Kreg Howk1, Jason Fortier2, Robert Poston3. 1. Covidien, Medical Affairs, Mansfield, MA. Electronic address: Kreg.howk@covidien.com. 2. Covidien, Research and Development, Bedford, MA. 3. Department of Surgery, University of Arizona Medical Center, Tucson, AZ.
Abstract
BACKGROUND: Achieving hemostasis during surgery is a common challenge across surgical specialties and procedures, including cardiovascular and peripheral vascular procedures. Although several hemostatic agents are available, they all become less effective as bleeding becomes more vigorous. Veriset™ hemostatic patch is a topical hemostatic agent that has been approved for use on solid organs and in soft tissue. The primary aim of these studies was to assess the safety of Veriset hemostatic patch during cardiovascular and peripheral vascular procedures. METHODS: Adult domestic swine were given intraoperative anticoagulation and systemic antiplatelet therapy, and then underwent a variety of cardiovascular coronary artery bypass graft (CABG anastomosis and aortotomy closure) and peripheral vascular (carotid arteriotomy with patch angioplasty) procedures. Bleeding was identified or created from each anastomotic site and was brisk in many cases. Veriset hemostatic patch, Surgicel(®) Nu-Knit(®) absorbable hemostat, or standard of care treatment was applied topically to the site of bleeding, and time to hemostasis was monitored for each animal. Animals were assessed during and after the surgical procedure to determine the effects of treatment on vessel diameter, clinical laboratory parameters, and host tissue response and/or tissue integration. RESULTS: Application of Veriset hemostatic patch had no effect on vessel diameter, similar to Surgicel Nu-Knit absorbable hemostat and standard of care treatment. Approximately 28 days after application, Veriset hemostatic patch and Surgicel Nu-Knit absorbable hemostat were completely absorbed, with no impact on serum chemistry profiles. Furthermore, Veriset hemostatic patch was as effective or more effective than Surgicel Nu-Knit absorbable hemostat when applied during carotid arteriotomy (30.0 ± 0.0 sec vs. 163.6 ± 86.9 sec, P < 0.001) and CABG anastomosis (91.9 ± 66.0 sec vs. 207.5 ± 159.2 sec, P = 0.053). CONCLUSIONS: Veriset hemostatic patch exhibits similar safety as Surgicel Nu-Knit absorbable hemostat, with effectiveness against cardiovascular and peripheral vascular bleeding. If these preclinical results are confirmed in clinical trials, this highly effective patch with a topical application requiring less than 30 seconds is likely to prove useful in many clinical settings.
BACKGROUND: Achieving hemostasis during surgery is a common challenge across surgical specialties and procedures, including cardiovascular and peripheral vascular procedures. Although several hemostatic agents are available, they all become less effective as bleeding becomes more vigorous. Veriset™ hemostatic patch is a topical hemostatic agent that has been approved for use on solid organs and in soft tissue. The primary aim of these studies was to assess the safety of Veriset hemostatic patch during cardiovascular and peripheral vascular procedures. METHODS: Adult domestic swine were given intraoperative anticoagulation and systemic antiplatelet therapy, and then underwent a variety of cardiovascular coronary artery bypass graft (CABG anastomosis and aortotomy closure) and peripheral vascular (carotid arteriotomy with patch angioplasty) procedures. Bleeding was identified or created from each anastomotic site and was brisk in many cases. Veriset hemostatic patch, Surgicel(®) Nu-Knit(®) absorbable hemostat, or standard of care treatment was applied topically to the site of bleeding, and time to hemostasis was monitored for each animal. Animals were assessed during and after the surgical procedure to determine the effects of treatment on vessel diameter, clinical laboratory parameters, and host tissue response and/or tissue integration. RESULTS: Application of Veriset hemostatic patch had no effect on vessel diameter, similar to Surgicel Nu-Knit absorbable hemostat and standard of care treatment. Approximately 28 days after application, Veriset hemostatic patch and Surgicel Nu-Knit absorbable hemostat were completely absorbed, with no impact on serum chemistry profiles. Furthermore, Veriset hemostatic patch was as effective or more effective than Surgicel Nu-Knit absorbable hemostat when applied during carotid arteriotomy (30.0 ± 0.0 sec vs. 163.6 ± 86.9 sec, P < 0.001) and CABG anastomosis (91.9 ± 66.0 sec vs. 207.5 ± 159.2 sec, P = 0.053). CONCLUSIONS: Veriset hemostatic patch exhibits similar safety as Surgicel Nu-Knit absorbable hemostat, with effectiveness against cardiovascular and peripheral vascular bleeding. If these preclinical results are confirmed in clinical trials, this highly effective patch with a topical application requiring less than 30 seconds is likely to prove useful in many clinical settings.
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