Authors
Michele Antonello, Simona Marrocco, Giovanni Pratesi, Umberto M Bracale, Raffaele Pulli, Diego Moniaci, Stefano Bonvini, Gianfranco Veraldi, Gabriele Piffaretti, Fabio Verzini, Domenico Milite, Sandro Irsara, Sandro Lepidi, Santi Trimarchi, Paolo Frigatti, Alessandro Medeot, Alberto Sacco, Alberto Dall'Antonia, Davide Esposito, Giulio Accarino, Rossella Di Domenico, Alberto Buonavita, Nicola Spadoni, Luca Mezzetto, Marco Franchin, Lorenzo Gibello, Andrea Xodo, Cristina Rocchi, Mario D'Oria, Paola Scrivere, Elena Guerrieri, Luca Porcellato, Viviana Grassi, Franco Grego, Michele Piazza, Francesco Squizzato, I-TREAT Collaborators
Published in
Journal of vascular surgery. Sep 29, 2026. Epub Sep 29, 2026.
Abstract
To investigate the outcomes of the Heli-FX EndoAnchor system (ESAR) in the prevention and treatment of proximal endograft failure after endovascular aneurysm repair (EVAR).
We conducted a retrospective data analysis from a multicenter registry of patients treated by ESAR (2017-2025). In the Prevention group (PG), endoanchors were used to prevent proximal endograft failure during primary endovascular repair (EVAR). In the treatment group (TG), endoanchors were used to treat a type Ia endoleak and/or migration after a prior EVAR. Endpoints were technical success, procedural success, and freedom from proximal endograft failure (new-onset type Ia endoleak, related reintervention, endograft migration).
There were 325 patients, 234 (72%) in the PG and 91 (28%) in the TG. Technical success was 100% in the PG and 97% in TG (P=.043), with a procedural success of 100% vs 88% (P<.001). After 5 years of follow-up (median 42 months), freedom from proximal endograft failure was 90.2% (95%CI 85-95) in the PG and 74.9% (95%CI 64-87) in the TG (P=.001). Neck length <7 mm (HR 2.11, 95%CI 1.18-4.56; P<.001) and use of endoanchors as a treatment (HR 3.48, 95%CI 1.61-7.51; P<.001) had a higher risk of proximal endograft failure. In the TG, the use of endoanchors alone (without a proximal aortic extension) (HR 4.00, 95%CI 1.19-8.65; P<.001) and the persistence of a type Ia endoleak at the completion angiography (HR 15.9, 95%CI 10.5-23.0; P<.001) were associated with a higher risk of proximal failure.
In this real-world registry, ESAR was used as an adjunct during primary EVAR in patients with a hostile proximal neck and as a salvage treatment of proximal endograft failure after a previous EVAR, with favorable success rates in both settings. In the preventive setting, outcomes were less favorable when the anatomical proximal neck length was <7 mm. In the treatment of type Ia endoleak, favorable results were obtained in up to 80% of cases, with a higher success rate when endoanchors were combined with a proximal aortic extension, and the persistence of a type Ia endoleak on the completion angiogram was a negative prognostic factor. Future comparative studies are necessary to better clarify the clinical efficacy of ESAR in a prevention and treatment setting.
PMID:
42810698
Bibliographic data and abstract were imported from PubMed on 30 Sep 2026.
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