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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Existing assessments of this procedure

    A European Network for Health Technology Assessment report on 'Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/REVAR)' was published in November 2019 (Agencia de Evaluación de Tecnologías Sanitarias-Instituto de Salud Carlos III, 2019). The report concluded:

    'Based on the results from observational studies, and within the limitations of the low-quality evidence available, the data suggest that the use of Heli-FX ™ EndoAnchor ™ in EVAR patients (prophylactically or as part of endograft migration or type I endoleak treatment) would be safe in the midterm follow-up for those presenting unfavourable neck anatomy and probably safe over longterm follow-up for those with friendly neck anatomies. However, comparative data on standard endovascular therapy are not currently available. We cannot form any conclusions regarding the safety of Heli-FX ™ EndoAnchor ™ in TEVAR patients.

    In terms of effectiveness, again the evidence precludes any firm conclusions as to whether the use of endoanchors in EVAR/TEVAR procedures results in better outcomes. Globally, the information compiled on critical outcomes (rate of type I endoleaks or migration, rate of reintervention, rate of aneurysm rupture or rate of aneurysm-related mortality), although of very low quality, would suggest effectiveness of the device. Nonetheless, evidence from high-quality comparative studies remains lacking. Results should be compared with treatment regimens without the Heli-FX ™ EndoAnchor™ system in randomised controlled trials for most of the critical and important outcomes.'