Anchoring barbs and balloon expandable stents: what is the risk of perforation and failed stent deployment?

PURPOSE: Balloon expandable stents may on occasion be deployed in close proximity to the anchoring barbs of endovascular grafts. The aim of this study was to determine the risk and effect of balloon perforation by anchoring barbs and to assess whether these risks are different if the balloon is protected by a covered stent mounted upon it. METHODS: A bench-top model was developed to mimic the penetration of anchoring barbs into the lumen of medium sized blood vessels. The model allowed variation of angle and depth of vessel penetration. Both bare balloons and those with covered stents mounted upon them were tested in the model to determine whether there was a risk of perforation and which factors increased or decreased this risk. RESULTS: All combinations of barb angle and depth caused balloon perforation but this was most marked when the barb was placed perpendicular to the long axis of the balloon. When the deployment of covered stents was attempted balloon perforation occurred in some cases but full stent deployment was achieved in all cases where the perforation was in the portion of the balloon covered by the stent. The only situation in which stent deployment failed was where the barb was intentionally placed in the uncovered portion of the balloon. This resulted in only partial deployment of the stent. CONCLUSIONS: Balloon rupture is a distinct possibility when deploying balloon-expandable stents in close proximity to anchoring barbs. Care should be taken in this circumstance to ensure that the barb is well away from the uncovered portion of the balloon.

How secure is the anastomosis between the proximal and distal body components of a fenestrated stent-graft?

OBJECTIVES: To examine the longitudinal migratory force required to cause disconnection of the bifurcated distal body component from the tubular proximal body of a fenestrated stent-graft. METHODS: Using a previously reported mathematical model distal distraction forces were calculated prior to performing in vitro pullout testing. The top end of the proximal body and the iliac limbs of the distal body were attached to the grips of a tensile tester via plastic sealing plugs and pneumatic clamps. Channels within the plugs allowed pressurisation of the inside of the stent-graft. Pullout tests were conducted in the vertical plane. Force and displacement data were recorded and tests repeated 8 times at room temperature with the stent-grafts either dry or wet and unpressurized, at 100 mmHg or at 120 mmHg. RESULTS: The median maximum pullout force was 2.9 N (2.6-4.1) when dry, 3.9 N (3.5-5.4) when wet and unpressurized, 6.3 N (4.8-8.3) when wet and pressurized at 100 mmHg and 6.5 N (4.8-7.2) when wet and pressurized at 120 mmHg. There was a significant difference between pressurized and unpressurized conditions (P < 0.01). CONCLUSIONS: The force required to distract the distal bifurcated component of a fenestrated stent graft is much lower than the reported proximal fixation strength of both a standard and fenestrated Zenith stent graft. Although this helps protect the fenestrated proximal body from the effects of longitudinal migration forces in vivo the current strength of the body overlap zone may actually be unnecessarily weak and requires careful surveillance in follow up.

Reprinted article "Factors associated with early failure of arteriovenous fistulae for haemodialysis access".

The radiocephalic arteriovenous fistula remains the method of choice for haemodialysis access. In order to assess their suitability for fistula formation, the radial arteries and cephalic veins were examined preoperatively by ultrasound colour flow scanner in conjunction with a pulse-generated run-off system. Intraoperative blood flow was measured after construction of the fistulae. Post-operative follow-up was performed at various intervals to monitor the development of the fistulae. Radial artery and cephalic vein diameter less than 1.6 mm was associated with early fistula failure. The intraoperative fistula blood flow did not correlate with the outcome of the operation probably due to vessel spasm from manipulation. However, blood flow velocities measured non-invasively 1 day after the operation were significantly lower in fistulae that failed early compared with those that were adequate for haemodialysis. Most of the increase in fistula diameter and blood flow occur within the first 2 weeks of surgery.

Measurement of pulsatile haemodynamic forces in a model of a bifurcated stent graft for abdominal aortic aneurysm repair.

The longitudinal haemodynamic force (LF) acting on a bifurcated stent graft for abdominal aortic aneurysm repair has been estimated previously using a simple one-dimensional analytical model based on the momentum equation which assumes steady flow of an inviscid fluid. Using an instrumented stent-graft model an experimental technique was developed to measure the LF under pulsatile flow conditions. The physical stent-graft model, with main trunk diameter of 30mm and limb diameters of 12 mm, was fabricated from aluminium. Strain gauges were bonded on to the main trunk to determine the longitudinal strain which is related to the LF. After calibration, the model was placed in a pulsatile flow system with 40 per cent aqueous glycerol solution as the circulating fluid. The LF was determined using a Wheatstone bridge signal-conditioning circuit. The signals were averaged over 590 cardiac cycles and saved to a personal computer for subsequent processing. The LF was strongly dependent on the pressure but less so on the flowrate. The measured forces were higher than those predicted by the simplified mathematical model by about 6-18 per cent during the cardiac cycle. The excess measured forces are due to the viscous drag and the effect of pulsatile flow. The peak measured LF in this model of 30 mm diameter may exceed the fixation force of some current clinical endovascular stent grafts.

Physics-based virtual environment for training core skills in vascular interventional radiological procedures.

Recent years have seen a significant increase in the use of Interventional Radiology (IR) as an alternative to open surgery. A large number of IR procedures commences with needle puncture of a vessel to insert guidewires and catheters: these clinical skills are acquired by all radiologists during training on patients, associated with some discomfort and occasionally, complications. While some visual skills can be acquired using models such as the ones used in surgery, these have limitations for IR which relies heavily on a sense of touch. Both patients and trainees would benefit from a virtual environment (VE) conveying touch sensation to realistically mimic procedures. The authors are developing a high fidelity VE providing a validated alternative to the traditional apprenticeship model used for teaching the core skills. The current version of the CRaIVE simulator combines home made software, haptic devices and commercial equipments.

Swirling flow pattern in a non-planar model of an interposition vein cuff anastomosis.

One of the main causes of long-term failure of ePTFE grafts is the development of anastomotic intimal hyperplasia which leads to graft thrombosis. Experimental studies with bypass grafts have shown an inverse relationship between mean wall shear stress and intimal hyperplasia. The geometry of the anastomosis has a strong influence on the flow pattern and wall shear stress distribution. The aim of this in vitro study was to investigate the influence of non-planarity in a model of a distal anastomosis with interposition vein cuff, an anastomosis configuration that is increasingly being used because of improved clinical results. Laser Doppler anemometer measurements were carried out in silicone rubber models of interposition vein cuff anastomoses with planar and non-planar inflow. The pulsatile flow waveforms were typical of those found in femoro-infrapopliteal bypass. Axial and radial velocities were measured in the proximal and distal outflow segments. As expected a symmetrical helical flow pattern (Dean flow) was evident in the planar model. The model with non-planar inflow, however, gave rise to swirling flow in both the distal and proximal artery outflow segments for during the systolic phase. In patients, the anastomosis is usually non-planar. Since the configuration depends in part upon the tunnelling of the graft, this may be altered to some extent. Non-planar anastomotic configurations induce a swirling flow pattern, which may normalise wall shear stress, thereby potentially reducing intimal hyperplasia.

A new device for in vitro evaluation of thrombogenicity.

A device to measure the time of coagulation of whole blood has been designed in order to facilitate testing of thrombogenicity of biomaterials. The principle of operation of the apparatus is to record the time taken for a sphere to fall through a sample of blood. The coagulation time is defined here as the time from collection of the blood sample to coagulation, coagulation having deemed to have occurred when the sphere is prevented from falling by the presence of the fibrin-cell network. The device was tested with homogeneous fluids of different viscosity, milk containing different amounts of rennin and calcium chloride and non anti-coagulated whole blood obtained from five volunteers. Repeat measurements made with each homogeneous fluid show that the variance in the transit time of the sphere is small and consistent with small dispersion. In contrast, the onset of coagulation in milk and blood samples was readily detected. The clotting of milk was highly dependant on the concentration of rennin and calcium chloride. The coagulation time of blood samples from five individuals ranged from 23 to 33 min but simultaneous measurements of samples from the same individual in two identical devices agreed to within +/-1 min in all cases. This device may be easily adapted for use in studies to determine the thromboresistance of biomaterials where the onset of coagulation of whole blood in contact with different materials may be readily compared.

Attachment, morphology and adherence of human endothelial cells to vascular prosthesis materials under the action of shear stress.

In an effort to improve the long-term patency of vascular prostheses several groups now advocate seeding autologous endothelial cells (ECs) onto the lumen of the vessel prior to implantation, a procedure that involves pre-treating the prosthesis material with fibrin, collagen and/or other matrix molecules to promote cell attachment and retention. In this study, we examined the degree to which human umbilical venous endothelial cells (HUVECs) adhered to three materials commonly used polymeric vascular prosthesis that had been coated with the same commercial extra cellular matrix proteins, and after exposure to fluid shear stresses representative of femoro-distal bypass in a cone-and-plate shearing device. We quantified cell number, area of coverage and degree of cell spreading using image analysis techniques. The response of cells that adhered to the surface of each material, and following exposure to fluid shear stress, depended on surface treatment, topology and cell type. Whereas collagen coating improved primary cellular adhesion and coverage significantly, the degree of spreading depended on the underlying surface structure and on the application of the shear stress. In some cases, fewer than 30% of cells remained on the surface after only 1-h exposure to physiological levels of shear stress. The proportion of the surface that was covered by cells also decreased, despite an increase in the degree to which individual cells spread on exposure to shear stress. Moreover, the behaviour of HUVECs was distinct from that of fibroblasts, in that the human ECs were able to adapt to their environment by spreading to a much greater extent in response to shear. The quality of HUVEC attachment, as measured by extent of cell coverage and resistance to fluid shear stress, was greatest on expanded polytetrafluoroethylene samples that had been impregnated with Type I/III collagen.

In vitro assessment of a continuous cardiac output catheter system.

Continuous measurement of cardiac output (CCO) is useful in assessing the cardiovascular status of patients during cardiac surgery and in intensive care. Recently, a CCO system (truCCOMS, Aortech, UK), capable of detecting rapid changes in cardiac output (CO) was introduced. The method is based on the energy required to maintain an integral heat-transfer device at constant temperature above the ambient value. The aim of this study was to assess the performance of this CCO system in vitro under in steady as well as pulsatile flow conditions representative of those in the pulmonary artery. In order to determine the sensitivity of the system to changes in vessel cross-sectional area and therefore local flow velocity, the catheter was deployed in a linear-tapered tube. Steady and pulsatile flows were generated, and the electrical power at various locations along the tapered tube was recorded. The results show significant differences in the performance under the two different flow conditions. In steady flow, the CO was highly dependent on the local velocity whereas in pulsatile flow, CO varied much less with local velocity. The sensitivity expressed as a percentage increase in CO per 100% increase in velocity at a CO of 5 l min(-1) was 87% in steady flow and 24% in pulsatile flow. Experiments carried out with three fluids with different viscosity show that the errors in determining CO in the tapered tube were also dependent on the Reynolds number and flow regime. The mean errors ranged from about 50% at 2 l min(-1) to less than 10% at 8 l min(-1). The correlation between the predicted and actual CO was generally good. In conclusion, the pulmonary artery catheter is not recommended in situations where blood flow is expected to be steady or of low pulsatility. It may, however, be suitable under normal pulsatile flow conditions in the pulmonary artery.

Outflow distribution at the distal anastomosis of infrainguinal bypass grafts.

Outflow distribution at the distal anastomosis of infrainguinal bypass grafts remains unquantified in vivo, but is likely to influence flow patterns and haemodynamics, thereby impacting upon graft patency. This study measured the ratio of distal to proximal outflow in 30 patients undergoing infrainguinal bypass for lower limb ischaemia, using a flow probe and a transit-time ultrasonic flow meter. The mean outflow distribution was approximately 75% distal to 25% proximal, with above knee anastomoses having a greater proportion of distal flow (84%) compared to below knee grafts (73%). These in vivo flow characteristics differ significantly from those used in theoretical models studying flow phenomena (50:50 and/or 100:0), and should be incorporated into future research.

Flow patterns in an endovascular stent-graft for abdominal aortic aneurysm repair.

Endovascular exclusion of the abdominal aortic aneurysm (AAA) has been carried out in selected patients during the past decade. The deployment of a complex multicomponent endovascular device in an aneurysmal aorta may alter the local haemodynamics and lead to thrombosis and intimal hyperplasia development. The aim of this in vitro study was to investigate the flow patterns using flow visualisation and laser Doppler anemometry in a commercial bifurcated stent-graft. Two configurations of the stent-graft, endo-stent and exo-stent, were investigated in an idealised planar AAA model. The flow structures in the main trunk in both configurations of the stent-graft are three-dimensional with complex secondary structures. However, these flow structures were not entirely caused by the stent-graft. The stent struts in the endo-stent configuration cause localised alteration in the flow pattern but the overall flow structures were not significantly affected. Low velocity regions in the main trunk and flow separation in the stump region and the curved segment of the iliac limbs were observed. These areas are associated with thrombosis in the clinical situation. Improvements in the design of endovascular devices may remove these areas of unfavourable flow patterns and lead to better clinical performance.

The distaflo graft: a valid alternative to interposition vein?

INTRODUCTION: the rationale behind the Distaflo graft is inhibition of myointimal hyperplasia through optimisation of haemodynamic forces at the distal anastomosis. This prospective study reports our early clinical results. METHOD: patients with critical limb ischaemia, but no autologous vein, underwent infrainguinal bypass using Distaflo. Clinical and Duplex assessment provided prospective data from which one year cumulative patency, limb salvage and survival rates were calculated using Kaplan-Meier analysis. Log rank test enabled comparison with an historical control group of Miller cuff grafts. RESULTS: fifty Distaflo were inserted over 29 months into 46 patients, median age 68.5 years, 27 male (59%), of which 27 (54%) were re-do procedures. Proximal anastomoses were to common femoral arteries in 40 cases (80%); distal anastomoses were to popliteal vessels in 20 (40%), and tibial vessels in 30 (60%). The Distaflo graft had patency, limb salvage and survival rates of 39, 50 and 82% respectively compared to 49, 56 and 85% respectively in the control group, with no statistical difference (p = 0.39; 0.65; 0.67 respectively; log rank). CONCLUSION: in this non-randomised study, the Distaflo has similar one year patency, limb salvage and survival rates to the Miller cuff, potentially justifying its use an alternative in distal prosthetic arterial reconstruction for critical limb ischaemia.

Steal phenomenon in radiocephalic arteriovenous fistula. In vitro haemodynamic and electrical resistance simulation studies.

OBJECTIVE: steal phenomenon following an arteriovenous fistula (AVF) creation is characterised by retrograde flow in the artery segment distal to the anastomosis and occurs in the majority of patients with radiocephalic AVF although this rarely leads to distal ischaemia. To investigate the local haemodynamics after the creation of an AVF, a simple electrical resistance model which assumes time-independent flow was used. The applicability of this model to pulsatile flow conditions was verified using an in vitro flow circuit. The effects of stenoses in various artery segments were also investigated. DESIGN OF THE STUDY: the electrical analogue model consists of a pressure source, constant resistances that represent the resistance to flow of various arterial segments and the fistula. The stenosis was modelled by a resistor and a non-linear term is simulated by a current-controlled voltage source. In vitro experiments were performed in pulsatile and steady flow and the results were compared with electrical simulations. The effects of fistula flow and the presence and severity of a stenosis on flow distribution, particularly the direction of flow in the distal radial artery and flow into the hand were assessed. RESULTS: steady and pulsatile time-averaged flows measured in vitro compared well with the results of electrical circuit simulations for cases without a stenosis. When a stenosis was present comparisons were made only in steady flow and these show good agreement for stenoses of 75% area reduction. The direction of flow in the distal radial artery was antegrade (towards the hand) at low fistula flow and became retrograde as fistula flow increased. The presence of a severe stenosis in the brachial artery was found to have the strongest influence on flow to the hand. CONCLUSIONS: an electrical resistance model of a radiocephalic AVF has been validated with an in vitro pulsatile flow circuit. One of the benefits of this model is that it can be easily analysed using standard circuit simulation software. The model also provide insights into the possible haemodynamics consequences of creating an AVF with or without the presence of a stenosis in the arterial segments.

Aortic side branch perfusion alone does not account for high intra-sac pressure after endovascular repair (EVAR) in the absence of graft-related endoleak.

OBJECTIVE: to examine the effect of stent-graft deployment on pressure within an aneurysm sac and to investigate the potential sources of intra-sac pressure. MATERIAL AND METHODS: intra-sac pressure was monitored during and immediately after endovascular repair via an indwelling catheter. Intra-sac pressure was also monitored during conventional open repair and was compared with the pressure measured within patent lumbar and inferior mesenteric side-branches, both before and after restoration of iliac arterial blood flow. Intra-sac and side-branch pressures were recorded and expressed as ratios of simultaneously measured radial artery pressure. RESULTS: in the absence of a graft-related endoleak (23/25 patients), endovascular repair resulted in a significant reduction in intra-sac pulse pressure (median ratio 0.31 IQR 0.10-0.46). There was no corresponding reduction in mean intra-sac pressure (median ratio 0.91; IQR 0.83-1.00). Application of clamps at conventional open repair resulted in a fall in both intra-sac pressure (median ratio 0.39, IQR 0.32-0.64) and pressure within side-branches (median ratio 0.45, IQR 0.33-0.64). Restoration of iliac blood flow resulted in a modest recovery of the side-branch pressure (median ratio 0.63, IQR 0.57-0.81), which nonetheless remained significantly less than the intra-sac pressure recorded after EVAR (p=0.01). CONCLUSION: reperfusion of the aneurysm sac through patent side-branches seems insufficient to account for persistent pressurisation of the aneurysm after endovascular repair. This finding supports the hypothesis that pressure may be transmitted directly through stent-graft fabric.

Experimental evaluation of flow patterns in interposition vein cuff anastomosis. The influence of non-planarity of the inflow.

Clinical evidence suggests that the development of myointimal hyperplasia in prosthetic femorodistal bypass grafts may be reduced by the interposition of a cuff of autologous vein between the graft and the recipient artery. Previous experimental work has shown that some of the benefits may be attributed to the geometry of the cuffed anastomosis. Since the distal anastomosis in vivo is often non-planar we have carried out a preliminary study in a model where the graft is at an angle of 45 degrees to the anterior-posterior plane of the anastomosis. This out-of-plane angulation produces highly asymmetric flow patterns in the anastomosis with significant flow separation on the ipsilateral side of the cuff. In the proximal and distal outflow, however, the velocity vectors show significant helical motion with temporal instability in the distal outflow.

Harnessing haemodynamic forces for the suppression of anastomotic intimal hyperplasia: the rationale for precuffed grafts.

OBJECTIVES: Standardisation of cuff geometry by manufacturing prosthetic precuffed grafts (PCG) theoretically optimises haemodynamic forces. This study was designed in order to determine whether these beneficial flow patterns are replicated in vivo in PCG. PATIENTS AND METHODS: Flow visualisation and Doppler studies performed on anatomically accurate PCG models characterised in vitro anastomotic flow patterns. Thirty-two patients (median age 68 years) in whom autologous vein was unavailable, underwent bypass using PCG. Post-operative analysis included qualitative assessment of flow within the distal anastomosis using Doppler colour flow mapping. Cardiac gating techniques and assessment of velocity distribution were performed to gain additional information. These in vivo results were validated against the bench studies. RESULTS: A cohesive vortex was identified within the distal anastomosis of in vitro models and had an integral relationship with the cardiac cycle. This flow structure was also characterised using Doppler colour flow mapping in both longitudinal and transverse planes, confirming the location of the vortex within the body and proximal part of the anastomosis. Twenty-two patients (69%) undergoing bypass with a PCG underwent successful Doppler assessment one week post-operatively, of whom 17 (77%) had a vortical flow structure identified at the distal anastomosis, similar to that characterised in vitro. Cardiac gating verified the same integral relationship of the vortex with the cardiac cycle as that described in vitro. CONCLUSION: The geometric configuration of precuffed grafts induced vortices within the distal anastomoses in 17 out of 22 patients undergoing arterial reconstruction, thereby harnessing the haemodynamic forces that may suppress anastomotic hyperplasia and improve patency rates.

Optimising miller cuff dimensions: the influence of geometry on anastomotic flow patterns.

OBJECTIVES: since cuff dimensions are variable, we studied the influence of cuff geometry on flow mechanics, in an attempt to identify the optimum configuration. MATERIALS AND METHODS: bench studies involved the manufacture of anatomically accurate models of varying cuff dimensions, perfused in a specifically designed flow rig, simulating physiological conditions. Flow visualisation studies incorporating laser illumination of tracer particles enabled accurate analysis of flow patterns. RESULTS: the vortex created within the proximal cuff of each model during the deceleration phase of the cardiac cycle was strongly influenced by the aspect ratio (AR=cuff height:length). The standard and high cuffs (AR=1.63 and 1.18, respectively) demonstrated cohesive vortices and stable flow patterns. Low and long cuffs (AR=2.6 and 2.25, respectively) created more complex vortices with large areas of flow separation and low velocities. CONCLUSIONS: aspect ratio has an important influence on flow within the distal anastomosis, with cuff dimensions of 13 mm long and 8-11 mm high (standard and high cuffs) creating beneficial flow patterns anticipated to optimise wall shear stress and inhibit myointimal hyperplasia.

Interposition vein cuff anastomosis alters wall shear stress distribution in the recipient artery.

OBJECTIVE: Interposition of a vein cuff between a prosthetic infrainguinal bypass graft and a recipient infrageniculate artery can improve graft patency. There is evidence that the improved performance may be explained by a redistribution of myointimal hyperplasia (MIH) away from the critical areas at the heel and toe of the cuff-artery anastomosis. It is widely accepted that there is an association between hemodynamic forces, more specifically, low wall shear stress (WSS), and the development of MIH. The aim of this study was to determine whether the reported redistribution of MIH in the interposition vein cuff (IVC) may be explained by differences in magnitude and distribution of WSS. Design of Study and Method: Detailed flow velocity measurements were made in life-size models of conventional end-to-side (ETS) and IVC anastomoses using a two-component laser Doppler anemometer under pulsatile flow conditions. Velocity vectors were determined in the plane of symmetry of the anastomosis, and the variation of WSS was estimated from near-wall velocity measurements on the floor and upper wall of the artery. RESULTS: The main flow features in the ETS anastomosis were flow separation at the graft hood, strong radial velocity at the heel, and a stagnation point on the floor of the artery that moved slightly during the flow cycle. In the IVC anastomosis, a coherent vortex that occupied most of the cuff volume was present from the systolic deceleration phase to end diastole. A stagnation point on the anastomosis floor was found to oscillate by about 4 mm. Critical regions of low mean WSS (ie, below 0.5 N/m(2)) were identified. In the ETS anastomosis, they were found at the heel and along the floor. In the IVC anastomosis, low mean WSS was found only on the floor, and it was generally less extensive than in the ETS anastomosis. CONCLUSION: The vein cuff anastomosis alters the mean WSS distribution within the recipient artery and removes the area of low WSS at the heel. This may explain the redistribution of MIH away from important sites in the recipient artery.

Characterization of vortices using pulsed-wave Doppler ultrasound.

The detection and characterization of vortices from a Kaman vortex generator by means of a 20 MHz pulsed-wave Doppler ultrasound system were assessed. Measurements were made at different steady flowrates in a 10 mm internal diameter polyurethane tube, 14 mm distal to a circular cylinder of diameter 2 mm, placed across the tube inlet. The results were compared with those obtained with a two-component laser Doppler anemometer system. There was generally good agreement between the two techniques in the measurement of convective flow velocity, frequency of vortex shedding and the circulation velocity of the vortices. It is concluded that pulsed-wave Doppler ultrasound is a suitable technique for investigating vortical flow structures.

Local haemodynamics of arterial bypass graft anastomoses.

One of the main causes of failure of expanded polytetrafluoroethylene (PTFE) bypass grafts used in the lower limbs is the development of myointimal hyperplasia (MIH). Clinical studies show that higher patency rates can be obtained with the use of an autologous vein cuff (the Miller cuff) interposed between the graft and artery. The reasons for the improved performance are still unclear, but preliminary studies suggest that the change in local haemodynamics due to the cuff geometry may be the significant factor rather than the presence of autologous material. If this is the case, then PTFE grafts can be produced with an integral cuff, i.e. a precuffed graft, with similar haemodynamic patterns to that of the Miller cuff. In this paper, two different types of precuffed graft are presented and their flow patterns are compared with those recorded in the Miller cuff and the conventional end-to-side anastomosis. The haemodynamic studies were carried out using optically clear silicone rubber models under simulated in vivo pulsatile flow conditions. Flow structures similar to those observed in the Miller cuff were seen in the precuffed grafts.