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The Journal of Thoracic and Cardiovascular Surgery, Vol 116, 689-703, Copyright © 1998 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
MD Dake, DC Miller, RS Mitchell, CP Semba, KA Moore and T Sakai
OBJECTIVE: Our goal was to determine whether endovascular stent- grafting
is feasible and effective for patients with aneurysms of the descending
thoracic aorta. METHODS: Starting in July 1992, we conducted a prospective,
uncontrolled clinical trial in 103 patients (mean age 69 years [range 34-89
years]) who underwent endovascular treatment of aneurysms of the descending
thoracic aorta using a custom-fabricated, self-expanding stent-graft
device. Follow-up was 100% complete and averaged 22 months. Sixty-two
patients (60%) were judged not to be reasonable candidates for a
conventional "open" surgical procedure. RESULTS: Complete thrombosis of the
aneurysm was ultimately achieved in 86 (83%) patients. The early mortality
rate was 9% +/- 3% (+/- 70% CL). Multivariable analysis revealed that
myocardial infarction or stroke was linked with a higher likelihood of
early death (P = .001). Early serious complications included paraplegia in
3% +/- 2% and stroke in 7% +/- 3%. Actuarial survival estimates at 1 year
and 2 years were 81% +/- 4% and 73% +/- 5% (+/- 1 SE), respectively; being
judged not to be a surgical candidate portended a higher probability of
death (P = .003). According to the intent-to-treat principle, "treatment
failure" (including all late sudden unexplained deaths) occurred in 38
patients; 53% +/- 10% of patients were free from treatment failure at 3.7
years. Stent-graft related complications occurred commonly and were linked
with several anatomic, technical, and patient-related risk factors.
CONCLUSIONS: This 5-year clinical trial involving use of a "first
generation" device indicates that endovascular stent-grafting of descending
thoracic aortic aneurysms is feasible with acceptable medium- term results.
More refined, commercially developed devices available today offer less
traumatic and more precise stent-graft deployment; these major technical
advantages, coupled with important lessons we have learned over time and
better patient selection, should be associated with more salutary clinical
results in the future.
ARTICLES
The "first generation" of endovascular stent-grafts for patients with aneurysms of the descending thoracic aorta
Department of Cardiovascular and Thoracic Surgery, Stanford University School of Medicine, Calif, USA.
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