Eligibility of Endovascular Repair for Popliteal Artery Aneurysms According the Instructions for Use

Hellwig, Konstantin; Hoffmann, Lutz; Rother, Ulrich; Meyer, Alexander; Lang, Werner; Schmid, Axel

doi:10.1016/j.avsg.2020.03.006

Cited by 5 publications

(4 citation statements)

References 19 publications

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“…One recent report found that 39.3% of PAAs were not eligible for Viabahn V R in accordance to IFU. 12 The described discrepancy of non-adherence to IFU might be that the present study reports from a very endovascular-oriented center inherently associated with a higher rate of IFU deviations. The present report appears to be the first to examine the adherence to IFU when treating PAA with stent grafts and analyze the relationship between IFU adherence and outcome.…”

Section: Discussionmentioning

confidence: 58%

Adherence to instruction for use after endovascular repair of popliteal artery aneurysm

et al. 2021

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Objectives Endovascular repair (ER) of popliteal artery aneurysm (PAA) is an alternative to open repair. However, there is no standardized protocol for when to opt for ER and the decision is therefore at the discretion of the clinician. This study aims to evaluate the adherence to the Instruction For Use (IFU) in patients undergoing ER for PAA and factors associated with stent graft patency at one year. Methods The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex follow-up was performed at 30 days and one year. Results The two groups of patients treated within ( n = 10) and not within ( n = 45) IFU did not differ in patient demographics, diagnostic assessment, treatment or outcome. Forty-five patients (81.8%) received stent graft placement with at least one deviation according to IFU. Distal oversizing >20% was the most frequent deviation against IFU ( n = 22, 40.0%). Primary patency at one year was 72%. Diameter size difference >1 mm between overlapping stent grafts (6/14 [43%], p = 0.013) and renal insufficiency (5/12 [42%], p = 0.0086) were associated with lower primary patency at one year. Age-adjusted analysis of tortuosity index (HR 1.78/SD, 95% CI 1.17–2.71; p = 0.0071) and maximal PAA angle (HR 1.73/SD, 95% CI 1.018–2.95; p = 0.043) were associated with major amputation/mortality at end of follow-up. Conclusion The majority of patients undergoing ER for PAA were not treated within IFU. Diameter size difference >1 mm between overlapping stent grafts was associated with a higher loss of primary patency at one year. Multi-center studies with larger sample size and long-term follow up of patency are warranted.

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Section: Discussionmentioning

confidence: 58%

Adherence to instruction for use after endovascular repair of popliteal artery aneurysm

et al. 2021

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“…In fact, to date, different causes have been identified to justify the failure of endovascular treatment, such as infolding, endoleak, or stent-graft dislocation. Thanks to a proper selection of patients to undergo endovascular treatment, many of these causes can be minimized today; but in spite of this, cases of ET failure can be found ( 15 ).…”

Section: Discussionmentioning

confidence: 99%

Observational study of endoluminal mural thrombotic apposition in popliteal artery aneurysm stenting and its relationship with stent-graft geometrical features

Spinella,

Conti,

Magliocco

et al. 2023

Front. Cardiovasc. Med.

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IntroductionThe development of intrastent thrombosis is one of the mechanisms related to medium- to long-term failure of endovascular treatment of popliteal artery aneurysm. The present study aims to investigate possible links between the development of endoluminal mural thrombotic apposition in the stented zone (EMTS) with both geometrical features of stent-graft(s) and time of follow-up.MethodsPatients with popliteal artery aneurysm who underwent endovascular treatment were recruited during the follow-up period. Segmentation of computed tomography angiography scan was performed to detect femoropopliteal artery lumen, leg bones, EMTS, and stent-graft(s). The following parameters were assessed: number, diameter, and length of stent-graft(s); and shape, volume, and length of thrombotic apposition within the stent(s). The spiral shape of the thrombotic apposition was evaluated as well.ResultsEighteen male patients were recruited in the study. EMTS was observed in 13 of them (72%) during the follow-up analysis. An average of 1.8 ± 0.79 stents-grafts were implanted per patient with a median diameter and length of 6.2 (1.9) mm and 125 (50) mm, respectively. The percentage of the stent length where EMTS was present was 42.1 on average (interquartile range: 42.4%) with a mean volume of 206.8 mm3. A positive correlation was found between the length and volume of EMTS (R-squared = 0.71, p < 0.01). Moreover, EMTS had a helical shape in 8/13 patients, with 4/5 with counterclockwise rotation with stent-grafts in the left leg and 3/3 with clockwise direction treated in the right leg. A higher frequency of EMTS was observed in patients with longer follow-up and higher risk factors, as well.ConclusionsEMTS is observed in most of the patients under analysis, especially in those with medium- to long-term follow-up. The pattern of such EMTS follows a helical shape having a direction that depends on which leg, right or left, is treated. Our results suggest a close surveillance of popliteal aneurysm stenting by follow-up examinations to control the onset and progression of EMTS.

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“…However, in the last ten years, there has been a move towards an endovascular approach that uses less invasive methods to restore blood supply by inserting a covered stent inside the popliteal artery itself [ 71 ]. Most cases reported in the literature refer to the use of the VIABAHN GORE, an e-PTFE membrane-coated stent that is superficially functionalized with heparin [ 72 ]. The positioning of this stent-graft allows a rapid switch from angiography to treatment, reducing the time of ischaemia of the lower limb.…”

Section: Clinical Applications Of Covered Stentsmentioning

confidence: 99%

Expanded Polytetrafluoroethylene Membranes for Vascular Stent Coating: Manufacturing, Biomedical and Surgical Applications, Innovations and Case Reports

et al. 2023

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Coated stents are defined as innovative stents surrounded by a thin polymer membrane based on polytetrafluoroethylene (PTFE)useful in the treatment of numerous vascular pathologies. Endovascular methodology involves the use of such devices to restore blood flow in small-, medium- and large-calibre arteries, both centrally and peripherally. These membranes cross the stent struts and act as a physical barrier to block the growth of intimal tissue in the lumen, preventing so-called intimal hyperplasia and late stent thrombosis. PTFE for vascular applications is known as expanded polytetrafluoroethylene (e-PTFE) and it can be rolled up to form a thin multilayer membrane expandable by 4 to 5 times its original diameter. This membrane plays an important role in initiating the restenotic process because wrapped graft stent could be used as the treatment option for trauma devices during emergency situations and to treat a number of pathological vascular disease. In this review, we will investigate the multidisciplinary techniques used for the production of e-PTFE membranes, the advantages and disadvantages of their use, the innovations and the results in biomedical and surgery field when used to cover graft stents.

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Eligibility of Endovascular Repair for Popliteal Artery Aneurysms According the Instructions for Use

Cited by 5 publications

References 19 publications

Adherence to instruction for use after endovascular repair of popliteal artery aneurysm

Adherence to instruction for use after endovascular repair of popliteal artery aneurysm

Observational study of endoluminal mural thrombotic apposition in popliteal artery aneurysm stenting and its relationship with stent-graft geometrical features

Expanded Polytetrafluoroethylene Membranes for Vascular Stent Coating: Manufacturing, Biomedical and Surgical Applications, Innovations and Case Reports

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