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.

Long-term outcomes in the smoking claudicant after peripheral vascular interventions.

OBJECTIVE: Emphasis on tobacco cessation, given the urgent and emergent nature of vascular surgery, is less prevalent than standard elective cases such as hernia repairs, cosmetic surgery, and bariatric procedures. The goal of this study is to determine the effect of active smoking on claudicating individuals undergoing peripheral vascular interventions (PVIs). Our goal is to determine if a greater emphasis on education should be placed on smoking cessation in nonurgent cases scheduled through clinic visits and not the Emergency Department. METHODS: This study was performed using the multi-institution de-identified Vascular Quality Initiative/Medicare-linked database (Vascular Implant Surveillance and Interventional Outcomes Network [VISION]). Claudicants who underwent PVI for peripheral arterial occlusive disease between 2004 and 2019 were included in our study. Our final sample consisted of a total of 18,726 patients: 3617 nonsmokers (19.3%) (NSs), 9975 former smokers (53.3%) (FSs), and 5134 current smokers (27.4%) (CSs). We performed propensity score matching on 29 variables (age, gender, race, ethnicity, treatment setting [outpatient or inpatient], obesity, insurance, hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, previous coronary artery bypass graft, carotid endarterectomy, major amputation, inflow treatment, prior bypass or PVI, preoperative medications, level of treatment, concomitant endarterectomy, and treatment type [atherectomy, angioplasty, stent]) between NS vs FS and FS vs CS. Outcomes were long-term (5-year) overall survival (OS), limb salvage (LS), freedom from reintervention (FR), and amputation-free survival (AFS). RESULTS: Propensity score matching resulted in 3160 well-matched pairs of NS and FS and 3750 well-matched pairs of FS and CS. There was no difference between FS and NS in terms of OS (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.82-1.09; P = .43), FR (HR, 0.96; 95% CI, 0.89-1.04; P = .35), or AFS (HR, 0.90; 95% CI, 0.79-1.03; P = .12). However, when compared with CS, we found FS to have a higher OS (HR, 1.18; 95% CI, 1.04-1.33; P = .01), less FR (HR, 0.89; 95% CI, 0.83-0.96; P = .003), and greater AFS (HR, 1.16; 95% CI, 1.03-1.31; P = .01). CONCLUSIONS: This multi-institutional Medicare-linked study looking at elective PVI cases in patients with peripheral artery disease presenting with claudication found that FSs have similar 5-year outcomes in comparison to NSs in terms of OS, FR, and AFS. Additionally, CSs have lower OS and AFS when compared with FSs. Overall, this suggests that smoking claudicants should be highly encouraged and referred to structured smoking cessation programs or even required to stop smoking prior to elective PVI due to the perceived 5-year benefit.

Non-White Patients Have a Higher Risk of Stroke Following Transcarotid Artery Revascularization.

INTRODUCTION: Carotid artery revascularization has traditionally been performed by either a carotid endarterectomy or carotid artery stent. Large data analysis has suggested there are differences in perioperative outcomes with regards to race, with non-White patients (NWP) having worse outcomes of stroke, restenosis and return to the operating room (RTOR). The introduction of transcarotid artery revascularization (TCAR) has started to shift the paradigm of carotid disease treatment. However, to date, there have been no studies assessing the difference in postoperative outcomes after TCAR between racial groups. METHODS: All patients from 2016 to 2021 in the Vascular Quality Initiative who underwent TCAR were included in our analysis. Patients were split into two groups based on race: individuals who identified as White and a second group that comprised all other races. Demographic and clinical variables were compared using Student's t-Test and chi-square test of independence. Logistic regression analysis was performed to determine the impact of race on perioperative outcomes of stroke, myocardial infarction (MI), death, restenosis, RTOR, and transient ischemic attack (TIA). RESULTS: The cohort consisted of 22,609 patients: 20,424 (90.3%) White patients and 2185 (9.7%) NWP. After adjusting for sex, diabetes, hypertension, coronary artery disease, history of prior stroke or TIA, symptomatic status, and high-risk criteria at time of TCAR, there was a significant difference in postoperative stroke, with 63% increased risk in NWP (odds ratio = 1.63, 95% confidence interval: 1.11-2.40, P = 0.014). However, we found no significant difference in the odds of MI, death, postoperative TIA, restenosis, or RTOR when comparing NWP to White patients. CONCLUSIONS: This study demonstrates that NWP have increased risk of stroke but similar outcomes of death, MI, RTOR and restenosis following TCAR. Future studies are needed to elucidate and address the underlying causes of racial disparity in carotid revascularization.

30-Day Risk Score for Mortality and Stroke in Patients with Carotid Artery Stenosis Using Artificial Intelligence Based Carotid Plaque Morphology.

BACKGROUND: The gold standard for determining carotid artery stenosis intervention is based on a combination of percent stenosis and symptomatic status. Few studies have assessed plaque morphology as an additive tool for stroke prediction. Our goal was to create a predictive model and risk score for 30-day stroke and death inclusive of plaque morphology. METHODS: Patients with a computed tomographic angiography head/neck between 2010 and 2021 at a single institution and a diagnosis of carotid artery stenosis were included in our analysis. Each computed tomography was used to create a three-dimensional image of carotid plaque based off image recognition software. A stepwise backward regression was used to select variables for inclusion in our prediction models. Model discrimination was assessed with area under the receiver operating characteristic curves (AUCs). Additionally, calibration was performed and the model with the least Akaike Information Criterion (AIC) was selected. The risk score was modeled from the Framingham Study. Primary outcome was mortality/stroke. RESULTS: We created 3 models to predict mortality/stroke from 366 patients: model A using only clinical variables, model B using only plaque morphology and model C using both clinical and plaque morphology variables. Model A used age, sex, peripheral arterial disease, hyperlipidemia, body mass index (BMI), chronic obstructive pulmonary disease (COPD), and history of transient ischemia attack (TIA)/stroke and had an AUC of 0.737 and AIC of 285.4. Model B used perivascular adipose tissue (PVAT) volume, lumen area, calcified volume, and target lesion length and had an AUC of 0.644 and AIC of 304.8. Finally, model C combined both clinical and software variables of age, sex, matrix volume, history of TIA/stroke, BMI, PVAT, lipid rich necrotic core, COPD and hyperlipidemia and had an AUC of 0.759 and an AIC of 277.6. Model C was the most predictive because it had the highest AUC and lowest AIC. CONCLUSIONS: Our study demonstrates that combining both clinical factors and plaque morphology creates the best predication of a patient's risk for all-cause mortality or stroke from carotid artery stenosis. Additionally, we found that for patients with even 3 points in our risk score model has a 20% chance of stroke/death. Further prospective studies are needed to validate our findings.

Small Arteriovenous Anastomosis in Fistula Creation: Establishing a Functional Vascular Access while Minimizing Steal Syndrome.

BACKGROUND: The size selection of the arteriovenous (AV) anastomosis in dialysis access creation requires a careful balance: the diameter must be large enough to accommodate sufficient flow for hemodialysis but small enough to minimize the complication of steal syndrome. Steal syndrome affects up to 10% of patients after creation of dialysis access with sometimes devastating consequences. Conventional teaching recommends a 7-10 mm anastomosis. We sought to assess the efficacy of using a smaller (5-6 mm) anastomosis in new arteriovenous fistula (AVF) creation. METHODS: We conducted a comparative retrospective analysis of patients who underwent fistula creation with a small versus regular size anastomosis at any upper extremity anatomic site between March 2019 and October 2020 at our institution. Anatomic sites included radiocephalic, brachiocephalic, and brachiobasilic. All AV anastomoses were measured intraoperatively to be 5-6 mm in diameter for the small size groups and 8-10 mm for the regular size group. Endpoints included steal syndrome, functional patency, primary patency, and secondary patency. RESULTS: Out of 110 patients who underwent an AVF creation, 59.1% received a 5-6 mm anastomosis with a median follow-up time of 10 ± 6 months. Patients' demographics and comorbidities were relatively similar between the 2 groups except for a higher rate of hyperlipidemia (55.4% vs. 28.9%, P = 0.008) in the small size group. Patients in the small size group were more likely to undergo a radiocephalic fistula (40% vs. 4.5%, P < 0.001) and to have a smaller mean vein diameter on preoperative duplex ultrasound (3.2±1 mm vs. 3.9±1 mm, P = 0.0016) when compared to their regular size counterparts. During follow-up, none of the patients in the small group developed steal syndrome (0% vs. 9%, P = 0.015). At 1 year, patients in the regular size group achieved higher rates of primary patency (67.9% vs. 46.9%, P = 0.02); however, no difference was seen in 1-year primary-assisted patency (84.9% vs. 73.6%, P = 0.3), secondary patency (89.6% vs. 79.5%, P = 0.3), or functional patency (87.7% vs. 82.2%, P = 0.64) between the small and regular size groups, respectively. CONCLUSIONS: The use of a 5-6 mm anastomosis in the creation of new AVFs of the upper extremities appears to be a technically safe option for dialysis access. Our experience suggests that smaller anastomosis still creates enough flow to maintain a functional AV access while minimizing the incidence of steal syndrome. Additionally, even with smaller vein sizes preoperative, adequate dialysis access can be created via a small sized anastomosis, including distal arm access. Larger studies with longer follow-up are needed to evaluate long-term outcomes of small anastomosis fistulas.

A Single-Institution Case Series of Total Endovascular Relining for Type 3 Endoleaks in Traditional Endovascular Aneurysm Repair (EVAR) Grafts with Raised Bifurcations.

BACKGROUND: The endovascular repair of infrarenal abdominal aortic aneurysms can be performed with a wide variety of devices. Many of these grafts elevate the aortic bifurcation which can limit future repairs if the graft material fails thereby creating a type III endoleak to aorto-uniliac grafts. Many manufacturers have grafts susceptible to this, but we have seen this in the Medtronic AneuRx graft. Our goal is to provide technical details and outcomes regarding a novel technique to reline these grafts while maintaining inline flow to the iliac arteries. METHODS: This was a single-institution review of patients who had endoleaks requiring intervention after a previously placed graft with an elevated aortic bifurcation. Primary outcomes included technical success defined as placement of all planned devices, resolution of type III endoleak, aneurysm size at follow-up, and requirement of reintervention. Secondary outcomes included 30-day complications, aneurysm-related mortality, and all-cause mortality. Technical details of the operation include back-table deployment of an Ovation device, modification of the deployment system tether and pre-emptive placement of an up and over 0.014″ wire. The wire is placed up and over and hung outside the contralateral gate. Once the main body is introduced above the old graft, the 0.014" is snared from the contralateral side and externalized. The main body is then able to be seated at the bifurcation as the limb is not fully deployed and then device deployment is completed per instructions for use. RESULTS: Our study consists of 4 individuals, 3 of which had an abdominal aortic aneurysm initially managed with an AneuRx endovascular aneurysm repair and 1 with a combination of Gore and Cook grafts. All 4 patients were male with an average age of 84.5 years at time of reline. All patients had at least 10 years between initial surgery and reline at our institution. Primary outcomes revealed no type 1 or 3 endoleaks at follow-up, technical success was 100% and 1 patient required reintervention for aneurysm growth and type 2 endoleak. In terms of our secondary outcomes, there was 1 postoperative complication which was cardiac dysfunction secondary to demand ischemia, aneurysm-related mortality was 0% and all-cause mortality was 25% at average follow-up of 2.44 years. CONCLUSIONS: As individuals continue to age, there are more patients who would benefit from less invasive reinterventions following endovascular aneurysm repair. Whether this is due to aortic degeneration, stent migration, or stent material damage is not always known. In this study, we present an endovascular approach to treating type III endoleak patients with a previous graft and elevated aortic bifurcation using Ovation stent grafts and found no evidence of type 1 or 3 endoleaks on follow-up imaging. This approach may allow patients with type III endoleak the option of a minimally invasive, percutaneous approach where they previously would not have had one.

Long-Term Patency Between Brachiocephalic and Brachiobasilic Fistulas: A Single Institution Review.

BACKGROUND: Dialysis access is a fundamental procedure performed by vascular surgeons. Commonly, upper extremity access is utilized via a brachiobasilic fistula (BBF) or brachiocephalic fistula (BCF). BCF is preferred due to ease compared to BBF without documented improved function. Few studies compare patency outcomes between BBF and BCF over time. Our goal was to evaluate the difference in outcomes between BBF and BCF. METHODS: This is a retrospective review of patients with BCF or BBF between 2019 and 2022. Patients were split by procedure: BCF and BBF. Data collected included demographics, vein size, tunneled catheter, and previous access. Primary outcomes included primary patency (PP), primary assisted patency (PAP) and secondary patency (SP). Secondary outcomes included 30-day complications, access abandonment, interventions and mortality. Linear regression, Kaplan-Meier, and log-rank test were performed. RESULTS: Our study had 184 patients, 109 (59%) with BCF and 75 (41%) with BBF. There were no differences in demographics except for body mass index and vein size (BBF: 4 vs. BCF: 3.6 mm, P = 0.020). There was no difference in PP at 1 year (41% vs. 47%, P = 0.547) or SP at 2 years (73% vs. 84%, P = 0.058) in BBF versus BCF. However, PAP was significantly greater in BCF (80% vs. 67%, P = 0.030) at 1 year. Secondary outcomes revealed no difference in wound complications (1% vs. 0%, P = 0.408), access abandonment (35% vs. 28%, P = 0.260), or number of interventions (1 vs. 1, P = 0.712) in BBF versus BCF. Mortality was significantly greater in the BBF patients (19% vs. 6%, P = 0.005). On adjusted analysis, BBF had 43 min longer operative time (P < 0.001) and 22 cc greater blood loss (P < 0.0001). CONCLUSIONS: In this single center review comparing BBF and BCF, no difference was seen between BBF and BCF in terms of PP or SP. Even with larger vein size, BBF did not confer a benefit in long term patency or access abandonment. Additionally, BBF did not confer decreased procedures to maintain patency and BBF had greater operative length and blood loss, as well as mortality. We believe this study demonstrates that for patients who must use an upper extremity location, when the cephalic vein is satisfactory, using the cephalic vein is preferred as it does not negatively impact long-term patency.

Propensity-Score Matched Analysis of Three Years Survival of Trans Carotid Artery Revascularization Versus Carotid Endarterectomy in the Vascular Quality Initiative Medicare-Linked Database.

OBJECTIVE: Carotid endarterectomy (CEA) remains the gold standard procedure for carotid revascularization. Transfemoral carotid artery stenting (TFCAS) was introduced as a minimally invasive alternative procedure in patients who are at high risk for surgery. However, TFCAS was associated with an increased risk of stroke and death compared to CEA. BACKGROUND: Transcarotid artery revascularization (TCAR) has outperformed TFCAS in several prior studies and has shown similar perioperative and 1-year outcomes compared with CEA. We aimed to compare the 1-year and 3-year outcomes of TCAR versus CEA in the Vascular Quality Initiative (VQI)-Medicare-Linked [Vascular Implant Surveillance and Interventional Outcomes Network (VISION)] database. METHODS: The VISION database was queried for all patients undergoing CEA and TCAR between September 2016 to December 2019. The primary outcome was 1-year and 3-year survival. One-to-one propensity-score matching (PSM) without replacement was used to produce 2 well-matched cohorts. Kaplan-Meier estimates, and Cox regression was used for analyses. Exploratory analyses compared stroke rates using claims-based algorithms for comparison. RESULTS: A total of 43,714 patients underwent CEA and 8089 patients underwent TCAR during the study period. Patients in the TCAR cohort were older and were more likely to have severe comorbidities. PSM produced two well-matched cohorts of 7351 pairs of TCAR and CEA. In the matched cohorts, there were no differences in 1-year death [hazard ratio (HR)=1.13; 95% CI, 0.99-1.30; P =0.065]. At 3-years, TCAR was associated with slight increased risk of death (HR=1.16; 95% CI, 1.04-1.30; P =0.008). When stratifying by initial symptomatic presentation, the increased 3-year death associated with TCAR persisted only in symptomatic patients (HR=1.33; 95% CI, 1.08-1.63; P =0.008). Exploratory analyses of postoperative stroke rates using administrative sources suggested that validated measures of claims-based stroke ascertainment are necessary. CONCLUSIONS: In this large multi-institutional PSM analysis with robust Medicare-linked follow-up for survival analysis, the rate of death at 1 year was similar in TCAR and CEA regardless of symptomatic status. The slight increase in the risk of 3-year death in symptomatic patients undergoing TCAR is likely confounded by more severe comorbidities despite matching. A randomized controlled trial comparing TCAR to CEA is necessary to further determine the role of TCAR in standard-risk patients requiring carotid revascularization.

Use of surgical augmented intelligence maps can reduce radiation and improve safety in the endovascular treatment of complex aortic aneurysms.

OBJECTIVE: The introduction of endovascular procedures has revolutionized the management of complex aortic aneurysms. Although repair has traditionally required longer operative times and increased radiation exposure compared with simple endovascular aneurysm repair, the recent introduction of three-dimensional technology has become an invaluable operative adjunct. Surgical augmented intelligence (AI) is a rapidly evolving tool initiated at our institution in June 2019. In our study, we sought to determine whether this technology improved patient and operator safety. METHODS: A retrospective review of patients who had undergone endovascular repair of complex aortic aneurysms (pararenal, juxtarenal, or thoracoabdominal), type B dissection, or infrarenal (endoleak, coil placement, or renal angiography with or without intervention) at a tertiary care center from August 2015 to November 2021 was performed. Patients were stratified according to the findings from intelligent maps, which are patient-specific AI tools used in the operating room in conjunction with real-time fluoroscopic images. The primary outcomes included operative time, radiation exposure, fluoroscopy time, and contrast use. The secondary outcomes included 30-day postoperative complications and long-term follow-up. Linear regression models were used to evaluate the association between AI use and the main outcomes. RESULTS: During the 6-year period, 116 patients were included in the present study, with no significant differences in the baseline characteristics. Of the 116 patients, 76 (65.5%) had undergone procedures using AI and 40 (34.5%) had undergone procedures without AI software. The intraoperative outcomes revealed a significant decrease in radiation exposure (AI group, 1955 mGy; vs non-AI group, 3755 mGy; P = .004), a significant decrease in the fluoroscopy time (AI group, 55.6 minutes; vs non-AI group, 86.9 minutes; P = .007), a decrease in the operative time (AI group, 255 minutes; vs non-AI group, 284 minutes; P = .294), and a significant decrease in contrast use (AI group, 123 mL; vs non-AI group, 199 mL; P < .0001). No differences were found in the 30-day and long-term outcomes. CONCLUSIONS: The results from the present study have demonstrated that the use of AI technology combined with intraoperative imaging can significantly facilitate complex endovascular aneurysm repair by decreasing the operative time, radiation exposure, fluoroscopy time, and contrast use. Overall, evolving technology such as AI has improved radiation safety for both the patient and the entire operating room team.

Loss of follow-up after carotid revascularization is associated with worse long-term stroke and death.

OBJECTIVES: Society for Vascular Surgery practice guidelines recommend surveillance with duplex ultrasound scanning at baseline (within 3 months from discharge), every 6 months for 2 years, and annually afterward following carotid endarterectomy or carotid artery stenting. There is a growing concern regarding the significance of postoperative follow-up after several vascular procedures. We sought to determine whether 1-year loss to follow-up (LTF) after carotid revascularization was associated with worse outcomes in the Vascular Quality Initiative (VQI) linked to Vascular Implant Surveillance and Interventional Outcomes Network (VISION) database. METHODS: All patients who underwent carotid revascularization in the VQI VISION database between 2003 and 2016 were included. LTF was defined as failure to complete 1-year follow-up in the VQI long-term follow-up dataset. Data about stroke and mortality were captured in the VISION dataset using a list of Current Procedural Terminology, International Classification of Diseases (Ninth Revision), and International Classification of Diseases (Tenth Revision) codes linked to index procedures in VQI. Kaplan-Meier life-table methods and Cox proportional hazard modeling were used to compare 5- and 10-year outcomes between patients with no LTF and those who were LTF. RESULTS: A total of 58,840 patients were available for analysis. The 1-year LTF rate was 43.8%. Patients who were LTF were older and more frequently symptomatic, with chronic obstructive pulmonary diseases, chronic kidney diseases, and congestive heart failure. Also, patients who underwent carotid artery stenting were more likely to be LTF compared with carotid endarterectomy patients (54.5% vs 42.3%; P < .001). The incidence of postoperative (30 days) stroke was higher in the LTF group (2.9% vs 1.7%; P < .001). Cox regression analysis revealed that LTF was associated with an increased risk of long-term stroke at 5 years (hazard ratio [HR]: 1.4, 95% confidence interval [CI]: 1.2-1.6; P < .001) and 10 years (HR: 1.3, 95% CI: 1.2-1.5; P < .001). It was also associated with significantly higher mortality at 5 years (HR: 2.5, 95% CI: 2.3-2.8; P < .001) and 10 years (HR: 2.2, 95% CI: 1.9-2.5; P < .001). Stroke or death was significantly worse in the LTF group at 5 years (HR: 2.3, 95% CI: 2.1-2.5; P < .001) and up to 10 years (HR: 2.02, 95% CI: 1.8-2.3; P < .001). CONCLUSIONS: One-year follow-up after carotid revascularization procedures was found to be associated with better stroke- and mortality-free survival. Surgeons should emphasize the importance of follow-up to all patients who undergo carotid revascularization, especially those with multiple comorbidities and postoperative neurological complications.

Long-term outcomes after lower extremity bypass in the actively smoking claudicant.

OBJECTIVE: Smoking is known to increase complications, including poor wound healing, coagulation abnormalities, and cardiac and pulmonary ramifications. Across specialties, elective surgical procedures are commonly denied to active smokers. Given the base population of active smokers with vascular disease, smoking cessation is encouraged but is not required the way it is for elective general surgery procedures. We aim to study the outcomes of elective lower extremity bypass (LEB) in actively smoking claudicants. METHODS: We queried the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network LEB database from 2003 to 2019. In this database we found 609 (10.0%) never smokers (NS), 3388 (55.3%) former smokers (FS), and 2123 (34.7%) current smokers (CS) who underwent LEB for claudication. We performed two separate propensity score matches without replacement on 36 clinical variables (age, gender, race, ethnicity, obesity, insurance, hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, previous coronary artery bypass graft, carotid endarterectomy, major amputation, inflow treatment, preoperative medications and treatment type), one of FS to NS and a second analysis of CS to FS. Primary outcomes included 5-year overall survival (OS), limb salvage (LS), freedom from reintervention (FR), and amputation-free survival (AFS). RESULTS: Propensity score matches resulted in 497 well-matched pairs of NS and FS. In this analysis we found no difference in terms of OS (HR, 0.93; 95% CI, 0.70-1.24; P = .61), LS (HR, 1.07; 95% CI, 0.63-1.82; P = .80), FR (HR, 0.9; 95% CI,0.71-1.21; P = .59), or AFS (HR, 0.93; 95% CI,0.71-1.22; P = .62). In the second analysis, we had 1451 well-matched pairs of CS and FS. There was no difference in LS (HR, 1.36; 95% CI,0.94-1.97; P = .11) or FR (HR, 1.02; 95% CI,0.88-1.19; P = .76). However, we did find a significant increase in OS (HR, 1.37; 95% CI,1.15-1.64, P <.001) and AFS (HR, 1.38; 95% CI,1.18-1.62; P < .001) in FS compared with CS. CONCLUSIONS: Claudicants represent a unique nonemergent vascular patient population that may require LEB. Our study found that FS have better OS and AFS when compared with CS. Additionally, FS mimic nonsmokers at 5-year outcomes for OS, LS, FR, and AFS. Therefore, structured smoking cessation should be a more prominent part of vascular office visits before elective LEB procedures in claudicants.

Dual Antiplatelet Therapy Is Associated with Increased Risk of Bleeding and Decreased Risk of Stroke Following Carotid Endarterectomy.

BACKGROUND: Despite many patients undergoing carotid endarterectomy (CEA) being on dual antiplatelet therapy (DAPT) for cardiac or neurologic indications, the impact of such therapy on perioperative outcomes remains unclear. We aim to compare rates of postoperative bleeding, stroke and major adverse events (stroke, death or MI) among patients on Aspirin alone (ASAA) versus DAPT (Clopidogrel and Aspirin). METHODS: Patients undergoing CEA for carotid artery stenosis between 2010 and 2021 in the Vascular Quality Initiative (VQI) were included. We excluded patients undergoing concomitant or re-do operations or patients with missing antiplatelet information. Propensity score matching was performed between the 2 groups ASAA and DAPT based on age, sex, race, presenting symptoms, major comorbidities [hypertension, diabetes and coronary artery disease (CAD)], degree of ipsilateral stenosis, presence of contralateral occlusion, as well as preoperative medications. Intergroup differences between the treatment groups and differences in perioperative outcomes were tested with the McNemar's test for categorical variables and paired t-test or Wilcoxon matched-pairs signed-rank test for continuous variables where appropriate. Relative risks with 95% confidence intervals were estimated as the ratio of the probability of the outcome event in the patients treated within each treatment group. RESULTS: A total of 125,469 patients were included [ASAA n = 82,920 (66%) and DAPT n = 42,549 (34%)]. Patients on DAPT were more likely to be symptomatic, had higher rates of CAD, prior percutaneous coronary intervention or coronary artery bypass grafting, and higher rates of diabetes. After propensity score matching, the DAPT group had an increased rate of bleeding complications (RR: 1.6: 1.4-1.8, P < 0.001) as compared with those on ASAA despite being more likely to receive both drains and protamine. In addition, patients on DAPT had a slight decrease in the risk of in-hospital stroke as compared with patients on ASAA (RR: 0.80: 0.7-0.9, P = 0.001). CONCLUSIONS: This large multi-institutional study demonstrates a modest decrease in the risk of in-hospital stroke for patients on DAPT undergoing CEA as compared with those on ASAA. This small benefit is at the expense of a significant increase in the risk of perioperative bleeding events incurred by those on DAPT at the time of CEA. This analysis suggests avoiding DAPT when possible, during CEA.

Comparing Outcomes of Transfemoral Versus Transbrachial or Transradial Approach in Carotid Artery Stenting (CAS).

BACKGROUND: While Transfemoral Carotid Artery Stenting (TFCAS) is a valid minimally invasive option for patients who also might be suitable for carotid endarterectomy (CEA) or transcarotid artery revascularization (TCAR), alternative access sites such as transbrachial (TB) or transradial (TR) are only utilized when anatomic factors preclude direct carotid or transfemoral access. In this study, we aimed to evaluate the outcomes of TR/TB access in comparison to TF for percutaneous carotid artery revascularization. METHODS: All patients undergoing non-TCAR carotid artery stenting (CAS) from January 2012 to June 2021 in the Vascular Quality Initiative (VQI) Database were included. Patients were divided into 2 groups based on the access site for CAS: TF or TR/TB. Primary outcomes included stroke/death, technical failure and access site complications (hematoma, stenosis, infection, pseudoaneurysm and AV fistula). Secondary outcomes included stroke, TIA, MI, death, non-home discharge, extended length of postoperative stay (LOS) (>1 day), and composite endpoints of stroke/MI and stroke/death/MI. Univariable and multivariable logistic regression models were used to assess postoperative outcomes, and results were adjusted for relevant potential confounders including age, gender, race, degree of stenosis, symptomatic status, anesthesia, comorbidities, and preoperative medications. RESULTS: Out of the 23,965 patients, TR/TB approach was employed in 819 (3.4%) while TF was used in 23,146 (96.6%). Baseline characteristics found men were more likely to undergo revascularization using TR/TB approach (69.4% vs. 64.9%, P = 0.009). Patients undergoing TR/TB approach were also more likely to be symptomatic (49.9% vs. 28.6%, P < 0.001). Guideline directed medications were more frequently used with TR/TB including P2Y12 inhibitor (80.3% vs. 74.7%, P < 0.01), statin (83.8% vs. 80.6%), and aspirin (88.3% vs. 84.5%, P = 0.003) preoperatively. On univariate analysis, patients with TB/TR approach experienced higher rates of adverse outcomes. After adjusting for potential confounders, TR/TB patients had no significant increase in the risk of stroke/death [aOR 1.10 (0.69-1.76), P = 0.675]; however, the use of TR/TB access was associated with a more than 2-fold increase in risk for in-hospital MI [aOR 2.39 (1.32-4.30), P = 0.004] and 2-fold increase in risk of technical failure [aOR 2.21 (1.31-3.73) P = 0.003]. The use of TR/TB access was also associated with a 50% reduction in the risk of access site complications [aOR 0.53 (0.32-0.85), P = 0.009]. CONCLUSIONS: This study confirms that although technically more challenging, TR or TB approach serves as a reasonable alternative with lower access site complications for CAS particularly in patients where anatomic factors preclude revascularization by TFCAS or TCAR. However, TR/TB is associated with an increased risk of technical failure and myocardial infarction, which requires further study.

Cost-Effectiveness Analysis of Open Versus Endovascular Revascularization for Chronic Mesenteric Ischemia.

BACKGROUND: Recent studies have shown a trend supporting endovascular revascularization (ER) in the treatment of chronic mesenteric ischemia (CMI). However, few studies have compared the cost effectiveness of ER and open revascularization (OR) for this indication. The purpose of this study is to conduct a cost-effectiveness analysis comparing open versus ER for CMI. METHODS: We built a Markov model with Monte Carlo microsimulation using transition probabilities and utilities from existing literature for CMI patients undergoing OR versus ER. Costs were derived from the hospital perspective using the 2020 Medicare Physician Fee Schedule. The model randomized 20,000 patients to either OR or ER and allowed for 1 subsequent reintervention with 3 other intervening health states: alive, alive with complications, and dead. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness. RESULTS: OR cost $4,532 for 1.03 QALYs while ER cost $5,092 for 1.21 QALYs, leading to an ICER of $3,037 per QALY gained in the ER arm. This ICER was less than our willingness to pay threshold of $100,000. Sensitivity analysis demonstrated that our model was most sensitive to costs, mortality, and patency rates after OR and ER. Probabilistic sensitivity analysis demonstrated ER would be considered cost effective 99% of iterations. CONCLUSIONS: This study found that while 5-year costs for ER were greater than OR, ER afforded greater QALYs than OR. Although ER is associated with lower long-term patency and higher rates of reintervention, it appears to be more cost effective than OR for the treatment of CMI.

Upper Extremity Access Has Worse Outcomes in F/BEVAR Using the VQI Dataset.

BACKGROUND: Physician-modified endografts and custom-manufactured devices use branched and fenestrated techniques (F/BEVAR) to repair complex aneurysms. Traditionally, many of these are deployed through a combination of upper and lower extremity access. However, with newer steerable sheaths, you can now simulate upper extremity (UEM) access from a transfemoral approach. Single-institution studies have demonstrated increased risks of access site complications and stroke when UEM access is used. This study compares outcomes after F/BEVAR in a national database between total transfemoral (TTF) access and mixed UEM access. METHODS: This study is an analysis of the Vascular Quality Initiative for all patients who underwent F/BEVAR from 2014 to 2021. Patients were stratified based on a TTF delivery of all devices versus any UEM access for deployment of target vessel stents. Primary outcomes included stroke, myocardial infarction (MI), and perioperative death. Secondary outcomes included access site hematoma, occlusion or embolization, operative time, fluoroscopy time, and technical success. Multivariable linear and logistic regression analyses were performed. RESULTS: Three thousand one hundred forty six patients underwent an F/BEVAR: 2,309 (73.4%) TTF and 837 (26.6%) UEM. Logistic regression analysis indicated a two-fold increased risk of death and MI and a three-fold increased risk of stroke in the UEM group. Furthermore, there is decreased operative time (221 vs. 297 min, P < 0.001) and fluoroscopy time (62 vs. 80 min, P < 0.001) in the TTF group and no difference in technical success between groups (96% vs. 97%, P = 0.159). Finally, there was a decrease in access site hematoma 2.54% vs. 4.31% (P = 0.013), access site occlusion 0.61% vs. 1.91% (P = 0.001), and extremity embolization 2.17% vs. 3.58% (P = 0.026) in the TTF versus UEM group. CONCLUSIONS: This study using Vascular Quality Initiative data demonstrates that patients who undergo an F/BEVAR using UEM access have an increased risk of perioperative MI, death, and stroke compared to TTF access.

Two-Stage Offers No Advantages over Single-Stage Arteriovenous Creation: An Analysis of Multicenter National Data.

BACKGROUND: Traditionally, arteriovenous fistulas (AVF) involving the basilic vein (BV) have been created in 1 or 2 stages to allow time for the vein to enlarge before superficialization for potential better fistula maturation. Previous single institution studies and meta-analyses have found conflicting outcomes between single-stage and 2-stage procedures. Our study aims to use a large national database to assess the difference in outcomes between single-stage and 2-stage procedures for dialysis access. METHODS: We studied all patients undergoing BV AVF creation in the Vascular Quality Initiative (VQI) from 2011 to 2021. Patients were split into single-stage or a planned 2-stage procedure for dialysis access. Primary outcomes included dialysis use with index fistula, maturity rate, and number of days from surgery to fistula use. Secondary outcomes included patency (defined by physical exam or imaging on follow-up), 30-day mortality, and postoperative complications (bleeding, steal syndrome, thrombosis, or neuropathy). Logistic regression models were used to assess the association between staged dialysis access procedures and primary outcomes of interest. RESULTS: The cohort consisted of 22,910 individuals of which 7,077 (30.9%) had a 2-staged dialysis access procedure and 15,833 (69.1%) had a single-staged procedure. Average follow-up was 345 days in the single stage and 420 days for 2-stage. Baseline characteristics were significantly different between the 2 groups in terms of medical comorbidities. Primary outcomes were significant for more patients in the 2-stage group undergoing dialysis with the index fistula compared to single stage (31.5% vs. 22.2%, P < 0.0001), significant decrease in days to use in current dialysis patients (103.9 days single stage versus 141.0 days 2-stage, P < 0.0001), and no difference in maturity at follow-up (19.3% single-stage and 17.4% 2-stage, P = 0.354). Secondary outcomes revealed no difference in 30-day mortality or patency (89.8% single-stage and 89.1% 2-stage, P = 0.383), but a significant difference in postoperative complications with a 2-stage procedure compared to 1-stage (1.6% vs. 1.1%, P = 0.026). Finally, a spline model was used to determine that a preoperative vein of 3 mm or less could be a cutoff in which a 2-stage procedure might be beneficial. CONCLUSIONS: This study demonstrates that when dialysis access fistulas are created using the BV, there is no difference in maturity rate or 1-year patency when assessing single-stage versus 2-stage procedures. However, 2-stage procedures significantly delay the time of first use of the fistula and increase postoperative complications. Therefore, we suggest performing single stage procedures when the vein is of appropriate diameter to minimize multiple procedures, complications and expedite time to maturity.

Effect of routine intracerebral completion angiography on outcomes after transcarotid artery revascularization.

OBJECTIVE: Completion cerebral angiography (CCA) after transcarotid artery revascularization (TCAR) has been used to identify distal embolization after stenting and serve as a measure of intraoperative quality control. Nevertheless, no general evidence has been reported regarding the benefit of performing routine CCA. The aim of the present study was to evaluate the potential risks and benefits of routine CCA. METHODS: We retrospectively reviewed the Vascular Quality Initiative database for TCAR from 2016 to 2021. The patients were divided into two groups: those with no CCA performed and those with CCA performed. The primary outcome was in-hospital stroke or death. The secondary outcomes included stroke, death, myocardial infarction, and a return to the operating room (RTOR). Clinically relevant and statistically significantly variables on univariable analysis were added to a logistic regression model clustered by center identifier. RESULTS: A total of 18,155 patients who had undergone TCAR were identified, of whom 11,607 (63.7%) had undergone routine CCA. The patients with routine CCA were more likely to have contralateral carotid occlusion and to have received general anesthesia. After adjusting for potential confounders, we found no differences in the risk of stroke/death (adjusted odds ratio [aOR], 1.03; 95% confidence interval [CI], 0.8-1.3; P = .820), stroke/transient ischemic attack (TIA; aOR, 1.00; 95% CI, 0.8-1.3; P = .998), stroke (aOR, 1.1; 95% CI, 0.8-1.4; P = .452), death (aOR, 0.98; 95% CI, 0.6-1.6; P = .953), myocardial infarction (aOR, 0.78; 95% CI, 0.5-1.2; P = .240), or RTOR (aOR, 1.5; 95% CI, 0.6-3.8; P = .412) between patients who had undergone CCA and those who had not. A subanalysis of the patients with new occlusions detected by CCA (69 patients [0.6%]; 19 not treated and 50 treated) indicated a higher risk of stroke/death for the patients with treated new occlusions (aOR, 7.1; 95% CI, 2.9-17.3; P < .001) and stroke/TIA (aOR, 5.8; 95% CI, 2.3-14.7; P < .001) than for the patients who had not undergone CCA. However, no differences were found in stroke/death (aOR, 3.3; 95% CI, 0.37-29.5; P = .283) or stroke/TIA (aOR, 3.1; 95% CI, 0.3-29.4; P = .327) for patients with nontreated new occlusions compared with patients who had not undergone CCA. CONCLUSIONS: In the present retrospective study, routine performance of CCA was not beneficial, with no significant differences in in-hospital stroke or death detected. The detection of new lesions on CCA was rare. Moreover, identifying new occlusions using CCA was associated with higher odds of stroke or death when these new lesions were treated. Further studies are needed to define the etiology of the worse outcomes for patients undergoing intervention for lesions discovered using CCA and delineate the optimal timing for further imaging and intervention.

Open Repair Versus Endovascular Repair in the Treatment of Symptomatic Popliteal Artery Aneurysms.

BACKGROUND: Endovascular and open surgical modalities are currently used to treat popliteal artery aneurysms (PAA). However, there is limited data on the comparative durability of both repairs to guide physicians especially in the treatment of patients presenting symptomatic. We aimed to study the comparative effectiveness of endovascular PAA repair (EPAR) versus open PAA repair (OPAR). METHODS: The vascular quality initiative (VQI)-Medicare linked database was queried for patients with symptomatic PAA who underwent OPAR or EPAR from January 2010 to December 2018. Kaplan-Meier estimates, log-rank tests and multivariable Cox proportional hazard regression were employed to study the outcomes of amputation free survival (AFS), freedom from first reintervention, freedom from major amputation, and overall survival in 2 years following the index procedure. RESULTS: A total of 1,375 patients were studied, of which 23.7% (n = 326) were treated with EPAR. Patients treated with OPAR were younger, less likely to have coronary artery disease (CAD) and chronic kidney disease (CKD), but more likely to be smokers and to present with acute lower extremity ischemia. OPAR treated patients had better 2-year AFS (84.5% vs. 72.5%, P < 0.001) and overall survival (86.2% vs. 74.7%, P < 0.001). Freedom from major amputation at 2 years were comparable between EPAR and OPAR (95.5% vs. 97.7%, P = 0.164) in the overall cohort. Within the sub cohort of patients with acute limb ischemia, freedom from major amputation was significantly higher for OPAR compared to EPAR (97.4% vs. 90.6%, P = 0.021). After adjustment for confounders, OPAR was associated with decreased risk of amputation or death (aHR, 0.62; 95% CI, 0.48-0.80; P < 0.001) and mortality (aHR, 0.63; 95% CI, 0.48-0.81; P < 0.001) at 2 years. OPAR and EPAR had comparable adjusted risk of 2-year major amputation in the overall cohort. However, for patients presenting with acute limb ischemia OPAR was associated with 72% lower risk of 2-year major amputation compared to EPAR (aHR, 0.28; 95% CI, 0.10-0.83; P = 0.021). CONCLUSIONS: In this multi-institutional observational study of symptomatic popliteal aneurysms, OPAR was associated with significantly better amputation free and overall survival compared to EPAR. For patients with acute limb ischemia, OPAR was associated with reduced risk of amputation. These findings suggest that OPAR may be superior to EPAR in the treatment of symptomatic PAA. A consideration of OPAR as first line definitive treatment for symptomatic PAA patients who are good surgical candidates is suggested.

A Single Center Review of a Total Transfemoral Approach to Upper Extremity Access in Branched and Fenestrated Physician Modified Endografts.

BACKGROUND: Aortic aneurysms are normally treated by an endovascular approach. Due to the lack of devices and increasing experience, there is a growing number of complex aneurysms undergoing repair by physician modified endografts (PMEGs). Previously, our practice was to target visceral vessels exclusively through upper extremity access. We have since then shifted to an all transfemoral approach when possible. This study aims to show the operative benefits of transfemoral only approaches. METHODS: Patients who underwent a PMEG at a tertiary center between 2015 and 2020 were included. Patients were stratified into 2 groups based on branched vessel approach-transfemoral only versus axillary or composite (axillary and femoral). Forty-one patients had a pararenal or type IV thoracoabdominal aortic aneurysm (TAAA) and 15 patients had more complex TAAA. Primary outcomes were operative time, radiation exposure, fluoroscopy time, contrast, and blood loss. Secondary outcomes were 30-day mortality and major adverse events. Linear regression models were used to evaluate the association between approach type and the main outcomes. RESULTS: Fifty-six patients were included with 48% (n = 27) in the transfemoral group and 52% (n = 29) in the axillary/composite group. Baseline characteristics were similar between the groups. Intraoperative outcomes revealed significant increase in the average operative time (418 vs. 246 min, P < 0.001), in radiation exposure (2,755 vs. 1,740 mGy, P = 0.03), in fluoroscopy time (108 vs. 74 min, P = 0.01) and in blood loss (579 vs. 202 cc, P = 0.002) in the axillary/composite group compared to the transfemoral group. There was no significant difference in 30-day mortality or major adverse events including stroke. CONCLUSIONS: This study shows a transfemoral approach to complex endovascular aortic aneurysm repair as opposed to axillary/composite approach has decreased operative time, radiation exposure, and fluoroscopy time and no significant differences in 30-day mortality or major adverse events. When treating complex aneurysms, improving efficiency is important to minimize morbidity to patients and operators.

Fluorescent cholangiography significantly improves patient outcomes for laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy (LC) is the most common elective abdominal surgery in the USA, with over 750,000 performed annually. Fluorescent cholangiography (FC) using indocyanine green dye (ICG) permits identification of extrahepatic biliary structures to facilitate dissection without requiring cystic duct cannulation. Achieving the "critical view of safety" with assistance of ICG cholangiogram may support identification of anatomy, safely reduce conversion to open procedures, and decrease operative time. We assess the utility of FC with respect to anatomic visualization during LC and its effects on patient outcomes. METHODS: A retrospective review of a prospectively maintained database identified patients undergoing laparoscopic cholecystectomy at a single academic center from 2013 to 2019. Exclusion criteria were primary open and single incision cholecystectomy. Patient factors included age, sex, BMI, and Charlson Comorbidity Index. Outcomes included operative time, conversion to open procedure, length of stay (LOS), mortality rate, and 30-day complications. A multivariable logistic regression was performed to determine independent predictors for open conversion. RESULTS: A total of 1389 patients underwent laparoscopic cholecystectomy. 69.8% were female; mean age 48.6 years (range 15-94), average BMI 29.4 kg/m2 (13.3-55.6). 989 patients (71.2%) underwent LC without fluorescence and 400 (28.8%) underwent FC with ICG. 30-day mortality detected 2 cases in the non-ICG group and zero with ICG. ICG reduced operative time by 26.47 min per case (p < 0.0001). For patients with BMI ≥ 30 kg/m2, operative duration for ICG vs non-ICG groups was 75.57 vs 104.9 min respectively (p < 0.0001). ICG required conversion to open at a rate of 1.5%, while non-ICG converted at a rate of 8.5% (p < 0.0001). Conversion rate remained significant with multivariable analysis (OR 0.212, p = 0.001). A total of 19 cases were aborted (1.35%), 8 in the ICG group (1.96%) and 11 in the non-ICG group (1.10%), these cases were not included in LC totals. Average LOS was 0.69 vs 1.54 days in the ICG compared to non-ICG LCs (p < 0.0001), respectively. Injuries were more common in the non-ICG group, with 9 patients sustaining Strasberg class A injuries in the non-ICG group and 2 in the ICG group. 1 CBDI occurred in the non-ICG group. There was no significant difference in 30-day complication rates between groups. CONCLUSION: ICG cholangiography is a non-invasive adjunct to laparoscopic cholecystectomy, leading to improved patient outcomes with respect to operative times, decreased conversion to open procedures, and shorter length of hospitalization. Fluorescence cholangiography improves visualization of biliary anatomy, thereby decreasing rate of CBDI, Strasberg A injuries, and mortality. These findings support ICG as standard of care during laparoscopic cholecystectomy.