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  • br Management of warfarin during pacemaker

    2019-04-17


    Management of warfarin during pacemaker/implantable cardioverter defibrillator insertion Until recently, warfarin use was halted before PM/ICD insertion and the patient was bridged with intravenous (IV) unfractionated heparin or subcutaneous low-molecular-weight heparin (LMWH) if the thromboembolic risk was considered high (usually CHADS2 ≥3) [34–36]. This was usually performed by discontinuing warfarin use five days before the procedure and initiating IV heparin or LMWH 3 days before the procedure, once the INR decreased below 2; the procedure was usually performed when the INR was less than 1.5 and after halting IV heparin 4h prior to the procedure or after halting the last dose of LMWH 24h prior [36]. This process is marred by several difficulties and logistical issues. To start IV heparin, the patient must be a hospital inpatient for several days before the procedure. In addition, heparin requires frequent checking of the PTT with dose adjustments to ensure a therapeutic time; LMWH is less problematic in terms of monitoring, but still requires daily injections and CrCl above 30mL/min [34]. Sometimes, the INR does not decrease below 1.5 on the day of the procedure, leading to the administration of vitamin K to decrease the INR, which results in restoring the INR to the therapeutic range after post-procedural reinitiation of warfarin and a further increase in hospital stay. Furthermore, several studies that this bridging strategy leads to significantly increased rate of device-pocket hematoma, ranging from 17% to 31% [37]. A recent systematic review demonstrated that compared to no heparin, heparin bridging was associated with a combined odds ratio of 4.47 for the development of pocket hematoma and prolonged hospital stay [38]. The consequence of a device-pocket hematoma is substantial, including the need for a prolonged period of time off anticoagulation with a risk of thromboembolism, the need for further procedures to clear the hematoma, an increased risk of infection, and an increase in hospital stay; when a hematoma occurs, the increased risk of infection can be as much as 22-fold higher, as demonstrated in the REPLACE registry [39]. A major change has recently occurred in the management of warfarin during pacemaker insertion because of the results of the large trial, BRUISE CONTROL, in which 661 patients with an annual thromboembolism risk greater than 5% per year (CHADS2≥3) were randomized to continued warfarin therapy versus bridging therapy during elective pacemaker/ICD entacapone [10]. The trial was performed after several case series and smaller trials had shown a benefit to continued warfarin therapy and several centers had shifted their clinical practice to continued warfarin therapy; a meta-analysis of these trials showed a benefit of continued oral anticoagulation versus bridging in terms of reduced device-pocket hematoma and hematoma drainage/revision [37]. The aforementioned bridging strategy was used in this trial. The trial was stopped early because the results showing 16% of the bridging group to have clinically significant hematoma versus just 3.5% of the continued warfarin group [10]. Furthermore, there was significantly more hematoma causing prolonged hospitalization, hematoma requiring interruption of anticoagulation and hematoma requiring an evacuation [10]. This study represents the main body of evidence for switching to a continued warfarin strategy in those at higher risk of thromboembolism. An algorithm for the peri-procedural management of warfarin is shown in Fig. 1. To provide evidence on whether a bridging strategy is beneficial in high risk patients, the recent BRIDGE study randomized 1884 patients to bridging with initiation of low-molecular-weight heparin three days before the procedure versus no bridging. The study showed an incidence of arterial thromboembolism of 0.4% in the no-bridging group versus 0.3% in the bridging group (95% confidence interval [CI], −0.6 to 0.8; P=0.01 for noninferiority), while the incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20–0.78; P=0.005 for superiority) [40]. Several additional studies have shown an increased risk of bleeding with bridging [35,36]. Indeed, a recent meta-analysis showed that compared with heparin bridge, continued oral anticoagulation at the time of CIED surgery was associated with a significantly lower risk of postoperative bleeding (OR=0.25, 95% CI 0.17–0.36, P<0.0000), but there was no difference noted in the risk of thromboembolic events between the 2 strategies (OR=1.86, 95% CI 0.29–12.17, P=0.57) [41]. In addition, continued warfarin therapy is much more cost effective than bridging therapy [42]. When performing device surgery without interruption of warfarin, the INR should be checked 3–7 days prior to the procedure to provide time for dose adjustment, and then once more on the day of the procedure. The INR on the day of the procedure should be less than or equal to the upper limit of the therapeutic range prescribed for the patient, usually ≤3 (≤3.5 for some prosthetic heart valves) [25].