Safety and efficacy of the perclose suture–mediated closure device after diagnostic and interventional catheterizations in a large consecutive population

Abstract

Arterial puncture sites after cardiac catheterization are a troublesome cause of complications. Closure devices have been developed to improve on patient comfort and safety. We evaluated a suture-mediated closure device, the Prostar-Plus device, in a consecutive population of over 10,001 diagnostic and interventional catheterizations. A significantly higher complication rate was noted for both major and minor complications in the diagnostic catheterization patients treated with the Prostar-Plus device compared to diagnostic catheterization patients treated with manual compression (2.6% major and 4.6% minor complication rate for the Prostar-Plus treatment group vs. 0.2% major and 1.8% minor complication rate for the manual compression treatment group). For the interventional patients, there were no statistical differences noted for both major and minor complications between patients treated with the Prostar-Plus device vs. manual compression. Subgroup analysis showed that older, thinner women were more likely to have complications related to the Prostar-Plus device.

Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures

“…The number of enrolled patients in the studies ranged from 60 to 10,001 (8,34), with 57% of studies having Ն100 patients in each arm. In all studies, most patients were men (range 56% to 94%) (5,8).…”

“…Studies assessing Angio-Seal (Angio-Seal Daig, Minnetonka, Minnesota) (3,6,9,11,12,(17)(18)(19)(20)(21)(22)(23), VasoSeal (VasoSeal Datascope Inc., Montvale, New Jersey) (4,5,19,24 -30), and Perclose (ProStar Plus or TecStar; Perclose, Redwood City, California) (7,8,10,12,13,18,19,21,23,29,(31)(32)(33)(34)(35) were included in the meta-analysis. Data on various devices as well as on diagnostic (Dx) catheterization and PCI were assessed separately and in combination.…”

An unusual cause of claudication

“…Three different devices are currently FDA-approved: the AngioSeal (St. Jude Medical), which sandwiches an intraarterial absorbable anchor on the luminal side of the vessel and a thrombin plug on the surface of the vessel using a self-cinching stitch [1]; the Vasoseal (Datascope, Montvale, NJ), which deposits a thrombin plug directly over the femoral artery puncture site [3]; and Perclose device (Perclose, Redwood City, CA), which uses a percutaneous means directly to suture and close the femoral artery puncture site [4]. While all three devices have been shown to reduce time to hemostasis, their rates of access site complication are similar to or greater than manual compression [2,4,5]. However, one study did show that in those patients on IIb/IIIa receptor antagonists, there were less complications in those patients who received closure devices rather than manual compression [6].…”

Vascular Injury From an Arterial Closure Device

“…3 In a retrospective trial that reported a higher overall complication rate in 10,001 device-treated patients, reported complications were hematomas (10.5%), pseudoaneurysms (2.7%), a need for transfusions (1.3%), and a requirement for surgical pseudoaneurysm repair (0.67%). 4 Another study reported that surgical repair was necessitated in 0.3% of cases after the use of arterial closure devices. 5 In addition to hematomas and pseudoaneurysms, other injuries have been described in patients treated with arterial closure devices, including arterial dissection, arterial occlusion, and retained devices, [5][6][7][8] but the overall incidences of these complications are difficult to extrapolate from the small sample sizes presented.…”