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

BACKGROUND: Chronic kidney disease (CKD) increases morbidity and mortality in most vascular procedures. However, a binary classification of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, which is often used in both modeling and clinical trials, may not be optimal for predicting clinical outcomes. OBJECTIVE: Determine the optimal eGFR cutoff for use in risk stratification and prediction models. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Retroperitoneal vs. Transperitoneal Approach for Non-Ruptured Open Conversion after Endovascular Aneurysm Repair.

OBJECTIVE: Several studies comparing the transperitoneal (TP) and retroperitoneal (RP) approach for 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 EVAR. METHODS: We included all patients who underwent open conversion after EVAR between 2010-2022 in Vascular Quality Initiative (VQI). 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 (IPW) 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. 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 [IQR, 70-79] years vs. 73.5 [IQR, 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 less frequently used in case 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 (aOR, 0.49; 95%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, and 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 lower adjusted odds of perioperative complications compared with the TP approach. The RP approach should be considered for open conversion after EVAR when feasible.

Prosthetic Conduits have Worse Outcomes compared to Great Saphenous Vein Conduits in Femoropopliteal and Infrapopliteal Bypass in Patients with Chronic Limb Threatening Ischemia.

OBJECTIVES: Single segment great saphenous vein (SSGSV) has traditionally been considered the gold standard conduit for infrainguinal bypass. There are data supporting similar outcomes with prosthetic femoral-popliteal bypass. Moreover, some have advocated for prosthetic conduit for femoral tibial bypass when GSV is inadequate or unavailable. We sought to evaluate long-term outcomes of infrainguinal bypass based on conduit type for treating chronic limb threatening ischemia (CLTI). METHODS: Data from the Best Endovascular versus Best Surgical Therapy of Patients with CLTI (BEST-CLI) multicenter, prospective, randomized controlled trial, comparing infrainguinal bypass with endovascular therapy in patients with CLTI, were evaluated. In this as-treated analysis, we compared outcomes of infrainguinal bypass using prosthetic, alternative autogenous vein (AAV), and cryopreserved vein (Cryo) with SSGSV bypass. Kaplan-Meier and multivariable analyses were performed to examine the associations of conduit type with major adverse limb event (MALE) events, reinterventions, above-ankle amputations, and all-cause death. RESULTS: In total, 784 bypasses were analyzed (120 prosthetic, 33 AAV, 21 Cryo, 610 SSGSV). For prosthetic and SSGSV, the distribution was 357 femoropopliteal (93 prosthetic and 264 GSV) and 373 infrapopliteal (27 prosthetic and 346 GSV). Mean age for the overall cohort was 67.1 years; 27.4% were female gender, 29.9% were non-White, and 11.5% were of Hispanic ethnicity. Patients undergoing prosthetic bypass were older (69.2 vs. 66.7 years), more likely to have chronic obstructive pulmonary disease (22.5% vs. 14%), prior coronary artery bypass grafting (88.9% vs. 66.5%), prior stroke (23.3% vs. 14%), but less often were of Hispanic ethnicity (5.8% vs. 12.6%) and had diabetes (59.2% vs. 71.3%) (P<.05 for all). For femoropopliteal bypass, use of prosthetic conduit was associated with increased major reinterventions at 3 years overall (19% vs. 11.5%, P=.06) and on risk adjusted analysis (HR 2.13, 95% CI 1.09 - 4.2, P=.028). No significant differences in MALE or death, above-ankle amputation, or death were observed. Outcomes were similar for bypasses to above knee popliteal targets and below knee popliteal targets. For infrapopliteal bypass, use of prosthetic conduit was associated with increased major reintervention (25.3% vs. 10.3%, P=.005), death (68.6% vs. 34.8%, P<.001), MALE or death (90% vs. 48.1%, P<.001) at 3 years. After risk adjustment, infrapopliteal bypass with prosthetic conduit was associated with higher major reintervention (HR 4.14, 95% CI 1.36 - 12.6, P=.012), above-ankle amputation (HR 4.64, 95% CI 1.59 - 13.5, P=.005), death (HR 2.96, 95% CI 1.4 - 6.2, P=.004), and MALE or death (HR 3.59, 95% CI 1.64 - 7.86, P=.001) compared to bypass with SSGSV. Overall, AAV had similar outcomes at 3 years to SSGSV, however Cryo had significantly higher above ankle amputation (50% vs 12.8%) (HR 4.2, 95% CI 1.68 - 10.5, P=.002), major reintervention (41.9% vs. 10.7%) (HR 3.12, 95% CI 1.18 - 8.22, P=.02), and MALE/death (88.8% vs. 37.8%) (HR 2.96, 95% CI 1.43-6.14, P=.004). CONCLUSIONS: Use of prosthetic conduit in infrainguinal bypass is associated with inferior outcomes compared to bypass using SSGSV, particularly for bypass to infrapopliteal targets. Cryo grafts were infrequent and also demonstrated inferior outcomes. SSGSV remains the preferred conduit of choice for infrainguinal bypass.

The Impact of Diabetes Mellitus on the Outcomes of Revascularization for Chronic Limb-Threatening Ischemia in the BEST-CLI trial.

OBJECTIVES: Several observational studies have demonstrated an association between diabetes mellitus (DM) and above ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular versus Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (CLTI) (BEST-CLI) trial. METHODS: Baseline characteristics were compared between patients with and without DM in the BEST-CLI trial. Cox regression was used to determine the association between DM and major outcomes of major adverse limb events (MALE), reintervention, above ankle amputation, and all-cause death. RESULTS: Among 1,777 patients who underwent LER, 69.2% had DM. Compared to patients without DM, those with DM were significantly younger, less likely to be White, and more likely to be Hispanic. Patients with DM were more likely to have hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, and renal disease and be on optimal medical therapy (antiplatelets and statins) while patients without DM were significantly more likely to be smokers and have chronic obstructive pulmonary disease. Patients with DM were significantly more likely to present with late Wound Ischemia foot Infection (WIfI) stages (3-4) (73.7% vs 45.9%, P<0.001) that were driven predominantly by differences in wound and infection grade. Conversely, patients without DM had significantly lower ankle pressures and toe pressures and were significantly more likely to have WIfI ischemia grade 3 compared to patients with DM (60% vs 52.5%, P=0.016). At three years, patients with DM exhibited higher rates of above ankle amputation and all-cause death compared to patients without DM. Kaplan-Meier analysis demonstrated significantly higher MALE or all-cause death compared to patients without DM (3-year estimate: 53.5% vs 46.4%, P<0.001). After adjusting for potential confounders, regression analysis demonstrated that DM was independently associated with increased above ankle amputation (1.75 [1.22-2.51]), all-cause death (1.63 [1.31-2.03]), and MALE or all-cause death (1.24 [1.04-1.47]). CONCLUSION: Patients with DM undergoing LER for CLTI experienced a greater incidence of MALE or all-cause death compared to patients without DM. The impact of DM seems to be mediated by more severe wounds and infections at the time of presentation, and a higher prevalence of cardiac and renal disease.

Factors associated with and outcomes of respiratory adverse events following thoracic endovascular aortic repair.

OBJECTIVE: Respiratory adverse events (RAEs) after thoracic endovascular aortic repair (TEVAR) remain poorly characterized owing to the lack of comprehensive studies that identify individuals prone to these complications. This study aims to determine the incidence, factors associated with, and outcomes of RAEs after TEVAR. METHODS: We identified patients in the Vascular Quality Initiative undergoing TEVAR isolated to zones 0 to 5 from 2010 to 2023 for nontraumatic pathologies. After determining the incidence of postoperative RAEs, we assessed baseline characteristics, pathology, procedural details, and postoperative complications stratified by respiratory complication status: none, pneumonia only, reintubation only, or both. We then examined preoperative and intraoperative variables independently associated with the development of postoperative RAEs using multivariable modified Poisson regression. Kaplan-Meier analysis and Cox proportional hazards regression models were used to determine associations between postoperative RAEs and 5-year survival adjusting for preoperative variables and other nonrespiratory postoperative complications in a separate model. RESULTS: Of 10,708 patients, 8.3% had any RAE (pneumonia only, 2.1%; reintubation only, 4.8%; both, 1.4%). Patients with any RAE were more likely to present with aortic dissection (any respiratory complication, 46% vs no respiratory complication, 35%; P < .001), and be symptomatic (58% vs 48%; P < .001). Developing RAEs after TEVAR was associated with male sex (adjusted relative risk [aRR], 1.19; 95% confidence interval [CI], 1.01-1.41; P = .037), obesity (aRR, 1.31; 95% CI, 1.07-1.61; P = .009), morbid obesity (aRR, 1.68; 95% CI, 1.20-2.32; P = .002), renal dysfunction (aRR, estimated glomerular filtration rate 30-45, 1.45; 95% CI, 1.15-1.82; P = .002; estimated glomerular filtration rate <30/hemodialysis, 1.7; 95% CI, 1.37-2.11; P < .001), anemia (aRR, 1.31; 95% CI, 1.09-1.58; P = .003), aortic diameter >65 mm (aRR, 1.54; 95% CI, 1.25-1.89; P < .001), proximal disease in the aortic arch (aRR, 1.23; 95% CI, 1.03-1.48; P = .025) or ascending aorta (aRR, 1.61; 95% CI, 1.19-2.14; P = .002), acute aortic dissection (aRR, 2.13; 95% CI, 1.72-2.63; P < .001), ruptured presentation (aRR, 3.07; 95% CI, 2.43-3.87; P < .001), same-day surgical thoracic branch treatment (aRR, 1.51; 95% CI, 1.25-1.82; P < .001), chronic obstructive pulmonary disease on home oxygen (aRR, 1.58; 95% CI, 1.08-2.25; P = .014), limited self-care or bed-bound status (aRR, 2.12; 95% CI, 1.45-3.03; P < .001), and intraoperative transfusion (aRR, 1.88; 95% CI, 1.47-2.40; P < .001). Patients who developed postoperative RAEs had higher 30-day mortality (27% vs 4%; P < .001) and 5-year mortality than patients without respiratory complications (46% vs 20%; P < .001). After adjusting for preoperative and postoperative variables, the 5-year mortality was higher in patients who developed any postoperative RAE (adjusted hazard ratio [aHR], 1.8; 95% CI, 1.6, 2.1; P < .001), postoperative pneumonia only (aHR, 1.4; 95% CI, 1.0, 1.8; P = .046), reintubation only (aHR, 2.2; 95% CI, 1.8, 2.6; P < .001) or both (aHR, 1.5; 95% CI, 1.1, 2.0; P = .008). CONCLUSIONS: RAEs after TEVAR are common, more likely to occur in male patients with obesity, renal dysfunction, anemia, chronic obstructive pulmonary disease on home oxygen, acute aortic dissection, ruptured presentation, same-day surgical thoracic branch treatment, who received intraoperative transfusion, and are associated with a two-fold increase in 5-year mortality regardless of the development of other postoperative complications. Considering these factors in assessing the risks and benefits of TEVAR procedures, along with implementing customized postoperative care, can potentially improve clinical outcomes.

Factors associated with nonhome discharge after endovascular aneurysm repair.

OBJECTIVE: This 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. METHODS: We 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. RESULTS: We 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). CONCLUSIONS: Several 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.

Management and outcomes of venous thoracic outlet decompression: A transition to the infraclavicular approach.

OBJECTIVE: Venous thoracic outlet syndrome (vTOS) is caused by compression of the subclavian vein at the costoclavicular space, which may lead to vein thrombosis. Current treatment includes thoracic outlet decompression with or without venolysis. However, given its relatively low prevalence, the existing literature is limited. Here, we report our single-institution experience in the treatment of vTOS. METHODS: We performed a retrospective review of all patients who underwent rib resection for vTOS at our institution from 2007 to 2022. Demographic, procedural details, and perioperative and long-term outcomes were reviewed. RESULTS: A total of 76 patients were identified. The mean age was 36 years. Swelling was the most common symptom (93%), followed by pain (6.6%). Ninety percent of patients had associated deep vein thrombosis, with 99% of these patients starting anticoagulation preoperatively. A total of 91% of patients underwent rib resection via the infraclavicular approach, 2% via the paraclavicular approach (due to a neurogenic component), and 7% via the transaxillary approach. Eighty-three percent of patients had endovascular intervention before or at the time of the rib resection, with catheter-directed thrombolysis (87%), followed by angioplasty (71%) and rheolytic thrombectomy (57%) being the most common interventions. The median time from endovascular intervention to rib resection was 14 days, with 25% at the same admission. The median postoperative stay was 3 days (2-5 days). There was no perioperative mortality or nerve injury. Fourteen percent of patients had postoperative complications, with bleeding complications (12%) being the most common. Waiting more than 30 days between initial endovascular intervention and rib resection was not associated with decreased risk of bleeding complications. Patients were seen postoperatively at 1-month (physical examination) and 6-month (duplex) intervals or for any new or recurrent symptoms. Twenty-two percent of our overall patient population underwent reintervention, most commonly angioplasty (21%). At last follow-up, 97% of subclavian veins were patent, and 93% of patients were symptom free. CONCLUSIONS: Over the last decade, we have transitioned to an infraclavicular approach for isolated vTOS, with low perioperative morbidity and good patency rates. These results support the adoption of the infraclavicular approach with adjunct endovascular techniques as a safe and efficacious treatment of vTOS.

Association of Body Surface Area versus Body Mass Index on Outcomes in Peripheral Arterial Disease.

BACKGROUND: Numerous studies have indicated that increased obesity in patients with established peripheral artery disease (PAD) is inversely associated with disease prognosis, a phenomenon coined as the "obesity paradox". A major cause of criticism in studies investigating the obesity paradox is the use of body mass index (BMI) as a surrogate marker in defining and quantifying the degree or severity of obesity. We conducted a retrospective review to verify whether the obesity paradox persists in patients with PAD when using body surface area (BSA) as an alternative anthropometric measure. METHODS: Patients undergoing surgery (open or endovascular) for PAD between January 2009 and March 2020 were identified from the Vascular Quality Initiative (VQI) national database. The association between BSA or BMI and risk of postoperative complications was evaluated using logistic regression and restricted cubic spline analysis, both of which were adjusted for demographic and comorbid risk predictors. When analyzing BSA and BMI as categorical variables, patients were grouped according to BSA quintiles and the World Health Organization (WHO) BMI categories. RESULTS: A total of 130,428 patients were included based on our eligibility criteria, of which 85,394 (65.5%) were men. Patients were typically hypertensive (87.8%), diabetic (50.4%), and overweight (63.0% over 25 kg/m2). Patients with a high BMI or BSA typically presented at a younger age and with greater preoperative administration of drugs (statin, angiotensin converting enzyme inhibitor, anticoagulant, and beta blocker). Our results indicate that BSA and BMI are inversely associated with postoperative risk of all-cause morbidity, mortality, and cardiac complications. This finding was displayed when analyzing BMI or BSA as a continuous variable or when indexing patients into BMI or BSA groups. CONCLUSIONS: Our data suggests that the obesity paradox persists in patients with PAD when using either BMI or BSA as anthropometric measures. Future studies with a prospective design and utilizing newer anthropometric indices should be conducted to fully verify the presence of this phenomenon.

Outcomes following carotid revascularization in patients with prior ipsilateral carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: The outcomes of carotid revascularization in patients with prior carotid artery stenting (CAS) remain understudied. Prior research has not reported the outcomes after transcarotid artery revascularization (TCAR) in patients with previous CAS. In this study, we compared the peri-operative outcomes of TCAR, transfemoral CAS (tfCAS) and carotid endarterectomy (CEA) in patients with prior ipsilateral CAS using the Vascular Quality Iniatitive. METHODS: Using Vascular Quality Initiative data from 2016 to 2023, we identified patients who underwent TCAR, tfCAS, or CEA after prior ipsilateral CAS. We included covariates such as age, race, sex, body mass index, comorbidities (hypertension, diabetes, prior coronary artery disease, prior coronary artery bypass grafting/percutaneous coronary intervention, congestive heart failure, renal dysfunction, smoking, chronic obstructive pulmonary disease, and anemia), symptom status, urgency, ipsilateral stenosis, and contralateral occlusion into a regression model to compute propensity scores for treatment assignment. We then used the propensity scores for inverse probability weighting and weighted logistic regression to compare in-hospital stroke, in-hospital death, stroke/death, postoperative myocardial infarction (MI), stroke/death/MI, 30-day mortality, and cranial nerve injury (CNI) after TCAR, tfCAS, and CEA. We also analyzed trends in the proportions of patients undergoing the three revascularization procedures over time using Cochrane-Armitage trend testing. RESULTS: We identified 2137 patients undergoing revascularization after prior ipsilateral carotid stenting: 668 TCAR patients (31%), 1128 tfCAS patients (53%), and 341 CEA patients (16%). In asymptomatic patients, TCAR was associated with a lower yet not statistically significant in-hospital stroke/death than tfCAS (TCAR vs tfCAS: 0.7% vs 2.0%; adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.11-1.05; P = .06), and similar odds of stroke/death with CEA (TCAR vs CEA: 0.7% vs 0.9%; aOR, 0.80; 95% CI, 0.16-3.98; P = .8). Compared with CEA, TCAR was associated with lower odds of postoperative MI (0.1% vs 14%; aOR, 0.02; 95% CI, 0.00-0.10; P < .001), stroke/death/MI (0.8% vs 15%; aOR, 0.05; 95% CI, 0.01-0.25; P < .001), and CNI (0.1% vs 3.8%; aOR, 0.04; 95% CI, 0.00-0.30; P = .002) in this patient population. In symptomatic patients, TCAR had an unacceptably elevated in-hospital stroke/death rate of 5.1%, with lower rates of CNI than CEA. We also found an increasing trend in the proportion of patients undergoing TCAR following prior ipsilateral carotid stenting (2016 to 2023: 14% to 41%), with a relative decrease in proportions of tfCAS (61% to 45%) and CEA (25% to 14%) (P < .001). CONCLUSIONS: In asymptomatic patients with prior ipsilateral CAS, TCAR was associated with lower odds of in-hospital stroke/death compared with tfCAS, with comparable stroke/death but lower postoperative MI and CNI rates compared with CEA. In symptomatic patients, TCAR was associated with unacceptably higher in-hospital stroke/death rates. In line with the postprocedure outcomes, there has been a steady increase in the proportion of patients with prior ipsilateral stenting undergoing TCAR over time.

Ten years of physician-modified endografts.

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.

Association between diabetes status and long-term outcomes following open and endovascular repair of infrarenal abdominal aortic aneurysms.

OBJECTIVE: Current literature reports conflicting findings regarding the effect of diabetes mellitus (DM) on outcomes of abdominal aortic aneurysm (AAA) repair. In this study we examined the effect of DM and its management on outcomes after open AAA repair (OAR) and endovascular AAA repair (EVAR). METHODS: We identified all patients undergoing OAR or EVAR for infrarenal AAA between 2003 and 2018 in the Vascular Quality Initiative registry data linked with Medicare claims. We excluded patients with missing DM status. Patients were stratified by their preoperative DM status, and then further stratified by DM management: dietary, noninsulin antidiabetic medications (NIMs), or insulin. Outcomes of interest included 1-year aneurysm sac dynamics, 8-year aneurysm rupture, reintervention, and all-cause mortality. These outcomes were analyzed with the χ2 test, Kaplan-Meier methods, and multivariable Cox regression analyses. RESULTS: We identified 34,021 EVAR patients and 4127 OAR patients, of whom 20% and 16% had DM, respectively. Of all DM patients, 22% were managed by dietary management, 59% by NIM, and 19% by insulin. After EVAR, DM patients were more likely to have stable sacs, whereas non-DM patients were more likely to have sac regression at 1 year. Compared with non-DM, DM was associated with a significantly lower risk for 8-year rupture in EVAR (EVAR hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.51-0.92). Compared with non-DM, NIM was associated with lower risk of rupture within 8-years for both EVAR and OAR (EVAR HR, 0.64; 95% CI, 0.44-0.94; OAR HR, 0.29; 95% CI, 0.41-0.80), whereas dietary control and insulin had a similar rupture risk compared with non-DM. However, compared with non-DM, DM was associated with a higher risk of 8-year all-cause mortality after EVAR and OAR (DM vs non-DM: EVAR HR, 1.17; 95% CI, 1.11-1.23; OAR HR, 1.16; 95% CI, 1.00-1.36). After further DM management substratification, compared with non-DM, management with NIM and insulin were associated with a higher 8-year mortality in EVAR and OAR (EVAR: NIM HR, 1.12; 95% CI, 1.05-1.20; insulin: HR, 1.40; 95% CI, 1.26-1.55; OAR: NIM HR, 1.27; 95% CI, 1.06-1.54; and insulin: HR, 1.57; 95% CI, 1.15-2.13). Finally, there was a similar risk of reintervention across the DM and non-DM populations for EVAR and OAR. CONCLUSIONS: DM was associated with a lower adjusted risk of rupture after EVAR as well as OAR in patients managed with NIM. Nevertheless, just as in patients without AAA, preoperative DM was associated with a higher adjusted risk of all-cause mortality. Further study is needed to evaluate for differences in aneurysm-related mortality between DM and non-DM patients, and studies are planned to evaluate the independent effect of NIM on aneurysm-related outcomes.

An international, expert-based, Delphi consensus document on controversial issues in the management of abdominal aortic aneurysms.

OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas.

Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair.

BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

An Expert Delphi Consensus on Risk Factors for Adverse Events After Endovascular Aortic Aneurysm Repair: Tier 1 Study From the International RIsk Stratification in EVAR (IRIS-EVAR) Working Group.

PURPOSE: Tier 1 of the International RIsk Stratification in EndoVascular Aneurysm Repair (IRIS-EVAR) project aimed to identify important risk factors for adverse events following endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Initially, the steering committee proposed a number of risk factors for adverse events following EVAR. A Delphi consensus was performed as expert panelists were presented with risk factors and provided the opportunity to propose additional risk factors during the process. Experts in EVAR completed an online survey via 3 structured rounds. The first round opened in July 2022, and the third round closed in December 2022. Panelists rated risk factors using a 4-point Likert scale. Consensus was defined as >70% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing with a statement in each round. RESULTS: Thirty-five panelists from 12 countries completed the 3 rounds of surveys. Of a total of 64 individual risk factors assessed by the panelists, 37 (58%) had consensus that they were important for adverse events following EVAR. Risk factors were stratified in 4 domains: 14 (38%) were related to preoperative anatomy, 3 (8%) related to the aortic device selection, 8 (22%) related to the procedure performance, and 12 (32%) related to postoperative surveillance. Factors with the highest consensus in each domain were as follows: proximal aortic neck length <15 mm (98% consensus), anatomy non-compliant with instructions for use (94% consensus), length of achieved proximal aortic neck post implantation <10 mm (98% consensus), and non-satisfactory seal at landing or overlapping zones/sac expansion/kink or stenosis (100% consensus each), respectively. CONCLUSIONS: Clinically important risk factors for adverse events after EVAR were identified via expert consensus. These factors will be used to develop an expert consensus-informed risk stratification and surveillance strategies. CLINICAL IMPACT: This is the first study to apply an in-depth Delphi methodology to achieve an expert consensus on risk factors for adverse events after endovascular aneurysm repair (EVAR). Important risk factors were stratified in 4 domains: preoperative anatomy (14 factors), aortic device (3 factors), EVAR procedure (8 factors), and postoperative surveillance (12 factors). This study will potentially influence future clinical practice by providing evidence informed by experts regarding predictors of adverse events following EVAR that can be taken into account during decision making and developing post-EVAR surveillance strategies. These findings will inform a risk stratification tool for everyday use by vascular surgeons.

The impact of travel distance in patient outcomes following revascularization for chronic limb-threatening ischemia.

BACKGROUND: Patient travel distance to the hospital is a key metric of individual and social disadvantage and its impact on the management and outcomes following intervention for chronic limb-threatening ischemia (CLTI) is likely underestimated. We sought to evaluate the effect of travel distance on outcomes in patients undergoing first-time lower extremity revascularization at our institution. METHODS: We retrospectively reviewed all consecutive patients undergoing first-time lower extremity revascularization, both endovascular and open, for CLTI from 2005 to 2014. Patients were stratified into 2 groups based on travel distance from home to hospital greater than or less than 30 miles. Outcomes included reintervention, major amputation, restenosis, primary patency, wound healing, length of stay, length of follow-up and mortality. Kaplan-Meier estimates were used to determine event rates. Logistic and cox regression was used to evaluate for an independent association between travel distance and these outcomes. RESULTS: Of the 1293 patients were identified, 38% traveled >30 miles. Patients with longer travel distances were younger (70 years vs 73 years; P = .001), more likely to undergo open revascularization (65% vs 41%; P < .001), and had similar Wound, Ischemia, foot Infection stages (P = .404). Longer distance travelled was associated with an increase in total hospital length of stay (9.6 days vs 8.6 days; P = .031) and shorter total duration of postoperative follow-up (2.1 years vs 3.0 years; P = .001). At 5 years, there was no definitive difference in the rate of restenosis (hzard ratio [HR], 1.3; 95% confidence interval [CI], 0.91-1.9; P = .155) or reintervention (HR, 1.4; 95% CI, 0.96-2.1; P = .065), but longer travel distance was associated with an increased rate of major amputation (HR, 2.1; 95% CI, 1.2-3.7; P = .011), and death (HR, 1.6; 95% CI, 1.2-2.2; P = .002). Longer travel distance was also associated with higher rate of nonhealing wounds (HR, 2.3; 95% CI, 1.5-3.5; P = .001). CONCLUSIONS: Longer patient travel distance was found to be associated with a lower likelihood of limb salvage and survival in patients undergoing first-time lower extremity revascularization for CLTI. Understanding and addressing the barriers to discharge, need for multidisciplinary follow-up, and appropriate postoperative wound care management will be key in improving outcomes at tertiary care regional specialty centers.

Presentation and patterns of reinterventions after revascularization in patients with premature peripheral arterial disease.

OBJECTIVE: Premature peripheral arterial disease (PAD) (age ≤50 years) has been shown to negatively impact the outcomes of lower extremity revascularization (LER). Patients with premature PAD have an increased risk of major amputation compared with older patients. The primary goal of this study is to compare the frequency of reinterventions after LER in patients with premature PAD to their older counterparts with common age of presentation (ie, 60-80 years). METHODS: A retrospective review of consecutive patients undergoing LER for PAD in a single center was performed. Clinical, procedural, and socioeconomic characteristics were compared between patients with premature PAD and the older group. Perioperative and long-term outcomes were captured and compared including mortality, major amputation, reintervention rate and frequency, as well as major adverse limb events. RESULTS: There were 1274 patients who underwent LER (4.3% premature, 61.8% age 60-80). Patients with premature PAD were more likely to be females of racial minorities. Notably, the mean Distressed Communities Index score was significantly higher in the premature PAD group compared with the older patients. Patients with premature PAD were significantly more likely to have end-stage renal disease but less likely to have hypertension, hyperlipidemia, and coronary artery disease compared with older patients. There was no significant difference in perioperative complications. After a mean follow-up of 5 years, patients with premature PAD were significantly more likely to undergo more frequent reinterventions compared with older patients. Kaplan-Meier curves showed similar overall survival and major adverse limb event-free survival between the two groups. CONCLUSIONS: Patients with premature PAD are likely to undergo more frequent reinterventions after initial LER and have similar 5-year survival curves compared with patients at least 20 years older. Demographic and socioeconomic differences impacting patients with premature PAD, even in this relatively underpowered institutional experience, are striking and warrant further investigation.

Comparison of open and endovascular left subclavian artery revascularization for zone 2 thoracic endovascular aortic repair.

OBJECTIVE: In patients undergoing elective thoracic endovascular aortic repair (TEVAR) and left subclavian artery (LSA) coverage, routine preoperative LSA revascularization is recommended. However, in the current endovascular era, the optimal surgical approach is debated. We compared baseline characteristics, procedural details, and perioperative outcomes of patients undergoing open or endovascular LSA revascularization in the setting of TEVAR. METHODS: Adult patients undergoing TEVAR with zone 2 proximal landing and LSA revascularization between 2013 and 2023 were identified in the Vascular Quality Initiative. We excluded patients with traumatic aortic injury, aortic thrombus, or ruptured presentations, and stratified based on revascularization type (open vs any endovascular). Open LSA revascularization included surgical bypass or transposition. Endovascular LSA revascularization included single-branch, fenestration, or parallel stent grafting. Primary outcomes were stroke, spinal cord ischemia (SCI), and perioperative mortality (Pearson's χ2 test). Multivariable logistic regression was used to evaluate associations between revascularization type and primary outcomes. Secondarily, we studied other in-hospital complications and 5-year mortality (Kaplan-Meier, multivariable Cox regression). Sensitivity analyses were performed in patients undergoing concomitant LSA revascularization to TEVAR. RESULTS: Of 2489 patients, 1842 (74%) underwent open and 647 (26%) endovascular LSA revascularization. Demographics and comorbidities were similar between open and endovascular cohorts. Compared with open, endovascular revascularization had shorter procedure times (median, 135 minutes vs 174 minutes; P < .001), longer fluoroscopy times (median, 23 minutes vs 16 minutes; P < .001), lower estimated blood loss (median, 100 mL vs 123 mL; P < .001), and less preoperative spinal drain use (40% vs 49%; P < .001). Patients undergoing endovascular revascularization were more likely to present urgently (24% vs 19%) or emergently (7.4% vs 3.4%) (P < .001). Compared with open, endovascular patients experienced lower stroke rates (2.6% vs 4.8%; P = .026; adjusted odds ratio [aOR], 0.50 [95% confidence interval (CI), 0.25-0.90]), but had comparable SCI (2.9% vs 3.5%; P = .60; aOR, 0.64 [95% CI, 0.31-1.22]) and perioperative mortality (3.1% vs 3.3%; P = .94; aOR, 0.71 [95% CI, 0.34-1.37]). Compared with open, endovascular LSA revascularization had lower rates of overall composite in-hospital complications (20% vs 27%; P < .001; aOR, 0.64 [95% CI, 0.49-0.83]) and shorter overall hospital stay (7 vs 8 days; P < .001). After adjustment, 5-year mortality was similar among groups (adjusted hazard ratio, 0.85; 95% CI, 0.64-1.13). Sensitivity analyses supported the primary analysis with similar outcomes. CONCLUSIONS: In patients undergoing TEVAR starting in zone 2, endovascular LSA revascularization had lower rates of postoperative stroke and overall composite in-hospital complications, but similar SCI, perioperative mortality, and 5-year mortality rates compared with open LSA revascularization. Future comparative studies are needed to evaluate the mid- to long-term safety of endovascular LSA revascularization and assess differences between specific endovascular techniques.

Outcomes of carotid revascularization stratified by procedure in patients with an estimated glomerular filtration rate of <30 and dialysis patients.

OBJECTIVE: Renal failure is a predictor of adverse outcomes in carotid revascularization. There has been debate regarding the benefit of revascularization in patients with severe chronic kidney disease or on dialysis. METHODS: Patients in the Vascular Quality Initiative undergoing transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (tfCAS), or CEA between 2016 and 2023 with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 or on dialysis were included. Patients were divided into cohorts based on procedure. Additional analyses were performed for patients on dialysis only and by symptomatology. Primary outcomes were perioperative stroke/death/myocardial infarction (MI) (SDM). Secondary outcomes included perioperative death, stroke, MI, cranial nerve injury, and stroke/death. Inverse probability of treatment weighting was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and preoperative symptoms. The χ2 test and multivariable logistic regression analysis were used to evaluate the association of procedure with perioperative outcomes in the weighted cohort. Five-year survival was evaluated using Kaplan-Meier and weighted Cox regression. RESULTS: In the weighted cohort, 13,851 patients with an eGFR of <30 (2506 on dialysis) underwent TCAR (3639; 704 on dialysis), tfCAS (1975; 393 on dialysis), or CEA (8237; 1409 on dialysis) during the study period. Compared with TCAR, CEA had higher odds of SDM (2.8% vs 3.6%; adjusted odds ratio [aOR], 1.27; 95% confidence interval [CI], 1.00-1.61; P = .049), and MI (0.7% vs 1.5%; aOR, 2.00; 95% CI, 1.31-3.05; P = .001). Compared with TCAR, rates of SDM (2.8% vs 5.8%), stroke (1.2% vs 2.6%), and death (0.9% vs 2.4%) were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%; aOR, 1.85; 95% CI, 1.15-2.97; P = .011) and cranial nerve injury (0.3% vs 1.9%; aOR, 7.23; 95% CI, 3.28-15.9; P < .001). Like in the primary analysis, asymptomatic tfCAS patients demonstrated higher odds of death and stroke/death. Symptomatic CEA patients demonstrated no difference in stroke, death, or stroke/death. Although tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, the 5-year survival was similar for TCAR and CEA (eGFR <30, 75.1% vs 74.2%; aHR, 1.06; P = .3) and lower for tfCAS (eGFR <30, 75.1% vs 70.4%; aHR, 1.44; P < .001). CONCLUSIONS: CEA and TCAR had similar odds of stroke and death and are both a reasonable choice in this population; however, TCAR may be better in patients with an increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, although patients with a reduced eGFR have worse outcomes than their healthy peers, this analysis shows that the majority of patients survive long enough to benefit from the potential stroke risk reduction provided by all revascularization procedures.

The rise of endovascular repair for abdominal, thoracoabdominal, and thoracic aortic aneurysms.

BACKGROUND: Given changes in intervention guidelines and the growing popularity of endovascular treatment for aortic aneurysms, we examined the trends in admissions and repairs of abdominal aortic aneurysms (AAAs), thoracoabdominal aortic aneurysms (TAAAs), and thoracic aortic aneurysms (TAAs). METHODS: We identified all patients admitted with ruptured aortic aneurysms and intact aortic aneurysms repaired in the Nationwide Inpatient Sample between 2004 and 2019. We then examined the use of open, endovascular, and complex endovascular repair (OAR, EVAR, and cEVAR) for each aortic aneurysm location (AAA, TAAA, and TAA), alongside their resulting in-hospital mortality, over time. cEVAR included branched, fenestrated, and physician-modified endografts. RESULTS: 715,570 patients were identified with AAA (87% intact repairs and 13% rupture admissions). Both intact AAA repairs and ruptured AAA admissions decreased significantly between 2004 and 2019 (intact 41,060-34,215, P < .01; ruptured 7175-4625, P = .02). Of all AAA repairs performed in a given year, the use of EVAR increased (2004-2019: intact 45%-66%, P < .01; ruptured 10%-55%, P < .01) as well as cEVAR (2010-2019: intact 0%-23%, P < .01; ruptured 0%-14%, P < .01). Mortality after EVAR of intact AAAs decreased significantly by 29% (2004-2019, 0.73%-0.52%, P < .01), whereas mortality after OAR increased significantly by 16% (2004-2019, 4.4%-5.1%, P < .01). In the study, 27,443 patients were identified with TAAA (80% intact and 20% ruptured). In the same period, intact TAAA repairs trended upward (2004-2019, 1435-1640, P = .055), and cEVAR became the most common approach (2004-2019, 3.8%-72%, P = .055). A total of 141,651 patients were identified with ascending, arch, or descending TAAs (90% intact and 10% ruptured). Intact TAA repairs increased significantly (2004-2019, 4380-10,855, P < .01). From 2017 to 2019, the mortality after OAR of descending TAAs increased and mortality after thoracic endovascular aneurysm repair decreased (2017-2019, OAR 1.6%-3.1%; thoracic endovascular aneurysm repair 5.2%-3.8%). CONCLUSIONS: Both intact AAA repairs and ruptured AAA admissions significantly decreased between 2004 and 2019. The use of endovascular techniques for the repair of all aortic aneurysm locations, both intact and ruptured, increased over the past two decades. Most recently in 2019, 89% of intact AAA repairs, infrarenal through suprarenal, were endovascular (EVAR or cEVAR, respectively). cEVAR alone increased to 23% of intact AAA repairs in 2019, from 0% a decade earlier. In this period of innovation, with many new options to repair aortic aneurysms while maintaining arterial branches, endovascular repair is now used for the majority of all intact aortic aneurysm repairs. Long-term data are needed to evaluate the durability of these procedures.