Abstract 9651: The Role of Instruction for Use in Endovascular Aneurysm Repair for Abdominal Aortic Aneurysm: Report From National Hospital Organization Network Study in Japan
Recent reports regarding a high incidence of aneurysm sac enlargement after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm focused on if strict adhesion to instruction for use (IFU) is essential. A total of 277 consecutive pts (male gender 84%, age: 77±7) who had EVAR with commercial devices at 10 national medical centers in Japan between July 2007 and September 2010 were retrospectively analyzed. Three devices were used (Zenith n=139, Excluder n=118. Powerlink n=19). Groups consisted of within IFU (WIFU) in 185 pts and beyond it (BIFU) in 92 pts. Mean age was similar between groups (77±7 vs 78±7). Female gender and hostile abdomen was more common and Physiological status of American Society of Anesthesiology was more advanced in BIFU. Anatomical feature in BIFU included angulated neck (n=23), short distal landing zone (n=20), short neck (n=13) bilateral iliac aneurysm (n=12) and access problem (n=10). No cases with proximal neck diameter more than 28mm were treated.
Results: In-hospital mortality was one case in each group. Patients in BIFU required longer procedure time and more blood transfusion than in WIFU. Endoleaks were observed in 72 patients (type I: WIFU vs BIFU =4 vs 5, type II: 37 vs 16, type III, 0 vs 4, type IV: 5 vs 1). Early morbidity included delayed wound healing or infection (n=8: 5 vs 3), deterioration of renal dysfunction (n=7: 5 vs 2), and stroke (n=3: 1 vs 2). Endoleaks, either type I or III was increased in BIFU, compared with WIFU. Fifteen late deaths during total follow-up term of 305 patient-year included two unknown causes and seven cardiovascular deaths. The survival rates freedom from all cause death at one year were 94.9±1.9% for WIFU and 94.8±2.6% for BIFU (P=0.318). The survival rates freedom from cardiovascular death and from aneurysm related death at one year were 97.8±1.3% and 94.8±2.6% (P=0.039), and 98.8±0.9% and 97.2±2.0%, (P=0.117) respectively. Of 13 endoleaks of either type I or III, eleven endoleaks were disappeared within 6 months, and two cases required re-intervention.
Conclusion: In the Japanese multicenter study, the early outcomes of EVAR in BIFU were satisfactory. It may be explained by the two reasons that recent generation of devices was used in all cases and that the proximal neck size in IFU was kept strictly.
- © 2011 by American Heart Association, Inc.