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

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Abstract

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 ambulation after the procedure. The study included diagnostic or interventional procedures. The suture-mediated closure was performed immediately after the procedure independent of the anticoagulation level, whereas manual compression was performed per hospital protocol with sheath removal relying on normalization of patient’s anticoagulation status. A significant reduction in time to achieve hemostasis (7.8 ± 4.8 vs 19.6 ± 13.2 minutes, p <0001) and time to ambulation (4.5 ± 6.5 vs 17.8 ± 5 hours, p <0001) was associated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population (5.7% for suturing device vs 11.3% for compression) or in the interventional patient subset (8.4% for suturing device vs 9.6% for compression). There was a significant 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 alternative to manual compression. Hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, with a potential reduction in access site complications.

Section snippets

Methods

A suture-mediated closure device for percutaneous use was compared with manual compression in order to achieve hemostasis at the femoral access site. The device incorporated 2 components: a sheath holding 1 or 2 pairs of needles connected by a suture loop, and a rotating barrel used to facilitate the positioning of the device before needle deployment and to guide the needles during their travel through the subcutaneous tract. The number of needles was related to the device size. The 6Fr device

Results

Between April and September 1996, 600 patients were enrolled in the study. Data analysis of the study end points was possible on 590 patients (98% of data). The patient population consisted of 189 interventional cases and 401 patients undergoing diagnostic catheterization procedure. The demographics of the 2 treatment groups were comparable and representative of the overall population undergoing catheterization procedures at our institution. There was no difference between the 2 groups

Discussion

We report a pilot study (registry) of >1,000 patients undergoing percutaneous vascular suture with the Techstar and the Prostar suture device between June 1995 and February 1996,9, 10 with high success and low complications. In this randomized, prospective study we could demonstrate a high device success rate (94.3%) after elective coronary angiography and coronary interventions, with a low local complication rate associated with suturing device closure compared with manual compression (device

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