A Study of Pullout Forces of the Components of Modular Multi-manufacturer Hybrid Endografts Used for Aortic Aneurysm Repair

Cinà, Davide P.; Grant, Gordon; Peterson, Mark D.; Campbell, V.; Garrido‐Olivares, Luis; Cinà, Claudio S.

doi:10.1016/j.ejvs.2009.02.017

Cited by 17 publications

(20 citation statements)

References 22 publications

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“…In this study, Cinà and colleagues tried to define the pullout forces (POFs) of modular stent graft systems from the same (nonhybrid) and different (hybrid) manufacturers. 16 The combination of Zenith body and Excluder limbs registered the second weakest POF (2.397 6 0.22 Newton) of all possible combinations between Anaconda (Vascutek, Terumo Corporation, Ann Arbor, MI), Excluder (Gore), Talent (Medtronic, Minneapolis, MN), and Zenith (Cook) grafts. The strongest combination was found to be the Zenith body with an Anaconda graft limb.…”

Section: Discussionmentioning

confidence: 99%

Hybrid Endograft Solution for Complex Iliac Anatomy: Zenith Body and Excluder Limbs

et al. 2010

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The purpose of this study was to evaluate single-center results with selective use of Gore Excluder limbs (W.L. Gore & Associates, Flagstaff, AZ) in a Cook Zenith body (Cook Inc, Bloomington, IN) for elective endovascular abdominal aortic aneurysm (AAA) repair. A prospectively held database for patients with AAA, who were treated endovascularly between March 1999 and July 2008, was queried for patients treated with a Cook Zenith body and one or two Gore Excluder limbs. Indication, technical success, late limb occlusion, and disconnection were evaluated. From 276 patients who were treated with a Zenith body, 29 underwent repair with hybrid graft components with, in total, 41 Gore Excluder limbs. The indication was always complex iliac anatomy. The primary technical success rate in this group was 89% (26 of 29 patients), with a primary assisted technical success rate of 100%. Mortality at 30 days was 0%. The mean follow-up was 19.4 months (range 2-64 months). Late mortality was 13.8% (4 of 29), with no aneurysm-related death. No graft limb occlusion or disconnection occurred during follow-up. No reintervention was needed in the hybrid endograft group. The use of a Cook Zenith body with Gore Excluder limb(s) in case of adverse iliac anatomy is feasible and showed no adverse effects at the midterm follow-up.

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Section: Discussionmentioning

confidence: 99%

Hybrid Endograft Solution for Complex Iliac Anatomy: Zenith Body and Excluder Limbs

et al. 2010

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“…18 This group also found that pullout forces were greater when measured in albumin (8.4965.48 N) than in a dry environment (7.9164.24 N) when all tests were considered. 18 This finding suggests that the pullout forces obtained in our study may represent an underestimate, as the properties of stent-grafts improve in a wet environment. The maximum median pullout forces obtained in our study ranged from a minimum of 1.17 N (7-mm Fluency deployed into renal branch) to a maximum of 3.82 N (9-mm Viabahn deployed into iliac branch).…”

Section: Discussionmentioning

confidence: 92%

“…17 The pullout forces of conventional abdominal aortic modular devices have also been examined to determine the likelihood of component separation. 18,19 To our knowledge, there are no data in the literature regarding the pullout force of bridging stent-grafts when used in branched grafts. Compo nent separation in this situation will not only lead to type III endoleak but also possible loss of target vessels (typically, the renal, superior mesenteric, and celiac arteries).…”

mentioning

confidence: 99%

Bridging Stent-Graft Pullout Force Analysis

Grenville

Tan

Tse

et al. 2011

Journal of Endovascular Therapy

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There is a small but significant difference in pullout forces among various bridging stent-grafts. As pullout forces may be one factor contributing to type III endoleaks in complex endovascular repairs involving fenestrated and branched stent-grafts, further study is warranted to compare these grafts clinically to determine if they perform differently. According to this study, the theoretical advantages associated with the Viabahn stent-graft make it a strong choice for minimizing branch dislocations.

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“…In ambient air, the maximum pullout force was 2.9 N, increasing when wet (3.9 N) and especially when wet and pressurized (6.3 and 6.5 N at 100 and 120 mm Hg, respectively). Cinà et al 13 tested the pullout forces needed to disconnect iliac limbs from main bodies, reporting forces between 2.5±0.5 and 11.2±0.6 N for components of the same stent-graft system. When combining components of different manufacturers, pullout forces increased to a range between 2.4±0.22 and 13.08±0.82 N. 13 Last, Bosman et al 14 evaluated pullout forces of main body endografts in bovine aortas.…”

Section: Discussionmentioning

confidence: 99%

“…Cinà et al 13 tested the pullout forces needed to disconnect iliac limbs from main bodies, reporting forces between 2.5±0.5 and 11.2±0.6 N for components of the same stent-graft system. When combining components of different manufacturers, pullout forces increased to a range between 2.4±0.22 and 13.08±0.82 N. 13 Last, Bosman et al 14 evaluated pullout forces of main body endografts in bovine aortas. Depending on neck length, they reported a longitudinal pullout force between 10.7 and 20.8 N with a sealing length of 15 mm and between 6.0 and 17.0 N with a 10-mm sealing length.…”

Section: Discussionmentioning

confidence: 99%

In Vitro Evaluation of the Gore Viabahn Balloon-Expandable Stent-Graft for Fenestrated Endovascular Aortic Repair

et al. 2019

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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.

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A Study of Pullout Forces of the Components of Modular Multi-manufacturer Hybrid Endografts Used for Aortic Aneurysm Repair

Abstract: The hybrid SGSs performed as well as or better than the non-hybrid systems, and should be considered for clinical testing in patients whose unique anatomy warrants the flexibility that the use of hybrids provides.

Cited by 17 publications

References 22 publications

Hybrid Endograft Solution for Complex Iliac Anatomy: Zenith Body and Excluder Limbs

Hybrid Endograft Solution for Complex Iliac Anatomy: Zenith Body and Excluder Limbs

Bridging Stent-Graft Pullout Force Analysis

In Vitro Evaluation of the Gore Viabahn Balloon-Expandable Stent-Graft for Fenestrated Endovascular Aortic Repair

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