The Technological Advancement to Engineer Next-Generation Stent-Grafts: Design, Material, and Fabrication Techniques.

Endovascular treatment of aortic disorders has gained wide acceptance due to reduced physiological burden to the patient compared to open surgery, and ongoing stent-graft evolution has made aortic repair an option for patients with more complex anatomies. To date, commercial stent-grafts are typically developed from established production techniques with simple design structures and limited material ranges. Despite the numerous updated versions of stent-grafts by manufacturers, the reoccurrence of device-related complications raises questions about whether the current manfacturing methods are technically able to eliminate these problems. The technology trend to produce efficient medical devices, including stent-grafts and all similar implants, should eventually change direction to advanced manufacturing techniques. It is expected that through recent advancements, especially the emergence of 4D-printing and smart materials, unprecedented features can be defined for cardiovascular medical implants, like shape change and remote battery-free self-monitoring. 4D-printing technology promises adaptive functionality, a highly desirable feature enabling printed cardiovascular implants to physically transform with time to perform a programmed task. This review provides a thorough assessment of the established technologies for existing stent-grafts and provides technical commentaries on known failure modes. They then discuss the future of advanced technologies and the efforts needed to produce next-generation endovascular implants.

Stress distribution in the walls of major arteries: implications for atherogenesis.

BACKGROUND: There is a correlation between the sites of atheroma development and stress points in the arterial system. Generally, pulse pressure results in stresses acting on the vascular vessel, including longitudinal stress, radial or normal stress, tangential stress or hoop stress and shear stress. This paper explores the relationship between arterial wall shear stress and pulsatile blood pressure with the aim of furthering the understanding of atherogenesis and plaque progression. METHODS: We computed the magnitude of the shear stresses within the carotid bifurcation geometry of a patient and calculated the increase in shear stress levels that would occur when the blood pressure and pulse pressures rise during exertion. We also determined in which layer of the artery wall the maximum shear stress is located, and computed the shear stress at different levels within the media. We used the theory of laminate analysis, (Classical Laminate Plate Theory), to analyse the stress distribution on the carotid artery wall. Computational Fluid Dynamics (CFD) analysis was used on anatomy based on a CT angiogram of the carotid bifurcation of a patient with a 90% stenosis on the right side and 10% on the left. The pulsatile non-Newtonian blood flow with a resting blood pressure of 120/80 mmHg and an exertion pressure of 200/100 mmHg was simulated and the resultant forces were transferred to an ANSYS Composite PrepPost (ACP) model for wall shear stress analysis. A multilayer elastic, anisotropic, and inhomogeneous arterial wall (intima, internal elastic lamina, media, external elastic lamina, and adventitial layers) was modelled and the shear stress magnitudes and change over time between the layers was calculated. RESULTS: Shear stress in the individual composite layers is far greater than that acting on the endothelium (less than 5 Pa). At rest, the maximum variation of shear stress in the arterial wall occurs in the intima (138 Pa) and adventitia (135 Pa). The medial layer has the lowest variation of shear stress. Under severe exertion, the maximum shear stress magnitude in the intimal layer and the adjacent medial layer is near the ultimate stress level. The maximum/minimum shear stress ratios during the cardiac cycle vary most widely in the innermost part of the media, adjacent to the intima, with a four-fold ratio increase. This compares with a less than two-fold increase in all the other layers including the intima and adventitia, making the inner media the most vulnerable layer to mechanical injury. CONCLUSIONS: This study showed that the magnitude of exertion-induced shear stress approaches the ultimate stress limit in the intima and the immediate adjacent medial layer. The variation in stress is maximal in the inner layer of the media. These findings correlate the site of atheroma development with the most vulnerable site for injury in the media and emphasise the impact of pulse pressure. Further biological studies are required to ascertain whether this leads to injury that initiates atheroma that then precipitates an injury/healing cycle.

Major gaps in human evidence for structure and function of the vasa vasora limit our understanding of the link with atherosclerosis.

Atherosclerosis is the major pathology causing death in the developed world and, although risk factor modification has improved outcomes over the last decade, there is no cure. The role of the vasa vasora (VV) in the pathogenesis of atherosclerotic plaque is unclear but must relate to the predictability of diseased sites in the arterial tree. VV are small vessels found on major arteries and veins which supply nutrients and oxygen to the vessel wall itself while removing waste. Numerous studies have been carried out to investigate the anatomy and function of the VV as well as their significance in vascular disease. There is convincing evidence that VV are related to atherosclerotic plaque progression and vessel thrombosis, however, their link to the pathology of plaque initiation remains an interesting but neglected topic. We aim to present the evidence on the anatomy and functional behaviour of VV as well as their relationship to the initiation of atherosclerosis. At the same time, we wish to highlight inconsistencies in, and limitations of, the evidence available.

Long-term Outcomes of the Western Australian Trial of Screening for Abdominal Aortic Aneurysms: Secondary Analysis of a Randomized Clinical Trial.

IMPORTANCE: Mortality from ruptured abdominal aortic aneurysms (AAAs) remains high. The benefit of screening older men for AAAs needs to be assessed in a range of health care settings. OBJECTIVE: To assess the influence of screening for AAAs in men aged 64 to 83 years on mortality from AAAs. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial performed from April 1, 1996, through March 31, 1999, with a mean of 12.8 years of follow-up (range, 11.6-14.2 years) included a population-based sample from a single metropolitan region in Western Australia identified via the electoral roll. Data analysis was performed from June 1, 2015, to June 1, 2016. INTERVENTIONS: Randomization to an invitation to undergo ultrasonography of the abdominal aorta or a control group without invitation. MAIN OUTCOMES AND MEASURES: Surgery for and mortality from AAA. RESULTS: A total of 49 801 men aged 64 to 83 years were identified for the study. Men living too far from screening centers (n = 8671) or who died before invitation (n = 2650) were excluded, resulting in 19 249 men in the invited group and 19 231 controls (mean [SD] age, 72.5 [4.6] years; 95% white). Of 19 249 men invited for screening, 12 203 (63.4%) attended. There were more elective operations (536 vs 414, P < .001) and fewer ruptured AAAs (72 vs 99, P = .04) in the invited group compared with the control group. Overall, there were 90 deaths from AAAs in the invited group (mortality rate, 47.86 per 100 000 person-years; 95% CI, 38.93-58.84) and 98 in the control group (52.53 per 100 000 person-years; 95% CI, 43.09-64.03) for a rate ratio of 0.91 (95% CI, 0.68-1.21). For men aged 65 to 74 years, the AAA mortality rate in the invited group was 34.52 per 100 000 person-years (95% CI, 26.02-45.81) compared with 37.67 per 100 000 person-years (95% CI, 28.71-49.44) in the control group for a rate ratio of 0.92 (95% CI, 0.62-1.36). The number needed to invite for screening to prevent 1 death from an AAA in 5 years was 4784 for men aged 64 to 83 years and 3290 for men aged 65 to 74 years. There were no meaningful differences in all-cause, cardiovascular, and other mortality risks. CONCLUSIONS AND RELEVANCE: Use of the electoral roll to identify and invite men aged 64 to 83 years for screening for AAAs had no significant effect on the overall mortality from AAAs. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN16171472.

Stress and strain behaviour modelling of the carotid bifurcation.

BACKGROUND: The aim of this study is to investigate the biomechanical stress and strain behaviour within the wall of the artery and its influence on plaque formation and rupture using computational fluid dynamics (CFD). METHODS: A three-dimensional finite-element model of the carotid bifurcation was generated to analyse the wall stress and strain behaviour. Both single-layer and multilayer models were created and structural analysis was compared between these two types of models. Systolic pressure of 180 mm Hg (~24 kPa) was applied in the inner boundary of the carotid bifurcation, and CFD analysis was performed to show the wall shear stress and pressure. RESULTS: The highest wall stress was found at the carotid bifurcation. When a high blood pressure (280 mm Hg) was applied to the carotid CFD model, the results showed that the stress at the carotid bifurcation may reach the rupture value. The multilayer carotid bifurcation model behaved differently from the equivalent single-layer model, with peak stress (Von-Mises) being higher in the multilayer model. CONCLUSION: The peak stress and strain was located at the origins of the internal and external carotid arteries. Significant shearing occurred between the layers in the wall of the artery at the bifurcation. Intramural shear stress in the CFD multilayer model has potential for intramural vascular injury. This may be responsible for plaque formation, plaque rupture and an injury/healing cycle.

Guidelines for patient selection and performance of carotid artery stenting.

BACKGROUND: The endovascular treatment of carotid atherosclerosis with carotid artery stenting (CAS) remains controversial. Carotid endarterectomy remains the benchmark in terms of procedural mortality and morbidity. At present, there are no consensus Australasian guidelines for the safe performance of CAS. METHODS: We applied a modified Delphi consensus method of iterative consultation between the College representatives on the Carotid Stenting Guidelines Committee (CSGC). RESULTS: Selection of patients suitable for CAS needs careful consideration of clinical and patho-anatomical criteria and cannot be directly extrapolated from clinical indicators for carotid endarterectomy (CEA). Randomized controlled trials (including pooled analyses of results) comparing CAS with CEA for treatment of symptomatic stenosis have demonstrated that CAS is more hazardous than CEA. On current evidence, the CGSC therefore recommends that CAS should not be performed in the majority of patients requiring carotid revascularisation. The evidence for CAS in patients with symptomatic severe carotid stenosis who are considered medically high risk is weak, and there is currently no evidence to support CAS as a treatment for asymptomatic carotid stenosis. The use of distal protection devices during CAS remains controversial with increased risk of clinically silent stroke. The knowledge requirements for the safe performance of CAS include an understanding of the evidence base from randomized controlled trials, carotid and aortic arch anatomy and pathology, clinical stroke syndromes, the differing treatment options for stroke and carotid atherosclerosis, and recognition and management of periprocedural complications. It is critical that all patients being considered for a carotid intervention have adequate pre-procedural neuro-imaging and an independent, standardized neurological assessment before and after the procedure. Maintenance of proficiency in CAS requires active involvement in surgical/endovascular audit and continuing medical education programs. These standards should apply in the public and private health care settings. CONCLUSION: These guidelines represent the consensus of an inter-collegiate committee in order to direct appropriate patient selection and the range of cognitive and technical requirements to perform CAS. Advances in endovascular technologies and the results of randomized controlled trials will guide future revisions of these guidelines.

Experimental measurement and mathematical modeling of pulsatile forces on a symmetric, bifurcated endoluminal stent graft model.

The objective of this study was to measure the pulsatile forces acting on a symmetric, bifurcated endoluminal stent graft to validate a computational fluid dynamics (CFD) and analytic model so that they can be used for various graft dimensions. We used a load cell to measure the force owing to the movement of an acrylic model of a bifurcated stent graft under pulsatile flow. This was then simulated with a CFD and analytic model. The main features of the experimental pulsatile force data and the CFD results were consistent. The results showed that the total force was proportional to the inlet pressure cycle. The force rose from 3.32 N at 130 mm Hg systolic to 17.5 N at 250 mm Hg systolic pressure. For the more variable regions of the flow, the experimentally measured forces lagged the computational and analytic results. The CFD and analytic models provide approximate descriptions for the forces acting on a bifurcated stent graft subjected to pulsatile flow. Such models should be of assistance to designers of endoluminal stent grafts.

Multislice CT angiography of fenestrated endovascular stent grafting for treating abdominal aortic aneurysms: a pictorial review of the 2D/3D visualizations.

Fenestrated endovascular repair of an abdominal aortic aneurysm has been developed to treat patients with a short or complicated aneurysm neck. Fenestration involves creating an opening in the graft fabric to accommodate the orifice of the vessel that is targeted for preservation. Fixation of the fenestration to the renal arteries and the other visceral arteries can be done by implanting bare or covered stents across the graft-artery ostia interfaces so that a portion of the stent protrudes into the aortic lumen. Accurate alignment of the targeted vessels in a longitudinal aspect is hard to achieve during stent deployment because rotation of the stent graft may take place during delivery from the sheath. Understanding the 3D relationship of the aortic branches and the fenestrated vessel stents following fenestration will aid endovascular specialists to evaluate how the stent graft is situated within the aorta after placement of fenestrations. The aim of this article is to provide the 2D and 3D imaging appearances of the fenestrated endovascular grafts that were implanted in a group of patients with abdominal aortic aneurysms, based on the multislice CT angiography. The potential applications of each visualization technique were explored and compared with the 2D axial images.

A laparoscopic endovascular aortobifemoral conduit that can be retained as a long-term bypass: a solution for patients with inadequate iliac access.

PURPOSE: To present a laparoscopic technique for placing a partially stented aortobifemoral (ABF) conduit that can be used for more proximal endovascular manipulations and then be retained as a permanent bypass of occlusive iliac disease. TECHNIQUE: Ethical approval was obtained to use a fresh frozen cadaver. The left common iliac artery, distal aorta, and proximal right common iliac artery were dissected laparoscopically. A curved hollow needle was inserted into the distal aorta, and wire access was obtained. A partially stented bifurcated Dacron bypass graft was deployed under fluoroscopic guidance into the distal aorta. The limbs of the bypass were then used as conduits for endovascular access before being tunneled behind the ureters and anastomosed to the femoral arteries in the usual way, retaining the stented graft as an ABF bypass. CONCLUSION: This novel technique combines laparoscopic access with endovascular manipulation to place an ABF conduit, which can be retained as a permanent bypass without the need for an abdominal incision. This technique could provide a minimally invasive solution for pelvic occlusive disease that hinders endovascular repairs, as well as a minimally invasive means of securing endoluminal access in patients with iliac arteries of inadequate caliber.

Type II endoleaks: when is intervention indicated and what is the index of suspicion for types I or III?

One of the principal reasons for failure of endovascular aneurysm repair (EVAR) is the occurrence of endoleaks, which regardless of size or type can transmit systemic pressure to the aneurysm sac. There is little debate that type I endoleaks (poor proximal or distal sealing) are associated with continued risk of aneurysm rupture and require treatment. Similarly, with type III endoleak, there is agreement that the defect in the device needs to be addressed; however, what to do with type II endoleaks and their effect on long-term outcome are not so clear. Aneurysm sac change is a primary parameter for determining the presence of an endoleak and assessing its impact. While diameter measurement has been the most commonly used method for determining sac changes, volume measurement has now been proven superior for monitoring structural changes in the 3-dimensional sac. Determining the source of an endoleak and the direction of flow are necessary for proper classification; however, while computed tomographic angiography has high sensitivity and specificity for detecting endoleaks, it is limited in its ability to show the direction of flow. Contrast-enhanced duplex ultrasound, on the other hand, is better able to quantify flow and characterize endoleaks. Flow is evidence of pressure, and increasing intrasac pressure increases wall tension, thus inducing progressive aneurysm expansion until rupture. Hence, determining intrasac pressure is becoming a vital component of endoleak assessment. All endoleaks can create systemic pressure inside the aneurysm sac, and there are a variety of intrasac pressure transducers being evaluated to assess this effect. A clinical pathway for patients with suspected type II endoleaks is based on a combination of imaging and pressure measurements. Imaging alone requires at least two interval examinations to determine the trend, while pressure measurements give immediate reassurance or an indication to intervene. Although still under development, pressure measurement is destined for general use and will provide a scientific basis for the management of type II endoleaks.

3D stereoscopic visualization of fenestrated stent grafts.

The purpose of this study was to present a technique of stereoscopic visualization in the evaluation of patients with abdominal aortic aneurysm treated with fenestrated stent grafts compared with conventional 2D visualizations. Two patients with abdominal aortic aneurysm undergoing fenestrated stent grafting were selected for inclusion in the study. Conventional 2D views including axial, multiplanar reformation, maximum-intensity projection, and volume rendering and 3D stereoscopic visualizations were assessed by two experienced reviewers independently with regard to the treatment outcomes of fenestrated repair. Interobserver agreement was assessed with Kendall's W statistic. Multiplanar reformation and maximum-intensity projection visualizations were scored the highest in the evaluation of parameters related to the fenestrated stent grafting, while 3D stereoscopic visualization was scored as valuable in the evaluation of appearance (any distortions) of the fenestrated stent. Volume rendering was found to play a limited role in the follow-up of fenestrated stent grafting. 3D stereoscopic visualization adds additional information that assists endovascular specialists to identify any distortions of the fenestrated stents when compared with 2D visualizations.

Computed tomography virtual intravascular endoscopy in the evaluation of fenestrated stent graft repair of abdominal aortic aneurysms.

BACKGROUND: This study aimed to investigate the diagnostic value of computed tomography virtual intravascular endoscopy (VIE) in the follow-up of patients with abdominal aortic aneurysm (AAA) treated with fenestrated stent grafts. METHODS: A total of 19 patients (17 males and 2 females; mean age: 75 years) with AAA undergoing fenestrated stent grafts were retrospectively studied. Pre- and post-fenestration computed tomography data were reconstructed for the generation of VIE images of aortic ostia and fenestrated stents and compared with two-dimensional axial and multiplanar reformation (MPR) images. Serum creatinine was measured pre and post fenestration to evaluate the renal function. RESULTS: The mean intra-aortic length measured by VIE, two-dimensional axial and MPR were 4.7, 4.4 and 4.6 mm, respectively, for the right renal stent; 5.0, 4.9 and 5.0 mm, respectively, for the left renal stent; and 5.9, 6.0 and 6.0 mm, respectively, for the superior mesenteric artery stent. Comparisons of these measurements did not show significant difference (P > 0.05). The mean diameters of renal artery ostia measured on VIE visualization pre and post fenestration were 9.2 x 8.3 and 10 x 8.9 mm for the right renal ostium; 8.3 x 7.1 and 9.9 x 8.9 mm for the left renal ostium, with significant changes observed (P < 0.01). No renal dysfunction was observed in this group. CONCLUSION: VIE is a valuable visualization tool in the follow-up of fenestrated stent graft repair of AAA by providing intraluminal appearance of fenestrated stents and measuring the length of stent protrusion.

Multislice CT angiography in the follow-up of fenestrated endovascular grafts: effect of slice thickness on 2D and 3D visualization of the fenestration stents.

PURPOSE: To investigate the effect of multislice computed tomography (CT) protocols on the visualization of target vessel stents in patients with abdominal aortic aneurysm (AAA) treated with fenestrated endovascular grafts. METHODS: Twenty-one patients (19 men; mean age 75 years, range 63-86) undergoing fenestrated endovascular repair of AAA were retrospectively studied. Multislice CT angiography was performed with several protocols, and the section thicknesses used in each were compared to identify any relationship between slice thickness and target vessel stents visualized on 2-dimensional (2D) axial, multiplanar reformatted (MPR), and 3-dimensional (3D) virtual intravascular endoscopy (VIE) images. Image quality was assessed based on the degree of artifacts and their effect on the ability to visualize the configuration, intra-aortic location, and intraluminal appearance of the target vessel stents and measure their protrusion into the aortic lumen. RESULTS: There were 7 different multislice CT scanning protocols employed in the 21 patients (25 datasets, with 2 sets of follow-up images in 4 patients). The slice thicknesses and numbers (n) of studies included were 0.5 (n=3), 0.625 (n=6), 1.0 (n=1), 1.25 (n=9), 2.5 (n=3), 3.0 (n=1), and 5.0 mm (n=2). Of these CT protocols, images (especially 2D/3D reconstructions) acquired at 2.5, 3.0, and 5.0 mm were significantly compromised by interference from artifacts. Images acquired with a slice thickness of 1.0 or 1.25 mm were scored equal to or lower than those acquired with a submillimeter section thickness (0.5 or 0.625 mm), with minor degrees of artifacts resulting in acceptable image quality. CONCLUSION: Visualization of the target vessel stents depends on the appropriate selection of multislice CT scanning protocols. Our results showed that studies performed with a slice thickness of 1.0 or 1.25 mm produced similar image quality to those with a thickness of 0.5 or 0.625 mm. Submillimeter slices are not recommended in imaging patients treated with fenestrated stent-grafts, as they did not add additional information to the visualization.

Modeling of antegrade and retrograde flow into a branch artery of the aorta: implications for endovascular stent-grafting and extra-anatomical visceral bypass.

PURPOSE: To compare antegrade and retrograde flow characteristics in a branch of a conduit under typical pulsatile pressure and flows, seeking an answer to the question: "Does it matter whether inflow to a branch vessel is antegrade or retrograde?" METHODS: A model was built to simulate an abdominal aorta with a branch designed to approximate a typical renal artery. Experiments were conducted to measure the flow rates from 40- and 200-mm-long inflow conduit tubes simulating a branch with antegrade and retrograde inflow configurations. For the base case with a flush origin of the branch, the pressure difference between the main conduit and branch vessel was adjusted so that the average branch flow rate was 1.22 L/min, representing average renal artery flow. A pump produced a pulsatile 5-L/min flow of a glycerol/water solution through a tube to mimic blood flow through the aorta at a mean inlet pressure of 97 mmHg, with systolic and diastolic pressures of 121 and 78 mmHg, respectively. Computational fluid dynamics (CFD) simulations were performed for the flush, antegrade inflow, and retrograde inflow cases. The CFD-predicted flow rates at the branch vessel outlet for all 3 geometries were compared with the experiments. RESULTS: From the experiments, the mean time-average branch vessel outflow rate through a 40-mm conduit for the antegrade case was 1.22+/-0.01 L/min, which was the same as the retrograde case (1.21+/-0.01 L/min; within the experimental error). However, the branch vessel outflow flow rate through a 200-mm conduit for the retrograde case was 0.07 L/min lower than the antegrade. The results from the CFD model were in good agreement with the experiments. CONCLUSION: The experiments and CFD results suggest that there is negligible difference in the outflow rates to a branch vessel in antegrade and retrograde directions for 40-mm-long conduits. However, for a 200-mm conduit, the flow to a branch vessel through the retrograde path is lower than for the antegrade direction, which has implications for the insertion of branches to stent-grafts and extra-anatomical surgical bypass for visceral revascularization.

CT virtual intravascular endoscopy in the visualization of fenestrated stent-grafts.

PURPOSE: To report the diagnostic value of computed tomographic (CT) virtual intravascular endoscopy (VIE) in the assessment of patients with abdominal aortic aneurysm (AAA) treated with fenestrated endovascular grafts. METHODS: Eight patients (7 men; mean age 76 years, range 70-82) with AAAs unsuitable for open surgery or conventional endovascular repair had fenestrated endovascular grafts implanted. Both pre- and post-fenestration multislice CT data were used to generate VIE images of the visceral artery ostia and the side branch fenestrated stents. CT VIE images were compared with conventional 2-dimensional (2D) axial CT and multiplanar reformatted (MPR) images for the ability to visualize the intraluminal appearance of stents, as well as to measure the length of stents that protruded into the aortic lumen. RESULTS: Various fenestrations were deployed in 27 aortic branches. Scalloped and large fenestrations were implanted in 6 side branch ostia, respectively, and small fenestrations in 15 renal artery ostia. Fewer than half of the stents (37%) were found to be circular on VIE images, while the remaining stents were flared to varying extents at the inferior portion. The majority (96%) of stents protruded into the lumen up to 7.0 mm. Although the configuration of the side branch ostia changed to a variable extent, no significant difference was apparent between the diameters of branch ostia before and after fenestration (p>0.05). CONCLUSION: Our preliminary study shows that VIE proved superior to conventional 2D or MPR images in visualizing the final configuration of the fenestrated vessels and was comparable to the other techniques in measuring stent protrusion into the aortic lumen. VIE could be a valuable technique to identify any suspected abnormalities associated with fenestrated endovascular grafts by demonstrating the final intraluminal configuration of the stents in the fenestrated vessels.

Large iliac arteries: a high-risk group for endovascular aortic aneurysm repair.

PURPOSE: To examine if the presence of large iliac arteries is a potential risk factor for the development of a type Ib endoleak (iliac sealing zone) or need for iliac artery-related secondary intervention in patients undergoing endovascular abdominal aortic aneurysm repair. METHODS: The medical notes and all preoperative and postoperative plain abdominal radiographs and computer tomographic scans were reviewed for a consecutive series of 100 patients (89 men; mean age 75 years, range 56-91) with large iliac arteries (mean 19.7 mm, range 16-22) who had Zenith endovascular stent-grafts inserted for management of aortoiliac aneurysmal disease from January 1999 until September 2002. Endpoints were all-cause mortality, aneurysm-related death, endoleak, secondary intervention, secondary interventions, and stent-graft migration. RESULTS: Mean follow-up was 30.1+/-8.3 months; at the last follow-up, 30% of patients were dead, 3% were aneurysm-related. Seven (7%) patients developed a type Ib endoleak, with the remainder being type II (29%), type Ia (2%), type III (1%), and type V (endotension, 1%). Eight (27.5%) type II endoleaks persisted, with the remainder closing spontaneously with sac shrinkage. The iliac artery-related secondary intervention rate was 10%, and the overall secondary intervention rate was 16%. CONCLUSION: Iliac arteries between 16 and 22 mm in diameter may be treated with a cuff to the iliac limb with an expectation of 90% efficacy. Surveillance is required, with a high index of suspicion for type 1b endoleaks. Early secondary iliac intervention with extension to the external iliac artery is recommended if there is an increase in sac size after 6 months.

Treatment of infrarenal abdominal aortic aneurysms with oversized (36-mm) Zenith endografts.

PURPOSE: To evaluate the outcome of treating infrarenal abdominal aortic aneurysms with unfavorable necks using the 36-mm Zenith endograft. METHODS: The indication for use of the 36-mm endograft for infrarenal aortic aneurysm was a minimum 20-mm-long sealing zone and a diameter >28 mm at any point but <34 mm, varying more than 3 mm in contour. A series of 67 patients (64 men; mean age 76.2 years, range 59.5 to 88.3) who had been treated with the 36-mm endografts between June 1999 and February 2004 were assessed for medium-term outcomes. The patients were identified from the device planning records. Follow-up was carried out using chart review and direct patient contact. The indication for use of the endograft was checked with the aneurysm neck profile from the original planning diagrams. Cause of death was ascertained from the treating clinician, the medical record, or the State Death Registry. Outcome endpoints were proximal type I and type III endoleaks, migration, sac size change, and death. RESULTS: The mean diameter of the sealing zone was 31.9+/-1.6 mm within the 20-mm segment from the lowest renal artery. Stent-graft delivery was achieved in all 67 patients. Two (3%) patients died within 30 days from non-graft-related cardiorespiratory causes. Proximal type I endoleaks were identified in 3 (4.5%) patients: 2 during deployment and another at 9 days. The mean follow-up period for the 65 patients who survived 30 days was 26.9+/-12.6 months (range 2-66). Migration occurred in 1 patient with development of a type III endoleak and sac reperfusion due to separation of the graft body from the bare anchor stent owing to suture breakage. Forty-seven patients were alive at the last review. The aneurysm sac had contracted or was unchanged in 45 (96%) cases. Minor enlargements of the sac were observed in 2 patients. The re-intervention rate was 16.4% (11 patients). There was 1 conversion to open repair to treat perigraft sepsis. The aneurysm- and procedure-related mortality was 4.5%; no patient experienced rupture. All-cause mortality was 29.9% (20/67). CONCLUSION: Large caliber endografts such as the Zenith 36-mm are an alternative option to open surgery or fenestrated endografting for some infrarenal aneurysms.

Short to midterm outcomes of fenestrated endovascular grafts in the treatment of abdominal aortic aneurysms: a systematic review.

PURPOSE: To perform a systematic review of the short to midterm outcomes of fenestrated endovascular grafts in patients with abdominal aortic aneurysms (AAA). METHODS: A search of PubMed and Medline databases for English-language literature was performed to find studies published between 1999 and 2006. Studies investigating the short to midterm results of fenestrated endovascular grafts for AAA were analyzed for clinical outcomes and postprocedural complications. RESULTS: Nineteen studies involving fenestrated endovascular grafting were retrieved, and 6 of them met criteria for inclusion in the analysis. The remaining studies were excluded because they dealt with technical or case reports or cumulative addition of previous cases. Pooled estimates (95% confidence interval) of postprocedural complications were 1.1% (0.4%-2.7%) for 30-day mortality; 8.3% (2.9%-13.6%) for late mortality; 97% (92%-100%) and 90% (85%-95%) for perfusion of fenestrated vessels at perioperative and late follow-up, respectively; 13.3% (4.1%-22.5%) for postprocedural renal dysfunction; and 11.2% (3.2%-22.5%) and 9.4% (2.6%-16.3%) for early and late endoleak, respectively. There was correlation between preoperative renal insufficiency and postprocedural renal dysfunction, although this was not a statistically significant difference (p=0.2). CONCLUSION: Our systematic review showed that fenestrated endovascular grafting provides an alternative technique to treat patients with complex aneurysm necks, achieving lower mortality than open repair under comparable conditions. Preoperative renal impairment is a strong indicator of postoperative renal dysfunction. Long-term stability and patency of the fenestrated vessels deserves to be validated.