Initial and midterm results of the Bolton Relay Thoracic Aortic Endovascular Pivotal Trial

Journal of Vascular Surgery
Mark A FarberChristopher J Kwolek

Abstract

To report the initial and midterm results of the Bolton Relay Thoracic Stent Graft for the endovascular treatment of thoracic aortic lesions [thoracic endovascular aortic repair (TEVAR)]. The Bolton Relay Thoracic Aortic Endovascular Pivotal Trial was a prospective, nonrandomized, multicenter, U.S. Investigational Device Exemption study conducted at 27 U.S. investigational sites. One hundred twenty TEVAR subjects were treated with the Relay device between January 2007 and May 2010, with 13 patients enrolled during the continued access phase through September 2012. TEVAR outcomes were compared with a prospectively and retrospectively enrolled surgical cohort consisting of 60 patients enrolled under similar inclusion/exclusion criteria. Follow-up examinations were prescribed at 1 month, 6 months, and yearly thereafter for 5 years. Major adverse events (MAEs) included stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, wound healing complications, and aneurysm-related mortality. Stent grafts were successfully delivered and deployed in 129 of 133 patients (97.0%). At 30 days, a lower rate of mortality was observed in the TEVAR arm (5.3% vs 10.0%; P = .230), and TEVAR was ass...Continue Reading

Citations

Mar 5, 2020·Scandinavian Journal of Surgery : SJS : Official Organ for the Finnish Surgical Society and the Scandinavian Surgical Society·Bruno De CosterGeert Maleux
May 26, 2020·Cardiovascular and Interventional Radiology·A Claire WatkinsMichael D Dake
Apr 3, 2019·International Angiology : a Journal of the International Union of Angiology·Lara R DiasArmando Mansilha
Nov 20, 2020·PloS One·Hazem El BeyroutiBernhard Dorweiler
Jan 9, 2020·European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery·Stefano GennaiUNKNOWN BTAI Study Group
Dec 12, 2018·Journal of Vascular Surgery·Theodoros KratimenosMichalis Argiriou
May 23, 2021·Journal of Vascular Surgery·William D JordanJon S Matsumura
Jun 5, 2021·The Cochrane Database of Systematic Reviews·Ala ElhelaliFionnuala Jordan
Aug 1, 2021·International Journal of Surgery Case Reports·E DinotoF Pecoraro
Nov 5, 2021·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Nikolaos TsilimparisTilo Kölbel

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