Real-world outcomes of endoanchors in the prevention and treatment of proximal endograft failure in a multicenter registry.

OBJECTIVE

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).

METHODS

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).

RESULTS

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.

CONCLUSIONS

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.