Aorfix Stent Graft for Abdominal Aortic Aneurysms Reduces the Risk of Proximal Type 1 Endoleak in Angulated Necks: Bench-Test Study

Albertini, Jean‐Noël; Masi, Mariangela De; Macierewicz, Jan; Idrissi, R. El; Hopkinson, Brian R.; Clément, Claude; Branchereau, A

doi:10.1258/rsmvasc.13.6.321

Cited by 21 publications

(13 citation statements)

References 10 publications

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“…Increasing aortic neck angulation has been shown to increase perigraft endoleak flow, thereby leading to poor seal and graft separation. 6,7 Consistent with this notion, severe aortic neck angulation has been associated with worse outcomes after EVAR in multiple prior studies. 8 In a prospective study of 81 EVAR repairs by Sternbergh et al, patients with severely angulated aortic necks had a 70% risk of experiencing one or more adverse events (including death within 30 days, acute conversion to open repair, aneurysm expansion, device migration, and type I endoleak) compared with a 17% risk in patients with mild (<40-degree) aortic neck angulation.…”

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confidence: 61%

“…These favorable results are likely due to the flexibility of the graft construction. In a bench study comparing existing aortic endografts, aortic neck angles $30 degrees caused a significant increase in endoleak flow rate in seven manufactured models ( 7 In contrast, neck angulation had no influence on the endoleak flow rate of the Aorfix. In a computational model comparing flexibility of the Aorfix with the Zenith stent grafts, the Aorfix graft performed better with respect to maximal luminal reduction rate, torque, strain, and stress for aortic neck angulation >60 degrees.…”

Section: Discussionmentioning

confidence: 99%

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Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks

Malas¹,

Hicks²,

Jordan³

et al. 2017

Journal of Vascular Surgery

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The U.S. PYTHAGORAS trial of the Aorfix endograft is the first EVAR clinical trial to include a majority of highly angulated (≥60 degrees) infrarenal aortic necks and is the first to produce evidence after 5 years of implantation. Despite predictors of worse short- and long-term outcomes, pertinent outcomes were better than or similar to those of trials with less severe anatomy. These results support the use of this "on-label" endovascular option, particularly in patients with highly angulated aortic neck anatomy.

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confidence: 61%

Section: Discussionmentioning

confidence: 99%

Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks

Malas¹,

Hicks²,

Jordan³

et al. 2017

Journal of Vascular Surgery

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“…Angulation of proximal and distal aneurysm necks is a well‐established predictive factor of adverse events following EVAR, particularly type 1 endoleaks . Bench test studies have shown that inadequate SG apposition on the arterial wall was a mechanism for type 1 endoleaks . Therefore, the results of the present simulation are relevant to the above‐mentioned clinical complications.…”

Section: Discussionmentioning

confidence: 84%

Deployment of stent grafts in curved aneurysmal arteries: toward a predictive numerical tool

Perrin

Demanget

Badel

et al. 2015

Numer Methods Biomed Eng

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The mechanical behavior of aortic stent grafts plays an important role in the success of endovascular surgery for aneurysms. In this study, finite element analysis was carried out to simulate the expansion of five marketed stent graft iliac limbs and to evaluate quantitatively their mechanical performances. The deployment was modeled in a simplified manner according to the following steps: (i) stent graft crimping and insertion in the delivery sheath, (ii) removal of the sheath and stent graft deployment in the aneurysm, and (iii) application of arterial pressure. In the most curved aneurysm and for some devices, a decrease of stent graft cross-sectional area up to 57% was found at the location of some kinks. Apposition defects onto the arterial wall were also clearly evidenced and quantified. Aneurysm inner curve presented significantly more apposition defects than outer curve. The feasibility of finite element analysis to simulate deployment of marketed stent grafts in curved aneurysm models was demonstrated. The study of the influence of aneurysm tortuosity on stent graft mechanical behavior shows that increasing vessel curvature leads to stent graft kinks and inadequate apposition against the arterial wall. Such simulation approach opens a very promising way toward surgical planning tools able to predict intra and/or post-operative short-term stent graft complications.

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“…Endoleaks and stent-graft (SG) limb thrombosis are among the most frequent causes of secondary interventions following EVAR. Endoleaks may be associated with incomplete SG apposition on the arterial wall (Albertini et al, 2001(Albertini et al, , 2005. Graft kinking has been proved to favor stenosis and thrombosis (Carroccio et al, 2002;Cochennec et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

Patient-specific numerical simulation of stent-graft deployment: Validation on three clinical cases

Perrin

Badel

Orgéas

et al. 2015

Journal of Biomechanics

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Endovascular repair of abdominal aortic aneurysms faces some adverse outcomes, such as kinks or endoleaks related to incomplete stent apposition, which are difficult to predict and which restrain its use although it is less invasive than open surgery. Finite element simulations could help to predict and anticipate possible complications biomechanically induced, thus enhancing practitioners' stent-graft sizing and surgery planning, and giving indications on patient eligibility to endovascular repair. The purpose of this work is therefore to develop a new numerical methodology to predict stent-graft final deployed shapes after surgery. The simulation process was applied on three clinical cases, using preoperative scans to generate patient-specific vessel models. The marketed devices deployed during the surgery, consisting of a main body and one or more iliac limbs or extensions, were modeled and their deployment inside the corresponding patient aneurysm was simulated. The numerical results were compared to the actual deployed geometry of the stent-grafts after surgery that was extracted from postoperative scans. We observed relevant matching between simulated and actual deployed stent-graft geometries, especially for proximal and distal stents outside the aneurysm sac which are particularly important for practitioners. Stent locations along the vessel centerlines in the three simulations were always within a few millimeters to actual stents locations. This good agreement between numerical results and clinical cases makes finite element simulation very promising for preoperative planning of endovascular repair.

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Aorfix Stent Graft for Abdominal Aortic Aneurysms Reduces the Risk of Proximal Type 1 Endoleak in Angulated Necks: Bench-Test Study

Cited by 21 publications

References 10 publications

Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks

Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks

Deployment of stent grafts in curved aneurysmal arteries: toward a predictive numerical tool

Patient-specific numerical simulation of stent-graft deployment: Validation on three clinical cases

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