Randomized controlled trial of sheaths in diagnostic neuroangiography

Abstract

PURPOSE: To determine the value of arterial sheaths in diagnostic neuroangiography in a randomized controlled trial. MATERIALS AND METHODS: A total of 842 patients (411 men, 431 women; mean age, 59.4 years; age range, 29.5-94.3 years) undergoing diagnostic neuroangiography were randomly assigned to groups in which a sheath was introduced immediately after puncture of the femoral artery (sheath group) or in which a diagnostic catheter was introduced without a sheath (control group). Two hundred twenty-four (26.7%) of 839 patients were receiving anticoagulants immediately prior to the procedure. RESULTS: Complications (mostly small hematomas of the groin) occurred in 106 (12.6%) of 842 patients, with no difference between groups (53 [12.6%] of 421 patients in both; P > .99). Ease of catheter manipulation was greater in the sheath group than in the control group. Incidence of bleeding at the femoral puncture site during the procedure was less in the sheath group (seven [1.7%] of 421 patients) versus the control group (150 [35.6%] of 421 patients), with a P value less than .001. Because of bleeding, sheath insertion was necessary in 165 (39.2%) of 421 patients in the control group. This crossover group also had a higher rate of local complications (28 [17.0%] of 165 patients) than the sheath and control groups. Serious complications, such as stroke (one [0.12%] of 842 patients) and transient ischemic attacks (five [0.60%] of 842 patients), occurred with equal frequency in both the sheath and control groups. CONCLUSION: Use of arterial sheaths lessens the incidence of intraprocedural bleeding at the femoral puncture site and increases ease of catheter manipulation without increasing the number of groin complications.