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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)