Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy

Jordan, William D.; Vries, Jean‐Paul P.M. de; Ouriel, Kenneth; Mehta, Manish; Varnagy, David; Moore, William M.; Arko, Frank R.; Joye, James D.; Henretta, John P.

doi:10.1177/1526602815574685

Cited by 50 publications

(53 citation statements)

References 24 publications

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“…Some other technology, including the Aptus system (Aptus Endosystems) to endostable the device proximally can also be used in patients with hostile neck anatomy. 19 …”

Section: Discussionmentioning

confidence: 99%

Aortic Neck Anatomic Features and Predictors of Outcomes in Endovascular Repair of Abdominal Aortic Aneurysms Following vs Not Following Instructions for Use

AbuRahma

Yacoub

Mousa

et al. 2016

Journal of the American College of Surgeons

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BACKGROUND A significant number of patients undergo endovascular repair of abdominal aortic aneurysms (EVAR) outside the instructions for use (IFU). This study will examine various aortic neck features and their predictors of clinical outcomes. STUDY DESIGN We performed a retrospective analysis of prospectively collected data on EVAR patients. Neck features outside IFU were analyzed. Kaplan-Meier and multivariate analyses were used to predict their effect as single features, or in combination, on outcomes. RESULTS Fifty-two percent of 526 patients had 1 or more features outside the IFU. The overall technical success rate was 99%, and perioperative complication rates were 7% and 12% for IFU vs outside IFU use, respectively (p = 0.04). Type I early endoleak and early intervention rates were 7% and 10% for IFU vs 18% and 24% for outside IFU (p = 0.0002 and p < 0.0001). At a mean follow-up of 30 months, freedom from late type I endoleak and late reintervention at 1, 2, and 3 years for IFU were 99.5%, 99.5%, and 98.4%, and 99.4%, 98%, and 96.8%; vs 98.9%, 98.1%, and 98.1%, and 97.5%, 96.2%, and 95.2% for outside IFU (p = 0.049 and 0.799), respectively. Survival rates at 1, 2, and 3 years for IFU were 97%, 93.5%, and 89.8%; vs 93.7%, 88.8%, and 86.3% for outside IFU (p = 0.035). Multivariate analysis showed that a neck angle > 60 degrees had odds ratios for death, sac expansion, and early intervention of 6, 2.6, and 3.3, respectively; neck length < 10 mm had odds ratios of 2.8 for deaths, 3.4 for early intervention, 4.6 for late reintervention, and 4.3 for late type I endoleak. CONCLUSIONS Patients with neck features outside IFU can be treated with EVAR; however, they have higher rates of early and late type I endoleak, early intervention, and late death.

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“…Some other technology, including the Aptus system (Aptus Endosystems) to endostable the device proximally can also be used in patients with hostile neck anatomy. 19 …”

Section: Discussionmentioning

confidence: 99%

Aortic Neck Anatomic Features and Predictors of Outcomes in Endovascular Repair of Abdominal Aortic Aneurysms Following vs Not Following Instructions for Use

AbuRahma

Yacoub

Mousa

et al. 2016

Journal of the American College of Surgeons

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“…Recently, some experiences reported the use of endoanchors as a prophylactic adjunct to EVAR in cases of hostile proximal neck anatomy. 20 These devices could be used to ensure the endograft's sealing during the midterm to long-term follow-up in cases of wide proximal neck for patients unfit for fenestrated EVAR, but at the moment, there is no evidence or long-term data. This study has several limits.…”

Section: Journal Of Vascular Surgerymentioning

confidence: 99%

Outcomes of endovascular aneurysm repair performed in abdominal aortic aneurysms with large infrarenal necks

Gargiulo

Gallitto

Wattez³

et al. 2017

Journal of Vascular Surgery

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“…15 The fixation of stent-grafts is variable depending on their design, with dislodgement C__Users_HLS352_Dropbox_Research%20Projects_Nellix_Relining%20forces_15-5604%20Swaelens%20EDIT [1].doc -page 6 forces in an in situ bovine model reported as ranging between 10.7 and 20.8 N for 3 different commercially available stent-grafts. 16 The original stent-graft fixation could be reinforced through the use of endoanchors prior to relining 17 ; however, the validity of this method is unknown. Nellix associated with the chimney technique has been described in juxtarenal aneurysm treatment.…”

Section: Discussionmentioning

confidence: 99%

Type IIIb Endoleak and Relining

et al. 2016

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Purpose: To examine the changes in distraction force following relining of a conventional abdominal aortic stent-graft with a type IIIb endoleak using the Nellix endovascular sealing device compared to a unilateral stent-graft. Methods:Relining is often used to repair type IIIb endoleaks, but the consequences to graft stability are unknown. A mathematical model was constructed based on pressure and volume flow through the stent-grafts, incorporating recognized distraction force equations. Steady flow was presumed at peak systolic pressures to calculate the maximum distraction force, with gravity ignored. Distraction forces for 28-to 36-mmdiameter stent-graft bodies with 16-mm limbs were calculated and compared to forces following relining with single and double Nellix devices or the Renu unilateral device.Results: Distraction forces for the 28-, 32-, and 36-mm stent-grafts prior to relining were 5.99, 10.21, and 14.99 N, respectively. Similar forces were reported after relining with bilateral Nellix devices (5.86, 10.08, and 14.86 N, respectively). However, use of a unilateral Nellix increased the distraction forces to 9.92, 14.14, and 18.92 N, respectively. These were comparable to the increase observed after relining with a Renu unilateral stent-graft (9.87, 14.09, and 18.86 N, respectively). The proportional increase in distraction force for a unilateral relining ranged from 26% to 66%, with the greatest increase noted in the smaller diameter main bodies. Conclusion:Relining a stent-graft with a type IIIb endoleak using bilateral Nellix devices does not increase the distraction force. However, a unilateral Nellix device or the Renu system could theoretically increase the distraction force by up to 66%, potentially risking migration and type Ia endoleak. In clinical practice, these results suggest that a relining with bilateral Nellix may have benefits over the Renu unilateral stent-graft.

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Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy

Abstract: Prophylactic EndoAnchor use for challenging aortic neck anatomy was associated with satisfactory midterm results.

Cited by 50 publications

References 24 publications

Aortic Neck Anatomic Features and Predictors of Outcomes in Endovascular Repair of Abdominal Aortic Aneurysms Following vs Not Following Instructions for Use

Aortic Neck Anatomic Features and Predictors of Outcomes in Endovascular Repair of Abdominal Aortic Aneurysms Following vs Not Following Instructions for Use

Outcomes of endovascular aneurysm repair performed in abdominal aortic aneurysms with large infrarenal necks

Type IIIb Endoleak and Relining

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