| | Outcomes of original and low-permeability Gore Excluder endoprosthesis for endovascular abdominal aortic aneurysm repairPresented at the Sixtieth Annual Meeting of the Society for Vascular Surgery, Philadelphia, Pa, June 1-4, 2006. Received 28 June 2006; accepted 14 October 2006. ObjectiveBecause of concern about the percentage of enlarging abdominal aortic aneurysms (AAAs) after endovascular repair with the Excluder device (W.L. Gore & Assoc, Inc, Sunnyvale, Calif), the graft material was modified to reduce its permeability and released for commercial use in mid-2004. We studied all AAA repairs with Excluder endografts performed at our institution, including the original-permeability (OP) version (n = 99) and the low-permeability (LP) version (n = 48). MethodsAll patients were followed up with serial computed tomography (CT) angiography and three-dimensional (3D) reconstruction. Morphologic measurements, including AAA diameter and 3D volume, were prospectively entered into a database to evaluate changes in AAA size over time. Owing to the length of available follow-up for the LP version, the primary end point was AAA size change at 6 and 12 months, evaluated by Mann-Whitney U test for unpaired samples. ResultsPreoperative and postoperative anatomy was similar in the two groups, including AAA diameter (OP, 5.6 ± 1 cm; LP, 5.8 ± 2 cm; P = .3), aortic neck length (OP, 21 ± 1 mm; LP, 22 ± 2 mm; P = .9), postoperative aortic seal zone (OP, 18 ± 1 mm; LP, 16 ± 1 mm, P > .1) and iliac seal zone (OP, 33 ± 1 mm, LP 31 ± 1 mm, P = .2). The rate of sac shrinkage differed significantly. Orthogonal diameter measurements showed a significant difference in the rate of shrinkage by 12 months postoperatively (OP, −2.1 ± 1 mm; LP, −5.1 ± 1 mm; P = .01). By 3D volume, the rate of shrinkage was considerably different between the two groups at both 6 and 12 months (12 months: OP, −6% ± 1%; LP, −20 ± 4%; P = .0006). There was no enlargement by diameter in either group at 6 or 12 months postoperative. By standard volume criteria, however, 12 of 99 patients in the OP group and one of 48 patients in the LP group had significant AAA enlargement ≤12 months (P = .04). Of these, four of 12 patients in the OP group had enlargement without apparent endoleak, even on delayed-contrast CT. The remainder had persistent type II endoleaks (8/12 in the OP group and 1/1 in the LP group). Multivariate analysis revealed graft permeability (P < .0001) and endoleak (P < .0001) as independent factors in aneurysm size change. In the OP group long-term, the average AAA enlarged at later time points compared with the prior scan: 24 months, −0.2%; 36 months, +0.2%; 48 months, +2%; and 60 months, +2% (P < .0002). ConclusionsIn early follow-up, the low-permeability Excluder device is associated with a significantly greater aneurysm shrinkage rate than the original version. Clinically important enlargement also appears significantly different within 1 year of implantation. Despite these promising results, longer follow-up is needed to determine whether these differences will persist. Multiple clinical studies have demonstrated the safety and efficacy of the original Gore Excluder endoprosthesis (W.L. Gore & Assoc, Inc, Sunnyvale, Calif), and it was commercially released in the United States in 2001.1, 2 More recent long-term studies, however, have documented higher rates of nonshrinkage and late sac expansion compared with other commercially available endografts.3, 4, 5, 6 Rates of abdominal aortic aneurysm (AAA) expansion appear to be increasing as the length of follow-up increases, with expansion rates in at least 33% of aneurysms by 4 years of implantation.4, 5, 6 With 30,000 Excluder endoprostheses distributed worldwide to date,6 this is a significant issue. The cause of the potentially higher sac expansion rates with the original Excluder device was not initially apparent. In most cases, sac expansion occurred in the absence of endoleak.4, 5, 7 Aneurysm enlargement without endoleak is not rare and has been observed with multiple endovascular devices,8, 9, 10, 11 different fabric types,12 and even after open repair,13, 14 but the incidence of expansion without endoleak appeared higher with the original Excluder endograft than with others.3, 4, 5, 6, 7 Explantation of the endograft typically confirms an absence of endoleak and the presence of gelatinous material within the sac, external to the endograft.1, 7, 10, 13, 14, 15 The natural history of continued sac expansion without endoleak in patients with an Excluder endograft is currently unclear but has led to a number of conversions to open repair and has been associated with aneurysm rupture with this device and others in rare cases.10 After investigations suggested that graft material permeability might explain the sac expansion in a significant number of cases, the expanded polytetrafluoroethylene microstructure was redesigned to reduce its porosity and transmigration of fluid through the graft material (Fig 1). This new low-permeability (LP) endograft became commercially available in the United States in mid-2004. Whether this modification alters aneurysm sac behavior over time compared with the original-permeability (OP) endograft remains unclear. In the following report, we detail follow-up of all OP and LP Excluder endograft implantations at our institution. Prior analysis of the enlarging aneurysms in the Gore Excluder US Pivotal trial confirmed that three-dimensional (3D) volume measurements detected aneurysm growth much earlier than diameter measurements did.5 This 3D method was used to evaluate the changes in aneurysm sac size over time with the OP and LP versions of the Excluder endograft. A detailed comparison of preoperative and postoperative anatomy was performed according to computed tomography (CT) scans, 3D reconstruction, and morphologic measurements. Methods  All patients who underwent endovascular AAA repair (EVAR) with an Excluder bifurcated endoprosthesis from January 1999 to December 2005 at Dartmouth-Hitchcock Medical Center (Lebanon, NH) were analyzed by using data obtained from a prospectively maintained database including morphometric 3D analysis. During this time period, 150 patients had Excluder devices implanted in clinical trials and commercial use (after 2001). These repairs represent a subset of >400 EVARs performed during the same time period at our institution. Before mid-August 2004, all Excluder endografts had one material design, the OP group, and all Excluder grafts placed thereafter were of LP group. Repairs that had components from other manufacturers in addition to Excluder components (n = 2) or had atypical pathology (penetrating ulcer causing aneurysm, n = 1) were excluded from this analysis, leaving 99 in the OP group and 48 in the LP group. All of these patients had a preoperative CT scan, at least two postoperative CT scans, and 3D reconstruction with validated measurements. Data collection was approved by the Institutional Review Board for human subjects at Dartmouth-Hitchcock Medical Center. Imaging Preoperative and postoperative imaging was primarily spiral CT with 3D reconstruction and Computer Aided Measurement, Planning and Simulation (3D CAMPS) software (Preview Medical Metrix Solutions, formerly Medical Media Systems, West Lebanon, NH). Scanning protocols covered a volume from the celiac to common femoral arteries, using a 3D CAMPS technique that has been previously published in detail.16, 17, 18, 19 Patients with severe renal insufficiency but not receiving dialysis underwent magnetic resonance angiography (MRA) to delineate the anatomy with 3D reconstruction and also unenhanced CT because MRA does not detect or display calcified plaque well. Alternate strategies included gadolinium-enhanced CT or, more recently, acetylcysteine prophylaxis and nonionic contrast agent in patients with moderate renal insufficiency (serum creatinine, 2 to 3 mg/dL). Electronic data from CTA or MRA were sent in Dicom format for postprocessing (Medical Metrix Solutions), including multiplanar reformats encompassing the entire volume of the scan in sagittal, coronal, and axial planes at 0.75-mm to 2-mm intervals and orthogonal reformats at 1-mm intervals. Measurements were performed using validated techniques, including electronic calipers, and standard measurement definitions, including Society for Vascular Surgery (SVS) Reporting Standards.20, 21 Key anatomic measurements included maximum AAA diameter change, with ≥5 mm considered significant, and 3D volume change measured from the lowest renal artery to the aortic bifurcation and from the lowest renal artery to the common iliac artery bifurcation to capture changes in patients with iliac aneurysms. Diameters were measured orthogonal to the vessel (ie, in a plane at a right angle to the centerline of the lumen). Methods for 3D volume used a standard 3D reconstruction technique described previously,17, 18, 19 validated on phantoms of known size and clinically on aortic aneurysms, with an interobserver variability <5%. For 3D volume changes, changes of ≥5% were considered significant according to interobserver variability and SVS Reporting Standards.18, 20 Other morphometric variables included neck length, diameter, and achieved apposition; initial sac diameter; iliac length, diameter, and achieved apposition; aortic neck angulation, device angulation over time; endoleak during interval being examined; and endoleak at any time. Spiral CT, 3D reconstruction images, and morphometric data for all patients were prospectively collected and entered into a database for comparison of aneurysm morphology over time. These data were used for patient evaluation and management purposes as standard-of-care. Comparison of the OP and LP groups was performed retrospectively for aneurysm size and other anatomic indices that might be predictive of outcomes after endovascular repair.17, 20, 21 Operative technique All EVARs were performed in the operating room with a 12-inch digital C-arm fluoroscopy unit (GE/OEC 9800, GE Medical Systems, Milwaukee, Wis; or initially, Philips BV 312, Philips Medical Systems, Santa Ana, Calif) and carbon fiber table. Completion arteriography was always performed, with antegrade contrast injection at the proximal attachment site and separate retrograde injection in both iliac arteries. Other injection sites were used, as deemed necessary if endoleak was present (junction injection, separate views), to rule out type I or type III endoleak. Pressure measurements were typically performed to ensure systemic pressure without pressure gradients to the femoral level. Patient follow-up Patients participating in phase II (Pivotal) or phase III (Continued Access) clinical trials were seen at follow-up at 1, 6, and 12 months, with annual visits thereafter. Interim visits were scheduled as clinically indicated or per manufacturer recommendations for trial patients. Each visit included a patient interview, review of systems, physical examination, determination of ankle-brachial index, and CT scan with 3D reconstruction including computer-aided volume measurements. Abdominal radiographs (4 views) were used to evaluate for fracture. Additional studies, including duplex ultrasonography and angiography, were performed as clinically indicated. Follow-up was nearly identical after the OP device became commercially available, with the exception that ankle-brachial indices were not routinely performed and patients without detectable endoleak on postoperative scan at 1 month were more likely to have a CT scan at 6 months or 12 months, rather than both. All patients had at least two postoperative scans, and one at either 6 or 12 months (within a 3-month window). Scans at 12 months were not done in 20 patients in OP group or in 11 in the LP group. Median follow-up was 33.4 months in the OP group and 11.3 months in the LP group. Statistical analysis Anatomic measurements were analyzed using the Statview statistical software package (SAS Institute, Cary, NC). Nominal variables were compared by χ2 or the Fisher exact test. Continuous variables were analyzed using parametric and nonparametric methods. Frequency distribution suggested that the data approximated a normal distribution within reason considering the sample size, and thus a t test was performed for preoperative demographic variables. For size change at 6 and 12 months, a repeated measures analysis of variance with one between factor and one within factor was used to account for repeated measures. This demonstrated that graft type was the predominant effect (see Results). We also used a nonparametric method for the end points of AAA size at 6 and 12 months so that a normal distribution was not necessary to the results, choosing the Mann-Whitney U test for unpaired samples, with correction for multiple comparisons implying P = .025 should be used for significance rather than P = .05. The nonparametric test returned very nearly the same P value. For simplicity, we report the values for the nonparametric test. Variables are reported as mean ± standard error, unless stated otherwise. Multivariate logistic regression analysis was performed for key variables, including all that were significant by univariate analysis. The primary outcome variable (sac size change) was categorized into quartiles for the regression analysis, as no aneurysm grew >5 mm in diameter in either group within the first year. Results The OP and LP groups were comparable in terms of patient characteristics, aneurysm size, and other anatomic indices reported to be predictive of outcomes for the aneurysm sac after endovascular repair (Table I). No statistically significant differences were found for any of the key patient characteristics associated with aneurysm expansion, such as smoking, gender, hypertension, and systemic blood pressure. A somewhat greater percentage of lower extremity peripheral vascular occlusive disease was found in the OP group, and more LP patients had hyperlipidemia. Anatomic variables were also very similar, including the key characteristics related to initial aneurysm size and available length for aortic and iliac attachment and sealing. Very small differences were noted in the aortic neck diameter and external iliac diameter that reached statistical significance. Aneurysm size change Aneurysm size change was evaluated relative to the initial preoperative CT scan and to the 1-month scan. The time from the preoperative CT scan to the operation was slightly longer in the OP group at 2.8 ± 0.3 months compared with 1.9 ± 0.3 months in the LP group (P = .035). This may reflect time related to clinical trial evaluation and device availability before commercial release of the OP device. Aneurysm size changed very little from the preoperative CT scan to the 1-month postoperative CT scan and was statistically similar for the two groups. The change in diameter was +0.5 ± 0.3 mm for the OP device compared with −0.3 ± 0.4 mm for the LP device (P = .11). Volume change from preoperative to 1 month postoperative was also similar between the groups: OP, +1.6% ± 1%, and LP, +0.5% ± 1% (P = .29 for volume measured from lowest renal artery to the aortic bifurcation, and similar for the renal-to-hypogastric volume, P = .55). To eliminate the effect of aneurysm growth between the preoperative CT and the procedure, AAA size change was primarily evaluated relative to the postoperative CT scan at 1 month. Aneurysm size change for diameter and volume from 1 to 6 months and from 1 to 12 months is shown in Fig 2 and Fig 3. On average, AAAs decreased in size with both devices. By orthogonal diameter measurements, there was no significant difference in the rate of shrinkage at 6 months, but by 12 months, the rate of shrinkage was statistically different (Fig 2). The rate of shrinkage by volume was considerably different between the two groups at both 6 and 12 months postoperatively, with more highly significant P values for both intervals (Fig 3, shown for 3D renal-to-hypogastric artery volume measurement). Data are very similar for 3D renal-to-aortic-bifurcation volume (not shown, P = .02 and P = .002). Aneurysm enlargement The incidence of aneurysm enlargement was specifically evaluated to detect individual aneurysm changes that might be masked by average trends in each group. Using standard diameter threshold (≥5 mm change), there was no enlargement in either group at the 6-month or 12-month postoperative periods. By standard volume criteria however (5% change in aneurysm volume), 12 of 99 patients in the OP group and one patient of the 48 in the LP group had significant enlargement within the first 12 months (P = .04). Four of 12 patients in the OP group (and none in the LP group) had aneurysm enlargement without apparent endoleak, even on delayed-contrast CT. Eight of 12 in the OP group and the single patient with enlargement in the LP group had persistent type II endoleaks. Attachment length and endoleak within the first year of implantation Variables that might explain the postoperative aneurysm size changes were also evaluated. No differences were found in aortic stent graft apposition (attachment length), iliac stent graft apposition, or endoleak (Table II). Slightly more endoleaks occurred in the LP group, but no significant difference whether evaluating by sac enhancement of any kind (ie, any enhancement that was not clearly calcification), or when evaluating using endoleak of a defined size (Table II). A single proximal type I endoleak occurred at implantation in the OP group, and this was corrected with a proximal cuff before the 1-month postoperative study. This was the only type I or III endoleak in either group at any time, and all endoleaks at 1 month and beyond were type II. Other key clinical outcomes No aneurysms ruptured in either group during follow-up, and aneurysm-related mortality was zero in both groups. No stent fractures occurred in either group. One migration >5 mm in the OP group was detected at 18 months, and no migration has been detected thus far in the LP group. There was no significant difference in secondary interventions between the two groups during the short period available for comparison. The OP group underwent four secondary procedures within the first year (3 coil embolizations for type II endoleak, 1 proximal cuff as described above), compared with two in the 48 patients in the LP group (2 proximal cuffs). Both aortic cuffs in the LP group were placed for devices with ≤5 mm circumferential neck apposition but no endoleak. One had an additional cuff and a Palmaz stent, the other a cuff alone. Multivariate analysis Multivariable logistic regression analysis was performed for variables potentially related to aneurysm size change, including all that were significant by univariate analysis. Analysis included graft permeability, gender, smoking status (current or not), hypertension, hyperlipidemia, lower extremity occlusive disease, aortic neck diameter, and iliac diameter. Of these variables, only graft permeability (P < .0001) and endoleak (P < .0001) were significantly associated with aneurysm size change relative to the 1-month postoperative scan by both diameter and volume. For sac size change determined by AAA volume (but not diameter), the presence of lower extremity arterial occlusive disease was also found to be a significant factor by this analysis (P = .001). Long-term sac behavior with the original permeability device Aneurysm size change during long-term follow-up of the OP group is shown in Fig 4. On average, most aneurysms initially demonstrated shrinkage with the original device, then stabilized, but subsequently began to enlarge in the 3-year to 5-year time frame. Trends for diameter change over time were nearly identical. The LP device has not been commercially available long enough for a similar evaluation. Discussion In this study, we found that the low-permeability Excluder device is associated with a significantly greater aneurysm shrinkage rate than the original version, even with relatively short follow-up. Perhaps more important, we found a significant difference in the incidence of aneurysm growth exceeding standard clinical thresholds for 3D volume. Our experience with the detection of aneurysm expansion indicates that 3D volume analysis will detect significant differences within 6 months to 1 year, and typically 1 year sooner than diameter changes.5, 17 Other groups have reported similar findings.22 This study reinforces that aneurysm size changes are detected more quickly and definitively by 3D volume than by diameter. Despite this fact, the shrinkage rate is statistically significant by diameter as well, and given the available evidence, the differences in clinically relevant sac expansion will likely be apparent using diameter thresholds within 1 to 2 years. The critical question is whether the differences found here are due to material permeability or some other factor. Notably, this single-center series contains two well-matched groups, with no clinically important changes in practice in the vascular anatomy selected for device implantation. Key characteristics such as aneurysm size, neck length, attachment vessel diameters, patient gender, smoking status, blood pressure, and other parameters were quite similar in the two groups even though half of the OP patients were enrolled in clinical trials that enforced the device instructions for use. This study suggests that type II endoleak can alter sac behavior after EVAR, but with no difference in endoleak presence, type, or size (even sac enhancement of any kind), it seems clear that the difference cannot be explained by endoleak. Moreover, multivariate analysis that included endoleak revealed that graft permeability was significantly and independently associated with aneurysm size change. It is also notable that there was growth without apparent endoleak in the OP group but not in the LP group. In long-term follow-up of the OP group in this study, the average AAA stabilized in volume from 1 to 3 years and then began to enlarge at later time points, so longer follow-up will be needed to definitively state that the improved performance of the LP device will persist. Despite this, most of the enlarging aneurysms in the Gore Pivotal trial could be detected within 1 year using 3D volume,5 and there were clear, statistically significant differences in aneurysm expansion rates within the first year in our present study. A recent in vivo animal study indicates that the endotension associated with the original material is related to transmission of pressure and serous fluid into the aneurysm sac.23 The material change now makes the fabric essentially impermeable, even with bench testing designed to make the material “wet out” and become permeable (Fig 1). Thus, it is expected that aneurysm enlargement owing to material permeability has been eliminated with the newer material. One could reasonably question the significance of the present findings. After all, we found no aneurysm-related mortality, aneurysm ruptures, catastrophic device failures, device deformation, or fractures in either group. There was only a single case of migration in the OP group. The rate of endoleak and secondary intervention in both groups was comparable to the literature and well within accepted standards for endovascular series at large institutions. Some have argued that if the incidence of enlargement with the OP device was clinically important, there should have been more aneurysm ruptures by now. Reports of rupture or exploration of the aneurysm sac in these patients typically does not reveal blood but rather a hygroma or gelatinous substance.1, 7, 10, 14 This evidence has been used to suggest that enhanced surveillance or other intervention is unnecessary for patients with sac enlargement in the absence of endoleak with the Excluder device. We believe the material change is clinically important, however. With 30,000 devices distributed worldwide,6 and at least 33% of treated aneurysms enlarging at 4 years,4, 5, 6 a large number of patients and treating physicians will have to decide what to do about aneurysm expansion. Although the incidence of rupture for aneurysms enlarging without endoleak appears low, some ruptures have been reported.10 A 3D morphologic analysis of the enlarging aneurysms in the Excluder US Pivotal Clinical Trial found that aneurysms expanding without detected endoleak enlarged at half the rate of those with endoleak.5 It is possible that the pressure generated from material permeability is lower than that of a typical type II endoleak, and thus it may take even more time for the average moderate-sized aneurysm to expand sufficiently to have substantial rupture potential. Even if rupture risk is lower for these patients, the expansion still makes follow-up more difficult. Patients are understandably concerned about aneurysm expansion, and the physician needs to determine whether the surveillance interval should decrease. As the aneurysm expands, the physician must determine an aneurysm size or rate of expansion that makes further evaluation or intervention appropriate. These values are currently unknown. One can argue that a rupture might only produce spillage of hygroma into the abdomen. Anecdotal reports suggest rupture in such a case may be managed successfully without operation in selected cases, although at least one such rupture may have been associated with a fatal bowel obstruction.10 Perhaps the most worrisome aspect of endotension, or enlargement without apparent endoleak, is that it might lend a false sense of security. A number of factors can cause expansion with any endograft, including the original Excluder endograft.5, 9, 24, 25, 26, 27, 28, 29, 30, 31 Attributing expansion to material permeability can result in delayed diagnosis of other causes of sac expansion, such as inadequate device attachment or undetected endoleak. Open exploration of the sac for endotension or enlargement without apparent endoleak revealed a missed endoleak in 25% of cases in the Excluder clinical trials.7 The expansion itself can cause other problems, such as a progressively decreasing seal zone within the proximal neck. This phenomenon has been seen at least once in this series with the OP device during late follow-up, and at least once in the 38 patients enlarging at 4 years in the Excluder Pivotal trial.5 Finally, there is the issue of cost. Questions related to material permeability with the OP device may lead to routine delayed-contrast CT studies, additional MRA surveillance, or angiographic evaluation when aneurysms expand. There is a significant cost to the increased patient visits, time for patient education and counseling about the issue, more frequent imaging and more extensive imaging. Thus we believe that the results with the LP device are extremely important, and that continued study of the LP device in a postmarket environment is also important. A multicenter study of the LP device is currently being conducted in the United States, with patient accrual completed in mid-2006. It is hoped that study and others will answer these important questions for the long-term. Author contributions Conception and design: MF, WT Analysis and interpretation: MF, WT Data collection: WT, MF Writing the article: WT, MF Critical revision of the article: MF, WT Final approval of the article: MF, WT Statistical analysis: MF, WT Obtained funding: MF Overall responsibility: MF WT and MF contributed equally to this work. We would like to acknowledge the contributions of Jack Cronenwett, MD, for his help and guidance throughout the abstract and manuscript process. We also thank and acknowledge co-investigators Christopher Alessi, MD, Jack Cronenwett, MD, Brian Nolan, MD, Richard Powell, MD, Eva Rzucidlo, MD, Daniel Walsh, MD, Mark Wyers MD, and Robert Zwolak, MD, for contributing their clinical experience, care, and follow-up of patients within the study, as well as review of the manuscript. References 1. 1Matsumura JS, Brewster DC, Makaroun MS, Naftel DC. A multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysm. J Vasc Surg. 2003;37:262–271. Abstract |
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6. 6W.L. Gore & Associates. GORE Excluder Bifurcated Endoprosthesis annual clinical update, February 2006. Flagstaff, AZ: WL Gore & Assoc; 2006. Available at http://164.109.63.17/library/Documents/AH1406.pdf. Accessed Oct 14, 2006. 7. 7Kong LS, MacMillan D, Kasirajan K, Milner R, Dodson TF, Salam AA, et al. Secondary conversion of the Gore Excluder to operative abdominal aortic aneurysm repair. J Vasc Surg. 2005;42:631–638. Abstract | Full Text |
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Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.  Correspondence: Mark Fillinger, MD, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756.
Competition of interest: Dr Fillinger and/or the Hitchcock Foundation has received grant and research support from W. L. Gore, Medical Metrx Solutions, Medtronic, and Boston Scientific within the past year. No corporate entities requested review or attempted to influence the study design, data collection, analysis, or interpretation in any way. PII: S0741-5214(06)01972-0 doi:10.1016/j.jvs.2006.10.042 © 2007 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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