Why Patencies of Femoropopliteal Bypass Grafts with Distal End-to-End Anastomosis are Comparable with End-to-Side Anastomosis.

OBJECTIVE: Despite the theoretical favourable hemodynamic advantage of end-to-end anastomosis (ETE), femoropopliteal bypasses with distal ETE and end-to-side anastomosis (ETS) have comparable clinical patencies. We therefore studied the effects of different in vivo anastomotic configurations on hemodynamics in geometrically realistic ETE and ETS in vitro flow models to explain this phenomenon. METHODS: Four ETE and two ETS models (30° and 60°) were constructed from in vivo computed tomography angiography data. With flow visualization physiological flow conditions were studied. RESULTS: In ETS, a flow separation and recirculation zone was apparent at anastomotic edges with a shifting stagnation point between them during systole. Secondary flow patterns developed with flow deceleration and reversal. Slight out of axis geometry of all ETE resulted in flow separation and recirculation areas comparable to ETS. Vertical flow patterns were more stable in wider and longer bevelled ETE. CONCLUSION: Primary flow disturbances in ETE are comparable to ETS and are related to the typical sites where myointimal hyperplasia develops. In ETS, reduction of anastomosis angle will diminish flow disturbances. To reduce flow disturbances in ETE, the creation of a bulbous spatulation with resulting axial displacement of graft in relation to recipient artery should be prevented.

Computational fluid dynamic analysis of the effect of morphologic features on distraction forces in fenestrated stent grafts.

OBJECTIVE: Secure fixation of endovascular stent grafts is essential for successful endovascular aneurysm repair. Hemodynamic distraction forces are generated by blood pressure and blood flow and act against fixation force to encourage migration that may eventually lead to late stent graft failure. The aim of this in silico study was to determine which morphologic features were associated with greater distraction force. METHODS: Computer models of 54 in situ fenestrated stent grafts were constructed from postoperative computed tomography scans by use of image processing software. Computational fluid dynamic analysis was then performed by use of a commercial finite volume solver with boundary conditions representative of peak systole. Distraction force results were obtained for each component of the stent graft. Distraction force was correlated with lumen cross-sectional area (XSA) at the inlet and outlet of components and was compared between groups of components, depending on the magnitude of four predefined angles within the aortoiliac territory that we describe in detail. RESULTS: Median total resultant distraction force (RDF) acting on the fenestrated proximal bodies was 4.8 N (1.3-15.7 N); bifurcated distal bodies, 5.6N (1.0-8.0 N); and limb extensions, 1.7 N (0.6-8.4N). Inlet XSA exhibited strong, positive correlation with total RDF in proximal body and distal body components (Spearman correlation coefficient ρ, 0.883 and 0.802, respectively). Outlet XSA exhibited a similarly strong, positive correlation with total RDF in limb extension components (ρ, 0.822). Outlet angulation ≥ 45 degrees was associated with greater total RDF in the limb extension components only (P = .004). CONCLUSIONS: For a given blood pressure, XSA was the most important morphologic determinant of total RDF. Angulation within the aorta was not large enough to influence this, whereas iliac angulation affecting outlet angulation of limb extension components was associated with significantly greater total RDF.

Closure technique after carotid endarterectomy influences local hemodynamics.

BACKGROUND: Meta-analysis supports patch angioplasty after carotid endarterectomy (CEA); however, studies indicate considerable variation in practice. The hemodynamic effect of a patch is unclear and this study attempted to elucidate this and guide patch width selection. METHODS: Four groups were selected: healthy volunteers and patients undergoing CEA with primary closure, trimmed patch (5 mm), or 8-mm patch angioplasty. Computer-generated three-dimensional models of carotid bifurcations were produced from transverse ultrasound images recorded at 1-mm intervals. Rapid prototyping generated models for flow visualization studies. Computational fluid dynamic studies were performed for each model and validated by flow visualization. Mean wall shear stress (WSS) and oscillatory shear index (OSI) maps were created for each model using pulsatile inflow at 300 mL/min. WSS of <0.4 Pa and OSI >0.3 were considered pathological, predisposing to accretion of intimal hyperplasia. The resultant WSS and OSI maps were compared. RESULTS: The four groups comprised 8 normal carotid arteries, 6 primary closures, 6 trimmed patches, and seven 8-mm patches. Flow visualization identified flow separation and recirculation at the bifurcation increased with a patch and was related to the patch width. Computational fluid dynamic identified that primary closure had the fewest areas of low WSS or elevated OSI but did have mild common carotid artery stenoses at the proximal arteriotomy that caused turbulence. Trimmed patches had more regions of abnormal WSS and OSI at the bifurcation, but 8-mm patches had the largest areas of deleteriously low WSS and high OSI. Qualitative comparison among the four groups confirmed that incorporation of a patch increased areas of low WSS and high OSI at the bifurcation and that this was related to patch width. CONCLUSIONS: Closure technique after CEA influences the hemodynamic profile. Patching does not appear to generate favorable flow dynamics. However, a trimmed 5-mm patch may offer hemodynamic benefits over an 8-mm patch and may be the preferred option.

Long-term resistance to fracture and/or corrosion of the nitinol wires of the talent stent-graft: observations from a series of explanted devices.

The biodurability of the Nitinol wires used in stent-grafts retrieved from reoperations and autopsy was analyzed to assess the possible causes of fracture and/or corrosion of the stents. The Nitinol wires of six explanted devices presented a corrosion-free surface after in vivo service. The drawing lines in the control wires were still present, but neither burrs nor flakes were observed. Pits and crevices were rare, but some shallow ones were present. Some abrasions of the surfaces of the Nitinol wires were also observed. The chemical composition of the explanted devices showed the presence of organic contamination that covered the thick layer of titanium oxide before reaching the Nitinol itself. The durability of the Nitinol employed in the manufacture of the Talent stent-grafts was confirmed; the results of this study show the Nitinol to be resistant to corrosion. We have also concluded that the fractures of the Nitinol wires in two devices were unique adverse incidents caused by compression and bending related to the sharp angle of the Nitinol wires.

Fatigue and/or failure phenomena observed in the fabric of stent-grafts explanted after adverse events.

In this study, we aimed to investigate changes to the fabric of Talent stent-grafts following implantation of aortic endografts and to determine the possible causes of fatigue and/or failure of the grafts. Six devices were explanted at reoperation (N=5) and autopsy (N=1). Selected segments were assessed nondestructively by gross observation and destructively by analyzing textile characteristics and chemical properties. All of the devices showed a 4/4 twill woven fabric of monofilament polyester. These devices, explanted at reoperation and autopsy, presented different levels of fatigue and/or failure. Numerous holes were found in the fabric of two devices. The minor damage caused by the passage of the sutures through the weave to fasten the Nitinol wires did not progress significantly over time. The sutures remained relatively intact, except for some distortions. The main failure mode was the abrasion of the yarns at the apices of adjacent Nitinol stents. In two devices, this abrasion resulted in fraying of the yarns and holes in the fabric tubes. This short series of explanted devices provides evidence of damage to polyester fabric used in aortic endografts and raises questions regarding their resistance to abrasion and the risk of endoleak associated with monofilament fabric yarn.

A purpose-built simulator for percutaneous ultrasound-guided renal biopsy.

AIMS: To construct a simple and affordable simulator for ultrasoundguided percutaneous renal biopsy. MATERIAL AND METHODS: The kidney biopsy phantom was constructed by embedding a porcine kidney in gelatine. Silicon carbide and aluminium oxide were used as scattering particles in order to mimic the ultrasound appearance of human tissues. Two porcine ribs were also embedded. A latex sheet was placed over the top of the gel layer to resemble skin. The simulator was used and feedback from participants obtained during a renal ultrasound course with an international audience of middle-grade trainees from adult and pediatric nephrology, many of whom had never done a renal biopsy. Biopsy was carried out a single-use biopsy gun. RESULTS: All participants were able to perform a biopsy and obtain a satisfactory sample. All trainees felt that our simulator was very realistic. 94% of participants agreed that the simulator would help to allay their fears in relation to renal biopsy The total cost of the simulator was around £ 50,- for consumables per simulator. CONCLUSIONS: We describe a purpose-built and affordable simulator for percutaneous ultrasound-guided renal biopsy. We suggest that others evaluate our simulator used as part of a structured approach to teach this important procedure.

French sizing of medical devices is not fit for purpose.

PURPOSE: The purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology. METHODS: The labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity. RESULTS: A total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm. The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average. CONCLUSIONS: Our results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

Fractured superior mesenteric artery stents after fenestrated endovascular aneurysm repair.

Stent fracture after fenestrated endovascular aneurysm repair is a recognized complication. In this report, we record the occurrence of superior mesenteric artery stent fractures in our series and describe the management of embolized stent fragments during secondary intervention.

Absence of tissue ingrowth through the textile fabric in a series of explanted clinic stent-grafts.

Using the retrieved devices from one autopsy and five reoperations, the biocompatibility of explanted Talent stent-grafts was investigated to highlight the capacity of the fabric to act as an effective scaffold to regenerate a blood conduit. The autopsy device was encapsulated both internally and externally, but the capsules did not penetrate through the fabric structure. The reoperation devices showed discrete patches of compact fibrin and irregularly scattered mural thrombi. Positive staining of α-actin, tissue plasminogen activator (tPA), urokinase (uPA), urokinase receptor (uPAR), and urokinase inhibitors (PAI 1, PAI 2, PAI 3, and protease nexin), and D-dimer was more frequently identified in the autopsy sample than in the reoperation samples. This preliminary assessment shows that the stent-graft retrieved during autopsy was better healed than those explanted at reoperation.

The accuracy of computed tomography central luminal line measurements in quantifying stent graft migration.

PURPOSE: This study evaluated the accuracy of central luminal line (CLL) measurements in quantifying stent graft migration. The bias of the CLL technique together with observer variability were assessed. METHODS: Stent grafts were deployed in plastic aortic phantoms at fixed locations from two side branches. Each phantom was filled with iodinated contrast, and a 2-mm multislice computed tomography (CT) scan was performed. The stent graft was then displaced caudally, its new location determined, and again, a CT scan performed. This created a series of 15 cases with known stent graft migration. CLLs were used to measure stent graft position on the CT scans and calculate migration (3 observers). In vivo stent graft migration was then evaluated in a similar manner using a series of follow-up CT scans from nine patients (2 observers). All CLL measurements were performed independently and were repeated on a separate occasion. RESULTS: The mean difference in CLL migration between the actual and observed measurements (bias) in the aortic phantoms was <1 mm. The 95% confidence intervals for the bias were within the interval (-1 and 1 mm), and the 95% limits of agreement were within -3 mm and +3 mm. The 95% limits of agreement for measurements within and between observers were -4 to 2 mm and -2 to 2 mm, respectively. The phantom study generated a coefficient of repeatability (RC) of 1 mm for within-observer measurements. Clinically, CLLs generated 95% limits of agreement within and between observers of -3 to 4 mm (RC, 2 mm) and -3 to +3 mm, respectively. CONCLUSIONS: Bias from CLL-determined migration is small and insignificant from a practical point of view. A small amount of measurement variability within and between observers does exist; it should be feasible to detect changes in stent graft position that are ≥4 mm.

Guidewire stiffness: what's in a name?

PURPOSE: To measure the stiffness of commonly used "stiff" guidewires in terms of their flexural modulus, an engineering parameter related to bending stiffness. METHODS: Eleven different intact stiff guidewires were selected to undergo a 3-point bending test performed using a tensile testing machine. Testing was performed on 3 new and intact specimens of each guidewire at 10 locations along the wire's length, excluding the floppy tip. The flexural modulus (in gigapascals, GPa) was calculated from the results of the bending test. RESULTS: The flexural modulus of the plain Amplatz wire was 9.5 GPa compared to 11.4 to 14.5 GPa for the "heavy duty" wires. Within the Amplatz family of guidewires, the flexural modulus was 17 GPa for the "stiff," 29.2 GPa for the "extra stiff," 60.3 GPa for the "super stiff," and 65.4 GPa for the "ultra stiff." The Backup Meier measured 139.6 GPa and the Lunderquist Extra Stiff 158.4 GPa. CONCLUSION: The Instructions for Use of some endovascular devices specify a wire type selected from a range of undefined "stiffness" descriptors. These descriptors have little correlation with the measured flexural modulus. Two guidewires with the description "extra stiff" can have a 5-fold difference in flexural modulus. We recommend that guidewire catalogues and packaging include the flexural modulus and that device manufacturers amend their Instructions for Use accordingly.

Magnitude of the forces acting on target vessel stents as a result of a mismatch between native aortic anatomy and fenestrated stent-grafts.

PURPOSE: To quantify the compression force acting on target vessel stents as a consequence of the misalignment between the native aortic anatomy and the fenestrated stent-graft owing to measuring errors during the design of the device. METHODS: The material properties of a fenestrated Zenith stent-graft were determined using a standardized tensile testing protocol. Aortic anatomy was modeled using fresh porcine aortas that were subjected to tensile testing. The net force acting on a target vessel stent due to incremental discrepancy between the target vessel ostia and the stent-graft fenestrations was calculated as the difference in wall tension between the aorta and the stent-graft in diastole and systole. The change in diameter between diastole and systole was set to 8%. RESULTS: Using the diastole model, underestimation of circumferential target vessel position by 15°, 22.5°, and 30° resulted in net forces on the target vessel stent of 0.6, 0.8, and 1.1 N, respectively. Overestimation of target vessel position by the same increments resulted in net forces of 0.3, 0.6, and 0.9 N, respectively. With the systolic model, underestimating target vessel position by 30° resulted in a 2.1-N maximum force on the stent, which potentially threatened the seal. In the longitudinal direction, underestimating target vessel separation by up to 10 mm resulted in a maximal force on the stent of 6.1 N, while overestimating target vessel separation did not result in any additional force on the stent due to fabric infolding. CONCLUSION: The magnitude of the forces generated solely due to mismatch between stent-graft design and native anatomy is modest and is unlikely to cause significant deformation of target vessel stents. Mismatch, however, may cause loss of seal.

Simulation of endovascular guidewire behaviour and experimental validation.

Guidewire manipulation is a core skill in endovascular interventional radiology procedures. Simulation-based training offers a valuable alternative for mastering these skills, but requires a faithful replication of complex guidewire behaviour inside the vasculature. This paper presents the integration of real flexural modulus (FM) measurements into our guidewire model that mimics the flexibility of standard guidewires. The variation of FM along the length of each wire was determined for seven commonly used guidewires using a three-point bending test for the main body and a two-point bending test for the flexible end. Guidewire FM values were then attributed to seven different models, each formed by a series of particles connected by links of variable FM and replicating the flexible end shape. The FM integration was done through a trial and error process matching real FM to virtual bending coefficient. This mass-spring representation captures the required range of behaviour and enables accurate deformation within virtual vasculature.

Guidewire and catheter behavioural simulation.

Guidewire and catheter manipulation is a core skill in endovascular interventional radiology. It is usually acquired in an apprenticeship on patients, but this training is expensive and risky. Simulation offers an efficient alternative for core skills training, though the instrument complex behaviour requires accurate replication. This paper reviews the mass-spring model used to simulate seven guidewires and three catheters, and the matching with their real world counterparts by tuning our model's bending coefficient, which allows replication of the instrument flexibility. This coefficient was matched through computed tomography imaging of a vascular phantom in which each instrument was inserted and manipulated. With an average distance of 2.27 mm (standard deviation: 1.54) between real and virtual instruments, our representation showed realistic behaviour.

Fenestrated stent-graft repair: which stent should be used to secure target vessel fenestrations?

PURPOSE: To investigate in an in vitro model the ability of different covered and uncovered stents to resist displacement/migration of a fenestrated stent-graft. METHODS: Three different types (2 covered, 1 bare) of commonly used 7-mm balloon-expandable stainless steel stents (Jostent, Advanta V12, and Palmaz Genesis) were investigated in a testing rig consisting of 2 overlapping tubes with 2 sets of 7-mm holes representing bilateral renal artery fenestrations and ostia. The rig was attached to a tensile tester via pneumatic clamps. The stents were deployed without flaring to 7 mm through the overlapping holes. The rig was moved apart at a constant rate of 12 mm/min up to a maximum displacement of 6 mm; force versus displacement values were recorded while stent deformation was observed. Tests were repeated at least 6 times for each stent type at room temperature. The median force required to cause a 25%, 50%, or 75% reduction in cross-sectional area of the bilateral "renal artery" stents was determined. RESULTS: The median force (interquartile range) required to cause a 50% reduction in cross-sectional area of identical bilateral "renal artery" stents securing fenestrations was 25.1 N (8.1) for a covered Jostent, 9.3 N (0.9) for a covered Advanta V12 stent, and 7.5 N (0.7) for a bare Palmaz Genesis stent. The differences were statistically significant (p<0.01) between stents at each of the 3 levels of cross-sectional area reduction. CONCLUSION: There is a significant difference in the ability of different commercial "non-dedicated" stents to withstand a crushing force when deployed within endograft fenestrations, which has important implications for clinical practice.

Comparison of the fixation strength of standard and fenestrated stent-grafts for endovascular abdominal aortic aneurysm repair.

PURPOSE: To determine whether fenestrated stent-grafts provide better stability to resist migration than standard non-fenestrated stent-grafts. METHODS: Truncated fenestrated stent-grafts with a single fenestration were deployed in bovine aortic segments with a side branch. Balloon-expandable stents were then delivered into the branches. Similarly, standard stent-grafts of the same dimensions were deployed for comparison. The aorta was pressurized to achieve stent-graft oversizing of 5%, 10%, or 20%. The force required to cause distal migration was recorded by a digital force gauge attached to the stent-graft. RESULTS: Displacement of the stent-grafts occurred in 2 distinct phases: an initial yield during which the barbs embedded in the aortic wall and a final displacement leading to significant migration and dislodgement of the device. The displacement force that initiated each phase was dependent upon the degree of oversizing of the stent-graft relative to the aortic diameter. For 5%, 10%, and 20% oversizing, the mean displacement forces in the initial displacement phase were 3.39+/-0.37, 4.32+/-0.63, and 7.69+/-1.18 N, respectively, in non-fenestrated grafts and 10.48+/-1.23, 11.45+/-1.48, 12.12+/-1.42 N in fenestrated grafts. The displacement forces in the final displacement phase were 8.10+/-0.92, 10.76+/-1.74, and 16.82+/-0.92 N for non-fenestrated and 22.56+/-1.60, 28.24+/-1.56, and 33.01+/-1.75 N for fenestrated stent-grafts. The differences in displacement forces between standard and fenestrated stent-grafts were significant for both phases (p<0.001) at all oversizing levels. CONCLUSION: Improvement in fixation strength was noted with increasing stent-graft oversizing of up to 20%. Fenestrated stent-grafts offer higher ultimate fixation compared to standard devices. However, the ultimate fixation strength was not recruited until an initial phase of short migration occurred as the barbs engaged. While this movement is inconsequential with standard stent-grafts, it has the potential to crush the stents placed into aortic side branches with fenestrated endografts.

EVAR in iliac occlusion.

PURPOSE: To report the recanalization of an occluded common iliac artery (CIA) to allow endovascular repair of an abdominal aortic aneurysm (AAA) with a bifurcated stent-graft. CASE REPORT: A 76-year-old man with a 75-mm infrarenal AAA and an occluded right CIA was successfully treated with a Zenith bifurcated stent-graft. The right CIA was recanalized allowing access, delivery, and deployment of the stent-graft. Follow-up computed tomography at 9 months showed no evidence of endoleak; maximum aneurysm diameter was reduced to 72 mm, and the iliac vessels were patent. CONCLUSION: Bifurcated stent-graft repair of an AAA can be performed following recanalization of an occluded CIA. This option may be preferable to an open repair or an aortomonoiliac stent-graft with extra-anatomical bypass in some patients. Long-term surveillance will be necessary to ensure freedom from iliac-related secondary intervention.

Poly-L-lactide surfaces subjected to long-term cell cultures: cell proliferation and polymer degradation.

Short term cell cultures are usually grown in contact with biomaterials to assess cytocompatibility. Depending on the rate of material degradation or corrosion, the time of culture can be a key-point in the method which, if too short, may not show any effect of the released material on the cells. A long term culture was therefore carried out with L929 fibroblast cells in contact with PLLA/PDLA samples for up to eight months. The degradation was measured in terms of shear-strength properties, intrinsic viscosity of the material and its cristallinity. The effect of the material on the cells was evaluated by measuring the growth rate of the cells. A significant decrease in the shear strength of the material was measured after three months. The rate of modification of the intrinsic viscosity was regular and decreased progressively throughout the culture period. Differential scanning calorimetry showed that the samples were initially essentially amorphous and that contact with the cell culture and its medium did not change its crystallinity level. The growth rate of the cells was not modified by the presence of the material when compared to the control. This study showed this material to be cytocompatible for a long period of time, even after detection of modifications of its physico-chemical properties.

Flow visualization in a model of a bifurcated stent-graft.

PURPOSE: To use an in vitro flow model to investigate the flow patterns in a bifurcated stent-graft for abdominal aortic aneurysm (AAA) repair. METHODS: Experiments were performed in an in vitro test rig incorporating a simplified non-planar model of an AAA. A two-component bifurcated device consisting of a stent structure and transparent polyurethane "graft" was deployed in the AAA model. Using a blood analogue fluid, a pulsatile blood flow waveform simulating resting flow condition was produced by means of a piston pump system. Flow patterns in the lateral and anteroposterior planes of the stent-graft were recorded and analyzed using flow visualization techniques. RESULTS: The flow patterns within the stent-graft were complex and influenced by the geometry of the stent-graft itself, as well as that of the aortic neck and iliac vessels. Regions of flow separation, low velocity and stagnation, and slow oscillatory flow near the walls were seen in the main body of the stent-graft. Constriction at the stump in the contralateral limb resulted in flow disturbances and flow separation. Kinking at the junctions of stent segments and folding of the graft compounded these complex flow structures. CONCLUSIONS: The flow structures within stent-grafts are complex, with features that may predispose to thrombus formation. Arterial geometry, including aortic neck angulation and iliac vessel tortuosity, and the design of the stent-graft are factors that influence hemodynamics and may impact the performance of aortic stent-grafts.