Evaluation of the Hemostatic Effect of an Innovative Tissue Adhesive during Extraction Therapy under Rivaroxaban in a Rodent Model

An increase in rivaroxaban therapies is associated with increased numbers of postoperative bleeding despite the use of hemostatic sponges, which are currently the gold standard treatment. VIVO has shown promising hemostatic results, favorable tissue properties, and ease of application, although it has not yet been used in the oral cavity. The aim of this study was to evaluate the hemostatic properties of VIVO in the extraction sockets of 31 rodents and compare this to gelatin sponge (GSP) therapy. At rivaroxaban concentrations of 264.10 ± 250.10 ng/mL, 62 extraction sockets were generated, of which 31 were treated with VIVO and 31 with GSP. The duration time, early and late bleeding events, and wound healing score were determined. Histologic examinations of the tissues were performed after 5 days. VIVO presented a longer procedure, 1.26 ± 0.06 min, but a significantly shorter bleeding time, 0.14 ± 0.03 min. There was no difference between the two groups in terms of the severity and timing of bleeding. More minor early bleeding events were observed for GSP. VIVO showed a significantly better healing score, with favorable histological results. In an animal study, VIVO showed promising hemostatic properties after tooth extraction under ongoing anticoagulative therapy.

[1]  S. Takenaka,et al.  In Vivo Assessment of the Apatite-Forming Ability of New-Generation Hydraulic Calcium Silicate Cements Using a Rat Subcutaneous Implantation Model , 2023, Journal of functional biomaterials.

[2]  A. Boccatonda,et al.  Perioperative Management of Antithrombotic Therapy in Patients Who Undergo Dental Procedures: A Systematic Review of the Literature and Network Meta-Analysis , 2023, International journal of environmental research and public health.

[3]  D. Botticelli,et al.  The Effect of Anticoagulants on Early Implant Failure: A Retrospective Cohort Study , 2023, Journal of functional biomaterials.

[4]  C. Apel,et al.  Long-Term Degradation Assessment of a Polyurethane-Based Surgical Adhesive—Assessment and Critical Consideration of Preclinical In Vitro and In Vivo Testing , 2023, Journal of functional biomaterials.

[5]  R. Di Lenarda,et al.  Is L-PRF an effective hemostatic agent in single tooth extractions? A cohort study on VKA and DOAC patients , 2023, Clinical Oral Investigations.

[6]  M. Marietta,et al.  Risk and Management of Bleeding Complications with Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Venous Thromboembolism: a Narrative Review , 2022, Advances in Therapy.

[7]  Xufeng Niu,et al.  Anti-Inflammatory and Mineralization Effects of an ASP/PLGA-ASP/ACP/PLLA-PLGA Composite Membrane as a Dental Pulp Capping Agent , 2022, Journal of functional biomaterials.

[8]  F. Hölzle,et al.  Evaluation of the long‐term results of vascular anastomosis using polyurethane adhesive and shape‐memory stent in the rat carotid artery model , 2022, Microsurgery.

[9]  Imai Yutaka,et al.  Frequency of hemorrhage after tooth extraction in patients treated with a direct oral anticoagulant: A multicenter cross-sectional study , 2022, PloS one.

[10]  S. Jockenhoevel,et al.  A polyurethane-based surgical adhesive for sealing blood vessel anastomoses-A feasibility study in pigs. , 2022, Journal of biomedical materials research. Part B, Applied biomaterials.

[11]  F. Hölzle,et al.  Host inflammatory response and clinical parameters around implants in a rat model using systemic alendronate and zoledronate acid drug administrations , 2022, Scientific Reports.

[12]  F. Hölzle,et al.  Biodegradation and Immunological Parameters of Polyurethane-based Tissue Adhesive in Arterial Microvascular Anastomoses - a Long-term in Vivo Study. , 2022, Macromolecular bioscience.

[13]  K. Jiao,et al.  Polyphosphate-crosslinked collagen scaffolds for hemostasis and alveolar bone regeneration after tooth extraction , 2021, Bioactive materials.

[14]  C. Maiorana,et al.  Comparative Risk of Bleeding of Anticoagulant Therapy with Vitamin K Antagonists (VKAs) and with Non-Vitamin K Antagonists in Patients Undergoing Dental Surgery , 2021, Journal of clinical medicine.

[15]  Ji-Yuan Liu,et al.  Risk factors for bleeding after dental extractions in patients receiving antithrombotic drugs - A case control study , 2021, Journal of dental sciences.

[16]  Hongzhong Jin,et al.  Rivaroxaban for treatment of livedoid vasculopathy: A systematic review , 2021, Dermatologic therapy.

[17]  F. Hölzle,et al.  Mechanical strength and hydrostatic testing of VIVO adhesive in sutureless microsurgical anastomoses: an ex vivo study , 2021, Scientific Reports.

[18]  M. Dieterlen,et al.  Haemostasis in oral surgical procedures involving patients with a ventricular assist device. , 2020, International journal of oral and maxillofacial surgery.

[19]  S. Minakuchi,et al.  Postoperative bleeding after dental extraction among elderly patients under anticoagulant therapy , 2020, Clinical oral investigations.

[20]  A. Barone,et al.  Implant Placement in Patients under Treatment with Rivaroxaban: A Retrospective Clinical Study , 2020, International journal of environmental research and public health.

[21]  F. Prunier,et al.  Direct Rivaroxaban-Induced Factor Xa Inhibition Proves to be Cardioprotective in Rats. , 2020, Shock.

[22]  R. Jacobs,et al.  Tranexamic acid to reduce bleeding after dental extraction in patients treated with non-vitamin K oral anticoagulants: design and rationale of the EXTRACT-NOAC trial. , 2019, The British journal of oral & maxillofacial surgery.

[23]  K. Lobastov,et al.  Rivaroxaban in the treatment of upper extremity deep vein thrombosis: A single-center experience and review of the literature. , 2019, Thrombosis research.

[24]  H. Yoshida,et al.  Safety of tooth extraction in patients receiving direct oral anticoagulant treatment versus warfarin: a prospective observation study. , 2019, International journal of oral and maxillofacial surgery.

[25]  G. Lied,et al.  Intraoperative anaphylaxis to gelatin-based hemostatic agents: a case report , 2019, Journal of asthma and allergy.

[26]  J. Connors Testing and monitoring direct oral anticoagulants. , 2018, Blood.

[27]  G. Chaushu,et al.  Evaluation of early wound healing scales/indexes in oral surgery: A literature review. , 2018, Clinical implant dentistry and related research.

[28]  A. Khorana,et al.  Use of Direct Oral Anticoagulants in Patients with Cancer: Practical Considerations for the Management of Patients with Nausea or Vomiting. , 2018, The oncologist.

[29]  Xinwei He,et al.  Rivaroxaban does not influence hemorrhagic transformation in a diabetes ischemic stroke and endovascular thrombectomy model , 2018, Scientific Reports.

[30]  W. Ageno,et al.  Antidotes for the direct oral anticoagulants: What news? , 2018, Thrombosis research.

[31]  Shinji Uemoto,et al.  Hemostatic Efficacy and Safety of the Novel Medical Adhesive, MAR VIVO-107, in a Rabbit Liver Resection Model , 2018, European Surgical Research.

[32]  P. Verhamme,et al.  Pragmatic approach to manage new oral anticoagulants in patients undergoing dental extractions: a prospective case-control study , 2017, Clinical Oral Investigations.

[33]  P. Chan,et al.  Influence of Direct Oral Anticoagulants on Rates of Oral Anticoagulation for Atrial Fibrillation. , 2017, Journal of the American College of Cardiology.

[34]  S. Nathwani,et al.  Novel oral anticoagulants and exodontia: the evidence , 2017, BDJ.

[35]  S. Halvorsen,et al.  A nationwide registry study to compare bleeding rates in patients with atrial fibrillation being prescribed oral anticoagulants , 2016, European heart journal. Cardiovascular pharmacotherapy.

[36]  G. Bawazeer,et al.  Documentation of various approaches and outcomes in patients on warfarin undergoing dental procedures: a review article. , 2016, American journal of cardiovascular disease.

[37]  E. Valmaseda-Castellón,et al.  Haemostatic agents in apical surgery. A systematic review , 2016, Medicina oral, patologia oral y cirugia bucal.

[38]  H. Aggarwal,et al.  Interventions for treating post-extraction bleeding. , 2016, The Cochrane database of systematic reviews.

[39]  G. Gómez-Moreno,et al.  Dental implant surgery in patients in treatment with the anticoagulant oral rivaroxaban. , 2016, Clinical oral implants research.

[40]  D. Rothamel,et al.  Prevention of post-operative bleeding in hemostatic compromised patients using native porcine collagen fleeces—retrospective study of a consecutive case series , 2016, Oral and Maxillofacial Surgery.

[41]  H. Shigeishi,et al.  Risk factors for postoperative complications following oral surgery , 2015, Journal of applied oral science : revista FOB.

[42]  A. Cafolla,et al.  The effectiveness of a new method using an extra-alveolar hemostatic agent after dental extractions in older patients on oral anticoagulation treatment: an intrapatient study. , 2015, Oral surgery, oral medicine, oral pathology and oral radiology.

[43]  M. Connelly,et al.  Arterial antithrombotic activity of rivaroxaban, an orally active factor Xa inhibitor, in a rat electrolytic carotid artery injury model of thrombosis , 2011, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[44]  L. Cunningham,et al.  Current thoughts on treatment of patients receiving anticoagulation therapy. , 2010, Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons.

[45]  E. Erdfelder,et al.  Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses , 2009, Behavior research methods.

[46]  C. Weinz,et al.  Metabolism and Excretion of Rivaroxaban, an Oral, Direct Factor Xa Inhibitor, in Rats, Dogs, and Humans , 2009, Drug Metabolism and Disposition.

[47]  Edgar Erdfelder,et al.  G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences , 2007, Behavior research methods.

[48]  G. Wells,et al.  An assessment of clinical wound evaluation scales. , 1998, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.