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ABSTRACT: OBJECTIVE: This article reports the incidence, timing, and related sequelae for proximal and distal migration of the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) used to treat abdominal aortic aneurysms. METHOD: A prospectively maintained database at a tertiary referral hospital was used to identify 83 patients who underwent endovascular repair using the Zenith fenestrated stent graft. Inclusion criteria included a postoperative computed tomography (CT) scan within 6 weeks of implantation and at least one additional follow-up CT scan (>5 months) available electronically at our institution. Eligible patients underwent assessment of stent graft migration using a CT-based central luminal line (CLL) technique. The proximal and distal margins of the stent graft were measured using CLLs relative to vascular landmarks on all available follow-up CT scans. Migration was defined as stent graft movement ≥4 mm. RESULTS: Fifty-five patients were included in this study, mean age was 74 ± 7 years, and 89% were men. Mean preoperative aneurysm diameter was 67 ± 9 mm. In these 55 patients, fenestrations were applied to 162 target vessels with the commonest design accommodating two renal arteries (RAs) and the superior mesenteric artery (SMA). Median follow-up was 24 (range, 5-97) months; 80% of patients (n = 44) had both the proximal and two distal attachment sites assessed for evidence of migration. Twelve iliac limbs in 11 patients were excluded from analysis due to occlusion of one internal iliac artery precluding CLL assessment (n = 7), or image quality issues (n = 5). Using CLLs and based on those patients who exhibited migration, the median proximal and distal migration distances were +5.0 (range, +4.0 to +8.1) mm and -5.0 (range, -4.3 to -21.3) mm, respectively. Kaplan-Meier analysis for proximal migration revealed migration rates of 14% and 22% at 12 and 36 months, respectively. Distal migration rates were lower at 3% and 8%, respectively. There have been no incidences of late rupture or open conversion. Of the patients with proximal migration, two patients lost a single target vessel (two RAs) and three patients were reported to have target vessel stenosis (two SMAs, one RA). These cases did not require reintervention. CONCLUSIONS: Both suprarenal fabric extension and visceral artery stenting are known to provide additional fixation for fenestrated aortic stent grafts. Despite this, minor proximal migration still occurs in up to one quarter of fenestrated endovascular repair patients by 4 years. We believe this is mainly due to the engagement of the barbs of the anchoring stent. Distal migrations occur with lower frequency.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 03/2013; · 3.52 Impact Factor
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ABSTRACT: 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.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 10/2012; · 3.52 Impact Factor
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ABSTRACT: To measure the stiffness of commonly used "stiff" guidewires in terms of their flexural modulus, an engineering parameter related to bending stiffness.
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.
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.
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.
Journal of Endovascular Therapy 12/2011; 18(6):797-801. · 2.86 Impact Factor
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ABSTRACT: 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.
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%.
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.
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.
Journal of Endovascular Therapy 08/2011; 18(4):569-75. · 2.86 Impact Factor
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Jonathan R Boyle,
Matt M Thompson,
S Rao Vallabhaneni,
Rachael E Bell, John A Brennan,
Tom F Browne,
Nicholas J Cheshire,
Robert J Hinchliffe,
Michael P Jenkins,
Ian M Loftus,
Sumaira Macdonald,
Mark J McCarthy,
Richard G McWilliams,
Robert A Morgan,
Olufemi A Oshin,
R Mark Pemberton,
Woolagasen R Pillay,
Robert D Sayers
Journal of Endovascular Therapy 06/2011; 18(3):263-71. · 2.86 Impact Factor
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ABSTRACT: To evaluate intra- and interobserver agreement of target vessel measured from computed tomography (CT) scans with 2 measuring techniques used in planning fenestrated endovascular aneurysm repairs (FEVAR): multiplanar reconstruction (MPR) and semi-automated central lumen line (CLL).
CT datasets from 25 FEVAR patients were independently analyzed by 2 experienced observers according to a standardized protocol using the MPR (Leonardo workstation) and CLL (Aquarius workstation) techniques for each patient. Longitudinal vessel separation and clock-face position of the visceral aortic branches were measured twice. The repeatability coefficient (RC) was calculated using the Bland and Altman method to measure intra- and interobserver variability. Differences between groups were examined by paired t test (continuous data) or chi-squared analysis (categorical). Clock-face discrepancy >30 minutes was considered significant.
Intraobserver mean difference was insignificant regardless of the measurement technique: the observer and workstation-specific RCs varied between 3.9 and 4.9 mm. Paired measurements differed by >3 mm in 8%. Interobserver variability was greater: observer and workstation-specific RC varied between 5.6 and 7.4 mm, with a tendency toward consistency using MPR, although the mean difference was insignificant. Paired measurements differed by >3 mm in 18%. There was no significant intraobserver variation in clock-face measurement, while interobserver variation was significant in 12% of measurements using the Aquarius workstation and 6% using the Leonardo workstation (p = 0.19).
Subjective interpretation of anatomical landmarks is more important than measurement techniques or workstations used in the generation of measurement inconsistencies. Introduction of consensus regarding interpretation of anatomical detail and development of fenestrated stent-grafts tolerant of measurement errors might ameliorate some of the problems encountered in FEVAR.
Journal of Endovascular Therapy 06/2010; 17(3):402-7. · 2.86 Impact Factor
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ABSTRACT: To determine whether the introduction of a policy of adjunctive stent insertion based on preoperative CT assessment or completion angiography reduced the incidence of limb occlusion after stent-graft implantation for endovascular aneurysm repair (EVAR).
A tertiary referral unit's endovascular database was retrospectively interrogated to compare the incidence of endograft limb occlusion in Zenith grafts following the introduction of a policy of selective adjunctive stent insertion. Group A included 288 limbs at risk in 146 patients (134 men; mean age 74+/-8 years) treated prior to August 2005 in whom adjunctive stents were inserted on an ad hoc basis only. Group B included 293 limbs at risk in 149 patients (127 men; mean age 76+/-7 years) treated after this date in whom a more aggressive adjunctive stenting strategy was adopted. Kaplan-Meier analysis was employed to compare outcomes.
In total, 295 patients underwent EVAR involving 581 iliac vessels, of which 11 (1.8%) occluded at a median of 24 months (0-27). Of 65 limbs extended into the external iliac segment, 5 (7.6%) subsequently occluded; in the remaining 516 limbs, there were 6 (1.1%) occlusions (p = 0.004). Across the study group, 38 (6.5%) adjunctive stents were deployed in limbs deemed at risk; 1 (2.6%) of these occluded. In the remaining 543 unstented limbs, 10 (1.8%) occlusions occurred (p = 0.15). There were 11 occlusions in group A, in which 5 (1.7%) adjunctive stents had been deployed, but none in group B, which had received 33 (11.2%) stents (p<0.0001). Kaplan-Meier survival curves identified primary patency rates at 36 months of 96% and 100%, respectively (p = 0.001).
Adjunctive stenting significantly reduces the risk of postoperative stent-graft limb occlusion without obvious compromise to the aneurysm repair.
Journal of Endovascular Therapy 02/2010; 17(1):108-14. · 2.86 Impact Factor
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ABSTRACT: To determine if oblique angulation of the image intensifier is adequate to image the entire length of the common iliac artery during endovascular aneurysm repair or if additional caudal tilt is necessary.
Using a 3D workstation, the apparent level of the iliac bifurcation (distal limit of the stent-graft) was determined on computed tomographic angiography by profiling the common iliac segment in oblique angulation only and repeated with a combination of oblique angulation and caudal tilt. Two independent observers measured twice the apparent length of the iliac segment in both profiles for 50 patients according to a set protocol. Intra- and interobserver variability was calculated using the Bland and Altman method; the differences between the two different profiles were tested using paired t tests.
Of the 50 CTA datasets reviewed, 2 datasets were excluded owing to extensive calcification of the iliac system that prevented accurate interpretation of the image. Of the 96 segments studied, the iliac segments appeared longer (better profiled) with a combination of caudal tilt and oblique angulation in 80%, with an average discrepancy of 9 mm for observer 1 (range -1 to +28) and 7 mm for observer 2 (0 to +26). The effect of caudal tilt was statistically significant for individual observers (p = 0.001 and 0.024, respectively). Forty-six percent of iliac segments measured by observer 1 and 35% by observer 2 showed that the addition of caudal tilt resulted in improved profiling by at least 10 mm. Although inter- and intraobserver variation was significant, the gain in apparent iliac length with the addition of caudal tilt was preserved.
When profiled with oblique angulation alone, the location of the iliac bifurcation may appear higher than its true location, resulting in underutilization of the iliac segment by >10 mm in over a third of the patients. The problem is corrected by employing additional caudal tilt.
Journal of Endovascular Therapy 06/2009; 16(3):373-9. · 2.86 Impact Factor
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ABSTRACT: Vascular grafts are surgically inserted conduits used for anatomic or extra-anatomic bypass of various arterial segments.
The most common indications are aneurysmal and occlusive disease. Aortic and lower limb reconstructions are common and upper
limb reconstruction is somewhat rare. Large blood vessels such as aorta and iliac arteries are usually replaced with prosthetic
material. Autogenous vein is the best conduit for infrainguinal reconstruction, but prosthetic conduits are used when this
is not feasible. An estimate of the numbers of prosthetic arterial grafts used annually in European countries is provided
in Table 1.
11/2007: pages 480-487;
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ABSTRACT: To determine whether fenestrated stent-grafts provide better stability to resist migration than standard non-fenestrated stent-grafts.
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.
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.
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.
Journal of Endovascular Therapy 05/2007; 14(2):168-75. · 2.86 Impact Factor
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ABSTRACT: To measure the tensile strength of the aneurysm wall and the matrix metalloproteinase (MMP) activity in similar samples of aortic tissue.
Detailed mechanical testing was conducted on 124 standardized specimens of aneurysm wall harvested from 24 patients undergoing elective aneurysm repair. The intrasac pressure required to cause aneurysm rupture was calculated based upon the Law of Laplace. In addition, MMP-2 and 9 were assayed from these specimens. Sixty specimens of nonaneurysmal aorta from 6 cadaveric organ donors served as controls. Intrasubject and intersubject variations were analyzed.
In the aneurysm specimens, the Young's modulus was 1.80x10(6) N/m(2), the load at break was 6.36 N, the strain at break was 0.30, the ultimate strength was 0.53x10(6) N/ m(2), and the MMP activity was 312 for MMP-2 and 460 for MMP-9. In the controls, the circumferential measurements were a Young's modulus of 1.82x10(6) N/m(2), a load at break of 5.43 N, strain at break of 0.29, ultimate strength of 0.61x10(6) N/m(2), and MMP activity of 395 for MMP-2 and 2019 for MMP-9. Longitudinal measurements in controls were a Young's modulus of 1.38x10(6) N/m(2), a load at break of 11.39 N, a strain at break of 0.33, and ultimate strength of 1.30x10(6) N/m(2). Intra and intersubject variation of all parameters was very high. Based upon the lowest measured tensile strength for each aneurysm, the intrasac pressure required to cause rupture varied from 142 to 982 mmHg.
Localized "hot spots" of MMP hyperactivity could lead to focal weakening of the aneurysm wall and rupture at relatively low levels of intraluminal pressure. These data suggest that tensile strength of the sac is just as important as intrasac tension in determining the risk of rupture. Moreover, these observations may explain why some small aneurysms rupture and larger aneurysms do not. Assessment of rupture risk based on computation or measurement of wall stress may be subject to error and inaccuracy due to variations in wall tensile strength.
Journal of Endovascular Therapy 09/2004; 11(4):494-502. · 2.86 Impact Factor
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ABSTRACT: To demonstrate the influence of radiographic positioning on the assessment of stent-graft migration using plain radiographs following endovascular abdominal aortic aneurysm repair.
Equations were derived to correct for artifactual stent-graft migration introduced by geometric distortion due to variations in positioning between radiographs acquired at different times. A phantom system was used to validate the equations.
Errors in stent position increase with (1) the distance of the aortic stent-graft from the midline and (2) differences in radiographic centering points in the craniocaudal direction; other variables have little effect. For typical stent positions, errors are small if the centering changes by <8 cm. Consistent radiographic positioning to within 4 cm on successive imaging studies limits errors to 1.5 mm. Even if artifactual migration is large, the true migration can be reliably calculated to within 2 mm.
Artifactual migration due to variation in radiographic centering is not usually clinically significant if care is taken to center radiographs consistently. Radiographs in which artifactual migration may be important are readily identified, and mathematical correction is straightforward.
Journal of Endovascular Therapy 10/2003; 10(5):902-10. · 2.86 Impact Factor
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ABSTRACT: To determine if pressure measured at a single location within aneurysm sac thrombus accurately reflects the force applied to the aneurysm wall and the risk of rupture by examining (1) if pressure is distributed uniformly within aneurysm thrombus, (2) the pressure transmission through aneurysm thrombus, and (3) the microstructural basis for pressure transmission.
Pressure within aneurysm thrombus was measured by direct puncture through the aneurysm wall at 121 sites in 26 patients during open abdominal aortic aneurysm repair. Measurements were taken prior to cross clamping and compared with intrasac pressure measured at 30 sites in 6 patients without aneurysm thrombus (controls). Transmission of pressure through aneurysm thrombus was further examined ex vivo by subjecting fresh thrombus to a pressure gradient in a custom-made pressure cell. Pressure transmission was correlated with matrix density as determined by light microscopy and image analysis.
Mean pressure within aneurysm thrombus was higher than mean systemic pressure in 11 patients, lower in 1, and identical in 9. In 5 patients, the pressure was greater than systemic in some areas of the thrombus but less in others. Sac pressure was identical to systemic pressure at all sites in the controls. In 12 thrombus specimens (6 patients) examined in the pressure cell, pressure transmission varied significantly between specimens, correlating directly with matrix density (R(2)=0.747, p=0.001).
Pressure transmission through aneurysm thrombus is variable and depends upon the microstructure of the thrombus. Pressure measured at a single location may not, therefore, accurately reflect the pressure acting on the aneurysm wall.
Journal of Endovascular Therapy 07/2003; 10(3):524-30. · 2.86 Impact Factor
