Percutaneous endovascular abdominal aortic aneurysm repair: methods and initial outcomes from the first prospective, multicenter trial.

AIM: A totally percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) has been shown in multiple single center reports to be feasible. Nonetheless, questions regarding the broader applicability of the approach remain due to the lack of a randomized multicenter trial, thus preventing more widespread adoption. We report the methods and outcomes from the roll-in phase of the first prospective, multicenter trial of PEVAR. METHODS: Among 19 institutions participating in the PEVAR Trial (NCT01070069), 38 consecutive patients with abdominal aortic aneurysm were enrolled in a roll-in phase between April 2010 and May 2011. PEVAR procedures with adjunctive "pre-close" of the common femoral arteries (CFAs) targeted for large sheath access using the ProGlide or Prostar XL closure devices were performed using the Endologix IntuiTrak System. All patients were followed periprocedurally and to 30 days for major adverse events and access-related vascular complications. RESULTS: Patients presented at a mean age of 71 years with mean aneurysm sac diameter of 5.6cm. Technical success of the pre-close procedure was 97% (37/38 patients). In one patient, ProGlide devices failed to achieve ipsilateral CFA hemostasis, leading to bleeding requiring transfusion and surgical vascular repair. All endovascular repairs were successful. No mortality or major adverse events occurred. Other pre-close related complications occurring within 30 days included pseudoaneurysm, lower extremity ischemia, and blood transfusion. CONCLUSION: PEVAR with adjunctive 'pre-close' techniques using the ProGlide or Prostar XL devices is safe and feasible as applied in this multicenter experience. Continued evaluation in the prospective, randomized trial is warranted.