Three Year Outcomes Of A Single Branch Off The Shelf Endovascular Stent Graft For Treating Aortic Arch Pathologies
Augusto D'Onofrio1, David Planer2, Mario Lachat3, Nicola Mangialardi4, Michele Antonello1, Hubert Schelzig5, Lyubov Chaykovska3, Andrew Hill6, Andrew Holden6, Thomas Lindsay7, Kong Ten Tan7, Matteo Orrico4, Sonia Ronchey4, Gino Gerosa1.
1UNIVERSITY OF PADOVA, PADOVA, Italy, 2Hadassah Medical Center, Jerusalem, Israel, 3Aorten-, Herz- und Gefässchirurgie Klinik Hirslanden, Zurich, Switzerland, 4Ospedale San Camillo-Forlanini, Roma, Italy, 5Universitätsklinik für Gefäß- und Endovaskularchirurgie, Düsseldorf, Germany, 6Auckland Hospital, Auckland, New Zealand, 7Peter Munk Cardiac Centre Toronto General Hospital, Toronto, ON, Canada.
BACKGROUND: Aim of this study was to report the medium-term clinical outcomes with the NEXUS Aortic Arch Stent Graft System, a single branch, two-stent graft endovascular system specifically designed to treat aortic arch pathologies (Figure 1). METHODS:Data of all patients included in a prospective muticenter study were collected and analysed. The system was implanted over a through-and-through guidewire from the brachiocephalic trunk to the descending aorta, with an ascending aorta stent graft. The ascending aortic stent graft is deployed into a designated docking sleeve to connect the two stent grafts and isolate the aortic arch pathology. The proximal landing zone in all cases was in Zone 0. Surgical debranching or parallel graft insertion was always performed to provide LCCA and LSCA flow. Safety and performance were evaluated through a minimum of three years of follow up. Survival analysis used the Kaplan-Meier method. RESULTS: In total, 28 patients were treated with the Nexus system and there was 100% complete follow up to 3 years. The primary pathology was an isolated aortic arch aneurysm in 17 (60.7%) of the patients while chronic aortic dissection was the principal pathology in 6 (21.4%) of patients. Sixteen patients had full surgical debranching and remainder had a RCC-LCC bypass. The median procedural time was 185 mins (IQR 148-254) and the hospital stay 8 days (IQR 7-14.7). There were no type 1a endoleaks throughout the study period and only a single type 1b leak (3.8%) present at 3 years. There were no device related deaths in the 3-year follow up period. There was only a single migration event and this was proximal migration of the distal end of the device. The brachiocephalic trunk branch remained patent in 100% of cases at 3-year follow-up, with no branch related endoleaks detected on follow up scans. CONCLUSIONS: The NEXUS Aortic Arch Stent Graft System demonstrates a high success rate with excellent three-year safety and performance.
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