Journal of Invasive Cardiology

ABSTRACT: The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell to ≤ 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 ± 3.6 vs. 13.8 ± 5.8 minutes; p = 0.02). Attainment of hemostasis in < 15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.

J INVASIVE CARDIOL 2008;20:579–584

The manufacture and use of topical hemostasis patches, which serve as adjuncts to manual compression to accelerate vascular hemostasis following percutaneous diagnostic and interventional procedures, has grown rapidly over the past few years. Hemostasis patches are promoted as a means to allow arterial sheath removal at higher levels of anticoagulation, shorten the time required to achieve hemostasis after sheath removal and reduce overall postprocedural bed rest time compared to conventional manual compression alone.1,2 At present, 10 competing topical patches, each incorporating one or more of a variety of procoagulant materials, have received United States Food and Drug Administration (FDA) clearance for clinical use. Despite the increasing popularity of these devices, prospective data supporting their utility and safety remains scant. To investigate whether the touted advantages of hemostasis patches might translate into actual clinical benefit, we designed a prospective, randomized, controlled trial to assess the efficacy of one such topical hemostasis patch incorporating a polysaccharide-based procoagulant (SafeSeal Patch, Possis Medical, Inc., Minneapolis, Minnesota) following endovascular intervention.

Methods

Patients. Patients 18 years of age or older who underwent percutaneous coronary or peripheral arterial intervention through a 6 Fr femoral arterial sheath at our institution from May, 2007 to October, 2007 were eligible. The protocol was approved by the Research Subjects Review Board at our institution. Patients gave written informed consent for participation in the trial prior to their catheterization procedure, and randomization occurred immediately following completion of the endovascular intervention.