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| AATS/NHLBI: Cardiothoracic Surgery Exploring Collaborative Clinical Research Opportunities |
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Title and Author Opportunities and Challenges for Thoracic Aortic EndograftsGrayson H. Wheatley, MD, FACS Abstract Treatment of thoracic aortic diseases is in the midst of a transformation as a result of the approval in 2005 of the first endovascular thoracic aortic stent-graft by the US Food and Drug Administration. Although the current generation of aortic stent grafts are approved for the treatment of degenerative atherosclerotic aneurysms of the descending thoracic aorta, these devices are being used for repair of other more complex aortic pathologies. This off-label use is being driven primarily by numerous single-center clinical studies with early to mid-term follow-up data. The reality of this approach brings with it an inherent opportunity for study with systematic, multi-center, prospective clinical trials for a number of different aortic pathologies. Of particular interest is the viability of endovascular treatment of thoracic aortic dissections and traumatic aortic transections. On another level, the long-term durability and outcome of endovascular �exclusion� of thoracic aortic aneurysms with endografts versus open surgical resection has yet to be validated. As a result, there is a lack of true consensus concerning which patients are candidates for endovascular repair versus open surgical repair. It is beyond the scope of device manufacturers to determine this type of data. A separate area of opportunity is the aortic arch and proximal aorta. The current thoracic aortic endografts have been engineered to treat and exceed the fatigue testing around the descending thoracic aorta. However, the aortic arch offers a different set of challenges with respect to the dynamic forces, great vessels and arch pathology. One potential �interim� technique has been to perform a hybrid arch repair which potentially combines the best of endovascular repair with open surgical techniques. As branched aortic stent grafts become available, additional data is needed to determine the success of the hybrid arch repair. A unique area for study from an endograft perspective is the ascending aorta. The design challenges of this location may be beyond the capability of a single device manufacturer and multi-center input may be needed. Key Research Gap Requiring NHLBI Leadership
Key Citations 1: 2010 ACCF/AHA/AATS/STS Guidelines for the Management of Patients with Thoracic Aortic Disease. J Am CollCardiol 2010; 55: e27-129.2: NienaberCA, Kische S, Akin I et al. Strategies for subacute/chronic type B aortic dissection: the Investigation Of Stent Grafts in Patients with type B Aortic Dissection (INSTEAD) trial 1-year outcome. J ThoracCardiovascSurg 2010:140(6 Suppl):S101-8. 3: Koullias GJ, Wheatley GH 3rd. State-of-the-art of hybrid procedures for the aortic arch: a meta-analysis. Ann Thorac Surg. 2010 Aug;90(2):689-97. |
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Copyright © 2012 American Association for Thoracic Surgery
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.