Use of EndoAnchors during index endovascular aortic aneurysm repair in patients with hostile proximal aortic neck anatomy.

PURPOSE: Standard endovascular aortic aneurysm repair (EVAR) is sometimes the only treatment option for patients with hostile aortic neck anatomy, but it carries an increased risk of both early and late procedure-related complications. The aim of this study was to report on single-center experience with the Heli-FX EndoAnchors (Medtronic, Santa Rosa, CA) as an adjunctive procedure to endovascular aneurysm repair (EVAR) for prevention and perioperative treatment of proximal neck complications in patients with hostile neck anatomy.  MATERIALS AND METHODS: A single-centre, retrospective study evaluating 24 consecutive patients treated with EndoAnchors during the index EVAR procedure between November 2018 and August 2021. EndoAnchor implantation was indicated for cases with hostile proximal aortic neck anatomy characterised by the presence of at least one of the following parameters: length of 28 mm, angle of >60°, circumferential thrombus/calcification involving ≥50%, and reverse taper. RESULTS:  Median follow-up period was 22.5 months (IQR 2-31.5 months) with no aneurysm-related death, rupture, or conversion to open surgical repair during the follow-up. The procedural success rate was 100%, with no type Ia endoleak at the completion angiography. A mean of 7 EndoAnchors was used per patient (range 4-12). There were no EndoAnchor fractures and dislocations or stent graft fabric damage due to anchor implants. Twenty-three patients (95.8%) remained free of type Ia endoleak and migration on follow-up imaging. Aneurysm sac regression was observed in 13 patients (54.1%), while in 8 patients (33.3%) the sac remained stable. Sac enlargement was present in 1 patient (4.2%) due to late type Ia endoleak. Two patients were lost to the follow-up immediately after the procedure. Between two groups of patients (sac regression versus failure to regress), the larger initial diameter of the proximal neck was the only significant independent factor associated with a lower possibility of sac regression (p= 0,021). CONCLUSIONS:  The use of EndoAnchors during the index EVAR procedure in cases with challenging aortic neck anatomy with or without perioperative type Ia endoleak was associated with good midterm results and led to sac regression in most of the patients (Tab. 4, Fig. 3, Ref. 31).

Evaluating postoperative outcomes in patients with hostile neck anatomy undergoing transcarotid artery revascularization versus transfemoral carotid artery stenting.

BACKGROUND: Carotid endarterectomy is relatively contraindicated in patients with a hostile neck anatomy who were historically revascularized with transfemoral carotid artery stenting (TFCAS). As transcarotid artery revascularization (TCAR) has progressively replaced TFCAS, evidence pertaining to hostile neck anatomy and TCAR is necessary to establish its safety and feasibility in this subgroup of patients. Therefore, we analyzed the impact of a hostile neck anatomy on outcomes in patients undergoing TCAR and further compared them with those undergoing TFCAS to establish recommendations for standard of care. METHODS: All patients undergoing TCAR and TFCAS from November 2016 to June 2021 in the Vascular Quality Initiative database were included. Patients were characterized into two groups based on the neck anatomy. Hostile neck anatomy was defined as a history of neck radiation or prior neck surgery including prior carotid endarterectomy or radical neck dissection. Primary outcomes included technical failure, access site complications (hematoma, stenosis, infection, pseudoaneurysm and arteriovenous fistula), and stroke or death. Secondary outcomes included stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and a composite end point of stroke or TIA. Patients with nonatherosclerotic or multiple lesions were excluded from the analysis. Primary analysis was performed with all patients undergoing TCAR and outcomes between patients with hostile and nonhostile neck anatomy were compared. Further analysis included a comparison of patients with a hostile neck anatomy undergoing TCAR and TFCAS. Univariable and multivariable logistic regression was used to assess impact of hostile neck anatomy on postoperative outcomes. Results were adjusted for relevant potential confounders including age, gender, race, degree of stenosis, symptomatic status, comorbidities, preoperative medications, anesthesia type, and protamine use. RESULTS: Among the 19,859 patients who underwent TCAR during the study period, 3636 (18.3%) had a hostile neck anatomy. On univariate analysis, both groups had comparable outcomes except for higher rates of stroke or death in patients with hostile neck anatomy. After adjusting for potential confounders, there were no differences in technical failure (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 0.59-2.21; P = .699), stroke (aOR, 0.86; 95% CI, 0.58-1.28; P = .464), death (aOR, 0.82; 95% CI, 0.39-1.71; P = .598), and MI (aOR, 1.18; 95% CI, 0.71-1.97; P = .518). However, patients with hostile neck were at a 30% increased risk of access site complications (aOR, 1.30; 95% CI, 1.0-1.6; P = .023). Further adjusted analysis comparing the outcomes in TFCAS and TCAR among patients with hostile neck anatomy showed an almost four-fold increase in risk of death (aOR, 3.77; 95% CI, 1.49-9.53; P = .005) and technical failure (aOR, 3.69; 95% CI, 1.82-7.47; P < .001) among patients undergoing treatment with TFCAS. CONCLUSIONS: Patients with a hostile neck anatomy undergoing TCAR experienced an increased risk of access site complications; however, the risk for technical failure and postoperative stroke/death, stroke, TIA, MI, or death was similar among both groups. TFCAS was associated with significant increase in the risk of death and technical failure compared with TCAR in this group of patients. These results confirm that TCAR should be the preferred minimally invasive revascularization procedure for patients with hostile neck anatomy.

The Impact of Proximal Neck Anatomy on the 5-Year Outcomes Following Endovascular Aortic Aneurysm Repair With the Ovation Stent Graft.

PURPOSE: Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). We investigated the impact of proximal neck anatomy on the outcomes following EVAR with the Ovation abdominal stent graft (Endologix, Irving, Calif). METHODS: We used prospectively collected data from the Effectiveness of Custom Seal with Ovation: Review of the Evidence database, compromised of pooled data from 6 clinical trials and the European Post-Market Registry of patients undergoing elective infrarenal EVAR (2009-2017). We investigated the impact of short neck length (<10 mm), wide neck diameter (≥28 mm), reverse taper shape (>10%), and neck angulation (>45°) on the outcomes. The primary outcome was type IA endoleak. Secondary outcomes included any type I/III endoleak, sac expansion, aneurysm-related reinterventions, and all-cause and aneurysm-related mortality, and a combined endpoint of type IA endoleak, graft migration, AAA-related reintervention, conversion, and aneurysm rupture. We used Kaplan-Meier analysis and Cox proportional hazards models to estimate the 30 day and 5 year rates and assess univariate and risk-adjusted differences. RESULTS: Of the 1020 patients, 60 patients had a short neck, 113 had a wide neck diameter, 279 were reverse taper shaped, and 99 had neck angulation >45°. Wide proximal neck was associated with higher 5 year type IA endoleak estimates compared with favorable neck anatomy (7.1% vs 4.3%; p=0.02). No association with 5 year type IA endoleak was found for short neck length (1.7% vs 4.3%; p=0.52), reverse taper shape (3.2% vs 4.3%; p=0.99), or neck angulation (6.1% vs 4.3%; p=0.13). A wide neck diameter compared with favorable anatomy was also associated with higher 5 year estimates of graft migration (3.8% vs 0.4%; p=0.03) and the combined neck-related adverse outcome endpoint (16% vs 9.5%; p=0.002). The estimates of aneurysm sac expansion, rupture, and overall and aneurysm-related mortality were similar between the hostile proximal neck anatomy cohorts and favorable anatomy. CONCLUSION: Wide proximal neck is associated with higher 5 year type IA endoleak rates for patients treated with the Ovation stent graft. However, short neck length, reverse taper shape, and neck angulation are not associated with higher 5 year type IA endoleak rates. CLINICAL IMPACT: Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair of abdominal aortic aneurysms. The Ovation stent graft platform uses a different proximal sealing method using a polymer inflatable ring, aiming to improve sealing between the graft and aortic wall. This study demonstrated that short, angulated, and reverse taper-shaped neck anatomy did not result in increased type IA endoleak estimates in patients treated with the Ovation stent graft platform. Potentially, the different sealing mechanisms played a role in mitigating the historically worse outcomes in patients with short, angulated, and reverse taper-shaped neck anatomy.

Early Results of Elective Endovascular Repair of Infrarenal Abdominal Aortic Aneurysms With the MinosTM Stent-Graft System.

PURPOSE: A variety of last-generation endografts are currently available for standard endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs). The purpose of this study is to report the preliminary clinical outcomes of the Minos trimodular stent-graft system, which was recently introduced to the European market. MATERIALS AND METHODS: Between February 2020 and 2022, we treated 41 consecutive AAA patients (mean age 72.2±8.5, 37 males) with elective standard EVAR using the Minos. The mean maximum diameter of AAAs was 54.7±6.6 mm, the mean proximal neck's (PN) diameter was 24.8±2.7 mm, while the relevant length and angulation were 16.0 mm and 21.7°, respectively. Overall, 22 (53.6%) patients presented with shorter and angulated PN, according to the stent-graft's instructions of use, and in 6 (14.6%) patients the PN angulation >60° was combined with concomitant iliac angulation >60°. Eleven (26.8%) EVARs were performed with concomitant enormous iliac artery narrowing and tortuosity. Finally, in 19 (46.3%) AAAs, the distal iliac landing zone was aneurysmatic and they were treated with the bell-bottom technique in 17 patients and with limb extension to the external iliac artery in two cases. We evaluated technical and clinical success of the index procedures, which was based on the combination of five factors: freedom from EVAR-related mortality, from graft-related endoleak of any type, from migration at any part of graft as well the absence of notable increase AAA's sac maximum diameter and the patency of bifurcated stent-graft and of access vessels. RESULTS: Primary technical and clinical success of index procedures was 100%. During a median 12-month radiological follow-up the clinical success remained 100%. No type I or III endoleak, stent-graft migration, EVAR-related death, AAA rupture, or graft-related adverse events or reinterventions were documented. Four (9.8%) type II endoleaks were detected with stable AAA sac diameter. The overall incidence of sac regression was 34.1% (n=14). CONCLUSION: The preliminary results of our series showed that Minos provided excellent feasibility and safety features even through angulated and tortuous iliac vessels and in short and angulated PNs. The overall clinical success at 1 year suggests that performance of Minos follows very high standards. Further validation of these promising results with long-term data is acquired to complete the evaluation of this recently introduced stent-graft system. CLINICAL IMPACT: The current study explored the clinical performance of a new in market ultra-low profile bifurcated abdominal aortic stent-graft, the MINOS. The early and 12-month results of study suggest that implantation of this stent-graft in standard EVAR, even in hostile proximal aortic neck and iliac vessels conditions, follows very high clinical standards and encourage the further clinical use of MINOS.

Subclavian to carotid artery bypass for a case of ocular ischemic syndrome.

BACKGROUND: Ocular Ischemic Syndrome (OIS) is a rare, vision threatening condition associated with severe carotid artery disease. There are few cases of OIS reported in the literature. METHODS: We present the case of a 54-year-old male with history of multiple previous carotid interventions including a right carotid stent, who presented with right-sided OIS. RESULTS: CTA and angiogram showed a severe calcific plaque causing restenosis of the right carotid stent, with a patent right internal carotid artery (ICA) in the very distal neck. The right common carotid artery (CCA) was patent but diseased with ulcerated plaque extending proximally to below the level of the clavicle. The left CCA was chronically occluded from its origin all the way to the bifurcation. Given our patient's surgical history, the imperative to revascularize the ipsilateral carotid, and a diffusely diseased ipsilateral CCA, he was successfully treated with an ipsilateral subclavian to internal carotid bypass. CONCLUSION: There is paucity of data regarding the best approach for carotid revascularization in OIS. This case report discusses our unique perioperative decision making as well as relevant literature.

Transcarotid artery revascularization is safe in necks with anatomy hostile for carotid endarterectomy.

OBJECTIVE: The outcomes associated with transcarotid revascularization (TCAR) have proved to be noninferior to the historical results established for carotid endarterectomy (CEA). Therefore, TCAR has been increasingly offered to patients with neck anatomy hostile for traditional CEA. The present investigation was completed to evaluate whether a difference exists for patients undergoing TCAR in de novo anatomy with unviolated surgical planes compared with those undergoing TCAR in necks with hostile anatomy. METHODS: The demographic data and outcomes were captured at two high-volume TCAR institutions from December 2015 to December 2021 via a query of two parallel, prospectively maintained, carotid intervention databases at these two health institutions. A hostile neck anatomy was defined as a history of previous ipsilateral neck radiation, oncologic dissection, or CEA. Univariate analysis was performed to compare the two cohorts at an α of 0.05. RESULTS: During the inclusion period, the data from 750 TCARs were captured, including 108 procedures in hostile neck anatomy and 642 in de novo necks. No significant differences were found in the baseline comorbidity burden using the Charlson comorbidity index or the indication for revascularization. Intraoperatively, no significant increase in case complexity was observed with respect to those with a hostile neck, except for the operative time, which was 10% longer (69.5 vs 63.4 minutes; P = .01). The flow reversal and fluoroscopic times, blood loss, radiation exposure, and contrast use were identical. Postoperatively, no differences were observed between the hostile and de novo necks with respect to stroke (0.9% vs 2.5%; P = .49), myocardial infarction (0.9% vs 0.2%; P = .27), and death (0% vs 1.5%; P = .37). Additionally, hematoma formation and the need for reintervention did not seem to vary between the two groups. Similarly, no differences in the two cohorts were noted during follow-up. CONCLUSIONS: According to the findings from our large, dual-institutional series, the performance of TCAR in surgical fields traditionally hostile for CEA was not associated with increased intraoperative complexity or postoperative morbidity.

Effect of abdominal aortic aneurysm sac shrinkage after endovascular repair on long-term outcomes between favorable and hostile neck anatomy.

OBJECTIVE: The aim of the present study was to analyze the influence of abdominal aortic aneurysm sac shrinkage on the long-term outcomes after endovascular aneurysm repair (EVAR) between patients with favorable and hostile neck anatomy. METHODS: In the present study, we retrospectively analyzed data from 268 patients with fusiform aneurysm and sac behavior who had been evaluated for ≥1 year after EVAR. Hostile neck anatomy was defined as a proximal aneurysmal neck length of <10 mm or proximal neck angle of ≥60°. The primary end point was sac shrinkage, and the secondary end points included reintervention and a composite of rupture, type Ia endoleak, and late open conversion. RESULTS: No differences were found in sac shrinkage between the patients with favorable and hostile neck anatomy (P = .47). Multivariate analysis revealed that an occluded inferior mesenteric artery (P = .04), the presence of posterior thrombus (P < .01), and no antiplatelet therapy (P = .01) were positive factors for sac shrinkage. The reintervention-free survival rate was better for patients with sac shrinkage compared with those without sac shrinkage regardless of the proximal neck anatomy (P < .01). The event-free survival rate of the composite end point at 5 and 10 years was 97.5% and 83.5% for patients with favorable neck anatomy and 86.8% and 81.0% for those with hostile neck anatomy, respectively (P = .02). In the subgroup with sac shrinkage, the event-free survival rates at 5 and 10 years were 98.7% and 98.7% for those with favorable neck anatomy and 92.7% and 82.4% for those with hostile neck anatomy, respectively (P = .02). In contrast, the event-free survival for patients without sac shrinkage did not differ between those with favorable and hostile neck anatomy (P = .08). Multivariate analysis showed that a hostile neck anatomy (hazard ratio, 3.32; 95% confidence interval, 1.26-8.80; P = .02) and no sac shrinkage (hazard ratio, 3.88; 95% confidence interval, 1.25-12.0; P = .02) were significant risk factors for the composite end point of rupture, type Ia endoleak, and late open conversion. CONCLUSIONS: Proximal neck anatomy did not affect sac shrinkage after EVAR. Sac shrinkage has been a good surrogate marker of better long-term outcomes after EVAR for patients with favorable neck anatomy. In contrast, critical events such as rupture and type Ia endoleak can occur even after sac shrinkage has been achieved in patients with hostile neck anatomy.

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.

Novel conformable stent-graft repair of abdominal aortic aneurysms with hostile neck anatomy: A single-centre experience.

OBJECTIVES: Abdominal aortic aneurysms (AAAs) demonstrating hostile neck anatomy (HNA) are associated with increased perioperative risk and mortality. A number of these patients are not suitable for standard endovascular aneurysm repair (EVAR) and are high risk for open surgery. We present our experience with the first implantations in Scotland of a novel conformable aortic stent-graft designed to overcome some of the challenges of HNAs. METHODS: From May 2018 to March 2022, 24 consecutive patients with non-ruptured AAAs demonstrating HNAs (neck length < 15 mm, or angulation > 60°) were treated with GORE Excluder Conformable AAA endoprosthesis (CLEVAR) (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) at a Scottish vascular centre. We assessed clinical outcomes and technical success of CLEVAR during deployment, primary admission and the post-operative period at 3- and 12-month clinical follow-up alongside CT angiography. RESULTS: Twenty-four patients (20 males, mean age 75.6) were included. Primary technical success of proximal seal zones and CLEVAR deployment (no type 1/3 endoleaks, no conversion to open repair, AAA excluded and patient leaving theatre alive) was achieved in 100% of patients. All patients were alive and clinically stable at 3- and 12-month follow-up. There were five patients requiring re-intervention; at the 3-month follow-up, one patient (4.2%) developed a type 1b endoleak requiring graft limb extension, one patient developed a right common femoral artery dissection requiring open repair and one patient required a limb extension of the right iliac limb due to risk of developing a type 1b endoleak. At the 12-month follow-up, two patients required embolization of type 2 endoleaks and no patients demonstrated type 1 or type 3 endoleaks.Conclusions: In-hospital and post-operative 3- and 12-month clinical and angiographic outcomes demonstrate safety and efficacy with CLEVARs in treating unruptured AAAs with HNA. Further research involving larger heterogenous sample sizes is warranted to determine long-term clinical outcomes.

Comparative clinical study of short-term outcomes between table fenestrated and chimney endovascular aneurysm repair for hostile neck aneurysms.

OBJECTIVES: Hostile neck abdominal aortic aneurysm (AAA) is challenging for standard endovascular aneurysm repair (EVAR). We sought to compare fenestrated endovascular aneurysm repair (fEVAR) and chimney endovascular aneurysm repair (chEVAR) for hostile neck AAA. METHODS: Patients were identified retrospectively. Hostile neck anatomy was defined as a proximal neck length of <15 mm or angulation >60°. The choice of fEVAR or chEVAR was based on neck anatomy and physician preference. Type I endoleak (T1EL) was the primary outcome. Other outcomes included type III endoleak (T3EL), visceral stent occlusion, renal insufficiency, reintervention, and mortality. RESULTS: A total of 84 patients were included from April 2012 to December 2021. fEVAR and chEVAR patients were 48 and 36 cases, respectively. Both groups showed similar rate of T1EL, T3EL, visceral stent occlusion, renal insufficiency, reintervention, and mortality. However, chEVAR patients had a more tortuous neck (61.1% vs. 16.7%, p < 0.001), while fEVAR patients had a greater neck size (29.5 ± 6.3 mm vs. 24.5 ± 4.8 mm, p < 0.001) and more reconstructing target arteries (2.2 ± 1.1 vs 1.3 ± 0.6, p < 0.001). CONCLUSIONS: fEVAR and chEVAR show similar safe and effective outcomes in well-selected hostile neck. fEVAR might be able to reconstruct multiple visceral arteries, and chEVAR seems justified in patients with poor anatomical suitability for fEVAR.

Preoperative Planning for EndoAnchor Use During Thoracic Endovascular Aortic Repair in the Distal Aortic Arch.

PURPOSE: To describe steps related to intraoperative C-arm orientations that can be taken during preoperative planning of thoracic stent-graft repair to facilitate the deployment of EndoAnchors in the distal aortic arch. TECHNIQUE: Previous experience from transcatheter aortic valve implantation (TAVI) may be helpful in addressing issues with C-arm orientation. In TAVI, preoperative computed tomography (CT) images are routinely obtained to generate a patient-specific curve that represents a virtually complete rotation of the C-arm perpendicular to the annulus. The curve clearly demonstrates that each adjustment in cranial or caudal view needs parallax correction in the left or right anterior oblique direction to remain perpendicular, and vice versa. This experience can be translated to the preoperative planning of EndoAnchor use in the aortic arch. By placing markers along the circumference of the proximal landing zone of the preoperative CT scan, the required C-arm orientations can be determined for each marker. CONCLUSION: Determining the optimal C-arm orientation during preoperative planning will facilitate successful EndoAnchor deployment and may contribute to improved durability of endovascular repair in hostile necks in the aortic arch.

Midterm Single-Center Results of Endovascular Aneurysm Repair With Additional EndoAnchors.

PURPOSE: To review midterm clinical outcomes of EndoAnchor placement during or after endovascular aneurysm repair (EVAR) or chimney EVAR (ch-EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted of 51 consecutive patients [median age 75 years; 38 men] who underwent EVAR/ch-EVAR with EndoAnchor placement between June 2010 and December 2016 to prevent seal failures (31, 61%) or to treat type Ia endoleak and/or migration (20, 39%). Median aortic neck diameter was 27.7 mm and median neck length was 9.0 mm. Thirty-three (65%) had a conical neck; 48 (94%) had at least 1 hostile neck characteristic. Thirty-two (63%) patients had severe comorbidities (ASA score ⩾III). Eight patients had a single ch-EVAR procedure. Baseline patient characteristics, anatomic variables, procedure details, early and late complications, reinterventions, and aneurysm-related and all-cause mortality rates were recorded. Follow-up imaging was performed with computed tomography angiography (CTA) or duplex ultrasonography. RESULTS: Median procedure time was 100 minutes; a median of 6 EndoAnchors were implanted. There were 10 (10%) residual type Ia endoleaks at the end of the procedure; 9 had resolved by the first postoperative CTA. One residual and 2 new type Ia endoleaks were identified at the first postoperative imaging. Median follow-up for the entire cohort was 24.0 months, during which 3 new type Ia endoleaks were identified. Five of the 6 type Ia endoleaks were treated, 1 resolved spontaneously. There was 1 endograft limb occlusion without clinical consequences, 1 chimney graft occlusion without possibilities for a reintervention, 1 rupture after type IV endoleak (a Nellix device was successfully deployed within the main device), and 1 complete graft explantation for infection. There was no new-onset hemodialysis. Kaplan-Meier estimates of freedom from type Ia endoleak, proximal neck-related reinterventions, and aneurysm-related mortality at 2 years were 87.3%, 92.2%, and 94.0%, respectively. CONCLUSION: EndoAnchors are helpful in the endovascular treatment of unfavorable proximal aortic necks, with fair midterm results.

Active proximal sealing in the endovascular repair of abdominal aortic aneurysms: early results with a new stent-graft.

PURPOSE: To investigate the performance of a new device that uses the STRATA polytetrafluoroethylene graft material and a mechanism that provides active proximal sealing in order to prevent type Ia endoleak during endovascular aneurysm repair (EVAR). METHODS: Between April 2013 and July 2014, 21 consecutive patients (all men; median age 71 years, range 60-84 years) with abdominal aortic aneurysm (median diameter 5.9 cm, range 4.9-7.8 cm) and suitable anatomy were offered elective EVAR using the AFX endograft. These patients had an irregular, conical, tapered, or bulging proximal neck, for which this specific device was considered appropriate. Aneurysm exclusion and incidence of type Ia endoleak were the primary outcomes; secondary outcomes included mortality, morbidity, migration, and other graft-related complications. RESULTS: Primary technical success was 90%; 2 intraoperative type Ia endoleaks due to low endograft deployment were treated with additional proximal cuffs. During a median follow-up of 10 months (range 2-15 months), no type I endoleak was observed. One type II endoleak was encountered, with no associated sac enlargement. There was no stent-graft migration or any other device-related complication. One patient had a nonfatal myocardial infarction and another developed renal failure requiring transient dialysis. No deaths occurred. CONCLUSION: In this early experience, this newly available device appears to be safe and efficient in providing seal along irregularly shaped necks over the short term.

Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy.

PURPOSE: To explore the use of EndoAnchors as an adjunct to endovascular abdominal aortic aneurysm repair for prevention of proximal neck complications in patients with challenging neck anatomy. METHODS: Over a 28-month period, 208 patients (159 men; mean age 72±8 years) were enrolled in the ANCHOR prospective, multicenter registry (ClinicalTrials.gov; identifier NCT01534819) for prophylaxis against proximal neck complications. Patients were eligible when, in the opinion of the investigators, they were at increased risk for type Ia endoleak or migration owing to a hostile neck (length <10 mm, diameter >28 mm, angulation >60°, mural thrombus or calcium >2 mm in thickness or >180° in circumference, or conical shape). Overall, 123/157 (78.3%) patients met the criteria for a hostile neck according to core laboratory assessment of 157 adequate preoperative computed tomographic (CT) images. RESULTS: Implantation of EndoAnchors was technically successful in 204/208 (98.1%) patients. The frequency of fracture was 0.3% (3/1118); there were no clinical sequelae associated with the fractures. Over the mean 14-month follow-up, 95.2% of patients were alive, and no deaths were attributable to EndoAnchors. There were no ruptures, migrations, or open surgical conversions. Aneurysm-related reinterventions were performed in 8 (3.8%) patients. Among 130 patients with postprocedure contrast CT studies, core laboratory analysis identified 2 (1.5%) patients with type Ia endoleaks. Aneurysm sac diameter decreased >5 mm in 42.9% of patients with CT scans at or beyond 1 year; 1.6% of patients developed sac enlargement >5 mm. CONCLUSION: Prophylactic EndoAnchor use for challenging aortic neck anatomy was associated with satisfactory midterm results.

The Challenge of Treating Abdominal Aortic Aneurysms with Hostile Neck Anatomy: An Overview.

Hostile aortic neck anatomy challenges the outcomes of endovascular abdominal aortic aneurysm repair (EVAR). Besides reverting to open surgical repair (OSR), thoughtful endograft selection and a number of advanced endovascular techniques have been suggested as potential solutions for preventing proximal seal zone complications, improving EVAR durability, and preventing aneurysm-related death. Each technique is associated with advantages and limitations and there has not been a credible direct comparison amongst them in the form of a well-designed prospective trial. The not infrequent presence of multiple hostile anatomic characteristics further complicates decision making and challenges the surgeon's skills. This paper serves as an overview of hostile neck anatomy and its implications on EVAR. We provide a concise literature review with the purpose of outlining the treatment modalities and outcomes in this patient population.

Aligning Orifice of the Renal Artery with Fish-Mouth FIXation Technique During Endovascular Aortic Aneurysm Repair for Hostile Neck Anatomy.

Background: As the success of endovascular aortic aneurysm repair (EVAR) depends on sufficient proximal fixation of the endograft to the aortic wall, the proximal hostile neck anatomy (HNA) is the major potential treatment-limiting factor in EVAR. The Aorfix endovascular stent graft was designed to operate on highly angulated aortic necks. The Aligning Orifice of the Renal artery with fish-mouth FIXation (AORFIX) technique uniquely and accurately aligns the trough part of the proximal stent end with the orifice of the lower renal artery and is used to optimize the proximal fish-mouth design for maximum proximal seal use. Herein, we aimed to evaluate the usefulness of the AORFIX technique for EVAR in patients with HNA. Methods: Eighty-one consecutive patients who underwent EVAR with the AORFIX technique (+AORFIX technique group, n = 16) and without (standard group, n = 65) were evaluated. The HNA was defined as any of the following: neck angulation ≥60°, neck length ≤15 mm, or neck thrombus or calcification ≥50% of the circumference and conical neck. Results: Each HNA criterion was similar between the two groups. However, the average number of HNA criteria was significantly higher in the +AORFIX technique group (1.9 ± .2 vs. 1.3 ± .1; P < .01). The two groups showed 100% procedural success. The concurrent renal angioplasty and stenting rates (88% vs. 4.6%; P < .01) were significantly higher in the +AORFIX technique group. There were no 30-day deaths in either group and no in-hospital device-related events in the +AORFIX technique group. The median follow-up period was 39 months, and there was no significant between-group difference in freedom from reintervention rate (+AORFIX group vs. standard group, 100% vs. 91.0%; P = .327). Conclusion: EVAR using the AORFIX technique might be useful even in patients with more complex HNA.

Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy.

INTRODUCTION: Endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) are established techniques to treat abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA). However, there are limitations when challenging proximal neck anatomy is present. Heli-FX EndoAnchors have been used in addition to EVAR and TEVAR to improve proximal sealing of a stent-graft, but there are limited data available on their outcomes, safety, and efficacy. AREAS COVERED: The properties and development of Heli-FX EndoAnchors are evaluated. The evidence of various clinical outcomes, safety, and efficacy is interrogated with the augmented use of Heli-FX EndoAnchors with EVAR or TEVAR. EXPERT OPINION: Challenging proximal neck anatomy can be problematic during EVAR or TEVAR. EndoAnchors may be part of the solution - used either prophylactically or therapeutically. The safety and efficacy databases are building but long-term data are still not available for this device and there remains inadequate data to support its routine use. Judicious patient selection is still needed.

Tailor-Made Tapering Grafts for Large-Neck Aorta.

Patients having a large aortic neck poses a challenge in abdominal aortic aneurysm surgery both in endovascular and open aneurysm repair, sometimes necessitating paravisceral or thoracoabdominal aneurysm repair which carries considerable perioperative risk. Here, we describe techniques of using a tailor-made tapering graft in open surgery that can be adjusted for large neck morphology. This technique helps avoid discrepancies between the proximal aorta and graft, and postoperative acute kidney injury by clamping at lower levels. The conscientious use of this technique in selected patients realizes satisfactory outcomes both in the short term and midterm in the demanding anatomy of large aortic necks.

Endografts for the treatment of abdominal aortic aneurysms with a hostile neck anatomy: A systematic review.

Background: Endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs) has emerged as a better alternative to conventional open surgery for AAAs. The purpose of the review is to define the improvement in the clinical management of the patient with hostile neck AAAs due to the introduction of new endografts while giving a thorough description of their instructions for use (IFUs), main characteristics and part sizing, reporting their outcomes from clinical studies and categorizing their usability. Methods: A MEDLINE search was conducted using keyword-specific combinations. Clinical studies were searched via the clinicaltrials.gov website. Relevant articles' references were also hand-searched. Results: We retrieved 640 records describing Alto, Ovation iX, Treovance, Aorfix, Anaconda, Conformable, and Endurant II/IIs endografts. Aortic necks >60° can be managed with Anaconda, Aorfix, and Conformable, which can treat up to 90° necks requiring ≥15 mm (Anaconda ≥20 mm), and Treovance, which is eligible for necks ≤75° with ≥15 mm length. Ovation's innovation of combining polymer-filled O-rings with integral anchors can treat conical necked AAAs giving Ovation iX and Alto an advantage. Short-necked AAAs can be treated with Alto, eligible for necks as short as 7 mm, and Endurant II, which can treat ≥10 mm necks or 4 mm if used in conjunction with the EndoAnchors system, respectively. Alto and Conformable report a 100% technical success rate, absence of AAA-related death, migration, ruptures, and limb occlusion during follow-up. Endurant II and Ovation iX report >99% technical success rate and are almost free from the AAA mortality rate, ruptures, migration, and limb occlusion, while Ovation iX has a high rate of sac dilation (15.5%) in a 5-year follow-up. Anaconda is slightly better than Aorfix and Treovance, which are related to the lowest technical success rates, 98.3%, 96.3%, and 96%, respectively. Aorfix has the highest AAA mortality rate, 4% in a 60 month follow-up. Conclusion: Most new generation endografts described have comparable results. They broaden the eligibility of patients for EVAR due to their unique technical characteristics described. There is a lack of comparative studies for newer endografts and postmarket clinical studies with long-term results concerning the most recently approved devices described, Alto and Conformable.