OBJECTIVE--To assess the efficacy and safety of a haemostatic bovine collagen plug (VasoSeal) in reducing patient immobilisation after cardiac catheterisation from a percutaneous femoral arterial approach. DESIGN--A non-randomised, prospective analysis of a new biodegradable haemostatic agent on an intention to treat basis. SETTING--The catheterisation suite of a regional cardiothoracic unit. PATIENTS--A series of 63 patients having various diagnostic investigations and therapeutic interventions agreed to participate in this study. INTERVENTIONS--Cardiac catheterisation was performed from a percutaneous femoral artery approach. Patients taking aspirin and those who required formal anticoagulation were not excluded. Patients were measured for the appropriate sized collagen delivery system at the beginning of the procedure. At the end of the procedure two bovine collagen plugs were applied to the surface of the femoral artery through the channel created by the application device. MAIN OUTCOME MEASURES--Incidence of successful delivery, insertion time, immediate outcome, inpatient complications, success of mobilisation of the patient at one and two hours after the procedure, and whether these variables relate to individual patient characteristics. RESULTS--Successful placement of the device was achieved in 57 of 63 consecutive patients (90.5%). The mean (SD) insertion time was 86 (24) seconds. Six (9.5%) patients did not receive the haemostat because of femoral artery perforation by the tissue dilator (n = 3), inability to compress the femoral artery proximal to the site of delivery (n = 1), pre-existing haematoma (n = 1), or patient withdrawal from the study (n = 1). Uncomplicated mobilisation within two hours of investigation was possible in 54 of 57 (94.7%) patients receiving this device. A sizeable haematoma (> 5 x 5 cm) prevented early mobilisation in the remaining three patients. Mobilisation was uncomplicated in 32 of 34 (94.1%) patients mobilised at two hours and 22 of 23 (95.6%) at one hour (NS). One patient who was mobilised early without complication later developed evidence of claudication in the treated leg. Femoral arteriography showed a smooth intraluminal filling defect attached to the wall of the femoral artery at the puncture site. This obstruction, presumed to be a collagen plug, was treated successfully with angioplasty. Sheath size, arterial pressure, the use of aspirin, heparin or warfarin, and body mass index did not influence patient outcome. The pattern of complications did not relate to a learning curve experience. CONCLUSIONS--The bovine collagen haemostat is a relatively safe and effective device that allows far earlier patient mobilisation than conventional haemostasis after diagnostic and therapeutic interventions from a percutaneous femoral artery approach. These results have important implications for patients undergoing investigation in mobile x ray units or in hospital based day case units.
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