Do novel anticoagulant agents increase the risk of perioperative complications during implantable cardiac rhythm device insertion?

Interactive CardioVascular and Thoracic Surgery, Jan 2017

A best evidence topic was written according to a structured protocol. The question addressed was ‘In patients requiring an implanted cardiac rhythm device, do novel oral anticoagulant agents lead to increased rates of peri-procedural complications?’ Altogether 1228 papers were found using the reported search, of which 5 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The novel oral anticoagulant agents (NOACs) assessed in the included studies were dabigatran (a direct thrombin inhibitor) and rivaroxaban (a Factor Xa inhibitor). Dabigatran was included in all five studies and showed bleeding complication rates of 0–4%. Rivaroxaban was included in one study and had bleeding complication rates of 4%. Warfarin was a comparator agent in three studies and had bleeding complication rates of 4.6–8%. The incidence rate of thromboembolic complications was 0–1% with dabigatran and 0% with rivaroxaban and warfarin in all studies. Based on the available studies, there is no evidence of significantly increased risk of bleeding or thromboembolic events with NOACs compared with warfarin when used at the time of cardiac rhythm device implantation. However, not all patients in the studies were actually receiving the specified NOAC at the time of device implantation, thereby limiting the available evidence.

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Do novel anticoagulant agents increase the risk of perioperative complications during implantable cardiac rhythm device insertion?

Interactive CardioVascular and Thoracic Surgery Do novel anticoagulant agents increase the risk of perioperative complications during implantable cardiac rhythm device insertion? Reece A. Davies 0 1 Nisal K. Perera 1 Yishay Orr 1 0 Faculty of Medicine, University of Sydney , Sydney , Australia 1 Department of Cardiothoracic Surgery, Westmead Hospital , Sydney , Australia A best evidence topic was written according to a structured protocol. The question addressed was 'In patients requiring an implanted cardiac rhythm device, do novel oral anticoagulant agents lead to increased rates of peri-procedural complications?' Altogether 1228 papers were found using the reported search, of which 5 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The novel oral anticoagulant agents (NOACs) assessed in the included studies were dabigatran (a direct thrombin inhibitor) and rivaroxaban (a Factor Xa inhibitor). Dabigatran was included in all five studies and showed bleeding complication rates of 0-4%. Rivaroxaban was included in one study and had bleeding complication rates of 4%. Warfarin was a comparator agent in three studies and had bleeding complication rates of 4.6-8%. The incidence rate of thromboembolic complications was 0-1% with dabigatran and 0% with rivaroxaban and warfarin in all studies. Based on the available studies, there is no evidence of significantly increased risk of bleeding or thromboembolic events with NOACs compared with warfarin when used at the time of cardiac rhythm device implantation. However, not all patients in the studies were actually receiving the specified NOAC at the time of device implantation, thereby limiting the available evidence. Cardiac pacemaker; Implantable defibrillator; Dabigatran; Rivaroxiban; Novel anticoagulant - A best evidence topic was written according to a structured protocol. This is fully described in the ICVTS [1]. regarding the risk of bleeding complications with continuation of NOACs at the time of cardiac rhythm device implantation. SEARCH STRATEGY THREE-PART QUESTION In [ patients requiring an implantable cardiac rhythm device] do [novel oral anticoagulant agents] lead to [increased rates of periprocedural complications]? The literature search was performed in Medline from 1950 to June 2016 using the PubMed interface. [Pacemaker OR pacing OR implant OR defibrillator OR resynchronisation] AND [NOAC OR Anticoagulant OR Factor Xa Inhibitor OR Antithrombin OR apixaban OR rivaroxaban OR dabigatran]. CLINICAL SCENARIO An 80-year old man is referred to you for consideration of a permanent pacemaker. He has paroxysmal atrial fibrillation and sinus node dysfunction and is on a novel oral anticoagulant (NOAC). Due to his history of diabetes, hypertension, previous stroke and consequently high CHADS2 score, the referring cardiologist wishes to maintain the patient on anticoagulation in the perioperative period. Recent studies have shown a decreased risk of bleeding complications with continued warfarin as opposed to heparin bridging [2, 3]. You decide to evaluate the available evidence Overall 1228 papers were identified using the reported search. From these, five papers were identified that provided the best evidence to answer the question (Table 1). Madan et al. [4] compared warfarin (86 patients) to interrupted dabigatran (47 patients) in patients undergoing surgery for © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. Best evidence papers Madan et al. (2016), Cardiovasc Diagn Ther, USA [4] Kosiuk et al. (2014), Circ J, Germany [5] 118 receiving dabigatran periprocedurally Device-related pocket haematomas 48 patients received uninterrupted dabigatran 14 patients received dabigatran withheld on the morning of the procedure 195 patients received uninterrupted warfarin (mean INR 1.82 ± 0.57) 93 patients received dabigatran periprocedurally 83 patients received rivaroxaban periprocedurally Rowley et al. (2013), Am J Cardiol, USA [8] 25 patients received dabigatran Time since last dabigatran dose preprocedure 14 patients (56%) had dabigatran withheld preprocedurally Thromboembolic complications Hb: haemoglobin; LoS: length of stay; IQR: interquartile range; h: hour(s). Major complication/mortality Device-related pocket haematoma Thromboembolic events Revision surgery for bleeding Hb change > 10% Thromboembolic events Length of hospital stay Thromboembolic complications Revision surgery for bleeding Thromboembolic events Length of hospital stay 3% in the dabigatran group versus 8% in the warfarin group (P = 0.075) 0% in the dabigatran group versus 1% in the warfarin group (P = 0.156) 5% in the dabigatran group versus 10% in the warfarin group (P = 0.092) 1% in the dabigatran group versus 0% in the warfarin (...truncated)


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Reece A. Davies, Nisal K. Perera, Yishay Orr. Do novel anticoagulant agents increase the risk of perioperative complications during implantable cardiac rhythm device insertion?, Interactive CardioVascular and Thoracic Surgery, 2017, pp. 126-128, 24/1, DOI: 10.1093/icvts/ivw282