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The Journal of Cardiovascular Surgery 2019 Mar 21

DOI: 10.23736/S0021-9509.19.10857-9

Copyright © 2019 EDIZIONI MINERVA MEDICA

lingua: Inglese

Mid-term outcomes of endovascular aneurysm repair in challenging aortic neck anatomy based on experience from the GREAT C3 registry

Tamer SAYED , Ahmed EL BASTY, Diane HILDEBRAND, Paul BACHOO, on behalf of the GREAT European C3 Module Investigators

Department of Vascular and Endovascular Surgery, Aberdeen Royal Infirmary, Aberdeen, UK


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BACKGROUND: The European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT) evaluates the outcome and deployment mechanism of the C3 Gore Excluder stent-graft. We aimed to assess the mid- to long-term durability of the C3 Gore Excluder stent-graft in the management of challenging aortic neck morphology, outside the instruction of use (IFU).
METHODS: The prospectively collected data from GREAT were retrospectively analysed. For each subject demographic, pre/intra- and postoperative variables were collected. The main outcomes measured were serious adverse events (device-related, cerebrovascular, cardiac, pulmonary, pulmonary embolism, limb ischemia, and renal complications) and re-intervention at the 6-year follow-up. In this study, outside IFU was defined as aortic neck length <15 mm and/or aortic neck angle >60°.
RESULTS: A total of 399 subjects (86.7% male, mean age 73.9 years) were identified. Sixty-eight subjects (17%) from 11 recruiting sites underwent endovascular aneurysm repair (EVAR) outside IFU, and 399 devices were implanted. Of these, 47% had neck length <15 mm, 72.3% had neck angulation > 60°, and 21% had both. Mean follow-up duration was 53.5 months (SD=22.3). At the 6-year follow- up, the group with challenging anatomy required significantly more re-interventions (23.5% vs. 13.3%, p<0.05) and reported more serious adverse events (42.6% vs. 30.6%, P<0.005) than those within IFU.
CONCLUSIONS: Midterm outcomes of the C3 Gore Excluder stent-graft are safe and effective within IFU. Outside IFU patients required significantly more all or device related re-interventions; however, they did not sustain significantly more serious adverse events.


KEY WORDS: Endovascular aneurysm repair - Challenging aortic neck - GREAT C3 Registry

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