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.
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine