Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial

Carpenter, Jeffrey P.; Trani, Jose; Hayes, Paul D.; Muluk, Satish C.; Vásquez, Javier; Buckley, Clifford J.; Hadro, Neal C.; Lalka, Steven; Arko, Frank R.; Ierardi, Ralph P.; Clair, Daniel G.; Kirksey, Lester Lee; Lee, Cheong; Hashemi, Homayoun; Healey, Christopher; Bernado, Nelson; Benenati, James F.; Sullivan, Timothy M.; Stephenson, Elliot; Tyndall, Steve H.; Silver, Mitchell; Murray, Steven R.; Reijnen, Michel M.P.J.; Harlin, Stuart A.; McDaniel, Huey G.; Lane, John S.; Cuff, Robert; Kansal, Nikhil; Krajcer, Zvonimir; Bruen, Kevin J.; Hussain, Sajjad; León, Luis R.; Böckler, Dittmar; Makaroun, Michel S.; Indes, Jeffrey; Sarac, Timur P.

doi:10.1016/j.jvs.2018.01.031

Cited by 34 publications

(44 citation statements)

References 13 publications

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“…12,[14][15][16] In 2016, EVAS FORWARD, an investigational device exemption trial, reported higher than expected rates of distal migration, type IA endoleak, and aneurysm sac expansion, leading to a refinement of the instructions for use (IFU). 17 The revised IFU addressed the proximal and distal seal zones and thrombus burden within the aneurysm, with a view to reducing device migration (Supplementary Table I, online only). The new IFU suggested that EVAS would be most effective and durable in large AAA with little thrombus and neck criteria similar to the IFU for other commercially available endovascular aneurysm repair (EVAR) stent grafts.…”

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confidence: 99%

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Stenson

Bruin

Loftus

et al. 2020

Journal of Vascular Surgery

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Background: Endovascular aneurysm sealing (EVAS) is a disruptive technology to treat abdominal aortic aneurysm (AAA). The use of sac filling rather than endograft fixation was designed to treat aortic aneurysms in a wide range of morphologic appearances and to reduce endoleaks. There are few data reporting outcomes beyond postoperative follow-up. This study reports outcomes up to 5 years for Nellix (Endologix, Irvine, Calif) EVAS. Methods: Data were prospectively collected for EVAS patients from the time of adoption of EVAS in 2013. All patients treated with the Nellix device are included in this study, and as such, it reports on infrarenal, ruptured, and iliac aneurysms as well as the Nellix-in-Nellix application. Juxtarenal and suprarenal aneurysms were treated using the EVAS system with parallel grafts into the visceral vessels and are included. Therapeutic failure, a composite outcome of migration, sac expansion >5 mm, type Ia and type Ib endoleak, and secondary aortic rupture, was the primary outcome along with all-cause mortality, aneurysm-related mortality, and reintervention rates. Results: There were 295 EVAS cases undertaken between March 2013 and July 2018. Indications for treatment were infrarenal (n ¼ 185), juxtarenal and suprarenal (n ¼ 73), ruptured (n ¼ 18), and iliac (n ¼ 13) aneurysms. There were 15 reinterventions using the Nellix-in-Nellix application. In some cases, EVAS was used to salvage failing endovascular or open aneurysm repairs. Median follow-up was 2.42 years (interquartile range, 1.07-3.57 years). Therapeutic failure was observed in 98 of the 295 cases (33.2%) overall and exceeded 50% in some subgroups. In 71 cases (24.1%), reintervention was performed, with reasons for no reintervention being mainly physiologic. Complications leading to therapeutic failure were most commonly seen beyond 2 years of follow-up. There were 15 secondary ruptures (5.36%), and 9 EVAS devices required explantation either electively or for aortic rupture. Conclusions: EVAS with the Nellix device has not met expectations, and early encouraging results have been eroded. The incidence of therapeutic failure has been high, occurring 2 years and beyond after implantation. The Nellix system has been voluntarily recalled by Endologix, and the CE mark has subsequently been suspended. The adoption of EVAS as a disruptive technology highlights the need for cautious adoption of novel technologies and the strict governance around such arrangements.

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confidence: 99%

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Stenson

Bruin

Loftus

et al. 2020

Journal of Vascular Surgery

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“…102,121 The risk of sac rapture has greatly diminished with new-generation endografts but remains a nonnegligible risk for young patients with long life expectancy ( Figure 8). 14,59,60,118,[122][123][124] This underscores the importance of surveillance post EVAR and prompt intervention for sac growth >5 mm or a persistent endoleak. 117,121 5.6 | Evidence supporting access site closure after EVAR Percutaneous femoral access for EVAR has increased compared to surgical cutdown.…”

Section: Guidelines For Aaa Surveillancementioning

confidence: 97%

“…The distal aortic body with the iliac limb is deployed first, followed by the proximal aortic body (Figure d,e). Polymer sealing design: For this low‐profile design, the aortic body is deployed first, a polymer is injected to create an aortic neck seal, the contralateral aortic limb gate is cannulated, and then the iliac limbs are deployed sequentially. Future devices in which a polymer is employed to fill and actively manage the AAA sac are still under clinical investigation (Figure f) …”

Section: Endovascular Aneurysm Repair Techniquesmentioning

confidence: 99%

“…96 Data from the new generation endografts will shift the balance favoring EVAR over surgical EVAR for most patients, and future trials will hopefully confirm that EVAR is the first-line treatment for all anatomically suitable AAA. 14,59,60,118,[122][123][124] Finally, a multidisciplinary team approach, including the vascular surgeon, interventional cardiologist and/or radiologist, may be necessary to ensure the safety and success of a comprehensive EVAR program. 130…”

Section: Guidelines For Aaa Surveillancementioning

confidence: 99%

“…Future devices in which a polymer is employed to fill and actively manage the AAA sac are still under clinical investigation ( Figure 2f). 14…”

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Percutaneous endovascular abdominal aneurysm repair: State‐of‐the art

Jabbar

Chanda

White

et al. 2019

Cathet Cardio Intervent

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Endovascular repair of abdominal aortic aneurysms emerged initially as an alternative treatment strategy for patients considered to be inoperable or high risk for surgery. The evolution of endovascular techniques has made this technology a safe and less invasive alternative to open surgery for patients with suitable aortic anatomy. This manuscript reviews the current state of the art for endovascular AAA repair techniques, clinical outcomes, guideline recommendations, and future applications.

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Aktuelle Neuerungen bei der endovaskulären Versorgung infrarenaler Aortenaneurysmen

et al. 2018

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Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial

Cited by 34 publications

References 13 publications

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing

Percutaneous endovascular abdominal aneurysm repair: State‐of‐the art

Aktuelle Neuerungen bei der endovaskulären Versorgung infrarenaler Aortenaneurysmen

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