The experience with the Epiclose-T vascular access closure device: a human study.

Objective: The Epiclose-T, a novel closure device for arterial access sites, is designed as a double-balloon device that applies direct pressure on the arteriotomy site, allowing natural coagulation and leaving no artificial material behind. We assessed prospectively the initial safety and efficacy of the Epiclose-T after diagnostic cardiac catheterization, and evaluated patient comfort.

Methods: In our randomized, controlled, prospective study, the study group consisted of 32 patients (17 male, mean age 52.8+/-11.0 years) treated with Epiclose-T device. The control group included 39 patients (20 male, mean age 55.5+/-11.0 years) treated with manual compression.

Results: Hemostasis was achieved successfully in 90.6% of the study group. For the 30-day follow-up, there were no statistically significant differences between the groups in the rate of major and minor complications. No bleeding requiring transfusion was seen in both groups. However, the number of major complications, including large hematoma (0 vs. 1 patient-2.6%) and pseudoaneursym (0 vs. 1 patient-2.6%), occurred more often in the control group. The number of small hematomas was 3 (7.7%) in the compression group and 2 (6.9%) in the Epiclose-T group. In the failure group (3 patients), body-mass-index was somewhat lower than that of the success group (median--26 (25-33) kg/m2 vs. 27 (24-32) kg/m2, p=0.07). Most patients were satisfied by the Epiclose-T closure device and grade it as excellent or good.

Conclusion: Hemostasis can be easily and safely achieved by Epiclose-T device with no significant minor and major complications with patients' total satisfaction.