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VasoSeal and AngioSeal Closure Devices in Patients Undergoing Coronary Angiography and Angioplasty

2016-04-18 / Categories:Vascular, Compression, Assist, Devices,
Both devices are effective in reducing the time to hemostasis and ambulation following both coronary angiography and intervention [1-6]. To our knowledge, there has been no randomized comparison of the AS and VS devices. This trial is a singlecenter, randomized study comparing the time to hemostasis, time to ambulation, device failure, and minor and major complications between the two devices in both angiographic and interventional procedures.


This study was conducted at Genesis Medical Center from May 1999 to May 2000. Patients undergoing diagnostic cardiac catheterization or percutaneous interventional procedures were included in the study if they did not meet any of the following exclusion criteria: arteriotomy larger than 8 Fr; any suspicion that the introducer has been placed through the superficial femoral artery and the profunda femoris or at the bifurcation of these two vessels; the presence of significant vascular disease as judged by the cardiologist; uncontrolled hypertension at the time of deployment of the device (SBP > 140 or DBP > 90); allergy to beef product, collagen, or polyglycolic or polylactic acid polymers; emergency cases; therapeutic thrombolysis; GP IIb/IIIa inhibitors or warfarin; vascular graft puncture; bleeding disorder; pregnant or lactating females; previous AS or VS placed within 6 weeks in the same common femoral artery; preexisting autoimmune diseases; morbid obesity (> 300 pounds); hematoma prior to the AS or VS placement; younger than 18 or older than 80 years of age; and needle depth indicator outside the range indicated on the needle depth measurement card for the VS device.

A total of 157 patients were enrolled in the study (79 AS, 78 VS). Time to hemostasis and to ambulation were recorded on 150 patients (data were incomplete on seven patients). Complications were recorded on 156 patients. All patients had a selective angiogram to the common femoral artery using a 20° ipsilateral angulation. Activated clotting time was checked for all angioplasty patients and was maintained at approximately 300 sec. Physicians who have passed supervised training for each device and performed at least 15 of each VS or AS were allowed to perform device delivery. All data were collected prospectively. Data were recorded daily until discharge to ensure compliance with protocol for ambulation and monitoring of complications.

Definition of Primary Endpoints

The primary outcomes of this study were time to hemostasis, time to ambulation, and complication rates until discharge and at 1-month follow-up (major and minor). Time to hemostasis was measured in 20-min increments. Twenty minutes of light manual pressure or tension spring was applied after VS or AS deployment, respectively. Increments of 20 min are added until hemostasis is achieved. Time to ambulation was measured in 90-min and 360-min increments for both angiogram and interventional procedures, respectively.

Increments of 90 and 360 min for angiography and interventional procedures were added respectively until successful ambulation was achieved. Successful ambulation was defined as walking for 5 min or 100 feet without bleeding complications. A major complication was defined as one of the following: the occurrence of a pseudoaneurysm, arterio-venous fistula, thrombosis of the common femoral artery, retroperitoneal bleed, infection, bleeding from the puncture site requiring transfusion, or death. Routine duplex ultrasound was not performed to the puncture site unless there was a clinical suspicion of a pseudoaneurysm or a fistula. A minor complication was defined as a localized allergic reaction, a hematoma not requiring transfusion, or a continuous mild oozing at the puncture site - Managing Risk of Complications at Femoral Vascular Access Sites in Percutaneous CoronaryIntervention at

Failure to deliver the collagen to the puncture site was recorded as deployment failure. No distinction between operator or device failure was made. For the first 51 patients enrolled (22 VS, 29 AS), the ankle brachial index (ABI) was measured and compared before and after the procedure.