Michael Dake, Stanford, USA, presented the initial results with the GORE TAG Thoracic Branch Endoprosthesis (TBE), a new device for treatment of the aortic arch at CX yesterday.
Dake, Stanford, USA, presented the initial results with the GORE TAG Thoracic Branch Endoprosthesis (TBE), a new device for treatment of the aortic arch.
Dake told delegates that the GORE TAG TBE is a single branch device that consists of an aortic component, a side branch component and an optional aortic extender. The side branch component is delivered through a sheath and docks into the aortic component portal which allows for perfusion of a single arch branch vessel. The device is currently being studied in a zone 2 (left subclavian) feasibility study and a zone 0/1 (brachiocephalic and left common carotid) early feasibility study in the USA.
Currently, there are 20 patients (10 men and 10 women, mean age 75.4 years) successfully enrolled in zone 2 and one patient enrolled in zone 0/1. All 20 patients in zone 2 had successful access and deployment of the TBE device with the side branch component patent at the end of the procedure. Additionally, all side branch components remain patent. At one month, there have been no reported patient deaths or stroke. The left ankle brachial index (1.1) remains the same from pre-procedure to one month. There were no endoleaks that required reintervention.
The first two zone 0 patients were treated with the TBE device at the University of Pittsburgh Medical Center by Michel Makaroun, and at the Mayo Clinic by Gustavo Oderich. The protocol requires the patient to be treated in two phases with phase 1 revascularisation and phase 2 endovascular procedure. In phase 1, the patient underwent cervical debranching of the arch via a carotid to carotid bypass followed by a left carotid to left subclavian transposition. The proximal left common carotid and left subclavian artery was suture ligated.
Dake spoke about the patient treated about Makaroun and said the patient tolerated the procedure well without any neurological complications. The patient was assessed and deemed stable to proceed to phase 2 after 24 hours. In phase 2, the aortic component was advanced and deployed at the target location near the brachiocephalic artery. The sheath was advanced without difficulty into the portal of the aortic component into the brachiocephalic artery. The side branch component was advanced and deployed. Final arteriography showed excellent flow into the arch vessels, aneurysm exclusion, and complete apposition of the aortic component both proximally and distally.
Dake concluded: “These early results are promising with 100% technical success and side branch patency along with 0% death or stroke at one month.”