Endosutured Aneurysm Repair of Abdominal Aortic Aneurysms with Short Necks Achieves Acceptable Midterm Outcomes-Results from the Peru Registry.

BACKGROUND: The study aims to describe midterm outcomes following treatment of infrarenal abdominal aortic aneurysms (AAAs) with short necks by endosutured aneurysm repair using the Heli-FX EndoAnchor system. METHODS: This is a retrospective study of prospectively collected data from 9 vascular surgery departments between June 2010 and December 2019, including treated AAAs with neck lengths ≤10 mm. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. There were 2 Groups further assessed according to neck length, A (≥4 and <7 mm) and B (≥7 and ≤10 mm). The main outcomes analyzed were technical success, freedom from type Ia endoleaks (TIaELs), sac size increase, all-cause and aneurysm-related mortality. RESULTS: Seventy-six patients were included in the study, 17 fell into Group A and 59 into Group B. Median follow-up for the cohort was 40.5 (interquartile range 12-61) months. A median of 6 (interquartile range 3) EndoAnchors were deployed in each subject. Technical success was 86.8% for the total group, 82.4% and 88.1% (P = 0.534) for Groups A and B respectively. Six out of 10 (60%) of TIaELs at the completion angiographies showed spontaneous resolution. Cumulative freedom from TIaEL at 3 and 5 years for the total group was 89% and 84% respectively; this was 93% and 74% for Group A and 88% at both intervals in Group B (P = 0.545). In total, there were 7 (9.2%) patients presenting with TIaELs over the entire study period. Two (11.8%) in Group A and 5 (8.5%) in Group B (P = 0.679). There were more patients with sac regression in Group B (Group A = 6-35.3% vs. Group B = 34-57.6%, P = 0.230) with no statistical significance. All-cause mortality was 19 (25%) patients, with no difference (4-23.5% vs. 15-25.4%, P = 0.874) between groups; whereas aneurysm-related mortality occurred in 1 patient from Group A and 3 from Group B. CONCLUSIONS: This study demonstrates reasonable outcomes for patients with short-necked AAAs treated by endosutured aneurysm repair in terms of TIaELs up to 5-year follow-up. EndoAnchor use should be judiciously evaluated in short necks and may be a reasonable option when anatomical constraints are encountered, mainly for those with 7-10 mm neck lengths. Shorter neck length aspects, as indicated by the results from Group A, may be an alternative when no other options are available or feasible.

Applications of artificial intelligence for patients with peripheral artery disease.

OBJECTIVE: Applications of artificial intelligence (AI) have been reported in several cardiovascular diseases but its interest in patients with peripheral artery disease (PAD) has been so far less reported. The aim of this review was to summarize current knowledge on applications of AI in patients with PAD, to discuss current limits, and highlight perspectives in the field. METHODS: We performed a narrative review based on studies reporting applications of AI in patients with PAD. The MEDLINE database was independently searched by two authors using a combination of keywords to identify studies published between January 1995 and December 2021. Three main fields of AI were investigated including natural language processing (NLP), computer vision and machine learning (ML). RESULTS: NLP and ML brought new tools to improve the screening, the diagnosis and classification of the severity of PAD. ML was also used to develop predictive models to better assess the prognosis of patients and develop real-time prediction models to support clinical decision-making. Studies related to computer vision mainly aimed at creating automatic detection and characterization of arterial lesions based on Doppler ultrasound examination or computed tomography angiography. Such tools could help to improve screening programs, enhance diagnosis, facilitate presurgical planning, and improve clinical workflow. CONCLUSIONS: AI offers various applications to support and likely improve the management of patients with PAD. Further research efforts are needed to validate such applications and investigate their accuracy and safety in large multinational cohorts before their implementation in daily clinical practice.

Nationwide Study in France To Predict One Year Major Bleeding and Validate the OAC3-PAD Score in Patients Undergoing Revascularisation for Lower Extremity Arterial Disease.

OBJECTIVE: Antithrombotic strategies are currently recommended for the treatment of lower extremity artery disease (LEAD) but specific scores to assess the risk of bleeding in these patients are scarce. To fill the gap, the OAC3-PAD bleeding score was recently developed and validated in German cohorts. The aim of this study was to determine whether this score performs appropriately in another real world nationwide cohort. METHODS: This 10 year retrospective, multicentre study based on French national electronic health data included patients who underwent revascularisation for LEAD between January 2013 and June 2022. The OAC3-PAD score was calculated and from this, the population was classified into four groups: low, low to moderate, moderate to high and high risk. A binary logistic regression model was applied, with major bleeding occurring at one year (defined using the International Classification of Diseases ICD-10) as the dependent variable. The performance of the OAC3-PAD bleeding score was investigated using a receiver operating characteristic curve. RESULTS: Among 161 205 patients hospitalised for LEAD treatment in French institutions, the one year incidence of major bleeding was 13 672 patients (8.5%). The distribution of the population according to the OAC3-PAD bleeding score was: 88 835 patients (55.1%), 34 369 (21.3%), 27 914 (17.3%), and 10 087 (6.3%) in the low, low to moderate, moderate to high, and high risk groups, respectively; with an incidence of one year major bleeding of 5.0%, 9.8%, 13.2%, and 21.3%. The OAC3-PAD model achieved an AUC of 0.650 to predict one year major bleeding following LEAD repair (95% CI 0.645 - 0.655), with a sensitivity of 0.67 and a specificity of 0.57. CONCLUSION: This nationwide analysis confirmed the accuracy of the OAC3-PAD model to predict one year major bleeding and served as external validation. Although further studies are required, it adds evidence and perspectives to further generalise its use to guide the management of patients with LEAD.

Percutaneous mechanical thrombectomy for limb graft occlusion after endovascular aneurysm repair: Results of a case series.

OBJECTIVE: Limb graft occlusion (LGO) is a recognised complication after endovascular aneurysm repair (EVAR). We present outcomes of a case series of LGO treated by percutaneous mechanical thrombectomy (PMT). METHODS: Six male patients (mean age 70.5 ± 7.5 years) presented with LGO after EVAR (n = 4), fenestrated EVAR with an iliac branch device (n = 1), branched EVAR (n = 1). Median time to occlusion was 28.5(IQR 90) weeks; all occlusions were unilateral. The presenting symptom was intermittent claudication (n = 4), chronic limb-threatening ischaemia (n = 1) or acute limb ischaemia (n = 1). PMT was undertaken using the 10F Rotarex Rotational Excisional Atherectomy System (Becton, Dickinson and Company, Franklin Lakes, USA) with optional stenting/reline of the affected limb. RESULTS: LGO was cleared in all 6 cases by PMT with limb stenting (n = 4)/limb reline (n = 2)/outflow stenting (n = 2). Post-operatively, novel oral anticoagulant therapy supplemented prior antiplatelet therapy in all cases. Length of stay was 2 (IQR 19) days. All cleared limbs remain patent at median 15 (IQR 185) weeks follow-up. CONCLUSION: This case series indicates that percutaneous mechanical thrombectomy is associated with high technical success rates and subsequent acceptable ensuing short-to-midterm patency. This approach is a valid alternative to surgical interventions in such cases, and represents our primary approach when LGO is encountered after EVAR.

Mid-term outcomes of the use of endoanchors during thoracic endovascular aortic repair in multicentre analysis.

OBJECTIVE: To describe mid-term outcomes of the use of EndoAnchors as an adjunct for arch and thoracic endovascular aortic repair (TEVAR). METHODS: A retrospective multicentre series from nine centres using the Heli-FX EndoAnchor System (Medtronic Inc, Minneapolis, USA) at TEVAR over May 2014-May 2019 is presented. The study is registered at ClinicalTrials.gov with number NCT04100499. The primary outcome was freedom from Type I endoleak at EndoAnchors deployments; secondary outcomes included evaluation of aortic wall penetration (AWP) at first computed tomography scan, EndoAnchor-related issues and mortality. RESULTS: 54 high-risk patients (35 males/19 females, age 73 ± 11 years) with arch, thoracic and thoracoabdominal aneurysmal disease (3 chronic post-dissection and one patch pseudoaneurysm), with a mean neck length 19.7 ± 6.6 mm that were treated with multiple hybrid and endovascular techniques were included. A total of 329 EndoAnchors were used with a mean of 6.1 ± 2.5 per patient. Overall adequate AWP was 86%, whereas arch (Ishimaru's zones 0-2) deployments achieved 80.6% when compared to 87.3% in descending thoracic aorta (dTA); although there was no statistical significance. Freedom from type I endoleaks was 88% at 2 year follow-up, due to 4 type IA endoleaks, two of them successfully treated, one with conservative treatment due to complexity of repair and remaining patient died 1 year later due to endograft infection. There were reported five EndoAnchor-related issues; four losses and one renal stent-graft was crushed due to catheter deflection solved with balloon reinflation. None of the losses had clinical significance. Overall mortality is described for 7 (9.5%) patients, one of them aneurysm-related. CONCLUSIONS: The adjunctive use of EndoAnchors in TEVAR and complex TEVAR procedures achieved acceptable outcomes at midterm in a high-risk series with hostile seal zones. Still, they should be still judiciously used as there is lack of data to suggest a more liberal use; therefore, the landing zone should not be compromised in favour of their use.

The Effect of EndoAnchors on Aneurysm Sac Regression for Patients Treated With Infrarenal Endovascular Repair With Hostile Neck Anatomies: A Propensity Scored Analysis.

PURPOSE: To analyze sac evolution patterns in matched patients with hostile neck anatomy (HNA) treated with standard endovascular aneurysm repair (sEVAR) and endosutured aneurysm repair (ESAR). METHODS: Observational retrospective study using prospectively collected data between June 2010 and December 2019. ESAR group data were extracted from the primary arm of the PERU registry with an assigned identifier (NCT04100499) at 8 centers and those from the sEVAR came from 4 centers. Suitability for inclusion required: no proximal endograft adjuncts (besides EndoAnchor use), ≤15 mm neck length and minimum of 12-months follow-up imaging. Bubble-shaped neck (noncylindrical short neck with discontinuous seal) aspect was analyzed. Both groups were analyzed using propensity score matching (PSM) for aortic neck length, width, angulation, and device fixation type. Main outcome assessed was sac evolution patterns (sac expansion and regression were defined as >5mm increase or decrease, of the maximum sac diameter respectively; all AAAs within this ±5 mm range in diameter change were considered stable) and secondary outcomes were type-Ia endoleaks; other endoleaks and mortality. A power analysis calculation >80% was confirmed for sac regression evaluation. RESULTS: After exclusions, PSM resulted in 96 ESAR and 96 sEVAR patients. Mean imaging follow-up (months) was 44.4±21.3 versus 43.0±19.6 (p=0.643), respectively. The overall number of patients achieving sac regression was higher in the ESAR group (n=57, 59.4% vs n=31, 32.3%; p<0.001) and the cumulative sac regression achieved at 5 years was 65% versus 38% (p=0.003) in favor of the ESAR group. There were no statistically significant differences in type-Ia endoleak and/or other endoleaks. Univariate analysis for sac regression patients in the sEVAR and ESAR group individually showed the bubble-shape neck as a predictor of sac regression failure. There were no statistical differences in overall and aneurysm-related mortality. CONCLUSION: Endosutured aneurysm repair provided improved rates of sac regression for patients with AAA and HNA when compared with sEVAR at midterm and up to 5 years, despite similar rates of type-Ia endoleaks, and the need to consider some important limitations. The presence of bubble-shaped neck was a predictor of sac regression failure for both groups equally. CLINICAL IMPACT: The use of EndoAnchors aids and improves EVAR treatment in hostile neck anatomies by an increased rate of sac regression when compared to EVAR treatment alone in up to 5 year analysis. Moreover, a trend to reduced number of type Ia endoleaks is also achieved, although not significant in the present study. This data, adds to current and growing evidence on the usefulness of EndoAnchors for AAA endovascular treatment.

Editor's Choice - Covered vs. Bare Metal Stents in the Reconstruction of the Aortic Bifurcation: Early and Midterm Outcomes from the COBRA European Multicentre Registry.

OBJECTIVE: To report outcomes following endovascular revascularisation for severe aorto-iliac occlusive disease (AIOD) using covered (CS) or bare metal (BMS) stent(s). METHODS: This was a retrospective cohort study including patients who underwent treatment with CS or BMS for AIOD between November 2012 and March 2020 in 12 European centres. Outcome measures included death, freedom from target lesion revascularisation (TLR), major amputation, and major adverse cardiac and cerebrovascular events (MACCE). RESULTS: Overall, 252 patients (53% males; mean age 65 ± 10 years) were included (102 with a bare metal and 150 with a covered aortic stent); 122 (48%) presented with chronic limb threatening ischaemia (CLTI). Severe arterial calcification was noted in > 65% of patients, 70% presented with Trans-Atlantic Societies Consensus (TASC) D lesions, 32% and 46% had aortic or iliac chronic total occlusion (CTO), respectively. Median follow up was 17 months (range 6 - 40; none lost to follow up). Median inpatient stay was two days (range two to four). During the first 30 days, two patients died (both with covered aortic stents, because of cardiovascular events), none required TLR, two (1%) patients had a major amputation (all presented with CLTI), and three (1%) had a MACCE. At 17 months, mortality (BMS 14% vs. CS 7%, hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.42 - 2.26, p = .94, log rank test) and TLR (11% vs. 10%, HR 1.98, 95% CI 0.89 - 4.43, p = .095) did not differ statistically significantly between the two groups; only three patients had a major limb amputation during late follow up (all with a covered stent). In a multivariable model, the use of an aortic CS did not influence TLR. In a conditional Cox regression, however, the concomitant use of aortic and iliac CSs was associated with improved freedom from TLR. CONCLUSION: Endovascular reconstruction with aortic CSs or BMSs for severe AIOD showed comparable midterm performance. The use of both aortic and iliac CSs seems to be associated with reduced TLR.

Automatic Measurement of Maximal Diameter of Abdominal Aortic Aneurysm on Computed Tomography Angiography Using Artificial Intelligence.

INTRODUCTION: The treatment of abdominal aortic aneurysm relies on surgical repair and the indication mainly depends on its size evaluated by the maximal diameter (Dmax). The aim of this study was to evaluate a new automatic method based on artificial intelligence to measure the Dmax on computed tomography angiography. METHODS: A fully automatic segmentation of the vascular system was performed using a hybrid method combining expert system with supervised deep learning. The aorta centreline was extracted from the segmented aorta and the aortic diameters were automatically calculated. Results were compared to manual segmentation performed by two human operators. RESULTS: The median absolute error between the two human operators was 1.2 mm (IQR 0.5-1.9). The automatic method using the deep learning algorithm demonstrated correlation with the human segmentation, with a median absolute error of 0.8 (0.5-4.2) mm and a coefficient correlation of 0.91 (P < 0.001). CONCLUSIONS: Although validation in larger cohorts is required, this method brings perspectives to develop new tools to standardize and automate the measurement of abdominal aortic aneurysm Dmax in order to help clinicians in the decision-making process.

Automatic Measurement of Vascular Calcifications in Patients with Aorto-Iliac Occlusive Disease to Predict the Risk of Re-intervention After Endovascular Repair.

BACKGROUND: There is currently a lack of consensus and tools to easily measure vascular calcification using computed tomography angiography (CTA). The aim of this study was to develop a fully automatic software to measure calcifications and to evaluate the interest as predictive factor in patients with aorto-iliac occlusive disease. METHODS: This study retrospectively included 171 patients who had endovascular repair of an aorto-iliac occlusive lesion at the University Hospital of Nice between January 2011 and December 2019. Calcifications volumes were measured from CTA using an automatic method consisting in three sequential steps: image pre-processing, lumen segmentation using expert system, and deep learning algorithms and segmentation of calcifications. Calcification volumes were measured in the infrarenal abdominal aorta and the iliac arterial segments, corresponding to the common and the external iliac arteries. RESULTS: Among 171 patients included with a mean age of 65 years, the revascularization was performed on the native external and internal iliac arteries in, respectively: 83 patients (48.5%), 107 (62.3%), and 7 (4.1%). The mean volumes of calcifications were 2,759 mm3 in the infrarenal abdominal aorta, 1,821 mm3 and 1,795 mm3 in the right and left iliac arteries, respectively. For a mean follow-up of 39 months, target lesion re-intervention was performed in 55 patients (32.2%). These patients had higher volume of calcifications in the right and left iliac arteries, compared with patients who did not have a re-intervention (2,274 mm3 vs. 1,606 mm3, P = 0.0319 and 2,278 vs. 1,567 mm3, P = 0.0213). CONCLUSIONS: The development of a fully automatic software would be useful to facilitate the measurement of vascular calcifications and possibly better inform the prognosis of patients.

Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry.

OBJECTIVES: We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR). METHODS: The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine (https://ClinicalTrials.gov). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. Follow-up imaging was scheduled according to each center's protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up. RESULTS: Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12-48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation. CONCLUSIONS: This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.

Treatment of Aortoiliac Occlusive Disease With the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique: Results of a UK Multicenter Study.

OBJECTIVE: This UK multicenter study aims to report early- and medium-term results following covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of aortoiliac occlusive disease (AIOD) in patients with chronic limb threatening ischemia (CLTI) or intermittent claudication (IC). MATERIALS AND METHODS: Retrospective case analysis was performed of patients who underwent CERAB between November 1, 2012 and March 31, 2020 in 6 centers across the United Kingdom. Anatomical data, including degree of plaque calcification, were assessed using preoperative imaging. Outcome measures included mortality, perioperative complications, target lesion reintervention (TLR), and major limb amputation. Primary, assisted primary, and secondary patencies were calculated at set intervals. RESULTS: A total of 116 patients underwent CERAB over the study period for the following reasons [48% presenting with CLTI (Rutherford 4-6) and 52% with IC (Rutherford 1-3)]; 82% presented had Trans-Atlantic Inter-Society Consensus (TASC) D AIOD disease. Median age was 65 years (range 42-90 years); 76% of the cohort were male. Severely calcified aortic and iliac lesions were noted in 90% and 80% of patients, respectively. Over a median follow-up of 18 months (range 1-91 months), 2 (1.7%) patients were lost to follow up. In total 5, (4.3%) patients died and 2 (1.7%) had a major amputation. Endovascular TLR was required in 14 (12.1%) patients at last follow up. Surgical TLR was performed in 4 (3.4%) patients at last follow-up. Seven (6%) patients developed an aortic/iliac stent occlusion at last follow-up. The Kaplan-Meier (KM) freedom from TLR at 1 year was 94% and KM 1-year primary patency, assisted primary patency, and secondary patency were 88%, 94%, and 98% respectively. Subanalysis found the following features were associated with need for TLR; TASC D disease (OR = 2.45, 95% CI 1.44 to 3.71), severe aortic calcification (OR = 2.01, 95% CI 1.03 to 2.20), and presence of tissue loss at baseline (OR = 1.43, 95% CI 1.01 to 4.63). CONCLUSION: Perioperative (<30 days) and medium-term morbidity, mortality, and patency rates in this pragmatic cohort of patients with severe AIOD lesions show that CERAB is a valid revascularization option. A direct comparison with surgical treatments for AIOD in a randomized controlled trial is justified.

Feasibility of the Application of Holographic Augmented Reality in Endovascular Surgery Using Microsoft HoloLens Head-Mounted Display.

OBJECTIVES: Advances in virtual, augmented (AR) and mixed reality have led to the development of wearable technologies including head mounted displays (HMD). The aim of this study was to investigate the feasibility to use HMD during endovascular surgery. METHODS: We propose an adaptation of AR-HMD using Microsoft HoloLens. Software was developed to enable visualization of the vascular system during endovascular procedures. A video was performed to present an overview of the device and show its use in real conditions. RESULTS: The device allowed a successful visualization of perioperative angiography during peripheral angioplasty, carotid angioplasty and aortic aneurysm endovascular repair. The device was operated on voice command, preserving the environment sterility. CONCLUSION: This video illustrated the feasibility of the application of holographic AR during endovascular intervention and brings perspectives to use artificial-intelligence derived tools for image-guided surgery.

Applications of Head-Mounted Displays and Smart Glasses in Vascular Surgery.

OBJECTIVES: Advances in virtual, augmented and mixed reality have led to the development of wearable technologies including head mounted displays (HMD) and smart glasses. While there is a growing interest on their potential applications in health, only a few studies have addressed so far their use in vascular surgery. The aim of this review was to summarize the fundamental notions associated with these technologies and to discuss potential applications and current limits for their use in vascular surgery. METHODS: A comprehensive literature review was performed to introduce the fundamental concepts and provide an overview of applications of HMD and smart glasses in surgery. RESULTS: HMD and smart glasses demonstrated a potential interest for the education of surgeons including anatomical teaching, surgical training, teaching and telementoring. Applications for pre-surgical planning have been developed in general and cardiac surgery and could be transposed for a use in vascular surgery. The use of wearable technologies in the operating room has also been investigated in both general and cardiovascular surgery and demonstrated its potential interest for image-guided surgery and data collection. CONCLUSION: Studies performed so far represent a proof of concept of the interest of HMD and smart glasses in vascular surgery for education of surgeons and for surgical practice. Although these technologies exhibited encouraging results for applications in vascular surgery, technical improvements and further clinical research in large series are required before hoping using them in daily clinical practice.

Endograft platform does not influence aortic neck dilatation after infrarenal endovascular aneurysm repair with primary endostapling.

OBJECTIVES: Aortic endografts used for endovascular aneurysm repair (EVAR) are based on varying skeletal platforms such as stainless steel or nitinol stents, using radial force applied to seal at the aneurysm neck, and varying proximal fixation methods, applying either suprarenal or infrarenal fixation. This study assesses whether varying skeleton/fixation platforms affect neck-related outcomes after primary endostapling with Heli-FX EndoAnchors at EVAR. METHODS: Retrospective analysis of a prospective database of infrarenal EVAR undertaken at a single centre. Chimney-EVAR, secondary cases were excluded. Primary outcomes analysed included neck diameter evolution from pre-EVAR to latest imaging follow-up, including a comparison of stent platforms to see if there was any outcome difference between those using stainless steel or nitinol, as also freedom from type I endoleakage and migration. Secondary outcomes assessed included average number of EndoAnchors, and sac size patterns before and after EVAR. RESULTS: A total of 101 patients underwent endostapled infrarenal EVAR between September 2013 and March 2020. After exclusion of ineligible patients, 84 patients (76 male, 8 female, age 73.7 ± 7.8 years) were available for analysis. 57/27 endografts used suprarenal/infrarenal fixation, whilst 16/68 devices were based on stainless steel/nitinol platforms, respectively. Mean oversizing was higher for stainless steel/suprarenal fixation endografts (p = 0.02). A total of 582 EndoAnchors were deployed, averaging 7 ± 2 per patient. Median neck diameter was 25 mm (IQR 22-31) with 22 necks having non-parallel morphology (conical, tapered or bubble). Median follow-up period was 28.5 (IQR 12-43) months. Neck evolution studies suggested aortic neck dilatation of 5 ± 4 mm (p <0.001, paired T-test), independent of platforms employed (p = NS, ANOVA). There was no endograft migration; one immediate post-EVAR endoleak settled by eight weeks. There was a mean 5.7 ± 8.2 mm sac size reduction (p < 0.001, paired T-test). CONCLUSION: Aortic neck dilatation occurs after EVAR with primary endostapling, but the process may be independent of stainless steel/nitinol platforms, possibly due to the attenuating effect of EndoAnchors. Adjunct aneurysm neck fixation by primary endostapling prevents migration regardless of whether suprarenal/infrarenal fixation is the primary fixative method. Device platform choice therefore may be left to the operator discretion if primary endostapling is applied at EVAR. Freedom from complications such as migration and endoleakage in the intermediate term suggests a higher level of 'tolerance' to aortic neck dilatation with primary endostapling. We would therefore suggest routine usage of EndoAnchors at EVAR when not otherwise contraindicated.

Evaluation of EndoAnchor Aortic Wall Penetration After Thoracic Endovascular Aortic Repair.

Purpose: To analyze aortic wall penetration of Heli-FX EndoAnchors after use in seal zones in the aortic arch or descending thoracic aorta during thoracic endovascular aortic repair (TEVAR). Materials and Methods: From May 2014 to May 2019, 25 patients (mean age 70.5±10 years; 16 women) were treated with TEVAR and adjunctive use of the Heli-FX device in 3 academic vascular surgery departments. Computed tomography scans were retrospectively reviewed to determine the location [arch or descending thoracic aorta (DTA)] of the EndoAnchors and the adequacy of aortic wall penetration, defined as adequate (≥2 mm), partial (<2 mm), or inadequate wall penetration (including loss). Endoleaks, reinterventions, and mortality were assessed. Results: A total of 161 EndoAnchors were deployed (median 7 per patient, range 4-9). Twenty-two EndoAnchors were place in the arch (zones 0-2) and 139 in the DTA (zones 3-5). A larger proportion of arch deployments (27%) had suboptimal penetration compared with the DTA (6.5%; p<0.005), resulting in a 91% adequate wall penetration rate for the series overall. Three EndoAnchors were lost (and only 1 retrieved) in 3 different patients, with no additional morbidity; thus, an overall deployment success rate of 88% was achieved. At a mean follow-up of 16.6±14 months, 4 patients required 5 (successful) reinterventions, including one for a type Ia endoleak treated with chimney TEVAR. One patient died 10 months after treatment due to endograft infection, without an opportunity for surgical correction. Conclusion: EndoAnchors have a higher risk of maldeployment in the arch, though this may be attributable to the small learning curve experience in this location. The best aortic wall penetration for this series was in the DTA, where EndoAnchors proved useful for distal endograft fixation during TEVAR.