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CLINICAL STUDIES

A randomized trial comparing heparin initiation 6 h or 24 h after pacemaker or defibrillator implantation

^a Division of Cardiology, Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, Michigan, USA

Manuscript received August 10, 1999; revised manuscript received December 16, 1999, accepted February 14, 2000.

Reprint requests and correspondence: Dr. Gregory F. Michaud, Division of Cardiology, University of Michigan Medical Center, 1500 E. Medical Center Dr., UH B1F227, Ann Arbor, Michigan 48109-0022
michaudg{at}umich.edu

OBJECTIVES

The purpose of this randomized study was to evaluate the prevalence of pocket hematomas in patients treated with heparin 6 h or 24 h after pacemaker or defibrillator implantation.

BACKGROUND

The risks of pocket hematoma and need for evacuation after device implantation have not been defined in patients who require anticoagulation.

METHODS

Forty-nine consecutive patients with an indication for anticoagulation with heparin after implantable defibrillator or pacemaker implantation were randomized to receive intravenous heparin either 6 h (n = 26) or 24 h (n = 23) postoperatively. Both groups also received warfarin on a daily basis starting the evening of surgery. Twenty-eight patients who received postoperative warfarin alone and 115 patients who did not receive anticoagulation were followed up in a study registry.

RESULTS

A pocket hematoma developed in 6 of 26 patients (22%) who were treated with intravenous heparin 6 h postoperatively, as compared with 4 of 23 patients (17%) who were treated with intravenous heparin 24 h postoperatively (p = 0.7). In total, a pocket hematoma developed in 10 of 49 patients (20%) treated with heparin, 1 of 28 patients (4%) treated with warfarin alone and 2 of 115 (2%) patients who received no anticoagulation (p < 0.001).

CONCLUSIONS

Intravenous heparin initiation 6 h or 24 h after pacemaker or defibrillator implantation is associated with a 20% prevalence of pocket hematoma formation. Warfarin therapy or no anticoagulation is associated with only a 2% to 4% risk of pocket hematoma formation.

Abbreviations and Acronyms   AF = atrial fibrillation   INR = international normalized ratio

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