Successful Use of Nellix and Endovascular Aortic Sealing Technology for Treatment of Aortic Rupture in a Porcine Model

Abstract

Endovascular aortic sealing (EVAS) represents a recent transformation in approach for treatment of aortic aneurysms. Initial reporting has shown that EVAS using the Nellix device is safe with similar complication rates to standard endovascular aortic repair (EVAR). What remains unknown is how EVAS technology will behave in the ruptured setting. The purpose of this report is to discuss how EVAS system and endobag technology behave when deployed in a porcine model of aortic rupture. A controlled left retroperitoneal rupture was created in 20 large swine. Following rupture, an EVAS system was deployed across the rupture site to seal the area. The primary end point was seal from ongoing hemorrhage. Other parameters were examined to include endobag extravasation, aortic wall pressure measurements and device behavior in a live tissue model. Of the EVAS systems used, 15 Nellix (Endologix, Irvine, CA) devices and 5 novel EVAS systems were used. Of the correctly deployed devices, 100% sealed the rupture (n=19). One device was deployed above the rupture site, and seal was not achieved secondary to malpositioning. Endobag extravasation was seen with an average protrusion of 7.7mm. No other areas of aortic injury were noted secondary to endobag trauma. Pressure recording from behind the endobag indicates loss of pulsatile flow to the aortic wall with polymer curing. Endovascular aortic sealing for rupture is feasible and performs well in a porcine model of aortic rupture. Polymer extravasation is seen and may be controllable by the implanter. Once the polymer has cured, pulsatile aortic wall pressure is no longer present. EVAS represents an emerging technology for treatment of aortic rupture.