New Procedure May Help Save Lives Of Patients With Aneurysms

Main Category: Vascular
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 Aug 2008 - 1:00 PDT

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The Vascular Medtronic Talent Thoracic Stent Graft™ System (VALOR) is a safe and effective endovascular therapy, as an alternative to open surgery in patients with thoracic aortic aneurysms who were considered candidates for open surgical repair, according to research published in the September 2008 Journal of Vascular Surgery, published by the Society for Vascular Surgery.

Ronald M. Fairman, MD, professor of surgery, chief of the division of vascular surgery at the Hospital of the University of Pennsylvania in Philadelphia and National Principal Investigator, reported the results of this prospective, non-randomized, multi-center, pivotal trial conducted at 38 sites. A total of 195 patients were enrolled in the VALOR Trial and 189 patients were identified as retrospective open surgical subjects. Endovascular enrollment occurred between December 2003 and June 2005 and endovascular results were compared with retrospective open surgical data from three centers of excellence.

The mean number of Talent™ Thoracic Stent Graft components implanted was 2.7 ± 1.3 devices per patient. Twenty-five percent of the proximal main Talent™ Thoracic Stent Graft components implanted had diameters smaller than 26 mm or larger than 40 mm. Left subclavian artery revascularization was performed prior to the initial stent graft procedure in 5.2 percent of patients, and iliac conduits were utilized in 21.1 percent of patients. Thirty-three percent of patients had the bare spring segment of the most proximally implanted device in zones 1 or 2 of the aortic arch. One hundred and ninety-four patients (99.5 percent) had successful vessel access and deployment of the Talent™ Thoracic Stent Graft at the intended site.

The 30 day VALOR results included perioperative mortality (2.1 percent), major adverse advents (41 percent), incidence of paraplegia (1.5 percent), paraparesis (7.2 percent), and stroke (3.6 percent). The 12 month VALOR results included all-cause mortality (16.1 percent), aneurysm-related mortality (3.1 percent), conversion to open surgery (0.5 percent), target aneurysm rupture (0.5 percent), stent graft migration > 10 mm (3.9 percent), endoleak (12.2 percent), stent graft patency (100 percent), stable or decreasing aneurysm diameter (91.5 percent) and loss of stent graft integrity (four patients). There were no instances of deployment-related events or perforation of the aorta by a graft component.

According to Dr. Fairman, "The Talent Thoracic Stent Graft showed statistically superior performance with respect to acute procedural outcomes (p<0.001), 30 day major adverse events (41 percent vs. 84.4 percent, p<0.001), peri-operative mortality (2 percent vs. 8 percent, p<0.01), and 12 month aneurysm-related mortality (3.1 percent vs. 11.6 percent, p<0.002) when compared to open surgery."

The submission of these Pivotal trial results lead to FDA approval of the Talent Thoracic Stent Graft System for treatment of thoracic aortic aneurysms in June, 2008.

About Journal of Vascular Surgery

Journal of Vascular Surgery provides vascular, cardiothoracic and general surgeons with the most recent information in vascular surgery. Original, peer-reviewed articles cover clinical and experimental studies, noninvasive diagnostic techniques, processes and vascular substitutes, microvascular surgical techniques, angiography and endovascular management. Special issues publish papers presented at the annual meeting of the Journal's sponsoring society, the Society for Vascular Surgery. Visit the Journal Web site.

About the Society for Vascular Surgery

The Society for Vascular Surgery (SVS) is a not-for-profit medical society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 2,600 vascular surgeons dedicated to the prevention and cure of vascular disease.

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