Introduction: The widespread use of PTCA and complex percutaneous interventional techniques has significantly increased peripheral vascular complications prompting the development of innovative hemostatic closure devices.
Methods: To evaluate the efficacy and safety of a bovine collagen plug (VasoSeal), we sealed 362 consecutive femoral artery puncture sites in 324 patients (240 males) (mean age 57.9 +/- 11.3 years), who underwent interventional procedures or diagnostic catheterization during acute or chronic anticoagulant treatment.
Results: Complete hemostasis was achieved in 2.31 +/- 1.97 minutes in 342 cases (94.4%), with a mean activated clotting time at collagen deployment of 197 +/- 56". In 20 cases, mechanical arterial compression was needed in order to obtain vascular hemostasis (mean time: 44 +/- 13 min). We observed 1 arteriovenous fistula and 1 acute arterial thrombosis (collagen related at surgical inspection) which underwent successful surgical treatment. Minor complications without clinical sequelae were: small hematomas in 13 cases (3.8%), 4 groin abscesses (1.1%) and 4 cases of lymphangitis (1.1%).
Conclusions: Percutaneous collagen application at the femoral artery puncture site allows quick and effective hemostasis with low incidence of peripheral vascular complications following interventional percutaneous procedures or catheterization during anticoagulant treatment.