One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial

Sean P Lyden; D Christopher Metzger; Steve Henao; Sonya Noor; Andrew Barleben; John P Henretta; Levester Kirksey

doi:10.1016/j.jvs.2022.08.016

One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial

J Vasc Surg. 2023 Feb;77(2):446-453.e3. doi: 10.1016/j.jvs.2022.08.016. Epub 2022 Aug 24.

Authors

Sean P Lyden¹, D Christopher Metzger², Steve Henao³, Sonya Noor⁴, Andrew Barleben⁵, John P Henretta⁶, Levester Kirksey⁷

Affiliations

¹ Department of Vascular Surgery and Aortic Center, Heart Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH. Electronic address: lydens@ccf.org.
² Ballad Health CVA Heart Institute, Kingsport, TN.
³ Division of Vascular Surgery, Presbyterian Hospital, Albuquerque, NM.
⁴ Division of Vascular Surgery, University of Buffalo, Buffalo, NY; Gates Vascular Institute, Kaleida Health, Buffalo, NY.
⁵ Division of Vascular and Endovascular Surgery, University of California San Diego, La Jolla, CA.
⁶ Department of Vascular Surgery, Mission Hospital, Asheville, NC.
⁷ Department of Vascular Surgery and Aortic Center, Heart Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH.

PMID: 36028158
DOI: 10.1016/j.jvs.2022.08.016

Abstract

Objective: This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the polymer based Endologix Alto Stent Graft System in treating abdominal aortic aneurysms (AAAs), with sealing 7 mm below the top of the fabric in aortic neck diameters from 16 to 30 mm.

Methods: Seventy-five patients were treated with Alto devices between March 2017 and February 2018 in 16 centers in the United States for infrarenal AAAs (max diameter ≥5.0 cm in diameter or size increase by 0.5 cm in 6 months or diameter ≥1.5 times the adjacent normal aorta). Patients were followed for 30 days, 6 months, and 1 year by clinical evaluation and computed tomography and abdominal x-ray imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture or surgical conversion, stent graft stenosis, occlusion, kink, thromboembolic events, and stent fracture attributable to the device requiring secondary intervention through 12 months. Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 1 year were analyzed.

Results: The mean patient age was 73 years, with 93% of patients being male. The 30-day major adverse event rate was 5.3%. At 1 year, the primary endpoint was met with a treatment success rate of 96.7%. Through 1-year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%.

Conclusions: This prospective study demonstrates the Endologix Alto is safe and effective in treating AAAs with appropriate anatomy at 1 year. The safety endpoint is met by a 5.3% 30-day major adverse event rate, whereas the effectiveness endpoint is met by a treatment success rate of 96%.

Trial registration: ClinicalTrials.gov NCT02949297.

Keywords: Abdominal aortic aneurysm (AAA); Alto; ELEVATE; Endovascular aneurysm repair (EVAR); Ovation.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aortic Aneurysm, Abdominal* / complications
Aortic Aneurysm, Abdominal* / diagnostic imaging
Aortic Aneurysm, Abdominal* / surgery
Blood Vessel Prosthesis / adverse effects
Blood Vessel Prosthesis Implantation*
Endoleak / diagnostic imaging
Endoleak / etiology
Endoleak / therapy
Endovascular Procedures*
Female
Humans
Male
Prospective Studies
Prosthesis Design
Stents / adverse effects
Treatment Outcome
United States

Associated data

ClinicalTrials.gov/NCT02949297