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Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device
U Gerckens1, N Cattelaens, E G Lampe
1Herzentrum Siegburg, Germany.
Insights
Suture-mediated closure devices significantly reduce the time to hemostasis and ambulation after catheterization compared to manual compression. This method offers a safe alternative, potentially decreasing vascular complications, especially in diagnostic procedures.
Area of Science:
- Cardiovascular Interventions
- Vascular Access Management
Background:
- Achieving effective hemostasis after catheterization presents challenges.
- Manual compression is a common but time-consuming method for achieving hemostasis.
Purpose of the Study:
- To compare the efficacy and safety of a suture-mediated closure device versus manual compression for achieving hemostasis after catheterization procedures.
- To evaluate the impact on time to hemostasis, time to ambulation, and incidence of vascular complications.
Main Methods:
- A randomized trial involving 600 patients undergoing diagnostic or interventional catheterization procedures.
- Comparison between immediate suture-mediated closure and manual compression based on hospital protocol.
- Primary endpoints included vascular complication rates and time to ambulation.
Main Results:
- Suture-mediated closure significantly reduced time to hemostasis (7.8 vs 19.6 minutes) and time to ambulation (4.5 vs 17.8 hours) (p <0.0001).
- Overall vascular complication rates were similar (5.7% vs 11.3%), but significantly lower in the diagnostic subset with suture-mediated closure (4.4% vs 12.1%, p <0.05).
Conclusions:
- Suture-mediated closure devices provide a safe and faster alternative to manual compression for achieving hemostasis post-catheterization.
- This approach can expedite patient ambulation and potentially lower access site complications, particularly in diagnostic procedures.
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.