Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry
Abstract Objective Patients on direct-acting oral anticoagulants (DOACs) are at high risk of perioperative bleeding complications. Intraoperative hemoadsorption is a novel strategy to reduce perioperative bleeding in patients on DOACs undergoing non-deferable cardiac surgery. The international STAR-...
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BMC
2025-01-01
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| Series: | Journal of Cardiothoracic Surgery |
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| Online Access: | https://doi.org/10.1186/s13019-024-03326-1 |
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| author | Michael Schmoeckel Matthias Thielmann Keti Vitanova Thomas Eberle Nandor Marczin Kambiz Hassan Andreas Liebold Sandra Lindstedt Georg Mächler Marijana Matejic-Spasic Daniel Wendt Efthymios N. Deliargyris Robert F. Storey |
| author_facet | Michael Schmoeckel Matthias Thielmann Keti Vitanova Thomas Eberle Nandor Marczin Kambiz Hassan Andreas Liebold Sandra Lindstedt Georg Mächler Marijana Matejic-Spasic Daniel Wendt Efthymios N. Deliargyris Robert F. Storey |
| author_sort | Michael Schmoeckel |
| collection | DOAJ |
| description | Abstract Objective Patients on direct-acting oral anticoagulants (DOACs) are at high risk of perioperative bleeding complications. Intraoperative hemoadsorption is a novel strategy to reduce perioperative bleeding in patients on DOACs undergoing non-deferable cardiac surgery. The international STAR-registry reports real-world clinical outcomes associated with this application. Methods The hemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit and active for the duration of the pump run. Patients on DOACs undergoing CABG and/or single valve surgery before completing the recommended washout were included. Outcome measurements included bleeding events according to standardized definitions and 24-hour chest-tube-drainage (CTD). Results A total of 62 patients were included from 7 institutions in Austria, Germany, Sweden, and the UK (mean age 69.9 ± 7.5years, 71% male). Approximately half were on apixaban and the other half was split between rivaroxaban and edoxaban with 21% of patients also on aspirin. Surgery occurred at a median time of 28.9 h since the last DOAC dose with single valve surgery accounting for 2/3 of cases. Mean CPB duration was 118.6 ± 46.4 min. Severe bleeding (UDPB ≥ 3) occurred in 4.8%, and BARC-4 bleeding occurred in 3.2% of the patients. Only one patient (1.6%) required reoperation for bleeding control. The mean 24-hour CTD was 771.3 ± 482.79mL. No device-related adverse events were reported. Conclusions This interim report of the ongoing STAR-registry shows that, in patients on DOAC undergoing non-deferable CABG and/or single valve surgery, the use of intraoperative hemoadsorption is associated with low rates of severe perioperative bleeding complications. Further prospective studies in larger cohorts are needed to validate the efficacy of this method. Clinical registration number ClinicalTrials.gov identifier: NCT05077124. |
| format | Article |
| id | doaj-art-5af032030cf541caad134db319684e1a |
| institution | Kabale University |
| issn | 1749-8090 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Cardiothoracic Surgery |
| spelling | doaj-art-5af032030cf541caad134db319684e1a2025-01-26T12:52:01ZengBMCJournal of Cardiothoracic Surgery1749-80902025-01-012011810.1186/s13019-024-03326-1Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registryMichael Schmoeckel0Matthias Thielmann1Keti Vitanova2Thomas Eberle3Nandor Marczin4Kambiz Hassan5Andreas Liebold6Sandra Lindstedt7Georg Mächler8Marijana Matejic-Spasic9Daniel Wendt10Efthymios N. Deliargyris11Robert F. Storey12Department of Cardiac Surgery, Klinikum Grosshadern, Ludwig-Maximilians-UniversityDepartment of Thoracic- and Cardiovascular Surgery, West German Heart and Vascular CenterDepartment of Cardiovascular Surgery, German Heart CentreAnesthiology & Intensive Care Medicine, MediClin Herzzentrum CoswigDepartment of Anaesthesia, Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Part of Guy’s and St Thomas’ NHS Foundation TrustDepartment of Cardiac Surgery, Asklepios Klinik St. GeorgDepartment of Cardiothoracic and Vascular Surgery, Ulm University Medical CenterDepartment of Cardiothoracic Surgery and Transplantation, Skåne University HospitalDepartment of Cardiac Surgery, Medical University GrazCytoSorbents Europe GmbHCytoSorbents Europe GmbHCytoSorbents Inc.Division of Clinical Medicine, University of SheffieldAbstract Objective Patients on direct-acting oral anticoagulants (DOACs) are at high risk of perioperative bleeding complications. Intraoperative hemoadsorption is a novel strategy to reduce perioperative bleeding in patients on DOACs undergoing non-deferable cardiac surgery. The international STAR-registry reports real-world clinical outcomes associated with this application. Methods The hemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit and active for the duration of the pump run. Patients on DOACs undergoing CABG and/or single valve surgery before completing the recommended washout were included. Outcome measurements included bleeding events according to standardized definitions and 24-hour chest-tube-drainage (CTD). Results A total of 62 patients were included from 7 institutions in Austria, Germany, Sweden, and the UK (mean age 69.9 ± 7.5years, 71% male). Approximately half were on apixaban and the other half was split between rivaroxaban and edoxaban with 21% of patients also on aspirin. Surgery occurred at a median time of 28.9 h since the last DOAC dose with single valve surgery accounting for 2/3 of cases. Mean CPB duration was 118.6 ± 46.4 min. Severe bleeding (UDPB ≥ 3) occurred in 4.8%, and BARC-4 bleeding occurred in 3.2% of the patients. Only one patient (1.6%) required reoperation for bleeding control. The mean 24-hour CTD was 771.3 ± 482.79mL. No device-related adverse events were reported. Conclusions This interim report of the ongoing STAR-registry shows that, in patients on DOAC undergoing non-deferable CABG and/or single valve surgery, the use of intraoperative hemoadsorption is associated with low rates of severe perioperative bleeding complications. Further prospective studies in larger cohorts are needed to validate the efficacy of this method. Clinical registration number ClinicalTrials.gov identifier: NCT05077124.https://doi.org/10.1186/s13019-024-03326-1HemoadsorptionAntithrombotic removalCardiac surgeryCytoSorbDOAC |
| spellingShingle | Michael Schmoeckel Matthias Thielmann Keti Vitanova Thomas Eberle Nandor Marczin Kambiz Hassan Andreas Liebold Sandra Lindstedt Georg Mächler Marijana Matejic-Spasic Daniel Wendt Efthymios N. Deliargyris Robert F. Storey Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry Journal of Cardiothoracic Surgery Hemoadsorption Antithrombotic removal Cardiac surgery CytoSorb DOAC |
| title | Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry |
| title_full | Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry |
| title_fullStr | Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry |
| title_full_unstemmed | Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry |
| title_short | Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry |
| title_sort | direct acting oral anticoagulant removal by intraoperative hemoadsorption in cabg and or single valve surgery interim analysis of the international safe and timely antithrombotic removal star registry |
| topic | Hemoadsorption Antithrombotic removal Cardiac surgery CytoSorb DOAC |
| url | https://doi.org/10.1186/s13019-024-03326-1 |
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