Management of arterial puncture site after catheterization procedures: Evaluating a suture-mediated closure device

To overcome the challenge associated with achievement in hemostasis after a catheterization procedure, a suture-based closure device was compared with manual compression in a 600-patient randomized trial. The major study end points included the incidence of vascular complications and the time to amb ulation after the procedure. The study included diagnostic or interventiona l procedures. The suture-mediated closure was performed immediately after t he procedure independent of the anticoagulation level, whereas manual compr ession was performed per hospital protocol with sheath removal relying on n ormalization of patient's anticoagulation status. A significant reduction i n time to achieve hemostasis (7.8 +/- 4.8 vs 19.6 +/- 13.2 minutes, p < 000 1) and time to ambulation (4.5 +/- 6.5 vs 17.8 +/- 5 hours, p < 0001) was a ssociated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population (5.7% for sutu ring device vs 11.3% for compression) or in the interventional patient subs et (8.4% for suturing device vs 9.6% for compression). There was a signific ant reduction in the incidence of vascular complications in the diagnostic procedure subset (4.4% for suturing device vs 12.1% for compression, p < 0. 05). Thus, the use of a suture-mediated closure device represents a safe al ternative to manual compression. Hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, with a potent ial reduction in access site complications. (C) 1999 by Excerpta Medico, In c.