In Vivo Evaluation of Customized Aortic Repair Using a Novel Survival Model

Doorschodt, Benedict M.; Brom, H. L. F.; Vries, A.C. de; Meers, Caroline Marie F; Jacobs, Michael J.

doi:10.1016/j.ejvs.2016.05.009

Cited by 5 publications

(3 citation statements)

References 23 publications

(12 reference statements)

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“… 20 21 Before clinical application, to prove feasibility and safety several in vitro and in vivo experimental studies with AneuFix have been conducted and published. 20 25 Recently, we published our initial experience and short-term results of T2EL treatment with AneuFix, for patients with AAA growth with T2EL after EVAR during follow-up. 26 …”

Section: Methods and Analysismentioning

confidence: 99%

Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol

Smorenburg,

Lely,

Jacobs

et al. 2024

BMJ Open

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IntroductionType II endoleaks (T2ELs) following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) can lead to aneurysm growth, compromising the stent graft seal and risking rupture. Preventing these endoleaks during EVAR involves filling the AAA sac around the stent graft to exclude the aneurysm and block any arteries causing the endoleak. This study investigates the feasibility and safety of using AneuFix, a biocompatible injectable polymer developed by TripleMed (Geleen, the Netherlands), for aneurysmal sac filling during EVAR in high-risk T2EL patients.Methods and analysisA feasibility, single-arm, single-centre clinical trial will initially include five patients with infrarenal AAA, eligible for EVAR, and at high risk for T2EL based on the number of patent lumbar arteries and the cross-sectional area of the aortic lumen at the level of the inferior mesenteric artery. Postevaluation by the Data Safety and Monitoring Board, the study cohort will extend to 25 patients. During EVAR and after stent graft deployment, the aneurysm sac is filled with AneuFix polymer using a filling sheath positioned parallel to the contralateral limb with the tip inside the aneurysm sac. Primary outcome is technical success (successful AAA sac filling). The secondary outcomes include clinical success at 6 and 12 months (occurrence of T2ELs and AAA growth assessed with CT angiography), intraoperative and perioperative complications, all endoleaks, adverse events, re-interventions, aneurysm rupture and patient survival.Ethics and disseminationThis trial was approved by the Dutch Authorities (Central Committee on Research Involving Human Subjects, IGJ), Amsterdam University Medical Centre Ethical Commission, and adheres to the Declaration of Helsinki and European Medical Device Regulation. Results will be shared at (inter)national conferences and in peer-reviewed journals.Trial registration numberNCT04307992.

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Section: Methods and Analysismentioning

confidence: 99%

Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol

Smorenburg,

Lely,

Jacobs

et al. 2024

BMJ Open

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“…Doorschodt et al describen en su estudio el método CAR (customized aortic repair) para la reparación de AAA que consiste en el uso de un balón con forma similar a un hueso, mientras que el resto del saco se llena con polímero, demostrando su potencial para el tratamiento en AAA. Por otro lado, los autores mencionan la necesidad de validar esta técnica en humanos 44 y la literatura actual menciona una alta mortalidad al utilizar esta técnica 45 .…”

Section: Modelos De Reconstrucción Endovascular En Especies Mayoresunclassified

Desarrollo, técnicas y utilidad de modelos animales experimentales de aneurismas aórticos torácicos y abdominales

Bravo-Reyna,

Mejía-Cervantes,

Verduzco-Vázquez

et al. 2024

ACM

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Los aneurismas son una de las entidades clínicas que pueden desarrollarse y afectar la aorta humana. Aunque en la mayoría de los casos tienen un carácter asintomático, estas dilataciones patológicas pueden resultar letales cuando se presentan con ruptura, por lo que el reconocimiento de factores predictores de esta complicación es crucial para evitar muertes. Fisiopatológicamente se han identificado eventos esenciales que ocurren en la pared del vaso, como inflamación, proteólisis, apoptosis del músculo liso, angiogénesis y remodelación. Las grandes especies como porcinos y ovinos han sido de utilidad para el desarrollo y evaluación del desempeño de dispositivos endovasculares en la aorta, así como la remodelación; con el advenimiento y disposición de estas técnicas mínimamente invasivas para su reparación existe una menor disponibilidad de tejido aórtico para el análisis molecular, celular e histopatológico, por lo que en las últimas tres décadas se han propuesto e introducido distintos modelos que han permitido, mediante la inducción focal de estas lesiones, el estudio de los mecanismos fisiopatológicos y posibles biomarcadores de utilidad como dianas diagnósticas y terapéuticas. El presente artículo de revisión aborda tipos de modelos animales disponibles, así como sus aplicaciones, consideraciones, ventajas y limitaciones para el desarrollo de estudios preclínicos y su importancia en el entendimiento de esta patología en la especie humana.

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“…This may be a result of caudal migration of the polymer and/or dilation of the aortic neck as a result of disease progression. Deployment of a self expanding stent covering the tapered edges of the cast, as described by Doorschodt et al, 13 may prevent non-apposition between polymer and aortic wall.…”

Section: Limitationsmentioning

confidence: 99%

Haemodynamics in Different Flow Lumen Configurations of Customised Aortic Repair for Infrarenal Aortic Aneurysms

Overeem¹,

Vries

Boersen

et al. 2019

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS This paper investigates the haemodynamics in three different flow lumen configurations of a custom, noncontained, non-cross linked polymer based endovascular approach in treating abdominal aortic aneurysms. The most favourable configuration was established by identifying flow velocity, vorticity, wall shear stress, and time averaged wall shear stress in an in vitro set up with laser particle imaging velocimetry. Based on the results, future research should focus on clinical applicability. Objective: Customised aortic repair (CAR) is a new and minimally invasive technique for the endovascular treatment of abdominal aortic aneurysms (AAAs). The aneurysm is completely sealed with a non-contained, non-cross linked polymer, while a new flow lumen is created with balloons. For CAR, the haemodynamically most favourable balloon and flow lumen configuration has not been established before; therefore, four flow parameters were assessed in an in vitro model. Methods: Three in vitro balloon configurations were implanted in an in vitro AAA model; a configuration with crossing balloons (CC) and two parallel configurations (PC1 and PC2). These three models were consecutively placed in a flow system that mimics physiological flow conditions. Laser particle imaging velocimetry (PIV) was used to resolve spatial and temporal flow patterns during the cardiac cycle. In house built algorithms were used to analyse the PIV data for the computing of (i) flow velocity; (ii) vorticity; (iii) wall shear stress (WSS); and (iv) time averaged wall shear stress (TAWSS). Results: Suprarenal flow patterns were similar in all models. The CC showed a higher infrarenal velocity than PC1 and PC2 (38 cm/s vs. 23 cm/s vs. 23 cm/s), and a higher vorticity at the crossing of the lumens (CC: 337/s; PC1 127/s; PC2: 112/s). The lowest vorticity was observed in PC2, especially in the infrarenal neck (CC: 200/s; PC1 164/s; PC2: 98/s). Although WSS and TAWSS varied between configurations, values were in the within non-pathological range. Conclusion: The flow lumens created by three balloon configurations used in an in vitro model of CAR have been studied, and resulted in different haemodynamics. The differences in velocity and lower vorticity, especially at the crossing section of the two balloons, showed that PC2 has favourable haemodynamics compared with the CC and PC1. Future research will be focused on the clinical applicability of CAR based on the PC2 design.

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In Vivo Evaluation of Customized Aortic Repair Using a Novel Survival Model

Abstract: The feasibility and mid-term biological safety of the CAR method for minimally invasive aneurysm repair was demonstrated using a simulated aneurysm survival model.

Cited by 5 publications

References 23 publications

Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol

Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol

Desarrollo, técnicas y utilidad de modelos animales experimentales de aneurismas aórticos torácicos y abdominales

Haemodynamics in Different Flow Lumen Configurations of Customised Aortic Repair for Infrarenal Aortic Aneurysms

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