Risk of hematoma complications after device implant in the clopidogrel era

Abstract

Background: Device implant pocket hematoma is a recognized complication after permanent pacemaker (PM) and implantable cardioverter-defibrillator (ICD) implantation. Pocket hematoma is associated with local discomfort, an increased risk of infection, and may require surgical intervention or lead to lengthier hospital stays. The purpose of the study was to identify the clinical factors associated with hematoma formation after PM or ICD device implantation.

Methods and results: The subjects of this prospective observational study were 935 consecutive patients at Beaumont Hospital who underwent implantation of a PM or an ICD. Clinical characteristics and anticoagulant/antiplatelet drug use were recorded. A pocket hematoma was documented in 89 of 935 patients. Significant predictors of device pocket hematoma included ongoing clopidogrel therapy (18.3% on therapy, 10.5% recently discontinued, and 7.9% off therapy; P<0.001) and use of intravenous heparin (22.0% on therapy versus 8.2%; P<0.0001). Patients in whom clopidogrel was discontinued >4 days before device implantation had no hematoma. Hematomas occur more frequently in patients receiving ICDs than those receiving PMs. Device pocket hematoma was associated with an increased median length of hospital stay (4 days [interquartile range, 1 to 9] days with versus 2 days [ interquartile range, 1 to 6] days without hematoma; P=0.004) and increased late complications or surgical intervention.

Conclusions: The use of clopidogrel or intravenous heparin significantly increased the risk of hematoma at the time of PM or ICD implantation. By withholding clopidogrel before surgery, the excess risk of bleeding complications may be reduced.