Document Detail

First United States experience of the TX2 Pro-Form thoracic delivery system.
MedLine Citation:
PMID:  20801606     Owner:  NLM     Status:  MEDLINE    
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.
W Anthony Lee; Tomas D Martin; Philip J Hess; Thomas M Beaver; Charles T Klodell
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of vascular surgery     Volume:  52     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-14     Completed Date:  2011-04-06     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1459-63     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Christine E. Lynn Heart and Vascular Institute, Boca Raton, FL 33431, USA.
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MeSH Terms
Aorta, Thoracic* / radiography
Aortic Aneurysm, Thoracic / radiography,  surgery*
Blood Vessel Prosthesis*
Blood Vessel Prosthesis Implantation / instrumentation,  methods*
Endovascular Procedures*
Prosthesis Design

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