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Minimally invasive vascular interventions with stent deployment have become a popular alternative to conventional open surgery in the treatment of many vascular disorders. However, the high initial success rates of endovascular repairs have been overshadowed by reported complications that cause re-interventions and, in the worst case, morbidity and mortality. The dangerous complications could be mitigated by better choice of device design and by the appropriate positioning of the implant inside the vessel. However, there is currently no possibility for the interventionist to predict the resulting position and the expanded shape of the device for a given patient, before the actual procedure, within the clinical setting. Motivated by this unmet clinical need and the lack of suitable methods, this thesis develops a methodology for modelling virtual deployment of implantable devices inside patient vessels, that features fast computational execution times and can be used in clinical practice. This novel deployment method was developed based on a spring-mass model and was tested in different deployment scenarios, expanding stents inside vessels in the order of seconds. Further, the performance of the novel method was optimised by calibrating a set of parameters with the help of a genetic algorithm, which utilises the outcomes of a finite element analysis as a learning reference. After the calibration, the developed stenting method demonstrated acceptable accuracy as compared to the "gold standard" of the finite element simulation. Finally, on a real patient case, 4 alternative stenting scenarios were investigated by comparing the subsequent blood flow conditions, via computational haemodynamics. The obtained results suggested that device design, dimensions, stiffness and positioning have important implications on the post-procedural haemodynamics of the vessel. Ultimately, the presented results can play a transformative role in aiding clinical decision-making and also give rise to overall improvements in implant design and deployment procedure.

名古屋大学博士学位論文 学位の種類 : 博士(医学)(課程) 学位授与年月日:平成21年3月25日 靍見有史氏の博士論文として提出された

京都大学 / 新制・論文博士 / 博士(医学) / 乙第13584号 / 論医博第2304号 / 新制||医||1070(附属図書館) / (主査)教授 江木 盛時, 教授 湊谷 謙司, 教授 江藤 浩之 / 学位規則第4条第2項該当 / Doctor of Medical Science / Kyoto University / DFAM

La bifurcation coronaire est un site privilégié d’athérosclérose. Jusqu’alors aucune des techniques de stenting provisionnel percutanées avec juxtaposition de ballons n’a démontré de bénéfice clinique. Ces échecs peuvent être expliqués par le non-respect de la géométrie fractale des bifurcations qui pourtant doit toujours guider la revascularisation (correction de la malapposition et optimisation de l’ostium de la branche collatérale). Fort de ce constat, nous avons imaginé une nouvelle technique séquentielle et simple, en 3 temps, le rePOT, associant Proximal Optimizing Technique (POT) initial, ouverture de la branche collatérale et POT final. Son évaluations s’est voulue progressive en 4 étapes : 1) concept, 2) preuve expérimentale de concept, 3) confirmation des bénéfices mécaniques in vivo, et 4) validation clinique. Dans ce travail nous avons donc d’abord expérimentalement démontré la supériorité du résultat mécanique final du rePOT par rapport aux techniques non séquentielles de provisional stenting (manuscrit # 1). Ainsi, le rePOT effondre la malapposition globale du stent, conserve la circularité proximale physiologique et optimise l’obstruction ostiale résiduelle de la branche accessoire. Ces excellents résultats sont confirmés indépendamment du design ou de la composition des stents (manuscrits # 2, 4). Nous avons par ailleurs démontré l’importance de chacune des 3 étapes du rePOT: POT initial (manuscrit # 1), ouverture de SB et POT final (manuscrit # 3). Enfin, fort de ces démonstrations expérimentales, nous avons confirmé in vivo avec mesures OCT itératives à la fois les excellents résultats expérimentaux et la bonne évolution clinique à moyen terme (manuscrit # 5). Ce travail démontre donc étape par étape, de l’expérimentale à la clinique, l’ensemble des bénéfices de cette nouvelle technique séquentielle de stenting provisionnel "rePOT", devenue une référence en Europe dans la revascularisation percutanée des bifurcations coronaires / Coronary bifurcations are a preferential location for atherosclerosis development. Until now, no technic with balloons juxtaposition demonstrated a clinical benefit in percutaneous coronary bifurcation revascularization by provisional stenting (with 1 stent). Successive failures could be explained by the absence of respect of the bifurcations fractal geometry, which need to be systematically followed during all revascularization (correction of the malapposition and optimization of the side branch ostium). Thus, we imagined a new technique, simple and sequential, in 3 steps, named rePOT. It is combining initial Proximal Optimizing Technique (POT), side-branch opening and final POT. We proposed a demonstration in 4 steps : 1) concept, 2) experimental proofs of concept, 3) confirmation of the clinical benefits in vivo, and 4) clinical validation. In this work, we experimentally demonstrated the superiority of the final mechanical results of the rePOT compared to all non-sequential provisional stenting (manuscript # 1). Thus, rePOT decreased stent global malapposition, maintained the initial proximal circularity and optimized the final ostial side branch obstruction. These excellent results were confirmed independently of stent design or material (manuscripts # 2, 4). Moreover, we demonstrated the specific benefits of each steps of the rePOT : initial POT (manuscript # 1), SB opening, and final POT (manuscript # 3). Finally, we confirmed in vivo, with serial OCT analysis, these excellent mechanical results and the good clinical outcome at mid-term. (manuscript # 5). Thank to this step by step demonstration, from experimental to clinic, we confirmed all benefits of this new provisional stenting sequential technique "rePOT". Thereby, before the last step of the demonstration, rePOT became a reference in Europe for the percutaneous revascularization of coronary bifurcations

Background: Sonolysis is an important factor in therapeutic use of ultrasound in patients with cerebrovascular diseases, it is ultrasound induced lysis of thrombus or embolus. The aim of this work was to asses safety and efficacy of therapeutic ultrasound effect (sonolysis) in acute stroke patients and in patients undergoing carotid artery intervention. First partial aim of this work was to confirm the safety and efficacy of endovascular sonolysis by using the EkoSonic Endovascular System in subjects with acute ischemic stroke. Second partial aim of this work was to test the clinical efficacy of sonolysis for reducing the risk of incidence of new brain ischaemic lesions detected on brain magnetic resonance imaging in patients undergoing elective CEA or CAS for severe internal carotid stenosis. In addition, we assessed the effects of sonolysis on cognitive function, morbidity, and mortality at 30 days post-surgery. Methods: Patients with acute ischemic stroke and occlusion of the middle cerebral artery or basilar artery were enrolled consecutively to the prospective study tested safety and efficacy of endovascular sonolysis using the EkoSonic Endovascular System (EKOS) in patients with acute stroke. The control group (44 MCA and 12 BA occlusions) was selected from historical controls. EkoSonic...

Background: Cerebral complications of coronary catheterizations are transient ischemic attack (TIA) and stroke. Silent stroke (SCI) does not cause acute neurological dysfunction. It might cause many disorders including dementia. Sonolysis is therapeutic method. Sonolysis should be the method for reducing the risk of symptomatic and asymptomatic brain ischemic lesions in patients undergoing elective coronary angioplasty or stenting. Aims: To analyse patients with cardiac disease indicated for elective coronary catheterization: 1) Assess the incidence of acute/subacute SCI on brain magnetic resonance (MR) imaging; 2) Investigate factors influencing the frequency and type of microembolic signals (MES) detected using transcranial Doppler (TCD) in patients undergoing elective coronary intervention, and to correlate the frequency and type of MES with detection of new brain ischemic lesions using MR. Examine changes in cognitive function at 30 days post procedure in relation to pretreatment scores; 3) Test the clinical efficacy and safety of perioperative sonolysis in patients undergoing elective coronary catheterization. Methods: 1) 144 patients were enrolled to the study. Brain MR was performed before cardiac intervention. The presence of acute and subacute SCI was evaluated, SCI volume was measured and risk...

Unterschiedliche zerebrale Protektionssysteme zur Verhinderung neurologischer Ereignisse während einer Karotis-Angioplastie sind derzeit im Einsatz. Dennoch zeigen Studien, dass diese Systeme die distale Mikroembolisation während der Intervention nicht vollständig verhindern können. Die vorliegende Arbeit vergleicht die Effektivität von zwei verschiedenen Protektionssystemen unter Anwendung der Methode der transkraniellen Dopplersonographie (TCD). Es wurden 42 Patienten mit einer hochgradigen Stenose der A. carotis interna während der Karotisangioplastie mit Stentimplantation untersucht. Zur Neuroprotektion wurde entweder ein Filtersystem (E.P.I. FilterWireTM, Boston Scientific, USA) oder ein proximales Ballonokklusionssystem (MO.MA-System Invatec, Italien) verwendet. Bei jedem Patienten erfolgte während der Intervention mittels TCD die Detektion der mikroembolischen Signale (MES). Die Anzahl der MES wurde während fünf verschiedener Prozedurphasen gezählt und miteinander verglichen. Die Ergebnisse der Arbeit zeigen, dass die Karotis-Angioplastie unter Schutz des MO.MA-Systems vor allem in den Phasen der Passage der Stenose, der Stentimplantation und der Nachdilatation mit signifikant niedrigeren MES assoziiert war, verglichen zur Angioplastie der A. carotis interna unter einem Filtersystem.

<p>Paper A: In this paper, the development and implementation of a contact algorithm based on C2-continuous surface representations is discussed. In 3D contact simulations involving models with arbitrarily curved surfaces (as in the case of vessel walls), the discretization of the contact surfaces by means of facet-based techniques could lead to numerical instabilities and finally loss of quadratic convergence. These instabilities arise mainly due to the sliding of contractor (slave) nodes over the boundaries of target (master) contact facets, where jumps of the normal vector are experienced. The paper addresses successfully this problem, by discretization of the target surfaces by means of C2-continuous parameterization schemes. Initially, the uniform cubic B-spline surfaces are introduced. Next, in an attempt for more accurate representations of the geometric models of the contact surfaces, a new parameterization based on the expression of cubic B-splines is developed. The two approaches are implemented into a finite element framework and more specifically, into the multipurpose finite element analysis program FEAP. The special merits of the developed algorithms and the advantages of the smooth surfaces over facet-based approaches are exhibited through a classical contact mechanics problem, considering incompressibility, finite deformations and large slidings. Next, a simulation of balloon angioplasty with stenting is presented, where the contact between both medical devices (balloon and stent) with the arterial wall is modeled. The arterial wall is modeled in this first approach, as hyperelastic, homogeneous, isotropic, while a cylindrically orthotropic model is developed to capture the nonlinear, anisotropic behavior of the balloon catheter under pressure. Two stents with the same geometry but different strut thickness, are studied. Both are considered elasto-plastic. The performed simulations point out the outcome of the balloon angioplasty and stenting in terms of luminal gain and mechanical strains. Finally, a comparison between the two stent configurations is presented.</p><p>Paper B: The second paper makes use of the contact tool developed in Paper A and focuses on the changes of the mechanical environment of the arterial wall due to stenting, as a function of a set of stent design parameters. In particular, Paper B presents a detailed geometric and material model of a postmortem human iliac artery, composed by distinct tissue components, each associated with specific mechanical properties. The constitutive formulation for the artery considers anisotropic, highly nonlinear mechanical characteristics under supraphysiological loadings. The material and structural parameters of the arterial model are obtained through uniaxial tensile tests on stripes extracted from the several arterial tissues that form the stenosis, axially and circumferentially oriented. Through cooperation with a well-established stent manufacturing company, an iliac stent was acquired. The dimensions of the stent are measured under a reflected-light microscope, while it is parameterized in such a way as to enable new designs to be simply generated through variations of its geometric parameters. The 3D balloon-stent-artery interaction is simulated by making use of the smooth contact surfaces with C2-continuity, as previously mentioned. Next, scalar quantities attempt to characterize the arterial wall changes after stenting, in form of contact forces induced by the stent struts, stresses within the individual components and luminal change. These numerically derived quantities allow the determination of the most appropriate stent configuration for an individual stenosis. Therefore, the proposed methodology has the potential to provide a scientific basis for optimizing treatment procedures, stent material and geometries on a patient-specific level.</p>

Darbo tikslas – įvertinti miego arterijų angioplastikos ir stentavimo ankstyvuosius ir vėlyvuosius rezultatus bei poveikį darančius veiksnius. Metodai. Tyrimo metu vertintos VMAS procedūros atliktos 2006-2013 metais. Iš viso buvo atliktos 227 procedūros 211 pacientų; iš jų 156 (75,3 proc.) vyrams ir 55 (24,7 proc.) moterims. Rezultatai. Tyrimas atskleidė, kad esant 3 aortos lanko tipui VMAS procedūros trukmė buvo reikšmingai ilgesnė, o mikroembolai apsaugos sistemose buvo nustatyti dažniau. Mikroembolai apsaugos sistemose buvo nustatyti dažniau kai VMAS procedūra truko ilgiau. Apsaugos sistemos atliekant VMAS procedūrą buvo naudotos 70,9 proc. pacientų. Vyrams ir jaunesnio amžiaus pacientams VMAS procedūros metu apsauga buvo taikyta dažniau. Mikroembolai apsaugos sistemose buvo nustatyti 17,6 proc. pacientų ir dažniau buvo nustatyti naudojant FilterWire EZ ir Embo-shield-NAV apsaugos sistemas. Didesnė dešinės VMA stenozė buvo dažnesnė rūkantiems pacientams, o kairės VMA sirgusiems miokardo infarktu bei rūkantiems. Apsauga dažniau buvo taikyta pacientams kurie turėjo didelio laipsnio kairės VMA stenozę. Ankstyvuoju po procedūriniu periodu vyrų ir moterų mirštamumas atitinkamai buvo 1,2 proc. ir 1,8 proc., o 2 metų laikotarpyje buvo 18,7 proc. ir 28,6 proc. Pacientų mirštamumas 2 metų laikotarpyje, kuriems buvo naudotos apsaugos sistemos buvo mažesnis. Galimybę patirti komplikacijas (GSI ar PSIP) didino 3 aortos lanko tipas ir dešinės bendrosios miego arterijos stenozė, mažino... [toliau žr. visą tekstą] / The aim - to assess the carotid artery angioplasty and stenting early and late results and influencing factors. Methods. The study assessed CAS procedures performed in 2006-2013. A total of 227 procedures performed in 211 patients, of which 156 (75.3%) males and 55 (24.7%) females. Results. The study revealed that CAS procedure duration among patient with 3 aortic arch type was significantly longer and the microemboli protection systems were used more frequently. Protection systems were used more frequently when the CAS procedure lasted longer. Protection systems in CAS procedure was used in 70.9% patients. In men and younger patients protection system has been used more frequently. Microemboli in the protection systems have been identified by 17.6% patients and were more determined using the EZ FilterWire and Emboshield-NAV protection system. Increased right ICA stenosis was more common in patients who smoke, and left ICA with a history of myocardial infarction and smoking. Protection system was often used in patients who have had severe left ICA stenosis. The lethality rate in the early post procedural period among men and women was 1.2% and 1.8%, and in 2-year period was 18.7% and 28.6%, respectively. The lethality rate during 2-year period, which have been used for protective systems have been lower. The possibility to experience complications (stroke or TIA) increased 3 aortic arch type and the right common carotid artery stenosis, reduced protection systems using. Focal... [to full text]