Comparison of Second-Generation Stents for Application in the Superficial Femoral Artery: An In Vitro Evaluation Focusing on Stent Design

Müller‐Hülsbeck, Stefan; Schäfer, Philipp; Charalambous, N.; Yagi, Hiroshi; Heller, Martin; Jahnke, Thomas

doi:10.1583/10-3069.1

Cited by 44 publications

(27 citation statements)

References 18 publications

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“…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: 99%

“…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: 99%

Section: Circulationmentioning

confidence: 99%

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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“…This study was further integrated by Meoli et al [38], who used FEA coupled to fatigue analysis to investigate two in vitro set-ups proposed by the literature [39,40] and to increase the understanding of fatigue behaviour of commercial Nitinol stents. Their results indicate that the two investigated testing conditions produce quite a different fatigue behaviour both in terms of constant-life diagram and strain distribution in the stents.…”

Section: Discussionmentioning

confidence: 99%

Patient-specific finite element analysis of popliteal stenting

et al. 2016

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Nitinol self-expanding stents are used for the endovascular management of peripheral artery diseases of the popliteal artery, which is located behind the knee joint. Unfortunately, the complex kinematics of the artery during the leg flexion leads to severe loading conditions, favouring the mechanical failure of the stent, calling for a specific biomechanical analysis. For this reason, in the present study we reconstruct by medical image analysis the patient-specific popliteal kinematics during leg flexion, which is subsequently exploited to compute the mechanical response of a stent model, virtually implanted in the artery by structural finite element analysis (FEA). The medical image analysis indicates a non-uniform configuration change of the artery during the leg flexion, leading to an increase of the vessel curvature above the knee. The computed mechanical response of the stent reflects the non-uniform configuration change of the artery as after the flexion the average stress is higher in the part of the stent located above the knee. Although the proposed analysis is limited to a case-study, it shows the capability of patient-specific FEA simulations to compute the mechanical response of a stent model subjected to the complex and severe loading conditions of the popliteal artery during leg flexion

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“…Muller-Hulsbeck et al . 82 performed fatigue testing of seven FPA stent designs in air at 37 °C and under 40% compression, 40° bending, and 30°/cm torsion. Stents were subjected to 5000–650,000 loading cycles, and the observed fracture rates are summarized in Table 2.…”

Section: Design Considerations For Improved Mechanical Performancementioning

confidence: 99%

Nitinol Stents in the Femoropopliteal Artery: A Mechanical Perspective on Material, Design, and Performance

et al. 2018

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Endovascular stenting has matured into a commonly used treatment for peripheral arterial disease (PAD) due to its minimally invasive nature and associated reductions in short-termmorbidity and mortality. The mechanical properties of the superelastic Nitinol alloy have played a major role in the explosion of peripheral artery stenting, with modern stents demonstrating reasonable resilience and durability. Yet in the superficial femoral and popliteal arteries, even the newest generation Nitinol stents continue to demonstrate clinical outcomes that leave significant room for improvement. Restenosis and progression of native arterial disease often lead to recurrence of symptoms and reinterventions that increase morbidity and health care expenditures. One of the main factors thought to be associated with stent failure in the femoropopliteal artery (FPA) is the unique and highly dynamic mechanical environment of the lower limb. Clinical and experimental data demonstrate that the FPA undergoes significant deformations with limb flexion. It is hypothesized that the inability of many existing stent designs to conform to these deformations likely plays a role in reconstruction failure, as repetitive movements of the leg and thigh combine with mechanical mismatch between the artery and the stent and result in mechanical damage to both the artery and the stent. In this review we will identify challenges and provide a mechanical perspective of FPA stenting, and then discuss current research directions with promise to provide a better understanding of Nitinol, specific features of stent design, and improved characterization of the biomechanical environment of the FPA to facilitate development of better stents for patients with PAD.

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Comparison of Second-Generation Stents for Application in the Superficial Femoral Artery: An In Vitro Evaluation Focusing on Stent Design

Cited by 44 publications

References 18 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

Patient-specific finite element analysis of popliteal stenting

Nitinol Stents in the Femoropopliteal Artery: A Mechanical Perspective on Material, Design, and Performance

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