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Strict morphologic criteria must be used for patient selection to achieve durable success with endovascular aortic aneurysm repair (EVAR). The goal of this study was to assess morphologic suitability (MS) of abdominal aortic aneurysms (AAAs) for 2 currently approved bifurcated stent grafts and identify reasons for exclusion from EVAR. The authors reviewed the electronic charts of 1,795 consecutive patients who were diagnosed as having AAA between January 1999 and July 2001 at their institution. Three hundred and twenty patients had an AAA with a diameter of > or = 5.0 cm, measured on computed tomography (CT). The records of 301 patients, 254 men, 47 women, with a mean age of 74 years were available for review, and these patients constituted the study cohort. Criteria used for MS included a proximal neck length > or = 15 mm; neck diameter between 18 and 26 mm; neck angulation < or = 60 degrees ; common or external iliac artery (CIA or EIA) diameters of 7-16 mm and 8-13 mm, respectively, for AneuRx (Medtronic Ave, Santa Rosa, CA) and Ancure (Guidant Cardiac and Vascular Division, Menlo Park, CA) bifurcated grafts. AAAs were suitable for AneuRx device in 14% of patients (43 of 301; 95% CI = 11-19%) and for Ancure in 5% (16 of 301; 95% CI = 3.1-9%). The main reason for exclusion was an inadequate proximal aortic neck (73%). The neck was too short in 49.5%, too wide in 64% and badly angulated in 12% of the patients. Iliac artery morphology precluded EVAR with AneuRx and Ancure devices in 52% and 80%. Both CIAs were too wide for EVAR in 43% and 77%, respectively. When iliac artery diameter < or = 20 mm was accepted, iliac suitability for AneuRx increased from 49% to 70% and overall suitability increased from 14% to 20%. When more permissive criteria were used for MS (neck length > or = 10 mm, neck diameter < or = 30 mm, CIA < or = 20), 39% of patients became candidates for EVAR. More than three fourths of the patients with an AAA > or = 5.0 cm in size, seen in a tertiary referral center, are morphologically not suitable for EVAR using 2 currently approved bifurcated endografts. The main reasons for exclusion are a short or wide proximal aortic neck. Considerable changes in size of the devices and in proximal attachment techniques have to occur before most AAAs will be suitable for EVAR. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To review early results of endovascular repair of abdominal aortic aneurysms (AAAs). PATIENTS AND METHODS: The first 100 patients who underwent endovascular repair of AAA (EVAR) between June 26,1996, and October 31, 2001, at the Mayo Clinic in Rochester, Minn, were studied retrospectively to evaluate technical success, freedom from reinterventions, and early clinical outcome. RESULTS: A total of 89 men and 11 women (mean +/- SD age, 76 +/- 7 years; range, 47-92 years) underwent EVAR. The procedure was successful in 97 patients. There was no early death. Major complications occurred in 25 patients. The 30-day technical success rate was 86% (95% confidence interval [CI], 77%-92%). The median intensive care unit stay was 1 day (range, 1-15 days), and the median hospital stay was 3 days (range, 1-35 days). Median follow-up was 7 months (range, 1-60 months). Endoleak (incomplete seal of the endovascular graft) at discharge was observed in 14 patients; 13 developed endoleak during follow-up. There were 23 reinterventions, 65% of which were percutaneous procedures. One aneurysm ruptured at 5 months, but the patient was successfully treated by open repair. Primary and secondary graft patency rates at 1 year were 83% (95% CI, 74%-93%) and 94% (95% CI, 87 %-99%), respectively. The freedom from reintervention rate at 1 year was 71% (95% CI, 59%-84%), with an overall success rate from EVAR of 92% (95% CI, 84%-100%). There were no differences in early patency, reinterventions, and success rates between unibody and modular devices. CONCLUSION: EVAR can be performed with high technical success and low mortality rates; however, nonfatal complications and catheter-based reinterventions are frequent, and EVAR may not prevent aneurysm rupture. Although stent graft repair for high-risk patients is appealing, current data are insufficient to support EVAR as the preferred treatment of AAAs. [ABSTRACT FROM AUTHOR]

Background: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths., Methods: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure., Results: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88)., Conclusions: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558., Competing Interests: Disclosures Dr Krishnan has served as a consultant to Abbott and Medtronic. Dr Nazif reports consulting fees or honoraria from Terumo Medical, Boston Scientific, Medtronic, Edwards Lifesciences, Teleflex, Opsens Medical, Encompass Technologies, and Columbia University Irving Medical Center. The other authors report no conflicts.

Objective: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year. This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory cohort., Methods: The 70 patients from the ANCHOR Registry were cohort submitted to regulators for approval of the Endurant short neck indication. Patients had an infrarenal neck length of ≥ 4 mm and <10 mm. At 5 years, this short neck cohort had clinical and imaging follow-up compliance rates of 85% (28/33) and 70% (23/33), respectively., Results: The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. Kaplan Meier freedom from all-cause mortality was 68.5 ± 6.2%, freedom from aneurysm-related mortality was 90.1 ± 4.5%, freedom from any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and freedom from rupture was 95.6 ± 3.2%. Eight patients had a total of nine type IA endoleaks detected through 5 years, of which three resolved spontaneously by the next follow-up visit. There were two patients with renal complications who did not undergo reintervention and there were no device migrations reported through 5 years. After 5 years, 68.2% of patients (15/22) had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared with their 1-month measurements., Conclusions: After ESAR treatment using Heli-FX EndoAnchors with Endurant, the 5-year outcomes of the short neck cohort from the ANCHOR registry had encouraging results with regards to proximal neck-related complications, secondary procedures, and sac regression. This review of ESAR in patients with short proximal necks showed positive outcomes through 5 years although follow-up of a larger cohort is necessary., (Copyright © 2023. Published by Elsevier Inc.)

In situ fenestration of endovascular stent-grafts has become a mainstream bailout technique to treat complex emergent aneurysms while maintaining native anatomical visceral and aortic arch blood supplies. Fabric tearing from creating the in situ fenestration using balloon angioplasty may extend beyond the intended diameter over time. Further tearing may result from the physiologic pulsatile motion at the branching site. A resultant endoleak at the fenestrated sites in stent-grafts could ultimately lead to re-pressurization of the aortic sac and, eventually, rupture. In an attempt to address this challenge, plain woven fabrics were designed. They hold a specific corona surrounding a square-shaped cluster with a plain weave fabric structure, a 2/2 twill, or a honeycomb. The corona was designed to stop potential further tearing of the fabric caused by the initial balloon angioplasty and stent or later post-implantation motion. The cluster within the corona was designed with relatively loose fabric structures (plain weave, 2/2 twill weave, and honeycomb) to facilitate the laser fenestration. Two commercial devices, Anaconda (Vascutek, Terumo Aortic) and Zenith TX2 (Cook), were selected as controls for comparison against this new design. All the specimens were characterized by morphology, thickness, and water permeability. The results demonstrated that all specimens with a low thickness and water permeability satisfied the requirements for a stent graft material that would be low profile and resistant to endoleaks. The in situ fenestrations were performed on all fabrics utilizing an Excimer laser followed by balloon angioplasty. The fabrics were further observed by light microscopy and scanning electron microscopy. The dimension of the fenestrated apertures was smaller than the balloon's diameter. The tearing was effectively confined within the corona. The clinical acceptability of this concept deserves additional bench testing and animal experimentation.

Objective: To provide the 5-year outcomes of the use of a composite device (proximal covered stent graft + distal bare stent) for endovascular repair of patients with acute, type B aortic dissection complicated by aortic rupture and/or malperfusion., Methods: Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE) II was a prospective, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe). Patients were enrolled between August 2012 and January 2015 at sites in the United States and Japan. Five-year follow-up was completed by January 2020., Results: In total, 73 patients (mean age: 60.7 ± 10.9 years; 65.8% male) with acute type B dissection complicated by malperfusion (72.6%), rupture (21.9%), or both (5.5%) were enrolled. Patients were treated with either a composite device (79.5%) or the proximal stent graft alone (no distal bare stent, 20.5%). Dissections were more extensive in patients who received the composite device (408.9 ± 121.3 mm) than in patients who did not receive a bare stent (315.9 ± 100.1 mm). The mean follow-up was 1209.4 ± 754.6 days. Freedom from all-cause mortality was 80.3% ± 4.7% at 1 year and 68.9% ± 7.3% at 5 years. Freedom from dissection-related mortality remained at 97.1% ± 2.1% from 1-year through 5-year follow-up. Within the stent-graft region, the rate of either complete thrombosis or elimination of the false lumen increased over time (82.1% of all patients at 5 years vs 55.7% at first postprocedure computed tomography), with a higher rate at 5 years in patients who received the composite device (90.5%) compared with patients without the bare stent (57.1%). Throughout the follow-up, overall true lumen diameter increased within the stent-graft region, and overall false lumen diameter decreased. At 5 years, 20.7% of patients experienced a decrease in maximum transaortic diameter within the stent-graft region, 17.2% experienced an increase, and 62.1% experienced no change. Distal to the treated segment (but within the dissected aorta), 23.1% of patients experience no change in transaortic diameter at 5 years; a bare stent was deployed in all these patients at the procedure. Five-year freedom from all secondary intervention was 70.7% ± 7.2%., Conclusions: These 5-year outcomes indicate a low rate of dissection-related mortality for the Zenith Dissection Endovascular System in the treatment of patients with acute, complicated type B aortic dissection. Further, these data suggest a positive influence of composite device use on false lumen thrombosis. Continuous monitoring for distal aortic growth is necessary in all patients., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

A 65-year-old woman had presented with a ruptured type B intramural hematoma associated with a right-sided aortic arch aneurysm, a large Kommerell diverticulum (KD) and an aberrant left subclavian artery (LSA). She underwent total aortic arch replacement with elephant trunk, thoracic endovascular aortic repair, and LSA ligation distal to the left vertebral artery. She subsequently developed a brisk type II endoleak into the KD via retrograde flow from the left vertebral artery. Percutaneous access of the left internal mammary artery with coil embolization of the proximal LSA and KD was performed. At 5 years, computed tomography angiogram showed complete thoracic aortic remodeling without an endoleak. The results from the present case have illustrated the novel use of the left internal mammary artery as an alternative access for LSA embolization in patients with type II endoleak and limited access options., (© 2022 The Authors.)

Objective: Thoracic endovascular aortic repair (TEVAR) is increasingly utilized in the management of acute type B aortic intramural hematoma (TBIMH). Optimal timing for intervention has not been described. The aim of this study was to evaluate TEVAR timing on postoperative aortic remodeling., Methods: A retrospective chart review was performed on patients who underwent TEVAR for TBIMH from January 2008 to September 2018. Imaging was reviewed pre- and postoperatively. Primary data points included true lumen diameter (TLD) and total aortic diameter (TAD) at the site of maximal pathology. Primary endpoint was aortic remodeling evidenced by a TAD/TLD ratio closest to 1.0. Secondary outcome was occurrence of aortic-related adverse events and mortality (AREM): aortic rupture, aortic-related death, progression to dissection, or need for aortic reintervention within 12 months. Patients undergoing emergent TEVAR (within 24 hours, 'eTEVAR') were compared with the remainder - delayed TEVAR ('dTEVAR')., Results: We analyzed 71 patients that underwent TEVAR for TBIMH; 25 underwent emergent TEVAR and 46 patients underwent dTEVAR (median, 5.5 days; range, 2-120 days). There were no differences in demographics and comorbidities, and patients did not differ in presenting IMH thickness (12.6 ± 3.1 vs 11.3 ± 4.1 mm; P = .186) nor presenting TAD/TLD ratio (1.535 ± 0.471 vs 1.525 ± 0.397; P = .928) for eTEVAR and dTEVAR groups, respectively. eTEVAR patients had larger average presenting maximal descending aortic diameter (45.8 ± 14.3 vs 38.2 ± 7.5 mm; P = .018) and higher incidence of penetrating aortic ulcer on presenting computed tomography angiography (52.0% vs 21.7%; P = .033). Thirty-day mortality was 2 of 25 (8.0%) for eTEVAR and 2 of 45 (4.4%) for dTEVAR (P = .602). Postoperative aortic remodeling was more complete in the dTEVAR group (1.23 ± 0.12 vs 1.33 ± 0.15; P = .004). Case-control matching (controlling for presenting descending aortic diameter and penetrating aortic ulcer) on 30 patients still showed better aortic remodeling in the dTEVAR group (1.125 ± 0.100 vs 1.348 ± 0.42; P < .001). The incidence of AREM was higher in the eTEVAR (6/25; 24.0%) group compared with the dTEVAR group (2/46; 4.3%). At 12 months, freedom from AREM was higher in the dTEVAR group (95.7% vs 76.0%; P = .011). Postoperative TAD/TLD ratio was the best predictor for late aortic-related adverse events (area under the receiver operator characteristic = 0.825; P = .003)., Conclusions: TEVAR for acute TBIMH within 24 hours of admission is associated with lower aortic remodeling and higher occurrence of late AREM. Delaying TEVAR when clinically possible could improve aortic remodeling and aortic-related outcomes., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Thoracic endovascular aortic repair (TEVAR) has become first-line therapy for complicated acute type B aortic dissection (aTBAD). However, the strategy for optimal proximal landing zone remains to be determined. We compared early outcomes and late aortic-related adverse events in patients undergoing TEVAR for complicated aTBAD with endograft deployment in proximal landing zone 2 vs 3., Methods: We performed a retrospective chart review of adult patients undergoing TEVAR for complicated aTBAD within 6 weeks of diagnosis from January 2008 to December 2018. We excluded patients with connective tissue disorders and prior type A repair. Patients were divided into landing zone 2 TEVAR (Z2T) and zone 3 TEVAR (Z3T) groups. Z2 patients were divided between left subclavian artery (LSA) revascularization (Z2R) vs LSA coverage without revascularization (Z2C). Groups were compared for the need for aortic reintervention within 36 months of initial admission and freedom from aortic-related adverse events and mortality (AREM), defined as the need for aortic reintervention, aortic-related death, or rupture., Results: Eighty-three patients underwent TEVAR for complicated aTBAD within a mean of 4.1 ± 7.8 days; 89.5% of patients had less than 2 cm of healthy proximal descending thoracic aorta. The landing zone was Z3T in 35 patients and 48 underwent Z2T: 10 Z2C and 38 Z2R. There were no differences between Z2T and Z3T in time from diagnosis to TEVAR, demographics, comorbidities, and diameter aortic measurements. The 30-day survival was 87.8%-89.5% for Z2R, 88.6% for Z3, and 80.0% for Z2C (P = .610). The postoperative spinal cord ischemia rate was 3.7%-2.7% for Z2R, 0% for Z3T, and 20.0% for Z2C (P = .012). The postoperative thoracic aortic rupture was 2.2% in Z2 and 0 in Z3. The need for aortic reintervention at 36 months after TEVAR was lower for Z2T (10.4%) vs Z3T (31.4%; P = .025). Freedom from AREM at 36 months was higher in Z2T vs Z3T (87.5% vs 68.6%; P = .048). The freedom from proximal reintervention was higher in Z2T (95.8%) compared with Z3T (80.0%; P = .019). Z3T deployment was predictive for AREM (odd ratio, 3.648; 95% confidence interval, 1.161-11.465; P = .027) and need for proximal reintervention (odds ratio, 5.542; 95% confidence interval, 1.062-28.927; P = .042)., Conclusions: Most patients with aTBAD have less than 2 cm of proximal healthy descending thoracic aorta. In patients treated for complicated aTBAD, Z2T is associated with a lower need for aortic reintervention and aortic-related adverse events than Z3T. Patients may benefit from a more aggressive proximal landing zone with similar perioperative morbidity when Z2T is done with LSA revascularization., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Central venous occlusive disease is a common cause of upper extremity arteriovenous access dysfunction in hemodialysis patients. When refractory to balloon angioplasty, the treatment options include central venous stenting and hemodialysis reliable outflow (HeRO; Merit Medical, South Jordan, Utah) graft. The purpose of the present study was to evaluate the outcomes of these options., Methods: A retrospective review was performed of patients who had undergone central venous stenting or HeRO placement for central venous obstruction from December 2008 to March 2018. The primary outcomes were the reintervention rates, patency, and mortality., Results: A total of 75 hemodialysis patients were identified after failed balloon angioplasty for central venous obstruction. Of the 75 patients, 44 underwent central venous stenting comprising coverage of the subclavian vein (n = 27), innominate vein (n = 18), and/or superior vena cava (n = 5). Six stent patients later underwent HeRO placement. The stents used were stent grafts in 65% (Viabahn, n = 9; Fluency/Flair, n = 19; iCast, n = 2; and other, n = 1) and bare metal stents in 35% (Wall-stent, n = 6; Protégé, n = 1; Cobalt, n = 1; and other, n = 9). The remaining 31 patients underwent HeRO graft placement. The venous outflow component insertion sites were the internal jugular (n = 20), external jugular (n = 1), subclavian (n = 6), axillary (n = 2), and other (n = 2). The stent and HeRO groups were similar in the previous central venous intervention rates (median, 0.6 [interquartile range (IQR), 0-3.0]; vs median, 3.5 [IQR, 0-10.1] annually; P = .679). After the index procedure, no difference was found between the two groups in the frequency of dialysis circuit interventions annually (median, 2.0 [IQR, 0-6.0]; vs median, 2.0 [IQR, 0-7.0]; P = .291) nor central venous interventions (ie, angioplasty of the central veins or within the portion of the HeRO inside the central veins) annually (median, 2.0 [IQR, 0-4.1]; vs median, 0 [IQR, 0-2.4]; P = .419). The 1-year access circuit primary patency was 8.1% for stenting and 22.2% for HeRO (P = .109). The 2-year access circuit secondary patency was 40.0% for stenting and 52.4% for HeRO (P = .401). The all-cause mortality was similar at 1 year (3.7% vs 4.8%; P = .856) and 2 years (11.8% vs 23.5%; P = .368)., Conclusions: Central venous stenting and HeRO were shown to have similar rates of reintervention and patency. The results from the present study suggest that the multiple treatment options available for this problematic disease process can yield similar results when careful patient selection is applied., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Authors' Note: On February 17, 2021, Medtronic Incorporated issued a global voluntary recall of the Valiant Navion Thoracic Stent Graft System (the device under study in the Valiant Evo Global Clinical Program that is the subject of this publication), and instructed physicians to immediately cease use of the Valiant Navion system and return any unused product. Medtronic initiated the recall in response to three clinical trial subjects recently observed with stent fractures, two of whom have confirmed type IIIb endoleaks. The data collection, analysis, and manuscript submission occurred before the notice of this recall, and, specifically, the 100 procedures reviewed for this series were free of events at 1 year related to the reason for this device recall. The authors of this article and the manufacturer were unaware of the recently detected adverse events at the time of the preparation of the manuscript, and the 1-year trial results, and imaging-based analyses described are unchanged. Management of thoracic aortic aneurysms continues to be a challenging problem and outcomes are dependent on patient anatomy. The present publication focuses on the importance of achieving proximal and distal seals and the consideration of the temporal changes of the aortic morphology as a part of the TEVAR planning process. The authors believe there is still scientific merit in disclosing this information, despite the current nonavailability of the Valiant Navion system., Objective: The Valiant Navion stent graft system (Medtronic Inc, Santa Rosa, Calif) is a third-generation device with improved conformability. We have reported the 1-year clinical trial outcomes, with a focus on an imaging-based analysis of the aortic morphology. We assessed the effects of graft implantation on the native anatomy and the effects of the 1-year changes in thoracic aorta morphology on the original seal zones of the stent graft., Methods: A total of 100 subjects were enrolled in a prospective single-arm clinical trial investigating the Valiant Navion stent graft system. An independent core laboratory (Syntactx, New York, NY) assessed the anatomic characteristics and performance outcomes., Results: Through 1 year of follow-up, the freedom from all-cause mortality, aneurysm-related mortality, and secondary procedures was 89.8%, 97.0%, and 94.8% respectively. Of the 100 patients, 5 had undergone a total of six secondary procedures, and 9 patients had developed an endoleak (type Ia and Ib in 1, type Ia in 1, type Ib in 3, and type II in 4 patients) within the first year. After 1 year, 2 of 76 patients (2.6%) had had an increase in their maximum aneurysm diameter of ≥5 mm, 62 (81.6%) had had stable sacs, and 12 (15.8%) had experienced sac shrinkage. Although no deployment failures had occurred, 36 of the 100 proximal (36%) and 31 of the 100 distal (31%) attachment zones were considered short according to our definitions. The stent graft had conformed to the native anatomy at implantation, because the preprocedural thoracic aorta tortuosity (1.45 ± 0.02) had not significantly changed at 1 month after implantation (1.46 ± 0.02). Despite a natural increase in thoracic tortuosity after 1 year (1.49 ± 0.02), wall apposition had been maintained over time, as evidenced by the low endoleak rates. Aortic elongation and dilation had occurred at the proximal end of the graft by an average of 1.2 mm and 1.6 mm, respectively. Aortic remodeling was more pronounced at the distal end, with an average increase of 4.2 mm in length and 2.8 mm in diameter., Conclusions: The included patients had had positive 1-year outcomes with high freedom from mortality, endoleak development, and secondary procedures. Aortic elongation and dilation were more prevalent at the distal end, emphasizing the importance of distal attachment zone consideration as part of preoperative planning. Because aortic remodeling can be expected to continue over time, additional follow-up and imaging analysis in the trial will be necessary to assess the aortic morphology and its effects on stent graft performance., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Treatment options for dialysis access steal syndrome (DASS) include distal revascularization with interval ligation (DRIL), proximalization of arterial inflow (PAI), access banding, and access ligation. This study examines the efficacy of DRIL in treating DASS and reports short-term bypass patency, access patency, and wound infection rates., Methods: A retrospective analysis was performed on adults diagnosed with DASS following hemo-dialysis access creation who underwent DRIL procedures between January 1, 2009 and May 11, 2017. Patients <18 years and those with lower extremity accesses or HeRO grafts that developed DASS were excluded. Data was obtained using electronic medical records and analyzed using SPSS software. Residual steal was defined as reintervention for DASS within 60 days of DRIL. Recurrent steal was defined as reintervention beyond 60 days., Results: Eighty-nine DRIL procedures were performed for correction of DASS. Population included 59.6% female (n = 53), 47.2% current/former smokers (n = 42), 76.4% diabetic (n = 68), and 79.8% AVF (n = 71). Symptom resolution was complete for 69.7% (n = 62), and partial for 25.8% (n = 23), with no improvement in 4.5% (n = 4). Following DRIL, mean DBI improved from 0.43 to 0.67 (P= 0.002). Mean steal classification improved from 3.04 to 0.64 (P< 0.001). Five patients required a subsequent procedure for DASS symptoms - 3 for residual steal and 2 for recurrent steal. Bypass patency at 6 months post DRIL was 93.3% (n = 83) primary, 97.8% (n = 87) primary-assisted, and 100% (n = 89) secondary patency. Access patency at 6 months post DRIL was 78.7% (n = 70) primary, 91% (n = 81) primary-assisted, and 94.4% (n = 84) secondary. Twenty-one patients (23.5%) had 24 cases of surgical site infections, with 70.8% (n = 17) occurring at the saphenectomy site. Wound infections re-solved within 60 days postoperatively in 23 out of 24 patients., Conclusions: DRIL is highly effective in relieving symptoms of DASS and has excellent rates of short-term access and bypass patency. However, consideration must be given to the high wound infection rate and the potential need for subsequent procedures., (Copyright © 2021. Published by Elsevier Inc.)

Background: The increasing proportion of elderly patients being treated for abdominal aortic aneurysm (AAA) in the endovascular era is controversial., Objectives: This study compared 30-day outcomes of endovascular aortic repair (EVAR) in nonagenarians (NAs) with non-nonagenarians (NNAs)., Methods: This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database included EVAR procedures performed from 2011 to 2017. Multivariate logistic regression in the unadjusted cohort, followed by propensity-score matching (PSM), was performed. Primary outcomes were 30-day mortality and 30-day major adverse events., Results: A total of 12,267 patients were included (365 NAs). Ruptured aneurysms accounted for 6.7% (n = 819): 15.7% (n = 57) in NAs versus 6.5% (n = 762) in NNAs (p < 0.001). Mean aneurysm diameter was 6.5 ± 1.8 cm in NAs versus 5.8 ± 1.7 cm in NNAs (p < 0.001). The unadjusted 30-day mortality was 9.9% in NA versus 2.2% in NNAs (p < 0.001). Multivariate analysis revealed age ≥90 years (odds ratio [OR]: 3.36), male sex (OR: 1.78), functional status (OR: 4.22), pre-operative ventilator dependency (OR: 3.80), bleeding disorders (OR: 1.52), dialysis (OR: 2.56), and ruptured aneurysms (OR: 17.21) as independent predictors of mortality. After PSM, no differences in 30-day mortality (intact AAA [iAAA]: 5.3% NA vs. 3% NNA [p = 0.15]; ruptured AAA [rAAA]: 38% NA vs. 28.6% NNA [p = 0.32]) or 30-day major adverse events (iAAA: 7% NA vs. 4.6% NNA [p = 0.22]; rAAA: 28% NA vs. 36.7% NNA [p = 0.35]) were observed., Conclusions: Age was identified as an independent predictor of 30-day mortality after EVAR on multivariate analysis. However, no differences were found after PSM, suggesting that being ≥90 years of age but with similar comorbidities to younger patients is not associated with a higher short-term mortality after EVAR. Age ≥90 years alone should not exclude patients from EVAR, and tailored indications and carefully balanced risk assessment are advised., Competing Interests: Funding Support and Author Disclosures All authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the response of various stent-grafts after laser fenestration and dilation with noncompliant balloons to determine the optimal therapeutic combination for this treatment technique., Materials and Methods: Five aortic stent-grafts were evaluated ex vivo: the Bolton RelayPlus, Jotec E-vita Thoracic 3G, Medtronic Valiant, Cook Zenith Alpha, and Vascutek Anaconda. Small holes were created using an excimer laser with the grafts submerged in saline. Five rows of 5 fenestrations were created, 4 holes in each row were dilated once with a 6-, 8-, 10-, or 12-mm-diameter noncompliant balloon to the specified nominal pressure (one hole served as the control). The saline solution from each stent-graft was collected and qualitatively analyzed for debris. The fenestrations were evaluated under light and scanning electron microscopes. The maximum diameter and area for each fenestration were measured. The direction and length of tears were assessed., Results: The fenestration was feasible and reproducible in all the stent-grafts. The mean area of fenestration ranged from 7.63±1.63 to 14.75±0.73 mm 2 when using balloons of 6- and 8-mm diameter, respectively. The 10- and 12-mm-diameter balloons caused a significant increase in area, variability, and tearing. The Anaconda graft tended to tear in the weft direction, while the other devices tore in the warp direction when using the 10- and 12-mm-diameter balloons. Dilation of the RelayPlus and Anaconda grafts with 6- and 8-mm-diameter balloons provided minimal tearing and precise fenestrations. Melted fiber remnants were observed after filtration of the saline solution for all devices., Conclusion: Laser fenestration and dilation with noncompliant balloons is a relatively simple and reproducible option for revascularization in urgent, complex aortic endovascular repairs. In our model, large balloons (ie, >10 mm) increased the destruction and tearing of the fabric. The maximum dilation recommended is 6 to 8 mm to avoid significant tears. Development of stent-grafts or novel fabrics designed explicitly for fenestration is needed to reduce potential complications.

We present a case series of 4 iatrogenic ascending aortic pseudoaneurysms that were all successfully repaired with a percutaneous approach. Pre-procedural imaging, device selection, and procedural techniques are described. With careful preparation and patient selection, catheter closure of iatrogenic ascending aortic pseudoaneurysms can be performed reliably and safely. ( Level of Difficulty: Advanced. )., Competing Interests: Dr. Stehli is supported by a Monash University scholarship. Dr. Panneton is a consultant for and in the Speakers Bureau of Medtronic, Terumo Aortic, WL Gore, and Penumbra. Dr. Mahoney is a consultant and proctor for Medtronic, Abbott, and Edwards. Dr. Alie-Cusson has reported that she has no relationships relevant to the contents of this paper to disclose. This project did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors., (© 2021 Published by Elsevier on behalf of the American College of Cardiology Foundation.)

We present the novel application of transcarotid artery revascularization (TCAR) in two high-risk patients with high-grade internal artery stenosis and concomitant atherosclerotic extracranial carotid artery aneurysms (ECAAs). ECAAs account for <1% of arterial aneurysms and are usually clinically silent at presentation. Historically, the treatment of ECAAs has been via open reconstruction or stent grafting. TCAR is an effective alternative for carotid revascularization in high-risk patients with high-grade carotid stenosis, but has not been widely used for aneurysmal management. We report two cases to describe our management of concomitant carotid stenoses and ECCA with TCAR., (© 2021 The Authors.)

Purpose: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions., Materials and Methods: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study ( ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR., Results: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and primary assisted patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status., Conclusion: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

Objective: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease., Methods: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis., Results: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years., Conclusions: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Intramural hematoma (IMH) is on the spectrum of acute aortic syndrome, but optimal management is poorly understood. The aim of this study was to evaluate outcomes of patients with type B IMH (TBIMH) after best medical therapy (BMT) and to assess for risk factors associated with failure of BMT., Methods: This is a single-institution retrospective chart review of all patients with TBIMH between January 2008 and December 2017. Failure of BMT was defined as any of the following end points: aortic rupture, aorta-related death, aortic enlargement to at least 55 mm or growth of >10 mm within 12 months, or need for surgical aortic intervention for failed BMT., Results: We identified 92 patients, of whom 25 received emergent thoracic endovascular aortic repair; 67 patients were initially managed with BMT, and of these, 32 underwent thoracic endovascular aortic repair within 14 days for early BMT failure. Two additional patients had early BMT failure; one died of aortic rupture due to retrograde type A dissection, and one patient was advised to undergo repair but did not comply and was lost to follow-up. Fourteen patients (20.9%) received endovascular therapy for late failure of BMT after the initial hospitalization. Medical management was successful in 19 patients (28.4%), although 5 patients had aortic enlargement but below the threshold for elective repair (maximal aortic diameter of 55 mm). On univariate analysis, presenting IMH thickness and growth of IMH thickness were risk factors for BMT failure. On multivariate analysis, presenting IMH thickness was the sole predictive risk factor for medical therapy failure (odds ratio, 1.083; 95% confidence interval, 1.021-1.149; P = .008), with an odds ratio of 6.810 (95% confidence interval, 1.921-24.146; P = .002) with a presenting IMH thickness of ≥8.0 mm, which was the calculated IMH thickness cutoff value with highest sensitivity and specificity to predict failure of BMT (area under the receiver operating characteristic curve = 0.795; P = .001; J = 0.62)., Conclusions: BMT for TBIMH is associated with a high failure rate and need for interventions. IMH thickness on admission is the most reliable factor to predict failure of BMT., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the safety and effectiveness of a composite device design (covered stent graft and bare metal stent) for the treatment of patients with acute, complicated type B aortic dissection (TBAD) presenting with aortic rupture and/or branch vessel malperfusion., Methods: In this prospective, nonrandomized, multicenter study, 73 patients (65.8% male; mean age, 60.7 years) with acute, complicated TBAD were enrolled between August 2012 and January 2015 to receive treatment with the Zenith Dissection Endovascular System (William Cook Europe, Aps, Bjaeverskov, Denmark) at institutions in the United States and Japan. The primary safety end point was the rate of freedom from major adverse events at 30 days, and the primary effectiveness end point was the rate of survival at 30 days. This article reports primary outcomes at 30 days and follow-up results through 1 year, reflecting study data as of March 2018., Results: Of 73 patients, 20 presented with aortic rupture (27%) and 57 presented with branch vessel obstruction/compromise (78%), including 4 patients presenting with both conditions. The covered stent graft was used in all patients (median, 1; range, 1-3; 1 stent graft used in 64.4%; 47/73), and the bare metal dissection stent was used in 58 of 73 patients (79.5%). Thirty-day mortality occurred in five patients (6.8%): one procedure related, three unrelated to dissection repair, and one indeterminate. Thirty-day major adverse events included myocardial infarction (1.4%), bowel ischemia (1.4%), renal insufficiency/renal failure requiring dialysis (6.8%), stroke (6.8%), paraplegia or paraparesis (5.5%), and prolonged ventilatory support (13.7%). Nine deaths occurred from 31 to 365 days (only one death related to dissection repair); the Kaplan-Meier estimate of freedom from all-cause mortality was 80.3% ± 4.7% at 1 year. Within 365 days, 9 of 73 patients (12.3%) underwent 10 secondary interventions; no patients required conversion to open surgery. At the 12-month follow-up, complete or partial thrombosis of the false lumen was seen in 100% of patients (46/46) within the stent graft region and in 97.4% of patients (38/39) within the dissection stent region. Growth (>5 mm) of the maximum transaortic diameter was observed in 14.9% of patients (7/47) in the stent graft region and in 38.5% of patients (15/39) within the dissection stent region at 12 months., Conclusions: Thirty-day and 1-year results from the STABLE II study demonstrated favorable clinical and anatomical outcomes for the treatment of rupture and malperfusion in the setting of acute, complicated TBAD. Five-year follow-up is ongoing., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Takayasu's arteritis (TA) is a systemic large vessel vasculitis that affects the aorta and its branches. Most patients with TA respond to medical therapy with a minority of patients requiring surgical intervention. In our report, we describe the case of a 59-year-old Caucasian female with TA who underwent revascularization due to cerebrovascular symptoms refractory to medical therapy. She initially presented with amaurosis fugax and developed episodes of syncope and slurred speech during corticosteroid tapering. Vascular studies showed right common carotid artery (RCCA), left internal carotid artery (LICA), and left subclavian artery (LSA) occlusion with the right vertebral artery (RVA) ostium stenosis, and retrograde flow through the left vertebral artery (LVA). The sole source of cerebral perfusion flowed through her stenosed RVA, so it was decided to first stent the RVA to restore adequate posterior cerebral circulation before creating a right subclavian artery to RCCA bypass to restore anterior circulation. This case represents the successful management of TA utilizing a two-staged combined endovascular and surgical approach., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic aneurysms. Herein, the 30-day primary safety and efficacy outcomes and secondary end points are presented., Methods: The Valiant EVO global clinical trial is a prospective, nonrandomized, single-arm trial. Patient enrollment occurred from April 2016 to October 2017. The primary end point was defined as access and/or deployment failure and/or a major device effect (MDE), including device-related secondary procedures, device-related mortality, conversion to open surgery, or thoracic aortic aneurysm rupture within 30 days of the index procedure. Other measures of stent graft performance including procedural data, rates of secondary procedures, and frequency of endoleaks are also reported., Results: Of the 87 consecutive patients undergoing thoracic endovascular aneurysm repair who were enrolled, 33 (37.9%) were female with 61 (70.9%) presenting with severe access artery tortuosity and 66 (85.7%) with high thoracic aortic tortuosity per core laboratory evaluation. The mean procedure duration was 88.7 ± 53.4 minutes and geographical differences existed such as percutaneous access (37/52 [71.2%]) in the United States and surgical cut down in the outside of the U.S. sites (28/35 [80.0%]). There were no access or deployment failures and only 2.3% of the patients (2/87; P < .0001; performance goal of 16%) experienced a MDE within 30 days of the index procedure. Two secondary procedures (n = 1 retrograde type A dissection; n = 1 aortic arch rupture) were required, and in the first 30 days, two patients died leading to a freedom from all-cause mortality of 97.7%. Endoleaks at 1 month were reported in 2.5% of patients (n = 1 type Ia; n = 1 type II)., Conclusions: Access/deployment failures, MDEs, and endoleaks were rare in the first 30 days of the Valiant Evo clinical trial. The Valiant Navion thoracic stent graft system has shown encouraging 30-day results in this challenging cohort and trial patients will continue to be followed through 5 years., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA., Methods: In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months., Results: In this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months., Conclusions: In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In situ fenestration of aortic stent grafts for treatment of aortic arch aneurysms is a new option for endovascular aortic arch repair. So far, only few reports have shown perioperative and short-term results of in situ fenestrations for aortic arch diseases. We present the multicenter experience with the aortic arch in situ fenestration technique documented in the AARCHIF registry for treatment of aortic arch aneurysms or localized type A aortic dissections and analyzed perioperative outcome and midterm follow-up., Methods: Patients with aortic arch pathologies treated by aortic arch in situ fenestration with proximal stent graft landing in aortic arch Ishimura zones 0 and 1 were included in the registry. Stent-graft in situ fenestrations were created using needles or radiofrequency or laser catheters and completed by implantation of covered connecting stent grafts. Single in situ fenestrations for the left subclavian artery (LSA) were excluded., Results: Between 06/2009 and 03/2017, twenty-five patients were treated by in situ stent-graft fenestrations for aortic arch pathologies at 9 institutions in 7 different countries, 3 of them as bailout procedures for stent-graft malplacement. In situ fenestrations were performed for the brachiocephalic trunk (n = 20), the left common carotid artery (n = 21) and the LSA (n = 9). Technical success for intended in situ fenestrations was 94.0% (47/50), with additional supraaortic bypass procedures performed in 14 patients. Perioperative mortality occurred in 1 (4.0%) patient, treated as a bailout procedure and 3 (12.0%) perioperative strokes were observed. One proximal aortic stent-graft nonalignment and 4 type III endoleaks, 2 early and 2 late, required reeintervention. During follow-up (1-118 months), the diameter of aortic arch aneurysms decreased from 61.5 ± 4.1 mm to 48.4 ± 3.2 mm (P = 0.02) and, so far, 6 patients died from diseases unrelated to their aortic arch pathologies with a mean survival time of 79.5 months and 3 endovascular reinterventions for distal aortic expansion were performed. Cerebrovascular event (n = 4) was the most relevant prognostic factor for mortality during midterm follow-up (P = 0.003)., Conclusions: The aortic arch in situ fenestration technique for endovascular aortic arch repair seems to be valuable treatment option for selected patients, although initial consideration of other treatment options is mandatory. Data about long-term durability are required., (Copyright © 2019. Published by Elsevier Inc.)

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.

Objective: Head and neck cancer can involve the surrounding vasculature and require technically challenging vascular interventions. These interventions can be complicated by tumor invasion, history of prior surgery, and history of radiation therapy. Our aim was to examine patients with vascular interventions in association with head and neck cancer to determine outcomes and best practice., Methods: We performed a retrospective review of cancer patients treated by head and neck surgery and vascular surgery between 2007 and 2014. Data concerning previous cancer treatment, operative details of head and neck surgery and vascular surgery, perioperative outcomes, and survival data were collected. Statistical analyses were performed using the χ 2 test, Student t-test, and binomial regression. Patency and survival data were determined by Kaplan-Meier analysis., Results: A total of 57 patients with head and neck cancer requiring vascular interventions were identified. Of these, 44 patients had squamous cell carcinoma, 4 had thyroid cancer, 3 had sarcoma, 2 had Merkel and basal cell carcinoma, and 1 each had a parotid tumor, paraganglioma, extrarenal rhomboid tumor, and malignant spindle cell neoplasm. The majority of the interventions (n = 36 [63%]) were performed on patients with recurrent or persistent malignancy despite prior treatment. The most common previous treatment was radiation therapy (n = 44 [77%]). Tumor resection and vascular intervention were performed concurrently in 26 patients (46%). The mean time between cancer treatment and vascular intervention was 37 months (range, 18 days-18 years). The most common indication for vascular intervention was bleeding (n = 21 [37%]), which included vessel rupture (n = 14), tumor bleeding (n = 5), and intraoperative bleeding (n = 2). The remaining indications for intervention included invasion/encasement of major vasculature (n = 25), stenosis/occlusion (n = 12), and aneurysm (n = 1). The most common intervention was stenting (n = 22 [41%]), followed by resection (n = 20 [35%]), exposure/dissection (n = 12 [22%]), bypass (n = 8 [15%]), and embolization (n = 3 [6%]). Of the 22 patients who were stented, 12 (55%) were placed electively (11 for stenosis and 1 for aneurysm) and 10 (45%) were placed emergently (6 for blowout and 4 for tumor bleeding). A total of six patients (11%) required reintervention after their index vascular procedure. There were no intraoperative mortalities. The 30-day mortality was 9% (n = 5). The 30-day stroke rate was 7% (n = 4; one s/p common carotid artery-internal carotid artery bypass and three with emergent intervention for vessel rupture). Primary patency at 1 year was 66% for stents and 71% for bypass (P = .604). Survival in those patients operated on emergently for bleeding at 1 year was 38%, with a trend toward worse survival compared with the 77% survival at 1 year for all other indications (P = .109). The overall survival in the cohort at 1 and 2 years was 62% and 44%, respectively., Conclusions: Vascular involvement in head and neck cancer is a marker for poor survival. Any intervention performed in light of mass resection, persistent disease, and previous radiation complicates management. Minimally invasive techniques can be used with emergent bleeding but the survival benefits are marginal. Vascular interventions, including reconstruction, are feasible but should be approached with adequate expectations and multidisciplinary support., (Copyright © 2018. Published by Elsevier Inc.)

Purpose: To compare outcomes of outpatient tibial artery procedures between an office endovascular center and a hospital angiography suite., Methods: A retrospective review was conducted of 204 outpatient tibial interventions performed on 161 patients (mean age 72±11.5 years; 81 men) in either an office (n=100) or hospital (n=104) angiography suite from April 2011 through September 2013. Patients who had an existing ipsilateral bypass that was completely proximal to the tibial trifurcation were eligible, as were patients with prior proximal endovascular interventions. Exclusion criteria included previous ipsilateral bypass involving the infrapopliteal vessels, in-patient status at the time of the procedure, planned admission after the procedure, and infrapopliteal stenting. Treatment included percutaneous transluminal angioplasty (PTA) or PTA with atherectomy. Primary outcomes were unplanned admission, emergency room visits, acute complications, and patency., Results: There were no significant differences in demographics or baseline Rutherford category between patients treated in an office endovascular suite vs a hospital angiography suite. Factors more prevalent in the hospital group included chronic obstructive pulmonary disease (16% vs 8%, p=0.045), renal insufficiency (37% vs 25%, p=0.017), and previous proximal bypass (12% vs 4%, p=0.045). Of the 100 office procedures, 25 involved PTA and 75 were PTA with atherectomy, while in the 104 hospital procedures, PTA was applied in 68 patients and PTA with atherectomy in 36. Thirty-day local complication rates (7% vs 11%, p=0.368), systemic complication rates (4% vs 8%, p=0.263), and mortality (1% vs 2%, p=0.596) in the office vs hospital setting were not statistically different. Unplanned postprocedure hospital admission rates for medical reasons were lower in the office group (2% vs 11%, p=0.01). Kaplan-Meier estimates of the 1-year follow-up data were better in the office group for primary patency (69% vs 53%, p=0.050), assisted primary patency (90% vs 89%, p=0.646), and amputation-free survival (89% vs 83%, p=0.476), but the differences were not statistically significant., Conclusion: Efficacy and safety of outpatient endovascular tibial artery interventions between office and hospital settings were similar, with lower unplanned admission rates and better patency. With appropriate patient selection, the office endovascular suite can be a safe alternative to the hospital angiography suite.

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.)

In recent years, endovascular procedures have become a first-line therapy for peripheral arterial disease. As a result, an increased number of patients received stent grafts to treat their persistent superficial femoral artery (SFA) lesions. Although the risk of stent-graft infection in that location exists, it is exceptionally rare. Successful management of this condition requires removal of the infected stent graft in combination with appropriate antibiotic therapy and debridement of necrotic tissue, as well as revascularization, with avoidance of prosthetic material. We describe 2 cases of infected stent grafts in the SFA that presented late after the original intervention. An 83-year-old man presented 8 years after the original operation, and a 57-year-old woman presented 2 years after the original operation. Both infected stent grafts were excised, and complete destruction of the native arterial wall was evident during exploration., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: Retrograde open mesenteric stenting (ROMS) through laparotomy was introduced as an alternative to surgical bypass in patients with acute mesenteric ischemia (AMI). The purpose of this study was to evaluate the indications and outcomes of ROMS for treatment of AMI and chronic mesenteric ischemia., Methods: We reviewed the clinical data and outcomes of all consecutive patients treated by ROMS in seven academic centers from 2001 to 2013. ROMS was performed through laparotomy with retrograde access into the target mesenteric artery and stent placement using a retrograde or antegrade approach. End points were early (<30 days) and late mortality, morbidity, patency rates, and freedom from symptom recurrence and reintervention., Results: There were 54 patients, 13 male and 41 female, with a mean age of 72 ± 11 years. Indications for ROMS were AMI in 44 patients (81%) and subacute-on-chronic mesenteric ischemia with flush mesenteric occlusion in 10 patients (19%). A total of 56 target mesenteric vessels were stented, including 52 superior mesenteric arteries and 4 celiac axis lesions, with a mean treatment length of 42 ± 26 mm. Retrograde mesenteric access was used in all patients, but 16 patients also required a simultaneous antegrade brachial approach. The retrograde puncture was closed primarily in 34 patients and with patch angioplasty in 17 patients; 1 patient had manual compression. Bowel resection was needed in 29 patients (66%) with AMI because of perforation or gangrene. Technical success was achieved in all (98%) except one patient for whom ROMS failed, who was treated by bypass. Early mortality was 45% (20/44) for AMI and 10% (1/10) for subacute-on-chronic mesenteric ischemia (P = .04). Early morbidity was 73% for AMI and 50% for subacute-on-chronic mesenteric ischemia (P = .27). Patient survival for the entire cohort was 43% ± 9% at 2 years. Primary patency and secondary patency at 2 years were 76% ± 8% and 90% ± 8%, respectively. Freedom from symptom recurrence and freedom from reinterventions were 72% ± 8% and 74% ± 8% at the same interval., Conclusions: ROMS offers an alternative to bypass or percutaneous stenting in patients with AMI who require abdominal exploration and in those who have flush mesenteric occlusions and have failed to respond to or are considered unsuitable for stenting by a percutaneous approach. Despite high technical success, mortality remains elevated in patients with AMI. Patency rates and freedom from symptom recurrence and reinterventions are comparable to the results achieved with stenting using percutaneous technique., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to determine the natural progression of popliteal artery aneurysms (PAAs) and clinical variables associated with their accelerated growth., Methods: Retrospective chart review of 224 patients with encounters between January 2008 and May 2016 and with at least one PAA was conducted. From this group, 65 asymptomatic patients had either unilateral (n = 43) or bilateral (n = 22) PAAs that were observed for at least 1 year of medical management before intervention. We divided these aneurysms into two groups based on whether their overall growth rate was above or below the eventual mean. Aneurysm diameter was taken from duplex ultrasound and computed tomography angiography., Results: There were 87 aneurysms evaluated among 65 patients. Mean age at diagnosis was 70.9 years (standard deviation [SD], 9.39 years), and 64 patients were male (98%); 50 (77%) were white and 7 (11%) were African American. The average body mass index was 27.69 (SD, 4.90). At or before initial diagnosis, 61 (94%) patients had a concomitant lower extremity or abdominal aortic aneurysm; 51 (78%) patients were current or former smokers; and 16 (25%) had atrial fibrillation. The average growth rate of all aneurysms was 1.22 mm/y (SD, 1.93 mm). The mean surveillance time from initial diagnosis to last follow-up or intervention was 3.12 years (SD, 1.66 years). Of 87 aneurysms, 25 (29%) were repaired; 18 (21%) were repaired because of size criteria, 2 (2%) because of symptom criteria (claudication or acute limb ischemia), and 5 (6%) because of both criteria. During our study window, 62 aneurysms (71%) remained asymptomatic or did not undergo an intervention. The mean initial diameter at diagnosis was 16.9 mm (SD, 5.32 mm). Within the study, 50 (57%) aneurysms presented with or developed mural thrombus. Univariate analysis identified larger initial diameter (19.2 vs 14.7 mm; P = .020), atrial fibrillation (35% vs 16%; P = .042), and mural thrombus (38% vs 20%; P < .001) as predictors of diameter expansion greater than the mean. Multivariable analysis of the significant univariate factors determined that only initial diameter (odds ratio, 5.53; P = .007) and the presence or development of mural thrombus (odds ratio, 4.00; P = .008) maintained significance., Conclusions: Patients presenting with a PAA at 20 mm or >20 mm in diameter, presence of luminal thrombus, or atrial fibrillation may need to be observed at more frequent scanning intervals than those without these risk factors. Further studies are required to validate these predictive growth factors., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Vascular complications remain a significant technical challenge for transfemoral TAVR (transcatheter aortic valve replacement). The goal of this study is to develop a preoperative tool for prediction of major vascular complications of TAVR., Methods: A retrospective review was performed of all patients who underwent transfemoral TAVR at a tertiary medical center from 2011 to 2015. Iliofemoral arterial measurements were obtained with computed tomography angiography three-dimensional reconstruction images and an Iliac Morphology Score (IMS) was created from these measurements. Vascular complications were defined by Valve Academic Research Consortium (VARC-2) criteria. Statistical analyses were performed utilizing chi-squared test, Student's t-test, and binomial regression., Results: We analyzed the data of 198 transfemoral TAVR patients. VARC-2 vascular complications were seen in 25 patients (13%). Major and minor vascular complication rates in the entire cohort were 4% (n = 7) and 9% (n = 18), respectively. Thirty-one patients (15.6%) required vascular surgery consultation. A total of 24 patients (12%) required surgical or percutaneous vascular interventions. Univariate analysis identified gender, iliac diameter, iliac calcification, and access type (open versus percutaneous) as predictors of major complications. The IMS was composed of ipsilateral minimum iliac diameter and iliac calcifications based on area under the receiver operator curve (AUROC) analysis (P < 0.05, AUROC = 0.82). Arterial size and calcification were classified with a value of 0-3 based on severity. Multivariate analysis identified gender and IMS as independent predictors of major complications. The mean IMS for the cohort was 3.4 (range 0-6). Patients were divided into high (IMS ≥ 5, n = 55) and low risk (IMS<5, n = 143) groups based on the inflection point for specificity (73%) and sensitivity (83%). The high-risk group had smaller iliac diameters, areas, luminal volumes, and a higher rate of major vascular complications (9% vs. 1%, P = 0.001). The 30-day mortality rate in the high score group was 9% and 1.4% in low score group (P = 0.02, AUROC = 0.72)., Conclusions: An IMS composed of ipsilateral minimum iliac diameter plus iliac calcification is an excellent predictor of major vascular complications and mortality. Alternative access in patients with high IMS may reduce major vascular complications and 30-day mortality., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Traditionally, the surgical management of acute type B aortic dissections was reserved for patients with signs of malperfusion, rapid expansion, retrograde dissection or rupture. The adjunct of endovascular techniques has brought a paradigm shift, leaning towards preventing long term dissection complications. Multiple risk factors have been proposed to identify patients at risk for long term aortic complications. The patients, who are offered a prophylactic endovascular therapy for uncomplicated aortic dissection, should be selected carefully, and offered intervention by an experienced team in a high-volume center. (This is a review article based on the invited lecture of the 57th Annual Meeting of Japanese College of Angiology.).

Objective: To report the initial and midterm results of the Bolton Relay Thoracic Stent Graft for the endovascular treatment of thoracic aortic lesions [thoracic endovascular aortic repair (TEVAR)]., Methods: The Bolton Relay Thoracic Aortic Endovascular Pivotal Trial was a prospective, nonrandomized, multicenter, U.S. Investigational Device Exemption study conducted at 27 U.S. investigational sites. One hundred twenty TEVAR subjects were treated with the Relay device between January 2007 and May 2010, with 13 patients enrolled during the continued access phase through September 2012. TEVAR outcomes were compared with a prospectively and retrospectively enrolled surgical cohort consisting of 60 patients enrolled under similar inclusion/exclusion criteria. Follow-up examinations were prescribed at 1 month, 6 months, and yearly thereafter for 5 years. Major adverse events (MAEs) included stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, wound healing complications, and aneurysm-related mortality., Results: Stent grafts were successfully delivered and deployed in 129 of 133 patients (97.0%). At 30 days, a lower rate of mortality was observed in the TEVAR arm (5.3% vs 10.0%; P = .230), and TEVAR was associated with a significantly lower rate of MAEs (20.3% vs 48.3%; P < .001), primarily driven by a lower frequency of respiratory failure in the cohort (5.5% vs 21.6%; P = .007) and procedural bleeding. Freedom from aneurysm-related mortality through 5 years was similar at 91.3% for the TEVAR cohort and 89.4% for the surgical cohort (P = .406); with 5-year freedom from all-cause mortality at 57.1% and 50.2% (P = .289), respectively. Freedom from MAEs through 5 years was significantly higher in the TEVAR cohort (65.7% vs 44.7%; P = .001). Six TEVAR patients (4.5%) experienced core laboratory-reported type I or III endoleaks, and secondary procedures were performed in 10 patients (7.5%), with seven procedures to correct endoleak and one surgical conversion. Endograft migration occurred in three patients (2.3%) and wireform fractures were assessed in two patients (1.5%). Aneurysm sac size decreased or remained stable in 113 patients (85.0%) over 5-year follow-up. There were no instances of rupture or endograft occlusion. A 38-subject subset treated with the newer Relay Plus Delivery System had a significantly reduced MAE rate (15.8% vs 35.8%; P = .035), and fewer perioperative strokes (2.6% vs 12.6%; P = .108)., Conclusions: Data from the Relay TEVAR clinical trial demonstrate safety and effectiveness of the Relay device compared with surgical controls, indicating continued device durability with a low rate of device-related complications through 5 years., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: We introduce a novel preoperative anatomic severity grading system for acute type B aortic dissections and validate the system in a cohort of patients who underwent thoracic endovascular aortic repair., Methods: We identified a cohort of patients who received thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection from 2008 to 2014. We developed an anatomic severity grading score (ASG) to measure attributes of aortic anatomy that we hypothesized may affect difficulty or durability of repair. Measurements were made using computed tomography angiography images and based on hypothesized severity, giving a potential score range of 0-38., Results: We analyzed the computed tomography angiography images on a cohort of 30 patients with acute type B aortic dissection who underwent TEVAR. We created an area under the receiver operating characteristic curve (AUROC) using anatomic severity grading to predict aortic-related reinterventions. The AUROC was 0.72 (95% CI 0.39 to 1.1). Guided by the AUROC, we divided patients into two groups: a low-score group with anatomic severity grading scores <23 (n = 22), and a high-score group with scores ≥23 (n = 8). With this cutoff, anatomic severity grading exhibited 80% sensitivity and 84% specificity in predicting aortic-related reinterventions, with reinterventions in 50% of high-score patients and 4.5% of low-score patients (P = 0.011). The high score group also had significantly greater blood loss (200 vs 100 mL, P = 0.038), fluoroscopy time (36.0 vs 16.6 min; P = 0.022), and a trend for increased procedure time (164 vs 95 min; P = 0.083) than the low-risk group. Kaplan-Meier analysis revealed that the high-score group had a significantly decreased freedom from aortic-related reinterventions than the low-score group (38% vs 100% at 12-month followup; log rank P = 0.001)., Conclusions: A preoperative anatomic severity grading score for acute type B aortic dissections consists of analysis of the proximal landing zone, curvature and tortuosity of the aorta, dissection anatomy, aortic branch vessel anatomy, and supraceliac aorta anatomy. Anatomic severity grading scores ≤23 are an excellent predictor of aortic-related reinterventions.

Background: The best management strategy for the left subclavian artery (LSA) in pathologic processes of the aorta requiring zone 2 thoracic endovascular aortic repair (TEVAR) remains controversial. We compared LSA coverage with or without revascularization as well as the different means of LSA revascularization., Methods: A retrospective chart review was conducted of patients with any aortic diseases who underwent zone 2 TEVAR deployment from 2007 to 2014. Primary end points included 30-day stroke and 30-day spinal cord injury (SCI). Secondary end points were 30-day procedure-related reintervention, freedom from aorta-related reintervention, aorta-related mortality, and all-cause mortality., Results: We identified 96 patients with zone 2 TEVAR who met our inclusion criteria. The mean age of the patients was 62 years, with 61.5% male. Diseases included acute aortic dissections (n = 25), chronic aortic dissection with aneurysmal degeneration (n = 22), primary aortic aneurysms (n = 21), penetrating aortic ulcers/intramural hematomas (n = 17), and traumatic aortic injuries (n = 11). Strategies for the LSA included coverage with revascularization (n = 54) or without revascularization (n = 42). Methods of LSA revascularization included laser fenestration with stenting (n = 33) and surgical revascularization: transposition (n = 10) or bypass (n = 11). Of the 54 patients with LSA revascularization, 44 (81.5%) underwent LSA intervention at the time of TEVAR and 10 (18.5%) at a mean time of 33 days before TEVAR (range, 4-63 days). For the entire cohort, the overall incidence of 30-day stroke was 7.3%; of 30-day SCI, 2.1%; and of procedure-related reintervention, 5.2%. At a mean follow-up of 24 months (range, 1-79 months), aorta-related reintervention was 15.6%, aorta-related mortality was 12.5%, and all-cause mortality was 29.2%. The 30-day stroke rate was highest for LSA coverage without revascularization (6/42 [14.3%]) compared with any form of LSA revascularization (1/54 [1.9%]; P = .020), with no difference between LSA interventions done synchronously with TEVAR (1/44 [2.3%]) vs metachronously with TEVAR (0/10 [0%]; P = .63). There was no significant difference in 30-day SCI in LSA coverage without revascularization (2/42 [4.8%]) vs with revascularization (0/54 [0%]; P = .11). There was no difference in aorta-related reintervention, aorta-related mortality, or all-cause mortality in coverage without revascularization (5/42 [11.9%], 6/42 [14.3%], and 14/42 [33.3%]) vs with revascularization (10/54 [18.5%; P = .376], 6/54 [11.1%; P = .641], and 14/54 [25.9%; P = .43], respectively). After univariate and multivariable analysis, we identified LSA coverage without revascularization as associated with a higher rate of 30-day stroke (hazard ratio, 17.2; 95% confidence interval, 1.3-220.4; P = .029)., Conclusions: Our study suggests that coverage of the LSA without revascularization increases the risk of stroke and possibly SCI., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Duplex ultrasound (DUS) criteria are well defined for evaluating high-grade stenosis (≥70%) of the native superior mesenteric artery (SMA) and celiac artery (CA). It has been shown that native vessel criteria overestimate the degree of in-stent restenosis (ISR) and that velocity criteria for SMA and CA ISR are not well established. The objective of this study was to define DUS velocity criteria for high-grade ISR of the SMA and CA., Methods: A retrospective review of all patients who underwent SMA or CA stenting from a single institution was performed from 2004 to 2013. Patients were excluded if they did not have a DUS examination <4 months before angiography to assess stent patency or adequate angiographic visualization of the ISR., Results: There were 103 paired DUS scans and angiograms analyzed: 66 SMA studies and 37 CA studies. The average peak systolic velocity (PSV) for SMAs was 367 cm/s with <70% ISR and 536 cm/s with ≥70% ISR. The average PSV for CAs was 302 cm/s with <70% ISR and 434 cm/s with ≥70% ISR. For an ISR ≥70% in the SMA, a PSV ≥445 cm/s produced the highest sensitivity (83%) and specificity (83%), with a positive predictive value of 81% and a negative predictive value of 86%. For an ISR ≥70% in the CA, a PSV ≥289 cm/s produced the highest sensitivity (100%) and specificity (57%), with a positive predictive value of 79% and negative predictive value of 100%., Conclusions: Increasing PSV correlates with an increasing degree of ISR for both the SMA and CA. Stented vessels have increased PSV, and therefore native PSV criteria are unreliable for the determination of ISR. The PSV criteria for ≥70% stenosis are higher for ISR than for native visceral vessel stenosis. The proposed new velocity criteria define ≥70% ISR as ≥445 cm/s in stented SMAs and ≥289 cm/s in stented CAs., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The aim of this study was to assess the applicability and outcomes of EndoAnchor use in the endovascular repair of thoracic and thoracoabdominal aortic aneurysms., Methods: A retrospective review was performed of all thoracic endovascular aortic repairs (TEVARs) performed with the use of EndoAnchors between December 2012 and January 2016. Primary study endpoints included freedom from migration, freedom from aortic- related intervention, and freedom from post-operative type I or type III endoleak., Results: During this study period, a total of 54 patients underwent TEVAR for thoracic or thoracoabdominal aneurysm with the use of EndoAnchors at our institution. Twenty-seven cases were performed as the index operation. Twenty-seven cases were considered redo operations. EndoAnchors were deployed for therapeutic and prophylactic indications. Mean follow-up was 9.6±8.8 months. EndoAnchors were used for therapeutic indications in 31.5% of patients and for prophylactic indications in 68.5%. The technical success of EndoAnchor deployment was 99.8%. The overall initial technical success of the operation was 98.1%. There were no instances of graft migration. The overall endoleak rate was 5.4% with prophylactic EndoAnchor use and 11.8% with therapeutic use. Aortic-related reintervention was required in 13.5% of patients who received prophylactic EndoAnchor placement and 23.5% of patients who received therapeutic EndoAnchor placement. Only one reintervention was performed for EndoAnchor failure. A p value of <0.05 was considered significant., Conclusions: EndoAnchors can be safely utilized in TEVAR with high rates of technical success. These results demonstrate the potential to enhance thoracic endograft efficacy and durability with the use of therapeutic and prophylactic EndoAnchors. Long-term data is needed to further define the use of this technology in the thoracic aorta.

Background: An anatomic severity grading (ASG) score for primary descending thoracic aortic aneurysms (DTAs) was developed. The objective of this study was to determine if an ASG score cutoff value for DTAs is predictive of procedural complexity, aortic-related reinterventions, and mortality in patients who undergo thoracic endovascular aortic repair (TEVAR)., Methods: A retrospective review from 2008 to 2013 of patient records was conducted of all consecutive patients who underwent TEVAR for a primary DTA. A comprehensive scoring system of preoperative DTA morphology on the basis of computed tomography angiography images was established to identify and classify anatomic features that might influence outcome after TEVAR. ASG score calculations were achieved using preoperative computed tomography angiography images. Primary outcomes included primary technical success, aortic-related reinterventions, aneurysm-related mortality, and all-cause mortality. Secondary outcomes included procedural complexity (unplanned adjunctive procedures, number of endografts implanted, contrast volume, and procedure time), endoleak formation, endoleak requiring reintervention, stroke and paraplegia, and conversion to open repair., Results: Of 469 patients with a diagnosis of a thoracic aortic aneurysm, 62 patients (13%) underwent TEVAR and had adequate preoperative imaging (mean age, 71 years). Applying the ASG score, we identified 39 patients (63%) with a score ≥24 (high-score group) and 23 patients (37%) with a score <24 (low-score group). Mean follow-up was 15.3 months (range, 4 days to 3.7 years; standard deviation, 1 year) for both groups. Freedom from all-cause mortality was significantly different in the high-score (87% at 1 year, 79% at 2 years, and 57% at 3 years) vs the low-score group (100% at 1, 2, and 3-years; log-rank test, P < .021). There was no significant difference between mortality in the high-score (97% at 1 year, 87% at 2 years, and 69% at 3 years) compared with the low-score group (100% at 1, 2, and 3 years; log-rank test, P = .162). Freedom from aortic-related reinterventions was significantly lower in the high-score (82% at 1 year, 68% at 2 years, and 35% at 3 years) compared with the low-score group (100% at 1, 2, and 3 years; log-rank test, P = .002). Operative difficulty in the form of intraoperative adjunct procedures, number of endografts implanted, and procedural time had significant differences between groups (18% vs 0%, P = .038; 79% vs 39%, P = .004; 120 vs 79 minutes, P = .005, respectively). No significant difference in 30-day combined stroke and paraplegia (16%) was present between groups, and no patient had a conversion to open repair during the follow-up period., Conclusions: Preoperative ASG score for primary DTAs predicted procedure complexity and aortic-related reinterventions after TEVAR., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of our study was to examine the predictive value of the anatomic severity grading (ASG) score for abdominal aortic aneurysms (AAAs) on implant-related complications, systemic complications, and mortality at 30-day and midterm, defined as 2 years, follow-up assessments., Methods: Patients who underwent endovascular aneurysm repair for infrarenal AAAs between 2009 and 2012 were retrospectively reviewed, and ASG scores were calculated from three-dimensonal computed tomography reconstructions. Two independent patient groups were created: those with a low ASG score (score <14) and those with a high ASG score (score ≥14)., Results: We identified 190 patients (77% male), with a mean age of 73 years, and 84% Caucasian, with 104 patients in the low-score group and 86 in the high-score group. Within 30 days of the index endovascular aneurysm repair, 10 implant-related complications occurred in six patients (3%) and 25 systemic complications in 18 (9%). The incidence of 30-day implant-related complications was not significantly different between the low-score group (2 [2%]) and the high-score group (4 [5%]; P = .41). The incidence of patients with 30-day systemic complications was significantly different between the low-score group (5 [5%]) and the high score group (13 [15%]; P = .023). A composite end point of combined implant-related and systemic complications at 30 days showed there was a statistically significant difference between the low-score (7 [7%]) and high-score group (17 [20%]; P = .007). At a midterm follow up of 26 months (range, 1-64 months), implant-related complications occurred in 21 patients (11%), and systemic complications occurred in 29 (15%). The incidence of implant-related complications was significantly different between the low-score group (7 [7%]) and the high-score group (14 [16%]; P = .037). The incidence of midterm systemic complications was significantly different between the low-score group (11 [11%]) and the high-score group (18 [21%]; P = .048). A composite end point of combined implant-related and systemic complications at midterm follow-up resulted in a statistically significant difference between the low-score group (16 [15%]) and the high-score group (26 [30%]; P = .014). Kaplan-Meier analysis revealed that the low-score group had fewer overall complications (combined implant-related and systemic) at 1 year (14% vs 34%) and 2 years (15% vs 45%) compared with the high-score group (P < .001). The low-scoring group also had significantly higher survival at 1 year (96% vs 86%) and 2 years (88% vs 84%) compared with the high-score group (P = .047)., Conclusions: The AAA ASG score can be used to predict patients at risk for midterm implant-related complications, 30-day and midterm systemic complications, and all-cause mortality., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Our objective was to characterize the predictive impact of computed tomography (CT) scan volumetric analysis on the natural history of acute uncomplicated type B aortic dissections (ADs)., Methods: We conducted a retrospective review of patients with acute type B ADs from 2009 to 2014. On an iNtuition workstation (TeraRecon, Foster City, Calif), volume measurements were obtained using the true lumen volume (TLV), false lumen volume (FLV), and total aortic volume from the left subclavian artery to the celiac artery. Growth rate was calculated as the change in maximal diameter between first and last available CT scans during the time interval. The primary outcome of the study was delayed aortic intervention. P < .05 was considered statistically significant., Results: During a 5-year period, 164 patients had CT scan evidence of acute type B ADs; 11 patients were excluded for lack of subsequent follow-up imaging; 36 patients who underwent urgent repair (<14 days from presentation) were also excluded. We evaluated a total of 117 patients: 85 patients who did not require intervention and 32 who underwent delayed (>14 days) thoracic endovascular aneurysm repair (29) or open repair (3). Mean age was 66 ± 12 years. Mean TLV/FLV ratio on initial CT scan was significantly higher in patients who did not eventually require an operation (1.55 vs 0.82; P = .02). The mean growth rate was higher in those eventually requiring operation (2.47 vs 0.42 mm/mo; P = .003). Patients were divided into three subgroups on the basis of their initial imaging TLV/FLV ratios (<0.8, 0.8-1.6, and >1.6). There was a significant difference in the growth rates between these three groups (4.6 vs 2.4 vs 0.8 mm/mo; P < .025). Area under the receiver operating characteristic curve analysis revealed that a TLV/FLV ratio <0.8 was highly predictive for requiring an intervention (area = 0.8; sensitivity, 69%; specificity, 84%: positive predictive value, 71%; negative predictive value, 81%), with an odds ratio of 12.2 (confidence interval, 5-26; P < .001). Conversely, a TLV/FLV ratio of >1.6 was highly predictive for freedom from delayed operation (sensitivity, 91%; specificity, 42%; positive predictive value, 61%; negative predictive value, 86%). After Kaplan-Meier analysis, 1-year and 2-year survival free of aortic interventions was 60% and 42% with a TLV/FLV ratio <0.8 and 92% and 82% with a ratio >1.6 (P = .001)., Conclusions: Initial CT scan volumetric analysis in patients presenting with uncomplicated acute type B ADs is a useful tool to predict growth and need for future intervention., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To report a successful method of managing an embolized Edwards SAPIEN XT aortic valve prosthesis using a thoracic endovascular aortic repair rescue., Case Report: An 84-year-old man underwent transcatheter aortic valve replacement using a 26-mm Edwards SAPIEN XT valve, which immediately embolized into the ascending aorta. Because of the severe tapering of the patient's transverse aortic arch, the embolized valve was unable to be maneuvered further down the aorta. Therefore, a Cook 36×80-mm Zenith Dissection Endovascular System (ZDES) bare metal stent was used on a compassionate basis to append the embolized valve between the patient's coronary artery ostia and the innominate artery takeoff within the ascending aorta, with no neurological or cardiovascular complications at 12-month follow-up., Conclusion: A Cook ZDES bare metal stent may be successfully used to append an embolized Edwards SAPIEN XT valve within the ascending aorta., (© The Author(s) 2015.)

Objective: The aim of our study was to perform a large multivariate analysis to identify demographic, anatomic, or procedural factors that affect iliac artery stent primary patency (PP)., Methods: Patients receiving iliac stents from 2007 to 2013 were retrospectively reviewed. Univariate analysis assessed cohort characteristics and their effect on PP. Variables considered significant (P < .05) were brought forward in the multivariate analysis., Results: A total of 213 patients underwent primary iliac artery stenting, and 307 limbs were analyzed. The average age was 66 years (range, 38-93 years), 54% were male, and 55% were Caucasian. Indications for procedure were claudication in 68%, rest pain in 20%, and tissue loss in 12%. All TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classifications were included: 51% TASC II A, 25% TASC II B, 13% TASC II C, and 11% TASC II D. The treated anatomic locations were 27% isolated external iliac artery (EIA), 56% isolated common iliac artery, and 17% combined common iliac artery and EIA. Multivariate analysis found three factors were correlated with decreased PP: non-Caucasian race (hazard ratio [HR], 1.84; 95% confidence interval [CI], 1.08-3.13; P = .025), younger age (HR, 1.04; 95% CI, 1.01-1.08; P = .006), and presence of EIA occlusion (HR, 2.02; 95% CI, 1.05-3.89; P = .036). Overall, Kaplan-Meier analysis at 1 and 3 years revealed a PP of 86% and 53%, assisted PP of 98% and 89%, and secondary patency of 99% of 98%. Kaplan-Meier analysis showed PP at 1 year for was 91% Caucasian patients vs 77% for non-Caucasian (P = .001). PP was 75% in patients aged <60 years, 86% in patients aged 60-70 years, and 96% in patients aged >70 years, with a significant difference between all groups (P < .001). PP was significantly different for those with and without EIA occlusion (P = .002), with 1-year PP of 71% and 88%, respectively., Conclusions: In our experience with a large number of iliac interventions, younger age, non-Caucasian race, and EIA occlusion were strong predictors for loss of PP., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Our institutional quality-improvement (QI) initiative instituted a well-defined office follow-up schedule after arteriovenous fistula (AVF) creation, including an office visit within 30 days, fistulogram within 40 days, if indicated, and a second office visit within 55 days. In addition, a patient liaison contacted patients and dialysis units to improve follow-up. The purpose of this study was to determine the effect of the QI initiative on patient compliance and overall time to AVF permission to cannulate., Methods: We performed a retrospective review of patients undergoing first-time radiocephalic, brachiocephalic, and basilic vein transposition creation before the QI initiative (pre-QI group: January to April 2012) and during the QI period (QI group: January to April 2013). Categoric data were compared using χ(2) analysis, and nominal data were compared using the Student t-test., Results: We reviewed 198 first-time AVF creations in patients (57% male) with a mean age of 61 years. Demographics and comorbidities between the pre-QI and QI groups were similar. Compliance with the first 30-day postoperative appointment increased significantly after the QI initiative, from 48% in the pre-QI group to 65% in the QI group (P = .015). Yet, the QI initiative did not maintain an effect on the subsequent follow-up checkpoints. No statistical difference was identified for compliance with fistulogram within 40 days of access creation (pre-QI, 12% vs QI, 25%; P = .093) or for compliance with the 55-day postoperative appointment (pre-QI, 33% vs QI, 23%; P = .457). Both checkpoints demonstrated a very high noncompliance rate. Accordingly, the mean time to permission to cannulate was 88 days for both the pre-QI and QI groups, with a failure to mature rate of 22% for the pre-QI group and 21% for the QI group (P = .816)., Conclusions: The QI initiative significantly increased the number of patients complying with the first 30-day follow-up appointment after AVF access creation. However, patient compliance with a timely fistulogram and the second follow-up appointment was poor and not influenced by the QI initiative, limiting the functional effect of the QI initiative on the time to AVF permission to cannulate., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: We seek to determine whether vascular closure devices (VCDs) are safe and effective for brachial artery access., Methods: A retrospective review of brachial artery access using either manual compression (MC) or a VCD for hemostasis from November 2005 to February 2011 was performed., Results: Brachial artery access was performed on 154 limbs: MC on 134 limbs and VCD on 20 limbs. The incidence of thrombotic (VCD n = 0 [0%] vs MC n = 7 [5.2%], P = .37), hemorrhagic complications (VCD n = 1 [5%] vs MC n = 7 [5.2%], P = .72), or major adverse events (VCD n = 1 [5%] vs MC n = 16 [12%], P = .32) was not significantly different between the techniques. After univariate and multivariate analysis, female sex (P = .07, relative risk [RR] = 5.7), sheath size > 6F (P = .008, RR = 14.6), and diagnostic versus interventional procedure (P = .04, RR = 0.4) all impacted the occurrence of thrombosis., Conclusions: Use of VCD in the brachial artery following an endovascular procedure showed equivalence to MC., (© The Author(s) 2014.)