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Article ; Online: Health technology assessment for pharmaceuticals in the European Union: what lessons after two decades?

Garattini, L / Bozzetto, M / Nobili, A / Mannucci, P M

2022 Volume 17, Issue 5, Page(s) 1251–1253

MeSH term(s)	European Union ; Health Policy ; Humans ; Pharmaceutical Preparations ; Technology Assessment, Biomedical
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2022-06-08
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2454173-4
ISSN	1970-9366 ; 1828-0447
ISSN (online)	1970-9366
ISSN	1828-0447
DOI	10.1007/s11739-022-03008-7
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Article ; Online: Flow-induced high frequency vascular wall vibrations in an arteriovenous fistula: a specific stimulus for stenosis development?

Bozzetto, Michela / Remuzzi, Andrea / Valen-Sendstad, Kristian

Physical and engineering sciences in medicine

2023 Volume 47, Issue 1, Page(s) 187–197

Abstract: Hemodialysis is the lifeline for nearly three million end stage renal disease patients worldwide. Native arteriovenous fistula (AVF) is the preferred vascular access, but 40% fail within 1 year. We recently demonstrated that AVFs harbour transitional ... ...

Abstract	Hemodialysis is the lifeline for nearly three million end stage renal disease patients worldwide. Native arteriovenous fistula (AVF) is the preferred vascular access, but 40% fail within 1 year. We recently demonstrated that AVFs harbour transitional flows and the goal of the present study was to investigate whether the associated high-frequency pressure fluctuations could promote vibrations within the vascular wall. We acquired MRI images and flow rates immediately after surgery in one patient and generated a 3D patient-specific model. High-fidelity fluid structure interaction simulations revealed the presence of wall vibrations in distinct frequency bands up to 200 Hz and amplitude of 200 μm. A sensitivity analysis to assess the impact of flow rates, and vascular wall stiffness and thickness, changes that typically occur during AVF maturation, confirmed the robustness of the results. Interestingly, the vibrations were always predominant at the anastomosis floor and on the inner venous side, which correlates with typical stenotic regions. As studies seeking to correlate aberrant stresses and vascular remodelling have been largely inconclusive, the focal colocalization between vibrations and stenosis may suggest an unknown mechanobiological process between high-frequency mechanical stresses within the vascular wall and adverse vascular remodelling.
MeSH term(s)	Humans ; Arteriovenous Shunt, Surgical ; Constriction, Pathologic/diagnostic imaging ; Vascular Remodeling ; Vibration ; Arteriovenous Fistula/diagnostic imaging
Language	English
Publishing date	2023-12-29
Publishing country	Switzerland
Document type	Journal Article
ISSN	2662-4737
ISSN (online)	2662-4737
DOI	10.1007/s13246-023-01355-z
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Article ; Online: Hemodynamics in AVF over time: A protective role of vascular remodeling toward flow stabilization.

Soliveri, Luca / Bozzetto, Michela / Brambilla, Paolo / Caroli, Anna / Remuzzi, Andrea

The International journal of artificial organs

2023 Volume 46, Issue 10-11, Page(s) 547–554

Abstract: The mechanisms underlying vascular stenosis formation in the arteriovenous fistula (AVF) for hemodialysis (HD) remain mostly unknown. Several computational fluid dynamics (CFD) studies have suggested a potential role for unsteady flow in inducing intimal ...

Abstract	The mechanisms underlying vascular stenosis formation in the arteriovenous fistula (AVF) for hemodialysis (HD) remain mostly unknown. Several computational fluid dynamics (CFD) studies have suggested a potential role for unsteady flow in inducing intimal hyperplasia and AVF stenosis, but the majority of these observations have been limited to a single time point after surgical creation. The aim of the present study was to investigate the relation between hemodynamic conditions and AVF vascular remodeling through a CFD longitudinal study. Non contrast-enhanced MR images and Doppler Ultrasound (US) examinations were acquired at 3 days, 40 days, 6 months, 1 year, and 1.5 years after surgery in a 72-year male referred for native radio-cephalic AVF. Three-dimensional AVF models were generated and high fidelity CFD simulations were performed using pimpleFoam, setting patient-specific boundary conditions derived from US. Morphological and hemodynamic changes over time were then analyzed. Analysis of vessel morphology and hemodynamics during follow-up showed that the AVF had a successful maturation process, characterized by a massive arterial and venous dilatation within the 6 months after surgery, a corresponding increase in blood flow volume and important flow instabilities. Between 6 months and 1 year, a stenosis developed in the juxta-anastomotic vein and caused AVF failure at 1.5 years. The development of stenosis was paralleled by the regularization of blood flow velocity pattern and consequent decrease in the near-wall disturbed flow metrics. These results suggest that development of intimal hyperplasia and vessel stenosis, triggered by unsteady flow, could be the result of vascular inward remodeling toward regularization of turbulent-like flow.
MeSH term(s)	Humans ; Male ; Arteriovenous Shunt, Surgical/adverse effects ; Arteriovenous Shunt, Surgical/methods ; Longitudinal Studies ; Vascular Remodeling ; Constriction, Pathologic ; Hyperplasia ; Hemodynamics/physiology ; Arteriovenous Fistula ; Renal Dialysis
Language	English
Publishing date	2023-09-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	80456-3
ISSN	1724-6040 ; 0391-3988
ISSN (online)	1724-6040
ISSN	0391-3988
DOI	10.1177/03913988231191960
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Article ; Online: Surgical planning of arteriovenous fistulae in routine clinical practice: A machine learning predictive tool.

Doneda, Martina / Poloni, Sofia / Bozzetto, Michela / Remuzzi, Andrea / Lanzarone, Ettore

The journal of vascular access

2023 , Page(s) 11297298221147968

Abstract: Background: Arteriovenous fistula (AVF) is the preferred vascular access (VA) for hemodialysis, but it is associated with high non-maturation and failure rates. Predicting patient-specific AVF maturation and postoperative changes in blood flow volumes ( ... ...

Abstract	Background: Arteriovenous fistula (AVF) is the preferred vascular access (VA) for hemodialysis, but it is associated with high non-maturation and failure rates. Predicting patient-specific AVF maturation and postoperative changes in blood flow volumes (BFVs) and vessel diameters is of fundamental importance to support the choice of optimal AVF location and improve VA survival. The goal of this study was to employ machine learning (ML) in order to give physicians a fast and easy-to-use tool that provides accurate patient-specific predictions, useful to make AVF surgical planning decisions. Methods: We applied a set of ML approaches on a dataset of 156 patients. Both parametric and non-parametric ML approaches, taking preoperative data as input, were exploited to predict maturation, postoperative BFVs, and diameters. The best approach associated with lowest cross-validation errors between predictions and real measurements was then chosen to provide estimates and quantify prediction errors. Results: The Conclusions: Our data-based approach provided accurate patient-specific predictions for different AVF configurations, requiring short computational time as compared to a physical model we previously developed. By supporting VA surgical planning, this fast computing approach could allow AVF surgical planning and help reducing the rate of non-maturation, which might ultimately have a broad impact on the management of hemodialysis patients.
Language	English
Publishing date	2023-02-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2252820-9
ISSN	1724-6032 ; 1129-7298
ISSN (online)	1724-6032
ISSN	1129-7298
DOI	10.1177/11297298221147968
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Article ; Online: Primary care in a National Health Service: time for radical reform.

Garattini, Livio / Bozzetto, Michela / Remuzzi, Giuseppe / Freemantle, Nick / Nobili, Alessandro

Family practice

2022 Volume 39, Issue 5, Page(s) 994–995

MeSH term(s)	Health Care Reform ; Humans ; Primary Health Care ; State Medicine
Language	English
Publishing date	2022-03-24
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605939-9
ISSN	1460-2229 ; 0263-2136
ISSN (online)	1460-2229
ISSN	0263-2136
DOI	10.1093/fampra/cmac019
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Article ; Online: Velocity vector comparison between vector flow imaging and computational fluid dynamics in the carotid bifurcation.

Poloni, Sofia / Bozzetto, Michela / Du, Yigang / Aiani, Luca / Goddi, Alfredo / Fiorina, Ilaria / Remuzzi, Andrea

Ultrasonics

2022 Volume 128, Page(s) 106860

Abstract: It has been largely documented that local hemodynamic conditions, characterized by low and oscillating wall shear stresses, play a key role in the initiation and progression of vascular atherosclerotic lesions. Thus, investigation of the flow field in ... ...

Abstract	It has been largely documented that local hemodynamic conditions, characterized by low and oscillating wall shear stresses, play a key role in the initiation and progression of vascular atherosclerotic lesions. Thus, investigation of the flow field in the carotid bifurcation can lead to early identification of vulnerable plaques. In this scenario, the development of novel non-invasive imaging tools that can be used in routine clinical practice to identify disturbed and recirculating blood flow becomes crucial. In this context, Vector Flow Imaging is becoming a relevant tool as it provides an angle independent assessment of blood flow velocity and multidimensional flow vector visualization. The purpose of the present study was to validate, in several locations of the carotid bifurcation, the high-frame rate vector flow imaging (HiFR-VFI) technique by comparing with computational fluid dynamic simulations (CFD). In all eight carotid bifurcations, HiFR-VFI accurately detected regions of laminar flow as well as recirculation and unsteady flow areas. An accurate and statistically significant agreement was observed between velocity vectors obtained by HiFR-VFI and those computed by CFD, both for vector magnitude (R = 0.85) and direction (R = 0.74). Our study demonstrated that HiFR-VFI is a valid technique for rapid and advanced visual representation of velocity field in large arteries. Thus, it has a great potential in research-based clinical practice for the identification of flow recirculation, low and oscillating velocity gradients near vessel wall. The use of HiFR-VFI may provide a great improvement in the investigation of the role of local hemodynamics in vascular pathologies, as well in the assessment of the effect of pharmacological treatments.
MeSH term(s)	Hydrodynamics ; Computer Simulation ; Carotid Arteries/diagnostic imaging ; Carotid Arteries/physiology ; Blood Flow Velocity ; Hemodynamics/physiology ; Models, Cardiovascular
Language	English
Publishing date	2022-10-08
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	200839-7
ISSN	1874-9968 ; 0041-624X
ISSN (online)	1874-9968
ISSN	0041-624X
DOI	10.1016/j.ultras.2022.106860
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Article ; Online: Biological and Physical Factors Involved in the Maturation of Arteriovenous Fistula for Hemodialysis.

Remuzzi, Andrea / Bozzetto, Michela

Cardiovascular engineering and technology

2017 Volume 8, Issue 3, Page(s) 273–279

Abstract: One of the most important limitations of hemodialysis (HD) treatment is the vascular access (VA) that is used to connect the patient's blood vessels to the extracorporeal circulation. The arteriovenous fistula (AVF) obtained with native vessels is the VA ...

Abstract	One of the most important limitations of hemodialysis (HD) treatment is the vascular access (VA) that is used to connect the patient's blood vessels to the extracorporeal circulation. The arteriovenous fistula (AVF) obtained with native vessels is the VA of choice for the low incidence of infections and the long-term patency, but it is affected by high incidence of non-maturation or primary failure. Before use for cannulation, AVF must undergo vascular remodeling, with progressive increase in vessel diameter, to accommodate the increase in blood flow. A growing body of evidence indicates that AVF maturation is related to the response of endothelial cells to changes in blood flow and wall shear stress. In the present report we examine the experimental and clinical evidences on the mechanisms that play a role in vascular remodeling during AVF maturation. The physical and biological factors that develop upon arteriovenous surgical connection affect endothelial and smooth muscle cell function, as well as extracellular matrix remodeling. They can explain to a great extent the process of vascular remodeling and put more light on cellular mechanisms of vessel wall adaptation. The understanding of these phenomena, besides indicating the reasons for non-maturation and primary failure, may be fundamental in the future to ameliorate clinical outcomes of AVF creation, with a great impact on the clinical management of HD patients and their quality of life.
MeSH term(s)	Arteriovenous Anastomosis ; Arteriovenous Fistula/physiopathology ; Arteriovenous Shunt, Surgical ; Hemodynamics ; Humans ; Quality of Life ; Renal Dialysis/methods ; Stress, Mechanical ; Vascular Access Devices ; Vascular Patency ; Vascular Remodeling/physiology
Language	English
Publishing date	2017-07-27
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2543111-0
ISSN	1869-4098 ; 1869-408X
ISSN (online)	1869-4098
ISSN	1869-408X
DOI	10.1007/s13239-017-0323-0
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Article ; Online: The use of AVF.SIM system for the surgical planning of arteriovenous fistulae in routine clinical practice.

Bozzetto, Michela / Poloni, Sofia / Caroli, Anna / Curtò, Diego / D'Haeninck, Annick / Vanommeslaeghe, Floris / Gjorgjievski, Nikola / Remuzzi, Andrea

The journal of vascular access

2022 Volume 24, Issue 5, Page(s) 1061–1068

Abstract: Background: The number of patients treated with hemodialysis (HD) in Europe is more than half a million and this number increases annually. The arteriovenous fistula (AVF) is the vascular access (VA) of first choice, but the clinical outcome is still ... ...

Abstract	Background: The number of patients treated with hemodialysis (HD) in Europe is more than half a million and this number increases annually. The arteriovenous fistula (AVF) is the vascular access (VA) of first choice, but the clinical outcome is still poor. A consistent number of AVFs fails to reach the desired blood flow rate for HD treatment, while some have too high flow and risk for cardiac complications. Despite the skill of the surgeons and the possibility to use Ultrasound investigation for mapping arm vasculature, it is still not possible to predict the blood flow volume that will be obtained after AVF maturation. Methods: We evaluated the potential of using a computational model (AVF.SIM) to predict the blood flow volume that will be achieved after AVF maturation, within a multicenter international clinical investigation aimed at assessing AVF.SIM predictive power. The study population included 231 patients, with data on AVF maturation in 124 patients, and on long-term primary patency in 180 patients. Results: At 1 year of follow-up, about 60% of AVFs were still patent, with comparable primary patency in proximal and distal anastomosis. The correlation between predicted and measured blood flow volume in the brachial artery at 40 days after surgery was statistically significant, with an overall correlation coefficient of 0.58 ( Conclusions: The results indicate that the use of the AVF.SIM system allowed to predict with a good accuracy the blood flow volume achievable after VA maturation, for a given location and type of anastomosis. This information may help in AVF surgical planning, reducing the AVFs with too low or too high blood flow, thus improving AVF patency rate and clinical outcome of renal replacement therapy.
MeSH term(s)	Humans ; Arteriovenous Fistula/surgery ; Arteriovenous Shunt, Surgical ; Brachial Artery/surgery ; Renal Dialysis ; Retrospective Studies ; Treatment Outcome ; Upper Extremity/blood supply ; Vascular Patency
Language	English
Publishing date	2022-01-06
Publishing country	United States
Document type	Multicenter Study ; Journal Article
ZDB-ID	2252820-9
ISSN	1724-6032 ; 1129-7298
ISSN (online)	1724-6032
ISSN	1129-7298
DOI	10.1177/11297298211062695
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Article ; Online: Is shear stress the key factor for AVF maturation?

Remuzzi, Andrea / Bozzetto, Michela / Brambilla, Paolo

The journal of vascular access

2017 Volume 18, Issue Suppl. 1, Page(s) 10–14

Abstract: Autologous arteriovenous fistula (AVF) is the preferred choice for providing vascular access to hemodialysis (HD) patients, but it is still affected by high incidence of non-maturation or early failure. After creation, AVF must undergo vascular ... ...

Abstract	Autologous arteriovenous fistula (AVF) is the preferred choice for providing vascular access to hemodialysis (HD) patients, but it is still affected by high incidence of non-maturation or early failure. After creation, AVF must undergo vascular remodeling, a process characterized by an increase in blood vessel diameter and wall thickness, to allow efficient and adequate HD. A growing body of evidence indicates that AVF maturation is related to the response of endothelial cells (ECs) to changes in wall shear stress (WSS), and in particular, to changes of its peak value. The reasons why important number of AVFs are affected by non-maturation or early failure still remain to be elucidated, but it has been suggested that local hemodynamic conditions with highly disturbed flow patterns may play an important role. In the present contribution, we addressed the role of WSS on AVF maturation, clarifying mechanisms that affect the clinical outcome of AVF creation. We also pointed out the need of non-invasive longitudinal studies, with repeated observations of hemodynamic parameters and structural changes during time, to obtain evidence of a cause-and-effect relationship between the presence of disturbed flow and AVF maturation failure. This understanding may be fundamental in the future to ameliorate clinical outcome of AVF creation, with a great impact on the clinical management of HD patients and their quality of life.
MeSH term(s)	Animals ; Arteries/pathology ; Arteries/physiopathology ; Arteries/surgery ; Arteriovenous Shunt, Surgical/adverse effects ; Blood Flow Velocity ; Endothelial Cells/pathology ; Graft Occlusion, Vascular/etiology ; Graft Occlusion, Vascular/pathology ; Graft Occlusion, Vascular/physiopathology ; Humans ; Regional Blood Flow ; Renal Dialysis ; Risk Factors ; Stress, Mechanical ; Time Factors ; Treatment Outcome ; Vascular Patency ; Vascular Remodeling ; Veins/pathology ; Veins/physiopathology ; Veins/surgery
Language	English
Publishing date	2017-03-06
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2252820-9
ISSN	1724-6032 ; 1129-7298
ISSN (online)	1724-6032
ISSN	1129-7298
DOI	10.5301/jva.5000686
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Article ; Online: Arteriovenous fistula creation with VasQ

Bozzetto, Michela / Soliveri, Luca / Poloni, Sofia / Brambilla, Paolo / Curtò, Diego / Condemi, Giuseppina Carmela / Cefalì, Pietro / Spina, Irene / Villa, Alessandro / Caroli, Anna / Remuzzi, Andrea

The journal of vascular access

2022 Volume 25, Issue 1, Page(s) 60–70

Abstract: 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 ... ...

Abstract	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 (VasQ 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 VasQ Conclusions: This study demonstrated the feasibility of characterizing the morphological and hemodynamic changes occurring over time in AVFs created using the VasQ
MeSH term(s)	Humans ; Arteriovenous Fistula ; Arteriovenous Shunt, Surgical/methods ; Constriction, Pathologic ; Feasibility Studies ; Hemodynamics ; Prospective Studies ; Renal Dialysis ; Vascular Patency ; Pilot Projects
Language	English
Publishing date	2022-04-22
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2252820-9
ISSN	1724-6032 ; 1129-7298
ISSN (online)	1724-6032
ISSN	1129-7298
DOI	10.1177/11297298221087160
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