Spontaneous cardiac tamponade associated with dabigatran use in an elderly woman

We report here a rare case of dabigatran-related spontaneous cardiac tamponade, which appeared in absence of the known risk factors that predispose the patient to bleed related to anticoagulant drugs. A 65-year-old lady presented to the emergency room with sudden onset dyspnea which woke her up in the early morning hours. Four days earlier, she had been started on dabigatran therapy for DVT. On examination, she was in shock. Transthoracic echocardiography confirmed cardiac tamponade. Emergent pericardiocentesis was done, draining 480 ml of haemorrhagic fluid, which tested negative for microbes and malignant cells. The patient recovered rapidly and fluid did not re-accumulate after withdrawal of dabigatran therapy. Spontaneous cardiac tamponade is rare with the use of direct anticoagulants, especially dabigatran, in the absence of predisposing risk factors. This case study highlights the need for clinicians to be cognizant of this potentially life-threatening adverse drug reaction of dabigatran so that appropriate timely action can be taken toward diagnosis and management of this complication.

Peri-interventional Triple Therapy With Dabigatran Improves Vasomotion and Promotes Endothelialization in Porcine Coronary Stenting Model

Objective: We evaluated the short and long-term effect of peri-interventional dabigatran therapy on vasomotion, endothelialization, and neointimal formation in a porcine coronary artery stenting model.Background: Stenting of coronary arteries induces local inflammation, impairs vasomotion and delays endothelialization.Methods: Twenty-eight animals underwent percutaneous coronary intervention (PCI) with drug eluting stents. Sixteen pigs started dabigatran therapy 4 days prior to PCI and continued for 4 days post-stenting, while 12 animals served as controls. Post-stenting dual antiplatelet therapy (75 mg clopidogrel and 100 mg aspirin) was continued in both groups until termination. Immediately post-stenting and at day 3 optical coherence tomography (OCT) was performed in all animals, followed by euthanasia of 8 dabigatran and 4 control animals. The remaining pigs (8 of each group) were followed up for 1 month, with control angiography and OCT. Tissue burden (degree of peri-strut structure—thrombus and/or fibrin) was evaluated. After euthanasia coronary arteries were harvested for in-vitro myometry and histology.Results: Thrombin generation was lower (p < 0.001) and tissue burden (0.83 ± 0.98 vs. 3.0 ± 2.45; p = 0.031) was significantly decreased in dabigatran treated animals. After 3 days post-PCI endothelium-dependent vasodilation was significantly improved (77 ± 40% vs. 41 ± 31%, p = 0.02) in dabigatran animals. Neither quantitative angiography nor histomorphometry showed differences between the groups. Endothelialization was faster in the dabigatran group as compared with controls (p = 0.045).Conclusion: Short-term peri-interventional triple therapy with dabigatran, aspirin, and clopidogrel led to an enhanced endothelium dependent vasodilation and faster endothelialization. However, neointimal formation 1-month after stent implantation was comparable between groups.

Idarucizumab (Praxbind®) for dabigatran reversal in patients undergoing heart transplantation: a cohort of ten patients

Background: Novel oral anticoagulants are used in atrial fibrillation. Idarucizumab has been approved for reversal of dabigatran in situations of life-threatening hemorrhage or emergency surgery. Objectives: We report a single center experience of ten patients on dabigatran therapy who were given idarucizumab prior to heart transplantation. Methods & results: The mean plasma concentration of dabigatran prior to reversal was 139 ± 89 ng/ml. Hemoglobin, hematocrit and platelet levels were decreased after surgery. Surgical procedures were successfully performed with no increased risk, especially regarding bleeding complications. All patients were alive after 90 days. Conclusion: Dabigatran reversal with idarucizumab in contexts of emergency surgery/urgent procedures is an attractive and safe option to be taken into consideration for patients with end stage heart disease awaiting transplantation and indication of anticoagulant therapy.

Clinical performance of the atrial fibrillation in the Russian population depending on the antithrombotic therapy: findings from the GLORIA-AF registry phase 2

Aim. To analyze clinical characteristics of patients with nonvalvular atrial fibrillation (AF) in the Russian population, enrolled in the GLORIA-AF registry phase 2, depending on the antithrombotic therapy received, and to assess the potential for patient retention with dabigatran during a 2-year follow-up.Material and methods. In the Russian Federation, 408 patients were included in the second phase of GLORIA-AF which is a global prospective observational registry of newly diagnosed patients with AF. The patient characteristics are presented depending on received antithrombotic therapy (dabigatran, factor Xa inhibitors, vitamin K antagonist, antiplatelet agents, or no antithrombotic therapy), with a dabigatran dosing regimen of either 110 mg or 150 mg twice daily. Duration of patient retention on dabigatran therapy was also analyzed during a 2-year follow-up.Results. Of the 405 patients with recently diagnosed nonvalvular AF, 358 (88%) received oral anticoagulants (OAC), and 47 (12%) patients received antiplatelet drugs or received no antithrombotic therapy. Most patients were treated with dabigatran (n=275, 68%), and 75 (19%) patients received vitamin K antagonist. Clinical and demographic characteristics of patients receiving dabigatran were comparable with those in the general group of the Russian patients. The mean age was 63,5 years. The most common comorbidities in Russian patients receiving dabigatran were hypertension (93%), congestive heart failure (57%), coronary artery disease (35%). It is noteworthy that 12% and 10% of patients had a previous myocardial infarction and stroke, respectively. The mean CHA2DS2-VASc score for stroke risk for these patients was 3,2; 88% of patients had a high stroke risk (score of >2). Of the 275 patients with AF who received dabigatran therapy, 164 (60%) patients received dabigatran at the dose of 150 mg twice daily, and 111 (40%) patients received 110 mg twice daily. Dabigatran doses of 110 mg twice daily were more frequently prescribed for female patients aged 65 years or older and patients with a previous coronary events and impaired renal function, who had a higher CHA2DS2-VASc score for stroke risk. There was a higher proportion of AF patients with marked symptoms in the dabigatran 150 mg twice daily group. A median duration of treatment with dabigatran with the initial dosing regimen was 24 months. The estimated dabigatran therapy retention rate was 0,87, 0,81 and 0,73 after 6, 12 and 24 months of follow-up, respectively.Conclusion. In the Russian Federation, patients with newly diagnosed AF who have an increased risk of stroke are more likely to receive OAC therapy, such as direct thrombin inhibitor (dabigatran), compared to the global cohort of the GLORIA AF Registry Program. Patients in the Russian cohort receiving dabigatran differ from the global cohort of patients by greater comorbidity. At the same time, patients receiving reduced doses of dabigatran, both in the Russian Federation and in the global Registry, are characterized by a greater proportion of patients aged >75 years, a higher incidence of previous myocardial infarction, coronary artery disease, heart failure, impaired renal function, higher CHA2DS2-VASc score for stroke risk. The potential dabigatran therapy retention rate after 24 months in the Russian Federation and in the global cohort was high and amounted to about 70%.

Dabigatran Use Associated with Hemopericardium and Hemothorax

Concurrent spontaneous hemopericardium and hemothorax due to anticoagulant use are extremely rare in clinical practice. Dabigatran is an oral direct thrombin inhibitor approved to prevent stroke or thromboembolic episodes in patients with nonvalvular atrial fibrillation. We report the case of a 73-year-old man who received dabigatran therapy (150 mg twice a day) for 3 months and developed massive spontaneous hemothorax and hemopericardium associated with fever. Emergency chest computed tomography scan established higher-density pericardial effusion (22HU) and left pleural effusion of heterogeneous density (5–15 HU) which could be hemorrhagic content while the heart ultrasound finding confirmed pericardial effusion 7–9 mm thick, without affecting hemodynamics. Almost 1100 mL of blood was drained by ultrasoundguided thoracentesis. After excluding other possible causes, diagnostic withdrawal was performed for dabigatran and no further pleural or pericardium effusion developed after dabigatran was discontinued. Therefore, practitioners could be aware of hemothorax as well as hemopericardium as a potential complication of dabigatran therapy.

P1902Comparison of efficacy of different anticoagulation strategies used during pulmonary vein isolation in left atrial blood samples

Introduction Ablation of atrial fibrillation is based on the isolation of the pulmonary veins (PVI) from the left atrium. Cerebral thromboembolism is a rare but serious complication of PVI, which highlights the importance of peri-procedural anticoagulation. Aim Studying the coagulation and endothelium activation during PVI in case of using different anticoagulation protocols. Method 52 patients undergoing PVI with cryoballoon technique were involved and were grouped according to three different pre-procedural anticoagulation strategies: in the first group patients received no anticoagulation before the procedure (non anticoag., 24 patients)-, in the second group patients received uninterrupted vitamin K antagonist therapy, and their INR value was in therapeutic range on the day of the procedure (VKA group, 11 patients) and in the third group patients were on uninterrupted dabigatran therapy (dabigatran group, 17 patients). Two blood samples were taken during PVI from the left atrium, the first one before ablation or iv. heparin administration, the second one directly after the last application at the end of the procedure. The samples were used to measure D-dimer, plasmin antiplasmin (PAP) complex, a2 plasmin inhibitor (a2PI), plasminogen, FVIII activity, von Willebrand factor (VWF) antigen levels. Results D-dimer levels increased in all three groups after ablation, but in the samples of patients on dabigatran therapy we detected significantly lower D-dimer levels in the pre- and post-procedural samples compared to patients on other therapeutic strategies (median values before or after PVI: non anticoag.: 0.48 and 1.09 mgFEU/L; VKA: 0.33 and 0.72 mgFEU/L, dabigatran: 0.12 and 0.30 mgFEU/L, p<0.001 non anticoag. vs. dabigatran, p<0.01 VKA vs. dabigatran). PAP complex values were increasing parallel with D-dimer levels and only in the dabigatran group did not increase significantly. VWF antigen and FVIII activity increased significantly in all three groups after ablation, but there was no significant difference between the groups. Conclusions the safest anticoagulation strategy for patients undergoing PVI was uninterrupted dabigatran therapy. The extend of endothelial damage was not affected by anticoagulation.

Proton Pump Inhibitors and Dabigatran Therapy: Impact on Gastric Bleeding and Dabigatran Plasma Levels

Dabigatran etexilate, a direct thrombin inhibitor, is now frequently used for long-term pharmacological prevention of stroke or systemic embolism in patients with atrial fibrillation. However, such long-term dabigatran therapy (DT) significantly increases the risk of upper gastrointestinal (GI) bleeding. This increased risk of gastric bleeds might be reduced with gastroprotective agents, such as proton pump inhibitors (PPIs). PPIs coadministrated with dabigatran reduce the risk of upper GI bleeding in patients on long-term oral DT. Nevertheless, there is heated discussion regarding interactions between PPI and dabigatran that lead to decreases in dabigatran plasma levels. This article reviews up to date data about the risk of gastric bleeding on dabigatran, the impact of PPI on the reduction of gastric bleeding, and the interaction between PPI and dabigatran leading to decreased dabigatran plasma levels.