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ȣ - 490628 90 |
| Safety and Efficacy of PADs as an Assisted Compression Device and Classic Arterial Closure Devices |
| Cardiovascular Center, Korea University Guro Hospital¹ , Korea University Ansan Hospital² , Korea University Anam Hospital³ |
| Seung-Woon Rha¹, Soon Yong Suh¹ , Uk Yeol Chwe¹ , Jin Won Kim¹ , Jeong Cheon Ahn² , Woo Hyuk Song² , Chang Gyu Park¹ , Hong Seog Seo¹ , Dong Joo Oh¹ , Young Moo Ro³ |
Background: Recently, several vascular closure devices have been developed to minimize complications and replaced manual compression. We sought to the safety and efficacy of two major closure devices (Perclose® for suture-mediated device and Angioseal® for implantable collagen plug device) and sealing pads (Neptune PAD®, TZ medical and Clo-Sur PAD®, Medtronic).
Methods: A total 331 patients (pts, age; 58.9 ± 9.5 years) underwent percutaneous coronary intervention have randomly received Perclose (n=177), Angioseal (n=154) or sealing pads (n=12). Aspirin 100mg, plavix 300-600mg and heparin (50 U/kg) were administered as the routine antiplatelet and antithrombotic regimen. In-hospital complications, bleeding and vascular access complications of both groups were compared.
Results: Baseline characteristics were similar among 3 groups. Despite higher mean ACT level in Perclose group (276±80 vs. 211±70, p=0.05), Angioseal group showed numerically higher rate of bleeding related complications compared with Perclose although they were not statistically significant (major hematoma 5.3% vs. 10.5%, P=0.85; any hematoma 2.4% vs. 14.3%, P=0.16; significant oozing 10.3% vs. 14.9%, p=0.31). Perclose group showed higher procedural failure rate (8.0% vs. 2.3%, P=0.002), longer time needed to achieve definite hemostasis (10.4±8.0min vs. 5.9min±3.9, P=0.01) and less satisfaction (comfort 23.3% vs.66.3%, P=0.002). Vascular complications including AV fistula and pseudoaneurysm and duration of hospital stay were similar between the two groups. The mean hemostasis time for 12 sealing pads was 31.1 min and there were no significant bleeding and vascular complications.
Conclusion: Although both bleeding and vascular complications are not different among the groups, Perclose group showed higher rate of procedural failure, less pts comfort and longer time for hemostasis and these differences might be minimized after enough learning period. Although the sealing hemostasis pad takes longer time for definite hemostasis, it seems to be safe and effective and can be a noble substitute for other closure devices.
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