A Single Center Study of ProGlide Used for Closure of Large-Bore Puncture Holes After EVAR for AAA.

ABSTRACT

PURPOSE: The objective of this study was to evaluate the primary and assisted secondary percutaneous and non-invasive technical success of the ProGlide device on all-comers in a consecutive case series of percutaneous endovascular aortic aneurysm repair (P-EVAR). METHOD: A single-center consecutive case series where 434 elective and acute P-EVAR procedures were registered prospectively between May 2011 and July 2017. The mean age was 74.5 years ± SD 11.4 years. 82.3% of the patients were male. All patients were pre-planned from CT angiography. Percutaneous access punctures, performed in local anesthesia in the common femoral artery, with a final introducer size between 12-22 Fr OD were included and stratified in 2 groups, 12-16 Fr and 17-22 Fr. RESULTS: By screening 868 access groins 22 groins were excluded. Of the remaining 846 groins, intended to be treated with ProGlide, 9 groins were excluded peri-procedurally and treated with the Fascia Suture Technique or surgical cutdown. The remaining 837 groins had access closure with ProGlide, with a mean value of 2.15 devices per groin with a slight significant difference between the 2 stratification groups. Primary ProGlide technical success was achieved in 68.1% of the groins. Secondary percutaneous or non-invasive technical success was achieved in 96.9%. Here there was no statistically significant difference between the 2 stratification groups. Thirty-one (3.7%) groin complications were registered during 30-day follow-up and 17 required additional treatment. Total mortality was 2.8%. None of these deaths were related to the access site. CONCLUSION: ProGlide by itself has a significant failure rate in the closure of large-bore access holes on an unselected cohort of patients eligible for P-EVAR. However, together with adjunct percutaneous or non-invasive methods a success rate of 97% can be achieved. The access complication rate was lower than 4% at 30-day follow-up.