ESVS Focused Update on AAA Guidelines Recommends Enhanced Surveillance of Patients Treated With Nellix EVAS System

January 18, 2023—A focused update of the European Society for Vascular Surgery (ESVS) guidelines for abdominal aortic aneurysm (AAA) was recently published addressing treatment with the Nellix endovascular aneurysm sealing (EVAS) system (Endologix). The update is intended to provide guidance on the surveillance and management of patients treated with EVAS.

The update by Jonathan R. Boyle, MD, et al on behalf of the ESVS AAA Guidelines Writing Committee and the ESVS Guidelines Steering Committee is available online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

As summarized in the document’s abstract, the investigator reported, “The EVAS has a very high incidence of late endograft migration resulting in proximal type I endoleak with risk of rupture, requiring open conversion with device explant. The reported mortality for elective explantation varies between 0% and 14%, while acute conversion for rupture has a very dismal prognosis with 67% to 75% mortality.”

The update concluded, “It is recommended that all patients in whom a Nellix device has been implanted should be identified, properly informed, and enrolled in enhanced surveillance. If device failure is detected, early elective device explant should be considered in surgically fit patients.”

A PDF of the complete focused update from EJVES is available online, here.

In January 2019, Endologix announced a voluntary recall of all existing Nellix EVAS system inventory and the stoppage of unrestricted sales and use of the device and then announced that the CE Mark certification for the Nellix EVAS system had been suspended in response to the recall and a Field Safety Notification.

In June 2019, the company announced that the CE Mark certification had been reinstated by GMED, the European Union Notified Body for the device, after an assessment of clinical evidence.