CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
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Analysis of renal function after aneurysm repair with a device using suprarenal fixation (Zenith AAA Endovascular Graft) in contrast to open surgical repair.

PURPOSE: This study was undertaken to assess the effect on renal function of open surgery and endovascular abdominal aortic aneurysm (AAA) repair with suprarenal fixation with the Zenith device.

METHODS: Data for 279 patients with similar preoperative comorbid conditions were prospectively analyzed after AAA repair. One hundred ninety-nine patients underwent endografting with the Zenith AAA Endovascular Graft, which incorporates suprarenal fixation (Zenith standard risk group, ZSR), and 80 patients underwent open surgery (standard surgical risk group, SSR). Endovascular repair was also performed in 100 patients considered poor candidates for open repair (Zenith high risk group, ZHR). Serum creatinine concentration (SCr) and anatomic defects were assessed before the procedure, before discharge, and at 1, 6, 12, and 24 months in all patients who underwent endovascular repair, and before the procedure and at 1 and 12 months in patients who underwent open surgical repair (only SCr was measured before discharge). Renal function was also analyzed, with a creatinine clearance calculation (Cockcraft-Gault). Renal insufficiency was defined as an increase in SCr greater than 30% from a preoperative baseline value, any SCr concentration in excess of 2.0 mg/dL, or any need for dialysis. Cumulative renal infarction and arterial occlusion rates were calculated with computed tomographic, ultrasonographic, and angiographic data, and reported as cumulative values.

RESULTS: Despite the initially superior renal function in the ZSR group at the pre-discharge evaluation (P =.01), there were no differences at 12 months with respect to rise in SCr greater than 30% (ZSR, 16%, vs SSR, 12%; P =.67), SCr rise greater than 2.0 mg/dL (ZSR, 2.5%, vs SSR, 3.4%; P =.66), incidence of renal artery occlusion (ZSR, 1%, vs SSR, 1.4%; P >.99), or infarction (ZSR, 1.5%, vs SSR, 1.4%; P >.99). Only one patient in each group required hemodialysis. Of note, both groups of patients demonstrated a reduction in creatinine clearance over 12 months, which then stabilized or improved by 24 months for ZSR patients.

CONCLUSIONS: Renal dysfunction occurs in a subset of patients regardless of type of repair (open or endovascular with suprarenal fixation). The cause of renal dysfunction after open or endovascular repair with a suprarenal stent is probably multifactorial. The observed dysfunction occurs in a small number of patients, and the effect in the endovascular group (no data for the surgical group at 24 months) appears to be transient. The initial dysfunction, apparent in both groups over 12 months of follow-up, stabilizes or improves at 12 to 24 months.

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