International consensus statement on the peri‐operative management of direct oral anticoagulants in cardiac surgery

Abstract

Despite current recommendations on the management of severe peri-operative bleeding, there is no pragmatic guidance for the peri-operative monitoring and management of cardiac surgical patients taking direct oral anticoagulants. Members of the Transfusion and Haemostasis Subcommittee of the European Association of Cardiothoracic Anaesthesiology, of their own volition, performed an independent systematic review of peerreviewed original research, review articles and case reports and developed the following consensus statement. This has been endorsed by the European Association of Cardiothoracic Anaesthesiology. In our opinion, most patients on direct oral anticoagulant therapy presenting for elective cardiac surgery can be safely managed in the peri-operative period if the following conditions are fulfilled: direct oral anticoagulants have been discontinued two days before cardiac surgery, corresponding to five elimination half-live periods; in patients with renal or hepatic impairment or a high risk of bleeding, a pre-operative plasma level of direct oral anticoagulants has been determined and found to be below 30 ng.ml À1 (currently only valid for dabigatran, rivaroxaban and apixaban). In cases where plasma level monitoring is not possible (e.g. assay was not available), discontinuation for 10 elimination half-live periods (four days) is required. For FXa inhibitors, a standard heparin-calibrated anti-Xa level of < 0.1 IU.ml À1 should be measured, indicating sufficient reduction in the anticoagulant effect. Finally, short-term bridging with heparin is not required in the pre-operative period.

Direct oral anticoagulants: peri‐operative considerations and controversies

“…In a patient with no renal impairment, they recommend a minimum cessation period of 2 days for dabigatran, apixaban and edoxaban. Rivoroxaban should be stopped for a minimum of 3 days . Unlike warfarin, bridging therapy is not recommended during this period, as it significantly increases the risk of peri‐procedural bleeding .…”

“…A recent classification system grades bleeding from insignificant (Class 0) to massive (Class 4) as a function of sternal closure, postoperative chest drain blood loss, transfusion requirements and re‐exploration or tamponade . Erdoes et al similarly grade DOAC‐associated bleeding tendency as mild, moderate or severe with stepwise, graded management strategies including: laboratory investigations; the use of tranexamic acid, reversal agents, prothrombin complex concentrate and fibrinogen concentrate; and allogeneic blood product transfusion . Although this seems more relevant to emergency surgery, where there may be inadequate pre‐operative cessation, some argue current cessation times fail to completely negate the risk of DOAC‐associated bleeding .…”

“…More recently, the International Council for Standardization in Haematology (ICSH) published their guidance . Reassuringly, the message in these and others is the same, and the authors of this new consensus statement for cardiac surgical patients have incorporated all these points in a clear manner . There is, nevertheless, much variation on the availability of quantitative tests among cardiac surgical centres, as the need to measure plasma drug levels for those prescribed a DOAC is only beginning to emerge.…”

“…Moreover, reversal agents, whether specific or non‐specific, are not without adverse effects such as thrombosis, which is especially relevant in the cardiac surgery setting. Finally, ultrafiltration effectively clears dabigatran in a matter of hours, and Erdoes et al rightly highlight the role of ultrafiltration during cardiopulmonary bypass to this end for cardiac surgical patients .…”

“…Although research on the management of DOACs in the peri‐operative period is increasing, knowledge among clinicians and formal guidance seems to be variable . This month in Anaesthesia , Erdoes et al report their consensus statement on DOACs for cardiac surgical patients . Their work provides an evidence‐based synthesis of available pharmacokinetic and clinical data; delivers recommendations for cessation, monitoring and reversal, and suggests management strategies for DOAC‐associated bleeding.…”