Journal of Heart and Cardiovascular Research

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Hemostasis Of Artery

A novel device for obtaining arterial hemostasis after invasive procedures was tested in 30 patients undergoing diagnostic catheterization (26 patients) or coronary angioplasty (4 patients). The device is deployed through an arterial sheath and forms a positive mechanical seal both inside and out of doors the defect within the arterial wall. The components are all bioabsorbable. Thirteen patients received a heparin bolus during the catheterization procedure. The activated time period recorded in 15 patients just before device deployment averaged 264 sec. 29 of 32 attempted device deployments were successful (91%); and therefore the remaining 3 devices pulled completely out as involved intentionally within the event of incomplete deployment. Twenty-nine patients ultimately achieved successful hemostasis using the device, with the opposite patient receiving manual hemostasis. Of these 29, hemostasis was immediate and complete in 19 patients. Light digital pressure was required in another 8 patients for fewer than 5 min. There was minor delayed bleeding requiring supplemental light pressure in several cases. A total of 11 patients required supplemental pressure additionally to the hemostasis device. The use of bolus heparin was significantly (P = 0.05, Fisher's exact test) associated with the need for supplemental pressure. Three patients developed hematomas, one among which was present before device deployment. The other two patients had received bolus heparin. No patient required transfusion or surgical repair.

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