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1.
PLoS One ; 16(6): e0252986, 2021.
Article in English | MEDLINE | ID: mdl-34161344

ABSTRACT

The current method of controlling the focus of an accommodating intraocular lens is based on ciliary muscle contraction and cannot be used in older patients with presbyopia. We aimed to develop a dynamically accommodating intraocular lens powered by a membrane-shaped ion polymer metal composite actuator that is thin enough to be inserted in the eye. This study addresses two key problems identified in our previous accommodating intraocular lens prototype: the lack of repeatability due to the use of swine lenses instead of artificial lenses and the occurrence of a sixth order aberration. Thus, we present a new accommodating intraocular lens design and a method to transfer energy to actuators. To accommodate lens deformation and depth of focus, we used a membrane-shaped ion polymer metal composite actuator, thin enough to be inserted in the eye, and used an artificial silicone lens. To prevent the sixth order aberration, we included a ring between the ion polymer metal composite actuator and the lens. Different voltage patterns were applied to the IPMC actuator and changes in focus were observed. We were able to obtain repeatability and prevent the sixth order aberration. The dioptric power changed to ±0.23 D when ±1.5 V was used; however, at >1.5 V, a large accommodating range occurred, in addition to astigmatic vision. Thus, we have developed a novel prototype that is completely artificial, allowing reproducible and repeatable results. Visual accommodative demands were successfully met; however, although astigmatic vision was lessened, it was not completely eradicated.


Subject(s)
Accommodation, Ocular/physiology , Lens Implantation, Intraocular/standards , Lenses, Intraocular/standards , Metals/chemistry , Polymers/chemistry , Prosthesis Design/standards , Animals , Humans , Swine
2.
Sci Rep ; 11(1): 5225, 2021 03 04.
Article in English | MEDLINE | ID: mdl-33664448

ABSTRACT

Unicompartimental and total knee arthroplasty is one of the most successful and most performed operations worldwide. In the last years the number of primary knee arthroplasty increased constantly. The aim of this study is to analyze the rising numbers of primary knee arthroplasty and to see how it is used in Germany. In this retrospective study data, provided by the Federal Statistical Office of Germany from 2008 to 2018 was analyzed, using operation codes from the German procedure classification system and characteristics like age, sex and type of the prosthesis. We found a slight increase of unicompartimental and total knee arthroplasty over the investigated 10 years from 150.504 in 2008 up to 168.479 procedures in 2018, with a maximum of 169.334 in 2017. Most patients were female and over 65 years old. Interestingly, there was an obvious decrease of regular TKA in the year 2013, with a relevant impact on the total number of procedures. In the following years the number rised again reaching the former level in 2015 and is still increasing. The highest increase was found in partial knee arthroplasty, with a constant rise every year, starting with 7988 in 2008 up to 21.072 in 2018. In contrast, we found a relevant reduction of constrained prosthesis in primary TKA, whereas the number of semi-constrained prosthesis in primary TKA is again rising after a decrease in 2015. We found that the number of bicondylar TKA and especially UKA increased from 2008 to 2018. Regarding an aging population, we can expect a rising number for Primary knee arthroplasty and in consequence a rising number of revision arthroplasty in the future. This will be a challenging cost factor for the healthcare system in Germany.


Subject(s)
Aging/pathology , Arthroplasty, Replacement, Knee/statistics & numerical data , Knee Prosthesis , Osteoarthritis, Knee/surgery , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Osteoarthritis, Knee/epidemiology , Osteoarthritis, Knee/pathology , Prosthesis Design/standards , Prosthesis Failure , Reoperation
3.
Circulation ; 143(2): 178-196, 2021 01 12.
Article in English | MEDLINE | ID: mdl-33428433

ABSTRACT

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.


Subject(s)
Aortic Valve/surgery , Calcinosis/surgery , Heart Valve Prosthesis Implantation/standards , Heart Valve Prosthesis/standards , Mitral Valve/surgery , Prosthesis Design/standards , Aortic Valve/diagnostic imaging , Calcinosis/diagnostic imaging , Cardiac Catheterization/methods , Cardiac Catheterization/standards , Cardiac Catheterization/trends , Heart Valve Prosthesis/trends , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/trends , Humans , Mitral Valve/diagnostic imaging , Mitral Valve Annuloplasty/methods , Mitral Valve Annuloplasty/standards , Mitral Valve Annuloplasty/trends , Prosthesis Design/methods , Prosthesis Design/trends
4.
Ann Thorac Surg ; 111(1): 314-326, 2021 01.
Article in English | MEDLINE | ID: mdl-33036738

ABSTRACT

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.


Subject(s)
Heart Valve Prosthesis Implantation/standards , Heart Valve Prosthesis/standards , Prosthesis Design/standards , Decision Trees , Humans
5.
Gait Posture ; 81: 41-48, 2020 09.
Article in English | MEDLINE | ID: mdl-32663775

ABSTRACT

BACKGROUND: Minimum Toe Clearance (MTC) is defined as the minimum vertical distance between the lowest point under the front part of the foot and the ground, during mid-swing. Low values of MTC and walking on inclines are both related to higher probability of tripping and falling in lower limb amputees. New prosthetic designs aim at improving MTC, especially on ramps, however the real effect on MTC still needs investigation. The objective of this study was then to evaluate the effect of different prosthetic designs on MTC in inclined walking. METHODS: Thirteen transtibial amputees walked on a ramp using three different prostheses: non articulating ankle (NAA), articulating hydraulic ankle (AHA), and articulating hydraulic ankle with microprocessor (AHA-MP). Median MTC, coefficient of variation (CV), and tripping probability (TP) for obstacles of 10 and 15 mm were compared across ankle type in ascent and descent. FINDINGS: When using AHA-MP, larger MTC median values for ascending (P ≤ 0.001, W = 0.58) and descending the ramp (P = 0.003, W = 0.47) were found in the prosthetic limb. Also significantly lower CV was found on the prosthetic limb for both types of AHA feet when compared to NAA for descending the ramp (P = 0.014, W = 0.45). AHA-MP showed the lowest TP for the prosthetic leg in three conditions evaluated. On the sound limb results showed the median MTC was significantly larger (P = 0.009, W = 0.43) and CV significantly lower (P = 0.005, W = 0.41) when using an AHA in ascent. INTERPRETATION: Both AHA prosthetic designs help reduce the risk of tripping of the prosthetic limb by increasing the median MTC, lowering its variability and reducing TP for both legs when ascending and descending the ramp. For most of the conditions, AHA-MP showed the lowest TP values. Findings suggest that AHA prostheses, especially AHA-MP could reduce the risk of tripping on ramps in amputees.


Subject(s)
Amputation, Surgical/adverse effects , Artificial Limbs/standards , Biomechanical Phenomena/physiology , Gait/physiology , Prosthesis Design/standards , Tibia/surgery , Toes/physiopathology , Adult , Female , Humans , Male , Walking
6.
Mil Med ; 185(Suppl 1): 490-499, 2020 01 07.
Article in English | MEDLINE | ID: mdl-32074296

ABSTRACT

INTRODUCTION: Powered prostheses are a promising new technology that may help people with lower-limb loss improve their ability to perform locomotion tasks. Developing active prostheses requires robust design methodologies and intelligent controllers to appropriately provide assistance to the user for varied tasks in different environments. The purpose of this study was to validate an impedance control strategy for a powered knee and ankle prosthesis using an embedded sensor suite of encoders and a six-axis load cell that would aid an individual in performing common locomotion tasks, such as level walking and ascending/descending slopes. MATERIALS AND METHODS: Three amputees walked on a treadmill and four amputees walked on a ramp circuit to test whether a dual powered knee and ankle prosthesis could generate appropriate device joint kinematics across users. RESULTS: Investigators found that tuning 2-3 subject-specific parameters per ambulation mode was necessary to render individualized assistance. Furthermore, the kinematic profiles demonstrate invariance to walking speeds ranging from 0.63 to 1.07 m/s and incline/decline angles ranging from 7.8° to 14°. CONCLUSION: This work presents a strategy that requires minimal tuning for a powered knee & ankle prosthesis that scales across a nominal range of both walking speeds and ramp slopes.


Subject(s)
Amputation, Surgical/psychology , Amputees/psychology , Electric Impedance/therapeutic use , Joint Prosthesis/standards , Walking/physiology , Amputation, Surgical/adverse effects , Amputees/rehabilitation , Biomechanical Phenomena , Humans , Prosthesis Design/standards
7.
BMC Musculoskelet Disord ; 21(1): 114, 2020 Feb 21.
Article in English | MEDLINE | ID: mdl-32085766

ABSTRACT

BACKGROUND: Several modern designs of metal-backed glenoids (MBG) have been devised to overcome flaws such as loosening and a high failure rate. This review aimed to compare rates of complications and revision surgeries between cemented polyethylene glenoid (PEG) and three examples of modern MBG designs. METHODS: Literature search was carried out using PubMed, Cochrane Library, EMBASE, and Google Scholar using MeSH terms and natural keywords. A total of 1186 articles were screened. We descriptively analyzed numerical data between the groups and statistically analyzed the categorical data, such as the presence of radiolucent line, loosening, and revision surgery (failure). Articles were divided into three groups based on follow-up duration: < 36-month, 36-72-month, and > 72-month subgroups. RESULTS: This study included 35 articles (3769 shoulders); 25 on cemented PEG and ten on the modern MBG. Mean age was 66.4 (21-93) and 66.5 years (31-88). The mean duration of follow-up was 73.1 (12-211) and 56.1 months (24-100). Overall, the rate of the radiolucent line was 354/1302 (27%) and 47/282 (17%), the loosening rate was 465/3185 (15%) and 22/449 (5%), and the failure rate was 189/3316 (6%) and 11/457 (2%), for PEG and MBG, respectively. The results of < 36-month and 36-72-month subgroups showed lower rates of radiolucency and loosening in the cemented PEG group, but there was no significant difference in failure rate (P = 0.754 and 0.829, respectively). In the > 72-month subgroup, MBG was better in terms of loosening (P < 0.001) and failure rates (P = 0.006). CONCLUSIONS: The modern MBG component, especially TM glenoid, seems to be a promising alternative to cemented PEGs, based on subgroup revision rates according to the follow-up duration and overall results of ROM and clinical scores. All polyethylene glenoids tend to increase loosening and failure over time. Three modern MBG designs seem to have no difference in failure, at least in the < 36-month and 36-72-month subgroups compared to the cemented PEG. More long-term follow-up studies on modern MBG should be ultimately conducted. LEVEL OF EVIDENCE: Level IV, systematic review.


Subject(s)
Arthroplasty, Replacement, Shoulder/trends , Bone Cements , Joint Prosthesis/trends , Prosthesis Design/trends , Reoperation/trends , Shoulder Joint/surgery , Arthroplasty, Replacement, Shoulder/adverse effects , Arthroplasty, Replacement, Shoulder/standards , Bone Cements/standards , Humans , Joint Prosthesis/standards , Metals/standards , Polyethylene/standards , Prosthesis Design/standards
8.
Magn Reson Imaging ; 68: 18-29, 2020 05.
Article in English | MEDLINE | ID: mdl-31981709

ABSTRACT

PURPOSE: We exploited 4-dimensional flow magnetic resonance imaging (4D Flow), combined with a standardized in vitro setting, to establish a comprehensive benchmark for the systematic hemodynamic comparison of surgical aortic bioprosthetic valves (BPVs). MATERIALS AND METHODS: 4D Flow analysis was performed on two small sizes of three commercialized pericardial BPVs (Trifecta™ GT, Carpentier-Edwards PERIMOUNT Magna and Crown PRT®). Each BPV was tested over a clinically pertinent range of continuous flow rates within an in vitro MRI-compatible system, equipped with pressure transducers. In-house 4D Flow post-processing of the post-valvular velocity field included the quantification of BPV effective orifice area (EOA), transvalvular pressure gradients (TPG), kinetic energy and viscous energy dissipation. RESULTS: The 4D Flow technique effectively captured the 3-dimensional flow pattern of each device. Trifecta exhibited the lowest range of velocity and kinetic energy, maximized EOA (p < 0.0001) and minimized TPGs (p ≤ 0.015) if compared with Magna and Crown, these reporting minor EOA difference s (p ≥ 0.042) and similar TPGs (p ≥ 0.25). 4D Flow TPGs estimations strongly correlated against ground-truth data from pressure transducers; viscous energy dissipation proved to be inversely proportional to the fluid jet penetration. CONCLUSION: The proposed 4D Flow analysis pinpointed consistent hemodynamic differences among BPVs, highlighting the not negligible effect of device size on the fluidynamic outcomes. The efficacy of non-invasive 4D Flow MRI protocol could shed light on how standardize the comparison among devices in relation to their actual hemodynamic performances and improve current criteria for their selection.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve/diagnostic imaging , Benchmarking , Bioprosthesis/standards , Heart Valve Prosthesis/standards , Magnetic Resonance Imaging , Prosthesis Design/standards , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Hemodynamics , Humans , Imaging, Three-Dimensional , In Vitro Techniques , Kinetics
9.
Artif Organs ; 44(7): E263-E276, 2020 Jul.
Article in English | MEDLINE | ID: mdl-31971269

ABSTRACT

In order to simulate hemodynamics within centrifugal blood pumps and to predict pump hemolysis, CFD simulations must be thoroughly validated against experimental data. They must also account for and accurately model the specific working fluid in the pump, whether that is a blood-analog solution to match an experimental PIV study or animal blood in a hemolysis experiment. Therefore, the Food and Drug Administration (FDA) benchmark centrifugal blood pump and its database of experimental PIV and hemolysis data were used to thoroughly validate CFD simulations of the same blood pump. A Newtonian blood model was first used to compare to the PIV data with a blood analog fluid while hemolysis data were compared using a power-law hemolysis model fit to porcine blood data. A viscoelastic blood model was then incorporated into the CFD solver to investigate the importance of modeling blood's viscoelasticity in centrifugal pumps. The established computational framework, including a dynamic rotating mesh, animal blood-specific fluid properties and hemolysis modeling, and a k-ω SST turbulence model, was shown to more accurately predict pump pressure heads, velocity fields, and hemolysis compared to previously published CFD studies of the FDA centrifugal pump. The CFD simulations were able to match the FDA pressure and hemolysis data for multiple pump operating conditions, with the CFD results being within the standard deviations of the experimental results. While CFD radial velocity profiles between the impeller blades also compared well to the PIV velocity results, more work is still needed to address the large variability among both experimental and computational predictions of velocity in the diffuser outlet jet. Small differences were observed between the Newtonian and viscoelastic blood models in pressure head and hemolysis at the higher flow rate cases (FDA Conditions 4 and 5) but were more significant at lower flow rate and pump impeller speeds (FDA Condition 1). These results suggest that the importance of accounting for blood's viscoelasticity may be dependent on the specific blood pump operating conditions. This detailed computational framework with improved modeling techniques and an extensive validation procedure will be used in future CFD studies of centrifugal blood pumps to aid in device design and predictions of their biological responses.


Subject(s)
Computer Simulation , Device Approval/standards , Heart-Assist Devices/standards , Models, Cardiovascular , Prosthesis Design/standards , Animals , Blood Flow Velocity/physiology , Blood Viscosity/physiology , Elasticity , Hemolysis/physiology , United States , United States Food and Drug Administration/standards
10.
Bone Joint J ; 102-B(1): 90-101, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31888362

ABSTRACT

AIMS: The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA). METHODS: Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening. Cox proportional hazard regression was the primary analytical approach. Manufacturing variables included resin type, crosslinking radiation dose, terminal sterilization method, terminal sterilization radiation dose, stabilization treatment, total radiation dose, packaging, and face asymmetry. Total radiation dose was further divided into G1 (no radiation), G2 (> 0 Mrad to < 5 Mrad), G3 (≥ 5 Mrad to < 10 Mrad), and G4 (≥ 10 Mrad). RESULTS: A total of 5,329 THAs were revised, 1,290 of which were due to aseptic loosening. Total radiation dose, face asymmetry, and stabilization treatments were found to significantly affect implant survival. G1 had the highest revision risk for any reason and for aseptic loosening and G3 and G4 the lowest. Compared with G1, the adjusted hazard ratio for G2 was 0.74 (95% confidence interval (CI) 0.64 to 0.86), G3 was 0.36 (95% CI 0.30 to 0.43), and G4 was 0.38 (95% CI 0.31 to 0.47). The cumulative incidence of revision for aseptic loosening at 12 years was 0.52 and 0.54 per 100 THAs for G3 and G4, respectively, compared with 1.95 per 100 THAs in G1. Asymmetrical liners had a lower revision risk due to aseptic loosening and reasons other than aseptic loosening compared with symmetric (flat) liners. In G3 and G4, stabilization with vitamin E and heating above melting point performed best. CONCLUSION: Polyethylene liners with a total radiation dose of ≥ 5 Mrad, an asymmetrical liner face, and stabilization with heating above the melting point demonstrate best survival. Cite this article: Bone Joint J 2020;102-B(1):90-101.


Subject(s)
Arthroplasty, Replacement, Hip/standards , Hip Prosthesis/standards , Polyethylene , Adult , Aged , Arthroplasty, Replacement, Hip/instrumentation , Arthroplasty, Replacement, Hip/statistics & numerical data , Biomedical Technology , Female , Hip Prosthesis/statistics & numerical data , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design/standards , Prosthesis Design/statistics & numerical data , Prosthesis Failure , Reoperation/statistics & numerical data , Risk Factors
11.
J Thorac Cardiovasc Surg ; 159(3): 865-896, 2020 03.
Article in English | MEDLINE | ID: mdl-31983522
12.
Disabil Rehabil Assist Technol ; 15(2): 219-224, 2020 02.
Article in English | MEDLINE | ID: mdl-30696308

ABSTRACT

Objective: Despite immense popularity of Jaipur foot as low cost prosthetic, not much work has been reported on its design for manufacturing standardization. Without manufacturing standardization, it cannot be mass produced using contemporary manufacturing technologies. The objective of this work is to carry out its computer aided design (CAD) followed by computer aided engineering (CAE) based on the material properties obtained from the previous work [1] of the authors. This may lead to the possible use of modern manufacturing processes for the Jaipur foot design.Design: After modelling using CAD tool including its organic surfaces, the designed foot was analysed using a CAE tool for balanced standing load conditions to determine maximum stresses and deformation in its various parts. The bending analysis was done to check the dorsiflexion movement so that the strained sections could be identified for more reliable and durable prosthetic foot. For the static load analysis, base of the foot was constrained and 300-500 N load was applied through the bolt whereas for bending, the part near the bolt was fixed and pressure was applied at junction of front foot and toes.Results: The results show that the maximum stress and deformation occur at the bolt, while the skin undergoes maximum strain. CAE analysis also proves the robustness of the Jaipur foot design and a well manufactured Jaipur foot as per standardized design should be able to withstand the real life conditions without failure. The CAD model is also used for FDM based printing for a nonfunctional prototype of Jaipur foot.Implications for rehabilitationThe results of this study will serve as an important guideline for further research regarding equivalent material replacement, material optimization and obtaining an optimized design after studying the foot for dynamic analysis.


Subject(s)
Computer-Aided Design/standards , Foot/physiopathology , Printing, Three-Dimensional/standards , Prostheses and Implants/standards , Prosthesis Design/standards , Humans , Materials Testing/standards
13.
Disabil Rehabil ; 42(1): 63-70, 2020 01.
Article in English | MEDLINE | ID: mdl-30182755

ABSTRACT

Purpose: To gather ideas from lower-limb prosthesis users and certified prosthetists regarding possible residual limb monitoring system features and data presentation. We also gathered information on the type of residual limb problems typically encountered, how they currently manage those problems, and their ideas for methods to better manage them.Materials and methods: Two focus groups were held; one with certified prosthetists and another with lower-limb prosthesis users. Open-ended questions were used in a moderated discussion that was audio recorded, transcribed, and assessed using applied thematic analysis.Results and conclusions: Seven individuals participated in each focus group. Prosthetists came from a mix of practice settings, while prosthesis users were diverse in level of amputation, aetiology, and years of experience using lower-limb prostheses. Residual limb problems reported by participants were consistent with those in the literature. Participants suggested better managing residual limb problems through improved education, better detection of residual limb problems, and using sensor-based information to improve prosthetic technology. Participants favoured short-term use of a possible residual limb monitoring systems to troubleshoot residual limb problems, with temperature and pressure the most frequently mentioned measurements. Participants described that an ideal residual limb monitoring system would be lightweight, not interfere with prosthesis function, and result in benefits with regard to prosthetic care and socket function that outweighed inconveniences or concerns regarding system use. A potential positive of system use included having objective data for reimbursement justification, although it was pointed out that the residual limb monitoring system itself also needed to be reimbursable.Implications for RehabilitationStakeholders suggested better managing residual limb problems through improved education, better detection of residual limb problems, and using sensor-based information to improve prosthetic technology.Stakeholders favored short-term use of a possible system to troubleshoot residual limb problems, with temperature and pressure the most frequently mentioned measurements.Stakeholders described that an ideal residual limb monitoring system would be lightweight, not interfere with prosthesis function, and result in benefits with regard to prosthetic care and socket function that outweighs any inconveniences or concerns regarding system use.Stakeholders indicated that a potential positive of system use included having objective data for reimbursement justification, although it was pointed out that the residual limb monitoring system itself also needed to be reimbursable.


Subject(s)
Amputation Stumps/physiopathology , Amputation, Surgical , Lower Extremity/surgery , Monitoring, Physiologic/methods , Postoperative Complications , Adult , Amputation, Surgical/adverse effects , Amputation, Surgical/methods , Amputation, Surgical/rehabilitation , Artificial Limbs/adverse effects , Artificial Limbs/standards , Female , Humans , Male , Postoperative Complications/diagnosis , Postoperative Complications/rehabilitation , Prosthesis Design/methods , Prosthesis Design/standards , Prosthesis Implantation/adverse effects , Prosthesis Implantation/methods
14.
J Card Fail ; 26(1): 70-79, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31593759

ABSTRACT

BACKGROUND: Left ventricular assist devices (LVADs) offer live-saving therapy to transplant-ineligible heart failure patients. A major limitation of the technology includes pump thrombosis, bleeding, and recurrent infection that prove difficult to predict from in vivo animal testing. Shear stress introduced by the LVAD affects more than just hemolysis because platelets, leukocytes, and plasma proteins all contribute to the propensity for complications. It is important to assess overall damage by a new device against a baseline as early as possible in the development process so that design iterations can be made if required. METHODS: Explanted VADs currently in clinical use (HeartMate 2 and HVAD) were carefully cleaned, inspected, and run at 5 L/min and pressure at 100 mmHg in a standard 500 mL mock circulatory loop using bovine blood. The CentriMag was used as a control pump because of its low blood damage profile. Samples were collected at regular intervals and the following were analyzed: complete cell counts, hemolysis, platelet activation, leukocyte-derived microparticles (LMPs), and von Willebrand factor (vWF) degradation. RESULTS: The HeartMate 2 had the highest levels of hemolysis and platelet activation after 6 hours compared with the HVAD and CentriMag. A decreased granulocyte count, high numbers of LMPs and CD11bBrightHLADR- LMPs, and decreased vWF collagen binding activity was most evident in the HVAD. CONCLUSIONS: The results indicate that it is possible to observe differences between different pump designs during in vitro testing that might translate to clinical performance. This study demonstrates the importance of developing standard in vitro total blood damage methods against which device developers could use to modify design to reduce complication risk long before implantation.


Subject(s)
Benchmarking/standards , Heart Failure/blood , Heart-Assist Devices/standards , Hemolysis/physiology , Platelet Activation/physiology , Prosthesis Design/standards , Animals , Benchmarking/methods , Cattle , Heart Failure/diagnosis , Heart Failure/therapy , Heart-Assist Devices/adverse effects , Hemorrhage/blood , Hemorrhage/diagnosis , Humans , Leukocytes, Mononuclear/metabolism , Prosthesis Design/methods , von Willebrand Factor/metabolism
15.
Braz J Cardiovasc Surg ; 34(5): 618-623, 2019 12 01.
Article in English | MEDLINE | ID: mdl-31719014

ABSTRACT

In aortic valve disease cases, prosthetic valves have been used for valve replacement, however, these prostheses have inherent problems, and their quality in some countries is lower comparing to new-generation models, causing shorter durability. Aortic valve neocuspidization (AVNeo) has emerged as an option, which can be applied to a wide spectrum of these diseases. Despite the promising results, this procedure is not widely spread among cardiac surgeons yet. We developed a surgical technique combining Bentall and Ozaki procedures to treat patients with concomitant ascending aorta replacement and AVNeo and we describe it in this paper.


Subject(s)
Aorta/surgery , Aortic Valve/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis/standards , Prosthesis Design/standards , Humans , Medical Illustration , Reproducibility of Results
16.
Sci Rep ; 9(1): 17379, 2019 11 22.
Article in English | MEDLINE | ID: mdl-31758013

ABSTRACT

The abdominal aortic aneurysm (AAA) anatomy influences the technical success of the endovascular aneurysm repair (EVAR), yet very few data regarding the aortic tree angles exist in the literature. This poses great limitations in the numerical analyses of endografts, constraining their design improvement as well as the identification of their operational limitations. In this study, a matrix Φ of 10 angles was constructed for the description of the pathological region and was implemented on a large dataset of anatomies. More specifically, computed tomography angiographies from 258 patients were analysed and 10 aortic angles were calculated per case, able to adequately describe the overall AAA shape. 9 dimensional variables (i.e. diameters and lengths) were also recorded. The median and extreme values of these variables were computed providing a detailed quantification of the geometrical landscape of the AAA. Moreover, statistical analysis showed that the identified angles presented no strong correlation with each other while no lateral or anterior/posterior symmetry of the AAA was identified. These findings suggest that endograft designers are free to construct any extreme case-studies with the values provided in a mix-and-match manner. This strategy can have a powerful effect in EVAR stent graft designing, as well as EVAR planning.


Subject(s)
Aorta, Abdominal/anatomy & histology , Aorta, Abdominal/pathology , Aortic Aneurysm, Abdominal/pathology , Blood Vessel Prosthesis , Prosthesis Design , Aged , Aged, 80 and over , Aorta, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis/standards , Blood Vessel Prosthesis Implantation , Computed Tomography Angiography , Datasets as Topic/statistics & numerical data , Endovascular Procedures , Female , Follow-Up Studies , Humans , Imaging, Three-Dimensional , Male , Middle Aged , Organ Size , Prosthesis Design/methods , Prosthesis Design/standards , Reference Values , Retrospective Studies , Stents/standards , Tomography, X-Ray Computed
17.
Rev. bras. cir. cardiovasc ; 34(5): 618-623, Sept.-Oct. 2019. tab, graf
Article in English | LILACS | ID: biblio-1042033

ABSTRACT

Abstract In aortic valve disease cases, prosthetic valves have been used for valve replacement, however, these prostheses have inherent problems, and their quality in some countries is lower comparing to new-generation models, causing shorter durability. Aortic valve neocuspidization (AVNeo) has emerged as an option, which can be applied to a wide spectrum of these diseases. Despite the promising results, this procedure is not widely spread among cardiac surgeons yet. We developed a surgical technique combining Bentall and Ozaki procedures to treat patients with concomitant ascending aorta replacement and AVNeo and we describe it in this paper.


Subject(s)
Humans , Aorta/surgery , Aortic Valve/surgery , Prosthesis Design/standards , Heart Valve Prosthesis/standards , Heart Valve Prosthesis Implantation/methods , Heart Valve Diseases/surgery , Reproducibility of Results , Medical Illustration
18.
Eur J Vasc Endovasc Surg ; 58(5): 746-755, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31548160

ABSTRACT

OBJECTIVES: The dynamic endovascular environment of stent grafts may influence long term outcome after endovascular aneurysm repair (EVAR). The sealing and fixation of a stent graft to the aortic wall is challenged at every heartbeat, yet knowledge of the cardiac induced dynamics of stent grafts is sparse. Understanding the stent-artery interaction is crucial for device development and may aid the prediction of failure in the individual patient. The aim of this work was to establish quantitative stent graft motion in multiphasic electrocardiogram (ECG) gated computed tomography (CT) by image registration and segmentation techniques. METHODS: Experimental validation was performed by evaluating a series of ECG gated CT scans of a stent graft moving at different amplitudes of displacement at different virtual heart rates using a motion generating device with synchronised ECG triggering. The methodology was further tested on clinical data of patients treated with EVAR devices with different stent graft designs. Displacement during the cardiac cycle was analysed for points on the fixating stent rings, the branches or fenestrations, and the spine. RESULTS: Errors for the amplitude of displacement measured in vitro at individual points on the wire frame were at most 0.3 mm. In situ cardiac induced displacement of the devices was found to differ per location and also depended on the type of stent graft. Displacement during the cardiac cycle was greatest in a fenestrated device and smallest in a chimney graft sac anchoring endosystem, with maximum displacement varying from 0.0 to 1.4 mm. There was no substantial displacement measurable in the spine. CONCLUSIONS: A novel methodology to quantify and visualise stent graft motion in multiphasic ECG gated CT has been validated in vitro and tested in vivo. This methodology enables further exploration of in situ motion of different stent grafts and branch stents and their interaction with native vessels.


Subject(s)
Computed Tomography Angiography/methods , Electrocardiography/methods , Endovascular Procedures/instrumentation , Hemodynamics , Prosthesis Retention/methods , Radiographic Image Interpretation, Computer-Assisted/methods , Stents/adverse effects , Aortic Aneurysm, Abdominal/surgery , Equipment Failure Analysis/methods , Humans , Materials Testing , Postoperative Complications/etiology , Postoperative Complications/physiopathology , Postoperative Complications/prevention & control , Prosthesis Design/classification , Prosthesis Design/standards
19.
Niger J Clin Pract ; 22(9): 1276-1280, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31489866

ABSTRACT

AIMS: The present study aims to improve the design of cementless femoral prosthesis stem and achieve better bone ingrowth and long-term stability. MATERIALS AND METHODS: Four models with different directional hollow holes at the proximal end of femoral prosthesis were designed and finite element analysis was applied to calculate the magnitude of conducting force within the differently angled holes and the stress distribution of the femur and prosthesis. RESULTS: Holes in prostheses make no difference on the stress values of femoral inner walls. The conducting forces in models trepanned on the lateral plane were 6.60N (0° pore) and 8.40N (45° pore) while forces in models trepanned on the anterior-posterior planes were 0.45N (upper 0° pore), 0.48N (lower 0° pore) and 1.57N (upper 45° pore), 1.51N (lower 45° pore), respectively. CONCLUSION: The position and direction of hollow holes influenced the conducting force in holes but had no influence on stress values of femoral inner walls. Prostheses with one 45° hole trepanned on the lateral plane of proximal prostheses presented best in elevating conducting force.


Subject(s)
Arthroplasty, Replacement, Hip/instrumentation , Femur/surgery , Finite Element Analysis , Hip Prosthesis , Imaging, Three-Dimensional/methods , Prosthesis Design/methods , Arthroplasty, Replacement, Hip/methods , Femur/diagnostic imaging , Humans , Male , Materials Testing , Middle Aged , Porosity , Prosthesis Design/standards , Stress, Mechanical , Tomography, Spiral Computed
20.
J Orthop Surg Res ; 14(1): 279, 2019 Aug 28.
Article in English | MEDLINE | ID: mdl-31462276

ABSTRACT

INTRODUCTION: In this study, we described a positioner which allows a combination of preoperative plan and intraoperative insertion of the cup to improve the reconstruction of the rotation center of the hip. MATERIALS AND METHODS: A retrospective study was conducted on 32 consecutive patients (group A) using this positioner and 40 consecutive patients (group B) using conventional method; radiological parameters and clinical measurements before operation and at last follow-up were collected and evaluated. RESULTS: Group A had a reconstructed center of rotation (COR) that was 0.19 mm closer to the anatomic COR in height (P < 0.005), compared with group B with 3.45 mm vertical dislocation. There were no statistically significant differences in the horizontal displacement between the two groups. The accuracy of cup inclination was 42.14 ± 3.57 in the group A and 38.73 ± 7.65 in the group B (P = 0.015). The accuracy of cup anteversion was 14.82 ± 1.44 in the group A and 13.08 ± 5.95 in the group B (P = 0.082). All cups in the group A were radiologically stable, while one cup in the group B was radiologically unstable and was successfully treated with second-stage revision. Both of the groups obtained a higher mean postoperative Harris Hip Score. CONCLUSIONS: Utilizing this positioner helps to restore the COR position more precisely and provides satisfactory radiological and clinical outcomes in the short term, and more studies are required before its widespread adoption for complicated cases.


Subject(s)
Acetabulum/diagnostic imaging , Acetabulum/surgery , Arthroplasty, Replacement, Hip/instrumentation , Arthroplasty, Replacement, Hip/standards , Hip Prosthesis/standards , Prosthesis Design/standards , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retrospective Studies
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