Italian PEVAR Registry Conducted With Abbott Vascular's Prostar XL and Proglide Closure Systems

November 18, 2015—In the Journal of Cardiovascular Surgery, Prof. Giovanni Pratesi, MD, et al reported outcomes from a multicenter Italian registry of femoral access percutaneous endovascular aneurysm repair (PEVAR) using Abbott Vascular’s Prostar XL and Proglide closure systems (2015;56:889-898).

The investigators concluded that the results of the multicenter Italian PEVAR registry (IPER) confirm the high technical success rate of PEVAR when performed by experienced operators, even in presence of demanding anatomies. They advised that femoral calcification represents the only predictor of percutaneous access failure.

As summarized in the Journal of Cardiovascular Surgery, the registry enrolled consecutive patients affected by aortic pathology treated by PEVAR at seven centers in Italy between January 2010 and December 2014. All operators had performed at least 50 percutaneous femoral access procedures. 

The IPER investigators prospectively collected data into a dedicated online database, including patient demographics, anatomic features, intraoperative outcomes, and postoperative outcomes. A retrospective analysis was conducted to report intraoperative and 30-day technical success and access-related complication rates. Univariate and multivariate analyses were performed to identify factors potentially associated with an increased risk of PEVAR failure.

A total of 2,381 accesses were collected in 1,322 patients. The majority of patients were male (94.4%), and the mean age was 73.5 ± 8.3 years (range, 45–97 years). The overall technical success rate was 96.8% (2,305/2,381). Major intraoperative access-related complications requiring conversion to surgical cutdown were observed in 3.2% of the cases (76/2,381).

The 1-month PEVAR failure rate was 0.25% (6/2,381). Presence of femoral artery calcifications was shown to be a significant predictor of technical failure (odds ratio, 1.69; 95% confidence interval, 1.03–2.77; P = .036) in multivariate analysis. There was no significant association observed with sex (P = .28), obesity (P = .64), common femoral artery diameter (P = .32), level of common femoral artery bifurcation (P = .94), and sheath size > 18 F (P = .24). The use of Proglide was associated with a lower failure rate compared to Prostar XL (2.5% vs 3.3%), but this was not statistically significant (P = .33), reported the IPER investigators in the Journal of Cardiovascular Surgery.