Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) or thoracic endovascular aortic aneurysm repair (TEVAR) procedures
Materials and Methods: This publication is a subgroup analysis of the 53 PEVAR and TEVAR patients from the SAFE MANTA Study. The SAFE MANTA study was a prospective, single-arm, multicenter study in patients undergoing transcatheter aortic valve replacement, PEVAR, or TEVAR at 20 sites in North America. Patient selection intended to test the MANTA device (Teleflex, Exton, PA) in populations without morbid obesity, severe calcification, or severely scarred femoral access area. Of the 263 patients in the in the primary analysis cohort, 210 underwent TAVR procedures (79.8%), and 53 (20.2%) underwent PEVAR or TEVAR procedures.
Results: The mean time to hemostasis in the PEVAR and TEVAR cohort was 35 ± 91 seconds, with a median time of 19 seconds, compared with 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 of 53 PEVAR and TEVAR cases (98%) compared with 97.7% in the overall SAFE MANTA population. A single MANTA device was deployed in 100% of cases. One (1.9%) major complication occurred in this subgroup compared with complications in 14 patients (5.3%) in the SAFE population. In the PEVAR and TEVAR group, one pseudoaneurysm was noted before discharge, one at 30-day follow-up, and one at 60-day follow-up. One of the three minor pseudoaneurysms was treated with ultrasound-guided compression (1.9%), and the other two required no treatment.
Conclusions: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR and TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR and TEVAR procedures.