Dataset Information

Stent-graft surface movement after endovascular aneurysm repair: baseline parameters for prediction, and association with migration and stent-graft-related endoleaks.

ABSTRACT: OBJECTIVES:To evaluate the influence of baseline parameters on the occurrence of stent-graft surface movement after endovascular aneurysm repair (EVAR) and to investigate its association with migration and stent-graft-related endoleaks (srEL). METHODS:In this retrospective, cross-sectional study, three-dimensional surface models of the stent-graft, delimited by landmarks using custom-built software, were derived from the pre-discharge and last follow-up computed tomography angiography (CTA). Stent-graft surface movement in the proximal anchoring zone between these examinations was considered significant at a threshold of 9 mm. The Cox proportional hazards model was used to determine baseline variables associated with the occurrence of stent-graft surface movement. The association between migration and srEL with stent-graft surface movement was tested with the chi-square and the Fisher exact test, respectively. RESULTS:Stent-graft surface movement was observed in 54 (28.9%) of 187 patients. Multivariate analysis revealed that age ([HR] 1.05; p?=?0.017), proximal neck diameter ([HR] 5.07; p?

SUBMITTER: Asenbaum U

PROVIDER: S-EPMC6828830 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Stent-graft surface movement after endovascular aneurysm repair: baseline parameters for prediction, and association with migration and stent-graft-related endoleaks.

Asenbaum Ulrika U Schoder Maria M Schwartz Ernst E Langs Georg G Baltzer Pascal P Wolf Florian F Prusa Alexander M AM Loewe Christian C Nolz Richard R

European radiology 20190627 12

<h4>Objectives</h4>To evaluate the influence of baseline parameters on the occurrence of stent-graft surface movement after endovascular aneurysm repair (EVAR) and to investigate its association with migration and stent-graft-related endoleaks (srEL).<h4>Methods</h4>In this retrospective, cross-sectional study, three-dimensional surface models of the stent-graft, delimited by landmarks using custom-built software, were derived from the pre-discharge and last follow-up computed tomography angiogr ...[more]

PMID: 31250169

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Project description:BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval.ObjectiveThis registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience.MethodsAll consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint.ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups.ConclusionsThe results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label.Trial registrationClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892.International registered report identifier (irrid)PRR1-10.2196/36995.

Project description:ObjectiveThe Society for Vascular Surgery reporting standards for endovascular aneurysm repair (EVAR) consider the presence of a type I or type III endoleak a technical failure. However, the nature and implications of these endoleaks in fenestrated EVAR (FEVAR) are not well understood.MethodsWe performed a single-center retrospective review of 53 patients who underwent FEVAR with the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) from 2013 to 2018. We excluded one patient without contrast-enhanced postoperative imaging who was lost to follow-up after discharge. Small, slow, type I and type III endoleaks on completion angiography were routinely observed. We identified patients with completion type I or type III endoleaks by angiography review and characterized endoleak type, location, and rate of resolution on initial postoperative imaging.ResultsFifty-two patients were included; mean age was 75 ± 8 years, 75% were male, and 91% were white. Of 146 visceral vessels (100 renal arteries and 46 superior mesenteric arteries), 145 (99%) were preserved with 103 fenestrations and 43 scallops; 102 (70%) target vessels were stented. After implantation of all device components, 31 patients (60%) had evidence of type I or type III endoleak. Twelve patients (39%) underwent further intervention at the index procedure, and three endoleaks resolved completely. Twenty-eight patients (54%) had a type I or type III endoleak on completion angiography. There were no differences between patients with and without completion endoleaks in baseline demographics, graft design, neck anatomy, or proportion of cases performed within the instructions for use of the device. Perioperative mortality was 1.9%. On initial postoperative imaging, 27 of 28 (96%) endoleaks resolved spontaneously. One small, persistent type IA or type III endoleak was identified on postoperative day 27 and was observed. This endoleak had resolved completely on computed tomography angiography 6 months postoperatively. In patients without a completion endoleak, one type IA endoleak secondary to graft infolding was discovered on postoperative imaging and was successfully treated with placement of endoanchors and Palmaz stent. Median follow-up was 269 days. No additional type I or type III endoleaks were identified in any patient for the duration of follow-up.ConclusionsWhereas completion type I and type III endoleaks are common after FEVAR with the ZFEN device, nearly all of these endoleaks resolve spontaneously by the initial postoperative imaging. These results suggest that select completion endoleaks after FEVAR with the ZFEN device do not require intervention at the index procedure.

Dataset Information

Stent-graft surface movement after endovascular aneurysm repair: baseline parameters for prediction, and association with migration and stent-graft-related endoleaks.

Publications

Stent-graft surface movement after endovascular aneurysm repair: baseline parameters for prediction, and association with migration and stent-graft-related endoleaks.

Similar Datasets

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