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Observational Study
. 2024 Jun 3;65(6):ezae206.
doi: 10.1093/ejcts/ezae206.

E-vita OPEN NEO in the treatment of acute or chronic aortic pathologies: first interim results of the NEOS study

Konstantinos Tsagakis  1 , Joerg Kempfert  2   3 , Andreas Zierer  4   5 , Andreas Martens  6 , Daniel-Sebastian Dohle  7 , Alessandro Castiglioni  8 , Randolph Hung-Leung Wong  9 , Kazimierz Widenka  10 , Oliver Liakopoulos  11 , Michael A Borger  12 , Aung Ye Oo  13 , Tomas Holubec  14 , Maximilian Luehr  15 , Juan José Legarra Calderón  16 , Martin Grabenwöger  17   18   19
Affiliations
Observational Study

E-vita OPEN NEO in the treatment of acute or chronic aortic pathologies: first interim results of the NEOS study

Konstantinos Tsagakis et al. Eur J Cardiothorac Surg. .

Abstract

Objectives: The aim of this multicentre study was to demonstrate the safety and clinical performance of E-vita OPEN NEO Stent Graft System (Artivion, Inc.) in the treatment of aneurysm or dissection, both acute and chronic, in the ascending aorta, aortic arch and descending thoracic aorta.

Methods: In this observational study of 12 centres performed in Europe and in Asia patients were enrolled between December 2020 and March 2022. All patients underwent frozen elephant trunk using E-vita OPEN NEO Stent Graft System. Primary end point was the rate of all-cause mortality at 30 days and secondary end points included further clinical and safety data are reported up to 3-6 months postoperatively.

Results: A total of 100 patients (66.7% male; mean age, 57.7 years) were enrolled at 12 sites. A total of 99 patients underwent surgery using the E-vita OPEN NEO for acute or subacute type A aortic dissection (n = 37), chronic type A aortic dissection (n = 33) or thoracic aortic aneurysm (n = 29), while 1 patient did not undergo surgery. Device technical success at 24 h was achieved in 97.0%. At discharge, new disabling stroke occurred in 4.4%, while new paraplegia and new paraparesis was reported in 2.2% and 2.2%, respectively. Renal failure requiring permanent (>90 days) dialysis or hemofiltration at discharge was observed in 3.3% of patients. Between discharge and the 3-6 months visit, no patients experienced new disabling stroke, new paraplegia or new paraparesis. The 30-day mortality was 5.1% and the estimated 6-month survival rate was 91.6% (standard deviation: 2.9).

Conclusions: Total arch replacement with the E-vita OPEN NEO can be performed with excellent results in both the acute and chronic setting. This indicates that E-vita OPEN NEO can be used safely, including in the setting of acute type A aortic dissection.

Keywords: Antegrade cerebral perfusion; Aortic arch aneurysm; Aortic dissection; Distal aortic perfusion; E-vita OPEN NEO; Frozen elephant trunk procedure.

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Figures

None
Graphical abstract
Figure 1:
Figure 1:
E-vita OPEN NEO Stent Graft System. (A) Images of the E-vita OPEN NEO Stent Graft System in three configurations (branched, straight, trifurcated) and the delivery system.
Figure 2:
Figure 2:
(A) Preoperative CT image. 3D reconstruction of an atherosclerotic aneurysm of the distal arch. (B) Postoperative CT image. Complete exclusion of the atherosclerotic aneurysm by the frozen elephant trunk procedure. CT: computed tomography.
Figure 3:
Figure 3:
Kaplan–Meier survival estimate demonstrates a 6-month survival rate of 91.6%.
See this image and copyright information in PMC

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