First United States experience of the TX2 Pro-Form thoracic delivery system

Objectives

Failure to conform to the arch (“bird-beaking”) can lead to endoleak and graft collapse after thoracic endovascular aortic repair. We report the first United States experience with the new TX2 Pro-Form (Cook Inc, Bloomington, Ind), a novel delivery system that became commercially available in October 2009, designed to enhance circumferential apposition of the TX2 thoracic endograft to the arch.

Methods

This was a single-institution retrospective study. Endograft-to-arch conformance was quantitatively analyzed using intraoperative angiograms of consecutive, reverse chronologic cohorts of TX2 Pro-Form, TX2 Z-Trak (prior delivery system; Cook), and Gore TAG (W.L. Gore and Assoc, Flagstaff, Ariz). Only native aortic arch deployments in zones 2 and 3 were included.

Results

During a 6-week period, 20 Pro-Form cases were performed, of which 17 patients met inclusion criteria. These were compared with 17 Z-Trak and 17 TAG patients. Endografts were successfully delivered to their intended proximal landing zones in all 51 patients. A higher proportion of dissections were treated in the Z-Trak (65%) and TAG (76%) patients (P = .03), but similar rates of zone 2/3 deployments (P = .30). Despite the mean arch angle being greatest for the Pro-Form patients (90° vs 74° vs 71°, P = .18), the mean separation between the leading endograft edge and the aortic wall along the inner curvature of the arch was significantly less (1.4 vs 4.1 vs 5.7 mm; P = .0002), with complete apposition achieved in 65% of Pro-Form patients (18% Z-Trak, 6% TAG, P < .0001). This resulted in the lowest reduction in aortic luminal diameter at the proximal landing zone (5.5% vs 13.4% vs 19.3%; P = .0006) compared with Z-Trak and TAG. Rates of type Ia endoleak were similar (P = .38).

Conclusions

The Pro-Form delivery system significantly improves endograft conformation to the arch, resulting in minimum bird-beaking even in severely angulated anatomies.