001). FAA were younger (65.143+/-9.59) compared to FC (69.16+/-10.32, P<0.00001). Comparison of comorbidities, smoking rates, pre-interventional medications and post-interventional outcomes are listed in Table 1. Multivariate analysis confirmed higher amputation rate among FAA compared to FC and to MAA and showed no significant difference in mortality. Conclusions: FAA patients who require interventional treatment for PAD have significantly higher rate of hypertension and diabetes compared to FC and MAA patients and have higher amputation rates. It appears that differences in clinical outcomes of PAD treatment in FAA are related mostly if not entirely to poorly managed comorbidities existed prior to intervention.

Lack of diversity in patients undergoing carotid artery stenting: Implications for the Distressed Community Index.

As the role of social determinants in carotid artery stenting (CAS) outcomes remains unclear, we investigated the association between the Distressed Community Index (DCI) (zip-code based) and post-CAS mortality/stroke outcomes. We analyzed patients undergoing CAS from 2015 to 2019 using the Medicare claims-linked Vascular Quality Initiative database. Patients were grouped based on high (DCI ⩾ 60) and low (DCI < 60) community distress. We analyzed 36-month mortality using Kaplan-Meier survival curves and hierarchical Cox regression, and 36-month stroke using cumulative incidence function curves and Fine-Gray models. The final cohort included 8717 patients (3032 DCI ⩾ 60), with a mean DCI score of 46.2 (± 28.5) and mean age of 74.7 (± 7.8) years. Most participants were men (64.3%), White (92.7%), and non-Hispanic/Latino (97.7%). There was no significant difference in the 36-month mortality incidence between high and low community distress groups (25.6% vs 23.5%, p = 0.22), and no significant association between high community distress and mortality (unadjusted HR: 1.04; 95% CI 0.90-1.21; adjusted HR: 1.02; 95% CI 0.89-1.17). The high community distress group experienced an elevated 36-month stroke incidence (26.8% vs 22.4%, p = 0.048), but no significant association with stroke was observed (unadjusted sub-HR: 1.12; 95% CI 1.00-1.24; adjusted sub-HR: 1.03; 95% CI 0.92-1.16). Our cohort showed underrepresentation in terms of sex, race, and ethnicity, with a skewed DCI distribution towards lower community distress. Contrary to what we know about community distress, no independent association between higher community distress and post-CAS stroke/mortality risk was found. Future work must examine whether accessibility barriers and selective CAS allocation explain our results.

Poor mid-term functional patency and post-operative outcomes in diabetic patients who undergo arteriovenous graft creation.

Diabetes mellitus is a leading cause of renal failure in the US and has been associated with higher mortality when compared to nondiabetic patients. This remains true despite initiation of renal replacement therapy. As such, we were interested in identifying any potential differences in access durability and postoperative outcomes in diabetic patients who receive arteriovenous fistulas versus grafts for hemodialysis. Diabetic patients undergoing their first arteriovenous (AV) access creation surgery in the Vascular Quality Initiative from January 2011 to January 2022 were included in our study. After exclusions, the study included two groups: those receiving AV fistulas and those receiving AV grafts for hemodialysis. Demographic characteristics were summarized and compared between these two groups using chi-square analysis or unpaired t-test. After propensity score matching was conducted, the effect of procedure type on functional patency, along with secondary outcomes including wound infection were assessed using chi-square analysis. A total of 20,159 diabetic patients who used their hemodialysis access were included in our study; 16,205 received AV fistulas while 3954 received AV grafts. Patients receiving AV grafts were more likely to be older, female, and have higher pre-operative catheter usage. After propensity score matching, patients who received AV grafts had a shorter time-to-use their conduit (50 vs 166 days, p < 0.0001), however, patients who received AV fistulas were more likely to have longer functional patency use for hemodialysis when compared to those who received AV grafts (mean survival time: 3.3 vs 2.9 years, p < 0.0001). These results were consistent between diabetics with insulin-dependent or insulin-independent diabetes. Patients diagnosed with diabetes mellitus had an increased risk for significantly inferior clinical outcomes related to newly created AV grafts, including lower rates of mid-term functional patency and higher rates of worse post-operative outcomes when compared to diabetics who received AV fistulas.

Analysis of Surgeon and Center Case Volume and Stroke or Death after Transcarotid Artery Revascularization.

It has been suggested that the annual hospital volume of cases may affect the number of adverse events following carotid endarterectomy (CEA). We aim to study the associations between hospital as well as surgeon volume and the risk of stroke/death following TCAR. Retrospective review of the Vascular Quality Initiative data of patients undergoing TCAR from 2016 to 2021. Surgeon and center volume were calculated based on the mean number of cases (MNC) performed yearly by each surgeon and center. The primary outcome was a composite endpoint of in-hospital stroke/death. A total of 22,624 cases were included. Surgeon volume was divided into three quantiles: low (MNC=4), medium (MNC=10), and high (MNC=26). Center volume was also divided into low (MNC=14), medium (MNC=32), and high (MNC=64). After adjusting for potential confounders, and when compared to high volume centers, low and medium center volume was not associated with any increased odds of in-hospital stroke/death, stroke, death, or stroke/TIA. Compared to high volume surgeons, low surgeons' volume was associated with a higher odd of stroke (OR: 1.5, 95%CI (1.1-2.04), P=0.008), and stroke/TIA (OR: 1.5, 95%CI (1.2-1.9), P=.002). However, medium surgeon volume was not associated with higher odds of stroke/death, stroke, and stroke/TIA. Neither low nor medium surgeon volume was associated with a difference in mortality compared to high surgeon volume. In this retrospective study, center volume was not associated with any differences in outcomes among patients undergoing TCAR. On the other hand, surgeons with low volume were associated with a higher risk of stroke/death/MI and stroke/TIA when compared to high surgeon volume. There was no difference in outcomes between medium and high surgeon volume.

Women Experience Higher Rates of Mortality Following Thoracic Endovascular Aneurysm Repair

ObjectivesThoracic endovascular aortic repair (TEVAR) and complex endovascular thoraco-abdominal aneurysm repair (cEVAR) has been increasingly adopted in the treatment of thoracic and thoracoabdominal aorta aneurysms, offering a less invasive approach for patients with appropriate anatomy. Women usually present with smaller aortic diameter. However, they usually have greater aneurysm growth rates. How sex can affect postoperative and short-term outcomes after TEVAR is not well reported. The aim of this study was to assess outcomes in female versus male patients undergoing TEVAR for treatment of thoracic and thoracoabdominal aneurysms in a Medicare-linked database. MethodsWe retrospectively reviewed patients undergoing TEVAR for thoracic and thoracoabdominal aneurysm repair in the Vascular Quality Initiative (VQI) Vascular Implant Surveillance and Interventional Outcomes Network (VISION) database from 2003 to 2018. Patients were divided into males and females. Patients presented with ruptured aneurysm were excluded from the analysis. Postoperative outcomes included in-hospital stroke, myocardial infarction (MI), spinal cord ischemia, and 30-day mortality. One-year outcomes included mortality, aneurysmal rupture, and reintervention. Postoperative outcomes were assessed using multivariable logistic regression analysis and one-year outcomes were evaluated using Kaplan Meier Survival and Cox regression analyses. ResultsA total of 3,058 males and 1,843 females were available for the analysis. Female patients had smaller median aortic diameter, were more likely to be black, with chronic obstructive pulmonary disease, and chronic kidney disease, and to be symptomatic on presentation. Male patients were more likely to be on preoperative medications such as aspirin, beta-blockers, angiotensin-converting enzyme inhibitors, P2Y12 antagonists, and anticoagulants. After adjusting for potential confounders, female gender was associated with double the risk of in-hospital stroke (OR: 2.3, 95%CI ((1.5-3.7), P<0.001) and 80% increase in 30-day mortality (OR: 1.8, 95%CI (1.3-2.6), P=0.001). At one year, female gender was associated with a higher risk of mortality (HR: 1.2, 95%CI (1.05-1.4), P=0.011). There was a trend towards higher risk of reintervention (HR: 1.2, 95%CI (0.97-1.6), P=0.079). ConclusionsMortality after TEVAR seems to be higher in female patients at 30 days and up to one year of follow-up. Female patients also face a two times higher risk of in-hospital stroke. Future studies with a larger female population should aim to identify and potentially ameliorate the factors associated with these unfavorable outcomes in females.

National Trends and Outcomes of Pedal Bypass Surgery

ObjectiveThe technical demands associated with pedal bypass (PB) surgery place it at risk of underutilization and may be limiting its widespread adoption as a valuable revascularization modality. This study aims to evaluate trends in PB performance, assess its outcomes, and compare its results between high- and low-volume centers. MethodsAll patients receiving a PB between 2003 and 2023 were identified in the Vascular Quality Initiative (VQI) infrainguinal bypass (IIB) module. The ratio of PB to total IIB performed was calculated for each year and trended over the study period. Centers performing PB were categorized according to their annual PB volume into tertiles of low-volume centers (LVC, <2 PB/year), medium-volume centers (MVC, 2-4 PB/year), and high-volume centers (HVC, >4 PB/year) for comparison. Patient characteristics and outcomes were compared using the χ2 or Fisher exact test as appropriate for categorical variables and the analysis of variance test or Kruskal-Wallis test as appropriate for continuous variables. Cox regression analysis was used to study the association between center volume and the primary outcomes of primary patency, primary-assisted patency, secondary patency, reintervention, amputation, and major adverse limb events (MALE), defined as the composite outcome of amputation and/or reintervention. ResultsA total of 3466 patients received a PB during the study period. The ratio of PB to IIB dropped from 14% to 4% between 2003 and 2023. Primary, primary-assisted, and secondary patency rates were 65%, 76%, and 80%, respectively, and limb salvage rate was 83% at 1 year. Nineteen percent of centers performing IIBs in the VQI did not perform any PBs during the study period. Of the 246 centers performing PBs, 78% were LVC, 15% were MVC, and only 7% were HVC. On Cox regression analysis, HVCs were associated with a lower risk of primary patency loss (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66-0.95; P = .010), reintervention (HR, 0.75; 95% CI, 0.60-0.95; P = .016), amputation (HR, 0.77; 95% CI, 0.61-0.98; P = .034), and MALE (HR, 0.78; 95% CI, 0.66-0.93; P = .005) compared with LVCs. No difference in secondary patency between high- and low-volume centers was observed (P = .680). ConclusionsThe utilization of PB operations experienced a four-fold decrease over the past 20 years, despite favorable patency and limb salvage outcomes. Centers with a higher operative volume in PB achieve better outcomes than LVCs, and accordingly, patients with extensive tibioperoneal disease may benefit from evaluation at centers with documented expertise in PB before resorting to an alternative revascularization modality or a major limb amputation.

Outcomes after endovascular revascularization for chronic limb-threatening ischemia from the only Vascular Quality Initiative (VQI) center in Asia

ObjectiveThis study compares chronic limb-threatening ischemia disease characteristics and endovascular revascularization outcomes in a multi-ethnic Asian cohort vs their North American counterparts. MethodsThe Society for Vascular Surgery Vascular Quality Initiative (VQI) registry database from the first and currently the only VQI center in Asia was reviewed to identify patients with chronic limb-threatening ischemia who underwent endovascular revascularization between July 2019 and April 2024. Standardized VQI reporting variables were compared against benchmarks derived from all participating centers in North America. ResultsA total of 2862 endovascular revascularization procedures from our center were benchmarked against 129,347 procedures from 406 North American centers. Our cohort had a higher burden of comorbidities (diabetes mellitus, end-stage renal disease, cardiac disease) and presented with more advanced Wound, Ischemia, and foot Infection stages. Our patients had more heavily calcified and longer (14.8 cm vs 6.0 cm) diseased vessels with higher prevalence of multi-level (87% vs 54.6%), infrapopliteal (52.6% vs 38.9%), and inframalleolar (9.6% vs 2.4%) disease. Rates of technical success (92.7% vs 93%) and symptom improvement (39.1% vs 40.4%) were comparable between cohorts. However, 1-year mortality rates (28.9% vs 25.1%) and major amputation rates (13.3% vs 7.8%) were significantly higher. ConclusionsShort-term outcomes of technical success and symptom relief in our center were comparable to benchmarked North American outcomes despite having a cohort with more diseased vessels, higher Wound, Ischemia, and foot Infection stages, and more comorbidities. However, this cohort fared worse in longer term outcomes of 1-year mortality and major amputation rates. Further studies are required to elucidate the causes to improve these outcomes.

Racial Differences in Adoption and Outcomes of Transcarotid Artery Revascularization among High-Risk Adults with Carotid Artery Stenosis

Differential access to new technologies may contribute to racial disparities in surgical outcomes but has not been well-studied in the treatment of carotid artery stenosis. We examined race-based differences in adoption and outcomes of transcarotid artery revascularization (TCAR) among high-risk non-Hispanic (NH) NH Black and NH white adults undergoing carotid revascularization. We conducted a retrospective analysis of TCAR, transfemoral carotid artery stenting (TF-CAS), and carotid endarterectomy (CEA) procedures performed for carotid artery stenosis from 1/2015 to 7/2023 in the Vascular Quality Initiative. NH Black and NH white adults were included if they met Centers for Medicare & Medicaid Services high-risk criteria. Hospitals and physicians were categorized as TCAR-capable if they had previously performed at least one TCAR prior to the time of a given procedure. We fit logistic and linear regressions, adjusted a priori for common demographic, clinical, and disease characteristics, to estimate associations of race with receipt of TCAR (versus CEA or TF-CAS), and to explore associations between race, hospital and physician characteristics, and perioperative composite stroke/death/myocardial infarction. Of 159,471 high-risk patients undergoing revascularization for carotid artery stenosis (mean age 72 years, 38.5% female, 5.3% NH Black), 28,722 (18.0%) received TCAR, including 16.9% of NH Black adults and 18.1% of NH white adults (P<0.001). After controlling for patient and disease characteristics, NH Black patients were less likely than NH white patients to receive TCAR (aOR 0.92, 95% CI 0.87 to 0.99). The use of TCAR did not vary by race among patients treated at TCAR-capable hospitals (aOR 0.98, 95% CI 0.91 to 1.05) or by TCAR-capable physicians (aOR 1.01, 95% CI 0.93 to 1.10); however, NH Black race was associated with lower odds of receiving treatment in these settings (TCAR-capable hospital: aOR 0.93 [0.88 to 0.98]; TCAR-capable physician: aOR 0.92 [0.87 to 0.98]). NH Black race was associated with higher odds of stroke/death/MI in the full cohort (aOR 1.18, 95% CI 1.03 to 1.36), but not in the subgroup of patients who received TCAR (aOR 0.87, 95% CI 0.56 to 1.34). TCAR attenuated racial disparities in perioperative morbidity and mortality associated with carotid revascularization, but NH Black adults were less likely than NH white adults to receive TCAR. Relatively worse access for NH Black adults to technologically-advanced treatment settings may partially explain the broader persistence of race-based differences in carotid revascularization treatment patterns and outcomes.

Operative Times and Outcomes of Complex Endovascular Repairs of Thoracoabdominal Aneurysms

IntroductionOwing to the significant morbidity and mortality of open thoracoabdominal aortic aneurysm surgery, complex endovascular repairs (eTAAA) have become increasingly common, but still carry substantial risk. These repairs require large bore access, with resultant pelvic and lower extremity ischemia. We therefore hypothesized that operative timing would be associated with outcomes, as efficient surgery would limit the ischemic time as well as anesthesia time. MethodsWe studied all eTAAA repairs (Crawford Types 1-3, 5) incorporating at least one branch vessel from 2014 to 2021 in the Vascular Quality Initiative, and categorized them into quartiles of total operating time. To account for variations in case complexity and intraoperative events, we performed a sub-analysis stratifying each surgeon by their median operating time. Multilevel logistic regression was employed to compare perioperative outcomes including mortality, thoracoabdominal life altering events (TALE:composite of perioperative death, stroke, permanent paralysis and/or dialysis), spinal cord ischemia (SCI), acute kidney injury (AKI), major adverse cardiac events (MACE), myocardial infarction, and dialysis. ResultsThere were 2,925 eTAAA repairs during the study period. Procedure times ranged from <204 minutes in the first quartile to >365 minutes in the fourth. Longer cases more commonly involved older patients who were more often female, and higher rates of prior stroke, and preoperative anemia. They involved larger, more extensive aneurysms, with higher rates of prior aortic surgery, and more commonly employed PMEGs or parallel grafting to incorporate more branch vessels. In addition, they were less often staged procedures, and used more spinal drains, femoral cutdowns, and upper extremity access. Operating time decreased as experience increased. In adjusted analyses, the odds of mortality and every morbidity studied increased stepwise with operating time, with 4 to 13-fold higher odds in the highest quartiles. Spinal cord ischemia had the strongest association with procedure times, with seven-fold higher odds (OR 7.2 [2.9-17.9], P<.001) of any SCI in the highest quartile compared to the lowest, and 13-fold higher odds of permanent SCI (OR 13.1 [3.9-44.7], P<.001). These results were consistent when surgeons were grouped into quartiles by their median operating times. Medium-term mortality was also higher in the upper quartile of operating time (HR 2.7 [1.4-5.1], P=.002). ConclusionLonger operating times for complex eTAAA repairs were associated with markedly higher rates of morbidity and mortality, especially spinal cord ischemia. These results emphasize the importance of expeditious repairs by experienced teams.

Outcomes of Carotid Artery Stenting and Endarterectomy in Patients with Prior Contralateral Carotid Revascularization

Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are available treatment options for stroke prevention in individuals with severe carotid stenosis. This study aims to compare the early postoperative outcomes in patients who underwent CEA or CAS after prior contralateral carotid revascularization. We conducted a retrospective review of the Society of Vascular Surgery (SVS) Vascular Quality Initiative (VQI) database, identifying patients who had prior carotid artery revascularization followed by a contralateral CEA or CAS between 2017 and 2023. Based on the sequence of the procedures performed, patients were categorized into four groups: 1) patients who had a prior unilateral CEA followed by a contralateral CEA (CEA-CEA); 2) patients who had a prior unilateral CAS followed by a contralateral CEA (CAS-CEA); 3) patients had a prior unilateral CAS followed by a contralateral CAS (CAS-CAS); and 4) patients had a prior unilateral CEA followed by a contralateral CAS (CEA-CAS). Univariate analysis (Pearson χ 2, Wilcoxon rank sum test) and multivariate logistic regression were employed to assess length of stay, rates of in-hospital stroke, myocardial infarction, new-onset arrhythmia, and 30-day mortality. A total of 20,761 patients with a history of prior unilateral carotid revascularization procedures were identified, of which 12,788 underwent contralateral CEA and another 7,973 underwent contralateral CAS. Compared to the CAS-CAS group, patients who underwent CEA followed by contralateral CAS (CEA-CAS group) were associated with higher rates of postoperative in-hospital stroke (1.8% vs. 1%, P = 0.003), new-onset arrhythmia (2% vs. 1.2%, P=0.006), and 30-day mortality (1.3% vs. 0.8%, P = 0.04). On multivariate analysis, preoperative use of statins and beta-blockers was associated with lower odds of in-hospital stroke (OR 0.42; 95% confidence interval [CI] 0.29 - 0.69; P = 0.0002) and new-onset arrhythmia (OR 0.62; 95% CI 0.49 - 0.9; P = 0.01), respectively, after CAS. There were no significant differences in outcomes for CEA-CEA and CAS-CEA groups. Patients with prior CEA undergoing contralateral CAS had higher rates of in-hospital stroke, new-onset arrhythmia, and 30-day mortality. Beta-blockers may reduce postoperative arrhythmia rates in these patients, and established regimens should not be discontinued in the perioperative period; however, further prospective studies are needed to confirm this finding. Optimized medical treatment and appropriate imaging follow-up remain crucial for improvement outcomes.

Presence of Atherosclerosis in Multiple Arterial Beds is Associated with Increased Mortality in Patients Undergoing Endovascular Aortic Aneurysm Repair

Patients with polyvascular disease are considered high risk for major adverse cardiac events (MACEs). This retrospective study utilised the Vascular Quality Initiative (VQI) database to quantify the effect of polyvascular disease on outcomes after endovascular aneurysm repair (EVAR). The VQI database was queried from to 2012 - 2022 for elective EVAR. Patients were identified as having peripheral arterial disease, coronary artery disease, or cerebrovascular disease, and then stratified based on the number of arterial beds involved (one to three). Primary outcomes were peri-operative death and MACEs. Multivariate analysis was performed to find associations between comorbidities and primary outcomes. Of the 21 160 patients with arterial disease included in the study, 83.7% were male and the mean age was 73.73 ± 8.57 years. After stratification, 16 892 patients had atherosclerosis in one arterial bed, 3 869 in two arterial beds, and 399 in three arterial beds. Pre-operatively, patients with atherosclerosis in three arterial beds were more likely to have hypertension, diabetes, and renal failure (all p < .001). Post-operatively, patients with disease in three arterial beds were more likely to experience a post-operative complication (11.5% vs. 8.3% vs. 5.4%; p < .001), including MACE (4.6% vs. 4.1% vs. 2.8%; p < .001) and death (3.0% vs. 2.5% vs. 1.7%; p < .010). On multivariate analysis, polyvascular disease was associated with MACEs (odds ratio 1.54, 95% confidence interval 1.29 - 1.84; p < .001). Kaplan-Meier analysis estimates showed statistically significant differences in survival at approximately the three year follow up (p < .001). In this review of patients undergoing elective EVAR, patients with polyvascular disease experienced worse peri-operative outcomes, including death and MACEs, the latter of which was confirmed on multivariable analysis. These patients should be considered high risk and managed accordingly.

Outcomes of Prosthetic and Biological Grafts Compared to Arm Vein Grafts in Patients with Chronic Limb Threatening Ischemia

ObjectivesThe optimal conduit for infrainguinal bypass (IIB) is single segment great saphenous vein (GSV). Unfortunately, GSV is not always available in patients with chronic limb threatening ischemia (CLTI). Other graft choices include arm vein grafts (AV), prosthetic grafts (PG) or biologic grafts (BG). Current data regarding the durability and limb salvage rates of those options is scarce, hence we aimed to investigate the impact of alternative graft types on post-operative and long-term outcomes on IIB in patients with CLTI. MethodsThe Vascular Quality Initiative (VQI) database was queried for patients undergoing IIB from January 2003 to April 2024. Patients were stratified into three groups: arm vein (cephalic, basilic), prosthetic grafts [Dacron, polytetrafluoroethylene (PTFE)], and biologic grafts (cadaveric, homograft, or xenograft). Saphenous vein grafts (greater and lesser saphenous) were excluded. Multivariate logistic regression analyzed postoperative outcomes: 30-day mortality, major adverse cardiovascular events (MACE), graft occlusion, prolonged length of stay >7days (PLOS), packed red blood cell (pRBC) transfusion >2 units, and infection. Cox Regression was used to report one-year outcomes: mortality, major amputation (above-ankle), and major adverse limb events (MALE defined as major amputation, thrombectomy or reintervention). ResultsA total of 9165 IIB procedures have been analyzed: AV 417 (4.55%); PG 7520 (82.05%); BG 1228 (13.40%). Compared to AV, patients receiving PG had higher odds of infection (aOR 2.89, p=0.045) and higher hazard of one-year mortality (aHR 1.51, p=0.035). On the other hand, patients receiving BG had higher risk of graft occlusion (aOR 4.55, p=0.040) and infection (aOR 2.78, p=0.046) as well higher hazard of one-year mortality (aHR 1.53, p=0.040), amputation (aHR 1.72, p=0.019) and amputation or death (aHR 1.52, p=0.005) compared to AV. After stratifying by bypass configuration, AV had the highest overall survival and amputation-free survival among the three alternative conduits in below-knee popliteal and tibial bypass targets. ConclusionsIn this large multi-institutional study investigating alternative conduits to GSV, AV are found to be the most resistant to infections and are associated with the best overall survival and limb salvage outcomes compared to PG and BG particularly in below-knee distal targets. In cases where no GSV is available, AV and PG are acceptable alternatives with comparable one-year amputation-free survival and MALE-free survival rates. On the other hand, BG are associated with higher risk of graft occlusion and lower freedom from major amputation and death compared to AV.

Association of Anemia and Transfusion with Major Adverse Cardiac Events and Major Adverse Limb Events in Patients Undergoing Open Infrainguinal Bypass

Anemia is highly prevalent patients with peripheral vascular disease and has been associated with postoperative cardiac events and mortality, and adverse limb events after revascularization procedures. Allogenic blood transfusions have also been associated with adverse events including hospital acquired infections, cardiac morbidity and reduced survival. The aim of this study was to evaluate the impact of blood transfusion on major adverse cardiac events (MACE) and major adverse limb events (MALE) in patients undergoing infrainguinal lower extremity bypass operations. We performed a retrospective cohort analysis of patients undergoing infrainguinal lower extremity bypass in the Society for Vascular Surgery Vascular Quality Initiative database between 2003 and 2020. Patients were first grouped by their preoperative hemoglobin (Hgb) number (severe anemia: Hgb 7-10g/dL; moderate anemia: 10-12g/dL; normal Hgb: >12g/dL) and then stratified by their transfusion status (perioperative transfusion vs. no perioperative transfusion). Primary endpoints were MACE, defined as myocardial infarction, new congestive heart failure, dysrhythmia, or stroke in the postoperative period, and MALE, defined as return to operating room for thrombosis, loss of primary patency on follow-up and major ipsilateral amputation on follow-up. Secondary outcomes included wound complications, graft infections, 30-day mortality and 1-year survival. Outcomes were compared between patients who received transfusions and those who did not at every anemic threshold. Multivariable logistic regression was performed to evaluate the impact of blood transfusion on primary outcomes. A total of 55,884 patients were included for analysis, of which 16.3% had severe anemia, 25.9% had moderate anemia and 57.8% had normal hemoglobin. Anemia severity was associated with increased rates of MACE (9.8% vs. 8.3% vs. 5.2%, p<0.0001) and MALE (32.2% vs. 24.8% vs. 18.6%, p<0.0001). On univariate analysis, transfusion was consistently associated with increased rates of MACE and MALE at every anemic threshold (p<0.0001 for all). Transfusion was also associated with increased rates of 30-day mortality at all anemic thresholds (p<0.0001 for all) and reduced 1-year survival at all anemic thresholds (log-rank p<0.0001 for all). On multivariable analysis for MACE, an interaction factor was observed between preoperative Hgb and transfusion status (p<0.0001). At every anemic threshold, transfusion was independently associated with MACE (severe: OR 2.4 [95% CI: 2.0 - 2.9]; moderate: OR 2.8 [95% CI: 2.5 - 3.2]; normal: OR 4.5 [95% CI: 4.0 - 5.0]). On multivariable analysis for MALE, an interaction factor was also observed between preoperative Hgb and transfusion status (p<0.0001). At every anemic threshold, transfusion was independently associated with MALE (severe: OR 2.1 [95% CI: 1.9 - 2.3]; moderate: OR 1.8 [95% CI: 1.7 - 2.0]; normal: OR 2.6 [95% CI: 2.4 - 2.8]). Perioperative blood transfusion in patients undergoing infrainguinal lower extremity bypass is independently associated with MACE and MALE in all patients with preoperative Hgb > 7 g/dL. Despite the morbidities associated with anemia, these findings highlight that transfusion may not be the optimal treatment modality, particularly in patients with higher preoperative Hgb. Future research is needed to define the transfusion threshold in this population.

Impact of Chronic Kidney Disease on Outcomes following Vascular Procedure in the Vascular Quality Initiative.

Chronic kidney disease (CKD) increases morbidity and mortality in most vascular procedures. However, a binary classification of estimated glomerular filtration rate (eGFR) <60mL/min/1.73 m2, which is often used in both modeling and clinical trials, may not be optimal for predicting clinical outcomes. Determine the optimal eGFR cutoff for use in risk stratification and prediction models. Vascular Quality Initiative (VQI) data for non-emergent, first-time OAR, EVAR, TEVAR, CEA, CAS, PVI, Supra- and infra-inguinal bypass were analyzed from to 2013-2023 and divided into cohorts based on eGFR (≥60, 45-59, 30-44, <30, and preoperative dialysis). χ2 and logistic regression were used to evaluate perioperative outcomes. Compared to patients with eGFR ≥60, those with eGFR 45-59 had similar odds of mortality following all procedures, except TEVAR. Driven by this group, the combined cohort showed a slight increase in the odds of mortality for eGFR 45-59 (0.6% vs. 0.7%, aOR 1.16, P=0.002). Those in the 30-44 group demonstrated increased odds of mortality both overall and in the individual procedure groups (0.6% vs. 1.2%, aOR 1.78, P<0.001). The odds of mortality continued to increase with worsening eGFR. The overall rate of new permanent dialysis was low for all eGFR cohorts, with a 0.02% difference between those with eGFR >60 and those in the 45-59 cohort (0.04% vs. 0.06%; a OR 1.65, P<0.001). The odds of permanent dialysis likewise continued to increase with decreasing eGFR. Rather than a binary eGFR cutoff of ≥60 and <60 to stratify patient risk, better risk stratification may be achieved by using five groups of ≥60, 45-59, 30-44, <30, and preoperative dialysis.

Factors associated with nonhome discharge after endovascular aneurysm repair

ObjectiveThis study aims to identify preoperative factors associated with nonhome discharge (NHD) after endovascular aneurysm repair (EVAR). NHD has implications for patient care, readmission, and long-term mortality; nevertheless, the existing literature lacks information regarding factors associated with NHD for patients undergoing EVAR. In contrast, our study assesses preoperative factors associated with NHD for this population by using national data from the Vascular Quality Initiative. MethodsWe identified adult patients who underwent elective EVAR in the Vascular Quality Initiative (2003-2022) and excluded those who were not living at home preoperatively. Multivariable logistic regression was used to identify preoperative factors associated with NHD. Kaplan-Meier methods and Cox-regression analyses were used to assess the impact of NHD on 5-year survival as a secondary outcome. ResultsWe included 61,792 patients, of which 3155 (5.1%) had NHD. NHD patients were more likely to be older (79 years [interquartile range, 73-18 years] vs 73 years [interquartile range, 67-79 years]), female (33.7% vs 18.2%; P < .001), non-White (16.0% vs 11.7%; P < .001), and have more comorbidities. NHD patients had higher rates of postoperative complications (acute kidney injury, 11.9% vs 2.0% [P < .001]; myocardial infarction, 3.8% vs 0.5% [P < .001]; and in-hospital reintervention, 4.7% vs 0.5% [P = .033]). Multivariable analysis revealed many preoperative characteristics were associated with higher odds of NHD: most notably, age (per additional decade: odds ratio [OR], 2.15; 95% confidence interval [CI], 2.03-2.28; P < .001), female sex (OR, 1.79; 95% CI, 1.63-1.95; P < .001) and aneurysm diameter >65 mm (OR, 2.18; 95% CI, 1.98-2.39; P < .001), along with potentially modifiable factors, including anemia, chronic obstructive pulmonary disease, chronic heart failure, weight, and diabetes. In contrast, aspirin, statin, and angiotensin-converting enzyme inhibitor/angiotensin II receptor blocekr use were associated with lower odds of NHD. NHD was associated with higher hazards of 5-year mortality, even after adjusting for confounders (40% vs 14%; adjusted hazard ratio, 2.13; 95% CI, 1.86-2.44; P < .001). ConclusionsSeveral factors were associated with higher odds of NHD after elective EVAR, including nonmodifiable factors such as female sex and larger aortic diameter, and potentially modifiable factors such as anemia, chronic obstructive pulmonary disease, chronic heart failure, body mass index, and diabetes. Special attention should be given to populations with nonmodifiable factors, and efforts at optimizing medical conditions with higher NHD likelihood seems appropriate to improve patient outcomes and quality of life after EVAR.

Race and the treatment of in-stent restenosis of the femoral-popliteal artery with paclitaxel drug-coated balloon angioplasty

ObjectiveThe aim of this study was to report the impact of race on paclitaxel drug-coated balloon (DCB) angioplasty for the treatment of femoral-popliteal artery in-stent restenosis (ISR). MethodsA prospective, non-randomized, post-market study of a paclitaxel DCB for the treatment of ISR of femoral-popliteal artery was conducted at 43 sites within the Vascular Quality Initiative (December 2016-January 2020). The primary endpoint was freedom from target lesion revascularization (F-TLR) through 12 months. Secondary endpoints included freedom from target vessel revascularization (F-TVR), freedom from major limb amputation, and survival. In this sub-analysis, the results were stratified by self-identified Black vs White race. ResultsBlack patients (n = 63) had a lower mean age (64.3 ± 9.7 vs 68.2 ± 9.7 years; P = .006) and were more often female (57.1% vs 37.0%; P = .004) compared with White patients (n = 219). Most patients had claudication (80.9%), with Black patients presenting with a higher rate of ischemic rest pain (30.2% vs 16.0%; P = .012). By Kaplan-Meier estimates, F-TLR was 91.3% vs 89.1% (log-rank P = .63) and 66.4% vs 74.0% (log-rank P = .41) at 12 and 24 months for Black vs White race. F-TVR was 87.8% vs 87.6% (log-rank P = .96) and 61.3% vs 70.6% (log-rank P = .29) at 12 and 24 months for Black vs White race. Freedom from major target limb amputation was 100.0% vs 99.5% (log-rank P = .59) and 100.0% vs 99.0% (log-rank P = .45) at 12 and 24 months for Black vs White race. Survival was 93.7% vs 95.9% (log-rank P = .47) and 84.1% vs 91.3% (log-rank P = .11) at 12 and 24 months for Black vs White race. In multivariable analysis, no significant predictors were identified for TLR or TVR through 24- months. Dialysis (hazard ratio [HR], 27.69; 95% confidence interval [CI], 10.35-74.09; P < .001), coronary disease (HR, 2.80; 95% CI, 1.29-6.06; P = .009), and lesion length (HR, 1.04; 95% CI, 1.02-1.07; P = .001) were associated with increased mortality through 24 months. Race was not significantly associated with TLR, TVR, or mortality. ConclusionsIn this sub-analysis of a Vascular Quality Initiative-based study, the treatment of femoral-popliteal ISR with paclitaxel angioplasty was equally safe and effective for Black and White races. The trend in reduced survival for patients of Black race at 2 years requires longer observation in a larger study.

Retroperitoneal vs transperitoneal approach for nonruptured open conversion after endovascular aneurysm repair

ObjectiveSeveral studies comparing the transperitoneal (TP) and retroperitoneal (RP) approach for abdominal aortic aneurysm (AAA) repair suggest that the RP approach may result in lower rates of perioperative mortality and morbidity. However, data comparing these approaches for open conversion are lacking. This study aims to evaluate the association between the type of approach and outcomes following open conversion after endovascular aneurysm repair (EVAR). MethodsWe included all patients who underwent open conversion after EVAR between 2010 and 2022 in the Vascular Quality Initiative. Patients presenting with rupture were excluded. The primary outcome was perioperative mortality. The secondary outcomes included perioperative complications and 5-year mortality. Inverse probability weighting was used to adjust for factors with statistical or clinical significance. Logistic regression was used to assess perioperative mortality and complications in the weighted cohort. The 5-year mortality was evaluated using Kaplan-Meier and Cox regression. ResultsWe identified 660 patients (39% RP) who underwent open conversion after EVAR. Compared with TP, RP patients were older (75 years [interquartile range, 70-79 years] vs 73.5 years [interquartile range, 68-79 years]; P < .001), and more frequently had prior myocardial infarction (33% vs 22%; P = .002). Compared with the TP approach, the RP approach was used less frequently in cases of associated iliac aneurysm (19% vs 27%; P = .026), but more frequently with associated renal bypass (7.8% vs 1.7%; P < .001) and by high-volume physicians (highest quintile, >7 AAA annually: 41% vs 17%; P < .001) and in high-volume centers (highest quintile, >35 AAA annually: 36% vs 20%; P < .001). RP patients, compared with TP patients, were less likely to have external iliac or femoral distal anastomosis (8.2% vs 21%; P < .001), and an infrarenal clamp (25% vs 36%; P < .001). Unadjusted perioperative mortality was not significantly different between approaches (RP vs TP: 3.8% vs 7.5%; P = .077). After risk adjustment, RP patients had similar odds of perioperative mortality (adjusted odds ratio [aOR], 0.49; 95% confidence interval [CI], 0.22-1.10; P = .082), and lower odds of intestinal ischemia (aOR, 0.26; 95% CI, 0.08-0.86; P = .028) and in-hospital reintervention (aOR, 0.43; 95% CI, 0.22-0.85; P = .015). No significant differences were found in the other perioperative complications or 5-year mortality (aHR, 0.79; 95% CI, 0.47-1.32; P = .37). ConclusionsOur findings suggest that the RP approach may be associated with a lower adjusted odds of perioperative complications compared with the TP approach. The RP approach should be considered for open conversion after EVAR when feasible.

Competing risk analysis to estimate amputation incidence and risk in lower-extremity peripheral artery disease.

Background: Patients with peripheral artery disease face high amputation and mortality risk. When assessing vascular outcomes, consideration of mortality as a competing risk is not routine. We hypothesize standard time-to-event methods will overestimate major amputation risk in chronic limb-threatening ischemia (CLTI) and non-CLTI. Methods: Patients undergoing peripheral vascular intervention from 2017 to 2018 were abstracted from the Vascular Quality Initiative registry and stratified by mean age (⩾ 75 vs < 75 years). Mortality and amputation data were obtained from Medicare claims. The 2-year cumulative incidence function (CIF) and risk of major amputation from standard time-to-event analysis (1 - Kaplan-Meier and Cox regression) were compared with competing risk analysis (Aalen-Johansen and Fine-Gray model) in CLTI and non-CLTI. Results: A total of 7273 patients with CLTI and 5095 with non-CLTI were included. At 2-year follow up, 13.1% of patients underwent major amputation and 33.4% died without major amputation in the CLTI cohort; 1.3% and 10.7%, respectively, in the non-CLTI cohort. In CLTI, standard time-to-event analysis overestimated the 2-year CIF of major amputation by 20.5% and 13.7%, respectively, in patients ⩾ 75 and < 75 years old compared with competing risk analysis. The standard Cox regression overestimated adjusted 2-year major amputation risk in patients ⩾ 75 versus < 75 years old by 7.0%. In non-CLTI, the CIF was overestimated by 7.1% in patients ⩾ 75 years, and the adjusted risk was overestimated by 5.1% compared with competing risk analysis. Conclusions: Standard time-to-event analysis overestimates the incidence and risk of major amputation, especially in CLTI. Competing risk analyses are alternative approaches to estimate accurately amputation risk in vascular outcomes research.

Impaired Pre-operative Ambulatory Capacity in Patients Undergoing Elective Endovascular Infrarenal Abdominal Aortic Aneurysm Repair is Associated with Increased Peri-operative Death

While ambulatory capacity is a readily assessable clinical indicator of functional status, its association with outcomes after endovascular aneurysm repair (EVAR) remains underexplored. This study aimed to investigate the association between pre-operative ambulatory status and outcomes following elective EVAR. A retrospective review of the multi-institutional Vascular Quality Initiative database was conducted for all patients who underwent elective infrarenal EVAR from 2009 - 2022. Patients were categorised into independent ambulation and impaired ambulation groups. A propensity score matched analysis was performed to produce two well matched cohorts in a 1:1 ratio without replacement. The primary outcome was 30 day death. Secondary outcomes included one year survival and in hospital major complications. Among 11 474 patients, 10 539 (91.8%) were independently ambulatory pre-operatively. Propensity score matching resulted in 885 matched pairs. The impaired ambulation group, although older (mean 77.6 vs. 76.3 years; p= .001), showed comparable baseline characteristics. Post-operatively, the impaired ambulation group had higher cumulative in hospital complications and death as well as 30 day death. Even after adjustment for age, impaired pre-operative ambulation was associated with increased in hospital and 30 day death (hazard ratio [HR] 2.27, 95% confidence interval [CI] 1.26 - 3.95; p= .006). Multivariable analysis demonstrated increasing cumulative risk of 30 day death in the setting of impaired pre-operative ambulatory status with age > 75 years requiring post-operative red blood cell transfusion > 2 units (HR 5.75, 95% CI 2.09 - 15.88; p < .001). Beyond 30 days, impaired pre-operative ambulation was not associated with increased one year death (HR 1.09, 95% CI 0.81 - 1.48; p= .570). Among patients who underwent elective infrarenal EVAR in this matched analysis, impaired pre-operative ambulatory capacity was associated with an increased risk of in hospital and 30 day death, further compounded by advanced age and post-operative transfusion. As such, a threshold higher than the traditional size criteria should be considered in shared decision making when determining options for the management of abdominal aortic aneurysm in this high risk cohort.