Research

OBJECTIVES: Data evaluating outcomes among patients with single-vessel tibial runoff are limited. Our aim was to compare outcomes across patients with sole anterior tibial (AT), peroneal, or posterior tibial (PT) runoff following revascularization for chronic limb-threatening ischemia (CLTI), and to evaluate whether the quality of peroneal communicating branches affects outcome risk within the peroneal runoff population.

METHODS: All patients undergoing first-time revascularization for CLTI were retrospectively reviewed (2005-2022) and stratified by sole runoff vessel (AT, peroneal, PT). Primary outcomes were wound healing, major amputation, major adverse limb events (MALE), and amputation/death, assessed by Kaplan-Meier analysis and multivariable Cox regression. A subset analysis stratified single-vessel peroneal runoff patients into a three-tiered, Peroneal Communicating Branch (PCB) Grade: Both branches present with at least one robust (PCB Grade 1), a single robust branch (PCB Grade 2), or no robust branch (PCB Grade 3), and compared each to the single-vessel AT/PT reference group.

RESULTS: Overall, 732 patients had single-vessel below-knee runoff: 225 AT, 315 peroneal, and 192 PT. Groups differed significantly in age, sex, and diabetes prevalence. Unadjusted two-year major amputation rates were significantly higher in the peroneal group (19% vs. 9.4% [AT] vs. 8.7% [PT]; P<.001), as were MALE rates (30% vs. 14% vs. 26%; P=.01). After adjustment, peroneal runoff was independently associated with higher risk of major amputation (HR 1.81 [1.04-3.13]) and MALE (HR 1.52 [1.03-2.25]) compared with AT/PT runoff. These associations persisted in the endovascular cohort (major amputation: HR 2.09 [1.06-4.13]; MALE: HR 1.59 [1.08-2.35]) but did not reach significance in the bypass cohort, which was limited by low event rates. When patients with single-vessel peroneal runoff were stratified by PCB Grades, unadjusted one-year major amputation rates followed a clear anatomically-driven pattern (6.9% (AT/PT) vs. 5.4% (PCB Grade 1) vs. 15% (PCB Grade 2) vs. 32% (PCB Grade 3); P<.001). After adjustment, when compared to AT/PT runoff, patients without any robust branch (PCB Grade 3) had significantly higher risk of major amputation (HR 3.21 [1.76-4.84]) and MALE (HR 2.41 [1.53-3.79]), while those with two branches with at least one being robust (PCB Grade 1) demonstrated higher rates of complete wound healing (HR 1.69 [1.09-2.62]) and no difference in major amputation or MALE.

CONCLUSIONS: Peroneal runoff is independently associated with worse limb outcomes following revascularization for CLTI, but this risk may be primarily driven by patients with absent or diminutive communicating branches. Those with robust branching demonstrate outcomes comparable to AT/PT runoff, underscoring the importance of further evaluation and pre-operative assessment of peroneal communicating branch quality - using the proposed PCB Grading system - in revascularization planning.

OBJECTIVE: Despite advances in the management of chronic limb-threatening ischemia (CLTI), a large proportion of these patients are not candidates for traditional revascularization and may be destined for major amputation. Given this medically complex and no-option patient population, deep venous arterialization (DVA) has been recently revitalized as a limb salvage technique, whereby an arteriovenous fistula in the lower leg is created to supply more oxygenated blood via the venous system to the foot. Recently, PROMISE II (Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia) demonstrated a 6-month amputation-free survival (AFS) rate of 66% after DVA. With this trial in mind, our study aimed to evaluate the real-world outcomes of this procedure.

METHODS: The study population included all patients undergoing a DVA from January 1, 2021, through December 31, 2023 among fee-for-service beneficiaries identified in the Medicare Fee-for-Service Carrier Claims file. DVA procedures were identified using Current Procedural Terminology code 0620T. Outcomes included limb salvage, freedom from major adverse limb events (defined as major amputation or ipsilateral reintervention), survival, and AFS. Cumulative incidences for outcomes that include death were estimated from traditional Kaplan-Meier methods; for non-death end points, outcomes were estimated from the cumulative incidence function, accounting for the competing risk of death.

RESULTS: Between 2021 and 2023, 134 patients underwent a DVA for CLTI. Among these, the median age was 70 years and the majority of patients were male (66%), White (63%), and had tissue loss (72%), hypertension (99%), hyperlipidemia (96%), chronic kidney disease (89%), and diabetes (83%). After a DVA for CLTI, the 6-month and 1-year AFS incidences were 42% and 33%, respectively. One-year incidences of limb salvage, freedom from major adverse limb events, and survival were 53%, 36%, and 65%, respectively.

CONCLUSIONS: Among patients with no traditional options for revascularization, our data demonstrate that DVA is a procedure that is, by its nature, performed on high-risk individuals who continue to have a high risk of limb loss and mortality. Importantly, AFS in our analysis was notably worse than that reported in PROMISE II and, as such, raises questions about the generalizability of this procedure in real world practice. Further investigation is needed regarding patient selection criteria for and the clinical usefulness of the DVA procedure.

OBJECTIVE: Routine imaging surveillance following endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) is critical for the timely diagnosis of late postoperative complications. Compliance with recommended EVAR surveillance is variable, and disparities in post-EVAR surveillance remain unclear. This study examines variability in EVAR surveillance and emergency health service use across several sociodemographic populations.

METHODS: All Medicare fee-for-service beneficiaries who underwent infrarenal EVAR for intact abdominal aortic aneurysm between January 2011 and December 2019 were included. Patients were stratified by several sociodemographic characteristics: age category (66-74, 75-84, >85 years), sex (male, female), race (White, Black, Asian, other), dual enrollment in Medicare and Medicaid (dual enrolled, Medicare only), and distressed communities index (distressed >80th percentile, nondistressed ≤80th percentile). The following postoperative health care use metrics were assessed: EVAR-related office visits, imaging studies, emergency department (ED) visits, and hospital readmissions. Annual incidence rates were calculated for each health care use metric at 2 and 5 years after EVAR and compared across groups using Poisson regression models, adjusting for sociodemographic and hospital characteristics and comorbidities.

RESULTS: In 111,381 Medicare beneficiaries who underwent EVAR, postoperative health care use varied substantially across sociodemographic groups. After adjustment, annual incidence rates of EVAR-related office visits at 2 years post EVAR were lower in patients who were >85 years vs 66-75 years (adjusted rate ratio [aRR], 0.95; 95% confidence interval [CI], 0.93-0.97), female vs male (aRR, 0.94; 95% CI, 0.93-0.95), dual enrolled vs Medicare only (aRR, 0.83; 95% CI, 0.81-0.85), and residing in distressed vs nondistressed communities (aRR, 0.95; 95% CI, 0.93-0.96). Rates of imaging studies were lower in patients who were >85 years (aRR, 0.98; 95% CI, 0.96-0.99), dual enrolled (0.97; 95% CI, 0.95-0.98), and residing in distressed communities (aRR, 0.97; 95% CI, 0.96-0.98). There was higher use of hospital services in patients who were >85 years (ED: aRR, 1.37; 95% CI, 1.33-1.41; readmission: aRR, 1.23; 95% CI,1.19, 1.28), female (ED: aRR, 1.19; 95% CI, 1.16-1.22; readmission: aRR, 1.15; 95% CI, 1.12-1.19), Black (ED: aRR, 1.10; 95% CI, 1.05-1.15; readmission: aRR, 1.15; 95% CI, 1.09-1.22), dual-enrolled (ED: 1.29; aRR, 95% CI, 1.26-1.33; readmission: aRR, 1.14; 95% CI, 1.09-1.18), and residing in distressed communities (ED: aRR, 1.03; 95% CI, 1.01-1.06; readmission: aRR, 1.02; 95% CI, 0.99-1.05). At 5 years post EVAR, similar trends across sociodemographic groups were observed, with the added finding of lower rates of EVAR-related office visits in Black vs White patients.

CONCLUSIONS: Significant variation in post-EVAR health care use exists among Medicare beneficiaries. Patients who were older age, of female sex, of Black race, or socioeconomically disadvantaged had lower rates of EVAR-specific follow-up and higher use of emergency health service. Barriers in access to care are apparent, underscoring the need for targeted interventions to enhance post-EVAR surveillance and improve outcomes in these populations.

OBJECTIVE: BASIL-2 demonstrated the superiority of an endovascular-first approach in patients with chronic limb-threatening ischemia (CLTI) for the primary endpoint of amputation-free survival (AFS); however, the generalizability of these data are unknown. Thus, we aimed to externally validate these findings by comparing open surgical bypass (BPG) to angioplasty ± stenting (PTA/S), using the BASIL-2 inclusion and randomization criteria.

METHODS: All patients undergoing a first-time lower extremity infrapopliteal revascularization for CLTI at our institution from 2005 to 2022 were retrospectively reviewed. To approximate BASIL-2, one-to-one propensity matching was performed. The primary outcome was AFS; secondary outcomes included perioperative complications, major reintervention, major amputation, and major adverse limb events (MALE). A sensitivity analysis was performed assessing the same PTA/S cohort vs BPG with only single-segment great saphenous vein (ssGSV) conduits. Outcomes in the matched cohorts were evaluated using χ2, Kaplan-Meier, and Cox regression analyses.

RESULTS: Of 1184 limbs undergoing a first-time infrapopliteal intervention for CLTI between 2005 and 2022, 490 underwent BPG, and 694 underwent PTA/S. After matching, 620 patients (310 BPG and 310 PTA/S) fit our criteria, with no baseline differences noted between groups. Between BPG and PTA/S, the mean age was 71.0 years in both groups, with similar rates of male sex (64% vs 66%), White race (74% vs 75%), coronary artery disease (49% vs 52%), diabetes (75% vs 77%), chronic kidney disease (27% vs 34%), dialysis dependence (17% vs 19%), and smoking history (65% vs 66%). There were no differences in perioperative mortality (4.5% vs 3.9%), stroke (1.0% vs 0.0%), myocardial infarction (2.9% vs 1.3%), or acute kidney injury (12% vs 16%) (all P > .05). BPG, as compared with PTA/S, did not demonstrate any difference in AFS (at 5 years, 36% vs 39%), major reintervention (15% vs 19%), major amputation (24% vs 22%), or MALE (32% vs 36%) (all P > .05). When limiting the BPG group to only ssGSV conduits (n = 267), despite no difference seen in AFS (32% vs 36%), we noted significantly lower rates of major reintervention (12% vs 19%) and MALE (29% vs 36%), demonstrating a 48% and 30% risk reduction, respectively (hazard ratio, 0.52; 95% confidence interval, 0.30-0.89 and 0.69; 95% confidence interval, 0.49-0.98).

CONCLUSIONS: Among patients undergoing infrapopliteal revascularization for CLTI, BPG and PTA/S do not differ in regard to AFS, raising concerns regarding the generalizability of BASIL-2. Importantly, infrapopliteal interventions following ssGSV BPG, as compared with PTA/S, do demonstrate significantly lower rates of major reintervention and MALE, reinforcing the benefits of this conduit in patients with CLTI.

OBJECTIVE: Socioeconomic disparities are known to contribute to adverse outcomes after surgery; however, the role of individual wealth and neighborhood environment on both follow-up and outcomes following endovascular aneurysm repair (EVAR) are not well-understood.

METHODS: We included all fee-for-service Medicare beneficiaries aged ≥66 years who underwent infrarenal EVAR with a bifurcated endograft for intact abdominal aortic aneurysm (AAA) from 2011 to 2019. Patients were divided into cohorts using dual enrollment in Medicare/Medicaid (vs Medicare only) as a measure of individual wealth and residence in a distressed community (vs non-distressed community) as a measure of regional wealth (as defined by the Distressed Community Index [DCI]). The primary outcome was the composite of late aneurysm rupture, aortic reintervention, conversion to open repair, or all-cause mortality at 9 years. The cumulative incidence of the primary composite outcome was determined using Kaplan-Meier methods and compared across groups using log-rank tests.

RESULTS: Of 111,381 patients who underwent EVAR, 9991 (9.0%) were dual-enrolled in Medicare/Medicaid, and 22,902 (21%) lived in distressed communities. A higher incidence of the primary outcome was observed in dual-enrolled vs Medicare-only patients (83% vs 72%; hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.38-1.47; P < .01) and in those living in distressed vs non-distressed communities (75% vs 72%; HR, 1.09; 95% CI, 1.06-1.11; P < .01). After adjustment for comorbidities and other disparity measures, the association between dual enrollment or DCI and the primary outcome was attenuated but remained significant (adjusted HR [aHR], 1.19; 95% CI, 1.15-1.23; aHR, 1.03; 95% CI, 1.00,1.05, respectively). When mortality was removed from the primary outcome, the relationships between dual enrollment or DCI and the composite outcome were no longer significant after adjustment (aHR, 1.02; 95% CI, 0.93-1.13; aHR, 0.95; 95% CI, 0.89-1.05). Among EVAR-specific secondary outcomes, rates of 9-year all-cause mortality and late rupture were higher in dual-enrolled vs Medicare-only patients, and mortality rates were higher in distressed vs non-distressed patients. In addition, both dual-enrolled and residents of distressed communities had lower rates of EVAR-related office visits and AAA-related imaging in follow-up and higher rates of emergency department visits.

CONCLUSIONS: Among Medicare beneficiaries who underwent EVAR for AAA, socioeconomically disadvantaged beneficiaries had a higher incidence of the primary composite outcome, driven primarily by higher all-cause mortality. This study highlights the need for interventions targeted at improving access to appropriate disease surveillance and management of comorbidities for patients who are most vulnerable.

OBJECTIVE: In 2023, the Centers for Medicare and Medicaid Services expanded coverage for transfemoral carotid artery stenting (tfCAS) to include standard-risk patients. Given this shift, we sought to identify predictors of postoperative stroke in patients undergoing tfCAS.

METHODS: We analyzed Vascular Quality Initiative data from 2011 to 2024, identifying tfCAS patients treated for atherosclerosis or restenosis. We excluded patients with interventions outside the internal carotid artery or bifurcation and procedures with concurrent intracranial treatment. We then stratified patients based on in-hospital postoperative stroke status. Baseline characteristics and outcomes were compared using χ2 tests, and factors associated with stroke risk were compared using logistic regression. Ten-fold cross-validation was used to identify predictors of stroke, and a point system was developed to predict the risk of in-hospital postoperative stroke.

RESULTS: In our cohort of 35,346 tfCAS cases, 693 patients (2%) had an in-hospital post-procedure stroke. Patients who had a post-procedure stroke were older, more likely to be female, non-White, and had a higher overall comorbidity burden. After 10-fold cross-validation using the original logistic regression model, the factors most strongly associated with increased odds of stroke included uncontrolled hypertension (23% vs 14%; adjusted odds ratio [aOR], 2.66; 95% confidence interval [CI], 1.94-3.71; P < .001), emergent surgery (41% vs 32%; aOR, 2.39; 95% CI, 1.74-3.27; P < .001), severe distal tortuosity (13% vs 8%; aOR, 1.62; 95% CI, 1.25-2.27; P < .001), age greater than 75 years (41% vs 32%; aOR, 1.53; 95% CI, 1.23-1.92; P < .001), preoperative stroke (44% vs 29%; aOR, 1.57; 95% CI, 1.30-1.90; P < .001), prior carotid endarterectomy (14% vs 12%; aOR, 1.44; 95% CI, 1.14-1.81; P = .002), type III arch (7.1% vs 5.5%; aOR, 1.45; 95% CI, 1.02-2.03; P = .03), and circumferential or protruding calcification (3.3% vs 1.7%; aOR, 1.43; 95% CI, 1.04-1.93; P = .02). Dual antiplatelet therapy and having a high-volume physician or center were associated with lower odds of stroke. Based on variable importance, a simplified point system was developed to predict postoperative stroke (receiver operating characteristic area under the curve = 0.68).

CONCLUSIONS: The identified mediators of stroke risk after tfCAS offer the opportunity to improve patient selection. These data highlight the importance of managing modifiable factors preoperatively, such as hypertension and antiplatelet therapy. The timing of surgery also emerged as a strong predictor of stroke, suggesting the need for careful consideration of the need for emergent or urgent surgery. Anatomic considerations such as vessel tortuosity, arch type, and calcification should also prompt consideration for an alternate revascularization strategy.