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Expert consensus document on the treatment of descending thoracic aortic disease using endovascular stent-grafts
Lars G Svensson1, Nicholas T Kouchoukos, D Craig Miller
1Center for Aortic Surgery and Marfan Syndrome Clinic, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio 44195, USA. svenssl@ccf.org
Insights
Diseases of the aorta are a growing concern, with stent-grafting emerging as a thoracic aorta treatment. Long-term durability and risks like radiation exposure require further study.
Area of Science:
- Vascular Surgery
- Medical Device Technology
- Aortic Disease Management
Background:
- Annual deaths from aortic diseases in the US range from 43,000 to 47,000, with increasing incidence.
- Thoracic aortic diseases are increasingly managed with stent-grafting, a less invasive approach.
- No prospective randomized trials directly compare stent-grafting to open surgical repair for thoracic aorta conditions.
Framework:
- Review of natural history of aortic disease and indications for repair.
- Analysis of outcomes from conventional open surgical treatments.
- Examination of insights from randomized studies on stent-grafts for abdominal aortic aneurysms.
Implementation:
- Currently, one Food and Drug Administration-approved stent-graft device exists for descending thoracic aortic aneurysms.
- Newer stent-graft devices show improved performance over early iterations.
- Off-label use and Investigational Device Exemption studies explore stent-grafts for traumatic rupture and aortic dissection.
Implications:
- Long-term durability of thoracic stent-grafts remains unknown, especially in younger patients.
- Concerns exist regarding the risk of irradiation-induced cancer from repeated CT scans in young patients.
- The document provides a review of current knowledge and offers treatment suggestions for aortic diseases.
Abstract:
Between 43,000 and 47,000 people die annually in the United States from diseases of the aorta and its branches and continues to increase. For the thoracic aorta, these diseases are increasingly treated by stent-grafting. No prospective randomized study exists comparing stent-grafting and open surgical treatment, including for disease subgroups. Currently, one stent-graft device is approved by the Food and Drug Administration for descending thoracic aortic aneurysms although two new devices are expected to obtain FDA approval in 2008. Stent-graft devices are used "off label" or under physician Investigational Device Exemption studies for other indications such as traumatic rupture of the aorta and aortic dissection. Early first-generation devices suffered from problems such as stroke with insertion, ascending aortic dissection or aortic penetration from struts, vascular injury, graft collapse, endovascular leaks, graft material failure, continued aneurysm expansion or rupture, and migration or kinking; however, the newer iterations coming to market have been considerably improved. Although the devices have been tested in pulse duplicators out to 10 years, long-term durability is not known, particularly in young patients. The long-term consequences of repeated computed tomography scans for checking device integrity and positioning on the risk of irradiation-induced cancer remains of concern in young patients. This document (1) reviews the natural history of aortic disease, indications for repair, outcomes after conventional open surgery, currently available devices, and insights from outcomes of randomized studies using stent-grafts for abdominal aortic aneurysm surgery, the latter having been treated for a longer time by stent-grafts; and (2) offers suggestions for treatment.
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