Update on the TREO endograft device: overview of its safety and efficacy

• Published in: Expert review of medical devices Vol. 19; no. 1; p. 31
• Main Authors: Georgakarakos, Efstratios, Karaolanis, Georgios I, Argyriou, Christos, Papatheodorou, Nikolaos, Karangelis, Dimos, Georgiadis, George S
• Format: Journal Article
• Language: English
• Published: England 02-01-2022
• Subjects: Aged; Aged, 80 and over; Aortic Aneurysm, Abdominal - surgery; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - adverse effects; Endovascular Procedures - adverse effects; Humans; Multicenter Studies as Topic; Prosthesis Design; Registries - statistics & numerical data; Risk Factors; Stents; Time Factors; Treatment Outcome; endoleak; EVAR; stent-graft; endograft; abdominal aortic aneurysm; TREO; infrarenal neck
• ISSN: 1745-2422
• DOI: 10.1080/17434440.2022.2020093

The TREO abdominal aortic stent graft system (Terumo Aortic, Sunrise, Fla) is a low-profile, trimodular endovascular endoprosthesis for the endovascular repair of abdominal aortic aneurysm (AAA). The objective of the present study was to collect and discuss all the available modern data of this device highlighting especially its mid-and long-term clinical results.
This updated review article presents the most current results from great-scale clinical studies and the RATIONALE registry involving also angulated neck anatomies and challenging AAA geometries, reflecting the real-world experience.
The global, multicenter RATIONALE registry prospectively enrolled 202 patients (mean age 73.0 ± 7.8 years) who underwent EVAR. Technical success, primary clinical success and assisted primary patency rate was 96%, 92.2% and 97%, respectively. The clinical success at 1 year was 96%. Another multicenter, non-randomized, clinical trial confirmed also high technical and clinical success. Additionally, a comparative study comparing favorable and hostile necks in AAA, demonstrated a comparable technical success (95.2%), achieving proper sealing and technical success in the hostile neck group. TREO endograft seems to be safe and effective for EVAR, especially in hostile neck anatomies. Long-term outcomes from ongoing registries are awaited to complete these results.