EARLY RESULTS FROM THE TRIVENETO GORE-REGISTRY: A GORE CONFORMABLE MULTICENTRIC OBSERVATIONAL STUDY

TOPIC:
Abdominal Aortic Aneurysms
AUTHORS:
Bonvini S. (Chirurgia Vascolare ed Endovascolare Trento e Rovereto ~ Trento ~ Italy) , Spadoni N. (Chirurgia Vascolare ed Endovascolare Trento e Rovereto ~ Trento ~ Italy) , Frigatti P. (Chirurgia Vascolare ed Endovascolare ~ Udine ~ Italy) , Antonello M. (Chirurgia Vascolare ed Endovascolare ~ Padova ~ Italy) , Veraldi G. (Chirurgia Vascolare ed Endovascolare ~ Verona ~ Italy) , Milite D. (Chirurgia Vascolare ed Endovascolare ~ Vicenza ~ Italy) , Galeazzi E. (Chirurgia Vascolare ed Endovascolare ~ Treviso ~ Italy) , Lepidi S. (Chirurgia Vascolare ed Endovascolare ~ Trieste ~ Italy) , Perkmann R. (Chirurgia Vascolare ed Endovascolare ~ Bolzano ~ Italy) , Tasselli S. (Chirurgia Vascolare ed Endovascolare Trento e Rovereto ~ Trento ~ Italy)
Introduction:
Nowadays endovascular procedures are the standard of care for abdominal aortic aneurysms but treatment of hostile infrarenal neck anatomy is still a challenge. The aim of this observational study is to report data from a multicentric experience with the Gore Excluder conformable endograft with active control system (CEXC Device, W.L. Gore and Associates, Flagstaff, AZ, USA) in abdominal aortic aneurysms (AAAs). Analysis focuses on cases with severe aortic infrarenal neck angulation (≥60o).
Methods:
All patients treated with CEXC Device in 8 Vascular Surgery centres of Triveneto area (Northeast Italy) for AAA between January 2019 and March 2022 were prospectively enrolled and retrospectively analysed. Age, comorbidities and aortic anatomical details were evaluated. Early endpoints were technical success, the use of axillary-femoral through-and-through, renal artery pre-cannulation, repositionability system and direction, unplanned aortic cuff/other procedures, oversizing, 30-day morbidity/mortality and reinterventions. Follow-up endpoints were endoleaks, endograft migration, aortic neck angulation changes, aneurismal sac shrinkage, survival, secondary procedures.
Results:
117 patients were enrolled from 8 Vascular Surgery centres (mean age: 78 [range 55-91] years, median AAA diameter: 59 [range 26-94] mm). Mean aortic infrarenal neck length, angulation (beta angle) and diameter were 26 (range 9-58) mm, 55o (range 0-152) and 22 (15-30) mm respectively. 48 (41%) had severe infrarenal neck angulation (beta angle ≥ 60 o). In this subgroup, mean infrarenal neck angulation was 82 o. Axillary-femoral through-and-through was used in 15 (31%) cases, renal artery was pre-cannulated in 7 (14%) cases. Endograft repositioning system was employed in 36 (75%) cases, the median number of manoeuvres was 1 (range 1-5) and the preferential direction was upward (15 vs 12, 9 up&down). The median proximal diameter of the main body and oversize were 28 (range 23-36) mm and 30% (range 16-44) respectively. An unplanned aortic cuff was positioned in 4 (8%) cases. Technical success was achieved in all cases. Intraoperative and perioperative morbidity and mortality were 10% and 0% respectively. Perioperative endoleaks were observed in 1 (2%, type IA) and 6 (12%, type II) patients, respectively. Mean follow-up was 13 months (range 1-28). 3 patients died at 1 year follow-up for aneurysm-unrelated causes. 2 reinterventions occurred: 1 coversion (2%) for type IA endoleak due to aortic neck progression and endograft migration and 1 sac embolisation (2%) for type II endoleak. Aortic neck mean post-operatory angulation was 75 o (range: 45-139). No other endograft migrations were observed, with mean renal-endograft distance stable at follow-up.
Conclusion:
Early results of the CEXC Device according to the Triveneto GORE Registry show good performance in severely angulated aortic infrarenal necks in terms of technical success and freedom from reintervention. These data, if confirmed in a longer follow-up, could further increase EVAR eligibility.
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