Design and evaluation of a novel subatmospheric pressure bioreactor for the preconditioning of tissue-engineered vascular constructs.

PURPOSE: The pre-conditioning of tissue-engineered vascular scaffolds with mechanical stimuli is being recognised as an essential step in producing a functional vascular construct. In this study we design and evaluate a novel bioreactor, which exerts a mechanical strain on developing vascular scaffolds via subatmospheric pressure. METHODS: We design and construct a bioreactor, which exerts subatmospheric pressure via a vacuum assisted closure unit. Vascular scaffolds seeded with human umbilical endothelial cells were evaluated for structural integrity, microbial contamination, cellular viability, von Willebrand factor (VWF) production, cell proliferation and morphology under a range of subatmospheric pressures (75-200mmHg). RESULTS: The bioreactor produced sustained subatmospheric pressures, which exerted a mechanical strain on the vascular scaffold. No microbial contamination was found during the study. The structural integrity of the vascular construct was maintained. There was no difference in cellular viability between control or subatmospheric pressure groups (p = 0.817). Cells continued to produce VWF under a range of subatmospheric pressures. Cells subjected to subatmospheric pressures of 125mmHg and 200mmHg exhibited higher levels of growth than cells in atmospheric pressure at 24 (p≤0.016) and 48 hour (p≤0.001). Negative pressure affected cellular morphology, which were more organised, elongated and expanded when exposed to subatmospheric pressure. CONCLUSIONS: We have constructed and validated a novel subatmospheric bioreactor. The bioreactor maintained a continuous subatmospheric pressure to the vascular scaffolds in a stable, sterile and constant environment. The bioreactor exerted a strain on the vascular sheets, which was shown to alter cellular morphology and enhance cellular proliferation.

Determining the influence of calcification on the failure properties of abdominal aortic aneurysm (AAA) tissue.

Varying degrees of calcification are present in most abdominal aortic aneurysms (AAAs). However, their impact on AAA failure properties and AAA rupture risk is unclear. The aim of this work is evaluate and compare the failure properties of partially calcified and predominantly fibrous AAA tissue and investigate the potential reasons for failure. Uniaxial mechanical testing was performed on AAA samples harvested from 31 patients undergoing open surgical repair. Individual tensile samples were divided into two groups: fibrous (n=31) and partially calcified (n=38). The presence of calcification was confirmed by fourier transform infrared spectroscopy (FTIR). A total of 69 mechanical tests were performed and the failure stretch (λf), failure stress (σf) and failure tension (Tf) were recorded for each test. Following mechanical testing, the failure sites of a subset of both tissue types were examined using scanning electron microscopy (SEM)/energy dispersive X-ray spectroscopy (EDS) to investigate the potential reasons for failure. It has been shown that the failure properties of partially calcified tissue are significantly reduced compared to fibrous tissue and SEM and EDS results suggest that the junction between a calcification deposit and the fibrous matrix is highly susceptible to failure. This study implicates the presence of calcification as a key player in AAA rupture risk and provides further motivation for the development of non-invasive methods of measuring calcification.

The biaxial biomechanical behavior of abdominal aortic aneurysm tissue.

Rupture of the abdominal aortic aneurysm (AAA) occurs when the local wall stress exceeds the local wall strength. Knowledge of AAA wall mechanics plays a fundamental role in the development and advancement of AAA rupture risk assessment tools. Therefore, the aim of this study is to evaluate the biaxial mechanical properties of AAA tissue. Multiple biaxial test protocols were performed on AAA samples harvested from 28 patients undergoing open surgical repair. Both the Tangential Modulus (TM) and stretch ratio (λ) were recorded and compared in both the circumferential (Ï´) and longitudinal (L) directions at physiologically relevant stress levels, the influence of patient specific factors such as sex, age AAA diameter and status were examined. The biomechanical response was also fit to a hyperplastic material model. The AAA tissue was found to be anisotropic with a greater tendency to stiffen in the circumferential direction compared to the longitudinal direction. An anisotropic hyperelastic constitutive model represented the data well and the properties were not influenced by the investigated patient specific factors however, a future study utilizing a larger cohort of patients is warranted to confirm these findings. This work provides further insights on the biomechanical behavior of AAA and may be useful in the development of more reliable rupture risk assessment tools.

The impact of long term freezing on the mechanical properties of porcine aortic tissue.

BACKGROUND: Preservation of the native artery׳s functionality can be important in both clinical and experimental applications. Although, simple cryopreservation techniques offer an attractive solution to this problem, the extent to which freezing affects the tissue׳s properties is widely debated. Earlier assessments of the mechanical properties post-freezing have been limited by one or more of the following: small sample numbers, uncontrolled inter-specimen/animal variability, failure to account for the impact of potential errors in thickness measurements, short storage times and uniaxial test methods. MATERIAL AND METHODS: Biaxial mechanical tests were performed on porcine aortic samples (n=89) extracted from superior, middle and inferior regions of five aortas, stored in isotonic saline at -20°C for 1 day, 1 week, 1, 6 and 12 months, thawed and retested. The sample׳s weight and thickness were also measured pre and post-freezing. A total of 178 tests were performed and elastic modulus was assessed by calculating the slope of the Cauchy stress-stretch curve at the low and high stretch regions in both the circumferential (θ) and longitudinal (L) directions. RESULTS: The weight of the samples increased post-freezing. However, in general, no significant difference was found between the elastic modulus of porcine aortic tissue before and after freezing at -20°C and was unaffected by storage time. Although more accurate measuring instruments are warranted to confirm this finding, minor changes to the elastic modulus as a result of freezing were negatively correlated with regional variances i.e. changes in the elastic modulus decreased from the superior to the inferior region. CONCLUSIONS: These results indicate that for applications which require preservation of the gross mechanical properties, storing the tissue at -20°C in isotonic saline, for an extended period of time, is acceptable.

The biaxial mechanical behaviour of abdominal aortic aneurysm intraluminal thrombus: classification of morphology and the determination of layer and region specific properties.

Intraluminal thrombus (ILT) is present in 75% of clinically-relevant abdominal aortic aneurysms (AAAs) yet, despite much research effort, its role in AAA biomechanics remains unclear. The aim of this work is to further evaluate the biomechanics of ILT and determine if different ILT morphologies have varying mechanical properties. Biaxial mechanical tests were performed on ILT samples harvested from 19 patients undergoing open surgical repair. ILT were separated into luminal, medial and medial/abluminal layers. A total of 356 tests were performed and the Cauchy stress (σ) and tangential modulus (TM) at a stretch ratio (λ) of 1.14 were recorded for each test in both the circumferential (θ) and longitudinal (L) directions. Our data revealed three distinct types of ILT morphologies, each with a unique set of mechanical properties. All ILT layers were found to be isotropic and inhomogeneous. Type 1 (n=10) was a multi-layered ILT (thick medial/abluminal layer) whose strength and stiffness decreased gradually from the luminal to the medial/abluminal layer. Type 2 (n=6) was a multi-layered ILT (thin/highly degraded medial/abluminal layer) whose strength and stiffness decreased abruptly between the luminal and medial/abluminal layer and Type 3 (n=3) is a single layered ILT with a lower strength and stiffness than Types 1 and 2. In a sub-study, we found the luminal layer to be stronger and stiffer in the posterior than the anterior region. This work provides further insights to the biomechanical behaviour of ILT and the use of our ILT classification may be useful in future studies.

3D-Printed Tissue-Mimicking Phantoms for Medical Imaging and Computational Validation Applications.

Abdominal aortic aneurysm (AAA) is a permanent, irreversible dilation of the distal region of the aorta. Recent efforts have focused on improved AAA screening and biomechanics-based failure prediction. Idealized and patient-specific AAA phantoms are often employed to validate numerical models and imaging modalities. To produce such phantoms, the investment casting process is frequently used, reconstructing the 3D vessel geometry from computed tomography patient scans. In this study the alternative use of 3D printing to produce phantoms is investigated. The mechanical properties of flexible 3D-printed materials are benchmarked against proven elastomers. We demonstrate the utility of this process with particular application to the emerging imaging modality of ultrasound-based pulse wave imaging, a noninvasive diagnostic methodology being developed to obtain regional vascular wall stiffness properties, differentiating normal and pathologic tissue in vivo. Phantom wall displacements under pulsatile loading conditions were observed, showing good correlation to fluid-structure interaction simulations and regions of peak wall stress predicted by finite element analysis. 3D-printed phantoms show a strong potential to improve medical imaging and computational analysis, potentially helping bridge the gap between experimental and clinical diagnostic tools.

Evaluation of xenogenic extracellular matrices as adjuvant scaffolds for the treatment of stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Tissue-engineered biomaterials have shown recent promise as adjuvant scaffolds for treating stress urinary incontinence (SUI). The objective of the present study was to compare their mechanical and regenerative properties with synthetic biomaterials in this urogynaecological setting. METHODS: The biomechanical properties of polypropylene (Serasis®; n = 12), four-ply urinary bladder matrix (UBM; n = 12) and four-ply small intestinal submucosa (SIS; n = 12) were determined with uni-axial tensile testing protocols and compared with stress-strain curves. Subsequently, human dermal fibroblasts (2.5 × 10(4)cells/cm(2)) were cultured onto each biomaterial under conventional laboratory growth conditions for 12 consecutive days. Attachment, viability, and proliferative activity of fibroblasts were evaluated and compared using quantitative viability indicators and scanning electron microscopy. RESULTS: There were no significant differences in the biomechanical properties of each biomaterial assessed. Incremental stiffness at 0-10 % strain measured 5.73 ± 0.36 MPa for polypropylene compared with 8.23 ± 0.92 MPa and 6.81 ± 0.83 MPa for SIS and UBM respectively (p > 0.05). Viability and proliferative activity of fibroblasts differed significantly on all three biomaterials with the luminal and abluminal surfaces of the UBM demonstrating significantly greater rates of fibroblast proliferation compared with polypropylene and SIS (p < 0.01). CONCLUSION: This is the first comparative study on porcine UBM, porcine SIS, and synthetic polypropylene as adjuvant scaffolds for the treatment of SUI. Our results demonstrate that porcine UBM may provide an attractive alternative owing to its superior remodelling potential.

Comparison of methods used to measure the thickness of soft tissues and their influence on the evaluation of tensile stress.

Measuring the physical dimensions of soft tissue is difficult due to its deformable nature. Such measurements are used to evaluate the tissue's mechanical properties. Imprecise measurements of the tissue's thickness can alter the assessment of tensile stress which may have significant clinical relevance when used as a diagnostic tool. The performance of routinely used measurement methods including a (i) vernier calipers, (ii) micrometer, (iii) thickness gauge, (iv) glass slide technique coupled with (i) and (ii) and a (v) laser displacement sensor were assessed by comparing them to a photogrammetric technique which was considered to be the measurement standard. All measurements were performed on two tissue types: porcine aorta and human intraluminal thrombus from an abdominal aortic aneurysm (AAA) and results were compared against predetermined criteria whose limits represented a 10% change in experimentally derived tensile stress. The inter-rater and retest reliability of the vernier calipers, micrometer and thickness gauge were also investigated. The thickness gauge was shown to be the most reliable and could accurately measure the thickness of aortic tissue. The conditions of the criteria were not met by any instrument used to measure the thickness of the AAA intraluminal thrombus, however, the micrometer, which proved highly reliable, was considered the most suitable (effects on tensile stress: +14.7%). For both tissues the glass slide and laser techniques significantly over estimated the thickness measurement altering the tensile stress by up to -29.6%. This study highlights the effects of inaccurate measurements on the assessment of tensile stress and recommends a thickness gauge be used to measure structured tissue (aorta) and a micrometer for unstructured tissue (AAA intraluminal thrombus).

Cell-seeded extracellular matrices for bladder reconstruction: an ex vivo comparative study of their biomechanical properties.

PURPOSE: Autogenous ileal tissue remains the gold-standard biomaterial for bladder replacement purposes; however, cell-seeded extracellular matrix (ECM) scaffolds have shown promise. Although the biological advantages of cell-seeded ECMs in urological settings are well documented, there is a paucity of data available on their biomechanical properties. In this study, the biomechanical properties of cell-seeded ECMs are compared with autogenous ileal tissue. METHODS: Human urothelial cells (UCs) and smooth muscle cells (SMCs) were obtained by bladder biopsy and cultured onto porcine urinary bladder matrix (UBM) scaffolds under dynamic and static growth conditions for 14 days. The biomechanical properties of cell-seeded UBM (n = 12), and porcine ileum (n = 12) were determined with uni-axial tensile testing protocols and compared with stress-strain curves. In addition, their biomechanical properties were compared with porcine bladder tissue (n = 12) and unseeded UBM (n = 12). RESULTS: There were significant differences in the biomechanical properties of each biomaterial assessed. Strain to failure occurred at 92 ± 24% for dynamically cultured cell-seeded UBM compared to 42.2 ± 5.20% for ileal tissue (p<0.01). Values for linear stiffness at 30% strain were significantly lower in dynamically cultured cell-seeded UBM compared to ileal tissue (0.36 ± 0.14 MPa versus 0.67 ± 0.32 MPa respectively, p<0.01). Bladder tissue remained the most distensible biomaterial throughout, with linear stiffness measuring 0.066 ± 0.034 MPa at 30% strain. CONCLUSIONS: Dynamically cultured cell-seeded ECMs are biomechanically superior to ileal tissue for bladder replacement purposes. Additional comparative in vivo studies will be necessary before their role as a reliable alternative is clearly established.

Spherical indentation of free-standing acellular extracellular matrix membranes.

Numerous scaffold materials have been developed for tissue engineering and regenerative medicine applications to replace or repair damaged tissues and organs. Naturally occurring scaffold materials derived from acellular xenogeneic and autologous extracellular matrix (ECM) are currently in clinical use. These biological scaffold materials possess inherent variations in mechanical properties. Spherical indentation or ball burst testing has commonly been used to evaluate ECM and harvested tissue due to its ease of use and simulation of physiological biaxial loading, but has been limited by complex material deformation profiles. An analytical methodology has been developed and applied to experimental load-deflection data of a model hyperelastic material and lyophilized ECM scaffolds. An optimum rehydration protocol was developed based on water absorption, hydration relaxation and dynamic mechanical analysis. The analytical methodology was compared with finite element simulations of the tests and excellent correlation was seen between the computed biaxial stress resultants and geometry deformations. A minimum rehydration period of 5 min at 37°C was sufficient for the evaluated multilaminated ECM materials. The proposed approach may be implemented for convenient comparative analysis of ECM materials and source tissues, process optimization or during lot release testing.

Finite element and photoelastic modelling of an abdominal aortic aneurysm: a comparative study.

Rupture prediction of abdominal aortic aneurysms (AAAs) remains a clinical challenge. Finite element analysis (FEA) may allow for improved identification for intervention timing, but the method needs further substantiation. In this study, experimental photoelastic method and finite element techniques were compared using an idealised AAA geometry. There was good agreement between the numerical and experimental results. At the proximal and distal end of the AAA model, the maximum differences in principle strain for an internal pressure of 120 mmHg had differences ranging from 0.03 to 10.01%. The maximum difference in principle strain for the photoelastic and the finite element model at a pressure of 120 mmHg was 0.167 and 0.158, respectively. The current research strengthens the case for using FEA as an adjunct to the current clinical practice of utilising diameter measurement for intervention timing.

Construction and evaluation of urinary bladder bioreactor for urologic tissue-engineering purposes.

OBJECTIVE: To design and construct a urinary bladder bioreactor for urologic tissue-engineering purposes and to compare the viability and proliferative activity of cell-seeded extracellular matrix scaffolds cultured in the bioreactor with conventional static growth conditions. MATERIALS AND METHODS: A urinary bladder bioreactor was designed and constructed to replicate physiologic bladder dynamics. The bioreactor mimicked the filling pressures of the human bladder by way of a cyclical low-delivery pressure regulator. In addition, cell growth was evaluated by culturing human urothelial cells (UCs) on porcine extracellular matrix scaffolds in the bioreactor and in static growth conditions for 5 consecutive days. The attachment, viability, and proliferative potential were assessed and compared with quantitative viability indicators and by fluorescent markers for intracellular esterase activity and plasma membrane integrity. Scaffold integrity was characterized with scanning electron microscopy and 4',6-diamidino-2-phenylindole staining. RESULTS: No significant difference in cell viability was identified between both experimental groups after 3 days of culture (P = .06). By day 4, the number of viable UCs was significantly greater in the bioreactor compared with the number cultured under static conditions (P = .009). A significant difference in UC viability was also present after 5 days of culture between the bioreactor and static group (P = .006). Viability/cytotoxicity assays performed on day 5 also confirmed the viability of UCs in both experimental groups. CONCLUSION: Significantly greater UC growth occurred on the extracellular matrix scaffolds cultured in the bioreactor compared with conventional static laboratory conditions after 3 days of culture. Our initial bioreactor prototype might be helpful for permitting additional advances in urinary bladder bioreactor technology.

Augmentation cystoplasty and extracellular matrix scaffolds: an ex vivo comparative study with autogenous detubularised ileum.

BACKGROUND: Augmentation cystoplasty (AC) with autogenous ileum remains the current gold standard surgical treatment for many patients with end-stage bladder disease. However, the presence of mucus-secreting epithelium within the bladder is associated with debilitating long-term complications. Currently, decellularised biological materials derived from porcine extracellular matrix (ECM) are under investigation as potential augmentation scaffolds. Important biomechanical limitations of ECMs are decreased bladder capacity and poor compliance after implantation. METHODOLOGY/PRINCIPAL FINDINGS: In the present ex vivo study a novel concept was investigated where a two-fold increase in ECM scaffold surface-area relative to the resected ileal segment was compared in ovine bladder models after AC. Results showed that bladder capacity increased by 40 ± 4% and 37 ± 11% at 10 mmHg and compliance by 40.4 ± 4% and 39.7 ± 6% (ΔP = 0-10 mmHg) after AC with ileum and porcine urinary bladder matrix (UBM) respectively (p < 0.05). Comparative assessment between ileum and UBM demonstrated no significant differences in bladder capacity or compliance increases after AC (p > 0.05). CONCLUSIONS: These findings may have important clinical implications as metabolic, infective and malignant complications precipitated by mucus-secreting epithelium are potentially avoided after augmentation with ECM scaffolds.

Evaluation of viability and proliferative activity of human urothelial cells cultured onto xenogenic tissue-engineered extracellular matrices.

OBJECTIVES: To evaluate the viability and proliferative activity of human urothelial cells (HUCs) cultured on tissue-engineered extracellular matrix scaffolds and to assess the potential of extracellular matrixes to support the growth of HUCs in their expected in vivo urine environment. METHODS: HUCs were obtained by bladder biopsy and cultured onto the luminal and abluminal surfaces of decellularized porcine small intestinal submucosa (SIS) and porcine urinary bladder matrix (UBM). In addition, HUCs were cultured in optimal in vitro growth conditions and in their expected in vivo urine environment. The attachment, viability, and proliferative activity of HUCs were evaluated and compared using quantitative viability indicators and fluorescent markers for intracellular esterase activity and plasma membrane integrity. RESULTS: The luminal and abluminal surfaces of the UBM demonstrated significantly greater HUC viability and proliferative activity compared with the luminal and abluminal surfaces of the SIS grafts (P < .0001). Culture of HUCs in a simulated in vivo urine environment significantly affected cell viability (P < .0001). Proliferative activity was immeasurable on cell-seeded scaffolds that were cultured in a urine environment after 48 hours of growth (P < .0001). CONCLUSIONS: This is the first comparative report of UBM and SIS. Our results have demonstrated that UBM has significantly greater regenerative potential for HUCs compared with SIS. However, the perceived potential for extracellular matrixes in reconstructive urology might be limited by their inability to induce urothelial regeneration in a urine environment.

An improved methodology for investigating the parameters influencing migration resistance of abdominal aortic stent-grafts.

PURPOSE: To develop an improved methodology for investigating the parameters influencing stent-graft migration, with particular focus on the limitations of existing methods. METHODS: A physiological silicone rubber abdominal aortic aneurysm (AAA) model for fixation studies was manufactured based on an idealized AAA geometry: the model had a 24-mm neck, a 50-mm aneurysm, 12-mm-diameter legs, a 60 degrees bifurcation angle, and 2-mm-thick walls. The models were authenticated in neck fixation experiments. The displacement force required to migrate stent-grafts in physiological pulsatile flow was tested dynamically in water at 37 degrees C. A commercially available longitudinally rigid stent-graft (AneuRx) and a homemade device with little longitudinal rigidity were studied in a number of different configurations to investigate the effect of neck fixation length and systolic pressure on displacement force. RESULTS: The AneuRx (6.95+/-0.49 to 8.52+/-0.5 N) performed significantly better than the homemade device (2.57+/-0.11 to 4.62+/-0.25 N) in pulsatile flow. The opposite was true in the neck fixation tests because the longitudinal stiffness of the AneuRx was not accounted for. Increasing pressure or decreasing fixation length compromised the fixation of the homemade device. This relationship was not as clear for the AneuRx because decreasing proximal fixation resulted in an increase in iliac fixation, which could assist fixation in this device. CONCLUSION: Assessing the migration resistance of stent-grafts based solely on proximal fixation discriminates against devices that are longitudinally stiff. Current in vivo models may give inaccurate displacement forces due to the high degree of oversizing in these studies. A novel in vitro approach, accounting for longitudinal rigidity and realistic graft oversizing, was developed to determine the resistance of aortic stent-grafts to migration in the period immediately after device implantation.

Factors that affect mass transport from drug eluting stents into the artery wall.

Coronary artery disease can be treated by implanting a stent into the blocked region of an artery, thus enabling blood perfusion to distal vessels. Minimally invasive procedures of this nature often result in damage to the arterial tissue culminating in the re-blocking of the vessel. In an effort to alleviate this phenomenon, known as restenosis, drug eluting stents were developed. They are similar in composition to a bare metal stent but encompass a coating with therapeutic agents designed to reduce the overly aggressive healing response that contributes to restenosis. There are many variables that can influence the effectiveness of these therapeutic drugs being transported from the stent coating to and within the artery wall, many of which have been analysed and documented by researchers. However, the physical deformation of the artery substructure due to stent expansion, and its influence on a drugs ability to diffuse evenly within the artery wall have been lacking in published work to date. The paper highlights previous approaches adopted by researchers and proposes the addition of porous artery wall deformation to increase model accuracy.

Fluid-structure interaction of a patient-specific abdominal aortic aneurysm treated with an endovascular stent-graft.

BACKGROUND: Abdominal aortic aneurysms (AAA) are local dilatations of the infrarenal aorta. If left untreated they may rupture and lead to death. One form of treatment is the minimally invasive insertion of a stent-graft into the aneurysm. Despite this effective treatment aneurysms may occasionally continue to expand and this may eventually result in post-operative rupture of the aneurysm. Fluid-structure interaction (FSI) is a particularly useful tool for investigating aneurysm biomechanics as both the wall stresses and fluid forces can be examined. METHODS: Pre-op, Post-op and Follow-up models were reconstructed from CT scans of a single patient and FSI simulations were performed on each model. The FSI approach involved coupling Abaqus and Fluent via a third-party software - MpCCI. Aneurysm wall stress and compliance were investigated as well as the drag force acting on the stent-graft. RESULTS: Aneurysm wall stress was reduced from 0.38 MPa before surgery to a value of 0.03 MPa after insertion of the stent-graft. Higher stresses were seen in the aneurysm neck and iliac legs post-operatively. The compliance of the aneurysm was also reduced post-operatively. The peak Post-op axial drag force was found to be 4.85 N. This increased to 6.37 N in the Follow-up model. CONCLUSION: In a patient-specific case peak aneurysm wall stress was reduced by 92%. Such a reduction in aneurysm wall stress may lead to shrinkage of the aneurysm over time. Hence, post-operative stress patterns may help in determining the likelihood of aneurysm shrinkage post EVAR. Post-operative remodelling of the aneurysm may lead to increased drag forces.

ECM-based materials in cardiovascular applications: Inherent healing potential and augmentation of native regenerative processes.

The in vivo healing process of vascular grafts involves the interaction of many contributing factors. The ability of vascular grafts to provide an environment which allows successful accomplishment of this process is extremely difficult. Poor endothelisation, inflammation, infection, occlusion, thrombosis, hyperplasia and pseudoaneurysms are common issues with synthetic grafts in vivo. Advanced materials composed of decellularised extracellular matrices (ECM) have been shown to promote the healing process via modulation of the host immune response, resistance to bacterial infections, allowing re-innervation and reestablishing homeostasis in the healing region. The physiological balance within the newly developed vascular tissue is maintained via the recreation of correct biorheology and mechanotransduction factors including host immune response, infection control, homing and the attraction of progenitor cells and infiltration by host tissue. Here, we review the progress in this tissue engineering approach, the enhancement potential of ECM materials and future prospects to reach the clinical environment.

Hip protectors in fracture prevention for aging adults at risk of falling: a study of user compliance.

PURPOSE: A compliance survey was conducted to establish factors that influence low user compliance with hip protectors amongst aging adults at risk of hip fracture. Medical professionals who deal with patients at risk of hip facture were also included in this survey. METHODS: For this descriptive study 2 questionnaires were designed, 1 for community dwelling aging adults at high risk of fall and hip fracture and 1 for medical professionals dealing with these patients. The questionnaires were presented, completed, and collected at individual appointments with aging adults and by group appointments with medical professionals. All data was statistically analysed to detect the most significant factors related to poor user compliance with hip protectors. For this descriptive study, frequency tests were used to analyse the data and therefore percentage of response was also reported. Certain demographic data such as age and gender was also collected. RESULTS: The outcomes in both interviewed groups were very similar. The main findings demonstrate that 51% of users find hip protectors very valuable while 41% reported the product to be uncomfortable and 29% of users found them difficult to put on. For potential users the high cost of the product and its appearance remains an issue. Also negative psychological aspects of wearing the hip orthoses appear to be common reasons for not wearing a hip protector. CONCLUSION: The study confirmed poor user compliance with hip protectors (18.9%). The information gathered from users and medical professionals regarding hip protectors provides valuable information which allows for the identification and development of new design features.

Geometrical enhancements for abdominal aortic stent-grafts.

PURPOSE: To compare the function of 2 stent-graft designs for endovascular abdominal aortic aneurysm repair. METHODS: Computational fluid dynamics was used to investigate the performance of a conventional stent-graft versus one with a novel tapered configuration (equal area ratios at the inlet and bifurcation). Idealized geometries (uniplanar) were formed first for both devices. To mimic the clinical setting with pulsatile blood flow, a realistic model (multiplanar) was created for the conventional stent-graft based on computed tomography scans from 3 patients with different aortic geometries. A similar model was created for the tapered stent-graft by mimicking the deployment of the conventional stent-graft through its centerline. RESULTS: The tapered stent-graft model demonstrated reduced secondary flow vortices and wall shear stresses in the iliac limbs compared to the conventional graft in the idealized scenario. The drag forces in the idealized models were similar for both designs, though the tapered stent-graft showed a 4% reduction. Flow was split more evenly between the tapered stent-graft limbs in the realistic scenario. CONCLUSION: The novel tapered design reduced flow velocities and secondary flows due to its smooth trunk-to-limb transition, while also splitting the flow between the iliac limbs more evenly. In multiplanar models, the out-of-plane curvature was the greatest cause of skewed flow, which reduced the benefits of the tapered stent-graft.