AA4. Endovascular Aneurysm Repair With Cordis Incraft in Extremely Narrow (<16 mm) Aortic Bifurcation Outside of Instructions for Use: A Multicenter Experience

Objective Endovascular aneurysm repair for ruptured abdominal aortic aneurysm is being increasingly applied as the intervention of choice. The purpose of this study was to determine whether survival and reintervention rates after ruptured abdominal aortic aneurysm vary between endograft devices. Methods This cohort study identified all ruptured abdominal aortic aneurysms performed at The Ottawa Hospital from January 1999 to May 2015. Data collected included patient demographics, stability index at presentation, adherence to device instructions for use, endoleaks, reinterventions, and mortality. Kruskal–Wallis test was used to compare outcomes between groups. Mortality outcomes were assessed using Kaplan–Meier survival analysis, and multivariate Cox regression modeling. Results One thousand sixty endovascular aneurysm repairs were performed using nine unique devices. Ninety-six ruptured abdominal aortic aneurysms were performed using three devices: Cook Zenith ( n = 46), Medtronic Endurant ( n = 33), and Medtronic Talent ( n = 17). The percent of patients presented in unstable or extremis condition was 30.2, which did not differ between devices. Overall 30-day mortality was 18.8%, and was not statistically different between devices ( p = 0.16), although Medtronic Talent had markedly higher mortality (35.3%) than Cook Zenith (15.2%) and Medtronic Endurant (15.2%). AUI configuration was associated with increased 30-day mortality (33.3% vs. 12.1%, p = 0.02). Long-term mortality and graft-related reintervention rates at 30 days and 5 years were similar between devices. Instructions for use adherence was similar across devices, but differed between the ruptured abdominal aortic aneurysm and elective endovascular aneurysm repair cohorts (47.7% vs. 79.0%, p < 0.01). Notably, two patients who received Medtronic Talent grafts underwent open conversion >30 days post-endovascular aneurysm repair ( p = 0.01). Type 1 endoleak rates differed significantly across devices (Cook Zenith 0.0%, Medtronic Endurant 18.2%, Medtronic Talent 17.6%, p = 0.01). Conclusion Although we identified device-related differences in endoleak rates, there were no significant differences in reintervention rates or mortality outcomes. Favorable outcomes of Cook Zenith and Medtronic Endurant over Medtronic Talent reflect advances in endograft technology and improvements in operator experience over time. Results support selection of endograft by operator preference for ruptured abdominal aortic aneurysm.

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Long-term survival after endovascular and open repair in patients with anatomy outside instructions for use criteria for endovascular aneurysm repair

Journal of Vascular Surgery ◽

10.1016/j.jvs.2019.01.081 ◽

2019 ◽

Vol 70 (6) ◽

pp. 1823-1830 ◽

Cited By ~ 9

Author(s):

Philippe Charbonneau ◽

Kiattisak Hongku ◽

Christine R. Herman ◽

Mohammed Habib ◽

Elie Girsowicz ◽

...

Keyword(s):

Open Repair ◽

Endovascular Aneurysm Repair ◽

Term Survival ◽

Long Term Survival ◽

Instructions For Use ◽

Aneurysm Repair

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Prognosis review and time-to-event data meta-analysis of endovascular aneurysm repair outside versus within instructions for use of aortic endograft devices

Journal of Vascular Surgery ◽

10.1016/j.jvs.2019.08.247 ◽

2020 ◽

Vol 71 (4) ◽

pp. 1415-1431.e15 ◽

Cited By ~ 5

Author(s):

George A. Antoniou ◽

Maciej T. Juszczak ◽

Hosaam Nasr ◽

Ranjeet Narlawar ◽

Stavros A. Antoniou ◽

...

Keyword(s):

Meta Analysis ◽

Endovascular Aneurysm Repair ◽

Event Data ◽

Time To Event ◽

Time To Event Data ◽

Instructions For Use ◽

Aneurysm Repair

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Challenging Anatomy Predicts Mortality and Complications After Endovascular Treatment of Ruptured Abdominal Aortic Aneurysm

Journal of Endovascular Therapy ◽

10.1177/1526602816658494 ◽

2016 ◽

Vol 23 (6) ◽

pp. 919-927 ◽

Cited By ~ 12

Author(s):

Hassan Baderkhan ◽

Frederico M. Bastos Gonçalves ◽

Nelson Gomes Oliveira ◽

Hence J. M. Verhagen ◽

Anders Wanhainen ◽

...

Keyword(s):

Cox Regression ◽

Endovascular Aneurysm Repair ◽

Aortic Aneurysms ◽

Cox Regression Analysis ◽

Aneurysm Neck ◽

Secondary Interventions ◽

Kaplan Meier ◽

Abdominal Aortic ◽

Instructions For Use ◽

Aneurysm Repair

Purpose: To analyze the effects of aortic anatomy and endovascular aneurysm repair (EVAR) inside and outside the instructions for use (IFU) on outcomes in patients treated for ruptured abdominal aortic aneurysms (rAAA). Methods: All 112 patients (mean age 73 years; 102 men) treated with standard EVAR for rAAA between 2000 and 2012 in 3 European centers were included in the retrospective analysis. Patients were grouped based on aortic anatomy and whether EVAR was performed inside or outside the IFU. Data on complications, secondary interventions, and mortality were extracted from the patient records. Cox regression analysis was performed to assess predictors of mortality and complications; results are presented as the hazard ratio (HR) with 95% confidence interval (CI). Survival was analyzed using the Kaplan-Meier method. Results: Of the 112 patients examined, 61 (54%) were treated inside the IFU, 43 (38%) outside the IFU, and 8 patients lacked adequate preoperative computed tomography scans for determination. Median follow-up of those surviving 30 days was 2.5 years. Mortality at 30 days was 15% (95% CI 6% to 24%) inside the IFU vs 30% (95% CI 16% to 45%) outside (p=0.087). Three-year mortality estimates were 33.8% (95% CI 20.0% to 47.5%) inside the IFU vs 56% (95% CI 39.7% to 72.2%) outside (p=0.016). At 5 years, mortality was 48% (95% CI 30% to 66%) inside the IFU vs 74% (95% CI 54% to 93%) outside (p=0.015). Graft-related complications occurred in 6% (95% CI 0% to 13%) inside the IFU and 30% (95% CI 14% to 42%) outside (p=0.015). The rate of graft-related secondary interventions was 14% (95% CI 4% to 22%) inside the IFU vs 35% (95% CI 14% to 42%) outside (p=0.072). In the multivariate analysis, neck length <15 mm (HR 8.1, 95% CI 3.0 to 21.9, p<0.001) and angulation >60° (HR 3.1, 95% CI 1.0 to 9.3, p=0.045) were independent predictors of late graft-related complications. Aneurysm neck diameter >29 mm (HR 2.5, 95% CI 1.1 to 5.9, p=0.035) was an independent predictor of overall mortality. Conclusion: Long-term mortality and complications after rEVAR are associated with aneurysm anatomy. The role of adjunct endovascular techniques and the outcome of open repair in cases with challenging anatomy warrant further study.

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Any nonadherence to instructions for use predicts graft-related adverse events in patients undergoing elective endovascular aneurysm repair

Journal of Vascular Surgery ◽

10.1016/j.jvs.2017.05.095 ◽

2018 ◽

Vol 67 (1) ◽

pp. 126-133 ◽

Cited By ~ 25

Author(s):

Christine R. Herman ◽

Philippe Charbonneau ◽

Kiattisak Hongku ◽

Luc Dubois ◽

Sajjid Hossain ◽

...

Keyword(s):

Adverse Events ◽

Endovascular Aneurysm Repair ◽

Instructions For Use ◽

Aneurysm Repair

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Spiral CT Angiography versus Aortography in the Assessment of Aortoiliac Length in Patients Undergoing Endovascular Abdominal Aortic Aneurysm Repair

Journal of Endovascular Therapy ◽

10.1177/152660289800500306 ◽

1998 ◽

Vol 5 (3) ◽

pp. 222-227 ◽

Cited By ~ 7

Author(s):

Matthew P. Armon ◽

Simon C. Whitaker ◽

Roger H.S. Gregson ◽

Peter W. Wenham ◽

Brian R. Hopkinson

Keyword(s):

Renal Artery ◽

Large Diameter ◽

Endovascular Aneurysm Repair ◽

Spiral Ct ◽

Abdominal Aortic Aneurysm Repair ◽

Aortic Aneurysms ◽

Aortic Bifurcation ◽

Abdominal Aortic ◽

Aneurysm Repair ◽

Level Of Agreement

Purpose: To compare measurements of aortoiliac length obtained with spiral computed tomographic angiography (CTA) and aortography in patients undergoing endovascular aneurysm repair. Methods: The distances from the lower-most renal artery to the aortic bifurcation and from the aortic bifurcation to the common iliac artery (CIA) bifurcation were measured using both CTA and aortography in 108 patients with abdominal aortic aneurysms. Results: The level of agreement between CTA and aortography was high, with 69% of aortic and 76% of iliac measurements within 1 cm and > 90% within 2 cm of each other. Mean differences were −0.35 ± 1.20 cm and 0.25 ± 1.10 cm, respectively, for aortic and iliac lengths. Aortography overestimated renal artery to aortic bifurcation length in comparison to CTA (p = 0.003), particularly in patients with large aneurysms (> 6.5 cm) and lumen diameters > 4.5 cm (p < 0.0001). Measurements of CIA length were shorter by aortography than CTA (p = 0.02). Conclusions: There is a high level of agreement between CTA and aortography in the measurement of aortoiliac length, but aortography overestimates renal artery to aortic bifurcation length in patients with large-diameter aneurysms and wide aneurysm lumens. CTA is sufficiently accurate in the majority of cases to be used as the sole basis for the construction of endovascular grafts.

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Any Deviation From Instructions for Use Predicts Device Failure in Patients Undergoing Endovascular Aneurysm Repair in Midterm Follow-up

Journal of Vascular Surgery ◽

10.1016/j.jvs.2016.08.009 ◽

2016 ◽

Vol 64 (5) ◽

pp. 1532-1533

Author(s):

Philippe Charbonneau ◽

Christine R. Herman ◽

Sandra Mekhaiel ◽

Kiattisak Hongku ◽

Sajjid Hossain ◽

...

Keyword(s):

Endovascular Aneurysm Repair ◽

Device Failure ◽

Instructions For Use ◽

Aneurysm Repair

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Midterm Results of Endovascular Aneurysm Repair Using the Endurant Stent-Graft According to the Instructions for Use vs. Off-Label Conditions

Journal of Endovascular Therapy ◽

10.1583/14-4795mr.1 ◽

2014 ◽

Vol 21 (6) ◽

pp. 841-847 ◽

Cited By ~ 18

Author(s):

Nicola Troisi ◽

Giovanni Torsello ◽

Kristin Weiss ◽

Konstantinos P. Donas ◽

Stefano Michelagnoli ◽

...

Keyword(s):

Stent Graft ◽

Endovascular Aneurysm Repair ◽

Midterm Results ◽

Off Label ◽

Instructions For Use ◽

Aneurysm Repair

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Double D Technique: An Innovative Modified Bifurcated Stent Graft Deployment Strategy for an Isolated Common Iliac Artery Aneurysm With a Challenging Renal Artery Anatomy

Vascular and Endovascular Surgery ◽

10.1177/1538574419862671 ◽

2019 ◽

Vol 53 (7) ◽

pp. 613-616 ◽

Cited By ~ 1

Author(s):

Yusuke Date ◽

Tamaki Takano ◽

Taishi Fujii ◽

Takamitsu Terasaki ◽

Masayuk Sakaguchi

Keyword(s):

Renal Artery ◽

Iliac Artery ◽

Common Iliac Artery ◽

Endovascular Aneurysm Repair ◽

Artery Aneurysm ◽

Aortic Bifurcation ◽

Iliac Artery Aneurysm ◽

Common Iliac Artery Aneurysm ◽

The Right ◽

Aneurysm Repair

Purpose: Endovascular aneurysm repair (EVAR) for an isolated common iliac artery aneurysm (iCIAA) sometimes requires a bifurcated stent graft (SG). In EVAR, it is essential to preserve the renal artery (RA). However, this is challenging in cases of anatomical variation. The double D technique (DDT) can be used in anatomically inadequate cases with a commercially approved bifurcated SG. Here, we report the repair of iCIAA in the presence of a challenging RA anatomy, through EVAR using the DDT. Case Report: An 84-year-old woman was diagnosed with a maximal 35-mm diameter left iCIAA and a nonaneurysmal aorta by computed tomography (CT), which also showed that the right RA arose 50-mm above the aortic bifurcation. The DDT was chosen because commercially approved bifurcated SGs typically require a distance of >70 mm from the proximal position to the aortic bifurcation. Postoperative CT showed excellent results with no endoleaks or SG kinking and occlusion, as well as preservation of robust blood flow to the right RA. Conclusion: Endovascular aneurysm repair using the DDT can be an alternative option for treatment of iCIAA with a challenging RA anatomy.

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A unique case of bilateral lower extremity post-endovascular aneurysm repair claudication

SAGE Open Medical Case Reports ◽

10.1177/2050313x20966128 ◽

2020 ◽

Vol 8 ◽

pp. 2050313X2096612

Author(s):

Rory J Loo ◽

Arvind Srinivasan ◽

Shahriar Alizadegan

Keyword(s):

Lower Extremity ◽

Perioperative Complications ◽

Endovascular Aneurysm Repair ◽

Abdominal Aortic Aneurysms ◽

Aortic Aneurysms ◽

Bilateral Lower Extremity ◽

First Case ◽

Abdominal Aortic ◽

Instructions For Use ◽

Aneurysm Repair

The majority of abdominal aortic aneurysms have been treated by endovascular aneurysm repair in the past decade. Common perioperative complications after this procedure are mostly related to vascular access and improper stent-graft placement. We present the first case of bilateral lower extremity claudication due to severe angulation of the graft–aorta interface, which may have been prevented by a more critical consideration of the patient’s anatomy. Treatment required open explantation and repair of the abdominal aortic aneurysms which led to complete resolution of claudication. The results of this case highlight the importance of adherence to instructions for use guidelines.

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