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- W4237147191 abstract "Thoracic endovascular aortic repair (TEVAR) is now the treatment of choice for most, if not all, thoracic aortic pathology. The study, “Five-year results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft,” provides additional contemporary information on the durability and effectiveness of TEVAR. The authors, on behalf of VALOR II investigators, detail the 5-year outcomes of 160 patients with descending thoracic aortic aneurysms treated by the Valiant stent graft (Medtronic, Minneapolis, Minn). The ultimate goal of TEVAR is durable prevention of aortic rupture. This was achieved in the current study, as indicated by a 95% freedom from thoracic aneurysm-related death at 5 years. Endoleaks were documented in 24% of patients, but most were type II, and less than one-third required reintervention. Conversion to open repair was necessary in only one patient. Aneurysm sac expansion, currently the best surrogate marker for potential risk of rupture, was seen in only 4% of patients at 5 years, whereas sac shrinkage, a marker for complete aneurysm exclusion, occurred in almost 50%. Other device-related outcomes were infrequent, with no documented wire fracture, fabric tear, infection, migration, or loss of graft patency. These device-related outcomes represent an improvement from the previous-generation Medtronic device, which was based on the Talent stent graft construct.1Foley P.J. Criado F.J. Farber M.A. Kwolek C.J. Mehta M. White R. et al.VALOR InvestigatorsResults with the Talent Thoracic stent graft in the VALOR trial.J Vasc Surg. 2012; 56: 1214-1221Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar, 2Fairman R.M. Tuchek J.M. Lee W.A. Kasirajan K. White R. Mehta M. et al.VALOR II InvestigatorsPivotal results for the Medtronic Valiant Thoracic Stent Graft system in the VALOR II trial.J Vasc Surg. 2012; 56: 1222-1231Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar These outcomes are also superior to other first-generation thoracic stent grafts, where wire fractures were documented in TX2 (4%; Cook Medical, Bloomington, Ind) and TAG (14%; W. L. Gore & Associates, Flagstaff, Ariz), and device migration was observed in TX2 (7.5%).3Matsumura J.S. Melissano G. Cambria R.P. Dake M.D. Mehta S. Svensson L.G. et al.Five-year results of thoracic endovascular aortic repair with the Zenith TX2.J Vasc Surg. 2014; 60: 1-10Abstract Full Text Full Text PDF PubMed Scopus (72) Google Scholar, 4Makaroun M.S. Dillavou E.D. Wheatley G.H. Cambria R.P. Five-year results of endovascular treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms.J Vasc Surg. 2008; 47: 912-918Abstract Full Text Full Text PDF PubMed Scopus (332) Google Scholar Medtronic's improvements in design were aimed at increasing graft apposition to the aortic wall and facilitating conformability and trackability. The results documented by the authors show this was achieved and associated with long-term durability, absence of device failure, and prevention of aneurysm rupture. However, these excellent results should be interpreted in the context of the patients included in the study. As is the case with all pivotal stent graft trials, strict adherence to the instructions for use is a given. In VALOR II, this resulted in a highly selected group of patients in which focal aortic pathologies, namely penetrating ulcers and saccular aneurysms, comprised one-third of the entire cohort. This was attended by an overall stent graft sealing configuration that consisted of a mean proximal neck length of 60 mm and distal neck length of 89 mm for aneurysms that were an average length of 117 mm. These seal lengths are far in excess of the 20 mm recommended by the instructions for use and clearly different from those in most patients treated by TEVAR in contemporary surgical practice. Nevertheless, the VALOR II experience documents that continued refinements in stent design do result in improvements in the durability and effectiveness of TEVAR. Patient outcomes are incrementally improved, and endovascular insights into the necessary structural requirements for graft apposition and conformability in the thoracic aorta are advanced. These advances are necessary foundational steps toward the goal of achieving the next frontier; namely, total endovascular management of pathology involving the ascending aorta and aortic arch. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent GraftJournal of Vascular SurgeryVol. 66Issue 2PreviewThe 1-year results of endovascular exclusion of degenerative descending thoracic aortic aneurysms (DTA) with the Valiant Thoracic Stent Graft (Medtronic Vascular, Santa Rosa, Calif) have been previously reported. With long-term follow-up now complete, the 5-year results are reported. Full-Text PDF Open Access" @default.
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- W4237147191 date "2017-08-01" @default.
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- W4237147191 title "Invited commentary" @default.
- W4237147191 doi "https://doi.org/10.1016/j.jvs.2017.01.036" @default.
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