Angio-Seal^TM Vascular Closure Device: An Evaluation of Cost Effectiveness ^†

Background: Optimal management of the vascular access site is crucial to early ambulation after percutaneous coronary intervention (PCI) and has thus major impact on the costs of the procedure. In this study, we assessed the cost-effectiveness, safety, and patient comfort of the Angio-SealTM Hemostatic Puncture Closing Device in PCI patients. Methods: In a single-centre trial, 43 patients were prospectively randomised to either immediate arterial sheath removal with Angio- Seal™ access site closure (Angio-Seal group; n = 21), or sheath removal 4 hours after elective PCI followed by manual compression (MC group; n = 22). In the Angio-Seal group, patients were ambulated 4 hours after PCI if haemostasis was achieved. In the MC group, patients were ambulated the day after PCI. Results: The time to achieve haemostasis was significantly shorter (Angio-Seal™: 2.0 ± 1.0 vs MC: 22.5 ± 4.6 min; p <0.001), and back pain after the intervention was significantly lower (Angio-Seal™: pain score 1.5 ± 1.4 vs MC: 6.0 ± 3.0; p <0.001) in the Angio-Seal group. Haemostasis was successful in all patients and no major complications occurred. The Angio- Seal™ device allowed earlier ambulation (Angio- Seal™: 4.0 ± 2.0 vs MC: 18.5 ± 2.7 hours; p <0.001). Total direct costs were significantly lower in the Angio-Seal™ compared to the MC group (514 Euro saved per patient, representing a reduction of 54%) due to reductions of nursing time (Angio-Seal™: 7.1 ± 2.5 vs MC: 9.4 ± 2.6 hours; p = 0.006) and time of the interventional physician (Angio-Seal™: 5.4 ± 7.9 vs MC: 22.5 ± 4.6 min; p <0.001). Conclusions: Compared to MC the use of the Angio-Seal™ is associated with cost saving due to shorter time to haemostasis and thus earlier ambulation and hospital discharge, as well decreased personnel and infrastructural demands. In addition, the use of Angio-Seal™ is safe and increases patient comfort.