Early Results from the ENGAGE Registry: Real-world Performance of the Endurant Stent Graft for Endovascular AAA Repair in 1262 Patients

Stokmans, R.A.; Teijink, Joep A.W.; Forbes, Thomas L.; Böckler, Dittmar; Peeters, Patrick; Riambau, Vincent; Hayes, Paul D.; Sambeek, Marc R.H.M. van

doi:10.1016/j.ejvs.2012.07.005

Cited by 118 publications

(119 citation statements)

References 18 publications

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“…The rate of reintervention for limb occlusion was low (0.7% within 30 days and 1.1% through 1 year) compared to earlier reports preceding the initiation of the EVAS FORWARD Global registry, 5 likely attributable to learning curve and development of procedural best practices around optimization of the flow lumen. The overall reintervention and aneurysm-related mortality rates in the EVAS FORWARD registry appear to be broadly similar to those described in large EVAR registries 8,9 but in a more anatomically challenging patient cohort.…”

Section: Discussionmentioning

confidence: 65%

“…In the present study the 12-month all-cause mortality was 5.2%, which is lower than the 7.4% reported in the ENGAGE registry. 8 This finding can be regarded as of only marginal interest at present due to the small number of patients, different period of recruitment, and short follow-up, but a continuing trend of this nature might prompt a comparative evaluation of EVAR and EVAS.…”

Section: Discussionmentioning

confidence: 99%

“…In terms of aortic morphology, the EVAS FORWARD Global registry embodies a more challenging patient cohort compared to patients entered into EVAR registries. In the EVAS FORWARD registry, 17% of patients had an aortic neck length <10 mm compared to 2% and 1.5%, respectively, in the ENGAGE 8 and GREAT 9 registries. Similarly, 20% of patients in the EVAS FORWARD registry had an iliac diameter >25 mm in comparison to 0.6% in the ENGAGE registry.…”

Section: Discussionmentioning

confidence: 99%

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Endovascular Aneurysm Sealing

et al. 2016

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Purpose: To report the early and 12-month results of a global registry of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic aneurysms (AAAs). Methods: The EVAS FORWARD Global Registry was a postmarket, multicenter, open-label, single-arm registry that enrolled 277 patients (mean age 75 years; 228 men) treated with the Nellix EVAS system for nonruptured AAAs at 18 sites over a 1-year period. The cohort had challenging aortic anatomy, with 17% having a proximal aortic neck length <10 mm, 8% a neck angulation >60°, and 20% an iliac diameter >25 mm. Baseline and follow-up computed tomography images were assessed by an independent core laboratory, and major adverse events were reviewed by an independent safety committee. Results: Three patients died within 30 days of the procedure (none device-related). There were 13 endoleaks recorded in this time frame: 8 type Ia, 1 type Ib, and 5 type II. Root cause analysis demonstrated that the majority of type Ia endoleaks were due to technical error (low device placement and underfilling of the endobags). Between 30 days and 1 year, there were 4 new type Ia endoleaks; all were treated. There was also 1 type III endoleak between a Nellix device and a distal extension limb. At 1 year, the persistent endoleak rate was 0.7% (1 type Ia and 1 type II). The Kaplan-Meier estimates of freedom from types I and II endoleak at 12-month follow-up were 96% and 98%, respectively. The estimate of freedom from open conversion (n=7) was 98% at 12 months and the rate of freedom from any reintervention was 92%. The need for secondary intervention was associated with aortic morphology; for patients meeting the requirements of the instructions for use (IFU), the freedom from reintervention at 12 months was 98% compared with 86% when the implant was outside the IFU (p=0.009). At 1 year, the estimates of freedom from aortic-related and all-cause mortality were 98% and 95%, respectively. Conclusion: The EVAS FORWARD Global Registry documents the 12-month outcome of EVAS in an unselected group of patients with challenging aortic morphology. The results at present appear acceptable with regard to perioperative outcomes and complications. The type II endoleak rate is low. The place of EVAS in the armamentarium of techniques to treat AAAs will be defined by durability data in the longer term.

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Section: Discussionmentioning

confidence: 65%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Endovascular Aneurysm Sealing

et al. 2016

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“…The ENGAGE study of 1262 patients (approximately one-fifth outside IFU) oversized 20% with respect to the inner vessel diameter reported with no stent migration at 1 year and with satisfactory outcomes [42]. Pitton et al showed strong results after 10-year follow-up with 20-25% oversizing of proximal diameters and 10-15% oversizing distally [73].…”

Section: Recent Sizing Our Experience Conclusionmentioning

confidence: 88%

“…In fact, migration following the EVAR has been reported in many studies with rates ranging from 0% to 45%, varying with different patient populations, follow-up times, and stent-grafts used [25,[41][42][43]. Migration can occur for a number of reasons, but can be best understood in the context of the biomechanical forces.…”

Section: Graft Migrationmentioning

confidence: 99%

Endograft Sizing for Abdominal Aortic Aneurysms

Sher¹,

Tadros²

2017

Aortic Aneurysm

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While a tight seal and fixation of aortic stent-grafts to the vessel wall are vital for positive outcomes in treating abdominal aortic aneurysms (AAAs), optimal aortic stent-graft sizing for endovascular aneurysm repair (EVAR) remains debatable. We performed a holistic review of the data surrounding the sizing of endografts using instructions for use (IFU) guidelines, as well as experimental, computational, and clinical studies. Most clinical studies that have investigated the role of sizing and outcomes are limited by the strict selection criteria, or the inability to account for the multitude of confounders associated with sizing. Currently, oversizing of endografts between 10 and 20% remains safe and favored, but sizing outside the IFU guidelines frequently occurs. Oversizing up to 25% appears to be associated with decreased rates of proximal endoleak and aneurysm sac enlargement, while excessive oversizing (>30%) has been linked to graft infolding, collapse, and aortic dilatation. It is unclear, however, whether there is an association between oversizing associated with neck dilatation and graft migration. During sizing, surgeons should take an individual approach and consider several factors including device type, calcification and/or thrombus of apposition site, hemodynamics, and aortoiliac morphology.

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