Outcomes of Endovascular Repair for Abdominal Aortic Aneurysms: A Nationwide Survey in Japan.

OBJECTIVE: To analyze data on patients treated with a bifurcated stent graft for abdominal aortic aneurysm (AAA).

BACKGROUND: The Japan Committee for Stentgraft Management (JACSM) was established in 2007 to manage the safety of endovascular aortic aneurysm repair (EVAR) in Japan. The JACSM registry includes detailed anatomical and clinical data of all patients who undergo stent graft insertion in Japan.

METHODS: Among 51,380 patients treated with bifurcated stent graft for AAA, we identified 38,008 eligible patients (excluding those with rupture or insufficient data). The analyzed factors included age, sex, comorbidities, AAA pathology and etiology, aneurysm and neck diameters, 7 anti-instructions for use (IFU) factors, and endoleaks at hospital discharge. The endpoints were death, adverse events, sac dilatation (≥5 mm), and reintervention.

RESULTS: The rates of intraoperative and in-hospital mortality were 0.08% and 1.07%, respectively. Infectious aneurysm and pseudo-aneurysm were associated with overall survival and reintervention. Older age, large aneurysm diameter, and all types of persistent endoleaks were strong predictors of adverse events, sac dilatation, and reintervention. Comorbid cerebrovascular disease, renal dysfunction, and respiratory disorders were also risk factors. In total, 47.6% of patients violated the IFU; among the anti-IFU factors assessed, poor access and severe neck calcification were strong risk factors for mortality, reintervention, and adverse events. The sac dilatation rate at 5 years was 23.3%.

CONCLUSIONS: Although the analysis included EVAR with poor anatomy, the perioperative mortality rate was acceptable compared with that in previous large population studies.