Device profile of the Zenith Dissection Endovascular System for aortic dissection

ABSTRACT

Introduction: Thoracic endovascular aortic repair has been increasingly used to treat type B aortic dissection (TBAD) when it is indicated, offering better outcome in terms of mortality and morbidity compared to open repair. Accepted goals for endovascular treatment of aortic dissections are the closure of the primary intimal entry tear, depressurization, and thrombosis of the false lumen.

Areas covered: This is a descriptive review on the Zenith Dissection Endovascular System (Cook Medical Inc., Bloomington, IN) which is a modular system specifically designed to treat TBAD, consisting of a proximal component, the Zenith TX2 TAA Endovascular Graft, and a distal component, the Zenith Dissection Endovascular Stent. The distal stents are uncovered to avoid blockage of dominant spinal cord intercostal arteries and allow for the deployment of the stents across branch vessel origins as needed to treat the dissection.

Expert opinion: The Zenith Dissection Endovascular System has already been used for the treatment of TBAD for the last decade mostly in experienced centers. Current evidence suggests that this is a feasible and safe technique with relative low early mortality and morbidity rates. It is important to highlight the potential benefit of Zenith Dissection Endovascular System on the remodeling the dissected aorta during the follow-up period.

KEYWORDS:

• Aortic dissection
• TEVAR
• endovascular repair
• false lumen
• remodeling

Article Highlights

• The Zenith Dissection Endovascular System (Cook Medical Inc., Bloomington, IN) is a modular system specifically designed to treat aortic dissection, consisting of a proximal component, the Zenith TX2 (without barbs) Dissection Endovascular Graft, and a distal component, the Zenith Dissection Endovascular Stent.

• The Zenith Dissection Endovascular Stent is available in multiple lengths (80, 120, 180, and 185 cm) and in two diameters (36 and 46 mm).

• Caution should be taken in terms of suitable vascular anatomy:(i) Proximal neck (fixation site) length >20mm and diameter of 20– 38 mm; the radius of curvature should be >35 mm along the length of the aorta that is intended to be treated, and localized angulation should be <45 degrees for the endograft.(ii) The distal aorta diameter of 20–38 mm; the radius of curvature >35 mm along the length of the aorta that is intended to be treated and the localized angulation <45 degrees for the bare stent.

• Two techniques have been described in the literature, the latter of which involves ballooning of the bare stent, which is not recommended in the IFU:(i) The PETTICOAT technique(ii) The STABILISE technique

• Currently available evidence suggests that the use of the Zenith Dissection Endovascular System is a feasible alternative with a high technical success rate and good midterm outcomes in terms of aortic remodeling.

• Detailed planning of the case and presence of experienced endovascular team are needed in terms of achieving good outcomes with the Zenith Dissection Endovascular System.

Declaration of interest

T Kölbel has intellectual property with Cook Medical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.