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Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms.

Authors
  • Eagleton, Matthew J1
  • Stoner, Michael2
  • Henretta, John3
  • Dryjski, Maciej4
  • Panneton, Jean5
  • Tassiopoulos, Apostolos6
  • Mehta, Manish7
  • Pearce, Benjamin8
  • Sharafuddin, Mel J9
  • 1 Division of Vascular and Endovascular Surgery, Fireman Vascular Center, Massachusetts General Hospital, Boston, Mass.
  • 2 Division of Vascular Surgery, University of Rochester Medical Center, Rochester, NY. Electronic address: [email protected]
  • 3 Department of Vascular Surgery, Mission Hospital, Asheville, NC.
  • 4 Department of Surgery, Buffalo General Medical Center, Buffalo, NY.
  • 5 Department of Vascular Surgery, Eastern Virginia Medical School, Norfolk, Va.
  • 6 Vascular and Endovascular Surgery Division, Stony Brook Medical Center, Stony Brook, NY.
  • 7 Department of Vascular Surgery, Vascular Health Partners of Community Care Physicians, PC, Latham, NY.
  • 8 Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, Birmingham, Ala.
  • 9 Department of Surgery, University of Iowa, Iowa City, Iowa.
Type
Published Article
Journal
Journal of vascular surgery
Publication Date
Jul 01, 2021
Volume
74
Issue
1
Identifiers
DOI: 10.1016/j.jvs.2020.10.083
PMID: 33253871
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The short- and mid-term outcomes of endovascular aortic aneurysm repair have made it a standard treatment of abdominal aortic aneurysms. However, newer generation devices have yet to demonstrate improved long-term rates for complications, reinterventions, and survival. The TREO stent graft is a latest generation device and was evaluated for approval in the United States. In a multicenter, nonrandomized, investigational device exemption clinical trial, we assessed the safety and effectiveness of the TREO device, with core laboratory assessment of the imaging studies and an independent adjudication of safety. The primary effectiveness endpoint was successful aneurysm treatment at 1 year. The primary safety endpoint was the incidence of major adverse events (MAE) at 30 days. A total of 150 patients (132 men; 88.0%) with infrarenal abdominal aortic (87.3%) or aortoiliac (12.7%) aneurysms were enrolled. The data were normally distributed. The mean age was 71.7 ± 7.4 years. The MAE incidence at 30 days was 0.7%. One subject experienced two MAE: myocardial infarction and procedural blood loss of 1000 mL. The proportion of successful aneurysm treatment at 1 year was 93.1%. Longer term follow-up continues, with no aneurysm-related mortality at the latest follow-up. At 3 years, the cumulative all-cause mortality and incidence of type I and type III endoleaks was 10.7% (n = 16), 2.7% (n = 4), and 0% (n = 0), respectively. In addition, aneurysm sac shrinkage >5 mm at 3 years had occurred in 54.3% of patients, and 9.3% had required a secondary intervention (n = 14). The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment at 1 year and aneurysm sac shrinkage >5 mm at 3 years in 54.3% of patients. Long-term follow-up continues to determine whether these favorable outcomes will be sustained. Copyright © 2020. Published by Elsevier Inc.

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