Active Proximal Sealing in the Endovascular Repair of Abdominal Aortic Aneurysms

Melas, Nikolaos; Stavridis, Kyriakos; Saratzis, Athanasios; Lazarides, John; Gitas, Christos; Saratzis, Nikolaos

doi:10.1177/1526602815573232

Cited by 31 publications

(24 citation statements)

References 39 publications

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“…Recently, several non-bioactive devices have been developed to prevent endoleaks (including type I), using polymer-injectable structures that either provide on-site fitting at the proximal neck, [19] or that fill the whole cavity [20]. While these structures may allow better initial sealing and adaptation of the SG structure to the vessel anatomy, they do not protect from progression of aneurysmal degeneration at the necks and do not promote biological fixation of SG into the vessel wall.…”

Section: Discussionmentioning

confidence: 99%

In Vitro and Pilot In Vivo Evaluation of a Bioactive Coating for Stent Grafts Based on Chondroitin Sulfate and Epidermal Growth Factor

Lequoy¹,

Savoji²,

Saoudi³

et al. 2016

Journal of Vascular and Interventional Radiology

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2 AbstractPurpose: To evaluate the potential of a bioactive coating based on chondroitin sulfate (CS) and tethered epidermal growth factor (EGF) for the improvement of healing around stent-grafts (SG). Methods:The impact of the bioactive coating on cell survival was tested in vitro on human vascular cells using polyethylene terephtalate films (PET) as a substrate. After being transferred onto a more "realistic" material (expanded poly(tetrafluoroethylene), ePTFE), the durability and mechanical behavior of the coating in addition to cell survival were studied. Preliminary in vivo testing was performed in a canine iliac aneurysm model reproducing type I endoleaks (3 animals with 1 control and 1 bioactive SG for each). Results:The CS and EGF coatings significantly increased survival of human smooth muscle cells and fibroblasts, compared with bare PET or ePTFE (P<.05). The coating also displayed good durability over 30 days according to ELISA and cell-survival tests.The coating did not affect the mechanical properties of ePTFE and was successfully transferred onto commercial SG for in vivo testing. According to CT-scan and macroscopic examinations, no difference was observed in endoleak persistence at three months, but the bioactive coating deposited on the abluminal surface of the SG (exposed to the vessel wall) increased the percentage of healed tissue in the aneurysm. Moreover, no adverse effect such as neointima formation or thrombosis was observed. Conclusion:The bioactive coating promoted in vitro cell survival, displayed good durability and was successfully transferred onto a commercial SG. Preliminary in vivo results suggest improved healing around bioactive SG.3

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Section: Discussionmentioning

confidence: 99%

In Vitro and Pilot In Vivo Evaluation of a Bioactive Coating for Stent Grafts Based on Chondroitin Sulfate and Epidermal Growth Factor

Lequoy¹,

Savoji²,

Saoudi³

et al. 2016

Journal of Vascular and Interventional Radiology

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“…The AFX device has been shown to prevent the risk of migration as the endograft is anatomically fixed directly on the aortic bifurcation. Moreover, the use of STRATA conformable ePTFE material located external to the stent may provide greater graft-wall contact over the long-term, providing advantage in challenging proximal neck anatomy [5–7]. In the present preliminary report we compared the behavior of the AFX endograft with an infrarenally fixated proximal component with the behavior of the Excluder endograft with an infrarenally fixated graft of the same material.…”

Section: Discussionmentioning

confidence: 99%

“…It is the only graft with anatomical fixation to the aortic bifurcation in comparison to all other grafts that use the infrarenal neck as the main fixation point. Its proximal neck is made to affix firmly to the aorta and reduce the possibility of device migration and leakage [5–7]. The proximal aortic extension is permitted to focus only on sealing, can be selected with infrarenal or suprarenal fixation, while the new expanded polytetrafluoroethylene (ePTFE) graft material called STRATA conforms to irregular surfaces.…”

Section: Introductionmentioning

confidence: 99%

“…The proximal aortic extension is permitted to focus only on sealing, can be selected with infrarenal or suprarenal fixation, while the new expanded polytetrafluoroethylene (ePTFE) graft material called STRATA conforms to irregular surfaces. In clinical trials, the AFX endograft is accompnied by a lower rate of complications, such as endoleak type I, behaving efficiently even in an aortic neck anatomy with an irregular shape [5]. …”

Section: Introductionmentioning

confidence: 99%

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Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Kouvelos

Nana

Bouris

et al. 2017

VSI

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PurposeThe newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder.Materials and MethodsA retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death.ResultsPrimary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18–26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34).ConclusionThe initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.

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“…A look at the AFX endograft (Endologix) in 21 consecutive patients with irregular, conical, tapered, or bulging proximal necks, showed 90 % primary technical success, with good results at 10-month median follow-up [24]. The AFX graft sits at the aortic bifurcation, establishing "anatomic fixation".…”

Section: Device Planningmentioning

confidence: 94%

Endovascular Management of Abdominal Aortic Aneurysms: the Year in Review

O’Mara

Bersin

2016

Curr Treat Options Cardio Med

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Endovascular aneurysm repair (EVAR) has become the predominant method of treatment for abdominal aortic aneurysms (AAA). The use of conscious sedation with local anesthesia and percutaneous femoral access has further decreased the morbidity of the procedure. Current devices can more effectively manage increasingly "hostile" aneurysm necks, while chimney grafts or dedicated fenestrated stent-grafts can be used for juxta-renal disease with favorable results. However, endovascular repair does present a new set of challenges, and endoleaks remain an area of concern. While there is general consensus that type I and type III endoleaks require treatment, type II endoleaks are the topic of ongoing research and debate. Development of devices and techniques to prevent and treat endoleak continues to progress. Advances in contrast-enhanced ultrasound are reducing reliance on computed tomography for post-operative monitoring. This is an important step in this population at high risk for the development of kidney failure. Despite these many innovations, further research is needed to optimize the care of patients with AAA.

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Active Proximal Sealing in the Endovascular Repair of Abdominal Aortic Aneurysms

Abstract: 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.

Cited by 31 publications

References 39 publications

In Vitro and Pilot In Vivo Evaluation of a Bioactive Coating for Stent Grafts Based on Chondroitin Sulfate and Epidermal Growth Factor

In Vitro and Pilot In Vivo Evaluation of a Bioactive Coating for Stent Grafts Based on Chondroitin Sulfate and Epidermal Growth Factor

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Endovascular Management of Abdominal Aortic Aneurysms: the Year in Review

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