Risk of hematoma complications after device implant in the clopidogrel era.
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.


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.
Kutinsky
Ilana B
IB
Department of Cardiovascular Medicine, William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, MI 48073, USA.
Jarandilla
Regina
R
Jewett
Maralee
M
Haines
David E
DE
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects*; D016009:Chi-Square Distribution; D000077144:Clopidogrel; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004554:Electric Countershock / Q000009:adverse effects* / Q000295:instrumentation; D005260:Female; D006406:Hematoma / Q000209:etiology*; D006493:Heparin / Q000009:adverse effects; D006801:Humans; D007902:Length of Stay; D016015:Logistic Models; D008297:Male; D008824:Michigan; D016017:Odds Ratio; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D006493:Heparin; D000077144:Clopidogrel; D013988:Ticlopidine