Incidence and predictors of pericardial effusion after permanent heart rhythm device implantation: prospective evaluation of 968 consecutive patients.

ABSTRACT

BACKGROUND: Pericardial effusion (PE) may complicate permanent heart rhythm device (HRD pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy) placement. Incidence of and risk factors for this complication have never been prospectively evaluated. METHODS AND RESULTS: The subjects of this prospective observational study were 968 consecutive patients undergoing HRD implantation or upgrade, and underwent echocardiographic evaluation before and 24h after the operation. PE was documented in 98 patients (10%), 14 (1.5%) of whom progressed to cardiac tamponade requiring pericardiocentesis (n=12; 86%) or surgical treatment (n=2; 14%). In 70% (10/14) of those patients a bloody effusion suggested cardiac perforation of an implanted lead; acute pericarditis was observed in the remaining 30% (4/14). At multivariate analysis, female gender (hazard ratio [HR], 2.7; 95% confidence interval [CI] 1.4-3.5, P=0.01) was predictive in the case of any post-procedural PE, whereas intake of antiplatelet medication (HR, 3.1; 95% CI 2.1-3.8, P=0.01) was predictive for cardiac tamponade. Previous cardiac surgery (HR, 0.70; 95% CI 0.50-0.92, P=0.02) was a protective factor in any PE and cardiac tamponade. None of the 84 patients with small or moderate PE required pericardial drainage. After 3.1±0.5 months, a PE was no longer observed at echocardiography in 71% of those patients. CONCLUSIONS: PE is frequently seen after HRD implantation, but rarely requires any therapy. Female gender and antiplatelet therapy are risk factors, whereas previous cardiac surgery was a protective factor.