Endurant stent graft demonstrates promising outcomes in challenging abdominal aortic aneurysm anatomy

Mwipatayi, Bibombe P.; Faraj, Joseph; Oshin, Olufemi; Fitridge, Robert; Wong, Jackie; Schermerhorn, Marc L.; Becquemin, Jean‐Pierre; Boeckler, Dittmar; Riambau, Vicenç; Teijink, Joep A.W.; Sambeek, Marc R.H.M. van; Verhagen, Hence J.M.; co-investigators, Engage Registry

doi:10.1016/j.jvs.2020.04.508

Cited by 13 publications

(8 citation statements)

References 46 publications

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“…25 According with the literature results, 4 almost 40% of patients were treated outside the IFU, in particular for the hostility of the proximal aortic neck. 11 Moreover, patients with hostile aortic anatomy are often older and with more comorbidities compared with patients with friendly anatomy, 26,27 as shown also by the population of this study, where the median age was 80 (range: 60-90) years with almost half of patients (48%) ASA 4. This type of patient is probably the one who benefits the most from a minimally invasive treatment.…”

Section: Discussionsupporting

confidence: 52%

“…6,7 As a matter of fact, specific features as repositionability and stent configuration allow their use in complex proximal anatomies. [8][9][10] Specifically, the angulation of the aortic neck is one of the main challenging aspects 11 and the Gore ® Excluder ® Conformable endograft (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) has been developed to address this issue.…”

Section: Introductionmentioning

confidence: 99%

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Endovascular Treatment of Abdominal Aortic Aneurysm With Severe Angulation of Infrarenal Aortic Neck by Gore Conformable Endograft

et al. 2022

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Introduction: The aim of the study is to report a single-center experience with the Gore Excluder conformable endograft with active control system (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) in abdominal aortic aneurysms (AAAs) with severe infrarenal neck angulation. Methods: All patients underwent EVAR with CEXC Device between September 2018 and 2020, were prospectively enrolled, and retrospectively analyzed. Anatomical details of the proximal aortic neck were evaluated. Early endpoints were the use of repositionability and angulation system, intraoperative unplanned cuff, technical success (TS), 30-day morbidity/mortality, and reintervention. Follow-up endpoints were type-I endoleaks, endograft migration, aortic neck dilatation, aneurismal sac shrinkage, survival (S), and freedom from reintervention (FFR). Results: Twenty-five patients were enrolled (median age: 80 [range = 60-90] years, median AAA diameter: 60 [range = 52-90] mm). All patients had severe infrarenal neck angulation (beta angle ≧ 60°), and 11 (44%) of those had neck beta angle ≧ 90°. Median infrarenal neck angle, length, and diameter were 70° (range = 60°-90°), 22 (range = 13-42) mm and 22 (range = 18-31) mm, respectively. Endograft repositioning system was employed in 15 (60%) cases and the median number of repositioning maneuvers was 1 (range:0-4). Active angulation system was used in 17 (68%) patients. The median proximal diameter of the main-body and oversize were 28 (range = 23-36) mm and 28% (range = 21%-38%), respectively. Proximal cuff was positioned in 1 (4%) patient. Technical success was achieved in all cases. Intraoperative and perioperative morbidity and mortality were 12% and 0%, respectively. Perioperative type-I/III and II endoleaks were observed in 0 and 4 (16%) patients, respectively. The median follow-up was 12 months (range: 3-30). One patient died at 12-month for AAA-unrelated causes. Abdominal aortic aneurysm-sac shrinkage and stability were observed in 9 (36%) and 15 (60%) cases, respectively. No type-I/III endoleak and reintervention occurred during the follow-up. One persistent type-II endoleak was observed. Estimated survival at 24 months was 92%. Conclusion: According to the present data, the CEXC Device allows an excellent rate of TS in severe angulated aortic neck. This preliminary data, could increase the rate of patients eligible for EVAR.

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Section: Discussionsupporting

confidence: 52%

Section: Introductionmentioning

confidence: 99%

Endovascular Treatment of Abdominal Aortic Aneurysm With Severe Angulation of Infrarenal Aortic Neck by Gore Conformable Endograft

et al. 2022

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“…Previously published data were obtained and subsequently collated from two sources; the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT) [9][10].…”

Section: Data Sourcementioning

confidence: 99%

“…ENGAGE (Clinicaltrials.gov identifier, NCT00870051) was designed to augment the knowledge base about endovascular aortic aneurysm repair in a real-world population implanted with the Medtronic stent graft system (Endurant) [9]. Patient enrollment in the ENGAGE registry occurred between 2009 and 2011, with a follow-up duration of 10 years.…”

Section: Data Sourcementioning

confidence: 99%

“…A total of 1263 patients from 79 international centers were enrolled with minimal inclusion criteria. Selected exclusion criteria included the probability of non-adherence to followup requirements and concurrent participation in another trial that might confound results [9]. Data on outcomes following five years of follow-up were utilized within this analysis.…”

Section: Data Sourcementioning

confidence: 99%

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The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR)

Barry¹,

Turley²,

Mwipatayi³

et al. 2021

Cureus

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Background Endovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU. Purpose To identify whether graft selection influences outcomes following EVAR outside of IFU. Methodology A retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff, Arizona). Analyses were performed to evaluate all-cause mortality, aneurysm-related mortality, endoleak occurrence, and surgical reintervention rates between the two cohorts. Results Of the 636 patients, 225 were from ENGAGE (mean age 73 years) and 411 were from GREAT (mean age 75 years). 17.8% were treated outside of IFU in the ENGAGE registry, while 12.4% were treated outside IFU in the GREAT cohort. Five-year freedom from all-cause mortality was similar in both cohorts (65.6% vs. 63.8%). The rate of type IA endoleak development was lower in the Excluder cohort, although this may have been impacted by the fact that only endoleaks that underwent reintervention were recorded within GREAT analysis (Endurant 10.6% vs. Excluder 7.0%). The reintervention rate was 16% at five years following the Endurant aortic graft while it was 13.3% at five years with the Excluder. Conclusion Treatment outside of IFU, be it with a suprarenal or an infrarenal fixation device, is associated with worse outcomes. This analysis reinforces the importance of the consideration of either fenestrated or open repair in those aneurysms that fail to satisfy IFU while endovascular repair in such a setting should be reserved as a last resort strategy.

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Suprarenal vs Infrarenal Fixation

Spanos,

Giannoukas

2024

Mastering Endovascular Techniques

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Endurant stent graft demonstrates promising outcomes in challenging abdominal aortic aneurysm anatomy

Cited by 13 publications

References 46 publications

Endovascular Treatment of Abdominal Aortic Aneurysm With Severe Angulation of Infrarenal Aortic Neck by Gore Conformable Endograft

Endovascular Treatment of Abdominal Aortic Aneurysm With Severe Angulation of Infrarenal Aortic Neck by Gore Conformable Endograft

The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR)

Suprarenal vs Infrarenal Fixation

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