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OBJECTIVES: To review the outcomes of PEVAR of complex aortic aneurysms using large-diameter sheaths for thoracic, fenestrated and branched stent-grafts.
METHODS: We reviewed the outcomes of all consecutive patients who underwent PEVAR of descending thoracic (DTA), thoracoabdominal (TAAA), pararenal (PRA) or aortoiliac aneurysms (AIAs) using large-diameter sheaths for placement of thoracic, fenestrated or branched stent-grafts. Patients treated by fenestrated and branched stent-grafts were enrolled in prospective physician-sponsored investigational device exemption protocols. A percutaneous approach was selected in patients with <50% posterior, minimal anterior or no calcification in the common femoral artery using standardized pre-closure technique with two Perclose® devices (Abbott, CA) in each femoral puncture site. End-points were technical success, conversion to open femoral artery repair, 30-day mortality and major adverse events, and freedom from femoral access-site complications.
RESULTS: There were 102 patients treated for 48 PRA, 27 TAAA, 19 DTA and 8 AIAs. A total of 171 femoral arteries were closed using pre-closure technique. Trans-femoral sheath size was 18Fr in 4 vessels (3%), 20Fr in 120 (70%) and ≥22Fr in 47 (27%). 83 patients (81%) had visceral branch incorporation, which required brachial artery access using small incision in 48. Technical success for percutaneous trans-femoral closure was 95% (162/171). Nine intraoperative failures were managed by open femoral conversion using primary repair in 6, interposition graft in 2, and patch angioplasty in 1. Mean estimated blood loss was 444±569 ml. There were no patients with had uncontrolled puncture-related hemorrhage, retroperitoneal hematoma or intra-operative hypotension. 30-day mortality was 0.9% (1/101) and 30-day rate of major adverse events was 15% (16/102). Spinal cord injury occurred in 1 patient (0.9%). There were 5 (3%) access-related complications, including femoral artery occlusion in 3 and hematoma or pseudoaneurysm in 1 each. Wound-related complications occurred in 1 patient (0.5%) who required open femoral artery conversion for exposure and repair. After a mean follow up of 1-year, freedom from femoral access-site complication was 97±2%.
CONCLUSION: PEVAR using pre-closure technique is safe and effective in select patients with complex aortic aneurysms who have minimal or no femoral calcifications and require large-diameter sheaths for thoracic, fenestrated and branched stent-grafts. Rate of puncture (3%) and wound-related complications (0.5%) is low, and uncontrolled puncture-related hemorrhage, retroperitoneal hematoma and systemic hypotension has not occurred in this series.