Use of vascular sealing devices (VasoSeal and Perclose) versus assisted manual compression (Femostop) in transcatheter coronary interventions requiring Abciximab (ReoPro)

Abstract

Transcatheter coronary interventions requiring abciximab (ReoPro) are associated with vascular access site complications. Several devices have been developed to aid in the closure of the femoral arteriotomy, including collagen plug devices (VasoSeal, AngioSeal), percutaneous suture closure (Perclose), and aids to manual compression (Femostop). In 185 patients who received abciximab plus aspirin and heparin for transcatheter coronary interventions, we compared femoral arteriotomy closure by three different methods: VasoSeal, Perclose, and Femostop. A composite endpoint of late complications defined as an access site-related bleed or hematoma that required blood transfusion or an extended hospital stay, pseudoaneurysm, arteriovenous fistula, arterial or venous thrombosis was compared. VasoSeal was initially successful in 41/52 patients (78.8%). The 11 patients who failed to have adequate hemostasis with VasoSeal required manual compression aided by Femostop, but had no late complications. There was one access site infection and one fatal retroperitoneal hematoma unrelated to the vascular access site (surgically explored). There were no late complications. Perclose was successful in 48/56 patients (85.7%). One Perclose failure required surgical repair for an extensive arteriotomy. The other Perclose failure required manual compression aided by Femostop, but had no late complications. There were no access site infections requiring intravenous antibiotics. There was one retroperitoneal bleed that extended the patient's hospital stay and for which a blood transfusion was required. Femostop was successful in 77/77 patients (100%). There were no infections. Late complications occurred in four patients. These included three episodes of bleeding or hematomas requiring blood transfusion, and one pseudoaneurysm. In patients receiving abciximab in addition to aspirin and heparin, VasoSeal and Perclose are at least as safe as Femostop when used to achieve homeostasis after sheath removal. VasoSeal and Perclose have a significantly lower initial rate of successful hemostasis than Femostop. The numbers of late complications between the VasoSeal, Perclose, and Femostop groups were not significantly different. In those patients in whom VasoSeal or Perclose failed, no late complications occurred. Access site infections were no different between VasoSeal, Perclose, and Femostop.