Nexus^tm Novel Total Aortic Arch Endograft: Midterm Results

Background:
Conventional surgical or hybrid repair of aortic arch aneurysms carries substantial risk of mortality and morbidity. There are numerous challenges in endovascular solution for aortic arch pathologies. Consequently, there are no approved endovascular dedicated devices for aortic arch repair. This is the midterm report of the Nexus aortic arch endograft experience.

Methods:
20 patient were enrolled in the FIM study or compassionate use of the Nexus™ (Endospan Ltd.) arch endograft (as of December 2016). All patient were considered as high surgical risk or non-operable. A unique pre-procedural planning and training were performed on a patient specific elastomeric 3D printed model. The device was implanted over a brachio-iliac through & through wire technique, with a modular extension to ascending aorta. Peri-procedural outcome and up to 2 years follow up will be presented.

Results:
Successful implantation of the modular graft was achieved in 100% of patients. There were no type Ia/III endoleaks. There were four cases (16%) of type Ib endoleak (from parallel graft gutters). Mortality rate was 5% (1/20), CVA 5% (1/20), retrograde type A dissection 5% (1/20) and guidewire / delivery system LV perforation in 5% (1/20). There was no graft migration or side branch occlusion.

Conclusion:
Midterm results of first 20 patient implanted shows promising safety and effectiveness profile, compared to historical surgical cohorts. Long term follow-up is ongoing.