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Risk-Benefit of..

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Whether or not to bridge with a heparin based product or to continue therapeutic warfarin before surgery can be a challenging decision to make; clinicians must balance the patient’s risk for bleeding versus the development of a thromboembolic (TE) event. The current guidance by the American College of Chest Physicians (ACCP) provides a grade 2C recommendation that patients with mechanical heart valve, atrial fibrillation, or venous thromboembolism at high risk for TE should hold warfarin and receive bridge therapy with therapeutic doses of low molecular weight heparin (LMWH) or unfractioned heparin (UFH).1 However, this is an off-label use and is based mostly on observational studies. In patients at moderate risk for a TE event, the decision to bridge is dependent on patient and surgery-related factors.1 Patients on warfarin therapy requiring pacemaker or implantable cardioverter-defibrillator (ICD) surgery present a particular challenge to providers because of the high risk of hematoma development in the device pocket area, which can result in prolonged hospital stay or need for additional surgery. Trials have attempted to investigate the risks and benefits of continuing warfarin or utilizing bridge therapy in pacemaker or ICD surgery, but they have not been of adequate size to have conclusive results.2,3 With this ambiguity, the Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL) set out to evaluate the risks and benefits of continuing warfarin versus bridging therapy.4

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In this study, investigators randomized patients on warfarin who are at moderate-to-high risk (≥ 5%/year) for TE event and required non-emergency pacemaker or ICD surgery, defined as a new device insertion, pulse-generator change, replacement of lead(s), or pocket revision. Patients were excluded for inability to provide consent, history of heparin-induced thrombocytopenia, non-compliance, an active device infection, or current participation in another study.5 Qualified patients were randomized to continue warfarin (CW) or to bridge therapy (BT); patients in the BT group received either LWMH (89%), UFH (10.7%) or both (0.3%). The two groups were similar; average age 71, 89% with atrial flutter/fibrillation, 72% male, and 28% mechanical heart valve. Patients assigned to the CW group had a target INR less than or equal to the upper end of the therapeutic range (≤ 3 or 3.5) on the day of surgery. Patients in the BT group held warfarin 5 days prior to surgery and initiated UFH or LMWH therapy 3 days prior to procedure. The last dose for LWMH was given >24 hours prior and UFH at least 4 hours prior to surgery. Patients on aspirin (39%) and clopidogrel for bare-metal stents (BMS) placed <1 year or any drug-eluting stent (4.9%) continued therapy during the procedure. Clopidogrel for BMS placed >1 year (6.1%) was stopped 5 days prior to surgery. Heparin-based therapy was started 24 hours after surgery and continued until warfarin was therapeutic. The primary outcome was clinically significant device-pocket hematoma, defined as hematoma resulting in further surgery, prolonged hospitalization, or withholding anticoagulation therapy. Secondary outcomes included major perioperative bleeding, TE events, all-cause mortality, quality of life, perioperative pain, and patient satisfaction.4

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