Sealing Device May Patch Up Failed EVAR

— Early results promising for Nellix device that relines AAA stent grafts

MedicalToday

An endovascular aneurysm sealing (EVAS) device that relines a failed stent graft was associated with technical success in all cases, according to the early experience of a single center.

For 15 consecutive patients with failed endovascular aneurysm repair (EVAR) of an abdominal aortic aneurysm, use of the Nellix EVAS system -- in combination with chimney procedures in two-thirds of the cases -- resulted in .

None required additional reintervention, , of Germany's Medical Center of Johannes Gutenberg-University Mainz, and colleagues reported online in the Journal of Endovascular Therapy.

There were no aneurysm-related mortalities, graft thrombosis, endoleaks, or chimney graft occlusions observed during a median follow-up of 8 months, the investigators added.

Even so, complications did occur: there was one endobag protrusion without sequelae, one ruptured aneurysm and multiple organ failure in the same patient resulting in death after 2 months, and one renal artery guidewire injury leading to active bleeding.

"The present preliminary experience demonstrates that the use of EVAS/chimney procedures in combination with EVAS is feasible for treatment of failed EVAR. This technique may be used as bailout or an alternative treatment when other established methods are infeasible or not available," Youssef's group concluded.

"They treated a small but challenging cohort of patients, many presenting urgently; some would have been difficult, if not impossible, to manage by other endovascular means. The authors' results are impressive, particularly the 100% technical success and the absence of visceral stent occlusion and endoleaks, albeit during a limited follow-up period," , of Royal Liverpool University Hospital in the U.K., and colleagues commented in an .

However, Torella's group emphasized that the Nellix experience reported is not "automatically reproducible" in other centers, as it was "achieved in large specialist centers with significant experience in both simple and complex EVAS."

"The reader should also be aware that, according to its instructions for use, the Nellix device is designed neither for secondary aortic procedures nor for the concomitant use of visceral chimneys," the editorialists added, though they reported that they have also had a positive experience with EVAS and chimney procedures in combination with EVAS in secondary aortic interventions for life-threatening situations where other procedures were not feasible.

"In these scenarios, where long-term outcome is much less of a concern than in other circumstances, the technique can prove to be life-saving," Torella and colleagues wrote. "We strongly recommend, however, that specialists considering its use should become thoroughly familiar with the Nellix device as well as advanced aortic endovascular techniques prior to introducing it to their practice."

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    Nicole Lou is a reporter for , where she covers cardiology news and other developments in medicine.

Disclosures

Youssef disclosed consulting for and receiving research funding from Endologix.

Torella reported receiving a research grant, professional fees, and educational support from Endologix

Primary Source

Journal of Endovascular Therapy

Youssef M, et al "Endovascular aneurysm sealing (EVAS) and chimney EVAS in the treatment of failed endovascular aneurysm repairs" J Endovasc Ther 2016; DOI: 10.1177/1526602816675622.

Secondary Source

Journal of Endovascular Therapy

Torella F, et al "Relining failing abdominal aortic stent-grafts with the Nellix endoprosthesis: a new technique in the endovascular armamentarium" J Endovasc Ther 2016; DOI: 10.1177/1526602816675791.