Periprocedural Anticoagulation Management Research Articles

Peri-procedural use of anticoagulants in radiology: an evidence-based review.

Peri-procedural anticoagulant management hinges on the balance of hemorrhagic and thrombotic complications. The radiologist is tasked with accurately assessing the hemorrhagic risk for patients undergoing procedures, taking into account procedural bleeding rates, underlying coagulopathy based on lab tests, and use of anticoagulants. The purpose of this article is to provide a contemporary review of commonly used anticoagulants and, incorporating published evidence, review their management related to image-guided procedures.

Direct Oral Anticoagulants: An Overview for the Interventional Radiologist.

The direct oral anticoagulants (DOACs) have emerged as a good alternative for the treatment of thromboembolic diseases, and their use in clinical practice is increasing rapidly. The DOACs act by blocking the activity of one single step in the coagulation cascade. These drugs act downstream in the common pathway of the coagulation cascade by directly antagonising the action of thrombin or factor Xa. The development of DOACs represents a paradigm shift from the oral vitamin K antagonists such as warfarin. This article aims to describe the properties of the currently available DOACs including pharmacology and dosing. We also address the strategies for periprocedural management and reversal of anticoagulation of patients treated with these agents.

How To Manage Oral Anticoagulation Periprocedurally During Ablations And Device Implantations.

More than 150, 000 patients undergo ablation for atrial fibrillation (AF) each year.Current guidelines recommend oral anticoagulation in all patients undergoing AF ablation. A large number of patients undergoing cardiac implantable electronic devices (CIEDs) are on long-term oral anticoagulation. These patients are at increased risk for thromboembolism with interruption of oral anticoagulation. Due to the increased risk for bleeding complications during the procedure combined with the need to prevent thromboembolism, periprocedural management of anticoagulation in these patients can be challenging. In this article we review the current evidence for periprocedural management of oral anticoagulation in patients undergoing ablation and CIED implantation.

‘The role of novel oral anticoagulants in patients undergoing cryoballoon ablation for atrial fibrillation’

AimPeri-procedural thromboembolic (TE) and hemorrhagic events are complications of major concern for patients undergoing cryoballoon (CB) ablation for atrial fibrillation (AF).While peri-procedural anticoagulation management could decrease the incidence of these complications, data on CB ablation are scarce. The role of novel oral anticoagulants (NOACs) has not been thoroughly tested in this population. MethodsIn the present study, we sought to assess acute peri-procedural complications in patients undergoing CB ablation for AF under different anticoagulation regimens; anticoagulation administration was performed according to the CHA2DS2-VASc score guidelines. To the best of our knowledge, this is the first study that compares 1) uninterrupted warfarin, 2) bridging therapy with low molecular weight heparin (LMWH), 3) aspirin and 4) NOACs in this subgroup of patients. ResultsNOACs were as effective as uninterrupted warfarin in terms of bleeding complications and TE events. Surprisingly, the aspirin group had more hemorrhagic complications than both the warfarin and NOACs groups. ConclusionIn the current study, the use of NOACs was an effective and safe approach in CB ablation.

Discontinuation and Management of Direct-Acting Anticoagulants for Emergency Procedures

Patients taking direct oral anticoagulants (DOACs) who then need an emergency invasive procedure require specialized management strategies. Appropriate patient evaluation includes assessment of the current anticoagulation state, including timing of the last dose. DOACs require particular coagulation assays to measure anticoagulation levels accurately, although standard coagulation screening tests may provide qualitative guidance. Specialty societies have endorsed general recommendations for patient management to promote hemostasis in anticoagulated patients requiring surgery or other invasive procedures. These include general stopping rules (such as ≥24 hours for low-risk procedures and ≥48 hours for high-risk surgery with normal renal function) for elective procedures. Bridging therapy when oral anticoagulant treatment is interrupted has recently been questioned, depending on the clinical scenario. Novel agents for the reversal of DOAC-induced anticoagulation have recently been developed. Idarucizumab, a humanized monoclonal antibody fragment that selectively binds dabigatran, was recently approved for clinical use in patients with life-threatening or uncontrolled bleeding, and for patients requiring emergency interventions. Idarucizumab can streamline the pre- and periprocedural anticoagulation management of dabigatran-treated patients, as it provides fast, complete, and sustainable reversibility. Andexanet alfa is an inactive, decoy factor Xa (FXa) molecule that binds FXa inhibitors, and ciraparantag is a synthetic molecule designed to bind fractionated and unfractionated heparins, and each of the currently approved DOACs. As clinical development of the additional anti-FXa-specific anticoagulant reversal agents proceeds, the respective role of each in the management of emergency bleeding events and invasive procedures will be better defined, and it is hoped they will make important contributions to patient care.

Use of oral anticoagulation for patients who undergo invasive procedures

The performance of invasive procedures in patients undergoing oral anticoagulation represents a risk. Without conclusive data on this issue, the recommendations on managing oral anticoagulation are generally weak, and its management is controversial and heterogeneous.We conducted a review of the evidence on the elective periprocedural management of oral anticoagulation following the publication of the 9th edition of the guidelines of the American College of Chest Physicians.Except for cases of procedures with minimal hemorrhagic risk, the use of oral anticoagulants is suspended with sufficient time so that it can be performed without a significant anticoagulant effect, which will depend on the half-life of the drug. For direct oral anticoagulants, the half-life is determined by the renal function.Recent studies have shown that the use of bridge therapy with heparin in patients who temporarily suspended the use of oral anticoagulation provided no benefits and increased the bleeding. However, there is no conclusive evidence against its use in patients with a high thromboembolic risk.

Uso de la anticoagulación oral en el paciente sometido a un procedimiento invasivo

The performance of invasive procedures in patients undergoing oral anticoagulation represents a risk. Without conclusive data on this issue, the recommendations on managing oral anticoagulation are generally weak, and its management is controversial and heterogeneous.We conducted a review of the evidence on the elective periprocedural management of oral anticoagulation following the publication of the 9th edition of the guidelines of the American College of Chest Physicians.Except for cases of procedures with minimal haemorrhagic risk, the use of oral anticoagulants is suspended with sufficient time so that it can be performed without a significant anticoagulant effect, which will depend on the half-life of the drug. For direct oral anticoagulants, the half-life is determined by the renal function.Recent studies have shown that the use of bridge therapy with heparin in patients who temporarily suspended the use of oral anticoagulation provided no benefits and increased the bleeding. However, there is no conclusive evidence against its use in patients with a high thromboembolic risk.

Periprocedural Anticoagulation Management of Patients with Thrombophilia

BackgroundAppropriate periprocedural management of the chronically anticoagulated patient with an inherited or acquired thrombophilia is uncertain. The objective of this study was to test “thrombophilia” as a potential predictor of the 3-month cumulative incidence of thromboembolism and major bleeding among chronically anticoagulated patients undergoing an invasive procedure. MethodsIn a prospective cohort study, consecutive chronically anticoagulated patients referred to the Mayo Thrombophilia Center for standardized periprocedural anticoagulation management who had venous thromboembolism and complete thrombophilia testing were categorized as “severe,” “non-severe,” or “no identifiable” thrombophilia. The 3-month cumulative incidence rates of thromboembolism, bleeding, and death were estimated using the Kaplan-Meier product limit method. ResultsAmong 362 patients with complete thrombophilia testing, 165 (46%) had a defined thrombophilia; 76 patients had severe thrombophilia, mainly due to antiphospholipid syndrome (66%). Half of the patients in each of the 3 groups received pre- and postprocedure heparin. During follow-up, there were no thromboembolic events, rare major bleeding events (1% for each group), and 4 deaths. Due to the very low event rates for each of these outcomes, Cox proportional hazard modeling could not be performed. ConclusionsPeriprocedural event rates were low irrespective of thrombophilia status. Inherited or acquired thrombophilia was not a predictor of thromboembolism, major bleeding, or mortality after temporary interruption of chronic anticoagulation for an invasive procedure.

Update on Anticoagulation: What the Interventional Radiologist Needs to Know.

The novel oral anticoagulants (NOACs) represent a major advance in the treatment of patients with nonvalvular atrial fibrillation and venous thromboembolism (VTE). They have several advantages over vitamin-K antagonists such as warfarin, including more predictable pharmacokinetics and improved safety, particularly with fatal bleeding and intracranial hemorrhage. However, several issues remain surrounding the use of NOACs in certain subpopulations and with the approach to reversal. The periprocedural management of anticoagulation with these relatively new agents can also present several challenges. This article reviews the basic pharmacology, efficacy, and safety of these drugs. Several populations at higher risk for complications with use of NOACs are discussed, including those undergoing procedures. Finally, several target-specific reversal agents have either received FDA approval or likely will be approved in the near future; these agents and their roles in the approach to anticoagulation reversal will also be discussed.

Abstract No. 628 - Periprocedural management of common and new anticoagulation and antiplatelet therapies for the interventional radiologist

Abstract No. 628 - Periprocedural management of common and new anticoagulation and antiplatelet therapies for the interventional radiologist

The Periprocedural Management of Anticoagulation and Platelet Aggregation Inhibitors in Endoscopic Interventions.

In Germany, more than half a million persons, most of them elderly, are under long-term treatment with anticoagulants. The approval of new oral anticoagulants and platelet aggregation inhibitors, as well as new data on periprocedural bridging with heparins, have introduced marked complexity to the management of treatment with anticoagulants and platelet aggregation inhibitors for endoscopic interventions in visceral surgery. This review is based on pertinent publications retrieved by a selective literature search in PubMed, as well as on the relevant guidelines. Robust data are available on the management of vitamin K antagonists (VKA) and platelet aggregation inhibitors for endoscopic procedures; on the other hand, the data on the periprocedural management of non-VKA oral anticoagulants (NOAC) are still inadequate. Endoscopic procedures that carry a low risk of bleeding can be performed under treatment with anticoagulants or platelet aggregation inhibitors. Before any procedure with a high risk of bleeding (≥ 1.5%) oral anticoagulants of any type and P2Y12 inhibitors should generally be discontinued. Patients in whom VKA are temporarily discontinued for this reason need bridging treatment with heparin only if they are at high risk of thromboembolic events (≥ 10% per year). For patients who are anticoagulated with NOAC, timely discontinuation of the drug depending on renal function is of key importance, and bridging is usually unnecessary. Adequate scientific evidence supports the current recommendations and treatment algorithms for the periprocedural management of oral anticoagulants and platelet aggregation inhibitors in endoscopic procedures. Larger-scale studies are still needed to provide a sound basis for the corresponding recommendations about NOAC.

Feasibility and safety of uninterrupted periprocedural apixaban administration in patients undergoing radiofrequency catheter ablation for atrial fibrillation: Results from a multicenter study.

Periprocedural anticoagulation management with uninterrupted warfarin and a "therapeutic" international normalized ratio is the best approach for reducing both thromboembolic and bleeding complications in the setting of catheter ablation for atrial fibrillation (AF). The purpose of this study was to evaluate the safety and feasibility of uninterrupted apixaban in this setting. This was a prospective multicenter registry of AF patients undergoing radiofrequency catheter ablation at 4 institutions in United States and Europe with uninterrupted apixaban. These patients were compared with an equal number of patients, matched for age, gender, and type of AF, undergoing AF ablation on uninterrupted warfarin.The apixaban group was comprised of consecutive patients who had taken their last dose of apixaban the morning of the procedure. A subset of 29 patients in the apixaban group underwent diffusion magnetic resonance imaging (dMRI) to detect silent cerebral ischemia. A total of 400 patients (200 patients in each group) were included in the study. The average age was 65.9 ± 9.9 years, 286 (71.5%) were male, and 334 (83.5%) had nonparoxysmal AF. There were no statistical differences with regard to major complications (1% vs 0.5%, P = 1), minor complications (3.5% vs 2.5%, P = .56), or total bleeding complications (4.5% vs 3%, P = .43) between the apixaban and warfarin groups. There were no symptomatic thromboembolic complications. All dMRIs were negative for "new" silent cerebral ischemia in the apixaban group. Uninterrupted apixaban administration in patients undergoing AF ablation seems to be feasibleand effective in preventing clinical and silent thromboembolic events without increasing the risk of major bleeding.

Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures

AbstractUsing data from ARISTOTLE, we describe the periprocedural management of anticoagulation and rates of subsequent clinical outcomes among patients chronically anticoagulated with warfarin or apixaban. We recorded whether (and for how long) anticoagulant therapy was interrupted preprocedure, whether bridging therapy was used, and the proportion of patients who experienced important clinical outcomes during the 30 days postprocedure. Of 10 674 procedures performed during follow-up in 5924 patients, 9260 were included in this analysis. Anticoagulant treatment was not interrupted preprocedure 37.5% of the time. During the 30 days postprocedure, stroke or systemic embolism occurred after 16/4624 (0.35%) procedures among apixaban-treated patients and 26/4530 (0.57%) procedures among warfarin-treated patients (odds ratio [OR] 0.601; 95% confidence interval [CI] 0.322-1.120). Major bleeding occurred in 74/4560 (1.62%) procedures in the apixaban arm and 86/4454 (1.93%) in the warfarin arm (OR 0.846; 95% CI 0.614-1.166). The risk of death was similar with apixaban (54/4624 [1.17%]) and warfarin (49/4530 [1.08%]) (OR 1.082; 95% CI 0.733-1.598). Among patients in ARISTOTLE, the 30-day postprocedure stroke, death, and major bleeding rates were low and similar in apixaban- and warfarin-treated patients, regardless of whether anticoagulation was stopped beforehand. Our findings suggest that many patients on chronic anticoagulation can safely undergo procedures; some will not require a preprocedure interruption of anticoagulation. ARISTOTLE was registered at www.clinicaltrials.gov as #NCT00412984.

Management of anticoagulants in the periprocedural period for patients with cancer.

Patients with cancer undergo surgeries and procedures for various purposes, including prophylaxis, diagnosis, staging, cure, debulking, palliation, and reconstruction. The diagnosis of cancer itself, along with the well-established complication of venous thromboembolism (VTE), places these patients at risk for perioperative thromboembolism. It is also well-established that continuing patients on oral anticoagulation therapy during the periprocedural period is associated with an increased risk of bleeding. Rates of periprocedural VTE and major bleeding are significantly higher in patients with cancer, presenting a complex problem for clinicians in terms of periprocedural anticoagulation management. This article reviews the current recommendations regarding periprocedural anticoagulation management in patients with cancer.

Abstract 16402: Feasibility and Safety of Uninterrupted Rivaroxaban in Patients Undergoing Radiofrequency Ablation for Long Standing Persistent Atrial Fibrillation

Introduction: Periprocedural anticoagulation management is key to minimize bleeding and thromboembolic complications during and after radiofrequency catheter ablation. Uninterrupted strategies with warfarin in high risk patients have shown superiority over interrupted strategies. We sought to assess the safety and feasibility uninterrupted rivaroxaban during atrial fibrillation (AF) ablation in patients with long standing persistent atrial fibrillation. Methods: One hundred and ninety six (196) consecutive patients undergoing AF ablation with uninterrupted rivaroxaban (last dose taken with food the night before the procedure and the following dose taken the night of the procedure) were matched by age and sex with an equal number of patients undergoing AF ablation with uninterrupted warfarin on a “therapeutic range”. All patients underwent pulmonary vein antrum isolation and ablation of non pulmonary vein triggers as disclosed by isoproterenol challenge test. Results: Baseline characteristics and procedural variables were similar between groups. Mean INR in warfarin group was 2.2 ± 0.5. CHADS2 Score was ≥ 2 in 141 (72%) in the rivaroxaban group and 130 (66%) in the warfarin patients (p=0.20). One pericardial tamponade and one groin hematoma occurred in rivaroxaban group while 2 patients in warfarin group developed groin hematoma. One TIA with positive MRI was present in the rivaroxaban group. Conclusions: Uninterrupted rivaroxaban therapy appears to be as safe and efficacious as uninterrupted warfarin strategy in preventing bleeding and thromboembolic events in patients undergoing long standing persistent AF ablation.

Abstract 18881: New Oral Anticoagulants for Periprocedural Management of Anticoagulation in Patients Undergoing Radiofrequency Catheter Ablation for Atrial Fibrillation: a Meta-analysis

Introduction: Thromboembolic events are the most feared complication of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). The traditional periprocedural anticoagulation approach is discontinuation of vitamin K antagonist and bridging with heparin. Newly procedures are done under therapeutic INR 2-3. Recent studies used periprocedural new direct oral anticoagulants (NOACs). Hypothesis: We evaluated the available evidence on the efficacy and safety of NOACs for periprocedural anticoagulation during RFCA of AF. Methods: Pubmed, Embase and Cochrane Central were searched. Retrospective and prospective studies published as peer-reviewed full-size articles were included if they reported embolic events and major and minor bleeding. Results: Fifteen studies were identified (14 observational studies, 1 small randomized trial). A total of 7050 patients were included (NOACs group: 2887 ). A total of 37 thromboembolic complications occurred (0,5%) with 17 events in the NOAC group (0,6%) and 20 in the warfarin group (0,5%) (odds ratio 0.97, 95% confidence interval (CI) 0.48 to 1.99). Major bleeding were numerically higher in the warfarin group compared to the NOACs group. However, the difference did not reach statistical significance (odds ratio 0.69, CI 0.43 to 1.10). Subgroup analysis did not reveal any differences in event rates. Conclusions: Our review suggests that dabigatran etexilate and rivaroxaban are as effective and safe as warfarin for periprocedural anticoagulation in patients undergoing RFCA of AF. However, it has to be acknowledged that the current evidence is mainly based on observational studies.

Oral anticoagulant use around the time of atrial fibrillation ablation: a review of the current evidence of individual oral anticoagulant use for periprocedural atrial fibrillation ablation thromboembolic prophylaxis.

Atrial fibrillation is the most common arrhythmia and ablation is becoming more prevalent as a treatment option. Appropriate treatment of atrial fibrillation mandates thromboembolic prophylaxis, and atrial fibrillation ablation periprocedural management of oral anticoagulation is paramount because of the unique susceptibility for thromboembolism that exists for a patient undergoing ablation. Uninterrupted warfarin therapy is the current standard approach for periprocedural atrial fibrillation anticoagulation. Novel oral anticoagulants, including direct thrombin and factor Xa inhibitors, are being used more frequently for thromboembolic prophylaxis in atrial fibrillation patients, but the best strategy for using novel oral anticoagulants in periprocedural anticoagulation is unknown. Optimal periprocedural anticoagulation management strategies with oral anticoagulants, limitations of using novel oral anticoagulants, and future directions in this field are discussed.

2014 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation

Atrial fibrillation (AF) is an extremely common clinical problem with an important population morbidity and mortality burden. The management of AF is complex and fraught with many uncertain and contentious issues, which are being addressed by extensive ongoing basic and clinical research. The Canadian Cardiovascular Society AF Guidelines Committee produced an extensive set of evidence-based AF management guidelines in 2010 and updated them in the areas of anticoagulation and rate/rhythm control in 2012. In late 2013, the committee judged that sufficient new information regarding AF management had become available since 2012 to warrant an update to the Canadian Cardiovascular Society AF Guidelines. After extensive evaluation of the new evidence, the committee has updated the guidelines for: (1) stroke prevention principles; (2) anticoagulation of AF patients with chronic kidney disease; (3) detection of AF in patients with stroke; (4) investigation and management of subclinical AF; (5) left atrial appendage closure in stroke prevention; (6) emergency department management of AF; (7) periprocedural anticoagulation management; and (8) rate and rhythm control including catheter ablation. This report presents the details of the updated recommendations, along with their background and rationale. In addition, a complete set of presently applicable recommendations, those that have been updated and those that remain in force from previous guideline versions, is provided in the Supplementary Material.

The Rate Of Complications Associated With Concomitant Use Of Dabigatran With Cryoballoon Ablation For Atrial Fibrillation.

Catheter ablation is an evolving therapeutic strategy for the management of atrial fibrillation (AF). It is associated with a risk of thromboembolic events. The peri-procedural anticoagulation management with warfarin has been successful in mitigating this risk. However, introduction of novel oral anticoagulants like dabigatran offers more flexibility in anticoagulation approaches. Previous studies had evaluated the safety and efficacy of dabigatran in the radiofrequency ablation, but data related to cryoballoon ablation is lacking. We performed a retrospective observational study involving patients who underwent cryoballoon ablation for drug-refractory, symptomatic AF while on dabigatran in periprocedural period. Thromboembolic, hemorrhagic or other complications occurring within the first 30 days after the ablation procedure were analyzed. Our study population comprised of 50 patients with mean age of 58.96 ± 3.54 years with 76% (n=38) being male. We found 3 (6%) minor complications in peri-procedural period including 2 groin hematomas and 1 trace asymptomatic pericardial effusion. There were no major intraprocedural or post procedural hemorrhagic or thromboembolic events. None of patients with the minor complications required significant additional workup or extended hospital stay. All the patients were able to continue dabigatran for 30 days without any additional side effects or complications. Dabigatran is a safe and efficacious agent in patients undergoing cryoballoon AF ablation.

Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial.

Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin. http://www.clinicaltrials.gov. Unique identifier: NCT01006876.