Performance of BeGraft and BeGraft+ Stent-Grafts as Bridging Devices for Fenestrated Endovascular Aneurysm Repair: An In Vitro Study

2019 ◽  
Vol 26 (6) ◽  
pp. 787-794 ◽  
Author(s):  
Giovanni Federico Torsello ◽  
Monika Herten ◽  
André Frank ◽  
Markus Müller ◽  
Susanne Jung ◽  
...  

Purpose: To investigate 2 generations of balloon-expandable covered stents as potential bridging devices using an in vitro model of stent-graft fenestrations. Materials and Methods: Twenty BeGraft and 20 BeGraft+ cobalt-chromium stents covered in expanded polytetrafluoroethylene (ePTFE) in 6- and 8-mm diameters were tested in sheets mimicking stent-graft fenestrations. Microscopy and radiography were employed to evaluate stent morphology after flaring. In vitro bench tests measured maximum pullout (perpendicular displacement) and the shear stress (axial displacement) forces needed to dislocate the stents. Results: No alteration of ePTFE coverage was detected in the flared stents. Digital radiography and computed tomography showed marked alteration of the stent geometry, which was more pronounced in the BeGraft group. No fractures were detected. Median (minimum–maximum) pullout forces for the 6-mm stent-grafts were 17.1 N (15.8–19.6) for the BeGraft device and 30.4 N (20.2–31.9) for the BeGraft+ device (p=0.006). Median (minimum–maximum) pullout forces for the 8-mm stent-grafts were 11.3 N (11–12.1) for the BeGraft device and 21.8 N (18.2–25.5) for the BeGraft+ device (p<0.001). The shear stress test showed median forces of 10.5 vs 15.28 N at 150% of the stent diameter for the 6-mm BeGraft and BeGraft+ stent-grafts, respectively, and 15.23 vs 20.72 N at 150% stent diameter for the 8-mm models (p=0.016 and 0.017, respectively). Conclusion: Flaring changed the stent geometry but did not provoke stent fractures. The BeGraft+ is superior to the BeGraft in terms of pullout and shear stress forces, demonstrating greater resilience.

2020 ◽  
Vol 27 (2) ◽  
pp. 258-265 ◽  
Author(s):  
Giovanni Federico Torsello ◽  
Monika Herten ◽  
Markus Müller ◽  
André Frank ◽  
Giovanni B. Torsello ◽  
...  

Purpose: To compare experimentally the biomechanical properties of the Viabahn Balloon-Expandable Stent Graft (VBX) with the widely used Advanta V12/iCast in the role of bridging stent-grafts for fenestrated endovascular aortic repair. Materials and Methods: Test sheets made of polyester having 2 rows of 5 fenestrations in 6-mm and 8-mm diameters were used to simulate a commercially made fenestrated aortic endograft. In total, 40 stent-grafts measuring 6×39 mm and 8×39 mm (10 of each size for each stent-graft) were implanted in fenestration sheets immersed in a 37°C water bath. After flaring, all stent-grafts were evaluated using microscopy and radiography. Biomechanical evaluation included pullout and the shear stress force testing; results are reported in Newtons (N) as the median (minimum–maximum). Results: After flaring, no damage or fracture to the stent-graft structures were detected. Pullout forces for the 6-mm stent-grafts were 27.1 N (20.0–28.9) for the VBX and 16.6 N (14.7–19.2) for the Advanta (p=0.008). Pullout forces for the 8-mm stent-grafts were 20.1 N (14.8–21.5) for the VBX and 15.8 N (12.4–17.5) for the Advanta (p=0.095). The shear stress forces necessary to dislocate the device at 150% stent diameter displacement was 12.5 N (VBX) vs 14.7 N (Advanta) for the 6-mm devices and 23.3 N (VBX) vs 20.2 N (Advanta) for the 8-mm stents (p>0.99 and p=0.222, respectively). Conclusion: In vitro tests simulating external pull and shear forces on bridging stent-grafts implanted in fenestrations showed that the VBX had resistance to dislocation equivalent to a well-known control device.


2019 ◽  
Vol 26 (3) ◽  
pp. 361-368 ◽  
Author(s):  
Giovanni Federico Torsello ◽  
Monika Herten ◽  
Markus Müller ◽  
André- Frank ◽  
Giovanni B. Torsello ◽  
...  

Purpose: To evaluate the safety and integrity of a new stent-graft as a potential bridging device in fenestrated stent-grafts using an in vitro fenestrated model. Materials and Methods: Polyester test sheets with ten 6-mm- or 8-mm-diameter fenestrations were used to simulate a fenestrated main body endoprosthesis. In total, 50 Viabahn balloon-expandable (VBX) stent-grafts of varying lengths (29 and 39 mm) and diameters (6, 7, and 8 mm) were implanted in the fitting fenestrations. After release, the 6- and 7-mm-diameter stent-grafts were flared with a 10×20-mm angioplasty balloon; a 12×20-mm balloon was used in the 8-mm-diameter devices. Safety of the devices was defined as absence of fractures detected on radiography or computed tomography (CT), as well as material failure detected by microscopy and water permeability testing. The forces (in Newtons, N) needed for perpendicular dislocation (pullout force) and axial dislocation (shear stress force) were also evaluated. Results: Forty VBX stent-grafts were subjected to digital radiographic imaging and multiplanar CT. None showed any stent fracture. Subsequent microscopy indicated no damage to the fabric or separation of the graft after flaring. Ten VBX stent-grafts underwent water permeability testing after flaring; no water passed through the graft wall during a 10-minute period under an intraluminal pressure at 120 mm Hg. Testing of 25 VBX stent-grafts revealed initial pullout forces between 11.3 and 31 N. Shear stress tests showed that the average force needed to dislocate the stent-grafts by 50% of their diameter ranged between 5.75 and 6.91 N (mean 6.1±0.5 N) for the 6-mm stents and between 3.31 and 5.4 N (mean 4.4±0.8) for the 8-mm stents. Conclusion: This preliminary study demonstrated the applicability of the VBX as a bridging stent-graft in a simulated fenestration model. A comparison with other stent-grafts and clinical assessment are required.


2018 ◽  
Vol 26 (1) ◽  
pp. 72-75
Author(s):  
Fabien Lareyre ◽  
Claude Mialhe ◽  
Carine Dommerc ◽  
Juliette Raffort

Purpose: To report the use of the Nellix endovascular aneurysm sealing (EVAS) system in the management of proximal stent-graft collapse associated with thrombosis following endovascular aneurysm repair (EVAR). Case Report: A 76-year-old man was admitted for proximal collapse of an aortic extension following bifurcated AFX stent-graft implantation associated with chimney grafts in both renal arteries and the superior mesenteric artery 1 month prior. Imaging identified thrombosis of the aortic stent-graft and the iliac limbs. A Nellix EVAS was placed into the AFX stent-graft to recanalize the aneurysm lumen and address the aortic thrombosis. There was no endoleak, and the renovisceral chimney stent-grafts remained patent over a follow-up of 25 months. Conclusion: While further studies are required to generalize its use, EVAS appears to be feasible in the management of aortic stent-graft collapse.


2009 ◽  
Vol 137 (1-2) ◽  
pp. 10-17 ◽  
Author(s):  
Lazar Davidovic ◽  
Momcilo Colic ◽  
Igor Koncar ◽  
Dejan Markovic ◽  
Dusan Kostic ◽  
...  

Introduction. Endovascular aneurysm repair (EVAR) has been introduced into clinical practice at the beginning of the 90's of the last century. Because of economic, political and social problems during the last 25 years, the introduction of this procedure in Serbia was not possible. Objective. The aim of this study was to present preliminary experiences and results of the Clinic for Vascular Surgery of the Serbian Clinical Centre in Belgrade in endovascular treatment of thoracic and abdominal aortic aneurysms. Methods. The procedure was performed in 33 patients (3 female and 30 male), aged from 42 to 83 years. Ten patients had a descending thoracic aorta aneurysm (three atherosclerotic, four traumatic - three chronic and one acute as a part of polytrauma, one dissected, two penetrated atherosclerotic ulcers), while 23 patients had the abdominal aortic aneurysm, one ruptured and two isolated iliac artery aneurysms. The indications for EVAR were isthmic aneurismal localisation, aged over 80 years and associated comorbidity (cardiac, pulmonary and cerebrovasular diseases, previous thoracotomy or multiple laparotomies associated with abdominal infection, idiopatic thrombocitopaenia). All of these patients had three or more risk factors. The diagnosis was established using duplex ultrasonography, angiography and MSCT. In the case of thoracic aneurysm, a Medtronic-Valiant? endovascular stent graft was implanted, while for the abdominal aortic aneurysm Medtronic-Talent? endovascular stent grafts with delivery systems were used. In three patients, following EVAR a surgical repair of the femoral artery aneurysm was performed, and in another three patients femoro-femoral cross over bypass followed implantation of aortouniiliac stent graft. Results. During procedure and follow-up period (mean 1.6 years), there were: one death, one conversion, one endoleak type 1, six patients with endoleak type 2 that disappeared during the follow-up period, one early graft thrombosis. No other complications, including aneurysm expansion, collapse, deformity and migration of the endovascular stent grafts, were registered. Conclusion. According to all medical and economic aspects, we recommend EVAR to treat acute traumatic thoracic aortic aneurysm, as well as in elderly and high-risk patients with abdominal or thoracic aneurysms, when open surgery is related to a significantly higher mortality and morbidity.


2019 ◽  
Vol 53 (6) ◽  
pp. 515-519
Author(s):  
Toshiya Nishibe ◽  
Toru Iwahashi ◽  
Kentaro Kamiya ◽  
Masaki Kano ◽  
Keita Maruno ◽  
...  

We present 3 cases of type IIIb endoleak after endovascular aneurysm repair (EVAR) using the Zenith stent graft system. Type III endoleak, like type I endoleak, is a high-pressure, high-risk leak that increases sac pressure up to or even above arterial pressure, and is associated with an increased frequency of open conversions or risk of aneurysm rupture. Type IIIb endoleak is rare but there is much concern that the incidence of type IIIb endoleak is likely to increase hereafter; the mechanism of type IIIb endoleak is deterioration of graft fabric in conjunction with stent sutures. Type IIIb endoleak is difficult to diagnose before rupture. The possibility of type IIIb endoleak should be highly suspected when the continued growth of an excluded aneurysm sac without direct radiologic evidence is observed during follow-up. Type IIIb endoleak can be repaired by relining of the stent graft with additional stent grafts.


2019 ◽  
Vol 70 (5) ◽  
pp. e133-e134
Author(s):  
Martin J. Austermann ◽  
Giovanni B. Torsello ◽  
Monika Herten ◽  
Marcus Müller ◽  
Andre Frank ◽  
...  

2009 ◽  
Vol 131 (4) ◽  
Author(s):  
Kurosh Darvish ◽  
Mehdi Shafieian ◽  
Vasily Romanov ◽  
Vittorio Rotella ◽  
Michael D. Salvatore ◽  
...  

Endovascular stent grafts for the treatment of thoracic aortic aneurysms have become increasingly utilized and yet their locational stability in moderate chest trauma is unknown. A high speed impact system was developed to study the stability of aortic endovascular stent grafts in vitro. A straight segment of porcine descending aorta with stent graft was constrained in a custom-made transparent urethane casing. The specimen was tested in a novel impact system at an anterior inclination of 45deg and an average deceleration of 55G, which represented a frontal automobile crash. Due to the shock of the impact, which was shown to be below the threshold of aortic injury, the stent graft moved 0.6mm longitudinally. This result was repeatable. The presented experimental model may be helpful in developing future grafts to withstand moderate shocks experienced in motor vehicle accidents or other dynamic loadings of the chest.


2018 ◽  
Vol 25 (3) ◽  
pp. 387-394 ◽  
Author(s):  
Simon P. Overeem ◽  
Esmé J. Donselaar ◽  
Jorrit T. Boersen ◽  
Erik Groot Jebbink ◽  
Cornelis H. Slump ◽  
...  

Purpose: To assess the dynamic behavior of chimney grafts during the cardiac cycle. Methods: Three chimney endovascular aneurysm repair (EVAR) stent-graft configurations (Endurant and Advanta V12, Endurant and Viabahn, and Endurant and BeGraft) were placed in silicone aneurysm models and subjected to physiologic flow. Electrocardiography (ECG)-gated contrast-enhanced computed tomography was used to visualize geometric changes during the cardiac cycle. Endograft and chimney graft surface, gutter volume, chimney graft angulation over the center lumen line, and the D-ratio (the ratio between the lengths of the major and minor axes) were independently assessed by 2 observers at 10 time points in the cardiac cycle. Results: Both gutter volumes and chimney graft geometry changed significantly during the cardiac cycle in all 3 configurations (p<0.001). Gutters and endoleaks were observed in all configurations. The largest gutter volume (232.8 mm3) and change in volume (20.7 mm3) between systole and diastole were observed in the Endurant-Advanta configuration. These values were 2.7- and 3.0-fold higher, respectively, compared to the Endurant-Viabahn configuration and 1.7- and 1.6-fold higher as observed in the Endurant-BeGraft configuration. The Endurant-Viabahn configuration had the highest D-ratio (right, 1.26–1.35; left, 1.33–1.48), while the Endurant-BeGraft configuration had the lowest (right, 1.11–1.17; left, 1.08–1.15). Assessment of the interobserver variability showed a high correlation (intraclass correlation >0.935) between measurements. Conclusion: Gutter volumes and stent compression are dynamic phenomena that reshape during the cardiac cycle. Compelling differences were observed during the cardiac cycle in all configurations, with the self-expanding (Endurant–Viabahn) chimney EVAR configurations having smaller gutters and less variation in gutter volume during the cardiac cycle yet more stent compression without affecting the chimney graft surface.


2021 ◽  
Vol 9 (B) ◽  
pp. 1494-1498
Author(s):  
Mohamed Hosny Sayed ◽  
Mohammed Ali Hassan ◽  
Ahmed Samir Hosny ◽  
Hisham Rashid ◽  
Mohamed Hosni El Dessoki

BACKGROUND: The availability of aortic stent-grafts has permitted an obvious change in the management of abdominal aortic aneurysms (AAA). For elective cases open surgical repair has been widely superseded by the use of stent-graft. With the rapid evolution of the endovascular technology, a significant development in stent-graft techniques was achieved in conjunction with a better understanding of how to utilize stent-grafts. METHODS: A multicenter prospective study in which 49 patients were enrolled, they underwent an elective endovascular aneurysm repair (EVAR) procedure for infrarenal AAA in two different institutions, Kasr Al-ainy School of Medicine, Cairo University and King’s College Hospital in London, the selected patients were followed up for 6 months after the procedure. Data relating to demographics and pre-operative comorbidities were recorded. Aneurysm morphology was reviewed by computed tomography angiography scans. Clinical data was collected through operative records and afterward through outpatient clinic follow-up sessions. RESULTS: Overall survival was 94% over a period of 6 months calculated using KaplanMeier Survival Curve. CONCLUSIONS: Endovascular repair resulted in fewer perioperative deaths. This study provides insight into clinical parameters that can be used to stratify patients’ post-EVAR surveillance and need for re-intervention and it came to the conclusion that EVAR could be considered as the standard repair for uncomplicated infrarenal AAA.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Arindam Chaudhuri ◽  
Ramita Dey ◽  
Weronika Stupalkowska

Abstract Aim Stent-grafts are finding a place in the treatment of femoral pseudoaneurysms (FpsAs), having been described in the treatment of infected pseudoaneurysms. We present the results of endovascular treatment of non-infected FpsAs using stent-grafts. Methods Case series of patients who underwent stent-graft coverage of FpsAs from January 2016 to December 2020. Stent-graft fractures, occlusions and reinterventions, length of stay (LOS) and 30-day mortality were assessed. Results 11 patients (mean age 75±10.3 years, 7 males; all ASA 3 or 4) underwent stent-graft coverage of FpsAs. Original procedures linked to the formation of FpsA were iliofemoral bypass (n = 3), femorofemoral crossover (n = 3), percutaneous coronary interventions (n = 2), aortobifemoral bypass (n = 1), endovascular aneurysm repair (n = 1) and femoral endarterectomy (n = 1). 3 patients had previous open FpsA repair. Technical success of deployment was 100%. Stent-grafts used included Viabahn Endoprosthesis (WL Gore & Associates, Flagstaff USA; n = 8), Viabahn VBX (WL Gore & Associates; n = 1) and BeGraft (Bentley InnoMed GmbH, Hechingen, Germany; n = 2). All patients were maintained on either antiplatelets or anticoagulant. 10 patients were available for analysis (1 lost to follow-up); radiological follow-up included initial computed tomography angiography and later combined duplex ultrasonography/plain radiography. Median LOS was 4 days (IQR 4). 30-day mortality was 0%. Median survival was 12 months (IQR 17). There was one stent-graft occlusion requiring thrombectomy but no fractures were observed in this series. Conclusions This small series suggests that there may be a role for stent-grafts in treatment of FpsAs in carefully selected patients. Given lack of data on long-term outcomes, continued surveillance is recommended.


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