Publications

OBJECTIVE: To determine the optimal estimated glomerular filtration rate (eGFR) cutoff for use in risk stratification and prediction models.

BACKGROUND: Chronic kidney disease increases morbidity and mortality in most vascular procedures. However, a binary classification of eGFR <60 mL/min/1.73 m 2 , which is often used in both modeling and clinical trials, may not be optimal for predicting clinical outcomes.

METHODS: Vascular quality initiative data for nonemergent, first-time open aortic repair, endovascular aortic aneurysm repair, thoracic endovascular aortic repair, carotid endarterectomy, carotid artery stenting, peripheral vascular intervention, supra-inguinal bypass, and infra-inguinal bypass were analyzed from 2013 to 2023 and divided into cohorts based on eGFR (≥60, 45-59, 30-44, <30, and preoperative dialysis). χ 2 and logistic regression were used to evaluate perioperative outcomes.

RESULTS: Compared with patients with eGFR ≥60, those with eGFR 45 to 59 had similar odds of mortality following all procedures, except thoracic endovascular aortic repair. Driven by this group, the combined cohort showed a slight increase in the odds of mortality for eGFR 45 to 59 (0.6% vs 0.7%, adjusted odds ratio(aOR): 1.16, P = 0.002). Those in the 30 to 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 to 59 cohort (0.04% vs 0.06%; aOR: 1.65, P < 0.001). The odds of permanent dialysis likewise continued to increase with decreasing eGFR.

CONCLUSIONS: Rather than a binary eGFR cutoff of ≥60 and <60 to stratify patient risk, better risk stratification may be achieved by using 5 groups of ≥60, 45 to 59, 30 to 44, <30, and preoperative dialysis.

OBJECTIVE: In October 2023, Centers for Medicare & Medicaid Services (CMS) approved transfemoral carotid artery stenting (tfCAS) for standard-risk patients. Thus, we sought to compare outcomes among tfCAS, transcarotid artery revascularization (TCAR), and carotid endarterectomy (CEA) in standard-risk and high-risk patients.

METHODS: All carotid revascularization procedures in the Vascular Quality Initiative after the CMS decision (October 2023-March 2025) were analyzed. Patients were classified as standard-risk or high-risk per CMS criteria and stratified by symptom status. The primary outcome was perioperative stroke/death. Inverse probability of treatment weighting was performed to mitigate selection bias in high-risk patients and included demographics, comorbidities, physician volume, and operative characteristics. Inverse probability of treatment weighting was also applied to symptomatic standard-risk patients to account for the large proportion of tfCAS cases performed outside of Society for Vascular Surgery guidelines.

RESULTS: Overall, 57,843 patients underwent revascularization (9123 tfCAS, 21,814 TCAR, and 26,906 CEA). Before weighting, tfCAS patients were more often symptomatic (standard-risk: tfCAS: 45% vs TCAR: 25% vs CEA: 31%, P < .01; high-risk: 35% vs 24% vs 28%, P < .01), more frequently had a modified Rankin score of 4 or 5 (standard-risk: 7.7% vs 2.4% vs 1.7%; high-risk: 6.6% vs 2.6% vs 2.4%, P < .01), and more frequently underwent urgent or emergent surgery (standard-risk: 33% vs 11% vs 16%, high-risk: 28% vs 12% vs 17%, P < .01). Standard-risk asymptomatic patients undergoing tfCAS had the highest rates of perioperative stroke/death (1.6% vs 1.2% vs 1.0%, P = .01), as did symptomatic patients (2.9% vs 1.9% vs 1.7%, P = .01). tfCAS was associated with higher overall odds of stroke/death compared with CEA (odds ratio [OR]: 1.89 [1.43, 2.48], P < .01) and TCAR (OR: 1.59 [1.15, 2.18], P < .01). Compared with CEA, tfCAS was associated with higher odds of stroke/death in both asymptomatic (OR: 1.71 [1.12, 2.55], P = .01) and symptomatic patients (adjusted OR [aOR]: 1.78 [1.21, 2.56], P < .01). After weighting, there were no significant differences in perioperative stroke/death overall for either tfCAS or TCAR compared with CEA in standard-risk symptomatic patients. In high-risk patients, TCAR was associated with lower odds of perioperative stroke/death overall compared with CEA (1.5% vs 2.1%, aOR: 0.75 [0.59, 0.94], P = .01), whereas tfCAS had higher odds of stroke/death compared with TCAR (1.5% vs 2.4%, aOR: 1.57 [1.25, 1.98], P < .01).

CONCLUSIONS: In this retrospective analysis, there were higher odds of perioperative stroke/death when comparing tfCAS with CEA overall and among asymptomatic and symptomatic standard-risk patients, as well as overall compared with TCAR. In high-risk patients, TCAR performed better with lower odds of stroke/death compared with both CEA and tfCAS.

OBJECTIVE: To evaluate the real-world safety and efficacy for standard surgical risk patients with extracranial internal carotid artery disease undergoing transcarotid artery revascularization.

METHODS: ROADSTER 3 is a prospective, multicenter, single-arm post-approval study. Patients <80 years old without anatomic or physiologic high-risk factors were included. Thirty-day incidence of major adverse events (stroke, death, or myocardial infarction) and cranial nerve injury were assessed. An independent clinical events committee adjudicated events, and independent certified health care personnel performed neurological assessments.

RESULTS: Between 2022 and 2024, 344 patients (intent to treat population) were enrolled at 48 sites in the United States. Because of 24 major protocol deviations, 320 patients remained in the Food and Drug Administration's analysis population (per protocol). In the per protocol population, there were 136 (42.5%) females and 49 (15.3%) symptomatic patients. Among symptomatic patients, 12 (24.5%) were treated within 2 weeks of the prior event. Technical success was 100%. For the entire study population, there were strokes in 3 patients with no instances of death or myocardial infarction. The 2 instances of cranial nerve injury (0.6%; 95% CI, 0.1-2.2% in the per protocol population) both resolved within 6 months. The composite 30-day stroke/death/myocardial infarction rate was 0.6% (95% CI, 0.1-2.2%) for the per protocol population and 0.9% (95% CI, 0.2-2.5%) for the intent to treat population.

INTERPRETATION: The 30-day results of the ROADSTER 3 study confirm that transcarotid artery revascularization is safe and effective in the standard-risk population. Longer-term follow-up is pending to confirm durable stroke prevention for these patients. ANN NEUROL 2026;99:705-712.

OBJECTIVE: Both standard and low-profile endografts have been used for physician-modified endografts (PMEGs) to treat complex aortic aneurysms; however, recent data from a 2025 multi-institutional analysis suggest that low-profile devices are associated with type IIIc endoleak rates as high as 15% at the 20-month follow-up. Early demonstrations of PMEG modifications, including fenestration reinforcement with polytetrafluoroethylene (PTFE) cuffs, have proposed a possible remedy to these elevated endoleak rates. This analysis evaluates a single center's experience with PTFE cuff reinforcement for PMEG fenestrations.

METHODS: All PMEGs performed at our institution between 2016 and 2025 were retrospectively reviewed. Each PMEG included fenestrations that were individually reinforced with a PTFE cuff and an embolization coil, secured with a running locking Ethibond suture. Primary outcomes included target vessel-related (type Ic and IIIc) endoleaks and endoleak-related reintervention. Outcomes were analyzed on both per-patient and per-fenestration bases. Bridging stent type (iCAST vs VBX) was also evaluated as a potential modifier of outcomes, with secondary outcomes including stent patency and target vessel instability. Rates of endoleak at 1 month and beyond were reported using Kaplan-Meier estimates.

RESULTS: Overall, 229 PMEGs (100% low profile; 861 PTFE cuffs) were included in our analysis with a median follow-up of 1.3 years. The median age was 76 years and patients were primarily White (89%) and male (72%). The majority of cases were done electively (82%) for juxtarenal aneurysms (65%). The median aneurysm diameter at time of repair was 62 mm, and 80% included four or more target vessel fenestrations. Through 2 years, 26% (n = 42) of patients underwent an aneurysm- or PMEG-associated reintervention; of these, nearly one-half (n = 21 [15% of all patients]) were endoleak related. The most common indication for endoleak-related reintervention was sac expansion from type II endoleaks (8.9%). Type Ic and IIIc endoleaks occurred in 2.2% and 1.1% of patients, respectively. Bridging stents included 358 iCAST and 489 VBX. Stent distribution differed significantly by vessel, yet no significant differences were observed in 2-year patency (98% vs 99%), stent-related stenosis/occlusion (2.1% vs 2.0%), or reintervention rates (1.0% vs 1.3%) (all P > .05). On a per-fenestration basis, type Ic and IIIc endoleaks occurred in 0.6% and 0.1% of fenestrations, respectively, with no difference based on stent type (iCAST, 0.7% vs VBX, 0.8%; P = .23). Overall, freedom from target vessel instability at 2 years was >98% across all groups and vessels, without any difference in bridging stent type (98.3% vs 98.6%; P = .82).

CONCLUSIONS: PMEG modification with individual fenestration reinforcement using a PTFE cuff and an embolization coil demonstrates effective fenestration sealing with notably low rates of target vessel-related endoleaks. Bridging stent choice does not appear to be a primary determinant of target vessel instability, endoleaks, or reinterventions, potentially underscoring the importance of fenestration modifications over stent platform differences. These findings suggest the value of using this technique for PMEG customization in low-profile devices.

OBJECTIVES: Hemodialysis-dependent (HD) patients with CLTI often present with complex, multi-level, calcified disease, and are among the highest-risk populations undergoing lower extremity revascularization. However, there are limited data evaluating outcomes among this cohort following tibial interventions. We aimed to compare outcomes in patients with CLTI and HD undergoing either infrapopliteal bypass (BPG) or angioplasty with or without stenting (PTA/S).

METHODS: All patients with HD undergoing a first-time infrapopliteal BPG or PTA/S for CLTI at our institution from 2005-2024 were retrospectively reviewed. Primary outcomes included perioperative complications, wound healing, patency, reintervention, major amputation, and amputation or death (amputation/death). Outcomes were evaluated using chi-squared, Kaplan-Meier, and Cox regression analyses.

RESULTS: Of 1,468 limbs undergoing a first-time infrapopliteal intervention for CLTI between 2005-2024, 280 had HD, of which 105 underwent BPG (87% ssGSV) and 175 PTA/S. Demographics were largely similar between BPG and PTA/S, with differences seen in non-white race (28% vs. 44%) and smoking history (65% vs. 44%) (all P<.05). BPG had higher rates of grade 4 femoropopliteal and infrapopliteal GLASS classification (35% vs. 8.0% and 43% vs. 28%, respectively) (all P<.05). Unadjusted perioperative outcomes were clinically yet not statistically different, including major amputation (1.0% (BPG) vs. 4.6% (PTA/S), P=.09), MI (1.0% vs. 6.3%, P=.05), and mortality (2.9% vs. 6.9%, P=.15), and remained non-significant following logistic regression. Following adjustment, data demonstrated an early protective effect of BPG against major amputation at two years (20% (BPG) vs. 32% (PTA/S); HR 0.10, 95% CI [0.03-0.40]), without long-term persistence (five-year rates: 31% vs. 38%; HR 0.37 [0.13-1.02]). BPG was associated with a 45% lower hazard of amputation/death (five-year rates: 71% vs. 83%; HR 0.55 [0.33-0.90]) and 44% lower hazard of death (66% vs. 79%; HR 0.56 [0.35-0.94]). A sensitivity analysis restricted to BPG performed with single-segment great saphenous vein (ssGSV) conduit demonstrated even greater benefit of BPG, with significantly higher likelihood of complete wound healing (six-month rates: 41% vs. 25%; HR 2.40 [1.03-5.58]) and lower hazard of major amputation (five-year rates: 27% vs. 38%; HR 0.36 [0.13-0.98]), in addition to amputation/death (73% vs. 83%; HR 0.56 [0.34-0.94]) and mortality (68% vs. 79%; HR 0.57 [0.33-0.96]) compared to PTA/S.

CONCLUSION: Patients with HD and CLTI undergoing infrapopliteal revascularization face high rates of amputation and mortality, yet contemporary advances in dialysis care have extended survival for many of these patients. As such, procedure durability and limb-preservation strategies have become increasingly relevant. Among appropriate surgical candidates, BPG is associated with lower mid- and long-term risk of major amputation, death, and amputation/death. In sensitivity analyses, ssGSV bypass offered even greater benefit, including higher wound-healing rates and substantially lower hazards of major amputation, amputation/death, and mortality. These findings support considering infrapopliteal bypass - particularly with high-quality ssGSV - in carefully selected hemodialysis-dependent patients.

BACKGROUND: Our institution previously reported excellent short- and long-term outcomes after dorsalis pedis bypass (DPB) for ischemic limb salvage; however, since then, percutaneous transluminal angioplasty with or without stenting (PTA/S) has become the more common management approach. This study aims to describe our nearly 20-year experience with DPB to compare the short- and long-term outcomes between these two revascularization strategies in patients with chronic limb-threatening ischemia.

METHODS: All patients undergoing DPB or tibial PTA/S between 2000 and 2022 at our institution were retrospectively reviewed. Primary outcomes included perioperative complications, complete wound healing, reintervention, major amputation, major adverse limb events, and a composite variable of major amputation or death (amputation/death). For a more direct comparison, analyses were restricted to procedures performed for chronic limb-threatening ischemia and after the introduction of PTA/S (2005) and to PTA/S patients that were suitable candidates for bypass, had Trans-Atlantic Inter-Society Consensus C or D disease, and a potential DPB target on angiography. Outcomes were evaluated using χ2, Kaplan-Meier, and Cox regression analyses.

RESULTS: Between 2000 and 2010, 462 DPB and 395 tibial PTA/S were performed; between 2011 and 2022, 101 DPB and 955 tibial PTA/S were performed. Of those, 259 DPB and 329 tibial PTA/S fit our criteria. Compared with tibial PTA/S patients, DPB patients were similar in age (69.9 years vs 70.8 years) yet were more often White (76% vs 64%) and male (73% vs 52%), and more commonly presented with tissue loss (91% vs 84%) (all P < .05). There were no differences in perioperative complications, including mortality (1.9% vs 3.9%), myocardial infarction (1.9% vs 2.1%), or acute kidney injury (5.8% vs 10%) (all P > .05). Between DPB and PTA/S, despite a trend toward higher rates of complete wound healing after DPB (6-month rate: 43% vs 32%; P = .07), no long-term outcome differences were seen, including reintervention (5-year rate: 41% vs 40%), major amputation (25% vs 24%), major adverse limb events (42% vs 40%), or amputation/death (59% vs 66%) (all P > .05). A sensitivity analysis comparing DPB with single-segment great saphenous vein (ssGSV; n = 213) vs tibial PTA/S demonstrated that DPB had higher rates of complete wound healing (6-month rate: 46% vs 32%; P = .03) and lower rates of amputation/death (5-year rate: 57% vs 66%; P = .04), both of which remained significant after Cox regression (hazard ratio [HR], 1.55 [95% confidence interval, 1.03-2.34] and HR, 0.73 [95% CI, 0.54-0.97], respectively). Conversely, non-ssGSV DPB (n = 47), compared with tibial PTA/S, were approximately 50% more likely to experience loss of patency (HR, 0.49; 95% CI, 0.25-0.98).

CONCLUSIONS: Although becoming less common, DPB still provides a durable repair, results in similar perioperative complications compared with tibial PTA/S, and, when performed with ssGSV, may result in higher rates wound healing and lower rates amputation or death. Ultimately, despite the notable decrease in DPB in the endovascular era, these data demonstrate the importance of both revascularization strategies in treating distal arterial disease.

OBJECTIVES: Physician-modified endografts (PMEGs) have expanded the scope of endovascular abdominal aortic repair beyond the infrarenal aorta. Patients with prohibitively high surgical risk and visceral segment disease are often candidates for this intervention, which mitigates much of the morbidity and mortality associated with conventional open repair. Here we present the institutional PMEG experience of a high-volume aortic center.

METHODS: We studied all PMEGs performed at our institution from 2012 to 2023. We included cases that were submitted to the US Food sand Drug Administration in support of an investigational device exemption (IDE) trial, as well as those in the subsequently approved IDE trial. Over this 11-year period, we assessed the changes in operative characteristics and perioperative outcomes over time. Additionally, we compared the outcomes from PMEG cases to those of Zenith fenestrated (ZFEN) grafts (done by the surgeon with the PMEG IDE), an alternative device used for aneurysms involving the lower visceral segment. Here we assessed operative characteristics, perioperative outcomes, and 5-year survival and reintervention rates.

RESULTS: When assessing the change over time for PMEG operative characteristics, we found a trend toward decreased fluoroscopy time and decreased proportions of completion type I and type III endoleaks (all P < .05). Perioperative outcomes have remained stable over this period, with an overall perioperative mortality rate of 4.9% (noting that this registry also includes cases that were urgent and emergent). Despite the increased complexity of PMEGs relative to ZFENs, we found comparable perioperative outcomes with regard to mortality (4.9% vs 4.3%; P = .86), permanent spinal cord ischemia (1.1% vs 0%; P = .38), postoperative myocardial infarction (4.3% vs 2.9%; P = .60), postoperative respiratory failure (7.1% vs 4.3%; P = .43), and new dialysis use (2.2% vs 4.3%; P = .35). Additionally, 5-year survival (PMEG 54% vs ZFEN 65%; P = .15) and freedom from reintervention (63% vs 74%; P = .07) were similar between these cohorts.

CONCLUSIONS: Throughout our >10-year experience with PMEGs, we have noted improvements in operative outcomes, which can likely be attributed to technological advances and increased physician experience. Additionally, we have found that PMEGs perform well when compared with ZFENs, despite being a more complicated repair that is able to treat a larger segment of the aorta. PMEGs are crucial for the comprehensive care of vascular patients with complex aortic disease. As further operative advancements are made, we only expect the use of this intervention to increase.

OBJECTIVE: Several 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).

METHODS: We 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.

RESULTS: We 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).

CONCLUSIONS: Our 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.

OBJECTIVE: The aim of this study was to compare perioperative and 5-year outcomes following endovascular (FEVAR) and open repair (OAR) of complex abdominal aortic aneurysms (cAAAs) in males and females separately, given the known sex-related differences in perioperative outcomes.

METHODS: We studied all elective cAAA repairs between 2014 and 2019 in the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) registry. We stratified patients based on sex. We calculated propensity scores for assignment to either OAR or FEVAR. Covariates including age, race, diameter, baseline comorbidities, proximal extent of repair, annual center volumes, and annual surgeon volumes were introduced into the model for estimating propensity scores. Within matched cohorts, perioperative outcomes and 5-year outcomes (mortality, reinterventions, and ruptures) were evaluated using multivariable logistic and Cox regression models.

RESULTS: We identified 2825 patients, of whom 29% were female. Within both the sexes, OAR was more commonly performed (OAR vs FEVAR: males: 53% vs 47%; females: 63% vs 37%). After matching, among males (n = 1326), FEVAR was associated with lower perioperative mortality (FEVAR vs OAR: 2.3% vs 5.1%; P < .001). However, FEVAR was associated with comparable 5-year mortality (38% vs 28%; hazard ratio [HR], 1.2; 95% confidence interval [CI], 0.92-1.4; P = .22) and a higher hazard of 5-year reintervention (19% vs 3.7%; adjusted HR, 4.5; 95% CI, 2.6-7.6; P < .001). Among females (n = 456), FEVAR and OAR showed similar perioperative mortality (8.3% vs 7.0%; P = .73). At 5 years, FEVAR was associated with higher hazards of mortality (43% vs 32%; adjusted HR, 1.5; 95% CI, 1.03-2.2; P = .034) and reintervention (20% vs 3.0%; adjusted HR, 4.8; 95% CI, 2.1-11; P < .001) compared with OAR.

CONCLUSIONS: Among males, FEVAR was associated with favorable perioperative outcomes compared with OAR, although these advantages attenuate over time. However, among females, FEVAR was associated with similar perioperative outcomes, eventually leading to higher reinterventions and possibly higher mortality within 5 years. Future efforts should focus on determining the factors associated with these sex disparities to improve outcomes following FEVAR in females. Based on current evidence, females undergoing elective cAAA repair should be selected with due caution, especially for endovascular repair.