Safety and effectiveness of total percutaneous access for fenestrated endovascular aortic aneurysm repair

Abstract

Background: Percutaneous femoral vascular access is frequently used for aortic endovascular procedures, with a local access complication rate of 5% to 16%. Fenestrated endovascular aneurysm repair (FEVAR) has recently emerged as a new technique for the repair of short-neck and juxtarenal abdominal aortic aneurysms. The safety and effectiveness of percutaneous access for FEVAR has not been established to date.

Methods: Since United States Food and Drug Administration approval of the Zenith fenestrated aortic endograft (Cook Medical, Bloomington, Ind), 94 patients (60 Zenith fenestrated, 6 p-Branch, and 28 custom-made devices) have undergone FEVAR. Percutaneous access was performed using the "preclose" technique with the Perclose Proglide device (Abbott Vascular, Redwood City, Calif). Open access was performed when severely disease or calcified femoral arteries prevented percutaneous access. Patient-based analysis was performed assessing outcomes for the access site used for the larger profile sheath of the main device.

Results: Percutaneous access was used in 90 patients (177 common femoral arteries) and open access in four (11 common femoral arteries). Arm access was used in 41 patients (44%). The median sheath size was 20F (interquartile range [IQR], 20F-22F). Median operative time was 207 minutes (IQR, 160-270 minutes), with a median blood loss of 500 mL (IQR, 300-700 mL). The percutaneous access success rate was 92%. No preoperative factors predicted technical failure. No 30-day deaths occurred. Patients with failed percutaneous closure and who required conversion to open repair had higher estimated median blood loss of 800 (IQR, 600-1200) vs 500 (IQR, 300-600) mL (P = .01) and a longer median time to start ambulation of 4 (IQR, 2-7) vs 2 (IQR, 1-3) days (P = .03). Patients undergoing percutaneous closure had lower median blood loss (500 mL; IQR, 300-600 mL) than patients who underwent open surgical access (800 mL; IQR, 750-800 mL). Postoperative complications related to vascular access occurred in 11 patients (12%).

Conclusions: Percutaneous femoral access is a safe and effective alternative to open access for FEVAR. Operative blood loss and longer time to ambulation are significantly increased after failed percutaneous closure.

Trial registration: ClinicalTrials.gov NCT02266719.