Objective: The study objective was to evaluate the safety and effectiveness of the second-generation, low-profile RelayPro (Terumo Aortic) thoracic endograft for the treatment of descending thoracic aortic aneurysm or penetrating atherosclerotic ulcer.
Method: A prospective, international, nonblinded, nonrandomized, pivotal trial analyzed a primary safety end point of major adverse events at 30 days (death, myocardial infarction, stroke, renal/respiratory failure, paralysis, bowel ischemia, procedural blood loss) and a primary effectiveness end point of treatment success at 1 year (technical success, patency, absence of aneurysm rupture, type I/III endoleaks, stent fractures, reinterventions, aneurysm expansion, and migration) compared with performance goals from the previous generation Relay pivotal study. The study was conducted in 36 centers in the United States and Japan and enrolled participants between 2017 and 2019.
J Vasc Surg Cases Innov Tech
March 2022
Infection of prosthetic vascular grafts can manifest as pain, pseudoaneurysms, or arterial insufficiency in the leg. We present the case of a female patient with a medical history of a right external iliac artery endofibrosis, with a persistently infected synthetic iliofemoral bypass graft, which we replaced with a bioengineered human acellular vessel. At the 12-month follow-up visit, the clinical and radiologic studies demonstrated adequate human acellular vessel patency, with no signs of infection, stenosis, or pseudoaneurysm.
View Article and Find Full Text PDFBackground: Isolated iliac artery aneurysms (IAAs), accounting for 2% to 7% of all abdominal aneurysms, are often treated with the use of iliac branched endografts. Although outside the manufacturer's instructions for use, iliac branched devices can be used solely, without the adjunctive placement of an endovascular aneurysm repair device, for the treatment of an isolated IAA. In the present study, we have described the outcomes of the use of the Gore iliac branched endoprosthesis (IBE; W.
View Article and Find Full Text PDFBackground: The purpose of this study was to examine the incidence of acute kidney injury and chronic renal impairment following branched endovascular aneurysm repair (BEVAR) of complex thoracoabdominal aortic aneurysms (TAAA) using the Medtronic Valiant Thoracoabdominal Aortic Aneurysm stent graft system (MVM), the physician-modified Visceral Manifold, and Unitary Manifold stent graft systems. The objective was to report the acute and chronic renal function changes in patients following complex TAAA aneurysm repair.
Methods: This is an analysis of 139 patients undergoing branched endovascular repair for complex TAAAs between 2012 and 2020.