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E-vita Open NEO: First In-Man Implantation

Friday, July 31, 2020

Tsagakis K, Bashir M, Weymann A, Ruhparwar A. E-vita Open NEO: First In-Man Implantation. July 2020. doi:10.25373/ctsnet.12746855

E-vita Open was the first commercially available hybrid graft for frozen elephant trunk (FET) surgery (1). Fifteen years after the first implantation in Essen, a new generation of grafts were developed to address the requirements of treatment according to the different aortic arch and descending aorta pathologies and anatomical morphologies. The E-vita Open NEO (Jotec/Cryolife) concept focuses on a more patient-tailored approach in arch zones 0 to 3, including a modern stent graft downstream.

Three E-vita Open NEO grafts with a different configuration of the aortic arch prosthesis have been launched: straight, branched, and trifurcated. In addition, a 10 mm side-branch for perfusion was included in all configurations. As to the new design of the distal end of the stent-graft, a “W”-stent inside the distal end of the stent graft was incorporated to improve sealing. The orientation of the Z-stents along the main stent graft body has been changed to “tip to valey” to improve alignment. Proximally, the stent graft becomes tapered according to the size of the arch graft. The stent graft length is designed according to the level of arch repair with longer stent-grafts for treatment in zone 0 (trifucated graft) and shorter in zones 1-3. A collar at the transition between the arch graft and the stent graft is used for the surgical fixation of the graft. Finally, the hybrid graft is mounted within a new highly flexible delivery system. This system is significantly shorter in comparison to the previous generation and allows for introduction by using a guide wire or not.

The surgical video demonstrates the worldwide first in-man implantation of the E-vita Open NEO graft in straight configuration in May 2020. The treatment was performed for a symptomatic distal aortic arch aneurysmal disease involving the left subclavian artery. Due to the aneurysm extent, the treatment was planned in arch zone 1 in combination with debranching of the left common carotid artery and the left subclavian artery. The postoperative CT angiography demonstrates the satisfactory alignment of the stent graft in the distal arch and descending aorta.

The E-vita Open NEO graft offers an increasing variability in open aortic arch surgery using the FET technique. Due to the changes on the arch graft design by adding side branches and in combination with the new delivery system, the arch graft is deployed free in the arch position and not within the stent graft as in the previous E-vita Open Plus. Thus, the distal anastomosis does not follow the principle of the otherwise easier modified elephant trunk anastomosis (2). From the endovascular view, the modern stent-graft may improve the simultaneous descending aorta repair.


References

  1. Jakob H, Tsagakis K, Leyh R, Buck T, Herold U. Development of an integrated stent graft-dacron prosthesis for intended one-stage repair in complex thoracic aortic disease. Herz. 2005;30(8):766-768.
  2. Tsagakis K, Jakob H. Which frozen elephant trunk offers the optimal solution? Reflections from essen group. Semin Thorac Cardiovasc Surg. 2019;31(4):679-685.

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Comments

Many congratulations for the Essen group. The E-vita Open NEO graft with 3 variability and provision of side arms eliminate the difficulties with the previous versions-looks very promising.

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