Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae

Shahverdyan, Robert; Tabbi, Paola; Mestres, Gaspar

doi:10.1016/j.jvs.2021.07.120

Cited by 7 publications

(3 citation statements)

References 31 publications

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“…The most common reason for hemodialysis was diabetic nephropathy (Table 1 ). This correlates with the data from the literature sources [ 9 , 10 ]. In all patients, the AVF procedure was performed on the non-prominent arm.…”

Section: Discussionsupporting

confidence: 90%

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients

Liebetrau

Zerwes

Kerndl

et al. 2023

Langenbecks Arch Surg

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Purpose Technical aspects are crucial for planning and performing endovascular arteriovenous fistula (AVF) creation. The Ellipsys® Vascular Access System represents a minimal invasive method for the creation of a proximal forearm fistula. This report summarizes the essential elements for AVF creation with the Ellipsys® Vascular Access System and investigates feasibility, efficacy, and safety procedures conducted on 16 patients. Materials and methods We performed a retrospective analysis of patients who underwent endovascular AVF creation with the Ellipsys® Vascular Access System between May 2020 and March 2022 at a tertiary referral center. Results The median age was 67.5 years (47–86 years). The mean BMI was 31.4 kg/m2. AV fistula was created on 15/16 patients on their left arm. The technical success was 100%. The mean operation time was 24.2 min. There were no complications associated with the procedure. All patients were examined after 30 days (± 5 days). Primary patency after 30 days was 94% (15/16). The mean fistula flow was 681.1 mL/min and the mean AVF diameter was 6.1 mm. Thirteen out of 15 patients met the criteria for potential hemodialysis. Conclusion With the Ellipsys Vascular Access System exist an additional possibility of an AV fistula creation. Based on above findings, the Ellipsys® Vascular Access System represents a feasible, safe, and effective method for AVF creation.

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Section: Discussionsupporting

confidence: 90%

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients

Liebetrau

Zerwes

Kerndl

et al. 2023

Langenbecks Arch Surg

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“…A lot of research has been conducted on improving vascular access outcomes, but no large breakthroughs have taken place since the introduction of the AVF. Most recent innovations focus on optimizing local hemodynamics, but show limited benefits [18], [19]. The supraphysiological flow causing complications remains ever-present, whereas dialysis is only performed for a limited number of hours per week [6].…”

Section: An Implantable Magnetic Drive Mechanism For Non-invasive Art...mentioning

confidence: 99%

An Implantable Magnetic Drive Mechanism for Non-Invasive Arteriovenous Conduit Blood Flow Control

White,

van der Kroft,

van der Bogt

et al. 2024

IEEE Trans. Biomed. Eng.

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Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions. Methods: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses. Results: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9±4.2 N, 46.7±1.9 N, 25.6±0.7 N, 13.5±0.6 N and 6.3±0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every

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“…Recent studies demonstrated the device is safe, and reported improved functional patency for AVFs created using the VasQ TM as compared to AVFs created with conventional surgery. [6][7][8][9][10][11] However, the effect of the device on hemodynamic conditions and its role in regularizing the blood flow have yet to be adequately assessed. We have recently shown that coupling non-contrast enhanced magnetic resonance imaging (MRI) and highresolution CFD provides a promising approach 12 to investigate AVF morphology and hemodynamics, possibly identifying critical hemodynamic conditions that may contribute to AVF remodelling after surgery.…”

Section: Introductionmentioning

confidence: 99%

Arteriovenous fistula creation with VasQ^TM device: A feasibility study to reveal hemodynamic implications

et al. 2022

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Background: Arteriovenous fistula (AVF) is the preferred vascular access (VA) for hemodialysis, but it is still affected by high non-maturation and early failure rates due to stenosis development. Increasing evidence suggests that the presence of turbulent-like flow may play a key role, therefore, to stabilize the flow in the venous segment, an external support device (VasQTM) has been designed. The aim of this study was to provide preliminary evidence of VasQTM impact on AVF hemodynamics as compared to AVFs created with conventional surgery. Methods: In this pilot single-center prospective randomized study six patients were enrolled, three in the VasQ group and three in the control group. Contrast-free magnetic resonance imaging (MRI) scans were acquired at 3 days, 3 months and 1 year after AVF surgery and were used to generate 3D patient-specific models. Computational fluid dynamic (CFD) simulations were performed using pimpleFoam, imposing patient-specific flow waveforms derived from ultrasound (US) examinations at the inlet of the proximal and distal artery, and a traction-free condition at the venous outflow. Morphologic and hemodynamic changes occurring over time were compared between VasQ and control AVFs. Results: Our MRI protocol provided high-quality images suitable for reliable segmentation and reconstruction of patient-specific 3D models of AVFs at all three timepoints in four out of six patients. The VasQTM device maintained the angle between the artery and the vein almost unchanged over time, with a more stable flow in the AVFs supported by the device. In contrast, one of the AVFs of the control group evolved to an extreme dilatation of the vein and highly disturbed flow, while the other developed a stenosis in the juxta-anastomotic region. Conclusions: This study demonstrated the feasibility of characterizing the morphological and hemodynamic changes occurring over time in AVFs created using the VasQTM device and provided preliminary evidence of the potential hemodynamic benefits of its use.

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Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae

Cited by 7 publications

References 31 publications

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients

An Implantable Magnetic Drive Mechanism for Non-Invasive Arteriovenous Conduit Blood Flow Control

Arteriovenous fistula creation with VasQ^TM device: A feasibility study to reveal hemodynamic implications

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Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae

Cited by 7 publications

References 31 publications

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients

An Implantable Magnetic Drive Mechanism for Non-Invasive Arteriovenous Conduit Blood Flow Control

Arteriovenous fistula creation with VasQTM device: A feasibility study to reveal hemodynamic implications

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Arteriovenous fistula creation with VasQ^TM device: A feasibility study to reveal hemodynamic implications