Key result
AneuRx stent-graft implantation for increasingly complex AAAs after FDA approval resulted in nonsignificantly higher rates of endoleak (17% vs 6%) and morbidity (18% vs 11%) compared to phase II cases.
Why the study?
Does routine clinical use of the AneuRx stent-graft for AAA exclusion post-FDA approval yield comparable short-term outcomes to those seen in the phase II clinical trial despite more complex aneurysm morphology?
Cohort (n=230)
No
Does routine clinical use of the AneuRx stent-graft for AAA exclusion post-FDA approval yield comparable short-term outcomes to those seen in the phase II clinical trial despite more complex aneurysm morphology?
Routine clinical use of the AneuRx stent-graft post-FDA approval involved more complex AAA anatomies but maintained short-term success rates comparable to clinical trial results.
Purpose: To compare a single-center experience with the AneuRx stent-graft system before and after FDA approval to results from the multicenter phase II clinical trial. Methods: The medical records of 230 consecutive patients (218 men; mean age 74 years) undergoing AneuRx stent-graft implantation for abdominal aortic aneurysm (AAA) exclusion since September 1999 were reviewed to collect patient characteristics, aneurysm morphology, procedure variables, perioperative morbidity, mortality, and short-term outcome. These data were compared to the 30 patients treated at our institution during the AneuRx phase II clinical trial and to the overall multicenter trial data. Stent-graft difficulty was categorized from 1 (straight neck and access of appropriate size) to 4 (proximal neck <10 mm long or angulated >60° and/or difficult access) based on aneurysm morphology. Results: Data from the 30 patients enrolled in the phase II trial at our institution were comparable in terms of patient characteristics and procedure variables to patients treated after FDA approval and to the multicenter data. However, the proportion of cases involving aneurysms with a more complex morphology (levels 3 and 4) rose 22% after FDA approval, reflecting a change in referral patterns. Our postoperative endoleak and morbidity rates increased nonsignificantly with respect to our own phase II experience (17% versus 6%, 18% versus 11%, respectively);however, they were not significantly different from the multicenter data. Reintervention was performed in 15 of 38 endoleak cases, mostly type I. Only 5 (2.1%) cases had a persistent endoleak at the time of discharge. Conclusions: Since FDA approval of the AneuRx device, our endovascular practice has changed toward the management of increasingly more complex AAAs. Although we are attempting more challenging cases, we are able to maintain similarly high short-term success rates while offering stent-grafting to an increasing number of patients. These results suggest that more patients may be candidates for endoluminal graft placement than determined by the clinical trial selection criteria, provided that strict surveillance and long-term follow-up is maintained.
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Ramaiah et al. (2002) conducted a cohort in Abdominal aortic aneurysm (AAA) (n=230). AneuRx stent-graft system after FDA approval vs. Phase II clinical trial patients (before FDA approval) was evaluated on Postoperative endoleak. AneuRx stent-graft implantation for increasingly complex AAAs after FDA approval resulted in nonsignificantly higher rates of endoleak (17% vs 6%) and morbidity (18% vs 11%) compared to phase II cases.
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