Percutaneous endovascular aortic aneurysm repair: a prospective evaluation of safety, efficiency, and risk factors.

PURPOSE To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. METHODS A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72+/-6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). RESULTS Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n = 16) or late (n = 7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p<0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p<0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p<0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p<0.05). Obesity was not a risk factor for any complication. CONCLUSION Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.