The "first generation" of endovascular stent-grafts for patients with aneurysms of the descending thoracic aorta.
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.
Dake
M D
MD
Department of Cardiovascular and Thoracic Surgery, Stanford University School of Medicine, Calif, USA.
Miller
D C
DC
Mitchell
R S
RS
Semba
C P
CP
Moore
K A
KA
Sakai
T
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation; D002423:Cause of Death; D019544:Equipment Failure Analysis; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality; D011446:Prospective Studies; D015607:Stents; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome