Direct oral anticoagulants over warfarin at discharge associated with improved survival and patency in infra-geniculate bypasses with prosthetic conduits.

OBJECTIVE: There is no consensus on the optimal anticoagulant regimen following lower extremity bypass. Historically, warfarin has been utilized for prosthetic or compromised vein bypasses. Direct-acting oral anticoagulants (DOACs) are increasingly replacing warfarin in this context, but their efficacy in bypass preservation has not been well-studied. Recent studies have shown that DOACs may improve outcomes following bypasses; however, it is unclear if this is dependent upon type of bypass conduit. The goal of this study was to evaluate whether a difference exists between vein and prosthetic infra-geniculate bypasses outcomes based on the anticoagulant utilized on discharge, warfarin or DOAC. METHODS: The Vascular Quality Initiative infra-inguinal bypass database was queried for all patients who underwent an infra-geniculate bypass and were anticoagulation-naive at baseline but were discharged on either warfarin or DOACs. A survival analysis was performed for patients up to 1 year to determine whether the choice of discharge anticoagulation was associated with differences between those with vein vs prosthetic conduits in overall survival, primary patency, risk of amputation, or risk of major adverse limb events (MALE). A multivariable Cox proportional hazards analysis was performed to control for differences in baseline demographic factors between the groups. RESULTS: During the study period (2003-2020), 57,887 patients underwent infra-geniculate bypass. Of these, 3230 (5.5%) were anticoagulated on discharge. There was a similar distribution of anticoagulation between vein (n = 1659; 51.4%) and prosthetic conduits (n = 1571; 48.6%). Thirty-two percent were discharged on DOACs, and 68.0% were discharged on warfarin. For prosthetic conduits, being discharged on a DOAC was associated with improved outcomes on univariate and multivariable analyses revealing lower risk of overall mortality (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.41-0.93; P = .021), loss of primary patency (HR, 0.70; 95% CI, 0.55-0.89; P = .003), risk of amputation (HR, 0.71; 95% CI, 0.54-0.93; P = .013), and risk of MALE (HR, 0.80; 95% CI, 0.64-1.00; P = .048). Patients with a vein bypass had improved univariate outcomes for survival and primary patency; however, with multivariable analysis, there were no significant differences in outcomes between DOAC and warfarin. CONCLUSIONS: Anticoagulation-naive patients who underwent an infra-geniculate prosthetic bypass had higher rates of overall survival, bypass patency, amputation-free survival, and freedom from MALE when discharged on a DOAC compared with warfarin. Those with vein bypasses had similar outcomes regardless of the choice of anticoagulation.

Intraoperative Staff Radiation Exposure During Aortic Endovascular Procedures.

BACKGROUND: The risk of radiation exposure in the surgical operating room (OR) and/or catheterization laboratory is now well established. Complex endovascular procedures often require multiple approaches and different positioning of the staff members around the patient, potentially increasing the levels of radiations exposure. Our goal was to evaluate the levels of radiation exposure of the members of the staff during endovascular aortic procedures in order to propose radioprotection optimization. METHODS: We included 41 aortic endovascular procedures out of 114 procedures performed between January 12, 2014, and August 31, 2015, including 24 standard endovascular aortic aneurysm repair (EVAR), 7 EVAR with iliac branch (EVARib), 8 complex fenestrated/branched EVAR (F/B EVAR), and 2 thoracic EVAR (TEVAR). Procedures were performed in an OR equipped with a carbon fiber table and a mobile fluoroscopy C-arm. We collected the usual dosimetry data given by the C-arm as well as the patient's peak skin dose (PSD). In all staff members, radiation exposure was measured with thermoluminescent chip dosimeters placed on both temples, on posterior sides of both hands, and on both lower legs. RESULTS: PSD levels were low for EVAR because 24 patients had values below the reading threshold. PSD significantly increased with more complex procedures. Main operator (MO) received the higher level of irradiation on whole body, hands, and ankles. Eye lenses irradiation was higher on both assistant operators (AOs). Other members received low levels of irradiation. We found a high ranges of radiation exposure with a high risk of exposure for the AO, mainly for F/B EVAR and EVARib. CONCLUSIONS: Even if all personal protections are used, staff positioning is a major point that must be considered. If MO is supposed to be the most exposed to X-rays, specific conditions of positioning of the AO may be at risk of exposure.

Endovascular Aneurysm Repair-First Strategy for Ruptured Abdominal Aortic Aneurysm Might Not Be Applicable to all Cases.

BACKGROUND: We evaluate the relationship between the hospital case volume (HCV) and mortality outcomes after open aortic repair (OAR) and endovascular aortic repair (EVAR) of intact (iEVAR) and ruptured (rEVAR) abdominal aortic aneurysm (AAA) using a contemporary administrative database. METHODS: The Healthcare Cost and Utilization Project Database for New York (2016) and New Jersey/Maryland/Florida (2016-2017) were queried using International Classification of Disease-10th edition to identify patients who had undergone OAR and EVAR. The hospitals were categorized into quartiles (Q) per overall (EVAR + OAR) volume, OAR-alone volume and EVAR-alone volume. Cox regression adjusted for confounding factors was used to estimate hazard ratios (HRs) for mortality. RESULTS: A total of 8,825 patients (mean age, 73.5 ± 9.5 years; 6,861 male [77.7%]) had undergone 1,355 OARs and 7,470 EVARs. Overall HCV had no impact on in-hospital mortality across quartiles after (iEVAR) (range, 0.7%-1.4%, P = 0.15), (rEVAR) (range, 20.5%-29.6%, P = 0.63) and open repair of intact AAA (iOAR) (range, 4.9%-8.8%, P = 0.63). However, the mortality rates after open repair of ruptured AAA (rOAR) in highest-volume (Q4) hospitals were significantly lower than those in the 3 lower quartile hospitals (23.1% vs. 44.7%, P < 0.001). When analyzed per OAR-alone volume, the same findings were observed (22.0% for Q4 vs. 41.6% for Q1-3, P < 0.001). Furthermore, in Q4 hospitals per the OAR-alone volume analysis, the mortality hazard was greater for rEVAR (39.0%) than for rOAR (22.0%) (HR = 2.3, 95% confidence interval, 1.02-5.34, P < 0.05). CONCLUSIONS: The mortality rates for iEVAR, rEVAR and iOAR were independent of HCV. However, after rOAR, mortality rates in high OAR volume hospitals were lower than those in the lower quartile hospitals, and, at least comparable to those of rEVAR. EVAR-first strategy for ruptured AAA might not be applicable to all cases. Patent-specific, individualized treatment should be the gold standard. For patients requiring rOAR, transfer to a regional center of excellence, when clinical safe, should be encouraged.

Outcome after revascularization with paclitaxel-coated devices in patients with chronic limb-threatening ischemia.

OBJECTIVE: Data regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. METHODS: We retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P < .001), primary patency (80.3% vs 76.9%; P < .001), and freedom from MALE (72.6% vs 67.9%; P < .001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P < .001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P < .001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P < .001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P = .07), but significant in the de-novo treated patients (73.9% vs 70.7%; P = .02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P = .02). CONCLUSIONS: FPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome.

Trends and outcomes associated with intravascular ultrasound use during femoropopliteal revascularization in the Vascular Quality Initiative.

OBJECTIVE: Intravascular ultrasound (IVUS) use in lower extremity interventions is growing in popularity owing to its imaging in the axial plane, superior detail in imaging lesion characteristics, and its enhanced ability to delineate lesion severity and extent compared with catheter angiograms. However, there are conflicting data regarding whether IVUS affects outcomes. The purpose of this study was to assess the effect associated with IVUS implementation in femoropopliteal interventions. METHODS: This retrospective cohort study used Vascular Quality Initiative data. Patients undergoing an index endovascular femoropopliteal revascularization from 2016 to 2021 were included. Patients were differentiated by whether or not IVUS was used to assess the femoropopliteal segment during intervention (no IVUS, IVUS). Propensity score matching, based on preoperative demographics and measures of disease severity was used. Primary outcomes were major amputation-free survival (AFS), femoropopliteal reintervention-free survival (RFS), and primarily patent survival (PPS) at 12 months. RESULTS: IVUS use grew steadily throughout the study period, comprising 0.6% of interventions in 2016 and increasing to 8.2% of interventions by 2021; growth was most dramatic in ambulatory surgical center or office-based laboratory settings where IVUS use grew from 4.4% to 43% to 47% of interventions. In unmatched cohorts, patients receiving interventions using IVUS tended to have lower prevalence of multiple cardiovascular comorbidities (eg, congestive heart failure, hypertension, diabetes, and dialysis dependence) and presented more often with claudication and less often with chronic limb-threatening ischemia (CLTI). Intraoperatively, IVUS was used more often in complex femoropopliteal lesions (Transatlantic Intersociety grade D vs A), and more often in conjunction with stenting and/or atherectomy. IVUS use was associated with improved AFS, but similar RFS and PPS at 12 months. However, in multivariable analysis IVUS was not associated with any of the primary outcomes independently; rather, all outcomes were influenced primarily by CLTI, dialysis dependence, and prior major amputation status; technical outcomes (ie, RFS and PPS loss) were further driven by complexity of lesion (worse in Transatlantic Intersociety grade D vs A lesions) and treatment setting (ie, ambulatory surgical center or office-based laboratory setting associated with increased hazard for RFS and PPS loss). CONCLUSIONS: IVUS implementation in femoropopliteal interventions is growing, with rapid adoption among interventions in ambulatory surgical centers and office-based laboratories. IVUS was not associated with an effect on technical outcomes at 12 months; improvement in major AFS was observed; however, multivariable analysis suggests this finding may be an effect of confounding by multiple factors highly associated with IVUS use, namely, in patients with lower prevalence of CLTI, dialysis dependence, and prior major amputations, thus conveying baseline lower risk for major amputation and death.

Use of direct-acting oral anticoagulants associated with improved survival and bypass graft patency compared with warfarin after infrageniculate bypass.

OBJECTIVE: No consensus has yet been reached regarding the optimal antiplatelet and anticoagulant regimen for patients after lower extremity bypass. Usually, patients who have undergone below-the-knee bypass will begin oral anticoagulation therapy. Historically, the bypass has been with prosthetic conduits and the anticoagulation therapy has been warfarin. However, the use of direct-acting oral anticoagulants (DOACs) has been increasing owing to their relative ease of dosing. The goal of the present study was to evaluate whether a difference exists in the postoperative outcomes for patients who have undergone infrageniculate bypass stratified by the use of on DOACs vs warfarin. METHODS: The Vascular Quality Initiative infrainguinal bypass database was queried for all patients who had undergone infrageniculate bypass, been anticoagulation naive at baseline, and been discharged with anticoagulation therapy. A survival analysis was performed for patients for ≤2 years postoperatively to determine whether discharge with warfarin vs DOACs was associated with differences in overall mortality, loss of primary patency, risk of amputation, and risk of major adverse limb events (MALE). A multivariable Cox proportional hazards analysis was performed to control for differences in the baseline demographic factors between the two groups. RESULTS: During the study period (2007-2020) 57,887 patients had undergone infrageniculate bypass. Of these patients, 2786 had been anticoagulation naive and discharged with either warfarin (n = 1889) or DOACs (n = 897). Discharge with a DOAC was associated with a lower risk of overall mortality (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.47-0.83; P = .001), loss of primary patency (HR, 0.74; 95% CI, 0.62-0.87; P < .001), risk of amputation (HR, 0.70; 95% CI, 0.57-0.86; P = .001), and risk of MALE (HR, 0.83; 95% CI, 0.71-0.97; P = .017). CONCLUSIONS: Anticoagulation-naive patients who had undergone infrageniculate bypass had had higher rates of overall survival, bypass patency, amputation-free survival, and freedom from MALE when discharged with a DOAC than with warfarin.

Celiac Artery Coverage During TEVAR for Dissection and Acute Aortic Injury is Not Associated with Worse Outcomes.

BACKGROUND: Studies have previously identified increased morbidity and mortality with celiac artery coverage during thoracic endovascular aortic repair (TEVAR) for aneurysmal disease. This study aimed to delineate the risks associated with celiac artery coverage in all patients undergoing TEVAR for dissection, trauma, or aneurysmal disease. METHODS: Using the Vascular Quality Initiative database, we identified all patients undergoing TEVAR from 2012 to 2020 and categorized them based on the underlying pathology (aneurysm, dissection, or acute/trauma). Patients were excluded if their endograft was deployed distal to aortic zone 6 or if they had any preoperative/operative celiac revascularization procedure. Univariate, regression, and Kaplan-Meier analysis were performed for all 3 groups, focusing on postoperative complications and survival. RESULTS: There were 8,265 patients who underwent TEVAR over the 8-year study period with 142 (1.7%) having celiac artery coverage during their index procedure. Of those patients, the celiac artery was covered during TEVAR in 1.2% of patients with dissection, 1.3% with aneurysm, and 0.7% with trauma. On unadjusted analysis, celiac artery coverage in TEVAR for aneurysmal disease was associated with increased in-hospital mortality (16% vs. 5%, P < 0.001), 30-day mortality (33% vs. 23%, P = 0.029), any postoperative complication (excluding death) (42% vs. 25%, P < 0.001), and postoperative bowel complication (3% vs. 0.7%, P = 0.003). There were no differences in outcomes for patients treated with celiac coverage versus those without celiac coverage during TEVAR for dissection or trauma on univariate analysis. After risk adjustment, celiac artery coverage remained predictive of worse postoperative outcomes in patients with aneurysmal disease: in-hospital mortality (odds ratio [OR] = 3.6, confidence interval [CI] 1.8-6.9), 30-day death (OR = 1.6, CI 1.0-2.4), any postoperative complication (OR 2.2, CI 1.4-3.5), and bowel-specific postoperative complication (3.3, CI 1.0-10.8). There were no differences in patient outcomes for those treated with celiac coverage versus those without celiac coverage during TEVAR for dissection or trauma on multivariate analysis. Kaplan-Meier curves show a significant difference in overall survival based on pathology, specifically lower survival rates for patients with celiac coverage treated for aneurysmal disease. Cox regression analysis showed that celiac artery coverage for aneurysmal disease was associated with significantly increased hazard ratio affecting overall survival (hazard ratio = 2.6, P < 0.001), but there was no impact on survival in patients who underwent TEVAR with celiac coverage for dissection or trauma. CONCLUSIONS: Celiac artery coverage for patients with aneurysmal disease was correlated with a significant increase in postoperative morbidity, mortality, and lowers overall survival. However, for patients with dissection or acute/traumatic aortic pathology, celiac artery coverage does not portend worse outcomes.

Precocious Rupture of Abdominal Aortic Aneurysms Below Size Criteria for Repair: Risk Factors and Outcomes.

BACKGROUND: Practice guidelines recommend elective repair for abdominal aortic aneurysms (AAAs) ≥ 5.5 cm in men and ≥ 5 cm in women to prevent rupture; however, some rupture at smaller diameters. We identify risk factors for rupture AAA (rAAA) below this threshold and compare outcomes following rAAA repair above/below size criteria. METHODS: The Vascular Quality Initiative (2013-2019) was queried for patients undergoing repair for rAAA and stratified based on diameter into small and large cohorts [Small: < 5.5 cm (men), < 5.0 cm (women)]. Univariate analysis was performed, and Kaplan-Meier analysis compared overall survival, aneurysm-related mortality, and reintervention at 12 months. RESULTS: Five thousand one hundred sixty two rAAA were identified. Small rAAA patients [n = 588] were more likely to have hypertension (81.3% vs. 77.0%, P < 0.02), diabetes (18.2% vs. 14.9%, P < 0.04), and end-stage renal disease (2.9% vs. 0.9%, P < 0.01) and be on optimal medical therapy (32.1% vs. 26.8%, P < 0.01). Women were more likely to rupture at smaller diameters compared to men (P < 0.01). Small rAAA patients were more likely to undergo endovascular aortic repair (EVAR) (70.2% vs. 56.0%, P < 0.01) and had lower in-hospital mortality (17.7% vs. 27.7%, P < 0.01) and fewer perioperative complications across all categories. At 12 months, small rAAA patients had better overall survival, freedom from aneurysm-related mortality, and freedom from reintervention, largely driven by EVAR approach. CONCLUSIONS: More than 11% of patients presenting with ruptured AAA were below the recommended size threshold for repair, and they tended to be younger, non-White, and have hypertension, diabetes, and/or renal failure. Patients with small rAAA experienced lower in-hospital morbidity and mortality and improved 1-year survival, and EVAR was associated with better outcomes than open repair. However, women more frequently rupture at smaller diameters compared to men. Given contemporary elective outcomes for women, a randomized controlled trial for EVAR versus surveillance at a sex-specific size threshold is needed.

Effect of intravascular ultrasound on clinical outcomes after thoracic endovascular aortic repair for blunt thoracic aortic injury.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) for blunt traumatic aortic injuries (BTAIs) can be complicated by inaccurate aortic measurements at the initial computed tomography angiography secondary to hypovolemic shock. The use of intravascular ultrasound (IVUS) has been proposed for more accurate aortic sizing, with prior data demonstrating larger aortic sizes measured by IVUS, potentially altering the vast majority of chosen endograft sizes. At present, and to the best of our knowledge, no studies have examined whether IVUS affects the clinical outcomes. The purpose of the present study was to examine the effect of IVUS on the clinical outcomes after TEVAR for BTAIs. METHODS: A retrospective cohort study was performed of patients who had undergone TEVAR for BTAIs in the VQI registry. The cohorts were defined by the use of IVUS. The primary outcomes were mortality and reintervention at 1 year. RESULTS: A total of 919 patients who had undergone TEVAR for BTAIs were included in the present analysis. The IVUS patients had presented with higher injury severity scores (36.2 vs 42; P = .0004) largely because of more extremity and external trauma. IVUS was more often used for patients with grade III injuries (49.1% vs 56.9%; P = .02) and less often for patients with rupture (21.1% vs 12.4%; P = .001). A trend toward a delay in TEVAR was seen for the patients for whom IVUS was used (1.8 vs 3.5 days; P = .38), with additional trends toward reduced intraoperative resuscitation and blood loss. The hemodynamic status of the patients and differences in aortic or endograft sizes could not be assessed with the available data. IVUS use was not associated with any differences in survival or reintervention rates in-hospital or at 1 year (Kaplan-Meier survival estimates: 0.91 no IVUS vs 0.92 IVUS; P = .46). Fifteen aortic-related reinterventions occurred across the entire patient cohort for all-available follow-up with comparable rates of type I endoleaks (1 no IVUS vs 2 IVUS), with no recorded cases of sizing-related complications such as device rupture, migration, or dissection. CONCLUSIONS: IVUS usage during TEVAR for BTAIs was associated with clinical scenarios in which patients were more stable and interventions to address BTAIs can be delayed. Despite this, the overall clinical outcomes were similar between cases in which IVUS was used and for which it was not.

Impact of interfacility transfer of ruptured abdominal aortic aneurysm patients.

OBJECTIVE: The interfacility transfer (IT) of patients with a ruptured abdominal aortic aneurysm (rAAA) occurs not infrequently to allow for a higher level of care. In the present study, we evaluated, using a contemporary administrative database, the effects of IT on mortality after rAAA repair. METHODS: The Healthcare Cost and Utilization Project Database for New York (2016) and New Jersey, Maryland, and Florida (2016-2017) was queried using the International Classification of Diseases, 10th edition, to identify patients who had undergone open or endovascular repair of AAAs. The hospitals were categorized into quartiles (Qs) per overall volume. The mortality rates for IT vs nontransferred (NT) rAAA patients stratified by treatment modality (open aneurysm repair of an rAAA [rOAR] vs endovascular aneurysm repair of an rAAA [rEVAR]) were compared. A Cox proportional hazard model was used to estimate the hazard ratios (HRs) for mortality. RESULTS: A total of 1476 patients had presented with a rAAA, of whom 673 (45.7%) were not treated. Of the remaining 803 patients, 226 (28.1%) were transferred, of whom 50 (22.1%) had died without repair after IT. The remaining 753 patients (IT, n = 176; NT, n = 576) had undergone rEVAR (n = 492) or rOAR (n = 261). The baseline characteristics were similar between the IT and NT patients, except for a greater proportion of black patients (P = .03), lower income families (P = .049), and rOAR (45.5% vs 31.4%; P = .001) for the IT patients. The overall mortality rates were similar between the NT (30.2%) and IT (27.3%) groups (P = .46). The subgroup analysis revealed that the operative mortality rates after rEVAR were similar between the NT and IT patients, without significant differences among the hospital quartiles. After rOAR, however, the operative mortality rates were lower for the IT patients, largely owing to improved outcomes in the Q4 hospitals (Q4 vs Q1-Q3, P = .001). Cox regression analysis demonstrated that age (HR, 1.03; 95% confidence interval, 1.00-1.06; P = .02) and treatment at a low-volume hospital (Q1-Q3; HR, 1.89; 95% confidence interval, 1.02-3.51; P = .04) were predictors of mortality. The total charges were similar (IT, $286,727; vs NT, $265,717; P = .38). CONCLUSIONS: The results from the present study have shown that <30% of rAAA patients deemed a candidate for repair will be transferred. We found that IT did not affect the mortality rates after rEVAR, irrespective of the hospital volume. For rOAR candidates, however, regionalization of care with prompt transfer to a high-volume center could improve the survival benefits without increased healthcare costs.

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms.

OBJECTIVE: Physician-modified endografts (PMEG) and parallel grafting (PG) are important techniques for endovascular repair of complex aortic aneurysms using off-the-shelf devices. However, there are few data regarding the relative efficacy and outcomes of these techniques in thoracoabdominal extent aneurysms. This study sought to compare the outcomes of PG and PMEG across different extents of thoracoabdominal aneurysms (TAAAs) for which they can be used. METHODS: The Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair/complex endovascular aortic repair module was queried for all patients undergoing repair of an unruptured, TAAA (extents I-IV) from 2012 to 2020; aneurysm types were defined by repair extent as determined by proximal and distal seal zones. Patients were differentiated based on whether they underwent repair with a PMEG or PG. The primary outcomes for this study were overall survival and freedom from aneurysm- or procedure-related mortality at 1 year determined via Kaplan-Meier analysis, with a Cox hazard regression analysis conducted to examine the independent association of repair modality with primary outcomes. RESULTS: There were 813 patients who met the inclusion criteria (TAAA I-III, n = 362; TAAA IV, n = 451; PG, n = 426; PMEG, n = 387). PMEG repairs were performed at centers with a nearly two- to three-fold higher annual volume of endovascular TAAA repairs. Type Ia endoleaks were reduced with PMEG repair, most significantly in TAAA IV (TAAA I-III, 2.2% PMEG vs 10% PG [P = .2]; TAAA IV, 1.2% PMEG vs 21.6% PG [P < .001]). Thoracoabdominal repairs demonstrated improved survival at 1 year with PMEG devices, significant for TAAA I to III repairs (TAAA I-III, PMEG 85% vs PG 74% [P = .01]; TAAA IV, 84% PMEG vs PG 78% [P = .08]). Freedom from aneurysm- or procedure-related mortality was also improved with PMEG repairs, remaining significant at 1 year in the case of TAAA IV (TAAA I-III:, PMEG 94% vs PG 86% [P = .06]; TAAA IV, PMEG 94% vs PG 88% [P = .02]). PMEG demonstrated decreases in several measures of postoperative morbidity, including stroke, death, major adverse cardiovascular events, and postoperative complications. In the multivariate analysis, repair modality was not associated with either primary outcome; rather, several perioperative complications conveyed the greatest hazard for both primary outcomes across repair extents. CONCLUSIONS: Survival after endovascular TAAA repair is improved with the use of PMEG compared with PG. Several key factors of this study demonstrate the shortcomings of PG in complex aneurysm repair, namely, high rates of critical endoleaks, the need for adjunctive access sites, and an increase in perioperative complications that influence longer term outcomes.

Outcomes of great vessel debranching to facilitate thoracic endovascular aortic repair.

OBJECTIVE: With the expanding application of endovascular technology, the need to deploy into zone 0 has been encountered on occasion. In the present study, we evaluated the outcomes of great vessel debranching (GVD) as a method of extending the proximal landing zone to facilitate thoracic endovascular aortic repair (TEVAR). METHODS: We performed a single-center retrospective review of all patients who had undergone GVD followed by TEVAR between May 2013 and December 2020. The primary outcome was primary patency of all targeted vessels, with all-cause perioperative mortality as a secondary outcome. Kaplan-Meier analysis was used to account for censoring of mortality and primary patency. The extent of hybrid aortic repairs was characterized into type I (GVD plus TEVAR without ascending aorta or aortic arch reconstruction, type II (GVD plus TEVAR with ascending aorta reconstruction), and type III (GVD plus TEVAR with ascending aorta and aortic arch reconstruction with an elephant trunk (soft [surgical] or frozen [endovascular]]). RESULTS: A total of 42 patients (23 men [54.8%]; mean age, 62.2 ± 11.2 years) had undergone GVD, with 122 vessels revascularized (42 innominate, 42 left common carotid, and 38 left subclavian arteries). The indication for TEVAR was aneurysmal degeneration from aortic dissection in 32 patients (76.2%), a thoracic aneurysm in 9 patients (21.4%), and a perforated aortic ulcer in 1 patient (2.4%). The median duration between GVD and TEVAR was 82 days. The mean follow-up period was 25.7 ± 23.5 months. Type I repair was performed in 4, type II in 16, and type III in 22 patients. The perioperative mortality, stroke, and paraplegia rates were 9.5%, 7.1%, and 2.4%, respectively. Neither the extent of repair (P = .80) nor a history of aortic repair (P = .90) was associated with early mortality. Of the 38 patients who had survived the perioperative period, 6 had died >30 days postoperatively. At 36 months, the survival estimate was 68.6% (95% confidence interval, 45.7%-83.4%). The overall primary patency of the innominate artery, left common carotid artery, and left subclavian artery was 100%, 89.5%, and 94.1%, respectively. The primary-assisted patency rate was 100% for all the vessels. CONCLUSIONS: We found GVD to be a safe and effective method of extending the proximal landing zone into zone 0 with outstanding primary patency rates. Further studies are required to confirm the safety and longer term durability for these patients.

Fenestrated Endovascular Repair With Large Device Diameters (34-36 mm) is Associated With Type 1 and 3 Endoleak and Reintervention.

BACKGROUND: Patients with abdominal aortic aneurysms undergoing EVAR with larger device diameters (34-36 mm) have worse outcomes due to proximal fixation failure and need for reintervention. We examine outcomes relating to standard fenestrated repair (FEVAR) with larger device diameters, and investigate whether a similar relationship exists. METHODS: Retrospective review of a prospectively maintained, single institution database of patients treated with the Cook ZFEN device between 2012-2017. Outcomes were stratified by device diameter into normal-diameter (ND,≤ 32 mm) and large-diameter (LD,34-36 mm). Primary endpoints were need for reintervention and composite type I/III endoleak. RESULTS: One-hundred consecutive patients treated were identified for inclusion. Overall mean age was 73.6 years and mean aortic diameter was 59.1 mm. Mean follow-up was 22 months. A total of 26 (26%) patients were treated with LD devices. Number of target vessels per patient was 2.8 in both groups. Infrarenal neck length and diameter were significantly different in the LD and ND patients, respectively (2.6 mm vs. 4.7 mm (P < 0.01) and 30.1 mm vs. 23.4 mm (P < 0.01)). Percent graft oversizing was lower in the LD cohort (19% vs. 24%; P = 0.006). No difference was seen in overall mortality at 30-days (0% vs. 2%; P = 0.4) or at latest follow up (6% vs. 14%; P = 0.6). Reinterventions were not significantly different at 30 days, but were significantly higher over the follow-up period in the LD cohort (46.2 vs. 17.6%; P = 0.002). LD diameter was associated with reintervention on univariate (HR 1.19, 95% CI 1.04-1.37), but not multivariate analysis. The composite endpoint of type I/III endoleak was higher in the LD cohort (15.4% vs. 2.7%; P = 0.004). CONCLUSIONS: FEVAR requiring 34- or 36-mm device diameters is associated with an increased risk of composite type I/III endoleak and reintervention. Patients undergoing fenestrated repair requiring LD devices should be closely monitored, with consideration for proximal or open repair.

Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia.

OBJECTIVE: Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX. METHODS: We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR. CONCLUSIONS: In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.

Renal Stent Complications and Impact on Renal Function after Standard Fenestrated Endovascular Aneurysm Repair.

BACKGROUND: To report renal outcomes including long-term patency, secondary interventions, and related renal function after fenestrated endovascular aortic repair (fEVAR). METHODS: Single-center retrospective review of patients undergoing fEVAR between 2012 and 2018 using the Cook ZFEN device. Renal stent complications, defined as any stenosis, occlusion, kink, renal stent-related endoleak, and reinterventions were tabulated. Estimated glomerular filtration rate (eGFR) was estimated using the Modification of Diet in Renal Disease formula. RESULTS: During the study period, 114 patients underwent elective fEVAR. Of 329 total target vessels, 193 renal arteries were stented (133 Atrium iCAST, 60 Gore VBX). Technical success was achieved in 97.4%, and the mean follow-up was 23.3 months. Seventeen renal complications occurred in 14 patients (12.3%), including 4 occlusions, 9 stenosis, 3 dislocations, and 1 type III endoleak. All stent complications underwent endovascular reintervention with a median hospital stay of 1 day (0-10) and a technical success of 94.2%. One patient suffered renal hemorrhage that warranted embolization. Patients with occlusion were treated the day of diagnosis, and mean time from diagnosis to intervention for stenosis was 21.5 days. Estimated primary patency was 92.1 % and 81.5% at 24 and 48 months, respectively. On multivariate analysis, larger native renal artery diameter was the only independent protective factor against patency loss (HR 0.23 (0.09-0.59)). Secondary patency at latest follow-up was 99.4%. Mean eGFR was not significantly different at latest follow-up between patients with renal complications versus those without (43.75 vs. 55.58 mL/min/1.73 m2, P = 0.09). Comparing patients with and without renal stent complications, 81.4% and 72.7% of patients had stable or improved renal disease by chronic kidney disease staging compared with baseline (P = 0.51). CONCLUSIONS: fEVAR is a durable option for the treatment of juxtarenal aortic aneurysms and is associated with excellent secondary patency. Renal stent complications have no significant impact on renal function, but smaller native renal arteries are at higher risk of stent-graft complications.

The Triple Wire Technique for Delivery of Endovascular Components in Difficult Anatomy.

We describe a novel endovascular technique in which three 0.014″ guidewires are placed in parallel through a 0.035″ lumen catheter, in order to create a stiff platform to allow for delivery of 0.035″ profile devices through challenging anatomy. Three illustrative cases are presented: a difficult aortic bifurcation during lower extremity intervention, a tortuous internal iliac artery during placement of an iliac branch device, and salvage of a renal artery after inadvertent coverage during proximal cuff deployment for type 1a endoleak. We also quantify the relative stiffness of the triple 0.014″ wire configuration, using several well-known 0.035″ wires for comparison. The "triple wire technique" is an effective method for tracking endovascular devices through difficult tortuous anatomy, and can be used in a variety of clinical settings. The technique is especially useful when a traditional, stiff 0.035″ wire will not track without "kicking out." Each 0.014″ wire is reasonably soft and traverses the tortuous vessel easily, but when the 3 wires are used together as a rail it provides a stiff enough platform for delivery.

Paclitaxel-Coated Peripheral Arterial Devices are Associated with Reduced Mortality in Younger Patients.

BACKGROUND: Paclitaxel-coated devices have been shown to decrease restenosis when used in the femoropopliteal artery. Recent reports have suggested a possible risk of increased late mortality in patients treated with paclitaxel. It has been suggested that younger patients and those with limited comorbidities may be at higher risk. Our objective was to analyze long-term mortality based on patient age comparing treatment with paclitaxel to uncoated devices. METHODS: We performed a retrospective review of 1,170 consecutive patients who underwent femoropopliteal percutaneous intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. Patients were grouped by age at the time of procedure: <60 years old (n = 244, 20.9%), 60-80 years old (n = 635, 54.3%), and >80 years old (n = 291, 24.9%). Within each group, patients were further divided by use of paclitaxel. The primary outcome measure was survival assessed by Kaplan-Meier analysis. Differences between the groups were analyzed with analysis of variance. Multivariable analysis was performed using Cox proportional hazard models. RESULTS: Of the 1,170 patients who underwent femoropopliteal percutaneous intervention, 654 (55.9%) received a paclitaxel-coated device during treatment and 516 (44.1%) did not. Mean age of the overall patient cohort was 70.4 ± 12.6 years and 663 (56.7%) were male. When comparing the groups by age we found an increase in age but a decrease in the proportion of patients who smoke. The use of paclitaxel-coated devices was similar across the groups (<60 years old, 56.2%; 60-80 years old, 57.0%; >80 years old, 52.6%; P = 0.45). Demographics and comorbidities were similar between the patients treated with and without paclitaxel within each age group except more males in the <60-year-old group treated without paclitaxel and more patients with chronic limb threatening ischemia in the >80-year-old group treated with paclitaxel. In patients <60 and 60-80 years old paclitaxel use was associated with increased survival at 4 years: <60 (80.7% vs. 64.4%; P = 0.04); 60-80 (63.2% vs. 55.1%; P = 0.04). Survival was similar in the >80-year-old group (46.6% vs. 32.8%; P = 0.65). CONCLUSIONS: Our data suggest that the use of paclitaxel-coated arterial devices is not associated with increased mortality. On the contrary, our data show that younger patients treated with paclitaxel show improved survival compared with those treated without paclitaxel. Paclitaxel-coated devices may be used with continued caution especially in patients at high risk for restenosis.

Elevated Neutrophil to Lymphocyte Ratio is Associated with Worse Outcomes after Carotid Endarterectomy in Asymptomatic Patients.

OBJECTIVE: Management of carotid artery stenosis (CAS) remains controversial and proper patient selection critical. Elevated neutrophil to lymphocyte ratio (NLR) has been associated with poor outcomes after vascular procedures. The effect of NLR on outcomes after carotid endarterectomy (CEA) in asymptomatic and symptomatic patients is assessed. MATERIALS AND METHODS: A retrospective review was conducted of all patients between 2010 and 2018 with carotid stenosis >70% as defined by CREST 2 criteria. A total of 922 patients were identified, of whom 806 were treated with CEA and 116 non-operatively with best medical therapy (BMT). Of patients undergoing CEA, 401 patients (290 asymptomatic [aCEA], 111 symptomatic [sCEA]) also had an available NLR calculated from a complete blood count with differential. All patients treated with BMT were asymptomatic and had a baseline NLR available. Kaplan-Meier analysis assessed composite ipsilateral stroke or death over 3 years. RESULTS: In sCEA group, the 3-year composite stroke/death rates did not differ between NLR < 3.0 (22.9%) vs NLR > 3.0 (38.1%) (P=.10). In aCEA group, patients with a baseline NLR >3.0 had an increased risk of 3-year stroke/death (42.6%) compared to both those with NLR <3.0 (9.3%, P<.0001) and those treated with BMT (23.6%, P=.003). In patients with NLR <3.0, aCEA showed a superior benefit over BMT with regard to stroke or death (9.3% vs. 26.2%, P=.02). However, in patients with NLR >3.0, there was no longer a benefit to prophylactic CEA compared to BMT (42.6% vs. 22.2%, P=.05). Multivariable analysis identified NLR >3.0 (HR, 3.23; 95% CI, 1.93-5.42; P<.001) and congestive heart failure (HR, 2.18; 95% CI, 1.33-3.58; P=.002) as independent risk factors for stroke/death in patients with asymptomatic carotid artery stenosis. CONCLUSIONS: NLR >3.0 is associated with an increased risk of late stroke/death after prophylactic CEA for asymptomatic carotid artery stenosis, with benefits not superior to BMT. NLR may be used to help with selecting asymptomatic patients for CEA. The effect of NLR and outcomes in symptomatic patients requires further study. Better understanding of the mechanism(s) for NLR elevation and medical intervention strategies are needed to modulate outcome risk in these patients.

Anatomic criteria in the selection of treatment modality for atherosclerotic carotid artery disease.

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

Percutaneous Endovascular Repair of a Ruptured Extent III Thoracoabdominal Aortic Aneurysm with Bilateral Large Common Iliac Aneurysms and Aortocaval Fistula.

Ruptured thoracoabdominal aneurysms (rTAAAs) are rare and carry a significant rate of morbidity and mortality. Aortocaval fistula secondary to rTAAA is even more infrequent. We describe an urgent and staged endovascular treatment of a ruptured extent III thoracoabdominal aortic aneurysm with an aortocaval fistula by performing vena cava stenting to treat aortocaval fistula as a damage control maneuver prior to transfer and subsequent TAAA repair with a physician-modified endograft at a quaternary level hospital.