Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions

Nikanorov, Alexander; Smouse, H. Bob; Osman, Karim; Bialas, Michael; Shrivastava, Sadhana; Schwartz, Lewis B.

doi:10.1016/j.jvs.2008.02.029

Cited by 140 publications

(107 citation statements)

References 31 publications

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“…[19][20][21] The lack of broad acceptance for PA stent placement is mainly attributable to the fear of stent fractures, with possible subsequent restenosis in this vascular bed with high biomechanical stress next to the knee joint. 7,9,16,22,23 Published data support assumptions that stent design and technical aspects during stent deployment (eg, stent elongation, stent overlap) play major roles in the appearance of stent fractures. 6,8,9 However, the incidence of fractures in second-generation stents was low and ranged between 0% and 8.1% during a 1-year follow-up.…”

Section: Discussionmentioning

confidence: 89%

“…7,9,16,22,23 Published data support assumptions that stent design and technical aspects during stent deployment (eg, stent elongation, stent overlap) play major roles in the appearance of stent fractures. 6,8,9 However, the incidence of fractures in second-generation stents was low and ranged between 0% and 8.1% during a 1-year follow-up. 6,13,17,24,25 Whether the stent fracture rate in the PA location might increase with longer duration of follow-up is not yet known and should be studied separately.…”

Section: Discussionmentioning

confidence: 89%

“…Because of excessive mechanical forces applied to the PA during motion, the PA is considered a no-stent zone, and stent placement is currently reserved for suboptimal results after PTA, such as significant recoil, flow-limiting dissection, or significant residual stenosis. [7][8][9] The goal of this prospective, multicenter, randomized trial was to investigate the efficacy and safety of NS placement compared with PTA for the treatment of obstructive lesions in the PA.…”

Section: Circulationmentioning

confidence: 99%

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Stent Placement Versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery

Rastan

Krankenberg

Baumgartner³

et al. 2013

Circulation

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G reater life expectancy and the increasing prevalence of diabetes mellitus in the developing world have led to a progressive rise in the number of patients with peripheral artery disease. Intermittent claudication and critical limb ischemia are the most common symptoms in patients with lowerextremity peripheral artery disease. 1-3 Editorial see p 2475 Clinical Perspective on p 2541Besides conservative therapy and bypass surgery, endovascular therapy has been established as a treatment option for femoropopliteal obstructive disease.2,3 During the past decade, randomized trials revealed that with increasing lesion length, nitinol stent (NS) placement frequently provides better patency, target-lesion revascularization (TLR) rates, and clinical improvement than percutaneous transluminal balloon angioplasty (PTA) alone after treatment of superficial femoral artery (SFA) lesions, including the proximal segment Background-Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery. Methods and Results-This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P=0.002). Targetlesion revascularization rates were 14.7% and 44.1%, respectively (P=0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class (P=0.31). Conclusions-Primary

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Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 89%

Section: Circulationmentioning

confidence: 99%

See 1 more Smart Citation

Stent Placement Versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery

Rastan

Krankenberg

Baumgartner³

et al. 2013

Circulation

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“…Both the artery and the stent undergo complex three-dimensional deformations, which over time lead to device fatigue and stent fracturing, and to the artery wall tissue stimulation and in-stent restenosis. For example, using planar radiography on human cadaver models, Nikanorov and his colleagues determined axial strains (from 3% to 23% for various locations) for stented and unstented SFA at 70°/20° and 90°/90° knee/hip flexion [3]. Using static in vivo MRI of the SFA, Cheng and his colleagues measured significant shortening (13% ± 11%) and twisting (60% ± 34%) of unstented SFA between supine and fetal positions [4].…”

Section: Introductionmentioning

confidence: 99%

Vascular stents: Coupling full 3-D with reduced-order structural models

Avdeev¹,

Shams²

2010

IOP Conf. Ser.: Mater. Sci. Eng.

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“…); unfortunately it has been observed that many of these stents implanted in peripheral vessels are fractured [3]- [4]. Currently, several peripheral stent designs are available on a dedicated, fast-growing market exhibiting a variable ability to withstand chronic deformation depending on stent design and the type of applied deformation [5], moreover many stent designs are designed only to survive under a standard pulsatile fatigue environment. Numerical simulations have shown to be a very useful tool in the investigation and optimization of stent design [6]- [7] and to provide novel insights on fatigue/fracture mechanics [8].…”

Section: Introductionmentioning

confidence: 99%

Numerical simulation of Nitinol p eripheral stents: from laser-cutting to deployment in a patient specific anatomy

Conti

Auricchio

Beule

et al. 2009

ESOMAT 2009 - 8th European Symposium on Martensitic Transformations

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Abstract.The current clinical trend is to use percutaneous techniques, exploiting Nitinol self-expanding stents, to treat peripheral occluded vessels such as carotid or superficial femoral arteries. Although this class of stents addresses the biomechanical requirements (i.e. flexibility, kink resistance, etc.), it has been observed that many of these stents implanted in peripheral vessels are fractured. Numerical simulations have shown to be very useful in the investigation and optimization of stents and also to provide novel insights into fatigue/fracture mechanics. To date most finite element based stent simulations are performed in a straight simplified anatomy and neglect the actual deployment process; consequently there is a need for more realistic simulations taking into account the different stages of the stent design process and the insertion in the target anatomy into account. This study proposes a virtual framework to analyze numerically Nitinol stents from the laser-cutting stage to the deployment in a (patient specific) tortuous anatomy.

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Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions

Cited by 140 publications

References 31 publications

Stent Placement Versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery

Stent Placement Versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery

Vascular stents: Coupling full 3-D with reduced-order structural models

Numerical simulation of Nitinol p eripheral stents: from laser-cutting to deployment in a patient specific anatomy

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