Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Abstract

Purpose: The perioperative management of patients on antithrombotic therapy is currently an unresolved problem as these therapies pose a considerable risk for perioperative hemorrhagic complications. The presented studies investigated the efficacy of a new collagen technology to achieve hemostasis. A polyethylene glycol-coated collagen pad (PCC) was compared to a marketed fibrinogen-thrombin coated collagen pad (FTC) for the treatment of an aortotomy incision in heparinized swine on dual antiplatelet therapy. Materials and Methods: Twenty-eight 3-mm aortotomy incisions were created in nine heparinized pigs without antiplatelet therapy and treated with PCC. Sixty-eight aortotomy incisions were created in ten heparinized pigs that received clopidogrel (10-11 mg/kg) and acetylsalicylic acid (8-11 mg/kg) orally for 5 days, and treated with either PCC or FTC (N = 34/group). Dual antiplatelet therapy resulted in significantly reduced platelet function. Aortotomy incisions resulted in lifethreatening bleeding of 35-292 ml/min. Results: In animals without antiplatelet treatment, PCC provided 96% immediate hemostatic success. In animals with antiplatelet treatment, FTC provided 18% immediate hemostatic success increasing to 74% after 10 min. Strikingly, PCC provided 94% immediate success increasing to 100% after 10 min. Controlling for differences in pretreatment bleeding rates, statistical model-estimated time to hemostasis was 12 times shorter in PCC-treated lesions (p < .02). Conclusion: The combination of a procoagulant collagen pad with a synthetic sealing component provides excellent hemostatic properties under a worst-case scenario. PCC rapidly and firmly adheres to tissue, thereby controlling severe arterial bleeding, even when platelet function is significantly reduced. Treatment with PCC provided superior time to hemostasis compared to FTC.

Safety and Efficacy of a Novel, Self-Adhering Dural Substitute in a Canine Supratentorial Durotomy Model

“…The porous structure of PCC is known to allow migration of fluid through the collagen pad, which reduces the fluid–tissue interface stress level and improves adherence. 42 , 43 An adhesive failure leads to a continual CSF leak regardless of pressure, whereas a cohesive failure retains function following transient increases in CSF pressure (eg, coughing, sneezing). Recent studies investigating the complication rate of nonwater tight closures suggest that the complication rate is clinically acceptable and comparable to water tight closures, 44 - 46 whereas true CSF leaks lead to worse surgical outcomes.…”

Properties of collagen-based hemostatic patch compared to oxidized cellulose-based patch

“…PCC is composed of a collagen backing coated with a synthetic N-hydroxysuccinimide functionalized polyethylene glycol (NHS-PEG), which rapidly affixes the collagen pad to tissue [ 10 ]. Collagen induces clot formation through platelet activation and NHS-PEG covalently binds the pad to the tissue surface and seals the wound effectively even when hemostasis is impaired by heparinization and antiplatelet therapy [ 11 ].…”

Case Report of a Novel Technique for Repair of the Vertebral Artery During Cranial Surgery

“…The collagen-based hemostatic patch consists of a bovine-derived collagen pad sourced from countries with negligible bovine spongiform encephalopathy risk according to the classification of the World Organization for Animal Health [2]. The collagen-based hemostatic patch has been shown to be equivalent or superior to other sealing hemostats, providing over 98% hemostatic success at 3 min or less [4,7,9]. The patch needs no prior preparation and is stored at room temperature [1], allowing rapid availability during surgery.…”

“…A polyethylene glycol-coated, collagen-based, sealing hemostatic patch (Hemopatch Ò , Baxter Healthcare Ltd.) has been designed to stop bleeding during surgical procedures and to simultaneously induce hemostasis [1,2]. This collagen-based hemostatic patch was safe and performed well against other sealing hemostats when tested in vivo using various surgical models [3][4][5][6][7][8][9], and in a range of surgeries in patients [10][11][12][13][14][15][16][17]. This case report is the first to describe the use of the collagen-based hemostatic patch for repair of vascular injury in a neurosurgical case involving the removal of meningioma in the foramen magnum.…”