Clinical Study

Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites

Table 3

Technical success (given in %) and number of complications at all 78 access sites based on sheath size. Additionally, values of Mann-Whitney Rank Sum Tests comparing smaller (≤16) and larger (≥18) access sites are given.

Sheath size (Fr) Compr.Surgical conversionPA (cons.)PA (surg.)Primary technical successContinued technical successMajor compl.Minor compl.

81100%100%0%0%
1021100%100%0%50%
121100%100%0%0%
142833189%89%11%14%
1682100%75%25%0%
189189%89%11%0%
2024211196%92%8%17%
221100%100%0%0%
243100%100%0%0%
251100%100%0%0%

≤1640431293%88%13%13%
≥1838221195%92%8%11%
0.4420.6970.5380.599n.a.n.a.n.a.n.a.

Compr.: need for prolonged compression; PA (cons.): pseudoaneurysm with conservative management; PA (surg.): pseudoaneurysm with surgical management; major/minor compl.: major/minor complications.