The safety and efficacy of "pre-closure" utilizing the Closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second Perclose Accelerated Ambulation and Discharge (PARADISE II) Trial

BACKGROUND: Suture-mediated closure devices have been developed to improve patient comfort and safety following percutaneous coronary interventions (PCI). The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial which we reported previously showed that the Prostar XL appears to be a safe and effective device to achieve hemostasis, improve time-to-ambulation and discharge post-PCI. The diameter of suture capture with the Closer 6 Fr suture-mediated closure device is larger than an 8 Fr hole. This study was performed to assess the pre-closure efficacy using the Closer device in terms of time-to-hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications. METHODS: Between January and September 2001, 153 consecutive patients were enrolled in this study. In 97 patients, the Closer sutures were introduced prior to insertion of the 8 Fr sheath (pre-closure arm). In 56 patients, the sutures were tied at the conclusion of PCI upon sheath removal (standard arm). RESULTS: The Closer device was successfully placed on 152 of 153 attempts. The time-to-hemostasis, ambulation and discharge of the pre-closure arm patients seemed to be comparable to those of the standard arm and the PARADISE trial. No major complications were reported. CONCLUSION: The Closer seems to be as safe and effective as the Prostar XL device. The pre-closure technique is a safe means of achieving hemostasis post-PCI using large-sized sheaths without major complications.