Objectives To evaluate efficacy and safety of percutaneous-endovascular aneurysm repair (p-EVAR) where large-bore access puncture holes were closed with a suture mediated closure device (SMCD) in all eligible patients. Methods A single-center cohort of prospectively collected data in an Internal Quality Control Registry (IQCR). An “All Comers” cohort of 368 patients with 736 access groins was assessed. All abdominal aortic aneurysm (AAA) patients eligible for p-EVAR after CTA evaluation were included. Patients with stenosis and occlusions requiring vascular Interventions during EVAR were excluded. The groins were stratified into two groups: low-profile (12Fr – 16Fr) and high-profile introducers (18Fr - 20Fr). PerClose ProGlide (Abbott Cardiovascular, IL, USA) and later the newer version PerClose ProStyle (Abbott Cardiovascular, IL, USA) SMCD devices were assessed. Primary endpoints were: Primary ProGlide technical success and Primary assisted percutaneous and non-invasive technical success. Secondary cutdown was an exclusions criterion. Safety endpoints were Freedom from early peri-operative and late 30-day groin access complications requiring vascular surgical intervention. Results Primary technical success was achieved in 66.4 % (473/712) groins . Primary assisted percutaneous and non-invasive technical success was achieved in 32.2 % (229/712) groins. Continuous hemorrhage in 1.4 % (10/712) groins required a cutdown. 98.6 % (712/736) of the groins were successfully closed percutaneously. Median age was 76 years (IQR 71, 80). 78.8 % were male. 92 % (330/368) of the p-EVAR were elective. Median AAA diameter was 57mm (IQR 53, 63). Few groins required surgical intervention. No statically significant differences were found between the PerClose ProGlide and the ProStyle (p < .05). Conclusions Percutaneous closure is efficient and safe. Low-profile introducers and EVAR components (12Fr – 16Fr) had slightly better primary technical and assisted technical success. 83.5 % of the patient groins were treated with low-profile introducers reflecting the drive in the vascular field toward lower-profile devices. No statistical difference between groups was observed for primary technical success and complication rate.
Mathisen et al. (Tue,) studied this question.