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Late Stent-Graft Migration Secondary to Separation of the Uncovered Segment From the Main Body of a Zenith Endoluminal Graft

Authors:
Karim Ghanim at Royal Perth Hospital
Karim Ghanim
Bibombe Patrice Mwipatayi at University of Western Australia
Bibombe Patrice Mwipatayi
Abbas Manzoor
Abbas Manzoor
Kishore Sieunarine at Hollywood Private Hospital
Kishore Sieunarine
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Abstract

To report a case of type I endoleak secondary to complete disruption of the sutures uniting the uncovered and covered segments of a bifurcated Zenith endoluminal graft, causing displacement and distal migration of the graft main body. A 76-year-old man had successful exclusion of an abdominal aortic aneurysm with a Zenith endoluminal graft in 1999. He continued to do well until the 4-year surveillance imaging [computed tomography (CT) and plain abdominal radiography] showed device migration and proximal endoleak, with consequent expansion of the aneurysm. A proximal extension stent-graft was inserted with good seal. The 1-month follow-up CT angiogram showed reduced aneurysm size and no evidence of any leak. This case shows that the failure of an endoluminal graft occurs at weak points in the construction of the graft, reinforcing the need for long-term surveillance. If detected promptly, such events can often be treated by another endovascular procedure.
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Late Stent-Graft Migration Secondary to Separation of the Uncovered ...
Ghanim, Karim;Mwipatayi, Bibombe P;Abbas, Manzoor;Sieunarine, Kishore
Journal of Endovascular Therapy; Jun 2006; 13, 3; ProQuest Health & Medical Complete
pg. 346
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
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  • Mar 2022
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... However, the junction between the suprarenal bare stent and the proximal part of the main body the graft may represent an area of weakness, and disconnections of the proximal uncovered stent have been reported with the rst generation of this device prior to 2002 [2][3]. At that time, the stent graft was modi ed with a double-suture reinforcement to secure the uncovered stent. ...
An Unusual Cause of Failure In Zenith Alpha Abdominal Endograft
Preprint
Full-text available
  • May 2021
Background The disruption of the stent component of the graft is an unusual complication of the endovascular abdominal aortic aneurysm repair (EVAR).Case presentationA 71-year-old man underwent EVAR followed by initial significant sac shrinkage. At 24 months, ultrasound and computed tomography showed sac growth associated with suprarenal stent graft separation from main body, without evidence of endoleak. A thoracic endograft was placed with complete relining of the previous graft.Conclusions.The report demonstrates un uncommon cause of endograft failure with suprarenal stent separation from a Zenith Cook main body and highlights the need for continuous follow-up.
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... The landing zone is a particularly important anatomical requirement in TEVAR and EVAR for two reasons: the stent graft procedure is technically feasible only when the landing zone is longer than 1.5 cm; and the landing zone anatomy is very important for clinical success (15). The most common and significant complication of TEVAR and EVAR is endoleak (16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). When the length of the landing zone is short, the risk of endoleak increases. ...
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Article
  • Mar 2013
  • Exp Clin Cardiol
Stent graft placement is an acceptable treatment option for aortic disease, particularly for abdominal aortic aneurysm. At present, the use of stent grafts is expanding beyond current indications for use. Fenestrated stent grafts are used in patients with abdominal aortic aneurysms whose aortic anatomy is unsuitable for repair using standard devices. The success of fenestrated stent graft placement is largely dependent on planning, including obtaining measurements and designing the stent. To demonstrate a measurement technique that may be used for the design of fenestrated stent grafts to repair endovascular aneurysms, and to compare these measurements, obtained using archived two-dimensional patient data, with measurements obtained using a three-dimensional (3-D) computer-assisted design model. Fenestrated stent grafts were designed and fabricated based on computed tomographic angiography images. 3-D models were constructed using modelling software and rapid prototyping technology incorporated with fused deposition modelling. The stent grafts were trunk-type, with four holes for the visceral branches (celiac axis, superior mesenteric artery, right renal artery and left renal artery). Computed tomography scans of 10 patients with abdominal aortic aneurysms were reviewed. Axial, multiplanar reconstruction and curved multiplanar reconstruction images were used to measure 11 parameters. Sizing of the fenestrated aortic stent grafts was performed independently by an experienced interventional radiologist, and the results were compared with the same measurements calculated using the 3-D aorta model (generated using Materialise Interactive Medical Image Control System software [Materialise NV, Belgium]). Data were reported as the mean of the measurements. Measurements were evaluated using Bland-Altman analysis and concordance correlation coefficients (CCCs). A total of 10 fenestrated stent grafts were fabricated. The proximal landing section above the celiac axis (one point of the wall being defined as the standard point) was 3 cm, and the distal flared section was 3 cm below the lowest renal artery. Ten computer-assisted design aorta models were successfully constructed. Measurements of the aortic diameter showed high agreement between those obtained using the archived patient computer system stent graft and those obtained using the 3-D aorta model. The CCC for variability was 0.9974. The distance from the standard point to the branch vessels also demonstrated good agreement. The CCC for variability was 0.9999. A direct measurement technique using a standard point was simple to perform and was easily applied to the fabrication process. Preparation time will likely be shortened and the versatility of stent grafts will be improved using this method. It will be possible to produce standardized fenestrated stent grafts once patients' measurements are recorded and analyzed. A fenestrated stent graft design technique using measurements of distance from a standard point generally showed a high level of agreement with a 3-D aorta model.
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Article
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Repair of a late endoleak following complete proximal endograft fixation strut separation
Article
Full-text available
  • Apr 2021
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An Extremely Rare Complication: Abdominal Aortic Aneurysm Rupture Caused by Migration of a Zenith Main Body Years After Repair of the Suprarenal Stent Separation
Article
  • Feb 2019
Purpose: To report an unusual case of an abdominal aortic aneurysm (AAA) rupture caused by migration of a Zenith stent-graft main body years after its separation from the suprarenal stent. Case report: A 72-year-old man underwent endovascular aneurysm repair with a Zenith stent-graft for an infrarenal AAA in year 2000. At that time, a femorofemoral bypass was performed because the left external iliac and common femoral arteries were dissected during treatment. In 2013, follow-up computed tomography (CT) showed disconnection of the uncovered proximal stent, which led to a type Ia endoleak. An additional Zenith main body and Large Palmaz XL balloon-expandable stent were deployed; the endoleak disappeared. In 2016, the patient had abdominal pain, and emergency CT showed AAA rupture caused by migration of the first main body deployed in 2000 under the distal edge of the contralateral (left) leg of the additional main body from 2013, which led to a type IIIa endoleak between the 2 main bodies. A converter and iliac legs were deployed to successfully seal the type IIIa endoleak. The patient remains well 18 months after the second repair; CT scans document stable stent-grafts and no endoleak. Conclusion: Physicians should be aware of the potential risk for AAA rupture caused by late main body migration after treatment for suprarenal stent separation from a Zenith stent-graft.
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The phase I multicenter trial (STAPLE-1) of the Aptus Endovascular Repair System: Results at 6 months and 1 year
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Article
Full-text available
  • Jul 2005
  • NEW ENGL J MED
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Systematic review of recent evidence for the safety and efficacy of elective endovascular repair in the management of infrarenal abdominal aortic aneurysm
Article
  • Aug 2005
Conventional management of abdominal aortic aneurysm (AAA) is by open repair and is associated with a mortality rate of 2-6 per cent. Endovascular aneurysm repair (EVAR) is an alternative technique first introduced in 1991. A systematic review was undertaken of the evidence for the safety and efficacy of elective EVAR in the management of asymptomatic infrarenal AAA. Thirteen electronic bibliographical databases were searched, covering biomedical, health-related, science and social science literature. Outcomes were assessed with respect to efficacy (successful deployment, technical success, conversion rates and secondary intervention rates) and safety (30-day mortality rate, procedure morbidity rates and technical issues-endoleaks, graft thrombosis, stenosis and migration). Of 606 reports identified, 61 met the inclusion criteria (three randomized and 15 non-randomized controlled trials, and 43 uncontrolled studies). There were 29 059 participants in total; 19,804 underwent EVAR. Deployment was successful in 97.6 per cent of cases. Technical success (complete aneurysm exclusion) was 81.9 per cent at discharge and 88.8 per cent at 30 days. Secondary intervention to treat endoleak or maintain graft patency was required in 16.2 per cent of patients. Mean stay in the intensive care unit and mean hospital stay were significantly shorter following EVAR. The 30-day mortality rate for EVAR was 1.6 per cent (randomized controlled trials) and 2.0 per cent in nonrandomized trials and case series. Technical complications comprised stent migration (4.0 per cent), graft limb thrombosis (3.9 per cent), endoleak (type I, 6.8 per cent; type II, 10.3 per cent; type III, 4.2 per cent) and access artery injury (4.8 per cent). EVAR is technically effective and safe, with lower short-term morbidity and mortality rates than open surgery. However, there is a need for extended follow-up as the long-term success of EVAR in preventing aneurysm-related deaths is not yet known.
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Endoleak as a Complication of Endoluminal Grafting of Abdominal Aortic Aneurysms: Classification, Incidence, Diagnosis, and Management
Article
  • Jun 1997
  • J Endovasc Surg
The inability to obtain or maintain a secure seal between a vessel wall and a transluminally implanted intra-aneurysmal graft is a complication unique to the evolving technique of endovascular aneurysm exclusion. Because the term “leak” has long been associated with aneurysm rupture, the term “endoleak” is proposed as a more definitive description of this phenomenon. Embracing both persistent blood flow into the aneurysmal sac from within or around the graft (graft related) and from patent collateral arteries (nongraft related), endoleak can be classified as primary or secondary depending on the time of occurrence (within 30 days of implantation or following apparent initial seal, respectively). Diagnostic techniques to detect endoleak include arteriography, intraprocedural pressure monitoring, contrast-enhanced computed tomography, abdominal X ray, and duplex scanning. Management strategies for endoleak range from observation with periodic imaging surveillance to correction by additional endoluminal or surgical procedures. Standardization of the terminology describing this important sequela to endovascular aneurysm exclusion should facilitate uniform reporting of clinical trial data vital to the evaluation of this emerging technique.
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Device migration after endoluminal abdominal aortic aneurysm repair: Analysis of 113 cases with a minimum follow-up period of 2 years
Article
  • Mar 2002
  • J VASC SURG
Device migration (DM) has been shown to cause late failure after endoluminal abdominal aortic aneurysm (AAA) repair. To establish the incidence rate and the predictive factors of distal migration of the proximal portion of the endograft, computed tomographic (CT) scans performed at different time intervals during follow-up examination of 113 patients were reviewed. Between April 1997 and March 1999, 148 patients underwent endoluminal AAA repair with a modular endograft with infrarenal fixation (Medtronic-AVE AneuRx, Santa Rosa, Calif) at our unit. CT scans performed at 1, 6, and 12 months after surgery and yearly thereafter were prospectively stored in a computer imaging database. Patient demographics, risk factors, operative details, and follow-up events were prospectively collected. No patients were lost to follow-up examination. Twelve patients died within 2 years of surgery, four patients underwent immediate conversion to open repair, and adequate CT measurements were not feasible in 19 cases, which left 113 patients available for a minimum 2-year assessment and 418 CT scan results reviewed. Two vascular surgeons, blinded to patient identity and history with tested interobserver agreement (kappa = 0.64), separately reviewed axial reconstructions of CT scans. DM was defined as changes of 10 mm or more in the distance between the lower renal artery and the first visible portion of the endograft at follow-up examination. Ten possible independent predictors of DM were analyzed with multivariate Cox proportional hazards regression model. One AAA rupture, which was successfully treated, occurred at a mean follow-up period of 28 months (range, 24 to 46 months). Seventeen patients (15%) showed DM. Eight patients (47%) with DM underwent reintervention: a proximal cuff was positioned in six patients and late conversion to open repair was performed in two patients. Of the 10 variables analyzed with Cox proportional hazards regression model, AAA neck enlargement of more than 10% after endoluminal repair (hazard ratio, 7.3; confidence interval, 1.8 to 29.2; P =.004) and preoperative AAA diameter of 55 mm or more (hazard ratio, 4.5; confidence interval, 1.2 to 16.7; P =.02) were positive independent predictors of DM. The probability of DM at 36 months was 27% according to life table analysis. DM occurred in a significant portion of our patients, yet aggressive follow-up examination and a high reintervention rate prevented aneurysm-related death. According to our data, dilatation of the infrarenal aortic neck is an important factor that contributes to the distal migration of stent grafts, and patients with large aneurysms are at high risk for DM.
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Stent-Graft Migration: A Reappraisal of Analysis Methods and Proposed Revised Definition
Article
  • Aug 2004
To demonstrate the need for a radiographic definition of migration that accurately describes a specific failure mode of an aortic stent-graft. The diagnosis of endograft migration, as defined by the Society for Vascular Surgery/American Association for Vascular Surgery (SVS/AAVS) standards, requires a synthesis of clinical and/or radiographic observations. Radiographic studies and clinical reports of 704 consecutive patients treated over a 6-year period with abdominal aortic endografts were retrospectively reviewed. According to the current SVS/AAVS standards, 25 patients were identified as having endograft migration. Follow-up computed tomographic scans and radiographs available for 24 of these patients were scrutinized from discharge to the time of any observed proximal or distal fixation system movement based upon the discharge or 30-day CT scan. Proximal migration was defined with respect to the origin of the superior mesenteric artery (SMA) as movement in a caudal or cranial direction of >/=10 mm or >2 times the reconstructed resolution of the imaging study (whichever measurement was less). Distal migration was similarly defined using the aortic bifurcation and respective hypogastric artery origin as reference points. In an effort to assess the scan-to-scan variation, the distance between the SMA and lowest renal artery, which was expected to remain consistent, was measured. Film analysis with application of the revised migration definition confirmed fixation system failure with respect to the native arterial system in 12 (50%) of the 24 patients. Subjects judged to have endograft migration according to the reporting standards but not to have radiographic evidence of migration based on the modified criteria included 2 proximal endoleaks without evidence of device movement treated with proximal extensions, 1 procedure-related migration, 2 type III endoleaks treated with a second prosthesis implanted within the first, 1 distal endoleak treated with a limb extension, 1 rupture with presumed distal limb migration, and 2 cases of component separation. Three limb extensions were placed in the absence of leak or migration. These 12 patients all had radiographic evidence that the proximal and distal aspects of the originally implanted device did not move with respect to the native arterial vasculature, thus confirming stability of the respective fixation system. Adherence to this comprehensive definition of device migration, which differs from the published reporting standards, allows differentiation of the specific mechanisms of device failure. Data viewed in this context will aid in the understanding of device strengths and weaknesses, potentially improve patient assessment, and encourage design modifications to address specific aspects relating to fixation failure.
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