Search

Background: Thoracic endovascular aortic repair (TEVAR) represents optimal therapy for complicated acute type B aortic dissection (aTBAD). Persistent knowledge gaps remain, including the optimal length of aortic coverage, impact on distal aortic remodeling, and fate of the dissected abdominal aorta., Methods: Review of the Emory Aortic Database identified 92 patients who underwent TEVAR for complicated aTBAD from 2012 to 2018. Standard TEVAR covered aortic zones 3 and 4 (from the left subclavian to the mid-descending thoracic aorta). Extended TEVAR fully covered aortic zones 3 though 5 (from the left subclavian to the celiac artery). Long-term imaging, clinical follow-up, and overall and aortic-specific mortality were reviewed., Results: Extended TEVAR (n = 52) required a greater length of coverage vs standard TEVAR (n = 40) (240 ± 32 mm vs 183 ± 23 mm; P < .01). In-hospital mortality occurred in 5.4% of patients (7.7% vs 2.5%; P = .27) owing to mesenteric malperfusion (n = 3) or rupture (n = 2). The overall incidences of postoperative stroke, transient paraparesis, paraplegia, and dialysis were 5.4% (3.9% vs 7.5%; P = .38), 3.2% (5.8% vs 0%; P = .18), 0%, and 0% respectively, equivalent between groups. Follow-up was 96.6% complete to a mean of 6.1 years (interquartile range, 3.5-8.6 years). There were significantly higher rates of complete thrombosis or obliteration of the entire thoracic false lumen after Extended TEVAR (82.2% vs 51.5%; P = .04). Distal aortic reinterventions were less frequent after extended TEVAR (5.8% vs 20%; P = .04). Late aorta-specific survival was 98.1% after extended TEVAR vs 92.3% for standard TEVAR (P = .32)., Conclusions: Extended TEVAR for complicated aTBAD is safe, results in a high rate of total thoracic false lumen thrombosis/obliteration, and reduces distal reinterventions. Longer-term follow-up will be needed to demonstrate a survival benefit compared to limited aortic coverage., Competing Interests: Disclosures Y.M.D. is a consultant for Cook Medical. W.D.J. is a consultant for W. L. Gore & Associates, Medtronic, Cook Medical, and Endologix (consultant). B.G.L. is a consultant for Medtronic and Endospan., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Efficacy of thoracic endovascular aortic repair (TEVAR) for chronic type B aortic dissection (CTBAD) is dependent on eliminating retrograde false lumen perfusion and remodeling the aorta. We describe the efficacy of a novel transcatheter electrosurgical technique to fenestrate the dissection flap and create a distal seal zone for TEVAR in CTBAD., Methods: A retrospective review of the Emory Aortic Database from 2016 to 2023 identified 33 patients who underwent TEVAR with intentional endovascular rupture of the dissection flap (Knickerbocker; KNICK) for CTBAD. In 11 patients, we performed transcatheter electrosurgical aortic septostomy (TECSAS) before KNICK. The technical aspects of TECSAS + KNICK are described and results compared with TEVAR + KNICK alone., Results: Dissection chronicity, aortic size, and preoperative demographics were similar between groups. Technical success was 100%, with zero stroke or paraplegia in both groups. Thirty-day mortality for TECSAS versus KNICK was 0% versus 13.6% ( P  = .199). Median follow-up was shorter after TECSAS versus KNICK, although not statistically significant (14.6 months vs 21.9 months; P  = .065). Elimination of retrograde false lumen perfusion (TECSAS 100% vs KNICK 68.2%; P  = .035) and complete false lumen thrombosis or obliteration (TECSAS 91.9% vs KNICK 54.6%; P  = .037) were more frequent after the TECSAS procedure. Aortic reinterventions were less frequent after TECSAS versus KNICK (0% vs 13.6%, P  = .199), although not statistically significant., Conclusions: The addition of TECSAS to intentional endovascular rupture of the dissection flap in CTBAD improves distal seal, eliminating retrograde false lumen perfusion. This technique is a safe and precise method to fenestrate a dissection flap and optimize TEVAR in CTBAD., Competing Interests: Y.M.D. serves as a consultant for Cook Medical. W.D.J. serves as a consultant for Gore, Medtronic, Cook Medical, and Endologix. V.C.B. serves as a consultant for Edwards, Abbott, Medtronic, Boston Scientific, and Transmural Systems, Inc. B.G.L. serves as a consultant for Endospan and as a Speaker's Bureau for Medtronic. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (© 2024 The Author(s).)

Hybrid repair of complex aortic arch disease typically requires aortic debranching to create a proximal landing zone for completion arch endografting. Despite advances in endograft technology, physician-modified endografting may be required to customize a prosthesis for challenging anatomy. We present a case of a complex distal arch aneurysm after a prior coarctation repair with a pediatric interposition graft several decades earlier, treated with hybrid repair by double transposition for arch debranching and physician-modified arch endografting for complete aneurysm exclusion., (© 2024 The Authors.)

Background: The pathophysiology and behavior of acute type B intramural hematoma (TBIMH) is poorly understood. The purpose of this study is to characterize the pathophysiology, fate, and outcomes of TBIMH in the endovascular era., Methods: A retrospective analysis of a US Aortic Database identified 70 patients with TBIMH from 2008 to 2022. Patients were divided into groups and analyzed based upon subsequent management: early thoracic endovascular aortic repair (TEVAR; Group 1) or hospital discharge on optimal medical therapy (OMT) (Group 2)., Results: Of 70 total patients, 43% (30/70) underwent TEVAR (Group 1) and 57% (40/70) were discharged on OMT (Group 2). There were no significant differences in age, demographics, or comorbidities between groups. Indications for TEVAR in Group 1 were as follows: 1) Penetrating atheroscletoic ulcer (PAU) or ulcer-like projection (n = 26); 2) Descending thoracic aortic aneurysm (n = 3); or 3) Progression to type B aortic dissection (TBAD) (n = 2). Operative mortality was zero. No patient suffered a stroke or spinal cord ischemia. During the follow-up period, 50% (20/40) of Group 2 patients required delayed surgical intervention, including TEVAR in 14 patients and open repair in 6 patients. Indications for surgical intervention were as follows: 1) Development of a PAU / ulcer-like projection (n = 13); 2) Progression to TBAD (n = 3), or 3) Concomitant aneurysmal disease (n = 4). Twenty patients did not require surgical intervention. Of the initial cohort, 71% of patients required surgery, 9% progressed to TBAD, and 19% had regression or stability of TBIMH with OMT alone., Conclusions: The most common etiology of TBIMH is an intimal defect. Progression to TBAD and intramural hematoma regression without an intimal defect occurs in a small percentage of patients. An aggressive strategy with endovascular therapy and close surveillance for TBIMH results in excellent short-term and long-term outcomes., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Historically, optimal medical therapy (OMT) has been the primary therapy for acute uncomplicated type B aortic dissection (auTBAD). However, recent data suggest that OMT provides poor long-term results, and aortic remodeling induced by thoracic endovascular aortic repair (TEVAR) may improve survival. This study compares adverse events and survival among auTBAD patients receiving either TEVAR or OMT. A retrospective analysis identified 146 consecutive auTBAD patients presenting to a single institution between 1/2012 and 10/2020. Patients were divided into 2 groups based upon whether they received TEVAR (n = 50) or OMT (n = 96) at index hospitalization. Major morbidity and survival were compared between groups. 67.1% of patients presented with a Debakey IIIB dissection with maximum thoracic aortic diameter of 4.3 ± 1.0 cm. Over follow-up, 35% of OMT patients failed medical therapy and underwent intervention (n = 23 TEVAR, n = 11 open). An additional 13 died for an all-cause failure rate of 49%. The composite incidence of renal failure, stroke, spinal cord ischemia, and retrograde type A dissections was similar between groups (TEVAR:6.0% vs OMT:4.2%). In-hospital mortality was 0%. Kaplan-Meier analysis demonstrated a trend towards improved survival among the TEVAR group at 1 and 3 years but no difference in overall survival (HR:0.30, 95% CI:0.08-1.08, P = 0.066). Five-year survival was 91% with TEVAR and 82% with OMT. Complete false lumen thrombosis was achieved in 72.1% with TEVAR and 20.0% with OMT (P < 0.001). In experienced centers, there is equivalent early mortality in the treatment of auTBAD with TEVAR compared to OMT. TEVAR provides superior aortic remodeling to OMT in auTBAD, which may translate into improved long-term survival., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Use of the American Society of Anesthesiologists (ASA) physical status classification is important for periprocedural risk stratification. However, the collective effect after adjustment for the Society for Vascular Surgery (SVS) medical comorbidity grading system on long-term all-cause mortality, complications, and discharge disposition is unknown. We examined these associations in patients after thoracic endograft placement. Data from three thoracic endovascular aortic repair (TEVAR) trials through 5 years of follow-up were included. Patients with acute complicated type B dissection (n = 50), traumatic transection (n = 101), or descending thoracic aneurysm (n = 66) were analyzed. The patients were stratified into three groups according to the ASA class: I-II, III, and IV. Multivariable proportional hazards regression models were used to examine the effect of ASA class on 5-year mortality, complications, and rehospitalizations after adjustment for SVS risk score and potential confounders. The largest proportion of patients treated by TEVAR across the ASA groups (n = 217) was ASA IV (n = 97; 44.7%; P  < .001), followed by ASA III (n = 83; 38.2%) and ASA I-II (n = 37; 17.1%). Among the ASA groups, the ASA I-II patients were, on average, 6 years younger than those with ASA III and 3 years older than those with ASA IV (ASA I-II: age, 54.3 ± 22.0 years; ASA III: age, 60.0 ± 19.7 years; ASA IV: age, 51.0 ± 18.4 years; P  = .009). Multivariable adjusted 5-year outcome models showed that ASA class IV, independent of the SVS score, conferred an increased risk of mortality (hazard ratio [HR], 3.83; 95% confidence interval [CI], 1.19-12.25; P  = .0239) and complications (HR, 4.53; 95% CI, 1.69-12.13; P  = .0027) but not rehospitalization (HR, 1.84; 95% CI, 0.93-3.68; P  = .0817) compared with ASA class I-II. Procedural ASA class is associated with long-term outcomes among post-TEVAR patients, independent of the SVS score. The ASA class and SVS score remain important to patient counseling and postoperative outcomes beyond the index operation., (© 2023 The Author(s).)

Background: Peripheral arterial disease (PAD) causes leg muscle damage due to inadequate perfusion and increases cardiovascular events and mortality 2- to 3-fold. It is unclear if PAD is a biomarker for high-risk cardiovascular disease or if skeletal muscle injury harms arterial health. The objective of this work is to test if serum myoglobin levels (myoglobinemia) are a marker of PAD, and if so, whether myoglobin impairs vascular health., Study Design: Patient blood samples were collected from PAD and control (no PAD) patients and interrogated for myoglobin concentrations and nitric oxide bioavailability. Patient mortality over time was captured from the medical record. Myoglobin activity was tested on endothelial cells and arterial function., Results: Myoglobin is a biomarker for symptomatic PAD and was inversely related to nitric oxide bioavailability; 200 ng/mL myoglobin in vitro increased endothelial cell permeability in vitro and decreased nitrate bioavailability. Ex vivo, 100 ng/mL myoglobin increased vascular tone in naive murine aortas approximately 1.5 times, impairing absolute vessel relaxation. In vivo, we demonstrated that myoglobinemia caused impaired flow-mediated dilation in a porcine model. Patients presenting with myoglobin levels of 100 ng/mL or greater had significantly more deaths than those with myoglobin levels of less than 100 ng/mL., Conclusions: Using a combination of patient data, in vitro, ex vivo, and in vivo testing, we found that myoglobin is a biomarker for symptomatic PAD and a potent regulator of arterial health that can increase vascular tone, increase vascular permeability, and cause endothelial dysfunction, all of which may contribute to the vulnerability of PAD patients to cardiovascular events and death.

Background: Luminal narrowing, suspected secondary to thrombus, occurs within stent grafts at an unclear incidence after thoracic endovascular aortic repair (TEVAR). The significance of this phenomenon has not been determined, nor have the risk factors for development of intragraft luminal narrowing. Small graft diameter is hypothesized to be a risk factor for the development of ingraft stenosis., Methods: A retrospective analysis was performed of a multicenter healthcare system including all patients who underwent TEVAR between July 2011 and July 2019 with at least 1 year of subsequently available surveillance contrast-enhanced computed tomography imaging. Standard demographic, preoperative, intraoperative, and postoperative variables were collected. Measurements were obtained via direct off-line images from computed tomography scans. Patent intragraft diameters were compared with baseline and interval change values were normalized to time to follow-up. The primary outcome measure was annual rate of intragraft luminal narrowing., Results: There were 208 patients who met the inclusion criteria (94 women, 114 men) with a median follow-up of 822 days. The mean annual rate of percent intragraft diameter reduction was 10.5 ± 7.7% for women and 7.6 ± 5.6% for men (P = .0026). Multivariate analysis demonstrated female gender (P = .0283), preoperative diagnosis of hypertension (P = .0449), and need for coverage of the left subclavian artery (P = .0328) were all significant predictors of intragraft luminal narrowing. Small aortic diameters were not found to be associated independently with ingraft luminal narrowing nor was the concomitant use of antiplatelet or anticoagulation medications. Significant amounts of ingraft luminal narrowing, defined as a greater than 20% intragraft diameter decrease, were associated with an increased need for any reintervention, including for malperfusion, endoleak, and symptomatic aneurysm (P = .0249). Kaplan-Meier estimates demonstrated a significant gender-associated difference in high rates of intragraft luminal narrowing (P = .00189)., Conclusions: In this analysis, female gender is shown to be a significant nonmodifiable risk factor for intragraft luminal narrowing after TEVAR. The development of this phenomenon is not benign; as such, these findings were associated with an increased need for reintervention. This finding may be attributable to differences in aortic compliance or gender-associated differences in coagulation pathways and merits further investigation. Surveillance after thoracic stent grafting must account for patient-specific variations in complication risk., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The Gore conformable TAG thoracic endoprosthesis (CTAG) was engineered to enhance conformability in the thoracic aorta and has demonstrated greater deployment accuracy and wall apposition than the original TAG device. The Food and Drug Administration approved the CTAG in 2011 based on the 1-year results of the pivotal trial for the CTAG device. In the present report, we have documented the outcomes for those patients through 5 years., Methods: The CTAG aneurysm study was a prospective, multicenter trial that assessed the safety and effectiveness of the CTAG device as treatment of descending thoracic aortic aneurysms. Follow-up imaging assessments consisted of radiographs and computed tomography at annual intervals through 5 years. A core imaging laboratory was used to assess the aneurysm size, device integrity, and endoleaks., Results: A total of 66 patients were enrolled (51 pivotal arm patients and 15 continued access patients) from October 2009 through September 2011. The baseline characteristics, procedural characteristics, and outcomes through 2 years were reported previously. Through 5 years, five patients (7.6%) had required device-related reintervention (one type Ia endoleak or contained rupture of the descending thoracic aorta, one type Ib endoleak, two indeterminate endoleaks, and one thoracic aortic pseudoaneurysm). Four patients (6.1%) had died of aneurysm-related causes, with one death occurring within 30 days of the index procedure. A total of 24 patients (36.3%) had died during the 5-year study period. Seven patients (10.6%) had experienced stroke or transient ischemic attack through 5 years, with one early stroke (postoperative day 28). Prosthesis or intercomponent migration was observed in six patients (9.1%) through 5 years; however, no patient had developed a type III junctional endoleak. No stent-graft fracture or compression was observed through 5 years. At 5 years, 14 patients (50.0%) showed sac regression, 5 (17.9%) showed sac expansion, and 9 (32.1%) showed sac stability using on a 5-mm threshold for change., Conclusions: Thoracic endovascular aortic repair with the CTAG device was associated with low rates of aneurysm-related mortality and reintervention through 5 years. Proximal endoleak was rare, and most patients showed sac regression or stability at 5 years after the initial thoracic endovascular aortic repair., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Left ventricular (LV) wall thickening occurs in patients following thoracic endovascular aortic repair (TEVAR). Clinical consequences of cardiovascular (CV) remodeling may be more significant younger patients with longer anticipated life spans. Risk factors for CV remodeling following TEVAR are unknown but may be related to graft size., Methods: A retrospective analysis was performed of a multicenter healthcare system including patients aged ≤60 who underwent TEVAR between 2011 and 2019 with at least 1 year follow-up computed tomography angiography imaging available. Standard perioperative variables, native aortic diameter, and stent graft specifications were collected. Graft oversizing was calculated by dividing proximal graft diameter by proximal aortic diameter on preoperative imaging. Posterior LV wall thickness was measured at baseline and interval increases were normalized to time-to-follow-up. Primary outcome was annual rate of posterior LV wall thickening., Results: One hundred one patients met inclusion criteria with a mean (SD) follow-up time of 1270 (693) days. Overall mean (SD) rate of LV wall thickness change was 0.534 (0.750) mm per year. Mean (SD) absolute LV wall thickness at most recent follow-up was 10.97 (2.85) mm for men, 9.69 (2.03) mm for women. Multivariate analysis demonstrated that higher rates of LV wall thickening were associated with narrower graft diameters (P = 0.0311). Greater absolute LV wall thickness at follow-up was associated with narrower grafts (P= 0.0155) and greater graft oversizing (P= 0.0376). Logistic regression demonstrated individuals who met criteria for LV hypertrophy were more likely to have narrower stent-grafts (P= 0.00798) and greater graft oversizing (P= 0.0315)., Conclusions: LV wall thickening occurred to a greater degree in individuals with narrower stent-grafts and higher rates of graft oversizing. This has significant implications for long-term cardiovascular health in younger patients may undergo TEVAR for atypical indications. Particular attention should be paid to long-term effects of stent-graft oversizing when selecting grafts in such populations., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: To investigate aortic remodeling of the supra- and infrarenal aorta from preoperative to 1 month and midterm follow-up after endovascular aneurysm repair (EVAR) by analyzing changes in angulation and curvature in patients with vs without late type Ia endoleak or device migration., Materials and Methods: From a multicenter database, 35 patients (mean age 76±5 years; 31 men) were identified with late (>1 year) type Ia endoleak or endograft migration (≥10 mm) and defined as the complication group. The control group consisted of 53 patients (mean age 75±7 years; 48 men) with >1-year computed tomography angiography (CTA) follow-up and no evidence of endoleaks. Suprarenal and infrarenal angles were measured on centerline reconstructions of the preoperative, 1-month, and midterm CTA scans. The value and location relative to baseline of maximum suprarenal and infrarenal curvature were determined semiautomatically using dedicated software. Changes were determined at 1 month compared with the preoperative CTA and at midterm compared with 1 month., Results: Preoperative suprarenal angulation was significantly greater in the complication group compared to the controls (34°±18° vs 24°±17°, p=0.008). It decreased significantly at 1 month in the complication group (29°±16°, p=0.011) and at midterm follow-up in the controls (20°±19°, p<0.001). Preoperative infrarenal angulation was not significantly different (57°±15° vs 49°±24°, p=0.114). This measurement increased significantly through midterm follow-up in the complication group (63°±23°, p<0.001) but remained stable in the controls (46°±22°). Preoperative suprarenal curvature was not significantly different (38±22 m -1 vs 29±25 m -1 , p=0.115). This variable increased significantly through midterm follow-up in the complication group (44±22 m -1 ) but remained constant in the controls (28±22 m -1 ). Preoperative infrarenal curvature was significantly greater in the complication group (77±29 m -1 vs 65±28 m -1 , p=0.047) and decreased significantly in both groups during midterm follow-up (50±17 m -1 vs 41±19 m -1 p=0.033). The location of the maximum curvature with regard to baseline shifted significantly distally in the complication group (54±43 to 72±41 mm, p<0.001), while it remained stable in the controls (46±33 to 48±31 mm)., Conclusion: At midterm follow-up, significant differences in supra- and infrarenal angulation and curvature were observed between patients with vs without type Ia endoleak or migration. The location of the maximum curvature shifted distally in patients with complications. The aortic morphology is more stable during midterm follow-up in the patients without endoleaks.

Competing Interests: Funding support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Conflicting evidence exists regarding the comparative effects of endovascular aneurysm repair (EVAR) with and without suprarenal fixation. We compare outcomes in patients treated by EVAR with baseline normal kidney function and moderate and severe chronic kidney disease., Methods: Patients with normal kidney function (glomerular filtration rate [GFR] ≥60 mL/min/1.73 m 2 ) or moderate (GFR = 30-59 mL/min/1.73 m 2 ) or severe (GFR <30 mL/min/1.73 m 2 ) kidney disease who underwent EVAR (N = 5534) were identified from the American College of Surgeons National Surgical Quality Improvement Program targeted database (2011-2015). Groups were determined by the presence (Cook Zenith [Cook Medical, Bloomington, Ind] or Medtronic Endurant [Medtronic, Minneapolis, Minn]) or absence (Gore Excluder [W. L. Gore & Associates, Flagstaff, Ariz]) of a suprarenal fixation system. Postoperative renal complications, defined as rise in creatinine concentration of >2 mg/dL without dialysis or new dialysis requirements, were analyzed within the first 30 days with results stratified by degree of kidney disease., Results: A total of 5534 patients underwent EVAR, with 3225 (58.3%) receiving a device using a suprarenal fixation system. Suprarenal fixation systems were less commonly used for symptomatic patients (11.0% vs 13.7%; P = .002) and patients with ruptured abdominal aortic aneurysm (4.5% vs 6.3%; P = .01). There was no difference in baseline kidney function between groups. EVAR with suprarenal fixation was associated with more renal complications (1.40% vs 0.65%; P = .008). In subgroup analysis, patients with moderate kidney dysfunction (n = 1780) had more renal complications (2.2% vs 0.8%; P = .02) with suprarenal fixation systems. No differences were seen in patients with normal kidney function (0.4% vs 0.2%; P = .32; n = 3597) or severe kidney dysfunction (14.3% vs 10.2%; P = .45; n = 157). This difference was driven mostly by postoperative elevation of creatinine concentration (0.6% vs 0.2%; P = .03) without requirements for new dialysis (0.8% vs 0.4%; P = .08). After adjustments with multivariate logistic regression models, EVAR with suprarenal fixation was associated with more renal complications (odds ratio, 2.65; 95% confidence interval, 1.32-5.34)., Conclusions: In our study, EVAR with suprarenal fixation devices was associated with more perioperative renal complications in patients with moderate kidney dysfunction. Long-term evaluation of these patients undergoing EVAR should be considered., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Thoracic endovascular aortic repair (TEVAR) with endograft coverage from the left subclavian artery to the celiac artery has been hypothesized to increase spinal cord ischemia. This study analyzes the impact of extended coverage on adverse outcomes and aortic remodeling in patients with complicated acute type B aortic dissection (aTBAD)., Methods: From January 2012 to October 2018, 91 patients underwent TEVAR for aTBAD. Median follow-up was 3.1 (interquartile range, 1.2-4.9) years and was complete in 94% of patients. The extent of aortic endograft coverage was categorized as standard (n = 39) or extended (n = 52). Contrast-enhanced imaging scans were analyzed to determine length of coverage, maximum aortic diameters, and false lumen (FL) status., Results: The mean age was 52.6 ± 13.9 years, and 66% were men. The most common indications for intervention were malperfusion (42%) and refractory pain (34%). Thirteen (14%) patients required a lumbar drain (preoperative: n = 3; postoperative: n = 10). Mean duration between scans was 2.0 ± 1.9 years. Length of aortic coverage was significantly longer in the extended group (241.7 ± 29.2 mm vs 180.8 ± 22.3 mm in the standard group; P < .001). In-hospital and overall mortality were 6% and 11%, respectively. There were no cases of paraplegia, and the incidence of spinal cord ischemia was 3%. After TEVAR, there was a higher incidence of FL obliteration or thrombosis at the distal descending thoracic aorta in the extended group (53% vs 16% in the standard group; P = .004)., Conclusions: Extended TEVAR carries a low risk of spinal cord ischemia and improves FL remodeling of the descending thoracic aorta in patients with aTBAD. This strategy may decrease the need for reinterventions on the thoracic aorta in the chronic phase of TBAD., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Frailty, characterized by physiologic depletion, predicts postoperative morbidity and mortality in vascular surgery patients. CT-derived sarcopenia is a valuable method for objectively staging frailty preoperatively., Purpose: With prior analyses primarily measuring psoas cross-sectional area on CT, we compared a method of measuring thoracic sarcopenia to existing techniques of lumbar sarcopenia and assessed the association with long-term survival and outcomes post-Thoracic Endovascular Aortic Repair (TEVAR)., Methods: Prospectively collected data of 217 patients undergoing TEVAR from 2009 to 2012 were reviewed. Thoracic sarcopenia was quantified by measuring total area of the rectus abdominis, latissimus dorsi, intercostal, erector spinae, and external and internal oblique muscles at the T12 vertebral level. Total psoas area at the L3 was used to measure lumbar sarcopenia., Results: 200 patients had preoperative imaging enabling measurements of thoracic sarcopenia, 186 of these patients were also assessed for lumbar sarcopenia. Thoracic sarcopenic patients were older, had lower body mass indices, were more commonly female, and most commonly being treated for aneurysms. Thoracic sarcopenic patients had significantly higher rates of congestive heart failure, hypertension, prior vascular intervention, and TEVAR-related adverse events. Thoracic sarcopenia was associated with significantly higher mortality at 2 and 5 years post-TEVAR (2-year mortality: 19% vs 8%, P = 0.02; 5-year mortality: 31% vs 18%, P = 0.03). Lumbar sarcopenia was not associated with increased mortality at any time point. Patients whose muscle mass degraded over 48-month follow-up did not experience significantly higher rates of adverse events., Conclusions: CT-derived thoracic sarcopenia, but not lumbar sarcopenia, is significantly associated with 5-year mortality post-TEVAR., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Guidelines from the Society for Vascular Surgery recommend elective repair in asymptomatic patients with an abdominal aortic aneurysm (AAA) only if their diameter is greater than or equal to 5.5 cm, yet smaller ones are routinely repaired. This study aims to evaluate perioperative outcomes based on aneurysm size at the time of repair., Methods: Male patients who underwent elective endovascular aneurysm repair (EVAR) or open abdominal aneurysm repair (OAAR) repair of an infrarenal AAA were abstracted from 2011 to 2015 Targeted National Surgical Quality Improvement Program (NSQIP) database. Patients with symptoms or with aneurysmal extension into the visceral or iliac vessels were excluded. Outcomes of open versus endovascular repair were reported, with multivariate analyses to identify factors associated with the decision to repair AAA ≤5.4 cm., Results: A total of 2115 (90.9%) patients underwent EVAR, while 213 (9.1%) underwent OAAR. The mean diameter in patients who underwent OAAR was 6.1 cm (interquartile range [IQR]: 5.2-6.1 cm) versus 5.7 cm (IQR: 5.2-6.0 cm) for EVAR. However, in 42.5% of EVAR and 32.8% of OAAR patients, the diameter of the AAA was 5.4 cm or less. The group undergoing repair of AAA ≤5.4 cm was younger compared to the larger AAA group (71.9 vs 73.9 years; P < .0001). Patients older than 80 years were less likely to have a repair of AAA measuring ≤5.4 cm (odds ratio [OR] = 0.45, 95% confidence interval [CI] = 0.30-0.65). Additionally, patients who underwent EVAR were more likely to have AAA measuring ≤5.4 cm repaired compared to those who underwent OAAR (OR = 1.62, 95% CI = 1.19-2.21). There were no differences in perioperative morbidity or mortality between the groups., Conclusion: There were no differences in perioperative outcomes after AAA repair, independent of aneurysm diameter. We found a higher likelihood of repairing AAA ≤5.4 cm in younger patients who were more likely to have been repaired with EVAR. Patients older than 80 years were less likely to undergo small AAA repair.

Objective: Surgeons' prescription practices and the opioid epidemic have received significant attention in the media. Limited data exist, however, on the impact of prior or coexistent opioid use on vascular surgery outcomes. This study aimed to quantify the incidence, economic burden, and clinical impact of pre-existing opioid dependency in patients undergoing lower extremity bypass (LEB) surgery., Methods: Data were collected from 1,132,645 weighted (230,858 unweighted) patient admissions for LEB in the National Inpatient Sample for the years 2002 to 2015. Patients with a concomitant diagnosis of opioid abuse or dependency were identified using International Classification of Diseases, Ninth Revision codes. Matched cohorts of patients with (n = 606 unweighted) and without (n = 32,343 unweighted) opioid dependence were created using coarsened exact matching to control for patient demographics. Linear regression was used to control for hospital-level factors and to identify differential outcomes for patients with opioid dependency. Our primary end points were hospital cost and length of stay. Our secondary end points were surgical complications and in-hospital mortality., Results: There were 1,132,645 (230,858 unweighted) patient admissions for LEB in the National Inpatient Sample during 2002 to 2015. There were 3190 (0.3%) patients (643 unweighted) who had a diagnosis of pre-existing opioid dependency. The incidence of opioid dependency rose over time (2002, 0.13%; 2015, 0.63%; R 2  = 0.90; P < .001). Before matching, opioid-dependent patients were younger (53.9 ± 12.3 years vs 66.7 ± 12.1 years; P < .001) and more likely to be male (65.2% vs 61.9%; P < .001), to be nonwhite (37.9% vs 24.1%; P < .001), to pay with Medicaid (29.6% vs 7.4%; P < .001), and to fall in the lowest income quartile based on ZIP code (39.6% vs 27.5%; P < .001). After matching, opioid-dependent patients (n = 606 unweighted vs n = 32,343 unweighted nonopioid-dependent patients) were at increased risk of surgical site infections (odds ratio [OR], 1.61; P = .006), major bleeding (OR, 1.56; P = .04), acute kidney injury (OR, 1.46; P = .02), and deep venous thrombosis (OR, 2.53; P = .005). Linear regression of matched cohorts revealed that opioid-dependent patients had an increased length of hospital stay (11.76 days vs 9.80 days; P < .001) and an increased mean inflation-adjusted in-hospital cost of U.S. $7032 ($37,522 vs $30,490; P < .001)., Conclusions: The incidence of pre-existing opioid dependency in patients undergoing LEB continues to rise. Patients with opioid use disorder undergoing LEB surgery have substantial increases in length of hospital stay and costs. These findings highlight the importance of early preoperative recognition of this disorder in vascular surgery patients and open the opportunity for early intervention in that cohort., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Deep vein thrombosis (DVT) may be associated with significant pain, swelling and the development of post-thrombotic syndrome. Early clot removal is facilitated by the use of percutaneous mechanical thrombectomy devices. Current techniques, however, vary in rates of technical success and in some cases are limited by the concomitant need for thrombolytics. An alternative percutaneous venous thrombectomy system (ClotTriever, Inari Medical, Irvine, Calif) may be helpful in the management of lower extremity DVT without the concomitant use of thrombolytics., Methods: A retrospective review of patients treated for DVT using the device was conducted. Demographics, initial presentation, and perioperative course were recorded. Outcomes after treatment were extracted from clinical records. Technical success was defined as complete clot evacuation after intervention., Results: Twelve patients were included in the study. The cohort was 50% female (6 patients) with a mean age of 55.6 years (range, 32-86 years). Two patients (16.7%) presented with chronic asymptomatic DVT who developed symptoms from an acute, recurrent iliofemoral DVT over the days before presentation. One patient (8.4%) presented with phlegmasia cerulea dolens, with the remaining patients presenting with disabling pain and swelling. Access was obtained via the popliteal vein (11 patients) and small saphenous vein (1 patient). Lytic therapy was not used in any case. Complete clot evacuation was obtained in all patients in a single session without repeat interventions. Symptom resolution before discharge was achieved in 100% of cases. There was no incidence of postoperative anemia (mean hemoglobin, 10.7 g/dL preoperatively vs 10.4 g/dL postoperatively) or acute kidney failure (mean creatinine, 0.86 mg/dL preoperatively vs 0.81 mg/dL postoperatively). The average length of stay was 2 days (range, 1-4 days) without the need for intensive care admission. At early follow-up, 11 patients (91.7%) continued to report significant symptom resolution. Two of 10 patients (20%) developed recurrent occlusive DVTs on follow-up duplex ultrasound examination., Conclusions: This novel percutaneous venous thrombectomy system is safe and effective for removing large volumes of lower extremity acute thrombus in a single session, without the need for lytic therapy, intensive care unit admission, or repeat intervention. Further studies are warranted to determine mid-term and long-term outcomes., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Abnormalities in glucose metabolism are common in patients with arterial disease. Chronic hyperglycemia and insulin resistance contribute to the complexity of vascular disorders. They also overlap with the effects of perioperative hyperglycemia on adverse perioperative outcomes. We provide an overview of the pathophysiologic consequences of dysglycemia and the evidence behind glycemic control in patients undergoing vascular surgery., Methods: We searched the literature for major studies evaluating the pathophysiology of hyperglycemia in microvascular and macrovascular beds, randomized trials in perioperative populations, and meta-analyses. The literature was summarized to guide therapy in the population of vascular patients and for the perioperative period., Results: National standards for glycemic control after vascular interventions were not identified. Mounting evidence exists for the long-term consequences of poor glycemic control on the progression of vascular disease. Similarly, there is a large body of evidence supporting tight control of hyperglycemia after general and cardiac surgery during the critical perioperative period. The absolute glucose target remains controversial. Randomized controlled studies are lacking in vascular surgery patients, but the current evidence can be extrapolated to guide management after vascular interventions. Glycated hemoglobin is a biomarker for increased mortality and vascular morbidity after vascular surgery., Conclusions: Hyperglycemia contributes to poor outcome in the vascular patient. Further vascular focused studies are required to determine the proper perioperative serum glucose target and the long-term glycated hemoglobin range., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Acute type A dissection with mesenteric malperfusion is a rare but lethal variant of aortic dissection. This study examines outcomes from various treatment algorithms., Methods: A review from 2003 to 2017 of the Emory Aortic Database identified 34 patients who presented with acute type A dissection with mesenteric malperfusion. Outcomes from 4 different treatment strategies were analyzed: ascending aortic/arch replacement followed by laparotomy (n = 13), axillary-bifemoral artery bypass followed by ascending/arch replacement (n = 3); ascending/arch and concomitant antegrade thoracic endovascular aortic repair (TEVAR) (n = 5), and TEVAR followed by delayed ascending/arch replacement (TEVAR-1st) (n = 13)., Results: The mean age of all patients was 53 ± 13 years and was equivalent among the groups. The incidence of concomitant renal and ileofemoral malperfusion was 52% and 41%, and the initial serum lactate level was 4.3 ± 2.1 mmol/L. Overall mortality was 55.8%. In the ascending aortic/arch replacement followed by laparotomy group, 77% of patients had postoperative bowel necrosis or intractable acidosis and the mortality was 69.2%. All patients in the axillary-bifemoral artery bypass followed by ascending/arch replacement group survived, but 66% required postoperative dialysis. In the ascending/arch and concomitant antegrade/TEVAR group, the mortality was 80% secondary to persistent postoperative bowel necrosis or intractable acidosis. Three patients in the TEVAR-1st group died before aortic replacement. In the 10 patients who underwent TEVAR followed by delayed aortic replacement, the mortality was 30%. There were no cases of postoperative bowel necrosis or intractable acidosis in the TEVAR-1st group., Conclusions: The TEVAR-1st strategy delays central aortic replacement until end-organ ischemia has resolved. This novel paradigm serves as a bridge to decision, and may improve survival compared with conventional treatment strategies in acute type A dissection with mesenteric malperfusion., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants., Methods: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck., Results: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups., Conclusions: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To investigate changes in penetration depths and angles of EndoAnchor implants with initially good penetration after therapeutic use in endovascular aneurysm repair., Materials and Methods: Patients were selected from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; ClinicalTrials.gov identifier NCT01534819). Inclusion criteria were (1) EndoAnchor implantation to treat intraoperative or late type Ia endoleak and (2) at least 2 postoperative computed tomography angiography (CTA) scans. Exclusion criteria were the use of adjunct procedures. Based on these criteria, 54 patients (44 men) with 360 EndoAnchor implants were eligible for this analysis. Penetration depth of each EndoAnchor implant into the aortic wall was judged as (1) good (≥2-mm penetration), (2) borderline (<2 mm or when there was a gap between the endograft and the aortic wall), or (3) no penetration. The penetration depth and longitudinal angles of EndoAnchors with good penetration were investigated on the last available postprocedure CTA scan. Endoleaks were also analyzed., Results: EndoAnchor penetration on the first postprocedure CTA scan was good in 187 (51.9%), borderline in 69 (19.2%), and missing in 104 (28.9%). On the last CTA scan, 182 (97.4%) of the 187 initially well-positioned EndoAnchors remained good. Five (2.6%) EndoAnchors in 4 patients changed configuration over time (4 became borderline and 1 became nonpenetrating), all without any clinical sequelae. The median orthogonal angles of the EndoAnchor implants with good penetration on the first and last CTA scans were 92° [interquartile range (IQR) 85, 98] and 90° (IQR 84, 97), respectively (p=0.822); for longitudinal angles, medians of 85° (IQR 71, 96) and 84° (IQR 70, 96) were found (p=0.043). Of the 18 (33%) patients who had a type Ia endoleak on the first postprocedure CTA, 6 resolved over time. Median follow-up was 13 months, during which no new type Ia endoleak was found., Conclusion: Despite the small number of EndoAnchors analyzed, this study showed that the sustainability of EndoAnchor implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of EndoAnchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence.

Background: Current surveillance recommendations after thoracic endovascular aortic repair (TEVAR) include contrast-enhanced computed tomography (CT) scans at 1-, 2-, 6-, and 12-month intervals, with annual scans thereafter. Patient compliance with such schedules remains inconsistent for all etiologies of aortic disease. It remains unclear which boundaries prevent compliance and whether compliance is associated with improved aorta-specific outcomes., Methods: A retrospective analysis was performed of a multicenter health-care system's electronic medical records to include all patients who underwent TEVAR from July 1, 2011 to April 1, 2016. Patients were assigned a compliance score of 0 through 4 based on the number of images received at the recommended time intervals. Whether patients underwent any postoperative imaging within 1 year of discharge was also recorded. Patients who died within 12 months of discharge were excluded. Aorta-specific complications included postoperative sac expansion, rupture, or need for additional aortic intervention., Results: A total of 262 patients were included; of whom, 203 (77.5%) received at least one postoperative contrast-enhanced CT scan. Race, insurance status, and distance to hospital were not associated with 12-month compliance or compliance score (all P > 0.05). Regarding 12-month compliance, 76.2% of aneurysm patients, 81.6% of dissection patients, 72.2% of transection patients, and 72.2% of penetrating aortic ulcer patients underwent at least 1 CT scan within the first year (all P > 0.05). There were no differences in compliance score based on indication for repair. The overall aorta-related complication rate was 34.7%. TEVAR for dissection was associated with increased long-term aorta-specific complications (49.5%, P < 0.05 when compared with other indications)., Conclusions: In this large, multihospital analysis of TEVAR outcomes, there was no difference in compliance among patients undergoing TEVAR for major indications, but patients with dissection who required TEVAR had a significant difference in aorta-specific complication rates. TEVAR for dissection should be subject to stricter surveillance guidelines than TEVAR for other indications., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: Controversy exists about the optimal treatment of acute uncomplicated type B aortic dissection (auTBAD). Optimal medical therapy (OMT) provides excellent short-term outcomes, but long-term results are poor. Ideally, auTBAD patients who will fail to respond to OMT in the chronic phase could be identified and undergo thoracic endovascular aortic repair. The purpose of this study was to identify radiographic predictors of auTBAD patients who will fail to respond to OMT., Methods: A review of the Emory aortic database from 2000 to 2017 identified 320 auTBAD patients initially treated with OMT. From this cohort, 121 patients with two or more contrast-enhanced imaging scans were available for analysis. These patients were initially divided into groups based on growth of the thoracic aorta ≥10 mm or intervention due to aneurysmal growth: growth (n = 72) and no growth (n = 49). TeraRecon (Foster City, Calif) imaging software was used to analyze characteristics of the primary intimal tear (PIT), false lumen, and overall aortic size. Finally, Cox proportional hazards models were constructed to estimate hazard ratios and to identify predictors of OMT failure., Results: The mean age of all patients was 54 ± 11 years, and 67% were male. Thirty-eight patients (53%) in the growth group underwent intervention. There were no differences between groups in age, hypertension, diabetes mellitus, tobacco abuse, or chronic obstructive pulmonary disease. The distance of the PIT from the left subclavian artery in patients with auTBAD was significantly shorter in the growth group (growth, 27 mm [9-66 mm]; no growth, 77 mm [26-142 mm]; P < .01). Multivariable Cox regression analysis identified the distance of the PIT from the left subclavian artery and a thoracic aortic diameter >45 mm as independent predictors of failure of OMT. Partial false lumen thrombosis was not a predictor of aortic growth., Conclusions: The distance of the PIT from the left subclavian artery is a predictor of aortic growth in auTBAD. Patients with a primary tear located in zone 3 of the proximal descending thoracic aorta should be monitored closely and may be considered for early thoracic endovascular aortic repair in the setting of auTBAD., (Copyright © 2018 Society for Vascular Surgery. All rights reserved.)

Objective: The objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults., Methods: Clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. We included newly diagnosed aortic coarctation (NCO), recurrent coarctation, and aneurysmal/pseudoaneurysmal degeneration (ANE) after prior open surgical repair (OSR) of coarctation. Primary end points were morbidity and mortality. Secondary end points were stent patency and freedom from reintervention., Results: There were 54 (58%) male and 39 (42%) female patients with a mean age of 44 ± 17 years. Thirty-two patients had NCO (mean age, 48 ± 16 years) and 61 had endovascular reinterventions after prior OSR during childhood (mean, 30 ± 17 years after initial repair), including 50 patients (54%) with recurrent coarctation and 11 (12%) with ANE. Clinical presentation included asymptomatic in 31 patients (33%), difficult to control hypertension in 42 (45%), and lower extremity claudication in 20 (22%). Endovascular treatment was performed using balloon-expandable covered stents in 47 (51%) patients, stent grafts in 36 (39%) patients, balloon-expandable uncovered stents in 9 (10%) patients, and primary angioplasty in 1 (1%) patient. Mean lesion length and diameter were 64.5 ± 50.6 mm and 19.5 ± 6.7 mm, respectively. Mean systolic pressure gradient decreased from 24.0 ± 17.5 mm Hg to 4.4 ± 7.4 mm Hg after treatment (P < .001). Complications occurred in nine (10%) patients, including aortic dissections in three (3%) patients and intraoperative ruptures in two patients; type IA endoleak, renal embolus, spinal headache, and access site hemorrhage occurred in one patient each. The aortic dissections and ruptures were treated successfully by deploying an additional covered stent proximal to the site of dissection or rupture. Two patients died within 30 days of the index procedure. After a mean follow-up of 3.2 ± 3.1 years, nearly all patients (98%) were clinically improved and all stents were patent. Reintervention was needed in 10 (11%) patients. Freedom from reintervention at 5 years was 85%. Two additional patients died during follow-up of coarctation-related causes, including rupture of an infected graft and visceral ischemia. Patient survival at 5 years was 89%., Conclusions: Endovascular repair is effective with an acceptable safety profile in the treatment of NCO and postsurgical complications of coarctation after initial OSR. Aortic rupture is an infrequent (2%) but devastating complication with high mortality. Balloon-expandable covered stents are preferred for NCO, whereas stent grafts are used for ANE. The rate of reinterventions is acceptable, with high procedural and long-term clinical success., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Optimal medical therapy (OMT) for uncomplicated type B aortic dissection (uTBAD) provides excellent short-term outcomes but is associated with a high incidence of failure. This study identified predictors of aortic intervention and mortality in uTBAD patients undergoing OMT., Methods: A retrospective review of the Emory University School of Medicine aortic database identified 314 uTBAD patients undergoing OMT from 2000 to 2016. Two hundred sixty-three (84%) patients had imaging at presentation analyzed for maximum aortic diameters (ADs), false lumen (FL) status, and visceral vessel perfusion. Cox proportional hazards models were constructed to estimate hazards ratios (HRs) and identify predictors of OMT failure., Results: The mean age of patients was 58 ± 12 years, and 67% were men. FL status was patent in 59.4%, partially thrombosed in 39.8%, and completely thrombosed in 0.8% of patients. Over a median follow-up of 5.6 (interquartile range, 1.4 to 8.5) years, 44.9% of patients failed OMT and underwent intervention (n = 58 open, n = 83 endovascular). The estimated incidence of OMT failure was 46%. Multivariate analysis identified the presence of diabetes, renal failure, DeBakey 3B dissection, and a descending thoracic AD of 4.5 cm or greater (HR, 1.39; 95% confidence interval, 1.24 to 1.56; p < 0.001) to be independent predictors of failure of OMT. FL status or the distribution of visceral vessels arising from the FL did not predict OMT failure., Conclusions: There is a significant incidence of OMT failure in uTBAD patients. A descending thoracic AD of 4.5 cm or greater at the time of diagnosis is an independent predictor of failure of OMT., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Endovascular aneurysm repair (EVAR) accounts for the majority of all abdominal aortic aneurysm (AAA) repairs in the United States. EVAR utilization in the aging population is increasing due to the minimally invasive nature of the procedure, the low associated perioperative morbidity, and early survival benefit over open repair. The objective of this study is to compare the outcomes of octogenarians after elective EVAR to their younger counterparts, a question that can be answered by a long-term, institutional data set., Methods: This was a retrospective series of 255 patients, who underwent elective EVAR within our institution from 2008 to 2015. A comparative analysis of patients aged 80 years and older and less than 80 years was performed. Outcomes measured included perioperative death and myocardial infarction (MI), length of stay, and readmission within 30 days. Aneurysm reintervention, long-term surveillance imaging, and aneurysm-related deaths were also evaluated. In addition, subset analyses of octogenarians were compared for survival at 24 months., Results: Overall, 255 patients were included in our analysis. Fifty-nine patients were octogenarians, and 196 patients were nonoctogenarians. The mean age difference between the two groups was significant (84.5 years [SD, ±3.44] vs. 69.6 years [SD, ±6.13] in the ≥80 and <80 groups, respectively; P < 0.0001). There was no significant difference in the mean aneurysm size (6.03 cm [SD, ±1.12] vs. 5.535 cm [SD, ±0.9]; P < 0.06) between the ≥80 and < 80 groups. Octogenarians had higher rates of perioperative MI (5% vs. 1%, P < 0.04), thirty-day mortality (7% vs. 0%, P < 0.003), a higher number of perioperative complications (0.64 incidence per patient [SD, ±1.11] vs. 0.31 [SD, ±0.69], P < 0.005), and a longer mean hospital stay (5.34 [SD, ±5.75] days vs. 3.16 [SD, ±3.23] days, P < 0.0003), and they were also less likely to be discharged home after surgery (75% vs. 91%, P < 0.002). In the evaluated long-term outcomes, the two groups were similar with regard to aneurysm reintervention (10% vs. 9%, P < 0.06) and the stability of aneurysm sac size on imaging at last follow-up (71% vs. 80%, P < 0.27). The overall aortic related cause of death was different between the groups (8% vs. 1%, P < 0.003); however, the long-term aortic related mortality was not different between the two groups (2% vs. 1%, P < 0.4). Finally, a subset analysis of the octogenarian group was performed comparing patients based on survival status at 24 months. Higher preoperative creatinine (1.73 mg/dL [SD, ±1.54] vs. 1.15 mg/dL [SD, ±0.46]) and lower preoperative hematocrit (33.9% [SD, ±3.43] vs. 37.2% [SD, ±4.9]) along with number of perioperative complications (1.2 incidence per patient [SD, ±1.74] vs. 0.45 [SD, ±0.73]) were associated with death at 24 months after the index operation., Conclusions: Elective endovascular repair of AAA in octogenarians carries a higher risk of perioperative mortality but acceptable long-term outcomes. Appropriateness of elective EVAR in octogenarians should be answered based on this potential short-lived survival benefit, taking into account that advanced age should not be the sole basis of exclusion for otherwise suitable candidates for elective EVAR., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: This study sought to quantify EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) penetration into the aortic wall in patients undergoing endovascular abdominal aortic aneurysm repair and to assess predictors of successful penetration and its relationship to postprocedural type IA endoleak., Methods: A subset of patients from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included if they met the following criteria: the indication for EndoAnchor use was to treat a type IA endoleak, and postprocedure contrast-enhanced computed tomography (CT) scans of sufficient quality were available for core laboratory review. Patients undergoing implantation of cuffs or stents during the EndoAnchor implantation procedure were excluded. Baseline anatomic characteristics were recorded. The cohort was divided into patients with and without persistent type IA endoleaks at the first postoperative CT scan. Penetration of each EndoAnchor measured on this CT scan was defined as good penetration when the EndoAnchor penetrated ≥2 mm into the aortic wall, borderline penetration when EndoAnchor penetration was <2 mm or a gap remained between the endograft and aortic wall, or no penetration when the EndoAnchor did not penetrate into the aortic wall. Differences between the groups were analyzed with the Mann-Whitney U test or Fisher exact test. Multivariate analyses were performed to identify independent predictors of EndoAnchor penetration, and procedural success was defined by absence of type IA endoleak., Results: Eighty-six patients of the primary (n = 61 [71%]) and revision (n = 25 [29%]) arms of the ANCHOR registry were included. There were 53 (62%) without and 33 (38%) with persistent type IA endoleaks on the first postprocedural CT scan. The median number of EndoAnchors with good penetration was significantly greater in the cohort without endoleaks, 4 (interquartile range, 3-5) vs 3 (interquartile range, 1.5-4), respectively (P = .002). A multivariate model for EndoAnchor penetration identified use of a Medtronic Endurant endograft as a factor associated with good penetration (P = .001), whereas poor penetration was associated with a larger aortic neck diameter 10 mm distal to the lowest renal artery (P < .001) and greater proximal neck calcium thickness (P = .004). EndoAnchor penetration was the only variable that attained significance (P < .001) in the multivariate model for successful treatment of a type IA endoleak., Conclusions: Adequate EndoAnchor penetration into the aortic wall is less likely when the aortic neck diameter is large or when the neck contains significant mural calcium. No penetration of the EndoAnchor was the only factor predictive of postprocedural type IA endoleak. This study stresses the importance of careful selection of patients based on preoperative assessment of the infrarenal neck on CT angiography and emphasizes careful deployment of EndoAnchors into the aortic wall to improve successful treatment of type IA endoleaks., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Although follow-up after open surgical and endovascular procedures is generally regarded as an important part of the care provided by vascular surgeons, there are no detailed or comprehensive guidelines that specify the optimal approaches with regard to testing methods, indications for reintervention, and follow-up intervals. To provide guidance to the vascular surgeon, the Clinical Practice Council of the Society for Vascular Surgery appointed an expert panel and a methodologist to review the current clinical evidence and to develop recommendations for follow-up after vascular surgery procedures. For those procedures for which high-quality evidence was not available, recommendations were based on observational studies, committee consensus, and indirect evidence. Recognizing that there are numerous published reports on the role of duplex ultrasound for surveillance of infrainguinal vein bypass grafts, the Society commissioned a systematic review and meta-analysis on this topic. The panel classified the strength of each recommendation and the corresponding quality of evidence on the basis of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system: recommendations were graded either strong or weak, and the quality of evidence was graded high, moderate, or low. The resulting recommendations represent a wide variety of open surgical and endovascular procedures involving the extracranial carotid artery, thoracic and abdominal aorta, mesenteric and renal arteries, and lower extremity arterial revascularization. The panel also identified many areas in which there was a lack of high-quality evidence to support their recommendations. This suggests that there are opportunities for further clinical research on testing methods, threshold criteria, and the role of surveillance as well as on the modes of failure and indications for reintervention after vascular surgery procedures., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To describe the added value of determining changes in position and apposition on computed tomography angiography (CTA) after endovascular aneurysm repair (EVAR) to detect early caudal displacement of the device and to prevent type Ia endoleak., Methods: Four groups of elective EVAR patients were selected from a dataset purposely enriched with type Ia endoleak and migration (>10 mm) cases. The groups included cases of late type Ia endoleak (n=36), migration (n=9), a type II endoleak (n=16), and controls without post-EVAR complications (n=37). Apposition of the endograft fabric with the aortic neck, shortest distance between the fabric and the renal arteries, expansion of the main body (or dilatation of the aorta in the infrarenal sealing zone), and tilt of the endograft toward the aortic axis were determined on the first postoperative and the last available CTA scan without type Ia endoleak or migration. Differences in these endograft dimensions were compared between the first vs last scan and among the 4 groups., Results: No significant differences in endograft configurations were observed among the groups on the first postoperative CTA scan. On the last CTA scan before a complication arose, the position of the fabric relative to the renal arteries, expansion of the main body, and apposition of the fabric with the aortic neck were significantly different between the type Ia endoleak (median follow-up 15 months) and migration groups (median follow-up 23 months) compared with the control group (median follow-up 19 months). Most endograft dimensions had changed significantly compared with the first postoperative CTA scan for all groups. Apposition had increased in the control group but had decreased significantly in the type Ia endoleak and migration groups., Conclusion: Progressive changes in dimensions of the endograft within the infrarenal neck could be detected on regular CTA scans before the complication became urgent in many patients.

Thoracic endovascular aortic repair (TEVAR) has been proven to be the optimal therapy for patients with a ruptured descending thoracic aortic pathology. In these emergent settings, TEVAR provides a rapid delivery of treatment to an unstable patient with a lethal disease. Typically, the greatest challenge is maintaining hemodynamic stability until the time of graft deployment. In this report, we describe our technique of performing awake TEVAR for ruptured descending thoracic aortic disease., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: We evaluated images of patients undergoing a thoracic endovascular aortic repair procedure using two reference points as a means for differentiating stent graft migration from aortic elongation. Conventional standards define migration of a stent graft as an absolute change in the distance from the distal graft ring to a distal landmark ≥10 mm compared with a baseline measurement. Aortic elongation occurs over time in both healthy individuals and patients with aortic disease. Aortic elongation in patients with stent grafts may result in increased distal thoracic aortic lengths over time. False-positive stent graft migration would be defined when these patients meet the standard definition for migration, even if the stent has not moved in relation to the elongating aorta., Methods: This retrospective study evaluated the aortic length of 23 patients treated with the conformable GORE TAG thoracic endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) in three clinical trials (dissection, traumatic injury, and aneurysm). Patients who met the standard definition for migration were selected. A standardized protocol was used to measure aortic centerline lengths, including the innominate artery (IA) to the most distal device ring, the IA to the celiac artery (CA), and the distal ring to the CA. Baseline lengths obtained from the first postoperative image were compared with length measurements obtained from the first interval at which they met the standard definition for migration. The conventional standards for migration using a single reference point were compared with the use of dual reference points., Results: Of the 23 patients with endograft changes, 20 were deemed to have aortic elongation rather than true migration. The remaining three patients were deemed to have migration on the basis of the IA to distal ring position compared with the IA to CA length change. The IA to CA interval length change was markedly greater in those with elongation compared with migration (23.8 ± 8.4 mm vs -3.5 ± 5.4 mm, respectively; P < .05). The distal ring to CA interval length change was greater in patients showing elongation rather than migration (18.5 ± 6.6 mm vs -9.8 ± 5.4 mm, respectively; P < .05). The distance between the IA and distal ring was similar for elongation and migration., Conclusions: These results highlight the dynamic changes that can occur in the aorta as a natural consequence of age. Employing two landmarks can account for these changes and proves to be an important factor, among others, in the differentiation of aortic elongation from true stent graft migration., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Diabetes and peripheral arterial disease (PAD) are independently associated with increased risk of amputation. However, the effect of poor glycemic control on adverse limb events has not been studied. We examined the effects of poor glycemic control (high hemoglobin A 1c level) on the risk of amputation and modified major adverse limb events (mMALEs) after lower extremity revascularization., Methods: Patients undergoing PAD revascularization who had hemoglobin A 1c (HbA 1c ) levels available within 6 months were identified in the Veterans Affairs database of 2003 to 2014 (N = 26,799). The diagnosis of preoperative diabetes mellitus (PreopDM) was defined using diabetes diagnosis codes and evidence of treatment. Amputation and mMALE risk was compared for HbA 1c levels using Kaplan-Meier analysis. Cox proportional hazards models were created to assess the effect of high HbA 1c levels on amputation and mMALE (adjusted for age, gender, race, socioeconomic status, comorbidities, cholesterol levels, creatinine concentration, suprainguinal or infrainguinal procedure, open or endovascular procedure, severity of PAD, year of cohort entry, and medications) for all patients and stratified by PreopDM., Results: High HbA 1c levels were present in 33.2% of the cohort, whereas 59.9% had PreopDM. Amputations occurred in 4359 (16.3%) patients, and 10,580 (39.5%) had mMALE. Kaplan-Meier curves showed the worst outcomes in patient with PreopDM and high HbA 1c levels. In the Cox model, incremental HbA 1c levels of 6.1% to 7.0%, 7.1% to 8.0%, and >8% were associated with 26% (hazard ratio [HR], 1.26; 95% confidence interval [CI], 1.15-1.39), 53% (HR, 1.53; 95% CI, 1.37-1.7), and 105% (HR, 2.05; 95% CI, 1.87-2.26) higher risk of amputation, respectively. Similarly, the risk of mMALE also increased by 5% (HR, 1.05; 95% CI, 0.99-1.11), 21% (HR, 1.21; 95% CI, 1.13-1.29), and 33% (HR, 1.33, 95% CI, 1.25-1.42) with worsening HbA 1c levels of 6.1% to 7.0%, 7.1% to 8.0%, and >8%, respectively (vs HbA 1c ≤6.0%). In stratified analysis by established PreopDM, the relative risk of amputation or mMALE was much higher with poor glycemic control (HbA 1c >7.0%) in patients without PreopDM., Conclusions: PAD patients with worse perioperative glycemic control have a significantly higher risk of amputation and mMALE. Incremental increases in HbA 1c levels are associated with higher hazards of adverse limb outcomes independent of PreopDM status. Poor glycemic control (HbA 1c >7.0%) in patients without a PreopDM diagnosis carries twice the relative risk of amputation and mMALE than in those with good glycemic control. These results suggest that screening of diabetic status and better management of glycemic control could be a target for improvement of perioperative and long-term outcomes in PAD patients., (Published by Elsevier Inc.)

Background: Currently, optimal medical therapy is first-line therapy for uncomplicated acute type B aortic dissection (aTBAD) despite poor long-term outcomes. This study examines the impact of thoracic endovascular aortic repair (TEVAR) in the acute and chronic phases on short-term and long-term survival of patients presenting with aTBAD., Methods: A review of the Emory aortic database from 2000 to 2016 identified 398 patients diagnosed with aTBAD. At index hospitalization, complicated patients underwent TEVAR (aTEVAR [thoracic endovascular aortic repair in the acute phase], n = 80) and uncomplicated patients received optimal medical therapy (n = 318). Uncomplicated patients were divided into subgroups based on final treatment: (1) TEVAR (cTEVAR [thoracic endovascular aortic repair in the chronic phase], n = 87); (2) open aortic replacement (n = 59); and (3) optimal medical therapy (n = 172). Kaplan-Meier curves assessed long-term mortality., Results: The mean age of patients was 57 ± 12 years. In the uncomplicated group, 146 patients (45.9%) patients failed optimal medical therapy and underwent open repair (n = 59) or endovascular repair (cTEVAR, n = 87) repair in the chronic phase. Inhospital mortality was 5% and equivalent between complicated and uncomplicated aTBAD groups at index hospitalization. For patients requiring intervention, mortality and renal failure were highest for open patients (16.9%, p < 0.01, and 10.2%, p = 0.05, respectively), and stroke was highest among aTEVAR patients (7.5%, p < 0.01). The incidence of paraparesis and paraplegia was low and equivalent among the three groups. Despite a higher mortality risk at presentation, there was a trend toward improved long-term survival among complicated aTBAD patients (complicated 84.1% versus uncomplicated 58.9%, p = 0.17). Intervention-free survival at 5 and 10 years for all uncomplicated patients was 50.4% and 32.9%, respectively., Conclusions: The treatment of uncomplicated aTBAD with optimal medical therapy results in a high incidence of surgical intervention and poor long-term survival. At the index hospitalization, TEVAR may confer a survival advantage and serve as optimal therapy for complicated and uncomplicated aTBAD patients., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: To report a methodology for 3-dimensional (3D) assessment of the stent-graft deployment accuracy after endovascular aneurysm repair (EVAR)., Methods: A methodology was developed and validated to calculate the 3D distances between the endograft fabric and the renal arteries over the curve of the aorta. The shortest distance between one of the renal arteries and the fabric (SFD) and the distance from the contralateral renal artery to the fabric (CFD) were determined on the first postoperative computed tomography (CT) scan of 81 elective EVAR patients. The SFDs were subdivided into a target position (0-3 mm distal to the renal artery), high position (partially covering the renal artery), and low position (>3 mm distal to the renal artery). Data are reported as the median (interquartile range, IQR)., Results: Intra- and interobserver agreements for automatic and manual calculation of the SFD and CFD were excellent (ICC >0.892, p<0.001). The median SFD was 1.4 mm (IQR -0.9, 3.0) and the median CFD was 8.0 mm (IQR 3.9, 14.2). The target position was achieved in 44%, high position in 30%, and low position in 26% of the patients. The median slope of the endograft toward the higher renal artery was 2.5° (IQR -5.5°, 13.9°)., Conclusion: The novel methodology using 3D CT reconstructions enables accurate evaluation of endograft position and slope within the proximal aortic neck. In this series, only 44% of endografts were placed within the target position with regard to the lowermost renal artery.

Objective: During the past decade, thoracic endovascular aortic repair (TEVAR) has increased as a treatment option for a variety of aortic pathologic processes. Despite this rise in the use of thoracic stent grafts, real-world outcomes from a robust, adjudicated, contemporary data set have yet to be reported. Previous studies have shown periprocedural mortality rates between 1.5% and 9.5% and procedure-related stroke rates of 2.3% to 8.2%. With advances in device engineering and increased experience of physicians, we hypothesized that the rates of these complications would be reduced in a more recent sample set. The purpose of this study was to determine current rates of mortality and stroke after TEVAR, to identify risk factors that contribute to 30-day mortality, and to develop a simple scoring system that allows risk stratification of patients undergoing TEVAR., Methods: We examined the 30-day mortality rate after TEVAR using the 2013 to 2014 American College of Surgeons National Surgical Quality Improvement Program database. Patients undergoing TEVAR for all aortic disease were identified using procedure codes. Bivariate analyses were performed to evaluate the association of preoperative, intraoperative, and postoperative variables with 30-day mortality, followed by multivariable logistic analysis using preoperative variables only, with P < .10 as the criterion for model entry. The predictive logistic model was internally validated by cross-validation. Variables included in the multivariable model were used to develop a risk score., Results: There were 826 patients included. The 30-day mortality and stroke rates were 7.63% (n = 63) and 4.5% (n = 37), respectively. In regression analysis, mortality was independently associated with age ≥80 years (odds ratio [OR], 2.32; 95% confidence interval [CI], 1.25-4.31), emergency case (OR, 2.61; 95% CI, 1.39-4.90), American Society of Anesthesiologists classification >3 (OR, 2.89; 95% CI, 1.34-6.24), transfusion >4 units in the 72 hours before surgery (OR, 2.86; 95% CI, 1.30-6.28), preoperative creatinine concentration ≥1.8 mg/dL (OR, 2.07; 95% CI, 1.05-4.08), and preoperative white blood cell count ≥12 × 10 9 /L (OR, 2.65; 95% CI, 1.41-4.96). Incorporating these factors, a 6-point risk score was generated and demonstrated high predictability for overall 30-day mortality., Conclusions: Recent data from a national, retrospective data set demonstrate that high perioperative mortality and stroke rates have persisted during the last decade. The risk score derived from this data set is simple and convenient and serves as a prognostic tool in the preoperative risk stratification of patients being evaluated for TEVAR., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Short neck length, and angulated infrarenal aortic necks, are historically associated with sac expansion following endovascular abdominal aortic aneurysm repair. Aorfix (Lombard Medical, Inc, Irvine, Calif), a conformable stent graft US Food and Drug Administration approved for highly angulated necks, was investigated in the US Pythagoras Trial. We investigated the incidence of, and factors related to, sac regression and expansion following implantation of the Aorfix device., Methods: Pythagoras trial data was assessed with mutivariable modeling for factors associated with sac regression or expansion (defined as change in maximum aneurysm diameter of ≥5 mm on annual follow-up computed tomography compared with last preoperative scan). All anatomic measurements were performed per protocol by a core laboratory (M2S; West Lebanon, NH)., Results: A total of 218 patients were enrolled; neck angle was ≥60° in 151 (69.3%), <60° in 67 (30.7%). Follow-up, including computed tomography imaging, was available at 1 year (n = 165), 2 years (n = 142), 3 years (n = 106), and 4 years (n = 70). Sac size decreased or was unchanged in 98.8% (1 year), 95.1% (2 years), 94.3% (3 years), and 92.9% (4 years). Mean neck length for the entire cohort was 22.3 mm; mean proximal neck angle was 71.4°. Maximum aneurysm diameter was 57.5 mm. Sac regression or expansion was not statistically associated with neck length, neck diameter, maximal aneurysm diameter, or patient sex (or 19 other demographic and medical history variables). Neck angle was not statistically associated with sac regression or expansion., Conclusions: In this study cohort, there is a low incidence of sac expansion with the Aorfix device. We were unable to demonstrate an association between neck length/angulation and sac expansion., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to evaluate outcomes of iliac vein stents placed for iliocaval venous obstruction (ICVO) and to determine if routine follow-up surveillance is warranted on the basis of timing of stent failure., Methods: All patients who underwent iliac vein stenting from 2003 to 2015 were identified from a prospectively maintained registry. Demographics of the patients, venous risk factors, prior venous interventions, indications, imaging, anatomic location of the ICVO, operative findings, procedural success, complications, and clinical follow-up were recorded. Clinical and ultrasound surveillance was performed at first postoperative follow-up and at routine subsequent intervals. Continuous data were analyzed with Student t-tests or Mann-Whitney U test, and frequency data were analyzed with χ 2 analysis or Fisher exact test. Primary patency was analyzed using Kaplan-Meier survival analysis., Results: Seventy-four limbs in 70 patients who underwent iliac vein stenting for ICVO were identified; 36 limbs (48.6%) were stented for nonthrombotic venous compression (stent-VC), and 38 limbs (51.4%) were stented for venous thrombosis (stent-VT). Twenty-seven limbs (71.1%) of the stent-VT group were treated for acute venous thrombosis requiring lysis followed by stenting for underlying venous lesions. The median number of follow-up visits for the stent-VC and stent-VT groups was two (interquartile range [IQR], 1-4) and two (IQR, 1-3), whereas the mean length of follow-up was 19.6 ± 29.5 months and 19.8 ± 26.5 months (P = .972), respectively. During the first 6 months, one limb (2.8% [n = 36]) in the stent-VC group occluded, whereas 13.2% (5/38) of the limbs in the stent-VT group occluded. In the stent-VT group, 57% of limbs (4 of 7) with acute venous thrombosis requiring thrombolytic therapy had limb occlusion at >6 months (median, 18.1 months; IQR, 16.6-30.1). Overall patency rates for the stent-VC and stent-VT groups were 97.2% (1/36) and 73.7% (10/38) at 36 months (standard error, ≤10%; P = .001), respectively., Conclusions: Iliac vein stents placed for nonthrombotic iliac vein compression had statistically higher patency than those placed for venous thrombosis, with few stent failures, all occurring within 6 months. Iliac vein stents placed for venous thrombosis continued with stent failure after 6 months and may benefit from extended surveillance., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Dilatation of the aorta within the proximal neck after endovascular aneurysm repair (EVAR) can be associated with late endoleaks and migration. This study was designed to identify predictors of early neck dilation in patients undergoing EVAR with Heli-FX EndoAnchors (Medtronic, Santa Rosa, Calif) measured perioperatively to 1 year at different longitudinal levels of neck length., Methods: The study group of Aneurysm Treatment Using the Heli-FX Aortic Securement System (ANCHOR) comprises 257 consecutive patients prospectively enrolled between April 2012 and September 2014 undergoing EVAR with Heli-FX EndoAnchor implantation at 38 investigational sites. Only patients undergoing EndoAnchor implantation at the time of the initial EVAR were included (primary treatment arm). Aortic diameter was measured at the suprarenal level and at three levels within the proximal neck. Neck dilatation was assessed in 209 patients with adequate computed tomography imaging at baseline and 1 month and in 62 patients at 1 month and 1 year (mean, 11.9 ± 4.0 months). Multivariable analyses were performed to identify independent predictors of perioperative (baseline to 1 month) and early postoperative (1 month to 1 year) aortic dilation at each level; analyses included 6 candidate variables, 6 clinical, and 14 anatomic run in eight models (one at each of the four aortic levels for both time frames)., Results: The mean aortic neck dilation at 1 month was 0.2 ± 1.7 mm, 0.7 ± 2.2 mm, and 0.9 ± 3.6 mm at 0 mm, 5 mm, and 10 mm below the lowest renal artery, and 0.0 ± 1.5 mm at the suprarenal level. From 1 month to 1 year, neck dilatation was 0.5 ± 1.6 mm, 0.4 ± 1.5 mm, 0.2 ± 1.8 mm, and -0.3 ± 1.1 mm at the same four levels, respectively. Dilatation of ≥3 mm at level 5 mm distal to the lowest renal artery was observed in 26 patients (12.5%) from preoperative to 1 month and in 5 patients (8.1%) between 1 month and 1 year. Multivariable regression identified several variables predictive of perioperative (preoperative to 1 month) neck dilatation: baseline neck diameter, mural calcium (protective), and endografts with a suprarenal stent. Neck dilatation between 1 month and 1 year was associated with baseline neck diameter, neck length (protective), neck angulation, device oversizing, number of EndoAnchors implanted (protective), and endografts with a suprarenal stent., Conclusions: Aortic diameter and graft oversizing appear to be independent risk factors for early aortic neck dilatation. EndoAnchors have a protective effect on neck dilatation at their usual level of deployment., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Early and midterm outcomes of the Prospective Aneurysm Trial: High Angle Aorfix Bifurcated Stent Graft (PYTHAGORAS) trial in patients with highly angulated aortic necks (≥60 degrees) have already been published and shown comparable outcomes to other endografts in normal anatomy. Herein, we present the long-term outcomes of the PYTHAGORAS trial of Aorfix (Lombard Medical, Irvine, Calif) for patients with highly angulated aortic neck anatomy., Methods: The Aorfix endograft is a highly conformable nitinol/polyester device designed for transrenal fixation. The U.S. trial enrolled 218 patients and observed all patients at 1 month, 6 months, and 12 months and then annually for a total of 5 years. Endovascular aneurysm repair (EVAR)-specific complications were compared between the standard-angle (<60 degrees) and highly angulated (≥60 degrees) neck groups at 5 years using standard statistical methods. Kaplan-Meier analysis was performed to evaluate the overall 5-year survival and freedom from aneurysm rupture, aneurysm-related mortality, and reintervention., Results: Of the 218 patients enrolled in the trial, there were 67 patients in the standard-angle neck group (I) and 151 patients in the highly angulated neck group (II). Mean proximal neck angle was 45 degrees in group I vs 83 degrees in group II (P < .001). At 5 years, 87% of surviving patients were followed up. The 5-year EVAR-specific results showed no type I or type III endoleak in either group, 4% migration in group I vs 3% in group II, and 4% sac expansion in group I vs 15.0% in group II (P ≥ .27). The 5-year freedom from all-cause mortality was 69% (73% in group I vs 68% in group II; P = .43); from aneurysm-related mortality, 96% (99% vs 95%; P = .44); from aneurysm rupture, 99% (99% vs 99%; P = 1.0); and from device-related secondary intervention, 83% (88% vs 80%; P = .18). None of these differed between groups., Conclusions: The U.S. PYTHAGORAS trial of the Aorfix endograft is the first EVAR clinical trial to include a majority of highly angulated (≥60 degrees) infrarenal aortic necks and is the first to produce evidence after 5 years of implantation. Despite predictors of worse short- and long-term outcomes, pertinent outcomes were better than or similar to those of trials with less severe anatomy. These results support the use of this "on-label" endovascular option, particularly in patients with highly angulated aortic neck anatomy., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)