Md. Dake et al., THE FIRST-GENERATION OF ENDOVASCULAR STENT-GRAFTS FOR PATIENTS WITH ANEURYSMS OF THE DESCENDING THORACIC AORTA, Journal of thoracic and cardiovascular surgery, 116(5), 1998, pp. 689-703
Objective: Our goal was to determine whether endovascular stent-grafti
ng is feasible and effective for patients with aneurysms of the descen
ding thoracic aorta. Methods: Starting in July 1992, we conducted a pr
ospective, uncontrolled clinical trial in 103 patients (mean age 69 ye
ars [range 34-89 years]) who underwent endovascular treatment of aneur
ysms 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: Co
mplete thrombosis of the aneurysm was ultimately achieved in 86 (83%)
patients. The early mortality rate was 9% +/- 3% (+/- 70% CL). Multiva
riable analysis revealed that myocardial infarction pr stroke was link
ed with a higher likelihood of early death (P = .001), Early serious c
omplications included paraplegia in 3% +/- 2% and stroke in 7% +/- 3%,
Actuarial survival estimates at 1 year and 2 years were 81% +/- 4% an
d 73% +/- 5% (+/- 1 SE), respectively; being judged not to be a surgic
al candidate portended a higher probability of death (P = .003). Accor
ding to the intent-to-treat principle, ''treatment failure'' (includin
g 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 com; plications occurred commonly and were Linked with s
everal anatomic, technical, and patient-related risk factors. Conclusi
ons: This 5-year clinical trial involving use of a ''first generation'
' device indicates that endovascular stent-grafting of descending thor
acic aortic aneurysms is feasible with acceptable medium-term results.
More refined, commercially developed devices available today offer le
ss traumatic and more precise stent-graft deployment; these major tech
nical advantages, coupled with important lessons we have learned over
time and better patient selection, should be associated with more salu
tary clinical results in the future.