Efficacy of fibrin sealant in patients on various levels of oral anticoagulant undergoing oral surgery

doi:10.1016/S1079-2104(98)90367-5

Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology

Volume 86, Issue 4, October 1998, Pages 421-424

https://doi.org/10.1016/S1079-2104(98)90367-5 Get rights and content

Abstract

Objective. The purpose of this study was to investigate the efficacy of fibrin sealant in patients on oral anticoagulant therapy undergoing oral surgery with varying degrees of surgical trauma and various intensities of anticoagulation.

Study design. A consecutive series of 69 subjects on oral anticoagulant therapy undergoing oral surgery without changing anticoagulation intensity is presented. For each subject, indication for anticoagulation, international normalized ratio on day of treatment (low, 1.0–2.0; medium, 2.1–3.0; high, 3.1–5.0), degree of surgical trauma (on a scale of 1–12), and complications were recorded and correlated.

Results. There were 32 (46.4%) patients with prosthetic valves, 23 (33.3%) with atrial fibrillation and rheumatic or ischemic heart disease, and 14 (20.3%) with previous thromboembolism. Twenty (29%) patients were on low-intensity anticoagulation (international normalized ratio, 1.0–2.0), 26 (37.7%) were on medium-intensity anticoagulation (international normalized ratio, 2.1–3.0), and 23 (33.3%) were on high-intensity anticoagulation (international normalized ratio, 3.1–5.0). Each of 39 (56.5%) patients was in surgical trauma category 1, 2, or 3; the remaining 30 (43.5%) patients were in surgical trauma categories 4 through 12. Complications occurred in 3 (4.3%) patients and took the form of minor postoperative bleeding. No correlation was found between complications and international normalized ratio or degree of surgical trauma.

Conclusions. The use of fibrin sealant in oral surgery for patients on oral anticoagulant therapy is safe, and it can be provided in an international normalized ratio range of 1.0 through 5.0 and in a surgical trauma scale range of 1 through 12.

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Cited by (62)

Comparison between two different local hemostatic methods for dental extractions in patients on dual antiplatelet therapy: a within-person, single-blind, randomized study
2023, Journal of Evidence-Based Dental Practice
Dual antiplatelet therapy (DAPT) provides additional risk reduction of ischemic events compared to aspirin monotherapy, at cost of higher bleeding risk. There are few data comparing new techniques for reducing bleeding after dental extractions in these patients.
This study investigated the effectiveness of the HemCon Dental Dressing (HDD) compared to oxidized cellulose gauze.
This randomized study included 60 patients on DAPT who required at least two dental extractions (120 procedures). Each surgical site was randomized to HDD or oxidized regenerated cellulose gauze as the local hemostatic method. Intra-oral bleeding time was measured immediately after the dental extraction and represents our main endpoint for comparison of both hemostatic agents. Prolonged bleeding, platelet reactivity measured by Multiplate Analyser (ADPtest and ASPItest) and tissue healing comparison after 7 days were also investigated.
Intra-oral bleeding time was lower in HDD compared with control (2 [2-5] vs. 5 [2-8] minutes, P=0.001). Prolonged postoperative bleeding was observed in 7 cases (11.6%), all of them successfully managed with local sterile gauze pressure. More HDD treated sites presented better healing when compared with control sites [21 (36.8%) vs. 5 (8.8%), P=0.03]. There was poor correlation between platelet reactivity and intra-oral bleeding time.
In patients on DAPT, HDD resulted in a lower intra-oral bleeding time compared to oxidized cellulose gauze after dental extractions. Moreover, HDD also seems to improve healing conditions.
Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline
2022, Chest
Citation Excerpt :
Management strategies that have been assessed include: continuing VKAs, with or without co-administered pro-hemostatic interventions that comprise antifibrinolytic drugs (eg, tranexamic acid) or local measures (eg, fibrin glue, topical hemostatic agents and sealants, sutures); partial (2-3 days’ pre-procedure) VKA interruption; and complete (5 days’ pre-procedure) VKA interruption.14 These studies had limitations, with one or more of the following: small (< 100 patients) study samples; variable definitions of bleeding and other outcomes; and uncertain outcome capture during follow-up.123-148 Among four randomized trials comparing VKA continuation vs interruption, none showed a significant increase in bleeding with VKA continuation.123,128,129,131
The American College of Chest Physicians Clinical Practice Guideline on the Perioperative Management of Antithrombotic Therapy addresses 43 Patients-Interventions-Comparators-Outcomes (PICO) questions related to the perioperative management of patients who are receiving long-term oral anticoagulant or antiplatelet therapy and require an elective surgery/procedure. This guideline is separated into four broad categories, encompassing the management of patients who are receiving: (1) a vitamin K antagonist (VKA), mainly warfarin; (2) if receiving a VKA, the use of perioperative heparin bridging, typically with a low-molecular-weight heparin; (3) a direct oral anticoagulant (DOAC); and (4) an antiplatelet drug.
Strong or conditional practice recommendations are generated based on high, moderate, low, and very low certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology for clinical practice guidelines.
A multidisciplinary panel generated 44 guideline recommendations for the perioperative management of VKAs, heparin bridging, DOACs, and antiplatelet drugs, of which two are strong recommendations: (1) against the use of heparin bridging in patients with atrial fibrillation; and (2) continuation of VKA therapy in patients having a pacemaker or internal cardiac defibrillator implantation. There are separate recommendations on the perioperative management of patients who are undergoing minor procedures, comprising dental, dermatologic, ophthalmologic, pacemaker/internal cardiac defibrillator implantation, and GI (endoscopic) procedures.
Substantial new evidence has emerged since the 2012 iteration of these guidelines, especially to inform best practices for the perioperative management of patients who are receiving a VKA and may require heparin bridging, for the perioperative management of patients who are receiving a DOAC, and for patients who are receiving one or more antiplatelet drugs. Despite this new knowledge, uncertainty remains as to best practices for the majority of perioperative management questions.
Intra-alveolar epsilon-aminocaproic acid for the control of post-extraction bleeding in anticoagulated patients: randomized clinical trial
2018, International Journal of Oral and Maxillofacial Surgery
Citation Excerpt :
In cases of bleeding complications, local haemostasis is usually effective, and hospitalization or more invasive interventions are usually not necessary19,30. For this reason, the efficacy of several haemostatic measures has been investigated in recent decades8,18,32–36, including the use of topical antifibrinolytics, especially TXA13,28,33. When anticoagulant therapy is maintained unchanged and INR is within the therapeutic range, a local haemostatic agent should be used (e.g., administration of TXA).
The aim of this study was to compare the effectiveness of the intra-alveolar administration of epsilon-aminocaproic acid (EACA) and daily gentle rinsing with EACA mouthwash with that of routine postoperative procedures for the control of bleeding after tooth extraction in anticoagulated patients. A randomized clinical trial was conducted involving 52 patients submitted to 140 tooth extractions, assigned randomly to two groups. The intervention group was treated with intra-alveolar administration of EACA immediately after surgery and gentle rinsing with EACA mouthwash during the postoperative period. The control group received routine postoperative recommendations. A single episode of immediate bleeding occurred in the intervention group. Late bleeding episodes occurred in 23 procedures (16.4%): 11 (15.7%) in the intervention group and 12 (17.1%) in the control group. Among the patients with late bleeding, 18 (78.3%) events were classified as moderate and were controlled by the patient applying pressure to a gauze pack placed over the extraction socket. The remaining five cases (21.7%) required re-intervention. No statistically significant difference in the frequency of postoperative bleeding was observed between the groups. Thus, routine measures were as effective for the control of bleeding after simple tooth extractions in anticoagulated patients as the topical administration of EACA.
Supportive topical tranexamic acid application for hemostasis in oral bleeding events – Retrospective cohort study of 542 patients
2018, Journal of Cranio-Maxillofacial Surgery
Citation Excerpt :
Oral surgeons use gauze, oxidized cellulose, gelatin sponges, and collagen fleeces with or without sutures to prevent or stop oral bleeding (Bajkin et al., 2009; Hong et al., 2010; Morimoto et al., 2011; Morimoto et al., 2015; Zirk et al., 2016). Furthermore, electrocautery, compression by an acrylic splint, or adjuvants such as fibrin or histoacryl glue are included in hemostatic therapy (Bodner et al., 1998; Halfpenny et al., 2001; Al-Belasy and Amer, 2003; Carter et al., 2003; Eichhorn et al., 2012). In some reports, additional antifibrinolytic solutions such as tranexamic acid mouthwashes are applied (Ramstrom et al., 1993; Souto et al., 1996; Carter and Goss, 2003).
Tranexamic acid (TXA) is widely used in the prevention of postsurgical oral bleeding. Tranexamic acid in addition to further surgical measures is widely utilized in prevention of post-surgical oral bleeding. The aim of the present study was to investigate: Can oral hemostasis be achieved by merely compression and topical application of tranexamic acid in different anticoagulant regimes among patients attending a general emergency department? Where are the limits to this procedure? Which has the greater impact on surgeons' choice for an invasive hemostatic approach—bleeding quality or oral anticoagulant therapy?
A retrospective cohort study of 542 patients who consecutively received treatment for oral bleeding was performed. We surveyed the values of the diverse hemostatic approaches. Special attention was granted to patient anticoagulant regimen and quality of the oral bleeding event.
A total of 199 of 542 (36.7%) oral bleeding events were stopped by compression with a gauze or gauze soaked with TXA (4.8%). Stopping an oral bleeding event with wound compression can be improved by factor 1.6 if the gauze is soaked with tranexamic acid (4.8%), p ≤ 0.05. LMWH presented significantly more moderate bleeding than bloody oozing of the wound, p < 0.05. The quality of bleeding had a strong influence on oral surgeons' decisions to apply further surgical means. Sutures and native collagen fleeces were the favored methods to stop moderate and severe bleeding (p < 0.05).
Topical application of TXA aids as a useful supportive tool to stop mild bleeding events such as the bloody oozing of an oral wound. The quality of an oral bleeding episode should be considered in the choice of hemostatic measure. Hemostatic approaches should begin with the least invasive procedure. TXA is a helpful tool.
Topical application of tranexamic acid in anticoagulated patients undergoing minor oral surgery: A systematic review and meta-analysis of randomized clinical trials
2017, Journal of Cranio-Maxillofacial Surgery
Citation Excerpt :
Growing evidence suggests that anticoagulant treatment does not need to be withdrawn or reduced before oral surgery, as long as local hemostatic measures including suture and irrigation of surgical site with TXA followed by mouthwash are performed for these patients. Other hemostatic agents such as autologous fibrin sealant, absorbable gelatin sponges, and oxidized cellulose polymer have also been indicated in surgical practice (Blinder et al., 1996; Bodner et al., 1998; Cannon and Dharmar 2003; Suwannuraks et al., 1999). However, we found one study comparing the efficacy of topical application of TXA with other absorbable hemostatic material, without differences between interventions (Carter et al., 2003).
To perform a systematic review and meta-analysis of randomized clinical trials (RCTs) investigating the efficacy and safety of topical tranexamic acid (TXA) to prevent postoperative bleeding in anticoagulated patients undergoing minor oral surgery.
We analyzed RCTs comparing the use of topical TXA versus other topical hemostatic agents or placebo solutions for minor oral surgeries. We assessed the risk of bias and strength of evidence according to the Cochrane guidelines and GRADE rating system, respectively. The pooled relative risk (RR) was calculated for the effect of topical application of TXA on postsurgical bleeding.
Five RCTs were included in the study. The combined RR for the number of patients receiving TXA in comparison to the control group was 0.13 (95% CI 0.05–0.36; P = 0.01), indicating a protective effect of topical TXA on bleeding after minor oral surgeries. Subgroup analysis revealed that topical TXA was effective in preventing postsurgical bleeding compared to placebo and epsilon-aminocaproic acid. No cases of thromboembolic events were reported.
Currently available evidence suggests that surgical site irrigation with TXA followed by mouthwash during the first postoperative week is safe and may reduce the risk of bleeding after minor oral surgeries in anticoagulated patients.
Risk factors for bleeding after oral surgery in patients who continued using oral anticoagulant therapy
2015, Journal of the American Dental Association
The authors assessed the incidence of postoperative bleeding in patients who were highly anticoagulated and in patients who underwent extensive oral surgical procedures and who continued using oral anticoagulant therapy.
The authors placed 125 patients receiving anticoagulant therapy into 1 of 3 groups. Group A had 54 patients who were highly anticoagulated (international normalized ratio [INR] ≥ 3.5) in whom up to 3 teeth were extracted. Group B had 60 patients with INR 2.0 to less than 3.5 in whom higher-risk dentoalveolar surgery (extraction of more than 3 teeth or other oral surgery procedure involving raising a mucoperiosteal flap, osteotomy, or biopsy) was performed. Group C had 11 patients whose INR values were 3.5 or higher and who required higher-risk dentoalveolar surgery. Eighty-five healthy participants who underwent surgical procedures similar to those performed in group A and group B were the control group.
Two patients in group A (3.7%), 3 in group B (5.0%), and 2 in group C (18.2%) experienced postoperative bleeding. In the control group, a single bleeding event (1.2%) occurred. All cases of hemorrhage were mild and easily controlled using local hemostatic measures.
Dental extractions in patients who are highly anticoagulated (INR, 3.5-4.2), as well as more extensive oral surgical procedures in patients who are therapeutically anticoagulated, can be performed safely without interruption or modification of the therapy.
Tooth extractions and even more extensive surgical procedures can be performed safely in patients who continue using anticoagulant therapy if proper local hemostatic measures are used and if no other coagulopathies are present.

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Efficacy of fibrin sealant in patients on various levels of oral anticoagulant undergoing oral surgery

Abstract

Blood Rev

Oral Surg Oral Med Oral Pathol

Thromb Res

J Am Dent Assoc

Oral Surg Oral Med Oral Pathol

J Am Dent Assoc

Oral Surg Oral Med Oral Pathol

Oral Surg Oral Med Oral Pathol

J Oral Maxillofac Surg

J Oral Maxillofac Surg